A transformative force in EHS
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Worldwide Environmental, Health and Safety Standards
August 2012
© 2002 Johnson & Johnson - All Rights Reserved TABLE OF CONTENTS
INTRODUCTION 3 DEFINITIONS 5 EHS STANDARDS 1. EHS Management System 15 2. Chemical Substances Management 27 3. Emergency Preparedness and Response 36 4. Contractor Management 41 5. Responsible External Supply Chain 45 6. Acquisitions and Divestitures 50 7. EHS by Design 53 8. External EHS Engagement 57 9. Air 59 10. Water and Wastewater Management 62 11. Waste Management 68 12. Tank System 74 13. Energy Management 79 14. Noise and Hearing Conservation 81 15. Biosafety 87 16. Radiation Safety 90 17. Employee Wellbeing 95 18. Occupational Health 99 19. Fall Prevention 103 20. Fire and Explosion Prevention 106 21. Process Safety Management 110 22. Machinery, Electrical, and Powered Industrial Vehicle Safety 139 23. Ergonomics 144 24. Control of Permit Required Work and Non Routine Activities 147 25. Fleet Safety 155 26. Warehouses & Storage Areas 184 27. Office Organizations 199 Appendix I Process Hazard Screening Tool 208 Appendix II Escalation Path of Serious EHS Incidents 211
WW EHS Standards 2 Version 7 August 2012 INTRODUCTION [TOC]
Throughout the world, there are a host of different environmental, health, and safety (EHS) regulations that apply to Johnson & Johnson (J&J) organizations. To ensure that all J&J organizations achieve and maintain a consistent and high level of EHS performance, a series of J&J standards, referred to as the Johnson & Johnson Worldwide Environmental, Health and Safety Standards, have been developed. These standards support Our Credo and the various J&J environmental, health, and safety policies. However, the J&J Worldwide EHS Standards may not meet all the specific requirements of the different local, regional, and national EHS regulations, law, and/or legislations. Therefore, each J&J organization is responsible for determining and complying with all applicable EHS regulatory requirements, in addition to meeting all applicable J&J Worldwide EHS Standards.
WHAT IS THE PURPOSE OF THE J&J WORLDWIDE EHS STANDARDS?
The purpose of these standards is to establish minimum management and operating standards to ensure the protection of our employees, community, and the environment. These standards also serve as the basis for the J&J Management Awareness and Action Review System (MAARS) self assessment and joint assessment program.
HOW WERE THE STANDARDS DEVELOPED?
J&J has had worldwide environmental standards since 1990 and safety & industrial hygiene standards since the 1980s. An initiative to combine and integrate the environmental, health, and safety standards began in early 2006. In addition to integration, the initiative called for the reduction of EHS requirements where doing so would not compromise proven and effective EHS practices. Reduction of requirements was achieved by focusing on what must be done and the intended outcome, and less prescription on how to accomplish it thus offering greater flexibility in implementation of solutions. This new set of EHS Standards was developed under the guidance of the J&J EHS Leadership Council.
The J&J Worldwide EHS Standards will be reviewed and updated, if applicable, every three years. More frequent revisions may be made, on an as needed basis. Any revisions to the standards will be published on August 1 of the year revisions are made.
HOW TO COMPLY WITH THESE STANDARDS?
First, identify which J&J Worldwide EHS standards are applicable to your operation. Read each standard chapter carefully and determine if your WW EHS Standards 3 Version 7 August 2012 organization does or does not comply with the Basic Responsibility and Minimum Required Elements. An easy way to determine this is to complete the Self- Assessment Checklist (questionnaire) posted on the Worldwide EHS website. If there are elements that your organization has not met, they shall be captured in your Management Action Plan (MAP) with corrective actions identified and promptly implemented. Contact Worldwide EHS for assistance on understanding and/or implementation of these standards, as well as request for deviation from a particular standard.
It is important to remember that in addition to complying with all applicable J&J Worldwide EHS standards, each organization must also comply with all applicable local, regional, and national EHS regulations.
WHERE TO OBTAIN ADDITIONAL INFORMATION AND/OR GUIDANCE?
Guidance documents and tools are available on the Worldwide EHS website, http://ehs.jnj.com/wwehs/compliance/standard_ehs/Pages/Standard_EHS.aspx
WW EHS Standards 4 Version 7 August 2012
DEFINITIONS [TOC] A B C D E F G H I J K L M N O P Q R S T U V W X Y Z [A] [back] Aboveground Tank A tank whose entire outer surface area (except for the bottom area if it sits on a concrete pad) is visible for inspection. The tank may be located within a vault, as long as the vault is not backfilled and can be entered for external inspections of the tank.
Accident An unplanned event causing death, occupational illness or disease, injury, or property and/or environmental damage or losses.
Accidental Release An accident or incident that results in the loss of a chemical or waste outside of normal containment structures into the air, water, soil or groundwater environment.
American Conference of Governmental Industrial Hygienists Threshold Limit Values ("ACGIH TLV") Airborne concentrations of substances, recommended by a private organization, under which it is believed that nearly all workers may be repeatedly exposed day after day without adverse health effects.
Active Ingredient (AI) A compound known to have pharmacological activity but does not have an API claim.
Active Pharmaceutical Ingredient (API) Any substance or mixture of substances intended to be used in the manufacture of a drug (medicinal) product and that, when used in the production of a drug, becomes an active ingredient of the drug product. Such substances are intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure and function of the body.
Adjusted Noise Reduction Rating (NRR), Standardized Noise Reduction (SNR), or equivalent The published scientific literature indicates that laboratory-obtained real ear attenuation for hearing protectors can seldom be achieved in the workplace. Therefore, the corrected noise reduction obtained by hearing protection is equivalent to the Estimated Exposure (dBA) = TWA (dBA) - (NRR - 7)
Example: TWA=100 dBA, muff NRR=19 dB Estimated Exposure = 100 - (19-7) = 88 dBA
WW EHS Standards 5 Version 7 August 2012 Administrative Control A work practice modification that either reduces employee exposure to a contaminant directly, such as handling solutions instead of powders, or indirectly, such as working in a contaminated atmosphere for 4 hours instead of 8 hours.
Aspect Element of an organization’s activities, processes, products, and/or services that can interact with the environment.
[B] [back] Backflow The flow of water or other liquids, mixtures, or substances into the distribution pipes of a potable supply of water from any source(s) other than its intended source. Backsiphonage is a type of backflow.
Backsiphonage Backflow resulting from negative pressures in the distribution pipes of a potable water supply.
Biological Waste Biological Wastes include: • All cultures and stocks of infectious agents and associated biologicals • Blood and body fluids containing visible blood • Semen and vaginal secretions • Unfixed human tissues or organs, other than intact skin • The following human body fluids: cerebrospinal, synovial, pleural, breast milk, peritoneal, pericardial, amniotic • Human pathological wastes
• All carcasses, body parts and bedding of animals known to have been exposed to infectious agents • All disposable items contaminated by the above-mentioned materials • All sharps (including hypodermic needles, syringes, Pasteur pipettes, microscope slides, culture dishes, and scalpel blades), used and unused • A material that is non-infectious, but to the lay person may appear to have been exposed to infectious agents or been generated by a health care facility Excluded from this category are feces, nasal secretions, sputum, sweat, tears, urine, and vomitus unless they contain visible blood.
Bloodborne Pathogens Pathogenic microorganisms that are present in human blood and can cause disease in humans. These pathogens include, but are not limited to hepatitis B virus (HBV), hepatitis C virus (HCV) and human immunodeficiency virus (HIV).
Business Critical Supplier A supplier that is critical to the business of a J&J organization, as determined by the J&J organization.
WW EHS Standards 6 Version 7 August 2012 [C] [back] Confined Space A confined space has three characteristics: it is large enough and so configured that an employee can partly or complete bodily enter and perform assigned work; AND has limited or restricted means for entry or exit; AND is not designed for continuous employee occupancy.
Contractor Individual(s) and/or a company who, in pursuit of independent business, undertakes to perform a job, piece of work, or service at a J&J facility, under their own supervision, after a contract including conditions has been established. The term and related requirements for contractor are also applicable to sub-contractors.
Control Devices (for Air Emissions) Devices that are intended to reduce or control air pollutant emissions. Examples include granular activated carbon filters, dust collector systems (baghouses), high efficiency particulate apparatus (HEPA) filters, cyclone separators, incinerators, and scrubbers.
Corrosive Liquid For the purpose of sewer testing, corrosive liquid is defined as any liquid with a pH less than 6.0 and more than 9.0 S.U.
Cross Connection Any actual or potential connection between the drinking water supply system and a source of contamination or pollution.
[D] [back] Day Tank A stationary tank (500 gallons [1,893 liters] or smaller) that provides fuel to an emergency generator or fire-water pump as a primary or secondary source of fuel. For the purpose of the J&J Worldwide EHS Standards, tanks that are connected to a larger fuel storage tank do not meet the definition of a day tank.
Document Information and its supporting medium. The medium can be paper and/or electronic.
[E] [back] EDGE2 J&J web-based Enterprise Data Gathering Engine (EDGE²) for reporting and collection of EHS performance data.
Engineering Control Physical changes, that may include a design modification or installation, to work stations, equipment, materials, production facilities or other relevant aspects of the work environment, which reduces or prevents exposure to workplace risk factors. WW EHS Standards 7 Version 7 August 2012 Examples include fume hoods and local exhaust ventilation.
External Manufacturer A supplier that provides an active pharmaceutical ingredient (API) and/or finished goods with the J&J logo on the label.
[F] [back] First Aid Refer to the Injury/Illness Recordkeeping/Recording Guideline
Fugitive Emissions
Air emissions that originate from sources that are technically infeasible to control and that emit directly into the environment. Examples include: leaks from process equipment, chemical transfer operations, liquid-filling lines, welding operations, and battery chargers and parts.
[H] [back] Hazard Property of a substance, source or physical situation with a potential for creating damage to human health, environment, and/or property.
Hazard Identification The process of recognizing that a hazard exists and defining its characteristics.
Hazardous Chemical Any chemical which is a physical hazard or a health hazard: Physical Hazard: A chemical for which there is scientifically valid evidence that it is: • a combustible liquid • a compressed gas • a corrosive material • explosive
• a flammable liquid • an organic peroxide • an oxidizer • pyrophoric • unstable (reactive) • water-reactive. Health Hazard: A chemical for which there is scientifically valid evidence that acute or chronic health effects may occur in exposed humans or animals. The term health hazard includes chemicals that are: • carcinogens • toxic or highly (acutely) toxic.
Hazardous Non-Routine Work at Height Control Process The process used to establish and communicate safe work methods for situations
WW EHS Standards 8 Version 7 August 2012 involving hazardous non-routine work at heights.
Hazardous Waste This is as defined by local regulations or laws. In the absence of an applicable law or regulation, hazardous waste is any discarded hazardous chemical. Note: Wastes which contain heavy metals such as arsenic, barium, cadmium, chromium, lead, mercury, selenium, and silver fall into the hazardous waste category, if heavy metals can be leached out of the waste material under mildly corrosive conditions.
High Inertia Equipment Machinery that continues to have motion and a potentially hazardous condition for a period of time after the power source has been disconnected from the incoming electrical utility by way of electrical or mechanical means.
Hot Work Any work that could create sparks, utilizes open flame, or generates other ignition forms in areas where flammable or combustible materials may be present.
Hot Work Control Process The process used to establish safe working procedures whenever activities may generate sparks, utilize open flame, or generate other forms of ignition sources, outside dedicated areas or under specific conditions, in areas where flammable or combustible materials may be present.
[I] [back] Immediately Dangerous to Life or Health (IDLH) Any condition or activity that poses an immediate or delayed threat to life or that would cause irreversible adverse health effects or that would interfere with an individual’s ability to escape unaided from a PRCS.
Incident An unplanned occurrence that interrupts normal operations and has the potential to lead to an accident.
Incident Report The notification submitted in EDGE2 (J&J web-based tool) by an organization within 72 hours of its knowledge of a reportable incident listed in Section 1.4.8.
Isolated Pharmaceutical Intermediate (IPI) A chemical produced and isolated in the synthesis of an API that must undergo further molecular change or processing and to which exposure to workers is possible. This may include solid, wet cakes, and liquids.
[L] [back] Life Transitions Significant changes in life, e.g., death, divorce, birth of a child, relocation, etc. Life transitions are usually associated with stress and are often not by choice versus
WW EHS Standards 9 Version 7 August 2012 lifestyle that connotes choice.
Lost Work Day Case (LWDC) An injury where an employee has been absent for at least one full day, in addition to the day on which the injury occurred.
Low-Level Radioactive Waste Any waste material containing radioactive constituents and which is not classified as high-level radioactive waste, transuranic waste, spent nuclear fuel, spent Cobalt-60 irradiator, or by-product material.
[M] [back] Machine Safety Category Based on EN954-1996, safety related parts of control circuits are defined in 5 categories. The selection of the category is based on a risk assessment and each of the categories imposes specific requirements on the architecture, components and usage.
Management Action Plan (MAP) A tool for tracking corrective action that includes a description of the deficiencies, action steps, responsible person(s), target completion dates, business impact, and current status.
Management Awareness and Action Review System (MAARS) A J&J global process for identification and elimination of EHS risks.
[N] [back] Non-Hazardous Waste Wastes that do not meet any of the criteria for a hazardous waste, biological waste, or low-level radioactive waste.
Non-Routine Activity A task/activity that was never or seldom before conducted and includes hazards that can result in significant adverse effects. Examples include, but not limited to, crane work, excavations, erecting and working on scaffolds, modifications or significant repairs to existing roofs, live electrical work, line braking, etc.
[O] [back] Occupational Exposure Limits (OELs) An airborne limit concentration of a substance. It is usually averaged over a reference period (normally 8 hours) at which, according to current knowledge, there is no evidence that it is likely to be injurious to employees if they are exposed by inhalation, day after day, to that concentration. Ozone Depleting Substances (ODS) Substances identified by the Montreal Protocol on Substance that Deplete the Ozone (1987) and subsequent amendments, which include chlorofluorocarbons (CFCs), Halons, carbon tetrachloride, methyl chloroform, methyl bromide and WW EHS Standards 10 Version 7 August 2012 hydrochlorofluorocarbons (HCFCs).
[P] [back] Permit Required Confined Space (PRCS) A confined space with one or more of the following characteristics: • Contains or has the potential to contain a hazardous atmosphere that results in: – oxygen deficiency (oxygen content below 19.5 percent); – oxygen enrichment (oxygen content above 23.5 percent); – flammable/explosive gas, vapor, or mist concentrations exceeding 10% of the lower flammable limit (LFL), or airborne combustible dust at a concentration that exceeds its LFL; – toxic chemicals at a concentration at or above the Threshold Limit Values (TLV), Occupational Exposure Limits (OEL) or local regulatory limits, whichever are more stringent; • Contains a material that could potentially engulf an entrant; • Has an internal configuration that could trap or asphyxiate an entrant such as inwardly converging walls or a floor that slopes downward and tapers to a smaller cross-section; • Contains any other serious safety or health hazard, including physical, electrical, mechanical, chemical, biological, radiological, thermal, and structural hazards.
Permit Required Confined Space Control Process The process used to establish safe work procedures for entering and performing work in, near, or around PRCSs when they are accessed or about to be accessed.
Personal Protective Equipment (PPE) Equipment designed to protect individuals from hazardous agents, e.g., gloves, eye protection, respirators, ear plugs, ear muffs, etc.
Piping For the purpose of sewer testing, piping is defined as wastewater collection and conveyance system that are within or beyond building boundaries with 6-inch (15- cm) diameter or smaller.
Polychlorinated Biphenyls (PCBs) Any chemical substance that is limited to the biphenyl molecule that has been chlorinated to varying degrees or any combination of substances that contains such molecule. This includes, but is not limited to, fluids sold under the following trade names: Arachlor, Arochlor, Abestol, Asbestol, Askarel, Chlorextol, Chlorinal, Chlorophen, Diaclor, Dk, Dykanol, Elemex, Eucarel, Hyvol, Intereen, Kennechlor, Penclor, Phenoclor, Pyralene, Pyranol, Pyraul, Pyroclor, Pyrolene, Saf-T-Kuhl, Sanotherm, and Therminol.
Powered Industrial Vehicle (PIV) Any mobile power-propelled truck, such as fork vehicles, tractors, platform lift vehicles, etc., used to carry, push, pull, lift, stack or tier materials. Powered Industrial Vehicles can be ridden or controlled by a walking operator. Earth moving WW EHS Standards 11 Version 7 August 2012 and over the road haulage trucks are not included in the definition. Equipment that was designed to move earth but has been modified to accept forks are also not included.
Process Hazard Analysis (PHA) An organized and systematic process to identify, evaluate and control the risks associated with potential process hazards inherent to process operations or which may evolve with changes to the existing process operations.
Process Tank Any vessel used for process unit operations, such as mixing, chemical reactions, heat transfer, evaporations, distillations, leaching and extractions, gas absorption, drying of solids, crystallization, or mechanical separation. For the purposes of these standards, a ‘Process Tank’ is not a “Storage Tank”.
Process Wastewater Any wastewater stream that is other than domestic sewage or uncontaminated non-contact cooling water or stormwater runoff.
[Q] [back] Qualitative Exposure Assessment An assessment of a worker’s potential exposure to environmental agents based on the integration of information and judgment, rather than quantitative data. The purpose of the qualitative exposure assessment is to develop a baseline sampling plan.
[R] [back] “Reach in Protection” A restrictive barrier between the operator’s hands, at typical operating position, and the hazardous component/danger zone (i.e. cutting tool) on manually operated shop tools. This may not provide protection from the sides, back, or top of the working area as required by equipment that needs to be Zero Access™ compliant.
Record Document stating results achieved or providing evidence of activities performed.
Recordable Case
Refer to the Injury/Illness Recordkeeping/Recording Guideline
Refrigerant A substance that produces a refrigerating effect while expanding or vaporizing. Examples of types of refrigerants include chlorofluorocarbons (CFCs, not permitted for use by J&J), hydrochlorofluorocarbons (HCFCs), hydrofluorocarbons (HFCs), ammonia, propane, carbon dioxide, and others. Examples of their applications include freezers, walk-in cold boxes, comfort cooling, and chillers. Their use may require sophisticated leak detection and response capabilities and their management and release may be subject to local, national, and/or international WW EHS Standards 12 Version 7 August 2012 environmental regulations or treaties.
Restricted Work Activity Refer to the Injury/Illness Recordkeeping/Recording Guideline
Risk The likelihood of injury, damage or loss, expressed as a function of hazard and exposure.
Risk Assessment The overall process of estimating the probability and magnitude of the risk, and then determining whether or not the risk is tolerable.
Risk Groups for Biosafety Four classification groups summarize and communicate the outcome of the risk assessment process performed on a microorganism or other material of biological origin. The Risk Group assignment is a relative ranking with the least hazardous biological agents and materials assigned to Risk Group 1, and those that pose the greatest hazard are assigned to Risk Group 4.
[S] [back] Secondary Containment An impervious structure that is designed to contain all leaks and spills and has a minimum capacity equal to 110 percent of the capacity of the largest container stored within.
Serious Injury & Illness Case (SIIC) An Injury or illness that has a major impact or effect on the health of the employee. Refer to the Injury/Illness Recordkeeping/Recording Guideline
Scenario An outline of a hypothesized chain of events.
Sewers
For the purpose of the sewer integrity testing, sewers are defined as wastewater collection and conveyance systems that are beyond building boundaries with 6- inch (15-cm) diameters or larger.
Similar Exposure Group (SEG) A group of workers having the same general exposure profile for the agent(s) being studied because of similarity and frequency of tasks they perform, the materials and processes with which they work, and the similarity of the way they perform the tasks.
Storage Tank Any vessel used for the storage of a liquid. For the purpose of the J&J Worldwide EHS Standards, the following types of storage tanks are not included in the
WW EHS Standards 13 Version 7 August 2012 program: • Propane (LPG), ethylene oxide, and hydrogen storage tanks; • Clean water storage tanks, e.g. clean process water, deionized water, or fire sprinkler system water; • Nitrogen, carbon dioxide, liquid oxygen, and inert gas storage tanks; • Storage tanks or sumps that are used for the collection of spills from secondary containment systems, for cooling tower storage, or for transformer containment; • Storage tanks or sumps used as septic systems with or without leach fields or for storage of sanitary wastes, or those that are part of a secondary wastewater treatment plant; • Hydraulic oil storage tanks integral to hydraulic power transmission systems.
Sumps Containers, usually constructed of concrete, located underground or inground and used for the temporary holding of wastewater or spilled/leaked liquids.
Supplier Any non-J&J company that provides goods or services.
[T] [back] Tank System The tank and all associated equipment (such as piping, fill pipe areas, vents, and pumps).
[U] [back] Underground Tank A tank that is located in the ground and its outer surface area is not visible for inspection.
Used Containers Any empty shipping containers that formerly contained a chemical or petroleum product that may or may not be hazardous. These containers are considered contaminated until they are purposefully decontaminated.
[W] [back] Waste Any material intended to be discarded or required to be discarded. Wastes are classified according to its origin (i.e., process) and based on hazardous characteristics as either hazardous or non-hazardous waste. It can be a solid, semi-solid, liquid or contained gas.
WRAPS (Worldwide Risk Assessment Process Software) A software tool developed by J&J for conducting detailed machinery hazard identification and risk evaluation during the design and/or acceptance process for machinery that shall be compliant with the J&J Zero Access™ Policy, J&J 7 Standards, or local legal requirements (US and EU).
WW EHS Standards 14 Version 7 August 2012 1. EHS MANAGEMENT SYSTEM [TOC]
BASIC RESPONSIBILITY
The organization shall establish, document, implement, maintain, and continually improve an environmental, health & safety (EHS) management system(s) to fulfill its EHS policy(s) and meet other applicable J&J EHS standards, as well as all applicable regulatory requirements.
MINIMUM REQUIRED ELEMENTS
1.1 Policy
1.2 Planning • Aspects/Hazards and Impacts/Risks • Regulatory Compliance • Objectives and Targets
1.3 Implementation and Operation • Resources, Roles, Responsibility and Authority • Competence, Training and Awareness • Communication and Consultation • Documentation • Control of Documents • Operational Control
1.4 Checking • Monitoring and Measurement • Nonconformity, Corrective and Preventive Actions • J&J Corporate Reporting • Control of Records • Management Awareness and Action Review System (MAARS) Self- Assessment
1.5 Management Review
1.6 Third-Party Certification of Management System
WW EHS Standards 15 Version 7 August 2012 1.1 Policy
1.1.1 Top management shall define and sign the organization’s environmental, health & safety (EHS) policy(s) that:
• Is appropriate to the nature, scale and EHS impacts and risks of its activities, products and services;
• Includes a commitment to prevention of pollution, creation of a safe and healthy work environment, encouragement of healthy lifestyles, and continual improvement;
• Includes a commitment to comply with applicable regulatory requirements and with other requirements to which the organization subscribes that relate to its EHS aspects and hazards;
• Provides the framework for setting, reviewing, and evaluating progress toward achieving its EHS, Healthy People, and Sustainability objectives and targets;
• Is documented, implemented, maintained;
• Is communicated and readily accessible to all persons working for or on behalf of the organization; and,
• Is available to the public.
1.2 Planning
Aspects/Hazards and Impacts/Risks
1.2.1 The organization shall establish, implement, and maintain a documented process to systematically:
• Identify and assess the EHS aspects and hazards of its activities, processes, products and services over which it has control and influence, taking into account planned or new developments, or new or modified activities, processes, products, and services; and,
• Determine those aspects that have or can have significant impact(s) on the environment and the hazards that pose or can pose a risk(s) to the health & safety of its employees, including behaviors that can put employees, contractors, visitors, and/or the environment at risk.
1.2.2 Information regarding the organization’s EHS aspects & hazards and impacts & risks shall be documented and maintained up to date.
WW EHS Standards 16 Version 7 August 2012 Regulatory Compliance
1.2.3 The organization shall establish, implement, and maintain a documented process to identify and evaluate compliance with all applicable EHS and workplace health regulatory requirements. This includes compliance with hazardous material transportation regulations, and, where applicable, regulations pertaining to the physical security of hazardous materials.
1.2.4 A matrix (list) of EHS laws and/or regulations that are applicable to the organization’s activities, processes, products, packaging and services shall be established and maintained up to date.
1.2.5 An inventory of EHS permits that have been issued by regulatory agencies to the organization shall be established and maintained up to date.
1.2.6 A tracking and alert system to ensure timely execution of routine activities in accordance with EHS regulatory requirements (i.e. collection of samples, submission of reports, permit renewals, employee training, medical surveillance evaluations, occupational injury/illness investigation and follow-up, etc) shall be established, implemented, and maintained.
1.2.7 The organization shall conduct and document EHS regulatory compliance audit(s) of its operations, products, packaging, and services on an annual basis. At least once every three years, the regulatory compliance audit(s) shall be conducted by an independent and qualified EHS consulting organization(s). Where applicable and to be fully implemented by December 31, 2012, the audits shall cover product stewardship regulations including, but not limited to, REACH (Registration, Evaluation, Authorization and Restriction of Chemicals), RoHS (Restriction of Hazardous Substances), WEEE (Waste Electronic, Electrical Equipment), Packaging and EPR (Extended Producer Responsibility) type of regulations.
1.2.8 All identified regulatory non-compliance issues that can not be corrected immediately shall be incorporated into the organization’s Management Action Plan (MAP) for follow-up. Appropriate corrective actions shall be initiated immediately and a state of compliance shall be returned as soon as possible.
1.2.9 The organization shall establish, implement, and maintain a documented procedure to be followed during an inspection by or inquiry from a regulatory agency.
Objectives and Targets
1.2.10 The organization shall establish, implement, and maintain documented EHS and healthy employee objectives and targets, that are measurable and consistent with its EHS policy(s), at relevant functions and levels within the organization, including activity-related (behavioral) objectives for all employees.
WW EHS Standards 17 Version 7 August 2012 1.2.11 A process for achieving the organization’s EHS and healthy employee objectives and targets shall be established, implemented, and maintained, including:
• Identification of personnel responsible for achieving objectives and targets at each relevant function and level of the organization; and,
• The means (for example, financial, physical, or human resources) and time frame by which they are to be achieved.
1.3 Implementation and Operation
Resources, Roles, Responsibility and Authority
1.3.1 Management at each organization shall ensure the availability of resources essential to establish, implement, maintain and continually improve its EHS management system(s) through system based ownership programs or similar leadership engagement programs.
1.3.2 Roles, responsibilities and authorities shall be defined, documented, and communicated in order to facilitate effective EHS management, including the expectation that management will support and promote the importance of safe and environmentally conscious behaviors in the performance of all work.
1.3.3 The organization shall ensure that it has access to sufficient competent Occupational Health providers appropriate to the site risks and that any on or off site clinics used are adequately equipped and meet appropriate standards. All external health providers shall have agreed levels of service which are tracked and monitored.
1.3.4 Top management shall appoint (a) specific EHS management representative(s) with the authority and responsibility for:
• Ensuring that the organization’s EHS management system(s) is established, implemented, maintained and periodically evaluated; and,
• Reporting to top management on the performance of the organization’s EHS management system(s), including recommendations for improvement.
Competence, Training and Awareness
1.3.5 The organization shall ensure and retain associated records that all person(s) performing tasks for it or on its behalf that have the potential to cause a significant EHS impact and/or risk:
WW EHS Standards 18 Version 7 August 2012 • Are competent on the basis of appropriate education, training and/or experience; and,
• Receive appropriate ongoing training on regulatory requirements, knowledge and skills that are pertinent to the assigned job functions and responsibilities.
1.3.6 Newly hired or appointed EHS staff shall receive training on J&J EHS standards and pertinent regulatory requirements as soon as possible, but no later than 3 months after assuming responsibilities.
1.3.7 The organization shall establish, implement, and maintain a documented training program to ensure person(s) working for it or on its behalf on-site are adequately informed of:
• The importance of conformity with its EHS policy(s) and procedures and with the requirements of the organization’s EHS management system(s);
• The significant EHS impacts & risks, actual or potential, of their work activities and the benefits of improved personal performance;
• Their roles and responsibilities in achieving conformity with the requirements of the organization’s EHS management system(s), including emergency preparedness and response requirements; and,
• The potential consequences of departure from specified operating procedures.
1.3.8 Management shall promote employees’ understanding of their health risks by developing an awareness of their health status and encouraging proactive maintenance of optimum health and safety, both on and off the job.
Communication and Consultation
1.3.9 The organization shall establish, implement, and maintain a documented procedure(s) for:
• Internal communication among various functions and levels of the organization, including contractors and visitors; this shall include a hazard assessment report to be communicated among EHS, Global Health, production management and any other appropriate parties; and,
• Receiving, documenting, and responding to relevant communications from external interested parties.
WW EHS Standards 19 Version 7 August 2012 1.3.10 If the organization made a decision to communicate externally about its significant EHS aspects and hazards, it shall establish and implement a method for this external communication.
1.3.11 The organization shall establish, implement, and maintain a documented process for consulting with employees and other interested parties regarding pertinent EHS information:
• In the development and review of policies, procedures and objectives to manage EHS impacts and risks relevant to their own activities; and,
• When there are any changes that affect workplace EHS, such as the introduction of new or modified equipment, materials, chemicals, technologies, processes, procedures, jobs and tasks.
Documentation
1.3.12 The organization shall maintain documentation that includes:
• Its EHS policy(s), objectives and targets;
• Description of the scope of its EHS management system(s);
• Description of the main elements of the EHS management system and their interaction, and reference to related documents;
• Documents, including records that are necessary to ensure the effective planning, operation and control of processes that relate to its significant EHS aspects and hazards; and,
• Documents that support compliance with applicable EHS regulatory requirements. These shall include, but are not limited to, hazard assessment and communication, risk and exposure assessment, exposure control, employee training records, injury/illness recordkeeping/documentation, and medical surveillance documentation.
Control of Documents
1.3.13 The organization shall establish, implement, and maintain a procedure(s) to:
• Approve EHS documents for adequacy prior to issue;
• Review and update as necessary and re-approve documents;
WW EHS Standards 20 Version 7 August 2012 • Ensure that changes and the current revision status of documents are identified;
• Ensure that relevant versions of applicable documents are available at points of use;
• Ensure that documents remain legible and readily identifiable;
• Ensure that documents of external origin necessary for the planning and operation of the EHS management system(s) are identified and their distribution controlled;
• Ensure the privacy and confidentiality of employee health records in compliance with J&J requirements and applicable regulations;
• Prevent the unintended use of obsolete documents and apply suitable identification to them if they are retained for any purpose; and,
• Retain documents according to their specified retention period.
Operational Control
1.3.14 The organization shall establish, implement, and maintain a documented process that stipulates operating criteria to control situations where their absence could lead to deviation from the EHS policy(s), objectives and targets. The operating criteria shall be based on a hierarchy of controls emphasizing process and engineering controls.
1.3.15 The organization shall establish an administrative process to manage the establishment, implementation, and maintenance of appropriate EHS rules and procedures.
1.3.16 The organization shall establish, implement, and maintain a documented procedure(s) related to the identified significant EHS aspects and hazards of goods and services used by the organization and communicating applicable procedures and requirements to suppliers, including contractors.
1.4 Checking
Monitoring and Measurement
1.4.1 The organization shall establish, implement, and maintain a documented procedure(s) to monitor and measure, on a regular basis, the key characteristics of its operations and activities that can have a significant EHS impact and/or risk.
WW EHS Standards 21 Version 7 August 2012 1.4.2 The monitoring and measurement procedure(s) shall include the documenting of information to monitor performance, applicable operations controls, and conformity with the organization’s EHS objectives and targets.
1.4.3 Monitoring and measurement equipment shall be calibrated and maintained to manufacturer specification, and the associated records shall be retained.
1.4.4 The organization shall establish, implement, and maintain a documented process to collect and validate data for reporting on J&J worldwide EHS goals (e.g. Healthy Future 2015 Goals).
Nonconformity, Corrective and Preventive Actions
1.4.5 The organization shall establish, implement, and maintain a documented procedure(s) for dealing with actual and potential nonconformity and for taking corrective action and preventive action, defining requirements for:
• Identifying nonconformity;
• Investigating nonconformity and determining the root cause;
• Taking appropriate actions to mitigate immediate EHS impacts and prevent recurrence of the nonconformity;
• Incorporating the corrective action(s) and/or preventive action(s) into the organization’s Management Action Plan (MAP); and,
• Reviewing the effectiveness of corrective and/or preventive action taken and evaluating the need to revise the EHS management system.
1.4.6 If the organization has soil and/or groundwater contamination on its property, it shall establish, implement, and maintain a remediation strategy that is protective of human health/safety and the environment, as well as in compliance with all applicable regulatory requirements.
Johnson & Johnson Corporate Reporting
1.4.7 The organization shall establish, implement, and maintain a documented procedure(s) for submitting required corporate reports according to their respective schedule to Worldwide EHS (refer to EHS Reporting Calendar posted on Worldwide EHS website).
1.4.8 An Incident Report shall be submitted in EDGE2 to notify Worldwide EHS within 72 hours of the organization’s knowledge of the following:
WW EHS Standards 22 Version 7 August 2012 • A J&J Lost Workday and/or Serious Injury/Illness Case for an employee, temporary worker, or contractor (including sub-contractor);
• An accidental release to the environment;
• An environmental, health and/or safety regulatory non-compliance that becomes part of public record or the enforcement history of the site, either as a result of self notification to regulators, written notification from regulators, or community complaints to the news media or regulators;
• Any significant risk or exposure that could lead to an adverse regulatory action or media coverage;
• A serious EHS incident that occurred at a “high priority supplier” or third party warehouse, including work-related fatality, major spill/release (that results in significant environmental damage, e.g. fish kill or community impact), or any EHS incident that is likely to receive media attention or result in cessation of operations;
• A suspension or revocation of the organization’s ISO 14001 certification; or
• A critical corrective action in the site’s Management Action Plan that missed the initial target completion date.
1.4.9 The organization shall ensure that serious EHS events/risks are escalated up J&J management per the Escalation Path in Appendix II. Incidents that shall be escalated include:
J&J Organization
• Work-related fatality of an employee, temporary worker, or contractor (including sub-contractor);
• Amputation;
• Major spill/release (that results in significant environmental damage, e.g. fish kill or local community impact);
• Knowledge of possible major fine (i.e. >US$50K);
• Hospitalization of an employee, temporary worker, or contractor (including sub-contractor) for a significant period of time (>3 days) as a result of a work-related injury or illness;
WW EHS Standards 23 Version 7 August 2012 • Hospitalization of 2 or more employees, temporary workers, or contractors (including sub-contractors) as a result of a single work- related event;
• Fire resulting in loss of life or hospitalization per the criteria above; or,
• Any EHS incident that results in media attention or cessation of operations.
J&J High Priority Supplier
• Work-related fatality;
• Major spill/release (that results in significant environmental damage, e.g. fish kill or community impact); or,
• Any EHS incident that is likely to receive media attention or result in cessation of operations.
1.4.10 The organization shall conduct and document a thorough investigation using the J&J tool, Learning to Look, or an equivalent tool, to determine the root cause(s) of each reported incident. Appropriate action shall be taken immediately to mitigate the EHS impact and effective corrective action shall be implemented to prevent a recurrence. This same process is also recommended for significant near-misses.
Control of Records
1.4.11 The organization shall establish, implement, and maintain a documented procedure(s) for the identification, storage, protection, retrieval, retention and disposal of EHS records.
1.4.12 Records shall be and remain legible, identifiable, and traceable.
Management Awareness and Action Review System (MAARS) Self-Assessment
1.4.13 The organization shall establish, implement, and maintain a procedure(s) for conducting, at a minimum, an annual Management Awareness and Action Review System (MAARS) self-assessment that includes an audit of its EHS management system(s).
1.4.14 The procedure(s) shall include the following:
• Assignment of responsibilities, taking into consideration the required skills of the responsible person;
WW EHS Standards 24 Version 7 August 2012 • Clear definition of the audit scope, criteria, frequency, and methods; and,
• Selection of auditors and conduct of audits that ensure objectivity and the impartiality of the audit process.
1.4.15 A Management Action Plan (MAP) shall be developed listing all the non- conformance issues that are identified and the appropriate corrective actions.
1.4.16 At defined time intervals, the organization shall participate in a joint assessment with representative(s) of Worldwide EHS and Global Health Services to verify its self-assessment results.
1.5 Management Review
1.5.1 Top management of each organization shall establish, implement, and maintain a schedule, at least semi-annually, to review the organization’s EHS management system(s) to ensure its continuing suitability, adequacy, and effectiveness.
1.5.2 Input to the management reviews shall include:
• Results of MAARS self/joint assessments and regulatory audits; • Communication(s) from external interested parties, including complaints, if any;
• EHS performance of the organization;
• Global Health performance, including progress towards healthy employee goals;
• Extent to which EHS functional, behavioral and technical objectives and targets have been met;
• Status of corrective and preventive actions;
• Follow-up actions from previous management reviews;
• Changing circumstances, including organizational changes and developments in regulatory and other requirements related to its EHS aspects; and,
• Recommendations for improvement.
1.5.3 Outputs from management reviews shall include any decisions and actions related to possible changes to EHS policy(s), objectives, targets and
WW EHS Standards 25 Version 7 August 2012 other elements of the EHS management system(s), consistent with the commitment to continual improvement.
1.5.4 If the management reviews in 1.5.1 are not inclusive of the organization’s Management Board, a summary review shall also be conducted with the Management Board on a semi-annual schedule.
1.5.5 Records of the management reviews shall be retained.
1.6 Third-Party Certification of Management System
1.6.1 All major manufacturing and Research & Development organizations shall obtain and maintain third-party certification to ISO 14001.
WW EHS Standards 26 Version 7 August 2012 2. Chemical Substances Management [TOC]
BASIC RESPONSIBILITY
The organization shall implement a chemical substances management program that covers procurement, R&D, manufacturing through to storage, distribution, and sale. The program shall include all J&J manufactured chemicals such as active pharmaceutical ingredients (APIs), isolated pharmaceutical intermediates (IPIs), new molecular entities (NMEs), in-licensed compounds, active ingredients (AIs) and generic drugs, as well as vendor chemicals, chemical mixtures, maintenance and cleaning chemicals.
MINIMUM REQUIRED ELEMENTS
2.1 Hazard Assessment and Communication
2.2 Risk Assessment and Exposure Monitoring
2.3 Medical Surveillance
2.4 Chemical Substances Management Program
2.5 Handling, Transportation, and Security
2.6 Storage
2.7 Spill Prevention and Control
2.8 Training
WW EHS Standards 27 Version 7 August 2012 2.1 Hazard Assessment and Communication
2.1.1 The organization shall establish, implement, and maintain a process to identify new chemical introductions, ensure that all relevant information is included on the site chemical inventory and ensure that the site chemical inventory is updated regularly.
2.1.2 The organization shall establish, implement, and maintain a process through Safety Data Sheets (SDSs, MSDS) or other appropriate data sources to obtain relevant health, safety and environmental data required for assessing and communicating chemical hazards. This process shall include both new and existing chemicals.
2.1.3 Each chemical and chemical mixture, except non-isolated chemical process intermediates, shall be evaluated to determine the health and physical hazards and the environmental aspects associated with its use, handling, storage, and disposal.
2.1.4 The organization shall establish, implement, and maintain a process to ensure that non-carcinogenic, non-hazardous or less hazardous material alternatives are considered for use, whenever possible. Chemicals, such as polychlorinated biphenyls (PCBs), shall be eliminated from use and storage.
2.1.5 Each hazardous chemical shall be assigned to the appropriate hazard class (e.g. NFPA, HMIS, GHS), using the process required by local regulations. In addition, J&J APIs, IPIs, NMEs and other AIs shall be assigned to the appropriate J&J Performance-Based Occupational Exposure Limit – Health Hazard Category (PBOEL-HHC).
2.1.6 The organization shall establish, implement, and maintain a process to obtain relevant toxicological data on APIs, IPIs, and AIs. These data shall be used to establish occupational exposure limits (OELs) or PBOEL-HHCs and environmental toxicity limits (Predicted No Effect Concentration or PNEC), where appropriate, using the J&J processes for OEL and PNEC establishment and approval. The OEL review process shall include the following key steps:
• OEL development and/or update are reviewed and approved by the Occupational Toxicology/Occupational Health Committee prior to communication;
• OELs are reviewed on a 5-year cycle;
• Yearly OELs selected for review includes prioritization from the Sector Leaders;
• EHS Leadership Council approves annual prioritization of OELs; and,
WW EHS Standards 28 Version 7 August 2012 • OELs and PNECs are communicated to the proper individuals within the organization responsible for these activities.
2.1.7 When sampling and analytical methods are to be developed for APIs, IPIs, and/or AIs, the organization shall use J&J-approved laboratories and/or follow the J&J analytical methods development and validation protocol or equivalent (e.g. specificity, sensitivity).
2.1.8 The organization shall establish, implement, and maintain a process for authoring, updating, and distributing SDSs for J&J products and obtaining and maintaining vendor SDSs to ensure that:
• A SDS for each API/AI manufactured by J&J is in the J&J centralized SDS system. Safety data sheets may be required for J&J products depending on local regulations. The organization shall be responsible for compliance with all applicable regulatory requirements of countries receiving the product; and,
• Vendor SDSs are available for each hazardous chemical on the site chemical inventory.
2.1.9 The organization shall establish, implement, and maintain a process to ensure that the hazards of chemicals are communicated to employees and customers via appropriate hazard warnings on stationary and portable containers. Chemical piping shall be identified as to its contents. Labels with the chemical name and hazard warnings are required for all portable containers not in the immediate control of the user. For R&D laboratories, all materials transferred from their original/primary containers or containers of “Discovery/Development” compounds shall be labeled with the contents or a laboratory notebook reference number.
2.1.10 The organization shall establish, implement, and maintain a process to ensure that hazardous chemicals brought to a work area by a contractor are labeled, accompanied by a Safety Data Sheet, approved for use by site, and communicated to affected employees, as part of the “Task-Specific Analysis of Aspects/Hazards and Impacts/Risks” stated in Chapter 4, Contractor Management.
2.1.11 The organization shall establish, implement, and maintain a process to communicate hazard assessment information and reports among EHS, occupational health, production management, and any other appropriate parties within the organization.
2.2 Risk Assessment and Exposure Monitoring
WW EHS Standards 29 Version 7 August 2012 2.2.1 The organization shall establish, implement, document, and maintain a process to develop an inventory of similar exposure groups (SEG), i.e. unit operations and tasks, reflective of site operations.
2.2.2 The organization shall perform qualitative risk assessments to drive the following outcome:
• Evaluation as to whether or not inhalation risks are managed below allowable exposure limits and dermal risk is controlled;
• Determination as to the need for personal air sampling data (quantitative risk assessment) when qualitative results indicate the exposure profile is uncertain or that exposures may exceed OELs;
• Quantitative risk assessments are required for operations and tasks where respirator use is mandatory;
• For voluntary or Quality required respirator use, a qualitative risk assessment must be conducted to reflect exposure risk;
• The appropriate personal protective equipment selected is based on documented risk assessments;
• Identification of any actions required to reduce risks associated with handling chemical agents;
• Identification of potential medical surveillance requirements; and/or,
• Establishment of exposure monitoring priorities.
2.2.3 The organization shall perform personal (breathing zone) industrial hygiene exposure monitoring, based on qualitative risk assessment outcome, to measure exposures during a given time period for each unit operation. Exposure monitoring process shall include:
• Requirements for calibration of sampling equipment;
• Requirement to conduct three or more samples to quantify exposure risk;
• Use of validated sampling protocols for APIs, IPIs, and AIs from J&J- approved laboratories;
• Use of a J&J-approved laboratory for analytical analysis of APIs, IPIs, and AIs;
WW EHS Standards 30 Version 7 August 2012 • Use of ISO17025-certified or AIHA-accredited industrial hygiene laboratories for all other chemical sampling and analytical methods;
• Random selection of employees (where practical) within each SEG to be sampled;
• Use of IOM sampling heads when monitoring for inhalable particulates;
• Collection of personal air monitoring outside of respiratory personal protective equipment;
• Application of statistical tools to determine 95th percentile of sampling results;
• When full-shift exposure monitoring is conducted for work-shifts exceeding 8 hours or a 40 hour work-week, adjustment of OELs for extended work shifts (e.g. overtime) shall be calculated when appropriate, using the Brief & Scala or an equivalent method;
• Statistical analysis of sampling results to determine respirator specification (e.g. assigned protection factor) if required; and,
• Sampling protocols for determining compliance to Country/State/Local OELs shall be conducted according to legislation requirements.
2.2.4 Full shift exposure monitoring (normally 6-8 hours in duration) results shall be compared to applicable exposure limits (e.g. ACGIH TLV, J&J OEL, etc.) to ensure employee exposures are controlled. Country/State/Local legislation exposure limits shall be followed when more stringent.
• Task duration and partial shift monitoring (e.g. time periods greater than 15 minutes to less than 6 hours) shall compare the measured concentration over the sampled period to the established exposure limit (e.g. OEL, TLV).
• An 8-hour time weighted average (8-hr TWA) calculation assuming zero exposure requires documentation of the employee activities during the unsampled period. Zero assumptions cannot be calculated unless all exposure risk is accounted for in each SEG encountered from day to day.
• A 15-minute time weighted average calculation shall compare the measured concentration over the sampled period to the established Short-Term Exposure Limit (STEL), when applicable.
WW EHS Standards 31 Version 7 August 2012 • Instantaneous measured concentrations shall be compared to the ceiling value (TLV-C), if established.
2.2.5 The organization shall utilize a Bayesian (which relies on PPE Assigned Protection Factor) or a Descriptive Statistics tool to determine the 95th percentile of sampling results (3 or more samples).
Exposure risk shall be managed using the 95th percentile as compared to J&J internally adopted exposure limits (e.g. OEL, TLV).
2.2.6 The organization shall establish, implement, and maintain a process to communicate:
• Personal exposure monitoring results to sampled employees;
• Aggregate sampling result to SEG; and,
• All results, interpretation, and recommendations to Occupational Health and other appropriate functional groups.
2.2.7 The organization shall develop an action plan to control employee exposures below the applicable J&J or Local/State/Country legislation OEL with the goal of reducing reliance on administrative and PPE controls. Management of risk shall follow the hierarchy of controls (preference most to least) to eliminate the hazard, substitute with less hazard, engineering controls, administrative controls, and reliance on personal protective equipment.
2.2.8 The organization, if required, shall establish, implement and maintain a respiratory personal protective equipment program that includes the following elements:
• Physical properties of the contaminant;
• Risk/exposure assessment;
• Respirator selection criteria, based on the 95th percentile probability or certainty that the respirator Assigned Protection Factor (APF) chosen will be sufficient to manage the exposure risk below the OEL;
• Annual quantitative fit testing for tight fitting (negative pressure) respirators, including single use disposable respirators;
• Donning and doffing (put on and take off) procedures;
• Proper use;
• Cleaning and sanitary storage; WW EHS Standards 32 Version 7 August 2012
• Maintenance;
• Personal hygiene procedures and facilities;
• Annual training for respirator users;
• Program supervision;
• Medical surveillance and clearance for use appropriate to the type of respirator;
• Management monitors effective respirator use and program compliance; and,
• Annual documented evaluation of program effectiveness.
2.2.9 The organization shall establish, implement, document, and maintain a process to specify, test, and maintain engineering controls intended to reduce/control employee exposures. The performance testing frequency shall be based on the equipment preventative maintenance schedule.
2.3 Medical Surveillance
2.3.1 The organization shall establish, implement, document, and maintain a process for medical surveillance in accordance with the requirements in Chapter 18, Occupational Health, which is based on a quantitative risk assessment process with supporting industrial hygiene data.
2.3.2 The results of medical surveillance shall be communicated to the employee and aggregate data communicated to the SEG, EHS, management and other relevant parties.
2.4 Chemical Substances Management Program
2.4.1 The organization shall establish, implement, document, and maintain a chemical substances management program(s) that contains general environmental, health and safety procedures and processes to ensure that all chemicals are properly managed. The program shall include:
• Implementation of appropriate facilities, equipment, safety controls, preventative maintenance, work practices, PPE, etc. to manage the EHS risk; and, • Control of physical hazards (e.g. water reactive, explosive, violent reactions, etc.), in addition to chemical exposure risk.
2.5 Handling, Transportation, and Security WW EHS Standards 33 Version 7 August 2012
2.5.1 The organization shall establish, implement, and maintain procedures, labeling, and hazard information for the safe handling of chemicals.
2.5.2 A program shall be established, implemented, documented, and maintained to ensure that external transportation (by contract, commercial, or J&J carriers) of its hazardous chemicals is in compliance with applicable regulations, including labeling, required hazard documentation (e.g. SDS), procedure(s) for responding to accidents en route and maintaining records of such incidents.
2.5.3 The organization shall establish, implement, and maintain procedures to ensure compliance with any applicable hazardous materials security regulations or requirements, as directed by government agency(s).
2.6 Storage
2.6.1 The organization shall design, construct, and/or maintain chemical storage that includes:
• Proper signage and labeling, that include hazardous classification (e.g. acids, bases, flammables);
• Capacity for segregation of incompatible chemicals;
• Adequate and impervious secondary containment;
• General and/or local exhaust ventilation when needed to control gases & vapors;
• Safety shower and eyewash equipment for certain categories of hazardous chemicals (e.g. corrosives);
• Readily available personal protective equipment;
• Adequate aisle & storage space;
• Fire and spill control equipment;
• If applicable, effective containment measures to prevent contaminated discharged fire sprinkler water from entering the environment;
• If applicable, antidote and other chemical specific emergency response materials; and,
• Communication system in event of chemical related emergencies. WW EHS Standards 34 Version 7 August 2012
2.6.2 The organization shall establish, implement, and maintain a documented periodic inspection program to ensure the safe storage of all chemicals.
2.7 Spill Prevention and Control
2.7.1 The organization shall establish, implement, and maintain spill prevention and control measures and/or procedures for all chemical handling operations, including chemical unloading, transfer, and use in process operations, and internal and external transport, to minimize the effects of chemical spills on human health and the environment, both on site and off site. The measures shall be integrated with the facility's overall Emergency Response Plan.
2.8 Training
2.8.1 The organization shall ensure that all employees working with or near hazardous chemicals receive initial and annual refresher training on the hazards, risks and safe handling of chemicals in their workplace.
WW EHS Standards 35 Version 7 August 2012 3. Emergency Preparedness and Response [TOC]
BASIC RESPONSIBILITY
The organization shall establish, implement, and maintain a program to identify and mitigate potential emergency situations that could affect personnel, the site, public infrastructure, and/or the surrounding community beyond the boundary of the facility. The organization shall ensure adequate resources, people and equipment, to effectively respond to these incidents and to ensure a process for appropriate medical surveillance of the site emergency response team.
MINIMUM REQUIRED ELEMENTS
3.1 Hazard Identification and Risk Assessment
3.2 Plant Emergency Organization
3.3 Emergency Response Plan
3.4 Incident Simulation
3.5 Medical Surveillance for Emergency Response Team (ERT)
WW EHS Standards 36 Version 7 August 2012 3.1 Hazard Identification and Risk Assessment
3.1.1 The organization shall establish, implement, and maintain a process to identify potential emergency situations, including for example, chemical or hazardous material related incidents, biological threats, flooding, severe weather, earthquakes, bomb threats, civil disturbance/riots, medical emergencies, among others, that can have impact on employee health, the environment, and/or the business.
3.1.2 A risk assessment shall be conducted for each potential emergency situation. At a minimum, the potential impact on employee/community health, the environment, and business recovery shall be considered. Based on the nature of the emergency, the likelihood of occurrence, existing controls, and the availability of internal and external response capabilities shall also be taken into account.
3.1.3 The hazard identification and risk assessment shall be documented and repeated whenever there is a significant change in regulations, operations, processes, or raw materials, or after the occurrence of accidents, emergency situations, or after an incident simulation as appropriate.
3.2 Site Emergency Organization
3.2.1 The organization shall establish, implement, and maintain a site emergency organization that consists of a chief and appropriate assistants, depending upon the size and complexity of the facility. The assistants should include but are not limited to maintenance personnel to control sprinklers, fire pump, electrical systems, etc., wardens to assure evacuation of all personnel, someone to contact the fire department, medical first responders, and others as required.
3.2.2 The organization shall establish and maintain an up-to-date list of all emergency responders at the site, including their roles and responsibilities.
3.2.3 All emergency response personnel shall:
• Complete all applicable training and maintain current certifications as required by the site emergency response team policy and local regulations;
• Be responsible for ensuring all emergency equipment and supplies are maintained appropriately (preventing expiration, performing calibration as indicated by manufacturer or site policy, etc.); and,
• Document emergency response activities in a consistent way, utilizing a procedure that is developed and maintained by the site, in compliance with any applicable documentation and privacy regulations, as well as local laws and regulations. WW EHS Standards 37 Version 7 August 2012
3.2.4 All medical emergency response personnel, in addition to complying with Section 3.2.3, shall:
• Follow the J&J Global Health AED guidelines when AEDs (i.e. defibrillators) are present at the site; and,
• Defer to the most senior licensed medical professional at the site (such as a medical doctor or nurse) for oversight on all medically- related emergency responses. In the absence of a medical doctor/nurse, the most medically qualified/certified responder may assume the role of designated lead.
3.3 Emergency Response Plan
3.3.1 The organization shall develop, implement, and maintain an up-to-date emergency response plan based on the outcomes of the risk assessments in order to minimize the potential effects of an accident or emergency situation on human health, the environment, and the business, both on and off site. The Emergency Response Plan shall contain the following minimum required elements:
• Emergency response command structure including roles and responsibilities;
• Emergency evacuation procedures;
• Shutdown of processes/equipment procedures;
• Assessment, containment or control, and mitigation of environmental impacts;
• Communication with regulatory agencies, other outside authorities, and community, if necessary;
• Appropriate management of waste;
• Personal protective equipment requirements;
• Appropriate health and safety precautions for emergency response personnel or as defined by regulatory requirements;
• Initial and periodic refresher training for site medical emergency responders;
WW EHS Standards 38 Version 7 August 2012 • Medical emergency procedures for receiving, triaging and treatment of potentially injured employees, appropriate transportation of employees to health care facilities, and maintenance of appropriate documentation;
• Medical surveillance process for emergency response team (ERT) members;
• Follow-up evaluations of incident responses;
• Emergency equipment such as spill response stations, medical response/first aid supplies, and fire control equipment; and,
• Training and drills for all employees.
3.3.2 The Emergency Response Plan shall establish the communication process to determine if an external disclosure is necessary, and if so, how to proceed, and shall include the following:
• Communications with J&J Corporate Communications/Media Relations and Worldwide EHS;
• Communications with employees' families and the public;
• Communications with the press and the media (obtain specific guidance from J&J Corporate Communications/Media Relations); and,
• Notifications to regulatory authorities.
3.3.3 The Emergency Response Plan shall establish post-event procedures, including:
• Decontamination of affected areas and equipment and management of contaminated debris;
• Evaluation and revision of the Emergency Response Plan, as necessary, and implementation of appropriate measures to prevent recurrence of the incident; and,
• Activation of the organization’s business recovery plan, if appropriate.
3.3.4 The Emergency Response Plan shall be reviewed and updated/revised as necessary at least annually or whenever there is a significant change in regulations, operations, processes, or raw materials, or after the occurrence of accidents, emergency situations, or after an incident simulation as appropriate.
WW EHS Standards 39 Version 7 August 2012
3.4 Incident Simulation
3.4.1 The organization shall conduct, using the worst case and more likely scenarios of incidents that may occur at the facility:
• Annual drill simulations to evaluate the competency of on–site emergency responders; and,
• Annual tabletop simulations to evaluate effectiveness of established communication procedures with external resources.
3.4.2 The organization shall decide, based on hazards, risks and controls in place, whether or not to develop, implement, and maintain a schedule to conduct drill simulations involving external emergency response resources to evaluate the external resources’ response time and effectiveness of coordination and agreed upon action.
3.4.3 All incident simulations shall be documented in writing, containing a detailed description of the exercise and a list of improvement recommendations and actions requiring follow up and inclusion in the Emergency Response Plan as appropriate.
3.4.4 Evacuation drills shall be performed at least annually on each shift, or more frequent based on risk and performance.
3.4.5 Appropriate documented training shall be provided to all members of on- site emergency response teams, including medical first responders.
3.5 Medical Surveillance for Emergency Response Team (ERT)
3.5.1 The organization shall establish, implement, and maintain the appropriate medical surveillance and recordkeeping program for the emergency response team in accordance with the requirements in Chapter 18, Occupational Health.
3.5.2 The organization shall establish, implement, and maintain a program to address the risks of blood borne pathogens for medical first responders and, if necessary, others in the ERT.
WW EHS Standards 40 Version 7 August 2012 4. Contractor Management [TOC]
BASIC RESPONSIBILITY
The organization shall establish, implement, and maintain a written contractor management program to identify, evaluate, and control environmental, health and safety (EHS) risks associated with contractors, including subcontractors, who provide a variety of administrative services, technical services associated with buildings, grounds, or equipment maintenance, and construction services.
MINIMUM REQUIRED ELEMENTS
4.1 Contractor Selection Process
4.2 Task-Specific Analysis of Aspects/Hazards and Impacts/Risks
4.3 Orientations and Inductions
4.4 Practical Organization, Communication and Evaluation of Contractors’ Work
4.5 Contractor Management Program Review
WW EHS Standards 41 Version 7 August 2012 4.1 Contractor Selection Process
4.1.1 The organization shall establish, implement, and maintain a documented process for selecting contractors who are competent to perform work at Johnson & Johnson facilities that includes, at a minimum, the following elements:
• A systematic decision making process conducted by a multidisciplinary team to classify all contractors as high, moderate or low risk;
• In depth screening of high-risk contractors’ EHS performance and management system;
• Identification of the environmental aspects/impacts and health & safety hazards/risks to select capable contractors who can complete the job in a safe and environmentally responsible manner; and,
• A continuous improvement program that strengthens contractor selection practices. Recommended improvement elements are detailed in the guidance document.
4.2 Task-Specific Analysis of Aspects/Hazards and Impacts/Risks
4.2.1 The organization shall establish, implement, and maintain a documented process related to task-specific analysis of aspects/impacts and hazards/risks that includes, at a minimum, the following elements:
• A systematic process to share the aspects/impacts and hazards/risks identified by site staff with the contractor;
• A systematic process to review, analyze and implement controls for the aspects/impacts and/or hazards/risks that contractors bring on site;
• A systematic process to create and share the results of risk assessments between contractor companies and the Johnson & Johnson contract owners prior to the commencement of a work or service relationship;
• Protection of individuals who may be at increased risk and/or the contractor’s responsibilities for any medical surveillance that is required for their employees; and,
• A continuous improvement program that strengthens the ability of the site and its contractors to apply systematic approaches for the development of safe work methods. Recommended improvement elements are detailed in the guidance document.
WW EHS Standards 42 Version 7 August 2012
4.2.2 For ongoing service contractors, the task-specific analysis of environmental aspects/impacts and health & safety hazards/risks shall be based on the scope, scale and contractor company classification at a frequency not to exceed 3 years.
Low Risk Moderate Risk High Risk 3 years 2 years Annual
4.3 Orientation and Induction
4.3.1 The organization shall establish, implement, and maintain a documented process related to orientation and induction that includes, at a minimum, the following elements:
• An induction/orientation that is provided to all contractor employees at the beginning of their assignment and refresher trainings that are conducted at defined time intervals not to exceed 3 years based on the contractor company risk classification;
Low Risk Moderate Risk High Risk 3 years 2 years Annual
• Inductions/orientations that take into consideration the contractor company risk classification, the nature of the job(s) being executed and the potential negative impact on affected employees;
• Explanations on site policies & emergency procedures;
• A formal record keeping process that tracks participation in induction/orientation sessions; and,
• A continuous improvement program that strengthens contractor safety induction/orientation practices. Recommended improvement elements are detailed in the guidance document.
4.4 Practical Organization, Communication and Evaluation of Contractors’ Work
4.4.1 The organization shall establish, implement, and maintain a process related to the practical organization, communication and evaluation of each contractor’s work that includes, at a minimum, the following elements:
• Equipment & tools brought on site by contractors that will be used to complete the job at hand must be suitable for the job, safe and meet local regulatory requirements;
WW EHS Standards 43 Version 7 August 2012 • Control and monitoring of contractor employee access to Johnson & Johnson sites;
• A systematic process for the Johnson & Johnson contract owner to monitor ongoing contractor performance that highlights at least five proven practices for EHS excellence in contractor management. Recommended improvement elements are detailed in the guidance document;
• A systematic “End of Job” or “Annual” evaluation by the Johnson & Johnson contract owner; and,
• A systematic process to share results of “Observations”, “End of Job” and/or “Annual” evaluations with the contractors.
4.5 Contractor Management Program Review
4.5.1 The organization shall establish, implement, and maintain a documented process related to the annual review of the contractor management program that includes, at a minimum, the following elements:
• Evaluation of contractor response/records regarding formulation and completion of recommended actions as a result of observations, end of job/annual reviews and accident/incident investigations;
• Consideration of contractor response/records to observations, end of job/annual reviews and accident/incident investigations when deciding if a contractor is to remain a company in good standing;
• Evaluation of all continuous improvement efforts to assure they are targeting weakest areas of the contractor management program. Recommended improvement elements are detailed in the guidance document; and,
• Involvement of a multidisciplinary team in all aspects of the contractor management program review process.
WW EHS Standards 44 Version 7 August 2012 5. Responsible External Supply Chain [TOC]
BASIC RESPONSIBILITY
An organization that engages with suppliers, including sales and marketing companies, shall establish, implement, and maintain a Responsible External Supply Program. This program is necessary to address external stakeholder expectations, manage risks that suppliers may pose to J&J’s reputation, encourage transparency with a supplier’s sustainability efforts and to build stronger partnerships with suppliers. This program is directly connected with our Standards for Responsible External Supply that we share with our suppliers and is intended to ensure a consistent and comprehensive program across J&J.
MINIMUM REQUIRED ELEMENTS
5.1 List of Suppliers
5.2 Supplier Compliance and Agreements
5.3 Supplier Review
5.4 Supplies/Services Purchased
5.5 Supplier Exposure Assessment
5.6 Performance Assessments/Audits
5.7 Assessment Ratings and Communications
5.8 Corrective Actions and Monitoring
5.9 Improvement Assistance
5.10 Incident Reporting and Response
5.11 Roles and Responsibilities
5.12 Recordkeeping
GUIDANCE
Tools and references may be found at the Global Procurement and Worldwide EHS websites: http://procurement.jnj.com/initiatives/Sustainability/Pages/Sustainability.aspx http://ehs.jnj.com/wwehs/Pages/home.aspx WW EHS Standards 45 Version 7 August 2012 5.1 List of Suppliers
5.1.1 The organization shall develop, implement and maintain a process to ensure that it has a confirmed list of basic details associated with all of its suppliers. Basic details that should be maintained are name, address, contact, and website (if available) of the supplier. This program requirement seeks to confirm our understanding of “who” we are doing business with.
5.2 Supplier Compliance, Transparency and Agreements
5.2.1 The organization shall develop, implement and maintain a process to ensure that suppliers are informed of our expectations to comply with all applicable legal requirements, be transparent about their organization’s Sustainability &/or Environment, Health and Safety efforts/programs and any J&J specific standard or policy including our Responsibility Standards for Suppliers. Compliance expectations shall be part of all supplier purchasing transactions, agreements and/or contracts.
5.3 Supplier Review
5.3.1 The organization shall develop, implement and maintain a process to review its suppliers and segment them into high priority vs. low priority. The review should be based on several business factors related to the supplier and the materials/services being purchased by J&J. The review should result in the identification of high priority suppliers that would require more analyses including a supplier exposure assessment (see Section 5.5) while low priority suppliers would require no further action beyond this review.
5.4 Supplies/Services Purchased
5.4.1 The organization shall develop, implement and maintain a process to confirm key details associated with its suppliers to complete a supplier exposure assessment for its high priority suppliers. Key details that should be maintained are material(s) and/or service(s) the organization is buying and where the materials/services are coming from (country/location of manufacture).
5.5 Supplier Exposure Assessment
5.5.1 The organization shall develop, implement and maintain a process to complete an exposure/risk assessment of its high priority suppliers. The exposure assessment shall include the following 3 factors that are all based on specific characteristics of the supplier’s operation: (1) level of impact, (2) likelihood of event/incident and (3) preparedness. The organization should consider the type of operations and the corresponding regulatory and physical environment when evaluating the impact. The organization should review regulatory compliance and EHS incidents when determining the likelihood. The organization should evaluate a supplier’s company structure, its transparency and site “strength” when determining its preparedness. When these 3 factors are WW EHS Standards 46 Version 7 August 2012 assessed, an overall risk exposure score/indicator (for example: high, medium, or low) should be assigned and further action be initiated, if necessary. The exposure assessment for individual suppliers shall be updated as new information is obtained on the supplier or at least every 3 years.
5.6 Performance Assessments and Audits
5.6.1 The organization shall develop, implement and maintain a performance assessment program to verify that high priority suppliers are in conformance with J&J’s expectations associated with the J&J Responsibility Standards for Suppliers. The type of assessment or audit, frequency, and level of expertise needed to conduct the assessment shall depend on risk factors reviewed by the organization and identified in Section 5.5. Performance assessments shall occur prior to signing/securing a contract with a new high priority supplier.
Note that if J&J owned manufacturing equipment or J&J owned product-process technology is in use at an external manufacturer or supplier, at a minimum, an onsite audit shall be conducted.
5.7 Assessment Ratings and Communications
5.7.1 Based on the performance assessment or audit, the organization shall establish, implement, and maintain a program to rate the high priority supplier as follows:
• Acceptable: In conformance with J&J’s expectations or minor non- conformances that are easily and quickly corrected are identified. No evidence of critical systemic management system deficiencies.
• Marginal/Conditionally Acceptable: A few significant non- conformances that require several months or longer to correct are identified. There is evidence of some critical systemic management system deficiencies.
• Unacceptable: Multiple significant non-conformances or any of the following: 1. Evidence of forced, bonded/indentured labor or involuntary prison labor at the facility, or 2. Evidence of harsh or inhumane treatment, or 3. Evidence of employees under the age of 16 at the facility, or 4. Evidence that young persons below the age of 18 are employed to perform hazardous work at the facility, or 5. Evidence of imminent threat to human life or that may have potential catastrophic impact to the facility, community, or environment and has not been mitigated and corrected in an appropriate time frame.
WW EHS Standards 47 Version 7 August 2012 5.7.2 If non-conformances are identified that pose an imminent threat to human life or may have catastrophic impact to the community or environment, the immediate threat shall be mitigated immediately and corrected as soon as possible to continue work with the supplier.
5.7.3 The organization shall develop, implement, and maintain a program to communicate the findings and outcomes of performance assessments/audits to the high priority supplier. For an onsite assessment or audit, the findings and outcomes shall be communicated in writing.
5.8 Corrective Actions and Monitoring
5.8.1 The organization shall develop, implement, and maintain a process for conducting ongoing monitoring (including follow-up audits, site visits to review progress or a re-evaluation of risk factors as illustrated in Section 5.5 Supplier Exposure Assessment) and according to the following assessment ratings: • Acceptable: 3 years • Marginal: 1- 3 years • Unacceptable: 6-12 months
5.8.2 For high priority suppliers rated marginal or unacceptable, the J&J organization and the supplier shall agree upon a written corrective action plan that details endpoints and target dates. For high priority suppliers rated unacceptable, the senior leadership at the supplier shall sign the corrective action plan. The J&J organization shall periodically review progress against the corrective action plan with the supplier until completed.
5.8.3 Depending upon the severity of the non-conformances or significance of the corrective action, the J&J organization shall revisit the supplier to verify corrective action plan completion prior to upgrading the supplier’s rating. If inadequate progress is made on the corrective action plan and/or the supplier’s performance does not improve by the next scheduled assessment, the contract/agreement shall be reviewed by the J&J organization to determine if future work with the supplier shall cease.
5.9 Improvement Assistance
5.9.1 The organization shall consider assisting suppliers with conformance to J&J’s expectations. Most J&J organizations have mature Sustainability and EHS programs, refined tools and substantial expertise. These assets may be used to help suppliers build or strengthen programs of their own by:
• Providing copies of appropriate J&J Policies & Practices;
• Educating suppliers on J&J goal-setting and performance measurement systems;
WW EHS Standards 48 Version 7 August 2012 • Conducting periodic workshops/information exchanges with suppliers;
• Sharing best practices and technical expertise; and/or,
• Developing advanced relationships as appropriate.
5.10 Incident Reporting and Response
5.10.1 The organization shall develop, implement, and maintain a process to ensure its high priority suppliers inform the organization of any serious EHS incidents that occur at the facility, including a work-related fatality, a major spill/release (that results in significant environmental damage, e.g., fish kill or community impact), or any EHS incident that is likely to receive media attention or result in cessation of operations.
5.10.2 The organization shall establish, implement, and maintain a process for reviewing such serious incidents and initiating an investigation as necessary. The process shall include notification to Procurement Management and through the EDGE2 system to notify Worldwide EHS (see Sections 1.4.9 and 1.4.8, respectively, for more details). Consideration of sharing lessons learned with other J&J organizations and suppliers if such learnings may prevent similar incidents is encouraged.
5.11 Roles & Responsibilities
5.11.1 The organization shall define roles and responsibilities as they relate to implementation of this program.
5.12 Recordkeeping
5.12.1 The organization shall develop, implement, and maintain a process to document records that support conformance with this program. Minimum requirements include:
• Applicable purchasing procedures;
• Supplier prioritization assessments;
• Supplier communications;
• Performance assessment reports; and,
• Corrective action plans.
WW EHS Standards 49 Version 7 August 2012 6. Acquisitions and Divestitures [TOC]
BASIC RESPONSIBILITY
The organization shall establish, implement, and maintain processes for the early identification, evaluation, and control of environmental, health & safety (EHS) risks associated with new business and/or property acquisitions, lease, and/or divestitures or site closures.
MINIMUM REQUIRED ELEMENTS
6.1 Notification
6.2 Due Diligence
6.3 Regulatory Review
6.4 Integration
WW EHS Standards 50 Version 7 August 2012 6.1 Notification
6.1.1 The organization shall establish, implement, and maintain a process to notify Worldwide EHS of any intended transactions related to leasing, acquisition, or divestiture.
6.2 Due Diligence
6.2.1 An environmental, health and safety due diligence review shall be conducted prior to any transaction that involves the acquisition or lease of a facility, real estate, or business for the purpose of identifying potential critical EHS liabilities.
6.2.2 When closing or divesting of a facility or real estate, an assessment shall be conducted and documented to identify all EHS liabilities and establish a baseline report on the EHS conditions of the property at the time of closure or transfer (refer to Facility Decommissioning Guide).
6.3 Regulatory Review
6.3.1 A broad review of the EHS regulatory compliance status of the intended acquisition’s operations shall be part of the due diligence to identify the estimated costs and resources for bringing the operations into full EHS regulatory compliance.
6.3.2 The organization shall coordinate/conduct a comprehensive EHS regulatory compliance audit of the new acquisition’s operations, products, packaging, and/or services, no later than 6 months after completing the acquisition.
6.3.3 The organization shall ensure that all major EHS regulatory non- compliances of the new acquisition shall be addressed (i.e., documented action plan) as soon as possible.
6.4 Integration
6.4.1 The organization shall establish, implement, and maintain a plan with identified resources, to bring the newly acquired organization into compliance with all applicable J&J EHS standards no later than 36 months after acquisition, that include:
• Immediately upon acquisition
– Report incidents per Sections 1.4.8 – 1.4.9 (incidents may be reported via e-mail or phone to Worldwide EHS until EDGE2 can be accessed);
WW EHS Standards 51 Version 7 August 2012 • Year 1
– Develop system to collect EHS performance data; and, – Participate in a Franchise-facilitated MAARS self-assessment;
• Year 2
– Begin to collect EHS performance data; – Begin to report energy and related CO2 data for the first full year; and, – Conduct a MAARS self-assessment;
• Year 3
– Begin to report EHS performance data per Section 1.4.7; and, – Participate in a MAARS joint assessment with Worldwide EHS.
Note: Incidents reported to J&J Worldwide EHS per Sections 1.4.8 – 1.4.9 will be included (i.e. counted) in J&J’s reporting of EHS performance to external parties (i.e. Sustainability Report) and internal customers (i.e. dashboards). This includes incidents incurred immediately after acquisition and during Years 1 and 2. New organizations may choose to report additional performance data per Section 1.4.7 in EDGE2 prior to Year 3 and have them included (i.e. counted) in J&J’s reporting of EHS performance to external parties and internal customers.
WW EHS Standards 52 Version 7 August 2012 7. EHS BY DESIGN [TOC]
BASIC RESPONSIBILITY
The organization shall establish, implement, and maintain a documented process to review and approve new or changes to J&J products, processes, packaging, equipment, and facilities during their early development or design phase or prior to procurement to ensure compliance with all applicable J&J EHS standards and regulatory requirements.
MINIMUM REQUIRED ELEMENTS
7.1 EHS Design and Assessments
7.2 Management of Change Process
7.3 Procurement Process
7.4 Authorization
WW EHS Standards 53 Version 7 August 2012 7.1 EHS Design and Assessments
7.1.1 The organization shall establish, implement, and maintain a process to perform EHS assessments during the early stages in the:
• Development of new J&J product, process, or packaging;
• Design and/or construction of new equipment or facility;
• Modification of existing product, process, packaging, equipment, or facility;
• Purchase of new equipment or facility; and/or,
• Introduction of new J&J product into existing process, equipment, or facility.
7.1.2 The organization shall ensure that the EarthwardsTM (EW) Process, or an equivalent process, is used for the environmental assessment of all new and redesign of products, processes, and/or packaging in various phases of development cycle, including early phases. The EW process steps that are required include ensuring compliance with applicable product stewardship regulations, performing life cycle reviews, and identification of improvement areas. While not a requirement, the EW process encourages business to make improvements and proceed with completing an application for an EW designation.
7.1.3 The EHS assessments shall be:
• Conducted formally by a skilled multidisciplinary team using sound evaluation techniques;
• Initiated early in the development, design, modification planning or procurement phase;
• Documented; and
• Inclusive of an evaluation on compliance against applicable product stewardship regulations employing a formal process developed and approved by the organization.
7.1.4 The organization shall apply and incorporate, where appropriate, the following EHS principles in the assessments:
• Eliminate hazards that can result in adverse risk to the environment, human health and/or safety;
WW EHS Standards 54 Version 7 August 2012 • Replace hazardous elements with less hazardous elements;
• Anticipate, assess, and evaluate the EHS risks related to identified hazards;
• Control EHS risks at the source;
• Utilize the hierarchy of controls (elimination, substitution, engineering, administrative and personal protective equipment) to reduce risk;
• Utilize best available technology and best practices;
• Include risk control measures and outcomes into equipment specification;
• Adapt the work to the individual through the application of sound, ergonomic principles;
• Adopt sustainability practices, by promoting the use of renewable resources and minimizing waste; and,
• Assure compliance with all applicable J&J EHS standards and regulatory requirements.
7.1.5 The organization shall ensure that:
• Take-back programs for J&J electronic products are identified, evaluated, and implemented where feasible;
• No PVC is used in all packaging of Consumer products and in secondary and tertiary packaging of MD&D and pharmaceutical products; and,
• Only office paper and paper packaging with more than 30% post- consumer recycled content and/or from certified forests are used.
7.1.6 Each Sector shall implement and maintain a process to continuously review the safety of their products ingredients/materials. Either through individual businesses or through Corporate commitments, each sector shall establish a process to identify materials of concern. Each sector is responsible for developing action plans to reduce or remove ingredients/materials of concern.
7.2 Management of Change Process
7.2.1 The organization shall establish, implement, and maintain a management of change (MOC) process to ensure that business, operational and/or administrative changes that may create adverse effects on people, WW EHS Standards 55 Version 7 August 2012 property or the environment are anticipated, evaluated and controlled early in the process for continual compliance with all applicable regulatory requirements and J&J EHS standards.
7.2.2 The MOC process shall address emergency changes that may occur outside the scope of the normal MOC process. These emergency changes shall be approved by authorized individuals and included in the normal MOC process for formal approval as soon as practicable.
7.3 Procurement Process
7.3.1 The organization shall establish, implement, and maintain a process to ensure that all purchases of equipment or facility include a specification of the applicable J&J EHS standards and regulatory requirements in the price quotation or Capital Appropriation Request (CAR). These requirements shall be as specific as possible to assist the architect/engineer, vendor, or supplier in understanding the organization’s EHS requirements.
7.4 Authorization
7.4.1 The organization shall establish, implement, and maintain a process to ensure that new or modified J&J products, processes, packaging, equipment, or facilities are/have been:
• Authorized for use;
• Evaluated for compliance with all applicable J&J EHS standards and regulatory requirements;
• Evaluated to verify the effectiveness of the control measures;
• Handed over to be used/operated after the users have received appropriate training to use, operate, maintain and/or occupy the purchase/ design or construction safely; and,
• Reevaluated after a suitable interval of time has elapsed to verify that all EHS risks are adequately controlled.
WW EHS Standards 56 Version 7 August 2012 8. External EHS Engagement [TOC]
BASIC RESPONSIBILITY
The organization shall establish, implement, and maintain an external engagement strategy focused on environmental, health & safety (EHS) risks, concerns, and transparency in support of Our Credo commitment to be “responsible to the communities in which we live and work”.
MINIMUM REQUIRED ELEMENTS
8.1 Liaison with External Stakeholders
8.2 External EHS Engagement Program
8.3 Transparency Report
WW EHS Standards 57 Version 7 August 2012 8.1 Liaison with External Stakeholders
8.1.1 The organization shall designate at least one contact person who can competently engage with the community, regulators, neighbors or customers who have or might have questions/concerns about facility or community environment, health and/or safety.
8.2 External EHS Engagement Program
8.2.1 The organization shall establish, implement, and maintain a proactive external EHS engagement program that is designed to:
• Identify community expectations/interests on EHS matters as regards to facility operations in that community;
• Share facility EHS information with interested parties to create familiarity with site operations and how site risks are managed to protect the public and the environment;
• Improve and sustain community and EHS regulatory relationships; and,
• Develop and sustain open lines of communication, so that when the organization needs to make operational changes or experiences an unintended operational upset, there is already a pathway for dialogue that is based on trust.
The EHS engagement program may be integrated with other community outreach programs (such as those often run through the Human Resources or Public Affairs department), but outreach must include EHS topics/discussion.
8.2.2 The extent and complexity of the organization’s external EHS engagement program shall be commensurate with the organization’s EHS risks and level of community interest/activism.
8.2.3 The organization shall document which external stakeholders the organization engages with, the EHS areas of interest to these stakeholders, and how two-way dialogue is encouraged or occurs.
8.3 Transparency Report
8.3.1 The organization shall prepare and post an updated Transparency Report on the J&J website biennially, by February 1 of every odd year, e.g. 2013, 2015, etc.
WW EHS Standards 58 Version 7 August 2012 9. Air [TOC]
BASIC RESPONSIBILITY
The organization shall establish, implement, and maintain a program to properly characterize and control all air emissions.
MINIMUM REQUIRED ELEMENTS
9.1 Air Emission and Stack Inventory
9.2 Air Emission Reduction and Control
9.3 Operation and Maintenance of Control Device
9.4 Refrigerant Gases
WW EHS Standards 59 Version 7 August 2012 9.1 Air Emission and Stack Inventory
9.1.1 The organization shall develop and maintain up to date an air emissions inventory that:
• Identifies the location of all stacks, vents, and exhausts that are air pollutant sources and the associated pieces of equipment;
• Lists the type of pollutant(s) emitted;
• Includes an estimated quantity of pollutant(s) emitted, including an estimate of fugitive emissions; and,
• Lists the associated control device(s).
9.2 Air Emission Reduction and Control
9.2.1 The organization shall ensure that all air emissions:
• Comply with all applicable regulatory requirements;
• Do not endanger public health or the environment; and,
• Do not create a public nuisance (e.g., opacity, smog, particulate deposition, odor).
9.3 Operation and Maintenance of Control Device
9.3.1 The organization shall establish, implement, and maintain a documented procedure(s) for operating and maintaining all control devices to ensure they are achieving their intended objectives.
9.3.2 Routine monitoring shall be conducted of parameters that can be used to predict and ensure optimal control device performance and regulatory compliance, if applicable.
9.4 Refrigerant Gases
9.4.1 The organization shall establish and maintain an inventory of all processes, operations, including utilities, and equipment that use refrigerant gases, and the amount of refrigerant gases used, added or removed from each equipment.
9.4.2 The organization shall implement appropriate containment practices to prevent releases of refrigerant gases and measures to detect leaks, and repair and/or replace leaking equipment in a timely manner.
WW EHS Standards 60 Version 7 August 2012 9.4.3 The organization shall ensure that all requirements of the “Montreal Protocol on Substances that Deplete the Ozone Layer”, as well as the following standards are met:
• Chlorofluorocarbons (CFCs), halons, carbon tetrachloride, 1,1,1 trichloroethane (methyl chloroform), hydrochlorofluorocarbons (HCFCs), hydrobromofluorocarbons, methyl bromide, and bromochloromethane are not used in any products, packaging, and/or manufacturing processes;
• Halons are removed from all fire suppression systems;
• No new CFC containing equipment is purchased. CFCs are removed from all existing HVAC/refrigeration equipment. CFC containing equipment may not be exported, imported, transferred or relocated;
• No new HCFC containing equipment is purchased. Existing equipment utilizing HCFCs may not be exported, imported, transferred or relocated;
• HCFCs shall be removed from all existing HVAC/refrigeration equipment no later than year end 2025. By year end 2014, a documented engineering study evaluating the replacement and/or retrofit of all existing equipment using HCFCs shall be performed. Accelerated replacement/retrofit (prior to end of service life or 2025, whichever is earlier) should be pursued for projects that are cost effective. Equipment utilizing HCFC-22 should be given priority in replacement/retrofit; and,
• In all cases, when new equipment is purchased, a review of available refrigerant technology shall be made. Hydrofluorocarbons (HFCs), due to their high global warming potential and potential for future regulatory phase-out, should not be used where alternatives (i.e., absorption chillers, use of ammonia, carbon dioxide, or hydrocarbons) can satisfy refrigeration requirements.
WW EHS Standards 61 Version 7 August 2012 10. Water and Wastewater Management [TOC]
BASIC RESPONSIBILITY
The organization shall establish, implement, and maintain a program to conserve water consumption, provide personnel with a safe supply of drinking water, and manage its wastewater ensuring protection of human health and the environment.
MINIMUM REQUIRED ELEMENTS
10.1 Water Conservation
10.2 Drinking Water Supply Management • Cross Connection Control • Treatment/Storage
10.3 Stormwater Management
10.4 Wastewater Management • Inventory • Drains and Conveyance System • Sampling and Analysis • Direct Discharges to the Environment • On-Site Treatment and Pretreatment
WW EHS Standards 62 Version 7 August 2012 10.1 Water Conservation
10.1.1 The organization shall develop, implement, and maintain a water conservation program that includes a water use inventory, a plan with goal(s), and measurement of progress.
10.2 Drinking Water Supply Management
10.2.1 The organization shall determine, at least annually, the acceptability of its drinking water supply by applying local, regional, or national drinking water- quality standards. Where there are no such standards, the World Health Organization (WHO) guidelines shall be applied.
10.2.2 The organization’s drinking water supply source(s) shall be protected against potential backflow or backsiphonage by installing a backflow prevention device at the inlet point of the water supply line to the facility.
Cross Connection Control
10.2.3 The organization shall protect its on-site potable water distribution system and water supply system from possible contamination or pollution potentially caused by backflow or backsiphonage and/or cross connections with a non-potable water source.
10.2.4 The organization shall establish, implement, and maintain an inspection, testing, and maintenance program for all on-site backflow prevention devices. If the public water supply authority has the responsibility for the maintenance of backflow prevention devices, the organization shall ensure that the program is being implemented on schedule and thoroughly.
10.2.5 All faucets and taps conveying non-potable water shall be clearly labeled to ensure that the water is not consumed for drinking by mistake.
Drinking Water Supply Treatment/Storage
10.2.6 Organization that treats and/or stores drinking water supply shall establish, implement, and maintain a program to properly operate and maintain the treatment and/or storage system to ensure it meets the designed efficacy.
10.2.7 Organization that treats and/or stores drinking water supply shall establish, implement, and maintain a program to periodically test the treated and/or stored water supply to ensure it meets governmental standards or WHO guidelines at points of use.
10.3 Stormwater Management
WW EHS Standards 63 Version 7 August 2012 10.3.1 The organization shall implement and maintain appropriate measures to prevent contamination of stormwater from cross connections and/or discharges with pollutants.
10.3.2 Where stormwater comes in contact with processes, hazardous chemical, or waste storage areas, the organization shall establish, implement and maintain a program to manage and monitor the stormwater to prevent discharges of contaminated stormwater to the environment.
10.4 Wastewater Management
10.4.1 The organization shall ensure that its sanitary and process wastewater are provided with primary treatment, and where appropriate in consultation with Worldwide EHS, secondary or tertiary treatment prior to its discharge to the environment.
Inventory
10.4.2 The organization shall establish and maintain up to date an inventory of wastewater sources that includes the quantity and characterization of the wastewater.
10.4.3 The organization shall establish, implement, and maintain a program to review, at least annually, all sources of wastewater for opportunities to reduce the generation of wastewater volume and/or introduction of pollutants into the wastewater.
Drains and Conveyance System
10.4.4 The organization shall review its sewer system layout, at least annually, and update associated drawings to ensure that wastewater generating processes discharge into the appropriate and designated sewer system.
10.4.5 The organization shall establish, implement, and maintain a program, with specified frequency based on risk but no less frequent than every 5 years, to evaluate the integrity of its underground, single-wall sewers (including sumps) conveying process wastewater and underground, single-wall piping, including sumps, conveying corrosive liquid and/or toxic chemicals (dilute or concentrated). Appropriate corrective actions shall be taken promptly if leaks are detected.
10.4.6 All new underground sewers that convey process or laboratory wastewater shall be double-walled with leak detection systems.
10.4.7 Appropriate measures shall be taken to minimize the likelihood of in- plant spills or leaks from entering plant drains that feed into a sewer, so as to preclude disruption of the on-site and/or off-site treatment process(s).
WW EHS Standards 64 Version 7 August 2012 10.4.8 The organization shall establish, implement, and maintain a system to clearly identify and distinguish all manhole covers, drain grates, access plates, cleanout caps and other wastewater pipe and sewer access entryways for rapid and accurate identification in the event of an emergency.
Sampling and Analysis
10.4.9 The organization shall establish, implement and maintain a documented procedure(s) to collect and analyze wastewater samples to determine compliance with all applicable regulatory requirements, or in their absence, J&J discharge guidelines.
10.4.10 If regulatory agencies collect wastewater samples to determine compliance, the organization shall make every attempt to collect additional samples, either by splitting the volume collected by the regulatory agency or by collecting side-by-side samples for independent compliance verification.
10.4.11 If there are no self-monitoring requirements imposed by regulators, the organization shall collect and sample, at least once per year, the combined facility discharge, to determine flow, Chemical Oxygen Demand (COD), Biochemical Oxygen Demand (BOD), Total Suspended Solids (TSS), Total Dissolved Solids (TDS) and pH. If there are multiple points of discharge, each point of discharge shall be tested separately.
10.4.12 Any organization that uses on site any active pharmaceutical ingredients (APIs), chemicals that are designed for medical potency (e.g. biologics and cytotoxins), any CMR (Carcinogenic, Mutagenic or Toxic to Reproduction), PBT (Persistent, Bioaccumulative, Toxic), or a National regulatory recognized endocrine active chemical shall determine the risks from presence of these compounds in its wastewater by performing, on an annual basis, one or both of the following options and implement a risk reduction plan:
• Option A – Chemical-specific risk analysis of each compound (mass balance approach)
• Option B – Whole Effluent Toxicity (WET) risk analysis. Use the following Decision Tree to determine the required WET actions for the organization.
WW EHS Standards 65 Version 7 August 2012
Direct Discharges to the Environment
10.4.13 If the organization discharges wastewater directly into a receiving water or onto soil, and where no regulatory standards apply or where regulators do not require monitoring of effluent quality, then the organization and Worldwide EHS shall work together to set site-specific effluent quality limits and monitoring schedules which shall remain in effect until local regulators begin to assume these responsibilities. The following guidelines, along with knowledge of receiving water quality, flow and current uses, shall be considered in setting such limits:
Surface Water Aquifer and Soil Discharge Effluent Discharge Effluent Quality Guidelines* Quality Pollutant (Unit) Guidelines* pH (S.U.) 6-9 6-9 BOD5 (mg/l) 50.0 60.0 COD (mg/l) 100.0 N/A NH3-N (mg/l) 2.0 N/A NO2+NO3-N (mg/l) N/A 10.0 TSS (mg/l) 50.0 N/A MBAS Surfactants (mg/l) 2.0 2.0 Oil & Grease (mg/l) 15.0 15.0 Cyanide (mg/l) 0.5 0.5 WW EHS Standards 66 Version 7 August 2012 Chromium VI (mg/l) 0.5 0.05 Total Toxic Organics1 (mg/l) 0.5 0.5 PCB (mg/l) 0 0 Total Toxic Metals (mg/l) 0.5 0.05 Temperature (oC) 35.0 N/A Acute toxicity LC50 > 100% N/A effluent with Daphnia sp. and 48 hr exposure
*These guidelines are applicable to all discharges (e.g. process, sanitary, cooling wastewater) and testing shall be performed at appropriate locations that are representative of wastewater streams. Twenty four (24)- hr composite samples (preferably flow-proportioned) shall be collected for testing of all parameters, except for pH and temperature, for which grab samples shall be collected.
On-Site Treatment and Pretreatment
10.4.14 If the organization operates on-site wastewater treatment or pretreatment system, it shall establish, implement and maintain a documented program to operate and maintain the wastewater treatment or pretreatment system to ensure consistent compliance with all discharge standards by ensuring that:
• Sufficient backup capacity and redundancy are installed and maintained to ensure continual compliance during routine maintenance activities;
• All operators of wastewater treatment or pretreatment system are appropriately trained in the proper and effective operation of the system and have obtained all required industry and/or governmental certifications prior to given the responsibility for its operation. Required certifications shall be maintained; and,
• On-line monitoring equipment, i.e. for flow, pH, dissolved oxygen, etc., are properly calibrated per manufacturer(s) specifications, and maintained to ensure their continual accuracy.
1 Acid extractables, base-neutral extractables, plus volatile organics WW EHS Standards 67 Version 7 August 2012 11. Waste Management [TOC]
BASIC RESPONSIBILITY
The organization shall develop, implement, and maintain a program to manage its waste compliantly and responsibly in regard to the environment, employee safety, and public health, from generation through collection, storage, transportation, and ultimate disposal.
MINIMUM REQUIRED ELEMENTS
11.1 Identification, Characterization, and Inventory
11.2 Storage and Handling
11.3 Treatment and Disposal
11.4 Used Container Management
11.5 Training and Supervision
WW EHS Standards 68 Version 7 August 2012 11.1 Identification, Characterization, and Inventory
11.1.1 The organization shall establish, implement, and maintain a documented process to identify and properly characterize all its waste streams.
11.1.2 An inventory of all waste generated on site shall be established and maintained up to date, that contains adequate information for sound management with the following minimum information for each waste type:
• Origin of the waste (process that created the waste);
• Hazardous characteristics and/or classification (corrosive, flammable, biological, infectious, radioactive, etc.) of the waste, if applicable;
• The radionuclide(s) and level of radioactivity (uci, Bq) for low-level radioactive waste;
• Typical annual generation rate; and,
• Current disposal method.
11.2 Storage and Handling
11.2.1 Hazardous and non-hazardous waste shall be clearly segregated from the time of generation until removal for off-site disposal and their respective accumulation and storage areas shall be clearly designated.
Non-Hazardous Waste
11.2.2 To the extent practicable, non-hazardous waste shall be segregated as either recyclable or non-recyclable and into general types of recyclable materials (for example, metals, cardboard, glass, and paper), if necessary, to promote recycling.
11.2.3 During construction activities when outside contractors are on site, special precautions shall be taken to ensure that the contractors do not mix their waste with the organization’s non-hazardous waste without prior authorization and that the contractors are familiar with all relevant procedures.
Hazardous (including Biological, Low Level Radioactive, and Liquid Non- Hazardous) Waste
11.2.4 Hazardous waste shall be stored in leak-proof containers that are clearly labeled and kept closed, except when adding or removing waste. The label shall identify that the material in the container is waste, what the waste material is (e.g. toluene, mixed chlorinated solvents, used oil etc.), and the hazardous characteristic(s) of the waste (e.g. flammable, corrosive, etc.).
WW EHS Standards 69 Version 7 August 2012
11.2.5 The hazardous waste storage area(s) shall be secured and managed as follows, to prevent releases to the environment:
• Located indoors or within a covered structure that prevents direct contact with rain water;
• Have an impervious floor (such as chemical resistant coating or chemical resistant material) that has been fitted with a totally surrounding secondary containment structure of sufficient size to contain a spill equivalent to at least 110 percent of the capacity of the largest container stored;
• Have suitable fire fighting, communication system, safety shower and eyewash equipment, and spill control equipment located in or near the storage area;
• If applicable, have appropriate containment measures to prevent contaminated discharged fire sprinkler water from entering the environment;
• Avoid the use of underground spill collection sumps, troughs, and piping, whenever possible; otherwise, all underground piping and sumps shall be evaluated for integrity every five years and a system shall be in place to quickly detect the presence of spilled liquid in the sumps;
• Provide separation of incompatible waste so that in the event of a spill, incompatible chemicals will not mix; and,
• Provide sufficient space between containers to enable the identification of each container’s label and the inspection of each container’s condition.
11.2.6 The organization shall establish, implement, and maintain a documented process for systematically inspecting the hazardous waste storage areas and containers for early signs of leaks and spills. The frequency of inspections shall be established by the organization using a risk-based approach, but no less frequent than required by local regulations or monthly, if regulatory requirements do not exist.
11.2.7 Hazardous waste shall be removed from site as soon as practicable. Local regulatory requirements shall determine the maximum holding time without requiring a permit or special regulatory approval. Holding waste for longer than 12 months shall be reviewed with Worldwide EHS, unless it is low-level radioactive waste being stored for decay purposes and allowed by regulatory authorities. WW EHS Standards 70 Version 7 August 2012
11.2.8 If the organization generates low-level radioactive waste, it shall implement the following additional requirements:
• Segregate low-level radioactive waste with long half-lives from those with short half-lives;
• Store and accumulate low-level radioactive waste with short half lives in a secured area until they are non-radioactive or their radioactivity levels are below regulatory thresholds for sewer discharge or disposal as non-radioactive waste, as applicable and allowed by laws and/or regulations; and,
• Avoid the mixing of low-level radioactive waste with hazardous or solid waste.
11.2.9 If the organization generates biological waste, it shall ensure that the waste is properly incinerated, or rendered non-infectious and non-recognizable prior to final disposal other than incineration.
11.3 Treatment and Disposal
11.3.1 An assessment shall be conducted of potential exposure posed by off- site management of each waste and material that was once managed as hazardous waste but now as a product-in-commerce to a third-party company for reuse, that considers: • the type of waste, • off-site management method(s), and • the receiving facility(s). This exposure assessment and the preferred management method(s) for each waste type or product-in commerce shall be documented and updated, as appropriate.
11.3.2 The organization shall establish, implement, and maintain a program to manage each waste, which includes the following prohibitions:
• Land disposal of organic solvents, polychlorinated biphenyls (PCBs), and other liquid hazardous waste, unless no other options are available and these wastes are solidified prior to land disposal; and,
• Intercontinental transport for disposal and ocean dumping.
11.3.3 All waste transport transactions and shipments shall be documented per regulatory requirements and with the following minimum information: date of shipment, identity and weight/volume of waste shipped, name and address of the receiving facility, and the method of treatment or disposal.
WW EHS Standards 71 Version 7 August 2012 11.3.4 All waste facilities shall be pre-approved for use. Approval of waste disposal facility requires an audit of the facility per table below, unless otherwise permitted by Worldwide EHS. The decision to approve a facility for use shall be based upon the judgment of two J&J EHS professionals, with one approver at manager level or above. Neither approver is required to be affiliated with the organization that wants to use the target disposal facility.
Prior to 1st Periodic Audit and Renewal of Approval Use Waste Type All Hazardous, Non-Hazardous Biological, and Low- Waste Level Radioactive Waste J&J facility location Americas-1 (Canada, Based upon risk Based upon risk United States, Puerto Required assessment. No assessment, but no Rico, Dominican Republic) minimum frequency. less frequently than every 5 years Americas-2 (Mexico, Based upon risk Based upon risk Venezuela, Colombia, Required assessment, but no assessment, but no Brazil, Argentina) less frequently than less frequently than every 3 years every 5 years EMEA-1 (Ireland, United Based upon risk Based upon risk Kingdom, France, Required assessment. No assessment, but no Belgium, Germany, minimum frequency. less frequently than Switzerland, Italy, Greece, every 5 years Spain, Sweden, Netherlands, Israel) EMEA-2 (Egypt, Mauritius, Based upon risk Based upon risk South Africa) Required assessment, but no assessment, but no less frequently than less frequently than every 3 years every 5 years A/P-1 (China, India, Based upon risk Based upon risk Japan, Korea, Malaysia, Required assessment, but no assessment, but no Thailand, Pakistan) less frequently than less frequently than every 3 years every 5 years A/P-2 (Australia) Based upon risk Based upon risk Required assessment. No assessment, but no minimum frequency. less frequently than every 5 years
11.3.5 The organization shall enter information related to the disposal sites it utilizes into EDGE2 annually. It is expected to utilize the aggregate information in EDGE2 to identify opportunities to share auditing burden, leverage spend, reduce costs associated with vendor management, and limit risk exposure by reducing the number of facilities utilized. EHS staff shall partner with appropriate procurement representatives in this effort.
WW EHS Standards 72 Version 7 August 2012 11.3.6 The organization, if it ships material that was once managed as hazardous waste but now as a product-in-commerce to a third-party company for reuse, shall establish, implement, and maintain a program to audit and approve the company(s). Based on the exposure assessment per Section 11.3.1, these companies may also require periodic re-audit and approval.
11.4 Used Container Management
11.4.1 The organization shall establish, implement, and maintain a program to minimize the use of containers and properly manage used containers. This program shall include all types of shipping containers and is intended to prevent environmental contamination from improper disposal and the misuse of used containers by unauthorized personnel. The organization shall ensure that all labels and/or markings that identify J&J or its affiliate companies are removed and that used containers are not given to employees or the community.
11.5 Training and Supervision
11.5.1 The organization shall establish, implement, and maintain a documented annual training and supervision program to ensure that appropriate facility personnel including contractors are properly trained and supervised in the handling and management of waste, during routine operations and emergencies.
WW EHS Standards 73 Version 7 August 2012 12. Tank System [TOC]
BASIC RESPONSIBILITY
The organization shall establish, implement, and maintain a tank system management program that ensures "no leaks, no spills" protection for the community in which the organization operates.
MINIMUM REQUIRED ELEMENTS
12.1 Process and Storage Tank System Management
12.2 Storage Tank Inventory and Classification
12.3 Performance Standards for Aboveground Storage Tanks
12.4 Performance Standards for Stand-Alone Liquid Fuel Day Tanks
12.5 Training and Supervision
12.6 Hydraulic Elevators
WW EHS Standards 74 Version 7 August 2012 12.1 Process and Storage Tank System Management
12.1.1 All new or replacement tank systems shall be above ground. Underground tanks shall be permitted only with approval from Worldwide EHS.
12.1.2 All storage tank systems shall have leak detection systems that are proven to be effective, efficient and responsive in providing early warning of any release. A risk assessment shall be performed on all process tank systems prior to installation to establish the need for leak detection systems.
12.1.3 All tank system components (such as liquid level monitoring, alarms, and switches) shall be installed and maintained properly to ensure their functionality. Testing and frequency of testing of each component shall be based on criticality evaluation, risk-based maintenance and/or supplier specifications. Documentation shall be maintained for all tank component maintenance activities.
12.1.4 The organization shall establish, implement, and maintain a documented inspection program, with specified schedules, to detect or predict potential failures of all tank systems.
12.1.5 Adequate preventive and containment measures shall be provided to prevent and capture all overflows or releases from tank vents, overfill lines, rupture disks, and emergency vents. Procedures shall be established, implemented, and maintained to dispose of the overflowed materials properly.
12.1.6 All abandoned or decommissioned underground tank system shall be removed, except where removal would undermine the foundations of existing structures or is not permitted by laws or regulations.
12.2 Storage Tank Inventory and Classification
12.2.1 The organization shall establish and maintain up to date, a documented inventory of all its storage tanks. The following information shall be included in the inventory:
• Type of tank (aboveground or underground);
• Tank identification number;
• Tank location;
• Tank capacity;
• Installation date;
• Contents of the tank (both currently and at any time in the past); WW EHS Standards 75 Version 7 August 2012
• Spill or overfill protection devices associated with the tank;
• Leak detection methods associated with the tank; and,
• Material of primary tank construction and any external protection (for example, coating, secondary containment, and corrosion protection).
12.3 Performance Standards for Aboveground Storage Tanks
12.3.1 All aboveground storage tank system shall contain the following elements:
• Internal tank wall and piping material that is compatible to the contents and non-corrosive;
• Periodic integrity evaluation (i.e. in accordance with manufacturer instructions);
• Electronic in-tank gauging or other appropriate level indicator;
• Overfill protection (overfill shut-off valve or high-level indicator and alarm);
• Double wall piping with leak detection or single wall aboveground piping with visual inspection, daily or on a frequency determined by the organization based on risk;
• Vapor recovery or treatment, as necessary, when storing volatile organic compounds (VOCs);
• Appropriate protection, such as cathodic protection, for all metal underground and on-ground components, including piping, that are in contact with the earth;
• If tank system is located outdoors, documented procedure(s) for managing rainwater that accumulate in the secondary containment dikes or sumps, and properly treating contaminated rainwater before discharge;
• Secondary containment for liquid transfer operations such as truck loading/unloading area; and,
• Fire protection for all tank systems containing flammable liquids.
12.3.2 Single wall storage tanks shall include the following additional elements:
WW EHS Standards 76 Version 7 August 2012 • Secondary containment dike or vault with chemical impervious material or chemical-compatible coating and water stops and/or a liner for storage tanks containing hazardous chemical or waste. Secondary containment shall be maintained in good condition and free of cracks and gaps; and,
• Electronic leak detection system (such as sump monitor) for prompt detection of leakage from storage tanks and piping containing toxic chemicals or flammable liquids. Alternative leak detection systems may be employed for storage tanks and piping containing other materials, e.g., visual inspection, daily or on a frequency determined by the organization based on risk.
12.3.3 Double wall storage tanks shall also include leak detection system (such as interstitial monitor).
12.4 Performance Standards for Stand-Alone Liquid Fuel Day Tanks
12.4.1 All stand-alone day tanks containing liquid fuel that are aboveground, not connected to a fuel storage tank, and with capacities less than 500 gallons or 1893 liters, shall contain the following elements:
• Internal tank wall and piping material that is compatible to the contents and non-corrosive;
• Periodic integrity evaluation;
• Double wall piping with leak detection or single wall aboveground piping with visual inspection, daily or on a frequency determined by the organization based on risk;
• Appropriate protection, such as cathodic protection, for all metal underground and on-ground components, including piping, that are in contact with the earth;
• Secondary containment for liquid transfer operations such as truck loading/unloading area; and,
• If tank system is located outdoors, documented procedure(s) for managing rainwater that accumulates in the secondary containment dikes or sumps, and properly treating contaminated rainwater before discharge.
12.4.2 Single wall day tank shall also include secondary containment dike or vault constructed of or coated with material that is impervious to the fuel stored.
WW EHS Standards 77 Version 7 August 2012 12.4.3 Double wall day tank shall also include leak detection system (such as interstitial monitor).
12.5 Training and Supervision
12.5.1 The organization shall establish, implement, and maintain a tank training and supervision program to ensure that all personnel including contractors who operate and/or manage tank systems are adequately trained and supervised to perform their assigned functions.
12.6 Hydraulic Elevators
12.6.1 All new elevator installations shall include the following system components:
• Secondary containment system for hydraulic shaft;
• Monitoring system for hydraulic oil leaks from the shaft; and,
• Use of food-grade oil in the hydraulic system, whenever possible.
WW EHS Standards 78 Version 7 August 2012 13. Energy Management [TOC]
BASIC RESPONSIBILITY
The organization shall establish effective mechanisms for creating, maintaining, and tracking an energy efficient facility and reducing carbon dioxide (CO2) emissions.
This chapter is not applicable to leased office facilities that are less than 50,000 square feet or 4645 square meters, where J&J does not have operational control (such as where J&J does not pay the energy supplier directly).
MINIMUM REQUIRED ELEMENTS
13.1 Energy Management
13.2 Energy Reporting
13.3 Climate Friendly Energy Policy
WW EHS Standards 79 Version 7 August 2012 13.1 Energy Management
13.1.1 The organization shall appoint an Energy Coordinator for each site to champion its program and provide updates to Worldwide EHS on the incorporation of the Energy Best Practices.
13.1.2 The organization shall establish, implement, and maintain a plan to review the Energy Best Practices, as they are periodically updated by Worldwide EHS to reflect current technology, and implement all recommended technologies that provide an internal rate of return of 15% or better.
13.1.3 All facilities constructed or renovated by J&J shall be compliant with the Policy for the Sustainable Design and Construction of Johnson & Johnson Facilities, and achieve a LEED certification, or equivalent.
13.1.4 Newly purchased or leased locations shall have 3 years to incorporate the Energy Best Practices that have an internal rate of return of 15% or greater.
13.2 Energy Reporting
13.2.1 The organization shall establish, implement, and maintain a process to validate and submit a yearly energy report to Worldwide EHS. That report shall include the consumption of electricity, fuel and other energy sources, the on-site use of renewable energy, and the purchase of renewable power and CO2 offsets (such as Renewable Energy Certificates or RECs). The report shall also include progress in implementing the Energy Best Practices with summaries of energy reduction projects.
13.3 Climate Friendly Energy Policy
13.3.1 The organization shall identify and implement best practices and projects to meet the J&J Climate Friendly Energy Policy.
WW EHS Standards 80 Version 7 August 2012 14. Noise and Hearing Conservation [TOC]
BASIC RESPONSIBILITY
The organization shall evaluate employee exposure to noise and, if necessary, control exposures and implement an effective hearing conservation program.
MINIMUM REQUIRED ELEMENTS
14.1 Sound Level Surveys
14.2 Personal Dosimetry
14.3 Communication of Results and Recommendations
14.4 High Noise Areas
14.5 Hearing Conservation Program
14.6 Engineering Control Plan Development
14.7 Specification and Performance Testing of Engineering Controls
14.8 Management of Potential Cases of Noise Induced Hearing Loss
WW EHS Standards 81 Version 7 August 2012 14.1 Sound Level Surveys (Qualitative Risk Assessment)
14.1.1 The organization shall have an up-to-date documented noise map which includes identified steady-state sound pressure levels (SPL or equivalent) equal to or greater than 82 dBA* to target areas that potentially exceed 85 dBA as a time-weighted average* (unless more stringent criteria is established per Country/State/Local regulations).
Note: Normal noise levels in office environments are typically below 80 dBA and unless significant noise sources are apparent, then these areas are exempt from this standard.
14.1.2 The organization shall ensure that sound level surveys are used to:
• Identify impulsive or impact noise levels greater than 140 dBC;
• Identify intermittent noise levels that may significantly impact the employee’s overall noise exposure (e.g. compressed air guns);
• Develop an inventory of similar exposure groups (SEG) for each area based on exposure risk. The inventory shall include those SEGs where sound pressure levels are 82 dBA* or greater;
• Capture changes to work area or equipment that impact the area SPL requiring an updated noise survey and associated documentation; and;
• Document pre and post calibration for sound level survey equipment.
14.2 Personal Dosimetry (Quantitative Risk Assessment)
14.2.1 The organization shall conduct and document personal noise dosimetry when sound pressure levels (Qualitative Risk Assessment) are greater than 82 dBA* to assess employee noise exposures. Personal dosimetry shall be used to:
• Clarify steady state exposures that are close to the 85dB(A)*; • Integrate intermittent noise fluctuations above or below steady state levels; • Capture impulsive or impact noise peak measurements; and, • Determine noise exposure associated with employee mobility.
The organization is permitted to use sound level surveys in lieu of personal noise dosimetry where sound pressure levels are expected to be 85 dBA* or greater to identify individuals to be included into the hearing conservation program when deemed appropriate (e.g. stationary tasks, non-routine job assignments, or transient worker exposures into high noise areas, etc.).
WW EHS Standards 82 Version 7 August 2012 When an organization chooses to exclude individuals from placement into a hearing conservation program when sound level surveys are greater than 82 dBA*, personal noise dosimetry is required to document exposure risk is less than 85 dBA*.
14.2.2 The organization shall ensure that dosimetry appropriately assesses the noise exposure risk:
• Set J&J dosimeter settings (e.g. ACGIH) for a threshold of 80 dB, A- weighting network, doubling (exchange) rate of 3 dB, and criterion level of 85 dB;
• Additional dosimetry settings (threshold, exchange rate, criterion level) may be required for determining compliance to Country/State/Local regulations more stringent than the ACGIH TLV for Noise;
• Document pre and post calibration for noise dosimetry equipment;
• An 8-hour TWA* calculation that assumes zero exposure requires documentation of the employee activities during unsampled period. Zero assumptions cannot be calculated unless all exposure risk is accounted for in each SEG encountered from day to day;
• Exposure risk shall be managed using the J&J adopted ACGIH TLV for Noise or Country/State/Local regulations if more stringent;
• J&J requires that SEG(s) with exposure(s) of 85dBA or greater as an 8-hour time-weighted average* must be included in a hearing conservation program; and,
• Noise dosimetry shall be updated if noise level changes are suspected or if required by Country/State/Local regulations.
14.3 Communication of Results and Recommendations
14.3.1 The organization shall communicate:
• Personal dosimetry results to sampled employees;
• Aggregate dosimetry result to SEG; and,
• Results, interpretation, and recommendations to Occupational Health and other appropriate functional groups.
14.4 High Noise Areas
WW EHS Standards 83 Version 7 August 2012 14.4.1 The organization shall communicate by signage where hearing protection is required.
14.5 Hearing Conservation Program
14.5.1 The organization’s hearing conservation program, where required by the Personal Dosimetry Section (above), shall include the following:
• A written hearing conservation program;
• Appropriately prescribed hearing protection devices;
• Adjusted Noise Reduction Rating (NRR), Standardized Noise Reduction (SNR) or equivalent;
• Proper care, insertion, and use;
• Cleaning and sanitary storage;
• Initial and annual training;
• Management monitors effective hearing protection device use and program compliance;
• Post signage as appropriate to indicate hearing protection is required;
• Medical surveillance; and
• Annual evaluation of program effectiveness.
14.6 Engineering Control Plan Development
14.6.1 The organization shall develop an action plan to investigate and document the feasibility of engineering controls in manufacturing, pilot plants (scale-up), laboratories, and R&D environments to reduce noise exposures equal to or greater than 85 dBA, 8-hour TWA*. When the organization determines the reduction of noise risk to levels below 85 dBA* is not supported by the business, the rationale shall be documented. Maintenance or facility areas such as boiler rooms, chiller rooms, and diesel fire pump rooms where there are not employee workstations are exempt from this requirement.
14.6.2 The organization shall manage risk by following the hierarchy of controls (preference most to least) to eliminate the hazard, substitute with less hazard, engineering controls, administrative controls, and reliance on personal protective equipment. If the organization determines after conducting the feasibility review that it will manage noise exposure risk by using PPE, an on-going and effective WW EHS Standards 84 Version 7 August 2012 hearing conservation program shall be implemented [see Hearing Conservation Program Section (above)].
14.7 Specification and Testing of Engineering Controls
14.7.1 The organization shall establish, implement, and maintain a process to ensure new noise sources do not cause personal noise exposures to exceed 85dBA as a TWA*. The process shall ensure that:
• A risk assessment is conducted to include evaluation of the additive effects of new and/or changes to existing noise generating equipment in the area and the room environment (floor, ceiling, wall surfaces etc);
• New equipment (as installed) limit noise exposure to 80 dBA or less where feasible unless Country/State/Local legislation is more stringent;
• Engineering controls are maintained and tested to ensure ongoing performance; and,
• Performance testing is conducted on all new engineering control equipment installations.
14.8 Management of Potential Cases of Noise Induced Hearing Loss
14.8.1 Medical surveillance shall be conducted on all employees in the hearing conservation program that includes the following:
• Baseline assessment, including audiometry, shall be completed prior to initial job assignment in hearing conservation program areas or within 6 months of working in the area; and,
• Medical surveillance shall be repeated annually or more frequently if required by Country/State/Local regulations. Medical surveillance shall include:
– Hearing questionnaire; – External ear examination; and, – Audiometric testing using calibrated equipment in a suitable and quiet facility.
Further guidance can be found in the hearing conservation medical surveillance guideline.
WW EHS Standards 85 Version 7 August 2012 14.8.2 All potential cases of noise induced hearing loss that meet the criteria outlined in the J&J Recordkeeping guideline shall be investigated and root cause identified, documented and communicated with EHS and management.
Note: *The 8-hour TWA limit of 85dBA (ACGIH TLV criteria) shall be adjusted as appropriate when work shifts extend beyond 8 hours or 40 hour work week or according to Country/State/Local regulations when more stringent. Additionally the steady-state sound pressure level trigger of 82 dBA shall be adjusted for extended work shifts (See Section 14.1).
WW EHS Standards 86 Version 7 August 2012 15. Biosafety [TOC]
BASIC RESPONSIBILITY
The organization shall establish, implement, and maintain a program for identifying, assessing, and controlling employee exposures to biological materials, biological toxins, and laboratory animal zoonoses (diseases transmitted by animals), and conducting medical surveillance of employees with potential exposure risks.
MINIMUM REQUIRED ELEMENTS
15.1 Basic Characterization
15.2 Hazard Assessment and Risk Group Ranking
15.3 Biological Safety Containment Levels and Classification
15.4 Biological Safety Program
15.5 Bloodborne Pathogen Exposure Control Plan
15.6 Engineering, Work Practice, and Personal Protective Equipment Controls
15.7 Shipment of Biological Materials/Toxins
15.8 Medical Surveillance and Recordkeeping
WW EHS Standards 87 Version 7 August 2012 15.1 Basic Characterization
15.1.1 The organization shall establish, document, and maintain a complete inventory of agents, tasks, and workers’ potential exposure to biological agents, that includes:
• Biological materials, biological toxins, and laboratory animal zoonoses;
• Job tasks that can result in employee exposure to these agents; and,
• Employees or groups of employees (similar exposure groups) with potential exposure to agents as a result of a job task.
15.2 Hazard Assessment and Risk Group Ranking
15.2.1 The organization shall establish, implement, and maintain a process to ensure that all biological materials, biological toxins, and laboratory animal zoonoses are classified and ranked according to potential hazards, and assigned to Risk Group 1, 2, 3 or 4.
15.2.2 The organization shall establish, implement, and maintain a process to assess the risks of off-site exposures to biohazards for employees who visit clinical settings. The risk assessment shall be documented and lead to adequate prevention and protection measures.
15.3 Biological Safety Containment Levels and Classification
15.3.1 The organization shall establish, implement, and maintain a process to ensure that facility design and physical containment are based on the risk group ranking of the biological materials/toxins in use, the scope of work and the related procedures.
15.4 Biological Safety Program
15.4.1 The organization shall establish, implement, and maintain a written biological safety program, including formation of a biosafety committee when working with biological materials/toxins and/or animals assigned to Risk Group 2 or higher, genetically modified organisms, and/or laboratory animal zoonoses. The program shall be reviewed and updated as necessary, annually or as determined by risk group ranking and containment levels. Initial training and appropriate periodic retraining of affected employees shall be included in the program. The extent of the training/instructions to personnel shall be commensurate with the potential for bio-hazardous agents/toxins/human-source materials. The program shall also address the approval, acquisition, and use of bio-hazardous agents/toxins/human-source materials.
WW EHS Standards 88 Version 7 August 2012 15.5 Bloodborne Pathogen Exposure Control Plan
15.5.1 The organization shall establish, implement, and maintain a written bloodborne pathogen exposure control plan when employees are identified as having potential occupational exposure to human bloodborne pathogens/human source materials. The plan shall include initial training and periodic retraining as per exposure risk and/or local legislation, of all persons with potential occupational exposure to human bloodborne pathogens/human source materials.
15.6 Engineering, Work Practice, and Personal Protective Equipment Controls
15.6.1 The organization shall establish, implement, and maintain a program for selection of appropriate controls to minimize employee exposures to biohazard. The program shall include documentations that specify for each type of biohazard and the related tasks:
• Engineering controls, including ongoing testing and maintenance;
• Work practices and procedures; and/or,
• Personal protective equipment, including proper selection, use, storage, donning (put on), doffing (take off), and maintenance.
15.7 Shipment of Biological Materials/Toxins
15.7.1 The organization shall establish, implement, and maintain procedures for safe and environmentally responsible shipping and receiving of biological materials/toxins, contaminated product returns, clinical trials, research & development applications, biological products and diagnostic specimens, that ensure:
• Compliance with all applicable regulations and guidelines; and,
• All international shipments meet all applicable national import and export requirements and permits.
15.8 Medical Surveillance and Recordkeeping
15.8.1 The organization shall establish, implement, and maintain a process for medical surveillance and recordkeeping on biohazard exposure-related issues in accordance with the requirements in Chapter 18, Occupational Health.
WW EHS Standards 89 Version 7 August 2012 16. Radiation Safety [TOC]
BASIC RESPONSIBILITY
The organization shall establish, implement, and maintain a program to ensure sufficient controls and management systems are in place to minimize exposures to ionizing radiation and non-ionizing radiation and assure compliance with all applicable regulations.
MINIMUM REQUIRED ELEMENTS
16.1 Materials and Equipment Inventory
16.2 Source Review and Risk Assessment
16.3 Licensing and Authorized Use
16.4 Radiation Safety Officer
16.5 Radiation Safety Program
16.6 Exposure Monitoring For Personnel
16.7 Area Surveys
16.8 Engineering, Work Practices, and Personal Protective Equipment Controls
16.9 Disposal of Radioactive Materials and Radiation Producing Equipment
16.10 Transfers and Shipping Radioactive Materials
16.11 Medical Surveillance
16.12 Communication of Results and Recommendations
16.13 Servicing and Maintaining Operations
16.14 Security
16.15 Decommissioning Funding
16.16 Program Records and Data
Guideline: Radiation safety Global Health Guideline: Ionizing/Non-Ionizing Radiation Medical Surveillance
WW EHS Standards 90 Version 7 August 2012 16.1 Materials and Equipment Inventory
16.1.1 The organization shall establish and maintain up to date an inventory of radioactive materials, radioactive sealed sources, and ionizing or non-ionizing radiation-producing equipment.
16.2 Source Review and Risk Assessment
16.2.1 The organization shall establish, implement, and maintain a process to review materials, equipment and/or procedures to determine applicable regulatory requirements and the potential for employee dose/exposure risk to ionizing and/or non-ionizing radiation. When the assessment indicates a potential for employee exposure or there are regulations that govern its use, all subsequent elements in this chapter shall be required (when applicable). Records of the assessments shall be maintained.
16.2.2 The organization shall establish, implement, and maintain a process to assess the risks of off-site occupational exposures to ionizing and non-ionizing radiation (examples to consider: visits to clinical/medical facilities, contract laboratories, contract sterilizers, or external manufacturers). Records of the assessments shall be maintained.
16.3 Licensing and Authorized Use
16.3.1 The organization shall establish, implement and maintain authorization by the necessary local/state/national regulatory agency to receive and use/operate all materials and/or equipment. This shall be confirmed by maintaining an up-to-date and approved license and/or registration of materials and/or equipment.
16.3.2 The organization shall establish, implement and maintain a process to assure that only authorized and appropriately trained personnel use sources of ionizing and/or non-ionizing radiation producing equipment identified by the site inventory.
16.4 Radiation Safety Officer
16.4.1 When ionizing and non-ionizing radiation sources are present that can potentially result in occupational exposure or when required by local regulations, the organization shall designate a Radiation Safety Officer to establish, implement, and maintain a radiation safety program.
16.5 Radiation Safety Program
16.5.1 When the risk assessment indicates that the potential for employee exposure exists, the organization shall establish, implement, and maintain a documented Radiation Safety Program that includes all of the requirements to
WW EHS Standards 91 Version 7 August 2012 identify, measure, and control potential exposures to sources of ionizing and non- ionizing radiation. Initial training and appropriate periodic retraining of affected employees shall be included in the program. The extent of the training/instructions to personnel shall be commensurate with the potential for radiation exposure/dose. The program shall also address approval and oversight for the use of ionizing and/or non-ionizing sources.
16.5.2 The organization shall establish, implement and maintain a management structure and system to over-see the complete Radiation Safety Program. The system shall include regular (annually at a minimum) reviews of the program and operations to verify adequacy of program and compliance.
16.6 Exposure Monitoring for Personnel
16.6.1 The organization shall establish, implement, and maintain a program for conducting and maintaining records of personal monitoring, when appropriate, to evaluate:
• Employee exposures to occupational sources of ionizing and non- ionizing radiation; and,
• That controls are effective, work practices are followed, and contamination has not occurred.
16.7 Area Surveys
16.7.1 The organization shall establish, implement, and maintain a program for conducting and maintaining records of area surveys:
• Periodically, based on applicable regulations and/or license conditions and program requirements; and,
• Immediately following any event during which radioactive materials have been released and may have resulted in employee, facility, or environmental contamination.
16.8 Engineering, Work Practices, and Personal Protective Equipment Controls
16.8.1 The organization shall establish, implement, and maintain a program for selection of appropriate controls to minimize operator, site employee and visitor exposures to ionizing and non-ionizing radiation. The program shall include documentations that specify:
• Engineering controls, including ongoing testing and maintenance;
• Work practices and procedures, including a regular review/update schedule; and/or,
WW EHS Standards 92 Version 7 August 2012
• Personal protective equipment, including proper selection, use, storage, donning (put on), doffing (take off), and maintenance.
16.8.2 The organization shall establish, implement and maintain controls to ensure the environment and local community are protected from potential radiation exposures and release of radioactive materials.
16.9 Disposal of Radioactive Materials and Radiation Producing Equipment
16.9.1 The organization shall establish, implement, and maintain a program to ensure the disposal of radioactive materials and/or radiation producing equipment meets all applicable regulatory and licensing or permitting requirements.
16.10 Transfers and Shipping Radioactive Materials
16.10.1 The organization shall establish, implement, and maintain a program to ensure the transfer (internal) of radioactive materials meets all applicable licensing and/or regulatory requirements.
16.10.2 The organization shall establish, implement, and maintain a program to ensure the shipping (off-site) of radioactive materials meets all applicable regulatory requirements.
16.11 Medical Surveillance
16.11.1 The organization shall establish, implement, and maintain a process for medical surveillance and recordkeeping on ionizing and non-ionizing radiation based on a formal risk assessment in accordance with the requirements in Chapter 18, Occupational Health.
16.12 Communication of Results and Recommendations
16.12.1 The organization shall establish, implement, and maintain a process to communicate the following:
• Personal exposure monitoring and medical surveillance results to sampled employees; and,
• Results, interpretation, and recommendations from risk assessments and sampling/data to Occupational Health and other appropriate functional groups.
WW EHS Standards 93 Version 7 August 2012 16.13 Non-Routine Activities, Servicing and Maintaining Operations
16.13.1 The organization shall establish, implement and maintain the same level of safety and protection during all non-routine activities, servicing procedures and maintenance as is maintained during normal operations. All contractors hired to perform any of the servicing (e.g., re-sourcing of irradiator) or maintenance procedures must be approved by the site’s contractor safety program (required steps are below and in Chapter 4.0 Contractor Management):
• Contractor Selection Process • Task-Specific Analysis of Aspects/Hazards and Impacts/Risks • Orientation and Induction • Practical Organization, Communication and Evaluation of Contractors’ Work
16.13.2 The organization shall establish, implement, and maintain a program that identifies additional controls, when needed (e.g., supervision of activity by independent knowledgeable expert), during non-routine activities that may pose higher than normal risk to the site/operations.
16.14 Security
16.14.1 The organization shall establish, implement, and maintain a program to ensure the security of its radioactive materials and/or radiation producing equipment. The program shall have sufficient controls to prevent unauthorized access to the materials and/or equipment by employees, contractors and visitors.
16.15 Decommissioning Funding
16.15.1 The organization shall establish, implement and maintain a process to ensure costs are identified, if needed, to decommission the site and facilities affected by the use of radioactive materials.
16.15.2 When funding is necessary to decommission the operation (facilities and site), the costs and funding shall be evaluated/verified at a frequency not to exceed every 5 years.
16.16 Program Records and Data
16.16.1 The organization shall establish, implement and maintain a process to document and keep up-to-date all data and records associated with the sources of radiation (ionizing and/or non-ionizing).
WW EHS Standards 94 Version 7 August 2012 17. Employee Wellbeing [TOC]
BASIC RESPONSIBILITY
The organization shall establish, implement, and maintain a program and processes to support employee health and wellbeing in accordance with J&J strategies and applicable laws and regulations.
MINIMUM REQUIRED ELEMENTS
17.1 Leadership Commitment
17.2 Culture of Health Programs
17.3 Communication and Promotion
17.4 Supportive Environment
17.5 Implementation of Appropriate Policies
17.6 Setting, Measuring and Tracking Goals
17.7 Data Collection and Analysis
WW EHS Standards 95 Version 7 August 2012 17.1 Leadership and Commitment
17.1.1 The organization’s leadership shall demonstrate their commitment to a culture of health by participating in health and wellness initiatives, understanding relevant population health risks, and reviewing progress against health goals.
17.2 Culture of Health Programs The organization shall support the deployment and sustainability of a culture of health by implementing programs targeted to address population health risk issues and tailored to the needs, size and nature of the operation, including but not limited to the following.
17.2.1 The organization shall establish, implement, and maintain a Tobacco Free Workplace that complies with the Johnson & Johnson Tobacco Free Workplace Policy by providing healthy, tobacco free workplaces and support for employees who wish to quit using tobacco.
17.2.2 The organization shall establish, implement, and maintain a program to provide HIV/AIDS support that complies with the Johnson & Johnson Global Workplace HIV/AIDS Policy by providing a supportive, nondiscriminatory work environment, and access to testing and treatment.
17.2.3 The organization shall establish, implement, and maintain a Health Risk Assessment (HRA) program that helps employees to know their health numbers (related to health risks) via a health risk assessment tool. Additionally, the aggregate data (no personal identifiers) can be used to track population health risks at the site and franchise/sector level. The HRA of choice within Johnson & Johnson is the Health Profile.
17.2.4 The organization shall establish, implement, and maintain a program to promote physical activity via a range of activities appropriate to the size and function of the operating company. Activities can include pedometer program/Million Step Challenge; walking/jogging trails around the site; on site fitness center; exercise reimbursement to attend an off-site fitness center; employee exercise and relaxation classes; company sports clubs; company teams entering charity events e.g. walking, running, cycling.
17.2.5 The organization shall establish, implement, and maintain a program to promote healthy eating via access to healthy affordable food and drinks choices in onsite cafeterias, vending machines, and at meetings; catering staff who are trained in healthy food preparation, placement and portion size; employee education on healthy food, including the Johnson & Johnson EatComplete program. This also encompasses overall awareness and compliance with safe food practices and handling.
17.2.6 The organization shall establish, implement, and maintain a program that provides access to a confidential, professional and culturally sensitive Employee Assistance Program that includes the following: WW EHS Standards 96 Version 7 August 2012
• Telephone and face-to-face counseling related to mental health, substance abuse, relationship issues, and lifestyle concerns; • Employee education, assessment and referral service related to mental health, substance abuse, relationship issues and psychosocial challenges; • Management referral of employees where indicated; • Support during critical incidents for individuals or organizations; and, • Consultation and coaching for managers; resiliency training, etc.
17.2.7 The organization shall establish, implement, and maintain programs and training that promote stress reduction, resiliency and energy management.
17.2.8 The organization shall establish, implement, and maintain a program to promote cancer awareness that includes awareness of the role of healthy lifestyles in the prevention of certain cancers, the identification of warning signs, the benefit of early diagnosis, and the benefit of age and country appropriate cancer screening.
17.2.9 The organization shall establish, implement, and maintain General Health Promotion programs that include widespread awareness of the impact of chronic diseases (e.g. diabetes); preventative measures such as Safe Sun, Healthy Heart etc.; and, incorporation of personal energy management program components.
17.3 Communication and Promotion
17.4.1 The organization shall proactively promote and communicate access to health tools, resources and health promotion programs to employees and, if appropriate, their dependants. (This shall include a process for communicating the availability of these programs in employee new hire orientation.) There shall be collaboration on implementation of these programs with key stakeholders, including employee representation groups.
17.4 Supportive Environment
17.5.1 Employee health and well-being shall be a consideration in the physical work environment, in job design, and in any employee services provided, so the healthy choice is the easy choice for the employee.
17.5 Implementation of Appropriate Policies
17.6.1 The organization shall implement the Johnson & Johnson Global Health and Wellness Policies (these are: Alcohol and Drug-Free Workplace; Employee Health Records & Confidentiality; Employee Assistance; HIV/AIDS; Medical Surveillance; Tobacco-Free Workplace; Travel Health; Wellness & Health Promotion) in accordance with applicable local laws.
WW EHS Standards 97 Version 7 August 2012 17.6 Setting, Measuring and Tracking Goals
17.7.1 The organization shall set health goals and targets aligned with enterprise goals and the site key health issues. Systems shall be put in place to measure against these goals and track performance. Goals shall have management visibility and communicated to relevant stakeholders.
17.7 Data Collection and Analysis
17.7.1 Appropriate data shall be collected and analyzed so as to identify population health risks and implement appropriate programs so that targeted action can be taken. Data shall demonstrate whether or not programs are effective. Data shall include:
− Population health risks and trending; − Employee satisfaction with interventions; and, − Analysis, summary, and conclusion data to demonstrate value and future planning/interventions.
17.7.2 Anonymous, aggregate data on EAP shall be collected to produce site specific organizational reports on an annual basis.
17.7.3 Confidentiality and privacy of Medical Records shall be maintained. See Section 18.7, Medical Records.
WW EHS Standards 98 Version 7 August 2012 18. Occupational Health [TOC]
BASIC RESPONSIBILITY
The organization shall establish, implement, and maintain a comprehensive occupational health program that includes, but is not limited to, the programs described in this chapter. These programs and services shall comply with all applicable laws and regulations and J&J requirements, and shall include a system of appropriate evaluations, documentation, communication, and follow- up.
MINIMUM REQUIRED ELEMENTS
18.1 New Hire Health Evaluations
18.2 Medical Surveillance
18.3 Medical Case Management for Occupational Injuries and Illnesses
18.4 Drug Free Workplace
18.5 Personal Sickness Absence and Disability Management
18.6 Travel Health
18.7 Recordkeeping
18.8 Medical Records - Confidentiality and Privacy
WW EHS Standards 99 Version 7 August 2012
18.1 New Hire Health Evaluations
18.1.1 In compliance with applicable regulations as well as J&J requirements, the organization shall establish, implement, and maintain a process for conducting new hire health evaluations to ensure that an individual can safely perform the essential functions of the job with or without accommodation.
18.2 Medical Surveillance Johnson & Johnson companies shall adopt the recommendations described in the Global Health Medical Surveillance guidelines so as to comply with these Standards, or implement an equally effective or more robust process that meets the requirements of the standards.
18.2.1 The organization shall establish, implement, and maintain a process to determine who shall be included in a specific medical surveillance program based on a documented risk assessment that is supported by valid data where available. This analysis shall then be reviewed against the specific medical surveillance inclusion criteria (defined in the Global Health Medical Surveillance guidelines and as required by law as well as any specific personal protective equipment requirements. Employees in similar exposure groups (SEG) will be determined jointly by Occupational Health and EHS.
18.2.2 The organization shall establish, implement, and maintain a process for conducting medical surveillance that complies with J&J requirements or applicable regulations, whichever is stricter, and includes appropriate baseline, periodic and applicable exit evaluations, other hazard specific surveillance elements, documentation, communication, and follow-up.
18.2.3 The organization shall establish, implement, and maintain a process to allow the worker, site EHS professional, and/or management to request an interim health evaluation if there is a health/safety issue related to the employee, a specific event, or potential exposure.
18.2.4 The organization shall establish, implement, and maintain a process to ensure that medical surveillance findings are compared for similarities in abnormal results, or normal results trending toward abnormal over a period of time, within similar exposure groups and for each individual worker.
18.3 Medical Case Management for Occupational Injuries and Illnesses
18.3.1 The organization shall establish, implement, and maintain a process for occupational injury/illness prevention based on early hazard recognition, employee training, data analysis, trend analysis, engineering and administrative controls.
18.3.2 The organization shall establish, implement, and maintain a process for early recognition and reporting to enable appropriate mitigation and preventative WW EHS Standards 100 Version 7 August 2012 measures to be taken. Early recognition shall be facilitated by employee education and training, data and trend analysis, and risk identification and quantification via risk assessments.
18.3.3 The organization shall establish, implement, and maintain a process for early medical intervention and diagnosis, injury/illness characterization as to work-relatedness, initiation of conservative treatment, assessment of work capability and implementation of appropriate alternate/modified duty, referral as applicable, and safe return to work processes.
18.3.4 The organization shall establish, implement, and maintain a treatment plan that includes systematic reassessment of worker health status and evaluation of treatment and referral options, follow-up, documentation and communication.
18.4 Drug Free Workplace
18.4.1 The organization shall establish, implement, and maintain a process to ensure an alcohol and drug free workplace as described in the Alcohol and Drug- Free Workplace Policy (#2214) and Alcohol and Drug-Free Workplace Guideline, and as allowable by local laws and regulations, including legislations related to privacy and confidentiality. This may include alcohol and drug dependency awareness training, documentation, communication and follow-up, and ensures a system, where appropriate of employee testing.
18.5 Personal Sickness Absence and Disability Management
18.5.1 The organization shall establish, implement, and maintain a process to effectively manage employees who are, or may become, unable to safely perform their normal work activity. This process shall comply with applicable regulatory requirements in a confidential, non-discriminatory and consistent manner.
18.5.2 Services, professionals, and other resources shall be utilized to minimize injury/illness related absence and/or disease impact and costs, to promote safe, accessible and healthy workplaces, and support effective return-to-work initiatives where allowed by applicable laws and regulations.
18.5.3 The organization shall, where legally allowable, support the timely return to work of employees who are absent due to personal illness or injury, making any reasonable accommodations necessary to enable them to perform the essential functions of their jobs, or alternative work, in a safe manner.
18.5.4 The organization shall provide information, training, and support to managers and employees on their roles in managing sickness absence and disability and the promotion of a timely and safe return to work.
WW EHS Standards 101 Version 7 August 2012 18.5.5 Where allowed by applicable laws and regulations and employer/employee contractual agreements, occupational rehabilitation shall be utilized to develop a rehabilitation plan based on an employee's occupational interests, skills and abilities, and psychosocial barriers that might impede returning to work.
18.6 Travel Health
18.6.1 The organization shall establish, implement, and maintain a process for assessment of potential travel health risks and communication of these to the business traveler, rendering health services, and providing health care access to employees traveling for business reasons. Services to these employees shall include appropriate and up-to-date travel vaccination, prophylactic medication, and general travel health advice. Injuries and illnesses that occur during business travel shall be reported/recorded as appropriate, and based on the Johnson & Johnson Recordkeeping and Reporting Guidelines.
18.7 Recordkeeping
18.7.1 The organization shall establish, implement, and maintain a process to maintain occupationally-related medical records that include the results of all medical examinations, evaluations and tests related to medical surveillance, for the duration of employment plus 30 years, or in compliance with applicable regulations, whichever is more stringent.
18.7.2 Occupational injury/illness shall be reported and recorded in accordance with J&J recordkeeping requirements and in compliance with applicable regulations.
18.8 Medical Records - Confidentiality and Privacy
18.8.1 The organization shall establish, implement, and maintain a process that safeguards the privacy and confidentiality of all employee medical records in compliance with applicable laws and regulations.
WW EHS Standards 102 Version 7 August 2012 19. Fall Prevention [TOC]
BASIC RESPONSIBILITY
The organization shall establish, implement, and maintain a fall prevention program to reduce and eliminate Slips, Trips & Falls-related incidents & accidents.
MINIMUM REQUIRED ELEMENTS
19.1 Hazard identification and Risk Assessment
19.2 Corrective Action Plan
19.3 Training and Communication
19.4 Falls From Heights
19.5 Incident Analyses and Program Review
WW EHS Standards 103 Version 7 August 2012 19.1 Hazard Identification and Risk Assessment 19.1.1 The organization shall perform an initial Fall Prevention Site Assessment to identify the potential slip, trip and fall hazards of the facility, and to evaluate the risks associated with the identified hazards.
19.1.2 The site assessment shall be repeated every 3 years and:
• Shall use the “J&J Slips, Trips and Fall Prevention Site Risk Assessment” or an equivalent approach;
• Can be integrated into routine site safety inspections; and,
• Shall be performed by persons trained and competent in performing a Slips, Trips and Falls-related risk assessment.
19.2 Corrective Action Plan 19.2.1 The organization shall establish, implement, and maintain a process to ensure that action items from the hazard identification/risk assessment are documented in a facility action plan.
19.3 Training and Communication
19.3.1 The organization shall establish, implement, and maintain a process to ensure that all affected employees receive training in fall prevention to understand the factors that contribute to slips, trips and falls.
19.3.2 The training shall be given initially and then every three years thereafter.
19.3.3 Education, promotion and other communication methods shall be used in the intermittent years to keep the level of awareness high for fall prevention.
19.3.4 Construction and maintenance engineers shall be familiar with the basic elements of the J&J Fall Prevention Program, as their expertise in facility design and maintenance will help to eliminate the physical hazards.
19.4 Falls from Heights 19.4.1 The organization shall establish, implement, and maintain written procedures to prevent falls from heights. These procedures shall include:
• A documented inspection and maintenance program to ensure the integrity of fall arrest equipment and their anchor points;
• Every 3 years, at a minimum, a “Falls from Heights” risk assessment conducted by an expert, skilled in the field, with the objective to classify activities where personal protective equipment is required
WW EHS Standards 104 Version 7 August 2012
• For activities considered as routine, the identification of the most appropriate control measures (material & method) to prevent falls from heights in conjunction with a rescue plan; and,
• For non-routine activities, the requirements spelled out in Chapter 24: CONTROL OF PERMIT REQUIRED WORK AND NON-ROUTINE ACTIVITIES apply.
19.4.2 Documented employee training on Falls from Heights shall be conducted that addresses Falls from Heights risks, proper use of related equipment, and current regulations.
19.5 Incident Analysis and Program Review 19.5.1 The organization shall conduct analyses of accident logs and incident records that involved slips, trips or falls in order to provide input for potential improvements in the facility’s Fall Prevention Program.
WW EHS Standards 105 Version 7 August 2012 20. Fire and Explosion Prevention [TOC]
BASIC RESPONSIBILITY
The organization shall establish, implement, and maintain a program to protect people, property, and the environment from fires and explosions.
MINIMUM REQUIRED ELEMENTS
20.1 Design and Construction of Facilities
20.2 Hazard Identification and Risk Assessment
20.3 Control Measures
20.4 Training
20.5 Documentation
WW EHS Standards 106 Version 7 August 2012 20.1 Design and Construction of Facilities
20.1.1 The organization shall ensure that each building at its facility(s) complies with the requirements of the J&J Worldwide Fire Safety Policy, unless an exemption has been obtained in accordance with the policy exemption process.
20.2 Hazard Identification and Risk Assessment
20.2.1 The organization shall conduct and document a comprehensive fire and explosion hazard identification/risk assessment.
20.2.2 The hazard identification/risk assessment shall be performed by a qualified person and consider the following:
• Scope and applicability of local codes, regulations, and industry standards related to fire safety;
• The intended use for all facility areas (e.g., storage, transfer, research, or manufacturing) including fire-rated construction, alarms systems, sprinkler protection, and portable fire extinguisher availability;
• Storage of flammable and combustible materials including proper labeling, housekeeping, container and cabinet design, storage density and height, spill control and containment, and proximity to ignition sources;
• Equipment failure, inadequacy, or improper placement including fire- rating (e.g., spark-proof, explosion-proof, or ‘lab-safe’), preventive maintenance procedures, bonding and grounding, ventilation, dust control, transfer systems, over/under pressure protection, and electrical requirements;
• Ignition source control including heat, sparks, arcs, open flames, static discharge, and runaway or uncontrolled chemical reactions; and,
• Other specialized fire and explosion risks based on the nature of the facility operations.
20.2.3 The risk assessment shall be updated annually or whenever there is a significant change in facilities, processes, or equipment.
20.3 Control Measures
WW EHS Standards 107 Version 7 August 2012 20.3.1 If the risks identified in the risk assessment cannot be eliminated, appropriate controls shall be established, implemented, and maintained to minimize the fire and explosion risk, including but not limited to:
• Effective emergency response procedures including evacuation drills, internal teams and fire brigades, external emergency response resources, and neighbors or outside organizations that may be affected;
• Exit route reliability to ensure that all exit routes, including the exit access, exit, and exit discharge are at all times maintained free of any locks, obstructions or impediments that would prevent full and immediate use; this includes also ice and snow;
• Inspection, testing and maintenance programs for critical fire safety equipment including container integrity, air-monitoring instruments, bonding and grounding devices, alarms and sprinkler systems, and portable fire extinguishers;
• Processes and procedures to minimize fire and explosion risk during the storage, handling, and use of equipment based ignition sources as well as flammable liquids and gases and combustible dusts;
• Integration of fire and explosion hazard identification and control measures assessment into a formal inspection program;
• Prohibition of smoking in all areas of the facility in compliance with the J&J Tobacco Free Policy;
• A housekeeping program to: − limit the accumulation of flammable and combustible materials; and, − ensure that exit signs, manual fire alarm stations, and other fire safety signs or devices are not blocked or screened from view;
• The provision for employee notification and alternate controls if any part of the fire suppression or fire alarm system is impaired; and,
• An employee relations program including signs, posters, and bulletins to increase the fire safety awareness of employees as well as their awareness of the fire hazards within the facility.
20.4 Training
20.4.1 The organization shall identify the affected personnel and establish, implement, and maintain a training plan for them that addresses fire and explosion hazards, prevention, and control measures. WW EHS Standards 108 Version 7 August 2012
20.4.2 All applicable fire and explosion risks and control measures shall be communicated to employees, contractors, and visitors during an initial safety introduction.
20.5 Documentation
20.5.1 The organization shall have access to current local codes and regulations and maintain records of risk assessments, control measures, inspections, and training.
WW EHS Standards 109 Version 7 August 2012 21. Process Safety Management [TOC]
BASIC RESPONSIBILITY
The Process Safety Management standard applies to all facilities identified as having a PSM Tier I or Tier II process as identified using the Process Hazard Screening tool in EDGE2. The organization with processes that have been identified as hazardous using the Process Hazard Screening tool shall establish, implement, and maintain a Process Safety Management (PSM) program for managing the hazardous processes and associated process installations to protect employees, facilities, and the environment. Facilities identified as PSM Tier II sites shall apply the requirements of this standard to the PSM covered process within their facility. Sites identified as having a Tier 1 PSM facility or process shall participate in a PSM audit on a three-year cycle, Tier II PSM facility or process shall participate in a PSM audit on a five-year cycle.
MINIMUM REQUIRED ELEMENTS
21.1 Identification of Hazardous Processes
21.2 Employee Participation
21.3 Process Safety Information (PSI)
21.4 Process Hazard Analysis (PHA)
21.5 Operating Procedures (OP)
21.6 Training
21.7 Contractors
21.8 Pre-Startup Safety Review (PSSR)
21.9 Mechanical Integrity (MI)
21.10 Hot Work Permits
21.11 Management of Change (MOC)
21.12 Emergency Planning and Response Plan (EPRP)
21.13 Incident Investigation (II)
21.14 Compliance Audit WW EHS Standards 110 Version 7 August 2012 21.1 Identification of Hazardous Processes
21.1.1 The organization shall utilize the Process Hazard Screening Tool in EDGE2 (see Appendix 1 for reference) to determine if any hazardous processes exist and whether a Process Safety Management (PSM) program is required. Please note that process means any manufacturing or R&D activity involving the use or in-process storage of a hazardous substance.
21.2 Employee Participation
21.2.1 The organization shall establish, implement, and maintain a written plan to ensure and describe employee participation in all aspects of the PSM program. Contractors shall be involved in the PSM program as required by local regulations.
21.3 Process Safety Information (PSI)
PURPOSE
21.3.1 The organization shall develop, implement, document, and maintain a process to obtain or develop appropriate and adequate process safety information (PSI).
RESPONSIBILITIES
21.3.2 The organization shall assign responsibilities to appropriate disciplines and ensure that they fulfill their responsibilities, including the following:
• Process Development shall:
– Obtain or develop appropriate process safety information for their products and processes (Center of Excellences at J&J, i.e., Corporate EHS, Process Safety Center, Toxicology, Engineering, etc. should be involved for the data generation and their expertise);
– Conduct hazard analysis and process studies at various stages of the new product development to identify hazards, safe operating conditions and consequences of deviation from the safe operations limits; and
– Include process safety information in the process transfer package.
• Process Development and Manufacturing Operations shall conduct appropriate process hazard analysis of new processes to be
WW EHS Standards 111 Version 7 August 2012 introduced in production.
• Manufacturing Operations shall obtain or develop appropriate process safety information data for established products and for process changes in established products.
PROCEDURES
21.3.3 The organization shall ensure that the process safety information are sufficiently detailed based on the complexity of the operations, the hazard severity of the chemicals used in the process, the physical hazards presented by the equipment, the potential number of employees that could potentially be involved in an incident, the known, or perceived, operating history of an existing, or conceptualized, operation.
21.3.4 The organization shall establish a mechanism for control, coordination and maintenance of process safety information for effective development, compilation and dissemination of the process safety information.
• Document control activities shall include: document layout, approval, issue, filing, change, modification, distribution and eventual removal of obsolete documents. The information present in specified documents, like MSDS, is subject to document control.
• Aspects of document control shall include that: – All documents have a unique identification; – Documents are periodically reviewed and updated; and, – Current versions of documents are available where needed for proper performance.
21.3.5 The organization shall utilize the following tables to determine the required process safety information at various stages in the development process. In the tables to follow, the “A” column represents the stage in which this information is advisable, and the “R” column represents the stage in which the information is required. The numeric coding of these stages is as follows:
Table Legend:
(1) Laboratory scale processes (2) Introductory pilot plant processes (First scale-up processes in pilot plant installations) (3) Developmental pilot plant processes (Development phase between first scale-up batches in pilot plant and full scale production) (4) Introduction to full scale production (Late stage development or existing commercial production)
WW EHS Standards 112 Version 7 August 2012 A. Compound Characteristics
A1. Compound Identification
Item Required for Source A R (*) (*) Name: Chemical Central database or - 1 Chemical compounds chemical catalogues or Name and/or MSDS Reference CAS-Number Common raw CAS-database 2 materials and intermediates when available
A2. Physical Properties
Item Required for Source A R Physical state Chemical Chemical catalogues or 2 4 at ambient compounds MSDS temperature Density Liquid raw Chemical catalogues or 3 4 materials MSDS Melting point Solids Central database, 2 4 except for higher chemical catalogues, melting compounds MSDS or testing lab like metals, carbon and inorganic salts Boiling point Low boiling liquids Central database, 2 4 or gases chemical catalogues or MSDS Vapor Solvents Literature or MSDS 2 4 pressure at ambient temperature Conductivity Solvents Literature, MSDS or 2 3 (classification: testing lab high/low)
WW EHS Standards 113 Version 7 August 2012
A3. Health Characteristics
This section helps to communicate in a summary fashion the concerns that should be addressed in a Process Hazard Analysis.
Item Requirements Source A R Emergency Immediate MSDS Emergency 2 3 overview emergency Overview or Hazards response concerns Identification Section and/or Label. First aid Measures to MSDS’s medical and 2 3 ameliorate the safety professionals effects of accidental exposure Exposure PBOEL-HHC and J&J OEL/PBOEL-HHC 2 3 limits OEL for active list; products and PBOEL-HHC for isolated process intermediates (J&J) Other compounds: MSDS suppliers, 2 3 gather exposure literature limits available from suppliers Potential Qualitative MSDS Emergency 2 3 health effects description of Overview or Hazards potential adverse Identification Section. health effects Should be supported by (acute or chronic) tox. data in the Tox. of exposure to the Information on MSDS substance
WW EHS Standards 114 Version 7 August 2012 A4. Safety Characteristics (Fire and Explosion)
Characteristics with source “testing lab” are explained at the Process Safety Center website http://psc.jnj.com
Item Required for Source A R Flammability Lower explosion Gases and Literature, MSDS 2 4 limit (LEL) solvents Upper explosion limit (UEL) Flash point Liquid raw Literature, MSDS or 2 4 materials; testing lab volatile liquid intermediates Burning Isolated solids Testing lab 2 4 behavior exposed to elevated temperature or milled Auto-ignition Volatile Literature, MSDS or 1 2 temperature compounds with testing lab liquid specific chemical functionality (*1) Pyrophoric Compounds with Literature, MSDS 1 2 properties specific chemical functionality (*2) Substances and Compounds with MSDS, testing lab 3 4 mixtures which metals or in contact with metalloids in the water emit chemical flammable structure gases Thermal Stability Exothermicity Liquid and solid MSDS, testing lab 1 2 compounds Ignition Solid compounds MSDS, testing lab 3 4 temperature which show large exothermicity in air; aerated test; Grewer test
WW EHS Standards 115 Version 7 August 2012 Item Required for Source A R Gas evolution Liquid and solid Testing lab 2 2 during compounds if decomposition large exothermicity is observed within 50 °C of process temperature range Explosive Properties Shock Materials with MSDS or testing lab 1 2 sensitivity specific chemical functionality (*3) or high decomposition energy
Dust Explosion Minimum Powders Testing lab - 4 ignition energy suspended in air Minimum Powders Testing lab 4 - ignition suspended in air temperature dust cloud Electrical Powders Testing lab 4 - Volume Resistivity Dust explosion Powders Testing lab - 4 severity, class, suspended in air KSt, Pmax as for example fast rotating mills and fluidized bed dryers (to prove adequacy of pressure shock resistant or vented equipment)
(*1)(*2)(*3) Specific chemical functionality See Bretherick’s Handbook of Reactive Chemical Hazards, http://www.hazmatnavigator.com
(*1) auto-ignition temperature (AIT) Index: Autoignition temperature
WW EHS Standards 116 Version 7 August 2012
(*2) pyrophoric properties Index: Pyrophoric alloys respectively catalysts, materials and metals
(*3) explosive properties Index: Explosibility
A5. Environmental/Ecological Characteristics
Information in this section is not directly related to the Process Safety Management program. However, the information should be readily available in the material balance and chemical characteristics tables generated in the process safety information. It serves to integrate the use of data in several programs and avoids duplication of effort.
The EARTHWARDSTM process (former DfE, Design for Environment) is also an essential part of the design of a process (J&J Worldwide EHS Standard). The J&J EARTHWARDSTM tool gives guidance for the environmental assessment of all new and redesign of products, processes, and/or packaging in various phases of development cycle, including early phases.
Item Requirements Source A R Wastewater a) Acceptable levels of Literature sources 2 3 Treatability toxicity to waste water internal studies or treatment organisms laboratory tests. b) Sufficient biodegradation Hazardous Sources, composition of Material balance 2 3 Waste streams. calculations or chemical analysis Recuperation Evaluation of Literature sources, 3 4 of waste recuperation of waste internal studies or streams streams laboratory test Solid Waste Sources, composition of Material balance 3 4 streams. calculations Gaseous Sources, composition of Material balance 2 3 Waste streams calculations
WW EHS Standards 117 Version 7 August 2012 A6. Compound Interactions
It is advisable that the compatibility (both chemical as with the processing materials) is present at the stage of introduction to pilot plant operations. It is required before introduction to commercial production scale.
A7. Chemical Compatibility
The chemical structure of a compound is used to determine if the compound is thermally, physically and chemically compatible with other chemicals used in a chemical process with the goal of preventing an unwanted reaction and toxic, explosive and/or flammable release. Compounds that may have no hazardous chemical reactivity properties in themselves may become hazardous upon mixing, therefore the effects of inadvertent mixing should be evaluated.
Potential chemical interactions between chemical compounds as well as those with air, oxidizing agents and reducing agents should be investigated.
A8. Compatibility with Processing Materials
Interaction of chemical compounds with processing materials and materials of construction should be evaluated. Interactions between materials during storage should also be evaluated. Possible interactions include corrosion and contact with air, nitrogen, steam, heat transfer fluids, light, vitreous enamel, stainless steel, iron, metals present in trace quantities.
B. Process Characteristics
B1. General Information
Item Requirements Source A R Block flow Major process -New processes/process 3 4 diagram equipment, transfer: and/or interconnecting Process and technology process flow process flow lines transfer documentation diagram and parameters (process owner) -Existing processes: production plant.
WW EHS Standards 118 Version 7 August 2012 Process Desired chemical -Process owner 1 2 chemistry reaction, side (Process and technology reactions relevant transfer documents) for possible scenarios of highly hazardous chemical release
B2. Safety Considerations
Normal Conditions:
Item Requirements Source A R Material Material balance data Possible sources are 3 4 balance must be specified in the waste cards, block flow appropriate detail and/or process flow depending on the diagrams, development possible process hazards information Energy Required for exothermic Manufacturing plant 2 3 balance reactive systems which (equipment specific!) demonstrate substantial heat accumulation (semi- batch reactions not controlled by dosing or batch exothermic reactions) Heat of Required for exothermic - Process owner 2 3 reaction reactive systems which - Safety testing lab could demonstrate substantial heat accumulation (f.e. > 50 degree Celsius theoretical adiabatic temperature rise) Gas Only if obvious from - Process owner 2 3 generation material balance and/or - Safety testing lab Rate of gas process chemistry generation* Safe upper Safe upper and lower Process Development 2 3 and lower limits for safety critical and Operations. limits parameters defined in Limits set based on the process. - Development knowhow - Process safety studies - Plant capabilities
WW EHS Standards 119 Version 7 August 2012 Abnormal Conditions:
This section should cover an evaluation of potential hazards (fire, explosion, occupational injury, potential adverse health effects to employees and host communities, etc.) resulting from an uncontrolled deviation. Typical PSI that shall be included in this section is maximum rate of temperature rise, maximum rate of pressure rise, exotherm onset temperature, etc. The operational conditions and ranges should be established and the consequences of deviation from the recommended ranges should be included. A preliminary evaluation of the process should be conducted to determine the pertinent process safety information.
C. Equipment Characteristics
The process safety information required for the equipment used in a process is governed by applicable regulatory statutes. This information can also be used to support the relevant qualification (DQ, IQ and OQ) and the mechanical integrity efforts. See Mechanical Integrity PSM chapter.
The following minimum information shall be compiled for the equipment involved in the process: – Information about the safety systems and process controls – Interlocks in automated systems – Monitoring devices (e.g., in-process monitoring, emission monitoring) – Emergency shutdown systems – Relief system design and design basis – Ventilation system design and design basis – Piping and instrumentation diagram (P&ID) – Specifications (e.g., pressure, temperature, flow, special conditions) – Materials of construction – Design codes referenced by good engineering practices or regulatory statutes (e.g., pressure vessels, storage tanks, pumps) – Standards – Electrical classification – Piping systems including physical dimensions, construction materials, gaskets, O-rings, valves – Plant energy balance based on process design intent.
WW EHS Standards 120 Version 7 August 2012 21.4 Process Hazard Analysis (PHA)
PURPOSE
21.4.1 The organization shall develop, implement, document, and maintain a process for conducting Process Hazard Analysis (PHA) and subsequent revalidation to prevent acute major and catastrophic events such as accidental hazardous product or energy releases, fires, explosions, unexpected process upsets from strong exothermic reactions, or the release of large volumes of gas.
RESPONSIBILITIES
21.4.2 The organization shall assign responsibilities to appropriate disciplines and ensure they fulfill their responsibilities, including the following:
• R&D shall:
– Perform physical hazard and reaction hazard testing and assessment for processes performed in the pilot plant and manufacturing operations; and
– Conduct process hazard analysis using appropriate review techniques to enable the design of safe and robust processes.
• Manufacturing Operations shall:
– Develop a list of potentially hazardous processes for their area or project responsibility. After initial development, the list shall be kept up to date as part of the Management of Change process;
– Conduct a PHA for applicable processes prior to the introduction of the process in the manufacturing plants (the Process Hazard Screening Tool helps to identify hazardous processes that need to undergo a complete PHA); and,
– Obtain or develop appropriate data (e.g., Incidents, deviation, and relevant technical data) for established products and for process changes in established products.
21.4.3 The team leader of the PHA shall be responsible for acquiring the resources necessary to review the equipment or process successfully. It is the team leader’s responsibility to assure that the review is intensive and covers all foreseeable hazardous aspects of the equipment or process. The team leader is also responsible for the documentation of the process hazard review and communication of the results and recommendations to management.
WW EHS Standards 121 Version 7 August 2012 • Process Engineer, Development Engineer or Facilities Engineer shall:
– Provide drawings and schematics of equipment or processes;
– Participate in the PHA to provide chemical, electrical, biological, and mechanical engineering expertise; and,
– Provide and maintain current (as built) drawings of piping and instrumentation drawings (P&IDs), schematics and other installation documentation work.
• Process Development Engineer shall:
– Describe the process chemistry or dynamics, including potential side reactions such as exothermic reactions and waste streams; and,
– For biotech processes, describe the fermentation/cell cultivation process as well as downstream product isolation and purification steps.
• Process/equipment operators and supervisors shall:
– Participate in the PHA to offer expertise in the operation of the equipment or the execution of the process. In certain plants settings, the Process Development Chemists and/or Engineers may fill this role.
• Health & Safety and Environmental professionals shall:
– Assist management in the risk assessment required to determine whether specific equipment or processes require a PHA; and,
– Participate in the PHA to address health, safety and environmental concerns.
PROCEDURES
21.4.4 The organization shall establish, implement, document, and maintain procedures for conducting a PHA of an existing, modified, or new process that has been identified as potentially hazardous by the use of the Process Hazard Screening Tool, including:
• Existing hazardous processes where additional process information becomes available which will enhance a previously completed hazard
WW EHS Standards 122 Version 7 August 2012 analysis;
• Major equipment installations or significant process changes as determined through Management of Change procedures. (e.g. solvent substitutions, greater than 20% batch size increases or decreases, change in equipment or location, etc.);
• Existing operations where there is a significant change in known or perceived hazards as demonstrated through incident reports, safety testing results, etc.;
• Existing processes or operations that require periodic repeat/ revalidation of the previous study; and,
• New processes or equipment that are not strictly classified as potentially hazardous but are of sufficient complexity to warrant a PHA. EHS department should be contacted to establish the appropriate PHA for these types of operations.
21.4.5 The organization shall set priorities and conduct a PHA for existing processes according to the potential for serious employee or public injury, facility or equipment damage and adverse environmental effects. Criteria to consider in prioritizing the processes for analysis shall include the extent of process hazards, number of people potentially affected, age of the process and operating history.
21.4.6 The organization shall assemble relevant process safety information as described in Section 21.3 (Process Safety Information) concerning the hazards of the materials, reactions and the processes for all operations covered by this procedure.
• Information can be obtained from J&J R&D for J&J-developed materials and reactions concerning thermal stability, explosion potential, chemical reaction hazards, and dust explosion potential as described in Section 21.3 (Process Safety Information); and,
• The equivalent reaction and material hazard information is required for licensed materials and reactions manufactured at J&J locations that were not developed by J&J’s Chemical Process Development. Licensing agreements must require the transfer of all relevant process hazard information. Manufacturing sites are responsible for obtaining any other process hazard information required for the PHA.
21.4.7 The PHA team shall select the particular methodology based upon the team’s experience level, the facility’s familiarity with the technology and the hazards of the materials or reactions. The effective application of any particular methodology depends on its context.
WW EHS Standards 123 Version 7 August 2012 21.4.8 The PHA shall consist of a qualitative review and, in some situations, quantitative studies are necessary. A more rigorous methodology is required if the team has limited experience, is unfamiliar with the chemistry or technology, or when the process involves hazardous materials or reactions. An example of where a quantitative study may be required could be an identified potential for a significant toxic gas release e.g. potential for a large release of chlorine gas.
21.4.9 The organization shall implement the following in the conduct of a PHA:
• Evaluate all processes and significant process modifications for process hazards by means of the Process Hazard Screening tool or by a MOC-procedure in PSM applicable environments. As projects are developed, identify process hazards as early as possible so that appropriate safeguards may be implemented in a cost-effective manner. In addition, comprehensive PHA, using appropriate review techniques, shall be conducted during process and product development when it would enable the design of safer, more robust processes;
• For new construction/modifications of facilities, perform preliminary (design phase) safety analysis before detailed process design commences to identify classes of hazards that may be encountered and recommend appropriate alternatives (e.g., chemical substitution);
• For new construction/modifications of facilities, perform a process hazard analysis, typically a HAZOP, after a well-formulated design is complete;
• Ensure that personnel conducting hazard analyses are trained in the appropriate selection and application of hazard analyses and evaluation techniques;
• Establish process hazard analysis performance specifications to be met during reviews. These specifications shall include requirements for team composition, method selection and documentation requirements;
• Address facility siting. Facility siting is defined as the spatial relationship between the locations of the hazards and the locations of persons who work on-site (i.e., defined work locations where people are assigned to work).
• Develop a program to administer the facility's hazard analyses and evaluation activities. The program shall document which existing processes within the facility require hazard analyses and evaluation studies and provide a schedule for performing them;
WW EHS Standards 124 Version 7 August 2012 • Address the following: – The hazards of the process; – Previous incidents with likely potential for major and catastrophic consequences; – Engineering and administrative controls; – Human factors (e.g. alarm handling, communication during shift change, ergonomic design of interfaces, staffing levels, etc.); and, – Qualitative evaluation of a range of possible safety, health and environmental effects of failure of controls on employees in the workplace based on likelihood and severity;
• Establish a system to promptly address the PHA team findings and recommendations. All findings, recommendations and corrective actions shall be documented;
• Communicate the actions to satisfy recommendations to operating, maintenance, contractors and other employees whose work assignments are in process and who may be affected by the recommendation or action;
• Perform a more comprehensive risk assessment, e.g., Quantitative Risk Assessment, for processes where the qualitative analysis does not provide sufficient information to make risk management decisions. All Quantitative Risk Assessments shall be led by persons properly trained in Quantitative Risk Assessments techniques, and qualified individuals shall be employed to ensure proper application of these sophisticated mathematical techniques; and,
• Keep on file, electronically or on paper, for the life of the process, all evaluations using the Process Hazards Screening Tool or via the MOC process.
21.4.10 The organization shall implement a PHA review process to ensure the following are addressed during PHAs:
• A PHA shall be updated, reviewed or performed at appropriate frequencies to ensure that the studies are consistent with current processes and operating practices. At a minimum, each PHA shall be reviewed within five years of the original date, unless the process has been discontinued or has not been scheduled for production. The frequency can be impacted by the perceived or known hazards, the risk of the operation, the stability of the operation, the magnitude or the number of changes to the operations, incidents happened, but the maximum interval stays 5 years;
• A review shall consider the following:
WW EHS Standards 125 Version 7 August 2012 − checks to ensure that modifications to processes since the last PHAs have gone through management of change procedures or PHAs; − an evaluation of process safety information (PSI) to ensure that it is complete, current and accurate; − verifications to ensure PHA specified procedures are adequate, up-to-date, and are being implemented; − determinations that existing PHA recommendations have been documented and implemented; and, − a review of all incident investigation reports to assure appropriate information from the reports has been added to PSI and has been incorporated into PHAs;
• The PHA shall be kept on file, electronically or on paper, for the life of the process, all initial PHA studies, updates or reviews and documented resolutions of recommendations;
• PHA documentation shall include the participants' names, their experience and the required functions they fulfill in records of the process hazard analysis;
• The organization shall ensure the competencies of the process hazard analysis team:
– Leader with formal training in the process hazard analysis technique that is used for the analysis; – Person with a thorough understanding of plant and/or process technology; – Person with a thorough understanding of the process (or equipment to be installed) under both ideal and stressed conditions; – Person able to interpret hazard data; – Environmental, Health & Safety representative, as required; and, – Operations/maintenance/process control representatives, as required;
• The risk matrix illustrated below (or equivalent) shall be used for PHA (HAZOP and SWIFT). The numerical Risk Score shall be compared against qualitative risk descriptions. Formal risk assessments require assumptions about operations, probabilities and impact that should only be made by personnel experienced in the operations and knowledgeable of the limitations in applying probabilistic models.
It is not the intention to re-evaluate all the risk assessments that have been done in the past years. The 5x5 matrix shall be used after implementation in the site specific procedures. For PHA-reviews, the
WW EHS Standards 126 Version 7 August 2012 5x5 matrix shall be used if there are more than 20% of the scenario’s changed during a review or as a part of MOC.
During a PHA it is important to evaluate the risk three times:
– First: the risk is assessed, without account being taken of the effectiveness and efficiency of existing preventive measures/controls = naked risk.
– Second: the risk is re-assessed with account being taken of the reliability, effectiveness and independence of existing preventive measures/controls
− Third: the risk is assessed with account being taken of the reliability, effectiveness and independence of existing and recommended preventive measures/controls.
Likelihood Risk Prioritisation Matrix 1 2 Severity Description Frequency Likelihood Insignificant Minor Serious Major Catastrophic 124610 One or more times per year x ≥ 100 Likely 10 10 20 40 60 100 Between 1 time per year and 1 -1 0 Possible 6 time per 10 years 10 ≤ x < 10 6 12243660 Between 1 time per 10 years -2 -1 Unlikely 4 and 1 time per 100 years 10 ≤ x < 10 4 8 16 24 40 Between 1 time per 100 years -3 -2 Very Unlikely 2 and 1 time per 1000 years 10 ≤ x < 10 2 4 8 12 20 Less than 1 time per 1000 -3 Extreme Unlikely 1 year x < 10 124610
LOCAL COMMUNITY & Limited annoyance, no Serious annoyance, no Reversible health Adverse health effects, No annoyance REPUTATION injuries injuries effects one or more fatalities
Severe injuries, 1 fatality on the site, Several fatalities on the HEALTH & SAFETY First aid cases, limited Severe injuries, permanent impairment, explosion or fire with site, explosion or fire STAFF injuries temporary impairment explosion or fire with moderate with serious limited consequences consequences consequences
SEVERITY Limited environmental Limited pollution Severe pollution ENVIRONMENTAL Minor release or spill Pollution on the site annoyance outside the site outside the site Financial loss < 20,000 20,000 $ ≤ Financial 200,000 $ ≤ Financial 2,000,000 $ ≤ Financial Financial loss ≥ BUSINESS IMPACT $ loss < 200,000 $ loss < 2,000,000 $ loss < 20,000,000 $ 20,000,000 $
Risk Classifications & Required Control Measures3 Immediately stop activities. V V Extreme High Risk Redesign needed - only technical solutions are allowed Measures are EHS critical measures Immediate implementation of risk reduction measures IV IV High Risk Permanent solutions required before next use: technical solutions are preferred Unacceptable* Measures are EHS critical measures Implementation of risk reduction measures Adequate programs like training, procedures, maintenance etc. are in place, but preference will III III Moderate Risk be given to technical solutions Measures are EHS critical measures if severity is major or catastrophic Attention required II II Low Risk Adequate programs like training & procedures are in place ALARP principal should be used (As Low As Reasonable Possible) Acceptable Very limited risk IIExtreme Low Risk No risk reduction measures required
(1) See SEVERITY TABLE sheet for more detailed information on the severity categories (2) See LIKELIHOOD TABLE sheet for more detailed information on the lik elihood categories (3) For every risk mitigation, the HIERACHY OF CONTROLS should always be evaluated * if residual risks of class III, IV or even V exists, those should always be approved by management
21.5 Operating Procedures (OP)
21.5.1 The organization shall establish, implement, document, and maintain operating procedures (OP) that provide detailed descriptions of the task(s) to be performed including operating conditions, emergency procedures, sampling and record keeping requirements, along with any other special precautions and procedures that shall be followed in order to perform the operation safely.
WW EHS Standards 127 Version 7 August 2012 21.6 Training
21.6.1 All employees, including “non-J&J” maintenance and contractor employees, involved in a hazardous process shall be trained in and cognizant of the safety, health and environmental hazards of the chemicals and processes they work with for the protection of themselves, their fellow employees, company assets, and the communities in which the operation resides.
21.6.2 The organization shall establish, implement, and maintain a training program that includes:
• Initial startup, normal operations, temporary operations, emergency operations, normal shutdown, emergency shutdown and startup following a turnaround or emergency shutdown and startup; and,
• Operating limits, consequences of deviations, steps required to avoid/control deviations, environmental, safety and health considerations (including properties and hazards of chemicals used and precautions for preventing exposure) and safety systems and their functions.
21.7 Contractors
21.7.1 The organization shall ensure that contractors comply with the requirements outlined in WWEHS Standards Chapter 4, Contractor Management.
21.8 Pre-Startup Safety Review (PSSR)
PURPOSE
21.8.1 The organization shall develop, implement, document, and maintain a process to perform a Pre-Start Up Safety Review (PSSR) prior to the introduction of hazardous chemicals into a process to verify that it is in a safe condition prior to use in order to prevent the release of hazardous materials or energies that can endanger employees, contractors and visitors, public safety, Johnson & Johnson (J&J) facilities, community and the environment, from new or infrequently used processes.
21.8.2 The PSSR shall be designed to confirm the following:
• Equipment and supporting structures are suitable for their intended purpose and have been installed in accordance with design specifications as well as with all applicable government regulations and company policies;
WW EHS Standards 128 Version 7 August 2012 • That a Process Hazard Analysis (PHA) has been completed (when required) for processes and facilities and that critical recommendations from the PHA have been resolved or implemented before start up;
• Adequate safety, operating and emergency equipment and procedures are in place;
• All employees involved (including contractors) have been trained on the applicable safety, operating and emergency procedures; and,
• Potential environmental impacts have been adequately addressed.
SCOPE
21.8.3 The PSSR shall apply to all processes that may present a significant health, safety, or environmental risk, as judged by a “qualified individual” or “group of individuals” in one or more of the following areas:
• Fire, explosion, or life-safety from ignition of gases, liquids, or finely- divided solids with explosion potential;
• Sudden release of stored energy or chemical reactivity; and/or,
• Direct or indirect adverse effects, resulting from acute or chronic exposures, on living organisms and the environment.
21.8.4 All new and existing processes shall be considered for a PSSR, including Pilot Plant and full-scale batch and continuous manufacturing processes, regardless of site, and irrespective of the quantity of chemical used. Processes involving the use of heat or steam for specific applications, such as steam sterilizers, shall be included.
21.8.5 A PSSR shall be conducted prior to the introduction of hazardous chemicals into infrequently used, idle or entirely new equipment or processes, or a facility that has been modified to the extent that a change in PSI is required. A PSSR is not required for minor equipment or process changes which are typical for batch plant operations. However, a documented safety evaluation by qualified persons is recommended.
RESPONSIBILITIES
21.8.6 The organization shall provide adequate resources, including financial, for the implementation of the PSSR program.
21.8.7 The organization shall assure resolution or final disposition of all recommendations resulting from any PSSR. WW EHS Standards 129 Version 7 August 2012 PROCEDURES
21.8.8 The organization shall implement a PSSR management system for PSM covered processes that includes the following:
• Team Formation - The PSSR shall normally be conducted by a cross functional team usually consisting of a range of individuals with different areas of expertise and including where appropriate, the project manager and representatives from; manufacturing, engineering, environmental, safety, process technology as well as scientists, operators, contractors, maintenance crew, managers or other people with relevant skills or knowledge.
• Process Evaluation - The PSSR shall be conducted by performing in the field verification. Observations should be made following commissioning and PHA activities. Field observations need to be recorded and documented as part of the PSSR.
• Field observations shall be reviewed by the cross function team who together decides which items are given a critical or non-critical priority. When the criticality of an item is not wholly evident, a determination can be made by the use of a risk assessment.
• Critical items shall be addressed prior to the introduction of hazardous chemicals or energizing the system. Non-critical items may be resolved at a time after start up depending on the risk level assessed for that item. Non-Critical items must be managed to completion by a suitable corrective action database, with appropriate management oversight.
• The PSSR is complete once all follow-up actions for critical items have been completed and non-critical actions have been assigned timing for future action along with responsible person and target due date.
Note* Pre-Start Up Safety Review checklist examples are located in the J&J WWEHS Homepage PSM section
21.9 Mechanical Integrity (MI)
PURPOSE
21.9.1 The organization shall develop, implement, document, and maintain a process to ensure that identified critical process equipment and utilities are designed, constructed, installed, maintained and operated properly to prevent the potential release of hazardous materials or energies.
WW EHS Standards 130 Version 7 August 2012 This procedure shall apply to all PSM covered equipment, utilities and systems.
RESPONSIBILITIES
21.9.2 The organization shall provide adequate resources necessary to develop and implement systems and processes to ensure the Mechanical Integrity requirements included in this standard are fulfilled.
21.9.3 Site Engineering/Maintenance Management shall implement the mechanical integrity program as well as monitor, resolve deficiencies, and report to senior management the performance of the program.
21.9.4 The organization shall operate and maintain equipment within the design parameters for which they were intended.
PROCEDURES
21.9.5 The mechanical integrity program shall consist of the following elements:
• Define the basis of equipment criticality; • Complete a criticality assessment of the equipment and systems; • Maintain a current list of critical equipment and systems; • Engineering and/or general industry standards (ASME VIII, DIN, AD- Merkblatter, API, etc.); • Preventive and Corrective Maintenance procedures; • Inspection and Operational Testing; • Quality Assurance; • Criticality spare parts inventory management; • Identification, evaluation and corrective action of equipment deficiencies; • Training; and, • Documentation.
21.9.6 Written procedures shall be established and implemented that specify the maintenance required to ensure the ongoing integrity of process equipment, utilities and systems.
21.9.7 Preventive maintenance shall be performed, including inspections and tests, to maintain process equipment and utility systems’ ongoing integrity.
21.9.8 A quality assurance system shall be included in the mechanical integrity program ensuring proper materials of construction are used, fabricated, inspected and installed according to the equipment qualification requirements. The QA assurance system shall include:
• Documentation, including “As Built” drawings, certifications of coded vessels and other equipment, as well as materials of construction; WW EHS Standards 131 Version 7 August 2012 • Maintenance of equipment, utilities and systems to allow field inspection and verification that specifications are met;
• Procedures for the installation of safety devices; and,
• Assurance that maintenance materials, spare parts and equipment are compatible for the process application for which they will be used.
21.9.9 Equipment deficiencies shall be corrected before further use, in a safe and timely manner, when required to allow safe operation of equipment, utilities and systems.
21.9.10 The organization shall train employees involved in operation of the equipment as designed. Training shall include: information related to the ongoing integrity of process equipment, utilities and systems, an overview of that process and its hazards, and the procedures required to operate in a safe and knowledgeable manner.
Documentation of training shall be consistent with company’s training documentation requirements. If unique qualifications or certifications are required of the affected personnel, management shall ensure the requirement is met.
21.9.11 The organization shall maintain documentation of current equipment, utilities and systems as required for the mechanical integrity program. Documentations shall include: Site Layout Drawings, P&IDs, Process Flow Diagrams, Area Electrical Classifications, As-built Drawings, Equipment Specifications including construction material, Relief system design basis, etc.
21.10 Hot Work Permits
PURPOSE
21.10.1 The organization shall develop, implement, document, and maintain a process to establish a safe working environment for operations involving hot work conducted on equipment or facilities where the hot work could cause fires and/or explosions. The process shall facilitate a formal communication and decision process with all involved parties to execute hot work activities. In addition, the requirements specified in Chapter 24 “Permit Required Work & Non-routine Activities”, shall apply.
RESPONSIBILITIES
21.10.2 The organization shall develop and implement adequate systems and procedures to fulfill all requirements on hot work as outlined in this standard, including:
WW EHS Standards 132 Version 7 August 2012 • Delegation of responsibility to line personnel for ensuring that detailed hot work requirements are enforced and shall neither lessen nor relieve authorized persons of final responsibility;
• Training of the fire watch in hot work hazard recognition as well as the use of atmospheric monitoring equipment. The fire watch shall perform no activities that might interfere with their primary duty to monitor the hot work activity; and,
• Development of a safe working process for operations involving hot work conducted on equipment, materials, or facilities where the work could cause fires and/or explosions.
PROCEDURES
21.10.3 The organization shall ensure hot work in situ shall be avoided to the maximum extent; other alternative work methods shall be explored as a first choice (e.g. disconnect duct or piping in the hazardous workplace and perform the hot work in the maintenance shop).
21.10.4 The organization can specify areas exempt from this procedure after documenting a thorough review identifying the area to be free of hot work hazards. An example would be areas of new construction (when no flammable materials are present), maintenance shop (e.g., designated welding area), etc.
21.10.5 The organization shall develop, implement, document, and maintain a process to conduct a “Hazard Identification/Risk Assessment” that addresses the following:
• Before performing any hot work, all hazards associated with the task shall be identified;
• Each hazard identified must have its level of risk assessed. The assessment shall consider at a minimum the following: – The task required; – The range of methods by which the task can be safely performed; – The selected method by which the task will be performed and the equipment to be used (including the required fire protection); – Emergency response procedures; and, – The number of persons and certifications or training required for the task.
• All affected parties (e.g., management, employees, contractors, H&S professional) shall be involved in this initial hazard identification and risk assessment.
WW EHS Standards 133 Version 7 August 2012 21.10.6 The organization shall develop, implement, and maintain a process to implement “Control Measures” which address the following:
• If the risk assessment identifies a risk to health or safety arising from the proposed task, the risk shall be eliminated or minimized to negligible levels by implementation of appropriate risk control measures, following the hierarchy of controls;
• The following are choices listed from most to least preferred to address hot work: – Employ a different method of performing a task that does not involve hot work; – Move the hot work to a location free from flammable and/or combustible materials and their handling; – Move the flammable or combustible materials to a safe distance, or properly shield combustible materials; – Schedule the hot work when operations will not be performed that could expose flammable or combustible materials (e.g., any transfers, opening of vessels, sampling or filling of containers with flammable or combustible materials) and verify that flammable vapor concentrations are at safe levels; or, – Shut down air handlers, or seal off entering or exiting air produced, via air handlers that are near the hot work hazard zone;
• When hot work is performed in potentially hazardous atmospheres, atmospheric monitoring (Oxygen, Lower Explosion Limit, etc.) shall be continuous;
• Previously used equipment brought into shops for hot work shall be tested and be free of flammable materials/vapors. Persons trained in the use of Oxygen/Lower Explosion Limit meters shall be involved in this review process; and,
• When the emergency alarm is sounded, the hot work shall be stopped immediately. Work shall not resume until a risk assessment and atmospheric testing has been completed.
21.10.7 The organization shall develop, implement, and maintain “hot work” documentation that meets the following requirements:
• The organization shall use a consistent format, using a standardized form (hot work permit) for assessing the hazards and defining the safety precautions;
• As a minimum, the hot work permit shall contain the following: – Date authorized for the work and time of issuance; – Effective dates and times of the permit; WW EHS Standards 134 Version 7 August 2012 – Location and outline of work to be performed on which object; – Approvals and clearances (involved departments, sections, units, etc.); – Precautions to be taken; – Atmospheric testing (Oxygen, Lower Explosion Limit, etc.); and, – Emergency procedures;
• During the hot work activity, atmospheric testing results shall be recorded on the permit every 30 minutes;
• Issued permits (or a copy) shall be conspicuously displayed at the worksite for the duration of the work. They shall be protected from damage and other causes that could result in degraded legibility;
• Management and affected employees shall to be trained in the hot work process;
• The organization shall establish practices to be followed for managing records for the hot work permits. Responsibilities for the management of the documents shall be clearly designated; and,
• The hot work permits shall be kept on file for 1 year for auditing purposes of the program.
21.10.8 The organization shall develop, implement, document and maintain a process to perform an annual program evaluation to ensure the program is effective and remains in compliance with the requirements of this standard.
21.11 Management of Change (MOC)
PURPOSE
21.11.1 The organization shall develop, implement, document, and maintain a Management of Change process to ensure changes to a process do not inadvertently introduce new hazards to the process or unknowingly increase the risk of existing hazards in the process.
RESPONSIBILITIES
21.11.2 The organization shall develop and implement adequate systems and processes to ensure the Management of Change procedures are fulfilled.
21.11.3 The organization shall ensure that the appropriate disciplines (operations, engineering, maintenance, safety, environment, sales, research and development, etc.) are involved in the MOC process, and ensure that all are adequately trained to fulfill their responsibilities.
WW EHS Standards 135 Version 7 August 2012 PROCEDURES
21.11.4 The organization shall ensure that each Change Request is documented and include the following elements:
• Reasons for the change; • A description of the change; • Time and quantity limits of the change, if the change is not permanent; • Initiator of the change; and, • An approval system for the change by the appropriate functions and management.
21.11.5 The organization shall develop, implement, and maintain a Change Request Review and Approval process that ensures the following:
• Potential environmental, health and safety impacts associated with the proposed change are identified, evaluated, and documented;
• Risks introduced by the proposed change are adequately mitigated;
• EHS personnel are involved in the identification and evaluation of environmental and safety impacts;
• Evaluation and mitigations are fully documented;
• Historical risk assessments (i.e. Hazard Operability studies) associated with a process being changed are reviewed and updated as appropriate; and,
• A formal sign-off by appropriate levels of management and functions to ensure the change is necessary, has been properly evaluated, and mitigations (if any) have been identified prior to the change being executed.
21.11.6 The organization shall ensure the MOC Mitigation Action Plan and Follow Up address all of the following:
• For each MOC where mitigations are identified, a documented corrective action plan shall be developed. The action plan shall include details that outline the risks, control measures, responsibilities and target dates for achieving mitigation objectives;
• Corrective actions required to close out safety or environmental items must be completed prior to process startup;
WW EHS Standards 136 Version 7 August 2012 • Periodic reviews and inspections shall be completed to ensure full implementation of the corrective action plan;
• As appropriate, reviews and inspections shall address the following:
– Formal review prior to the start of change; – Frequent reviews during the change process; – Pre-start-up site inspection or a detailed Pre-Startup Safety Review; and, – Total system review once the system is in operation to validate the proposed change is working as intended.
21.11.7 The MOC process shall ensure that affected personnel are informed of the change and provided necessary training prior to the implementation of the change.
21.11.8 The MOC process shall address emergency changes that may occur outside the scope of the normal change approval process. These emergency changes shall be approved by authorized individuals and then submitted in the normal MOC process for formal approval as soon as practical.
21.11.9 The MOC process shall ensure that temporary changes have a defined expiration date and a process to ensure that once the expiration date for the temporary change has passed the system is converted back to its original specification.
21.11.10 The final step of the MOC event is the closure of the change process which shall include a formal approval that the implementation of the permanent change and any completion of identified corrective actions have been executed according to plan and that any temporary changes have been removed or reassigned.
21.11.11 The organization shall conduct, at least annually, a review of the MOC program to ensure the process is effective and remains in compliance with the requirements of this standard.
21.12 Emergency Planning and Response Plan (EPRP)
21.12.1 The organization shall establish, implement, and maintain a written plan and conduct drills for potential emergencies, consistent with the requirements in Chapter 3, Emergency Preparedness and Response, to ensure effective response by the site, along with the community, to mitigate the impact on people, the facility, and the environment.
21.13 Incident Investigation (II)
21.13.1 The organization shall establish, implement, document, and maintain a process for the investigation of all incidents and near-incidents to prevent occupational injuries & illnesses and unwanted environmental impacts.
WW EHS Standards 137 Version 7 August 2012 21.14 Compliance Audit
21.14.1 The organization shall periodically evaluate compliance with the process safety requirements, including the adequacy of procedures and practices and whether they are being followed.
21.14.2 PSM facilities & processes designated as Tier I per the “Process Hazard Screening Tool” (see Appendix I) shall be audited against the “J&J Process Safety Management (PSM) Tier I Assessment Process”.
21.14.3 The compliance audit shall be conducted by at least two people trained as PSM auditors for the Tier I assessments. The number of trained PSM auditors for Tier II assessments shall be commensurate with the complexity of the PSM process and determined by the PSM lead auditor. Audit findings, action plan, and resolution of identified deficiencies shall be documented.
21.14.4 The two most recent compliance audit reports shall be retained on file.
WW EHS Standards 138 Version 7 August 2012 22. Machinery, Electrical, and Powered Industrial Vehicle Safety [TOC]
BASIC RESPONSIBIITY
The organization shall establish, implement, and maintain programs and processes to ensure machinery and equipment is purchased, built, operated, and serviced in accordance with the J&J Zero Access™ philosophy; prevent electrical shock or arc blast injuries; provide safe installations and electrical maintenance practices that protect personnel from the unexpected release of hazardous kinetic and potential (stored) energy; and, ensure the safe and environmentally conscious use of person-operated Powered Industrial Vehicles (PIVs).
MINIMUM REQUIRED ELEMENTS
22.1 Machine Safeguarding Process
22.2 Hazardous Energy Control (Lock Out/Tag Out) Program
22.3 Electrical Safety Program
22.4 Powered Industrial Vehicle Program
22.5 Training
WW EHS Standards 139 Version 7 August 2012 22.1 Machine Safeguarding Process
22.1.1 The organization shall establish, implement, and maintain a process for conducting a risk assessment, using WRAPS or equivalent, to determine conformance with J&J Zero Access™ philosophy, i.e., ”Hazardous parts shall not be accessible during normal and/or abnormal operation either intentionally or unintentionally”, of machines purchased or fabricated for use, including the following:
• Machinery in non-production areas operated by J&J employees, including utility support equipment (unless secured against unauthorized access) and pilot R&D equipment; and,
• Machines operated at third party sites, i.e., external manufacturers, but owned by J&J.
22.1.2 Machinery shall be audited by a competent person at 3-year intervals or aligned with the site management of change process, and deficiencies included in a corrective action plan and corrected in a highest-risk-first approach.
22.1.3 Manually-operated shop tools shall be:
• Equipped with “Reach in Protection”;
• Provided with interlocked guarding/braking, when applicable;
• Operated only by suitably trained and skilled employees as determined by local management; and,
• Restricted from operation by unauthorized persons.
22.1.4 The organization shall establish, implement, and maintain a process to ensure that the performance of safety controls for newly acquired machinery is proportional to the risks as determined by use of the risk graph provided in ISO’s Safety of Machinery standard, #13849-1. This standard requires the determination of a required performance level (PLr) and proof that the design of the machine safety controls meets that PLr.
22.1.5 The organization shall establish, implement, and maintain a process to ensure that the architecture for safety related parts of control circuits of existing selected machinery that has the potential to cause amputations or other serious injuries are complying, at a minimum, with the requirements of Category 3 as provided in ISO 13849-1.
• The selection shall be made based upon accident history, near misses, local judgment by experienced people or local legislation
WW EHS Standards 140 Version 7 August 2012 • Equipment already upgraded to Category 3 is grandfathered from this requirement.
22.1.6 The organization shall establish, implement, and maintain a process to:
• Ensure that “high inertia” equipment is suitably protected, i.e., wherever reasonably practical the stopping time should not exceed 1 minute;
• Eliminate unauthorized bypassing of safety systems;
• Communicate the “Code of Conduct” to affected employees; and,
• Include appropriate machine-related behaviors in Behavior-Based program.
22.2 Hazardous Energy Control (Lock Out/Tag Out) Program
22.2.1 The organization shall establish, implement, and maintain a written Hazardous Energy Control Program to protect personnel from unexpected startup, dangerous movement of machinery or equipment during service, maintenance, cleaning or repair.
22.2.2 General lockout/tagout procedures shall be written that address:
• General machinery and equipment operation;
• Special situations such as group lockout and the transfer or removal of lockout devices;
• Use of standardized, durable and difficult to remove locks and tags; and,
• Reliable methods for identifying the employee(s) who applied the lockout device(s).
22.2.3 Each lockout/tagout event shall be conducted in accordance with written procedures that include the following components:
• Preparation for shutdown (e.g., notifying affected employees);
• Preparation for and conduct of machinery or equipment shutdown;
• Isolation of all relevant machinery or equipment energy sources;
• Application of locks and tags;
WW EHS Standards 141 Version 7 August 2012 • Verification of isolation, i.e. an electrically Safe Work Condition shall be established using the three-step process verified by a qualified person and using an approved test instrument when unprotected energized electrical surfaces may be contacted or exposed;
• Release of remaining stored energy; and,
• Return to normal operating condition.
22.2.4 The responsible J&J employee shall coordinate appropriate lockout/isolation practices with outside contractor personnel.
22.2.5 Purchase specifications for new equipment shall require that isolation devices on all sources of energy are lockable in the “off” position.
22.2.6 All Hazardous Energy Control procedures and the functioning of the site’s Hazardous Energy Control processes shall undergo a detailed multidisciplinary review at least once per year.
22.3 Electrical Safety Program
22.3.1 The organization shall designate a knowledgeable individual, e.g., the site Expert Electrical Person, with the authority to oversee electrical installations, activities, and methods from a safety and code compliance perspective.
22.3.2 The organization shall establish, implement, and maintain appropriate electrical safe work practices in accordance with local requirements to utilize insulated tools and require electrical personal protective equipment based on the electrical hazards and risks at the facility.
22.3.3 Work on energized electrical equipment shall be performed only under authorization of a Permit-to-Work approved by the Expert Electrical Person or authorized designee.
22.3.4 The organization shall establish, implement, and maintain specifications for insulated tools, test meters and personal protective equipment that meet applicable standards and regulatory requirements.
22.3.5 The power distribution system shall be maintained in accordance with local requirements to prevent failures, explosions, or fires as a result of improperly maintained, serviced, or adjusted equipment.
22.3.6 One Line Power distribution diagrams and short circuit/fuse coordination/arc flash hazard analysis (as required by local regulations) shall be kept current and accurate.
WW EHS Standards 142 Version 7 August 2012 22.4 Powered Industrial Vehicle (PIV) Program
22.4.1 The organization shall apply requirements provided in Section 26A.1 of the Worldwide EHS standard Chapter 26 – Warehouses & Storage Areas. 22.5 Training
22.5.1 The organization shall establish, implement, and maintain a training program for:
• Machinery/equipment operators, maintenance and supervisory personnel, on the operation and service of machinery and equipment in accordance with manufacturer’s and J&J’s instructions;
• "Affected" employees and other employees who may encounter locked out/tagged out machinery or equipment, on the Hazardous Energy Control Program including the roles and responsibilities of "Authorized" employees;
• Employees and their supervisors who are potentially exposed to injury due to electrical hazards, on the Electrical Safe Work Practices including the roles and responsibilities of “Qualified” and “Unqualified” persons; and,
• Powered Industrial Vehicle operators, on the theoretical and practical training by qualified instructors for each type of equipment to be used.
WW EHS Standards 143 Version 7 August 2012 23. Ergonomics [TOC]
BASIC RESPONSIBILITY
The organization shall establish, implement, and maintain a cultural ergonomics program that helps J&J maintain a workplace free from ergonomics risks and related injuries as well as improve the efficiency, productivity, comfort and well being of our associates. By proactively implementing good ergonomic principles and fitting the job to the person, quality, product design and job satisfaction will be optimized and human error reduced.
MINIMUM REQUIRED ELEMENTS
23.1 Ergonomics Culture
23.2 Ergonomics Risk Identification and Assessment
23.3 Intervention
23.4 Prevention
23.5 Training and Education
23.6 Ergonomics Program Assessment
23.7 Medical Surveillance and Recordkeeping
23.8 Ergo Injury/Illness Investigation
23.9 Ergo Injury/Illness Tracking
WW EHS Standards 144 Version 7 August 2012 23.1 Ergonomics Culture
23.1.1 The organization shall establish, implement, and maintain a site strategy for the development and maintenance of an ergonomics culture.
23.2 Ergonomics Risk Identification and Assessment
23.2.1 The organization shall conduct documented ergonomics risk assessments using the appropriate Ergo Job Analyzer (EJA). All new manufacturing risk assessments shall be carried out using eTools. The risk assessments shall be maintained up to date.
23.3 Intervention
23.3.1 The organization shall establish, implement, and maintain an action plan to mitigate high and moderate risk tasks to the lowest possible level with preference given to engineering controls over administrative controls. Actions shall be prioritized based on the identified risk level.
23.4 Prevention
23.4.1 The organization shall conduct an ergonomics evaluation of new and/or modified equipment, tool, and/or processes, using the ERGO Engineering Design Guidelines, prior to use at the site to ensure that ergonomics risks are not introduced to the facility.
23.5 Training and Education
23.5.1 The organization shall provide appropriate ergonomics training to all employees (new hires, EHS Professionals, medical personnel/health professionals, engineers, skilled work teams). This shall include recognition of the most common work related musculoskeletal conditions and the need for early reporting. Training shall be refreshed periodically.
23.6 Ergonomics Program Assessment
23.6.1 The organization shall establish, implement, and maintain a process to periodically review the site’s Ergo Program to ensure that it is effective in driving a positive ergonomics culture.
23.7 Medical Surveillance and Recordkeeping
23.7.1 The organization shall establish, implement, and maintain a process to encourage effective early reporting of any potential work related ergonomic condition so that effective early interventions can be taken to prevent significant injuries and/or illnesses.
WW EHS Standards 145 Version 7 August 2012 23.7.2 The organization shall establish, implement, maintain, and document a process for medical surveillance in accordance with the requirements in Chapter 18, Occupational Health, and Global Health Guideline on Ergonomics Medical Surveillance. For sites that have on-site Occupational Health resources and demonstrable effective early reporting, then formal periodic medical surveillance may not be required.
23.8 Ergo Injury/Illness Investigation
23.8.1 The organization shall establish, implement, maintain, and document a process to investigate all ergonomics-related recordable cases using the “Learning to Look for Ergonomics” methodology or an equivalent method.
23.9 Ergo Injury/Illness Tracking
23.9.1 The organization shall record and analyze trends (types, causes, numbers, etc.) of ergonomics injuries and illnesses data for the past three years.
WW EHS Standards 146 Version 7 August 2012 24. Control of Permit Required Work and Non Routine Activities [TOC]
BASIC RESPONSIBILITY
The organization shall establish, implement, and maintain a written program to control certain types of work, activities, or tasks that have been identified as potentially hazardous. The preferred system shall be a Permit to Work (PTW) system, but other systems may also be suitable, provided that they can demonstrate a comparable level of control.
The program shall ensure that the hazards associated with the work, activities, or tasks have been identified and that the risks have been assessed. The necessary controls must be agreed upon, implemented, and communicated to those involved in the execution of the work, activities, or tasks.
The system shall be appropriate for the scope and scale of the operation.
MINIMUM REQUIRED ELEMENTS
24.1 General
24.2 Organizational and Procedural Aspects
24.3 Work Permit Related Elements
24.4 Specific Requirements for Confined Spaces
24.5 Specific Requirements for Hot Work
24.6 Specific Requirements for Work at Heights
WW EHS Standards 147 Version 7 August 2012 24.1 General
24.1.1 The organization shall establish, implement and maintain a documented process to ensure that the hazards associated with non-routine work are identified and the risks are assessed. Necessary controls must be agreed upon, implemented and communicated to all involved in the execution of the work, activities or tasks. This standard applies to all non-routine work of a construction or maintenance nature carried out by J&J employees or contractors.
24.2 Organizational and Procedural Aspects
24.2.1 The organization shall establish, implement, and maintain a written process to ensure that all those with responsibility under the PTW system are clearly identified, trained, and aware of their responsibilities.
24.2.2 All individuals issuing permits shall be formally authorized, competent, and suitably trained.
24.2.3 Issued permits shall be suitably displayed at the location where the work is taking place or at another location defined by local management.
24.2.4 A procedure shall be developed and implemented for times when work has to be suspended or extends beyond a single shift.
24.2.5 A system shall be established, implemented, and maintained to enable cross-referencing of permits for work activities that may interact or affect one another.
24.2.6 A formal handover procedure shall exist to ensure that the part of the plant, equipment, or installation affected by the work under the PTW system has been removed from service.
24.2.7 The organization shall establish, implement, and maintain a formal hand back procedure to ensure that the part of the plant, equipment, or installation affected by the work under the PTW system or similar process is in a safe condition and ready for reinstatement after the work is finished.
24.2.8 The organization shall monitor and review all processes, at least annually, to ensure their intended performances.
24.3 Work Permit Related Elements
24.3.1 The system shall provide for a permit document or form (either paper, electronic or a combination of both) that:
• Provides the date the permit is issued and the time for which it is valid;
WW EHS Standards 148 Version 7 August 2012 • Identifies the plant or department/ area/ equipment/ installation for which the permit is valid;
• Cross-reference other permits that may interact or affect one another;
• Clearly identifies and documents the scope, nature and extent of the job at hand and the hazards involved;
• Clearly identifies the measures necessary to control the identified hazards;
• Identifies the person(s) approving the proposed safety control measures. As a minimum this shall be:
– The J&J responsible person, or a formally authorized contractor who represents J&J, issuing the permit; and,
– The person or his authorized replacement in charge of the plant or in charge of the department/area/equipment/installation where the work is undertaken.
• Identifies the people accepting the job at hand and the proposed safety control measures;
• Depending on the scope, scale and complexity of the described job at hand the permit form should provide for the identification of the person granting permission to start the work described on the permit form;
• Identifies the person(s) agreeing that the work is completed and the department/ area/ equipment/ installation on which the permit required work was completed is left in a safe condition. As a minimum this shall be:
– The person or his authorized replacement in charge of the plant or in charge of the department/ area/ equipment/ installation where the work is undertaken; and,
– The person representing the crew that completed the job at hand.
24.4 Specific Requirements for Confined Spaces
General
24.4.1 The organization shall establish, implement, and maintain a written Confined Space Entry Program (CSEP) that details the requirements, including WW EHS Standards 149 Version 7 August 2012 the following, for protecting employees from the hazards of entering Permit Required Confined Spaces (PRCS). Before making an entry, consideration shall be given to other means of performing a required task that makes the need for the entry unnecessary.
• The CSEP shall document specific assignments of responsibility; and,
• If a non-J&J employee (contractor) performs a task that involves a PRCS entry, then the contractor shall be informed that a permit is required prior to entry. The contractor shall be told why the space is a PRCS, the PRCS hazards, and procedures that have been implemented to protect all employees.
Confined Space Hazard Identification/Risk Assessment
24.4.2 The organization shall establish, implement, and maintain a process to conduct and document a facility-wide survey by a qualified person at least every two years to identify and inventory all confined spaces. After the survey is completed, the organization shall determine whether any of the confined spaces shall be classified as a Permit Required Confined Space (PRCS).
24.4.3 The location of all PRCSs shall be formally documented, appropriately communicated, and identified by signage that clearly states DANGER – PERMIT REQUIRED CONFINED SPACE.
24.4.4 All new equipment and installations shall be evaluated as to whether they contain a Permit Required Confined Space. If new equipment is determined to contain PRCS(s):
• The potential hazards of the new PRCS shall be formally evaluated; and,
• The new equipment/PRCS shall be added to the current documented PRCS inventory.
Confined Space Entry Control Measures
24.4.5 The organization shall establish, implement, and maintain a process for authorizing entry into PRCSs throughout the facility by using a standardized written or electronic permit form. It shall be comprehensive to ensure that all conditions affecting safe entry are identified and evaluated, and be completed for each PRCS entry by qualified personnel.
24.4.6 Prior to entering any Permit Required Confined Space, a hazard identification and risk assessment shall be completed and documented (the permit form may incorporate this risk assessment). This process shall address
WW EHS Standards 150 Version 7 August 2012 the potential hazards of the confined space itself and the potential hazards of the specific task(s) to be performed in the space and meet as a minimum the requirements defined in Section 24.3.
Training
24.4.7 Training shall be provided to all personnel assigned PRCS responsibilities. Initial training shall be provided before employees perform PRCS duties. Personnel shall not perform functions relative to entry without receiving proper training. Refresher training shall be provided to maintain competence.
Confined Space Medical Evaluation
24.4.8 All personnel involved in PRCS entries shall undergo a medical evaluation to determine fitness to perform their assigned duties.
Confined Space Rescue and Emergency Response Plan
24.4.9 The organization shall establish, implement, and maintain a formal rescue plan for each PRCS entry. The minimum requirements of this plan shall include the ability to retrieve the entrant(s) in an emergency without requiring any additional personnel to enter the space, e.g., retrieval by use of a lifeline actuated by use of lifting device providing mechanical advantage.
24.4.10 If retrieval of entrant(s) during an emergency requires entry of additional personnel into the space, a rescue team shall be readily available to perform the rescue.
24.4.11 Where primary rescue capability is provided by on-site personnel at time of entry, the organization shall ensure that:
• Each rescue team member is provided with, and trained to properly use, the personal protective and rescue equipment necessary for safely making rescues from PRCSs;
• The rescue and retrieval equipment are regularly inspected to ensure its adequacy and reliability;
• Each rescue team member is trained to perform the assigned rescue duties and receive the same training as authorized entrants;
• Each rescue team member practices PRCS rescues at least annually using appropriate equipment and dead weight manikins to simulate actual facility environments; and,
WW EHS Standards 151 Version 7 August 2012 • At least one (1) rescue team member holds current certification in first aid and cardiopulmonary resuscitation (CPR).
24.4.12 Where primary rescue capability is provided by outside rescue services, the organization shall ensure that the outside rescue services:
• Partner in developing response plans and practice rescue operations on site;
• Are informed of the hazards of the particular PRCS from which they may perform a rescue;
• Are given access to all PRCS from which rescue may be necessary so they can develop appropriate rescue plans and practice rescue operations; and,
• Are contacted prior to each entry to determine whether they should be on-site during the planned entry.
24.4.13 To facilitate non-entry rescue, retrieval systems or similar methods shall be used whenever an authorized entrant enters a PRCS, unless the retrieval equipment increases the overall risk of entry or does not aid in the entrant’s rescue.
Confined Space Program Evaluation
24.4.14 The organization shall evaluate the program, at least annually, to ensure its intended performance.
24.5 Specific Requirements for Hot Work
General
24.5.1 The organization shall establish, implement, and maintain a written Hot Work program to address systems and procedures required to ensure safe performance of Hot Work outside dedicated areas or under specific conditions at the facility, including at a minimum:
• Clear identification of who is responsible for various aspects of the program and the work to be performed;
• A standardized Work Permit form meeting the requirements defined in Section 24.3; and,
• The requirement that Hot Work “in place” shall be avoided to the maximum extent possible and alternative work methods used whenever practical, e.g. disconnect duct or piping in the workplace WW EHS Standards 152 Version 7 August 2012 and perform the Hot Work in an area formally reserved for safe performance of Hot Work.
Hot Work Hazard Identification/Risk Assessment
24.5.2 The organization shall establish, implement, and maintain a process to conduct a risk assessment by all affected parties, e.g., management, employees, contractors, EHS professional, etc., to identify all hazards associated with the Hot Work task and eliminate or minimize the risks to negligible levels by implementation of appropriate control measures.
24.5.3 When dismantling enclosed equipment that previously contained flammable materials, the conduct of Hot Work shall be approved only after all other options have been exhausted.
Hot Work Program Training
24.5.4 The organization shall ensure that affected management and employees are aware of the requirements associated with Hot Work activities.
24.5.5 All employees and contractors with defined roles & responsibilities associated with hot work execution shall be trained in the requirements of the Hot Work program, including the immediate cessation of Hot Work when the site emergency alarm is sounded.
Hot Work Program Evaluation
24.5.6 The organization shall evaluate the program, at least annually, to ensure its intended performance.
24.6 Specific Requirements for Working at Heights
General
24.6.1 The organization shall establish, implement, and maintain a written process to evaluate the risks associated with working at heights, and develop systems and procedures to control those risks, including at a minimum:
• Clear identification of who is responsible for the various aspects of the program and the work to be performed; and
• A standardized Work Permit Form for assessing the hazards and defining the safety precautions of the work to be performed meeting the requirements defined in Section 24.3.
WW EHS Standards 153 Version 7 August 2012 Applicability
24.6.2 The process shall only be used when dealing with non-routine working at heights situations.
Falls from Heights Hazard Identification/Risk Assessment
24.6.3 The organization shall establish, implement, and maintain a process to conduct a risk assessment by all affected parties, e.g., management, employees, contractors, EHS professional, etc., to identify all hazards associated with the Working at Heights task under the permit and eliminate or minimize the risks to negligible levels by implementation of appropriate control measures.
Falls from Heights Rescue and Emergency Response Plan
24.6.4 The organization shall establish, implement, and maintain a formal rescue plan to deal with non-routine working at heights situations. The minimum requisite of this plan shall include the requirement to have a “standby person” who is knowledgeable in “suspension trauma” hazards, i.e., dangerously slow release from fall prevention PPE, and is prepared to summon emergency responders in case the worker’s safety harness is deployed.
Annual Review
24.6.5 The organization shall evaluate the program, at least annually, to ensure its intended performance.
WW EHS Standards 154 Version 7 August 2012 25. Fleet Safety [TOC]
BASIC RESPONSIBILITY
The workplace posing the highest risk for any employee of Johnson & Johnson (J&J) or its affiliates is the vehicle. The purpose of this standard is to outline basic requirements that are intended to protect the safety and well-being of our drivers. J&J drivers are responsible for meeting our business goals and objectives in a safe and responsible manner while exerting a positive impact on the global road traffic system within which they operate and which they share with other road users. The requirements contained in this document must be included in the local fleet safety policies/standards of all operating companies.
Our SAFE Fleet Vision is that “drivers around the world return home safely at the end of each day.”
The objectives of this fleet safety standard are: 1. To protect our employees, families, customers and our community members from injury on the road. 2. To improve the driving skills and behavior of our J&J fleet drivers through education, awareness, driver training and the implementation of recommended support programs. 3. To support Johnson & Johnson and its affiliates to create and sustain awareness and accountability for safe, responsible and fuel efficient driving. 4. To promote safe driving practices and safety standards which contribute to environmental sustainability. 5. To protect the reputation of J&J and its affiliates. 6. To assist our operating groups in reducing the financial impact of fleet vehicle related crashes, incidents and injuries.
MINIMUM REQUIRED ELEMENTS
A. SAFE Fleet (not covered by the MAARS process) 25A.1 Mobile Phones and Other Electronic Devices 25A.2 Motor Vehicle Operation 25A.3 New Hire Eligibility and Driver Requirements 25A.4 Major Driving Events: Classification and Remedies 25A.5 Driver Training and Coaching 25A.6 Vehicle Maintenance and Condition 25A.7 Management Accountability 25A.8 Crash, Incident and Injury Reporting 25A.9 Vehicle Safety Features
WW EHS Standards 155 Version 7 August 2012 B. Plant Vehicle Safety covered by the MAARS process 25B.1 Mobile Phones and Other Electronic Devices 25B.2 Motor Vehicles Operation 25B.3 Driver Training and Coaching 25B.4 Vehicle Maintenance and Condition 25B.5 Vehicle Safety Features
The standards contained herein may recommend practices supplemental to the requirements of local, state, and country motor vehicle legislation. However, nothing herein is intended to replace, amend, supersede or otherwise depart from such requirements. In the event of any conflict or contradiction between the provisions of this document and local legislation, applicable local legislation shall prevail. Each J&J affiliate is responsible for determining and complying with all applicable local legal and regulatory requirements when incorporating these standards into their local policies or standards. Should the J&J affiliate choose to adopt standards that are more stringent than those contained in this document, the J&J affiliate’s standard(s) must be followed.
J&J and its affiliates may authorize persons, including qualified and immediate family members, to drive company-owned or leased vehicles for personal use. Such persons will be referred to in this document, as Authorized drivers. Each country and franchise must determine the eligibility requirements for Authorized drivers.
WW EHS Standards 156 Version 7 August 2012 Application of Fleet Safety Standards to Vehicle and Driver Categories* Vehicle/Driver Categories Worldwide Fleet Safety Standards That Apply All Employees of J&J and its affiliates who drive their Mobile Phone and Electronic Devices personal vehicle on company business. Examples include, but are not limited to traveling between J&J Motor Vehicle Operation companies or any off-site location to conduct business, running of office errands or transportation of a fellow employee or business associate for business purposes. All employees of J&J and its affiliates who drive rental vehicles on company business. Suppliers of transportation services under contract with Mobile Phone and Electronic Devices J&J or its affiliates, such as taxi or other driver services. J&J local affiliates are responsible for ensuring that the Motor Vehicle Operation applicable standards are included and/or referenced as requirements in the contracts with transportation service suppliers. Company owned or leased motorized plant vehicles, Mobile Phone and Electronic Devices security, maintenance and other vehicles used on company site premises or off-site from time to time or Motor Vehicle Operation used regularly to conduct company business. These vehicles are typically shared and driven by more than Note: Other standards that apply, as applicable to one individual. the plant vehicle category, are outlined starting on Page 22.
Authorized drivers of company-owned or leased vehicles Mobile Phone and Electronic Devices other than the employee driver (e.g., spouse or domestic partner). Motor Vehicle Operation
At each J&J affiliate’s discretion, and based on a formal New Hire Eligibility and Driver Requirements authorization process outlined at the company and/or country level, individuals other than the employee may be Major Driving Events: Classification and authorized to drive a company owned or leased vehicle Remedies for personal/non-work related use. Crash, Incident and Injury Reporting
It is ultimately the responsibility of the J&J affiliate Note: Operating companies must establish a employee to be aware of the driving habits/histories of personal vehicle use policy for qualified, employee those authorized to drive the company vehicle, and to family members who are authorized to drive restrict use when requirements are not adhered to. company owned or leased vehicles. The policy must establish who is qualified to become an Authorized driver and outline driver training requirements in order to minimize the added risk. The policy must also address the Authorized driver who has been involved in a Major Driving Event (i.e., falls into a high risk driver category), including the possible loss of vehicle use. Employees of J&J and its affiliates who drive company- All Standards Apply owned or leased vehicles as a regular part of their job and for personal use; and/or employee-owned vehicles driven for company business as a “regular part” of their job; and/or long-term rental vehicles for which the employee receives a regular allowance to cover rental expenses. “Regular part” is defined as more than 10% of the total yearly miles driven with that particular vehicle. Employees who drive their own vehicles typically receive either some form of car allowance to purchase their own vehicle, and/or are reimbursed for fuel, maintenance, WW EHS Standards 157 Version 7 August 2012 parking, insurance and other miscellaneous charges associated with vehicle upkeep, or mileage allowance on a regular basis. This group is generally regarded as the “fleet” audience and may include sales, marketing, service, clinical and other field-based representatives, or management personnel who are eligible for a company vehicle. International transfers or long-term assignees, who are All Standards Apply eligible to receive a company vehicle as part of their compensation package. (Note: Crashes, incidents and injuries involving international transfer drivers must be included within the host affiliate CPMM, IPMM and injury reporting.)
Vehicle/Driver Categories Worldwide Fleet Safety Standards That Apply Persons who are contracted/rented to work solely for J&J All Standards Apply and its affiliates (e.g., merchandisers, field sales/service contractors) providing authorization to use the J&J owned or leased vehicle was given by J&J and they are directly supervised by a J&J manager or J&J affiliate manager. Distributors, outsourced sales/service representatives or These Standards are not enforceable unless they other contracted groups who drive vehicles that are are included as part of the contract language. J&J owned or leased by the distributor or contracting agency affiliates can contribute greatly to global road (in the U.S., an example would be Quintiles, or Modern safety and are encouraged to have distributors Pharmaceutical in the UAE). and contractors adopt our fleet safety standards or similar standards within their contractual agreements. Minimally, these groups (i.e., distributors, outsourced sales/service representatives, or other contracted groups) must ensure that their drivers abide by all local, state and country traffic regulations and ensure they follow their company’s policies.
It is encouraged that operating companies share elements of their Fleet Safety program and materials as applicable. In particular, drivers representing J&J and its affiliates should be advised of the Mobile Phone and Electronic Devices and Motor Vehicle Operation standards. The distributor or contracting agency should have in place a protocol identifying high risk drivers and outlining remedial actions. Enforcement of these standards is the responsibility of the distributor or contracting agency management. Roles and responsibilities must be clearly established in the contractual agreement.
*Note: Should the country team or J&J affiliate choose to adopt standards that are more stringent than those contained in this document, the country team or J&J affiliate’s standard(s) must be followed.
We support and encourage distributors and other suppliers of transportation services to adopt ISO 39001 standards to enhance their Road Traffic Safety (RTS) management systems
WW EHS Standards 158 Version 7 August 2012 25A.1 Mobile Phones and Other Electronic Devices
25A.1.1 Drivers traveling in a company vehicle, whether on company business or on personal time, or who are driving a rental vehicle for business purposes are prohibited from using hand-held electronic devices and text messaging devices including, but not limited to, mobile phones, Blackberrys, iPods/iPads (or equivalent), laptop computers and two-way radios at any time while the vehicle is in operation. A vehicle that is stopped on the roadway, in traffic, and not properly parked, is considered a vehicle in operation and therefore the hand-held use of any device is still strictly prohibited. The primary responsibility of the driver is to operate the vehicle in a safe and responsible manner. When a driver concentrates on tasks other than driving, visual (taking eyes off the road), manual (taking hands off the wheel) or cognitive (taking mind off the task) distractions are likely to occur. As a result, driving performance is degraded and the exposure to risk of crashes or injuries increases.
Drivers using personal vehicles for company business are prohibited from using hand-held devices at any time while the vehicle is in operation, and while conducting company business, as outlined above.
Note: In Canada, Puerto Rico and the United States, drivers who are traveling in a company-owned or leased vehicle, whether on company business or on personal time, or who are driving a rental vehicle for business purposes, are prohibited from using hand-held and hands-free electronic devices (including blue-tooth type technology) and text messaging devices (including, but not limited to, mobile phones, Blackberrys, iPods/iPads, laptop computers, two-way radios) at any time while the vehicle is in operation.
25A.1.2 The use of music players with ear buds or headsets is prohibited while the vehicle is in operation.
25A.1.3 The driver shall not accept incoming calls, or place a call while using any hand-held device unless the vehicle is completely stopped and properly parked in a safe location. The shoulder of the road is not considered a safe location; a parking lot is.
25A.1.4 Mobile phones and other electronic devices must be stored in a secure location while the vehicle is in motion to protect vehicle occupants from injury in the event of sudden stops, turns or impact. To avoid theft, company assets should not be left in the vehicle. If they must be left in the vehicle, they must be stored and secured out of sight.
25A.1.5 Drivers must follow guidelines that maximize the safe handling and use of approved GPS units or GPS-enabled devices. GPS units or GPS-enabled devices must be securely attached and must be used in hands-free, auditory mode. The GPS may not be manually adjusted while the vehicle is in operation. (Suction mounts on the windshield are not to be used where prohibited. In general, suction cup GPS windshield or glass fastening devices should be WW EHS Standards 159 Version 7 August 2012 avoided as these can release without notice, causing a sudden distraction). GPS units must be securely stored when not in use.
Refer to Appendix A: Global Positioning System (GPS) Use
25A.2 Motor Vehicle Operation
25A.2.1 Driver’s License. Employees and other Authorized drivers must possess a current and valid driver's license issued by the controlling authority where the applicant currently resides. It is the responsibility of the Employee or other Authorized driver to inform the J&J affiliate management if, for any reason, the driver’s license is suspended or revoked. Failure to do so may result in remedial action by the local affiliate, including termination. Driver’s licenses will be checked, at minimum, on a yearly basis by the J&J affiliate with a record of confirmation or license photocopy to be kept in personnel files.
25A.2.2 Traffic Regulations. Employees and other Authorized drivers must abide by all local, state, provincial, and country traffic regulations including, but not limited to, laws governing speed limits, blood alcohol levels, safety belt use, distraction (such as texting and cell phone use), night time visibility, etc. It is important to note that country or state laws regarding texting and/or cell phone use while driving may not be as stringent as those outlined in this standard; however, regarding distraction-related standards, such as mobile phones and electronic devices, employees and other Authorized drivers of company vehicles must follow J&J’s requirements.
25A.2.3 Safety Belt Use. All Employees and other Authorized drivers driving a company vehicle including their passengers are required to wear safety belts and use other appropriate restraints (e.g., infant and child safety seats) at all times, while the vehicle is in operation. All drivers, using their personal vehicle on company business, and their passengers, are required to wear safety belts or use other appropriate restraints at all times while the vehicle is in operation. Employees who are using public transportation on company business (e.g., riding in a taxi) must wear their safety belts, if they are available. Employees should encourage the public transit driver to do the same.
25A.2.4 Helmet Use and Two-Wheeler Driver Visibility. All drivers of two- wheeled vehicles are required to wear helmets while the vehicle is in operation. Helmets must be of the full face type and conform to one of the recognized international standards. Helmet chin straps must always be securely fastened. Drivers of two-wheeled vehicles must also wear reflective vests or clothing where possible or clothing that is bright in color to increase their visibility to other road users especially during evening hours. Evening riding should be discouraged wherever possible.
25A.2.5a Alcohol/Drug Use. Johnson & Johnson's alcohol and drug standards are intended to protect our drivers, family members, other drivers, the community, and the Company from alcohol and drug related injuries and losses. WW EHS Standards 160 Version 7 August 2012 Employees and Authorized drivers may never drive on company business or drive a company vehicle (whether on company business or personal time) while under the influence of alcohol and/or drugs as defined by state or country legal requirements.
With regard to alcohol consumption, drivers must act responsibly and consider their risks and options. Responsible actions include, but are not limited to: Assigning a designated driver; using alternate means of transportation; staying in a hotel room; taking whatever actions are necessary to not drink and drive. During business related social events, it is the responsibility of management to provide necessary measures so that employees may avoid drinking and driving (e.g., provide buses, taxis, offer hotel accommodations, etc.)
Employees or Authorized drivers of company owned or leased vehicles or employees who drive employee-owned vehicles for company business as a “regular part” of their job who are arrested for or receive a Driving Under the Influence or Driving While Intoxicated (DUI/DWI) citation, must report this information to their management within 24 hours of the arrest or 24 hours of the receipt of a citation, whichever occurs earlier. Failure to do so may result in disciplinary action, including termination. Upon conviction of a DUI/DWI, the driver must again notify his/her management regarding license suspension, or driving restrictions.
If stopped for a DUI, drivers must comply with blood alcohol content (BAC) testing as required by law. Should a driver receive a DUI citation, driving of the company vehicle must be immediately suspended until further assessment is completed. In some countries, the assessment will be performed by the Employee Assistance Professional and the Occupational Health Nurse. If the driver loses his/her driver’s license, he/she will lose fleet vehicle use until the license is reinstated and the driver is cleared to drive per J&J affiliate review and assessment processes. Employee termination is possible after a driver's first alcohol or drug related driving incident (citation) and mandatory after a second incident (citation). Other Authorized drivers who are involved in alcohol or drug related driving incidents may lose their fleet vehicle driving privileges per local J&J affiliate policy and local laws.
25A.2.5b Alcohol/Drug Screening
For Cause Employees and other Authorized drivers who are involved in serious driving incidents may be requested to take a drug or alcohol screening as part of the incident investigation process. This practice may vary according to local affiliate policies and regulations.
For Safety Driving a company vehicle is considered a safety-sensitive activity, and as such, drug screening for safety reasons may be a required condition for hiring. (A WW EHS Standards 161 Version 7 August 2012 "safety-sensitive activity" is one deemed by the corporation to present significant risks should the employee's judgment or skill be impaired by the use of alcohol or drugs.). This practice (i.e., drug screening) will vary according to local policies, laws and regulations.
Please refer to the SAFE Fleet website and click on the “Standards” tab for links to the U.S. and Global Alcohol and Drug Policies: http://ehs.jnj.com/safefleet.
25A.2.6 Medication. Medication should only be used when taken under the prescribed advice of a physician. Employees should discuss safety concerns (e.g., impairment) regarding the use of prescription drugs with their physicians or company medical personnel. Drivers are responsible for knowing the side effects of any medications (either prescribed or over-the-counter) which may impair their ability to drive (e.g., cause drowsiness, etc.). If medication that may cause drowsiness or other impairment must be used, then the employee and Authorized driver must refrain from driving.
25A.2.7 Driver Alertness. Employees and other Authorized drivers shall not operate a vehicle in a state of fatigue that may adversely impact their ability to safely operate the vehicle. It is the responsibility of the J&J affiliate to inform drivers of how to identify fatigue and alertness problems and the appropriate means for addressing these situations. The Global SAFE Fleet team has educational on-line training related to such topics. It is the responsibility of the driver not to drive when fatigued.
25A.2.8 Securing of Loose Articles. Employees and other Authorized drivers must properly secure all loose articles (including, but not limited to, company assets such as equipment, samples, brochures, tools, cell phones, computers etc.) to protect vehicle occupants from injury in the event of sudden stops, turns or impact. Safety screens must be installed in mini-vans and station wagons/combis used to carry cargo loads according to local policy or regulations. Drivers must consider vehicle load capacity and properly secure their loads in their vehicles.
25A.2.9 Journey Management and Driver Fatigue. Employees and other Authorized drivers must take safe journey planning into consideration before each trip. This includes (but is not limited to) assessing the need to travel, the mode of transport (e.g. train, bus or taxi as opposed to car), the amount and distance of travel required with rest stops scheduled every 2 hours, choice of route, planning the logical order of daily visits, planning of overnight stays if needed to avoid drowsy driving, arranging for transportation from airports if jet lag and time zone differences may result in fatigue.
25A.3 New Hire Eligibility and Driver Requirements
This standard applies to:
WW EHS Standards 162 Version 7 August 2012 − Job applicants who are not employed by J&J or its affiliates and who apply for a position within J&J and its affiliates − Job applicants who are employees of J&J and its affiliates who are not assigned to a company owned or leased vehicle at the time of application − Spouse/Domestic Partners seeking to become Authorized drivers
The J&J affiliate must arrange for written authorization to be obtained from all job applicants, or others seeking to become Authorized drivers, prior to conducting a review of their motor vehicle driving records (as local regulations allow), for the purpose of risk mitigation and identifying a history of unsafe driving behaviors.
To the extent that the country laws allow driving records to be reviewed prior to hire, with the written authorization of the applicant, the screening process must include the criteria listed below.
Screening Criteria (within the past three years) Eligibility for Hire A. Any alcohol and/or drug related driving offense Not Eligible for Hire including driving while under the influence of alcohol or drugs or driving while intoxicated. This also includes refusal to submit to testing. B. Suspension or revocation of a driver’s license. Not Eligible for Hire (recruiter may use discretion if the suspension was due to administrative reasons and/or the applicant is able to produce documentation that his/her driver’s license is currently valid) C. Leaving the scene of a crash or a hit and run as Not Eligible for Hire defined by the law of the state/country in which the violation occurred. D. At fault in a fatal crash as defined by the law of Not Eligible for Hire the state/country in which the crash occurred. E. Any combination of three (3) or more violations Not Eligible for Hire or crashes, while the vehicle was moving, within the past three (3) years. The eligibility assessment is based on the date(s) of the actual violation versus when the conviction occurred or,
Any combination of two (2) or more violations or crashes, while the vehicle was moving, within any six (6)-month period. The eligibility assessment is based on the date(s) of the actual violation versus when the conviction occurred.
The aforementioned information may be collected and recorded in accordance with local laws and regulations. WW EHS Standards 163 Version 7 August 2012 In the event that the screening process using the above criteria cannot be implemented due to limited access to motor vehicle data (i.e., citations/violations), or due to restricted access as dictated by local laws and regulations, the J&J affiliate must implement a High Risk related screening process achieving the same objective of risk mitigation.
Alternative screening criteria (e.g., risk rating criteria utilizing pre-determined point values that are assigned to crashes and/or violations) must be reviewed by the Global SAFE Fleet Leadership Team to ensure that the designation of risk is appropriate for screening out drivers who exhibit a history of unsafe driving practices. The screening criteria must be in compliance with applicable local laws and regulations.
Hiring of Fleet Vehicle Drivers Identified in the Major Driving Events Classification Who Are Transferred from One J&J Affiliate to Another
A driver with a record of excessive traffic offenses and/or collisions poses a risk to J&J, its affiliates and our communities. Even in the case of an employee transferring from one J&J affiliate to another, the employee applicant’s driver history must be considered as a key factor in the hiring decision.
25A.4 Major Driving Events (High Risk Driver): Classification and Remedies
To the extent that the region/country laws allow driving violations and crashes to be recorded and processed by J&J and its affiliates and in strict compliance with these laws, J&J and its affiliates must have a process in place for the identification and tracking of drivers who are responsible for one or more of the Major Driving Events, as defined hereunder, so that appropriate remedies may be followed. The remedies must be designed to improve driving skills and driving behaviors.
The Major Driving Events to be identified and recorded are described below.
Major Driving Events Classification Criteria A. An alcohol and/or drug related driving offense including driving while under the influence of alcohol or drugs or driving while intoxicated. This also includes refusal to submit to alcohol or drug testing. B. Suspension or revocation of a driver’s license where the driver is found to be at fault for engaging in high-risk related behavior, such as speeding. C. Leaving the scene of a crash or a hit and run as defined by the law of the state/country in which the violation occurred. D. At fault in a fatal crash as defined by the law of the state/country in which the crash occurred. E. Any combination of three (3) or more violations or crashes, while the vehicle was moving, within the past three (3) years. Major Driving Events classification is based on the date(s) of the actual violation(s) versus when the conviction(s) occurred or,
WW EHS Standards 164 Version 7 August 2012 Any combination of two (2) or more violations or crashes, while the vehicle was moving, within any six (6)-month period. Major Driving Events classification is based on the date(s) of the actual violation(s) versus when the conviction(s) occurred.
Each driver who is identified in an aforementioned Major Driving Event must be informed in writing of his/her identification in this classification and follow-up actions shall be taken as required hereunder.
In the event that the identification process using the above criteria cannot be implemented due to limited access to motor vehicle data (i.e., citations/violations) or due to restricted access as outlined by local laws and regulations, the J&J affiliate must implement an alternative process which would achieve the same objective of preventing vehicle crashes or driver injury and reducing the risk of harm to our driver and other road users.
In addition, the J&J affiliate may, for other reasons, choose to institute alternative risk assessment criteria (e.g., risk rating criteria using point systems) that would achieve the same objective to deter and prevent vehicle crashes and driver injuries. Alternative risk assessment criteria and related processes must be reviewed by the Global SAFE Fleet Leadership Team to ensure that the designation of risk is appropriate for identifying drivers who exhibit a history of unsafe driving practices. The process must be in compliance with applicable local laws and regulations.
Follow-Up Actions
A high risk driver with a record of excessive traffic offenses and/or collisions may potentially present a serious risk not only to himself or herself, but also to others such as drivers, passengers, pedestrians and cyclists in our communities. High risk drivers also present a risk to Johnson & Johnson.
J&J and its affiliates must establish a process to ensure that these drivers receive appropriate training and coaching that will improve their driving skills, attitudes and behavior. The process must include: - A notification process to inform the driver that he/she has been identified in the Major Driving Events classification; - Follow-up action steps, including behind-the-wheel training or other relevant training and designated activities, such as supplemental Commentary Drives, to be discussed and agreed upon with the driver and his/her manager and/or a Human Resource representative (within 90 days of notification is recommended). - A review and compliance tracking process involving the driver and his/her manager and/or Human Resource representative.
WW EHS Standards 165 Version 7 August 2012 The primary objective of the follow-up actions must be to mitigate the risk of a crash or injury, and motivate the driver to improve his/her driving skills and to modify his/her driving attitudes and behaviors.
A high risk driver will be removed from the Major Driving Events classification if: (a) the driver has not been involved in any further crashes or has not received any additional violations within a consecutive 12-month period after notification of his/her identification in the Major Driving Events classification, or within a specified timeframe as defined in an alternative classification system, and (b) the driver has met any required follow-up actions.
Disciplinary Actions
Each organization’s management must identify the disciplinary actions proportionate to the severity of Major Driving Events. Disciplinary actions must also be defined to address situations where drivers, who have been notified of their identification in the Major Driving Events Classification, are involved in additional crashes and/or receive additional violations within a defined period of time after the initial notification.
25A.5 Driver Training and Coaching
25A.5.1 All J&J and affiliate employees driving a company vehicle or using their own vehicle on company business as a regular part of their job must: • Participate in a new hire orientation to review Fleet Safety standards and other related training or policies established by the J&J affiliate. • Attend behind-the-wheel training within a designated timeframe after hire (within 90 days of hire is highly recommended). Timing may vary based on class availability; however, timely completion of training is critical to mitigating the risk of crash/injury. • Participate in behind-the-wheel training at a minimum of once every three years, after the initial new hire training, unless a risk-based assessment process has been established in which case the frequency and type of training may vary by driver risk level. Note: International transfer employees must attend a behind-the-wheel or similar training upon placement in their host country to reduce crash risk and to ensure familiarity with their new driving environment preferably within one month of placement. • Participate in Fleet Safety training modules as defined and required by the affiliate. Affiliates should promote the use of the SAFE Fleet training portal. • Complete at a minimum, one Commentary Drive per year. Countries and affiliates may set the frequency requirements higher. This is a critical component of setting expectations and reinforcing driver accountability for adopting a crash-free, injury-free approach to driving. The Commentary Drive content and process may differ
WW EHS Standards 166 Version 7 August 2012 according to local practices; however, it must include one on one time with the manager or an external provider, and incorporate confirmation of proper vehicle maintenance, current licensure and other proper vehicle documentation. • Complete a coaching session with the supervisor after any crash to analyze and identify causal factors and agree on preventative training or other actions.
25A.6 Vehicle Maintenance and Condition
25A.6.1 All company vehicles are required to undergo preventative maintenance as recommended by the manufacturer, leasing company or J&J affiliate at designated mileage or kilometer intervals, with all service activities recorded.
25A.6.2 A process must be established for monitoring and recording overall vehicle condition (exterior and interior) on a regular basis.
25A.6.3 J&J affiliates may hold drivers financially accountable for any damage, to company owned or leased vehicles, resulting from negligence (e.g., not adhering to required maintenance schedules or being involved in highly preventable crashes, such as parking and backing).
25A.6.4 Vehicles found to be unfit for safe driving should be removed by the J&J affiliate from the road network.
25A.7 Management Accountability
J&J affiliates must establish line management’s roles and responsibilities that uphold employee safety as a value and managers must lead by example, creating and maintaining an internal environment in which employees can become fully involved in achieving J&J’s fleet safety objectives. Included in, but not limited to the manager’s responsibilities with regards to their drivers, are the completion of: - SAFE Fleet Field Manager training module (or equivalent training) - Commentary Drive (a minimum of one per year) - Post-crash review and coaching process to identify the root cause of the crash in the interest of prevention and to establish accountability. - Review of quarterly SAFE Fleet metric results. - Inclusion of SAFE Fleet materials into meeting agendas.
SAFE Fleet must be addressed as part of the driver and manager performance reviews to establish accountability for fleet safety results alongside business results. Metrics should include both leading and lagging measures such as, safe driving performance, completion of required training, adherence to vehicle
WW EHS Standards 167 Version 7 August 2012 maintenance schedules, and/or involvement in supervisory activities that contribute to crash prevention.
25A.8 Crash, Incident and Injury Reporting
Crashes, incidents and injuries must be accurately reported according to the definitions outlined in Appendix B to ensure consistent data reporting across all J&J affiliates worldwide. It is the responsibility of all SAFE Fleet leaders to ensure that their fleet drivers are accurately reporting crashes, incidents and injuries based on these definitions and it is the responsibility of fleet reporters to ensure they categorize crashes, incidents and injuries using these definitions when reporting their results. Teams must have a self-audit system in place to ensure accurate reporting. Leasing companies must be informed by the J&J affiliate of the reporting definitions found herein and they must adhere to accurately reporting crashes, incidents and injuries based on the definitions outlined in Appendix B.
25A.9 Vehicle Safety Features
The following minimum vehicle safety features are required in all company purchased or leased vehicles: - 4 or 5 star ratings based on reputable new car rating systems (e.g., NHTSA, IIHS, ANCAP, Euro NCAP, and other established organizations that publish vehicle safety ratings.) - Safety belts (three-point) for driver and all passengers, front and back seats - Anti-lock brakes (ABS) - Dual front driver and passenger airbags
If the above vehicle safety features are not yet available in a given country or not offered by a given manufacturer in that country, then the J&J representatives who are responsible for the vehicle selection process will, as quickly as feasible, incorporate vehicles into their selector lists that comply with the above requirements.
In company vehicles that already feature technological safety aids (e.g., parking/reversing sensors, speed limit warnings, lane departure warning, blind spot elimination technologies etc.), the driver must not disable or disengage such safety features as they are designed to maximize driver and passenger safety.
Radar detectors are not allowed even if local laws may permit their use.
Vehicle selector requirements should include other aspects such as ergonomics and fuel efficiency requirements alongside total cost of ownership targets.
WW EHS Standards 168 Version 7 August 2012 Appendix A: Global Positioning System (GPS) Use
A driver’s first responsibility is the safe operation of the vehicle and the best practice is not to operate electronic devices such as GPSs while driving.
A GPS unit is intended to provide a driver with route suggestions and assist with route planning. It is not designed to replace the need for driver alertness and attentiveness. Drivers need to be aware of road conditions, other drivers, weather, road closures and other factors that may impact the safe operation of their vehicles. Some country policies may not allow a GPS unit to be installed in the company vehicle unless it is approved by the local affiliate. For vehicles that do not come equipped with a GPS unit, drivers of those vehicles must check the local policy requirements prior to any after- market installations.
• When using a GPS unit, the driver must become familiar with the Safety and Product information booklet provided with the GPS unit before operating it.
• The screen should be large enough and secured in a location that can provide “at a glance” information, similar to viewing the dashboard. The GPS unit must not create a blind spot that obstructs the driver’s vision.
• GPS units must be programmed in advance of the trip. Drivers must never input destinations or change settings while their vehicle is in motion. If the GPS unit offers a safety feature that restricts the input of data while driving, then this feature must be enabled.
• Drivers must ensure the vehicle is safely parked before making any adjustments to the unit. The shoulder of the road is not a safe place; a well-lighted parking lot is a safer option.
• Drivers must check their state, provincial and country laws and ordinances for any restrictions that may apply to the use and installation of GPS units.
• Suction cup GPS windshield or glass fastening devices should be avoided as these can release without notice, causing a major distraction.
• GPS enabled devices such as blackberries and mobile phones with built in GPS units are not designed for hands-free use and may not be used as a hands-free GPS device. In addition, the smaller screen size is not suitable for maintaining safe use behind the wheel.
It is important to note that even hands-free GPS units can create a distraction and draw attention away from the task of driving; therefore, it is critical to ensure that the unit does not cause the driver to look away from the road for prolonged or frequent periods and that the precautions stated above are followed. GPS units must be removed and stored out of view along with all valuables as they are a target of theft and vehicle break-ins.
WW EHS Standards 169 Version 7 August 2012 Appendix B: Crash, Incident and Injury Reporting Standards
The prompt reporting of crashes, incidents and injuries based on the definitions outlined in this document is critical to ensure consistent worldwide reporting of key fleet safety metrics and must be precisely followed.
J&J and its affiliates must have a process in place to communicate these definitions to those responsible for data collection and the reporting of Corporate fleet safety results including leasing companies and other third party suppliers.
Definitions/Assumptions:
Vehicle
Any motorized vehicle not operating on rails in which a person or object can be transported.
Total Vehicle Mileage Reporting Requirements
At the end of each reporting period, the distance travelled by the company vehicle must be reported to the SAFE Fleet reporter.
Employees who drive company owned or company leased vehicles must report both business and personal mileage.
Employees who drive their own vehicles and receive a cash allowance must report business-related reimbursed mileage only.
Mileage as indicated on the odometer, fuel card data provided through the fleet management supplier or fuel supplier, fuel data transmitted via black box technology or travel reports are acceptable sources of mileage.
Mileage calculated based on fuel consumption, service hours, or any other methods are not acceptable sources of mileage. J&J affiliates reporting mileage in this manner must move to an acceptable method of collecting sources of mileage within one year of receiving this standard. Exceptions must be requested in writing by the Regional SAFE Fleet Manager/Director.
Fleet Vehicle Crash
Any event involving a fleet vehicle that results in death or injury to any person is considered a crash. If a crash occurs while a J&J or affiliate employee or Authorized driver is driving, the crash must be reported to the employee’s manager or, if unavailable, another member of line management within 24 hours of the crash. Failure to report within 24 hours will be considered a serious violation and may result in disciplinary action, up to and including termination of the employee or withdrawal of driving privileges.
WW EHS Standards 170 Version 7 August 2012 The occurrence of a work-related vehicle fatality or occurrence of a vehicle fatality during personal hours driving company owned or leased vehicle or crashes involving a company owned or leased vehicle that result in the fatality of the “other driver” or a pedestrian must be reported to the Regional Manager/Worldwide Director of Fleet Safety within 24 hours of the knowledge of the occurrence.
If no death/injury occurs, material damage arising from the following categories (regardless of the repair cost) is also considered a crash and must be reported to the employee’s manager, or, if unavailable, another member of line management within 24 hours. − Collision between vehicles in motion − Collision of Authorized driver with stationary object − Non-Collision crash – events that involve Authorized driver overturning, spinning, skidding and/or running off the road
Fleet Vehicle Incident
Any event involving a fleet vehicle that results in material damage only (apart from the three crash categories above) is considered an incident. If an incident occurs while an employee or Authorized driver is driving, the incident must also be reported to the employee’s manager or, if unavailable, another member of line management within 48 hours and insurance contact within a designated period of time after the incident).
If the fleet vehicle was properly parked, occurrences resulting in vehicle or property damage only are considered an incident. A “properly parked vehicle” is a vehicle parked in a public or private area where parking or loading and unloading of passengers or cargo is permitted. The vehicle should be parked in a safe location, legally designated, with the parking brake applied and the doors closed. A vehicle waiting in traffic for any reason is not considered properly parked.
Normal Wear and Tear
Normal “wear and tear” that may occur over time and is not attributed to a specific identifiable event and that does not visibly alter the appearance or performance of the vehicle will be considered neither a crash nor an incident. Fine scratches which accumulate over the course of vehicle use are an example of “wear and tear.” Scratches, dents and other visible occurrences are not considered “wear and tear” and as such must be reported as a crash or incident.
Crashes per Million Miles (CPMM)
CPMM is a measure of crash rate. To calculate the CPMM, the number of crashes are multiplied by 1,000,000 and the result is divided by the total mileage driven by the vehicles.
This metric is expressed by the following formula:
WW EHS Standards 171 Version 7 August 2012 CPMM = Number of crashes x 1,000,000 Total vehicle mileage
Injuries Per Million Miles (IPMM)
IPMM is a measure of injury severity. To calculate the IPMM, the number of crashes with injury is multiplied by 1,000,000 and the result is divided by the total mileage driven by the vehicles.
This metric is expressed by the following formula:
IPMM = Number of drivers injured x 1,000,000 Total vehicle mileage
Two categories of IPMM are measured and reported:
1. Crashes with injury to J&J Employee or Authorized Drivers * 2. Crashes with injury to J&J Employee Drivers only**
* In some countries, this category may include first aid type injuries. **This category will be measured against the Worldwide and Regional IPMM targets, and includes “recordable” injuries only as defined below.
Crash Reporting Assumptions (see chart for classifications)
If a crash occurs while an employee or Authorized driver is driving a company-owned or company-leased vehicle, the crash must be reported to SAFE Fleet regardless of whether it occurs on company or personal time.
If a crash occurs while in an employee-owned or employee-leased vehicle on personal time, the crash is not considered a fleet crash and is not reported to SAFE Fleet.
If a crash occurs while in an employee-owned or employee-leased vehicle in the course of conducting business, it must be reported to SAFE Fleet.
Incident Reporting Assumptions (see chart for classifications)
If an incident occurs while an employee or Authorized driver is driving a company- owned or company-leased vehicle, the incident must be reported to SAFE Fleet regardless of whether it occurs on company or personal time.
If an incident occurs while in an employee-owned or employee-leased vehicle on personal time, the incident is not considered a fleet incident and is not reported to SAFE Fleet.
If an incident occurs while in an employee-owned or employee-leased vehicle in the course of conducting business, it must be reported to SAFE Fleet.
WW EHS Standards 172 Version 7 August 2012 Injury Reporting Assumptions (for vehicle related injuries)*
An injury must be reported if it meets any one of the following criteria:
- Medical treatment is rendered beyond first aid - Restricted work activity is imposed or an employee is temporarily or permanently transferred to another job - There is a lost work day or work days from work - There is a loss of consciousness - It is considered a Serious Injury or Illness Case (SIIC), i.e., an injury that has a major impact or effect on the health of the employee. This includes: o Death o Amputation o Fracture (other than hairline fracture of any bone or non-displaced fracture of a digit) o In-patient hospitalization (other than for observation) o Surgical intervention* o Continuous impairment*
*Surgical intervention: Any procedure that has the potential for inducing permanent anatomic (physical) or functional impairment (e.g., joint replacements, splenectomy, laminectomy, carpal tunnel syndrome, de Quervains and other tendonitis or trigger finger conditions, rotator cuff repair, hernia repair or equivalent procedures) would be considered a SIIC. Excluded from this definition are minor** laceration repairs or extraction of foreign bodies (e.g., splinter, metal fragment).
** Procedures that require only a local anesthetic and don’t meet any of the SIIC inclusion criteria (e.g. wound suturing)
*Continuous Impairment: A confirmed work-related physical/mental injury or illness that directly results in serious, persistent, life-altering conditions and that lasts for more than six months/180 calendar days (without remission or recovery), and requires work restrictions or lost time, and/or results in permanent sensor neural loss (such as hearing, sight, taste or nerve damage) regardless of restricted or lost time. This includes confirmed occupational hearing loss.
For additional details on these categories, please consult EHS and/or Global Health representatives or refer to the link provided below for additional information. Injury/Illness reporting protocol beyond SAFE Fleet reporting requirements must be followed based on franchise reporting requirements.
Injury reporting must capture injury to employees of J&J and its affiliates or other Authorized drivers. Depending on the severity of the injury, SAFE Fleet is required to follow an escalation pathway, up to the executive management level in some cases. In cases of fatality or other life-threatening injuries (involving our driver or others), your management and the Regional SAFE Fleet contact must be notified within 24 hours of knowledge of the incident.
WW EHS Standards 173 Version 7 August 2012 http://hrportal.jnj.com/English/totalrewards/globalbenefits/globalhealth/Documents/Forms/AllItems.aspx?R ootFolder=http%3a%2f%2fhrportal%2ejnj%2ecom%2fEnglish%2ftotalrewards%2fglobalbenefits%2fglobal health%2fDocuments%2fOccupational%20Health%2fOccupational%20Health%20Guidelines%2fEmploye e%20Health%20Records%20and%20Recordkeeping%20Guidelines%2fRecordkeeping%20Guidelines&F olderCTID=0x012000901B22740C266A48BC73458FF89675BE
Classification for Reporting: Crash
Crashes are classified into main categories with detailed causes under each category. “J&J Driver” is equivalent to “J&J or Affiliate Driver” or other Authorized driver. Each J&J affiliate must ensure that a system is in place to categorize crashes and incidents as listed below and must ensure all third party vendors follow the same reporting conventions.
Injury Vehicle (our Employee or Employee Driver vehicle or other Description Authorized Driver driver vehicle) or Other Property Damage Only 1) Collision between vehicles in motion: Hitting or being hit by a vehicle causing death, injury, material damage 1.1) J&J Driver failed to give right of way Report as Crash Report as Crash Report as Crash (failed to yield).
1.2) Other driver failed to give right of way Report as Crash Report as Crash Report as Crash (failed to yield).
1.3) J&J Driver hit rear of other vehicle. Report as Crash Report as Crash Report as Crash
1.4) Other driver hit rear of J&J vehicle. Report as Crash Report as Crash Report as Crash
1.5) J&J Driver parking/”unparking”* (while Report as Crash Report as Crash Report as Crash Other Driver was in motion or stopped, but not parked) *J&J Driver motion may be moving forward or backing out. (Note: This category will be a future addition in EDGE2.)
1.6) Other Driver parking/”unparking”* Report as Crash Report as Crash Report as Crash (while J&J Driver was in motion or stopped, but not parked) *Other Driver motion may be moving forward or backing out.
1.7) J&J Driver Hit and Run (Hit Other Report as Crash Report as Crash Report as Crash Driver). 1.8) Other Driver Hit and Run (Hit J&J Report as Crash Report as Crash Report as Crash Driver). 1.9) Other collision between vehicles in Report as Crash Report as Crash Report as Crash motion.
WW EHS Standards 174 Version 7 August 2012 2) Collision with stationary object: Hitting a stationary object causing death, injury or material damage.
2.1) J&J Driver parking/”unparking” (J&J Report as Crash Report as Crash Report as Crash Driver motion may be moving forward or backing out) 2.2) Evasive action Report as Crash Report as Crash Report as Crash J&J Driver swerved to avoid another car or object and incurred material damage and/or injury as a result.
2.3) J&J Driver Failed to Observe Report as Crash Report as Crash Report as Crash Clearance (e.g., driver misjudges space between stationary objects such as poles or barriers). 2.4) J&J Driver Skidded or Slid into a Report as Crash Report as Crash Report as Crash stationary object.
2.5) Other Collision with Stationary Object. Report as Crash Report as Crash Report as Crash
3) Non-Collision Crashes 3.1) J&J Driver lost control of vehicle (e.g., Report as Crash Report as Crash Report as Crash rollover of the vehicle causing death, injury or material damage).
3.2) J&J Driver run off the road causing Report as Crash Report as Crash Report as Crash death, injury or material damage.
3.3) Other Non-Collision Crashes. Report as Crash Report as Crash Report as Crash
4) Contact with Pedestrians or Report as Crash Report as Crash Report as Crash Bystanders: Death or injury caused by impact with vehicle, an object carried on the vehicle or set in motion by the vehicle.
WW EHS Standards 175 Version 7 August 2012 Classification for Reporting: Incidents
Incidents are classified into main categories with detailed causes under each category.
Vehicle or Other Property INCIDENTS Injury Damage Only
Acts of Nature: Report as Incident Report as Incident Damages resulting from acts of nature such as ice, rain, lightning, earthquakes, severe storm, etc.
Properly Parked Vehicle: Report as Incident Report as Incident Occurrences resulting in damage when vehicle is properly parked (See definition of properly parked vehicle under “Definitions/Assumptions” section).
Contact With (or avoidance of) Report as Incident Report as Incident Animals, Rocks, Gravel, Tar or Debris: Damage resulting from contact with above (includes damage to windshield from contact with rock, gravel or other debris).
Objects Falling on a Motor Vehicle: Report as Incident Report as Incident Damage caused solely by object(s) falling on the vehicle (e.g., falling tree, rocks, items falling off or out of another vehicle and hitting our vehicle, etc.).
Fire, Theft or Vandalism: Damage Report as Incident Report as Incident resulting from fire, vandalism or theft (i.e., breaking into vehicle).
Vehicle or Equipment Failure: Report as Incident Report as Incident Damage resulting from vehicle or equipment failure (e.g., electrical fire, tire blow-out). Other Incident Report as Incident Report as Incident
WW EHS Standards 176 Version 7 August 2012 HISTORICAL RECORD
Issue Issue Description of Change Number Date 1 8-8-2008 NA 2 4-8-2012 (effective 1- • Additional references related to “Application of Fleet 1-2013) Safety Standards to Vehicle and Driver Categories” • Reference to mobile phone restrictions (total ban implemented in US, Canada, Puerto Rico) • Helmet Use and Driver Visibility • Additional reference related to Alcohol/Drug Use • Securing of Loose Articles • Driver Training and Coaching – expanded • Management Accountability – expanded • GPS Use requirements incorporated • Vehicle Safety Features – expanded • Crash and Incident definitions related to Contact with Animals and J&J Driver Parking and Backing under “Collision Between Vehicles In Motion” (reporting definition changes are effective January 1st, 2013 and will be reflected in EDGE2 at that time.)
3 6-28-2012 (effective • Addition of Plant Vehicle Safety Requirements 1-1-2013)
WW EHS Standards 177 Version 7 August 2012 25B. Plant Vehicle Safety Requirements The requirements in this section apply to plant vehicles which are not covered by the formal SAFE Fleet assessment process but are covered under the MAARS process. Plant Vehicles include those vehicles that support site operations, such as motorized vehicles, security, maintenance, and other vehicles used on or off the company site. Examples of the type of plant vehicles covered in this section include sedans, two-wheelers, trucks, vans/mini-vans, buses, golf carts. Access to these vehicles is typically given to more than one individual. NOTE: This standard does NOT include Powered Industrial Vehicles (e.g., forklifts, pallet jacks, etc.).
25B.1 Mobile Phones and Other Electronic Devices
25B.1.1 Drivers traveling in a company vehicle are prohibited from using hand-held electronic devices and text messaging devices including, but not limited to, mobile phones, Blackberrys, iPods/iPads (or equivalent), laptop computers and two-way radios at any time while the vehicle is in operation. A vehicle that is stopped on the roadway, in traffic, and not properly parked, is considered a vehicle in operation, and therefore the hand-held use of any device is prohibited. The primary responsibility of the driver is to operate the vehicle in a safe and responsible manner. When a driver concentrates on tasks other than driving, visual (taking eyes off the road), manual (taking hands off the wheel) or cognitive (taking mind off the task) distractions are likely to occur. As a result, driving performance is degraded and the exposure to risk of crashes or injuries increases.
Note: In Canada, Puerto Rico and the United States, drivers who are traveling in a company-owned or leased vehicle are prohibited from using hand-held and hands-free electronic devices (including blue-tooth type technology) and text messaging devices (including, but not limited to, mobile phones, Blackberrys, iPods/iPads, laptop computers, two-way radios) at any time while the vehicle is in operation.
25B.1.2 The use of music players with ear buds or headsets is prohibited while the vehicle is in operation.
25B.1.3 The driver shall not accept incoming calls, or place a call while using any hand-held device unless the vehicle is completely stopped and properly parked in a safe location. The shoulder of the road is not considered a safe location; a parking lot is.
25B.1.4 Mobile phones and other electronic devices must be stored in a secure location while the vehicle is in motion to protect vehicle occupants from injury in the event of sudden stops, turns or impact. To avoid theft, company assets should not be left in the vehicle. If they must be left in the vehicle, they must be stored and secured out of sight.
WW EHS Standards 178 Version 7 August 2012 25B.1.5 Drivers must follow guidelines that maximize the safe handling and use of approved GPS units or GPS-enabled devices. GPS units or GPS-enabled devices must be securely attached and must be used in hands-free, auditory mode. The GPS may not be manually adjusted while the vehicle is in operation. (Suction mounts on the windshield are not to be used where prohibited. In general, suction cup GPS windshield or glass fastening devices should be avoided as these can release without notice, causing a sudden distraction). GPS units must be securely stored when not in use.
Refer to Appendix A: Global Positioning System (GPS) Use
25B.2 Motor Vehicle Operation The affiliate must ensure that only authorized drivers have access to company owned or leased vehicles.
25B.2.1 Driver’s License Employees and other Authorized drivers must possess a current and valid driver's license issued by the controlling authority where the applicant currently resides. It is the responsibility of the Employee or other Authorized driver to inform the J&J affiliate management if, for any reason, the driver’s license is suspended or revoked. Failure to do so may result in remedial action by the local affiliate, including termination. Driver’s licenses will be checked, at minimum, on a yearly basis by the J&J affiliate with a record of confirmation or license photocopy to be kept in personnel files.
25B.2.2 Traffic Regulations Employees and other Authorized drivers must abide by all local, state, provincial, and country traffic regulations including, but not limited to, laws governing speed limits, blood alcohol levels, safety belt use, distraction (such as texting and cell phone use), night time visibility, etc. It is important to note that country or state laws regarding texting and/or cell phone use while driving may not be as stringent as those outlined in this standard; however, regarding distraction- related standards, such as mobile phones and electronic devices, employees and other Authorized drivers of company vehicles must follow J&J’s requirements.
25B.2.3 Safety Belt Use All Employees and other Authorized drivers driving a company vehicle including their passengers are required to wear safety belts and use other appropriate restraints (e.g., infant and child safety seats) at all times, while the vehicle is in operation. Note: Some vehicle types may not be equipped with safety belts (e.g., vehicles that may be used to transport material goods on site, such as golf carts). In these cases, the J&J affiliate must ensure that minimum local regulatory requirements related to that particular vehicle type are satisfied. The installation and use of safety restraints for driver and passengers in these vehicles may be feasible, and if so, encouraged. We recommend contacting the manufacturer prior to any after-market installation of safety restraints.
WW EHS Standards 179 Version 7 August 2012 25B.2.4 Helmet Use and Two-Wheeler Driver Visibility All drivers of two-wheeled vehicles are required to wear helmets while the vehicle is in operation. Helmets must be of the full face type and conform to one of the recognized international standards. Helmet chin straps must always be securely fastened. Drivers of two-wheeled vehicles must also wear reflective vests or clothing where possible or clothing that is bright in color to increase their visibility to other road users especially during evening hours. Evening riding should be discouraged wherever possible.
25B.2.5a Alcohol/Drug Use Johnson & Johnson's alcohol and drug standards are intended to protect our drivers, family members, other drivers, the community, and the Company from alcohol and drug related injuries and losses. Employees and Authorized drivers may never drive on company business or drive a company vehicle while under the influence of alcohol and/or drugs as defined by state or country legal requirements.
• With regard to alcohol consumption, drivers must act responsibly and consider their risks and options. Responsible actions include, but are not limited to: Assigning a designated driver; using alternate means of transportation; staying in a hotel room; taking whatever actions are necessary to not drink and drive. During business related social events, it is the responsibility of management to provide necessary measures so that employees may avoid drinking and driving (e.g., provide buses, taxis, offer hotel accommodations, etc.)
• Employees or Authorized drivers of company owned or leased vehicles who are arrested for or receive a Driving Under the Influence or Driving While Intoxicated (DUI/DWI) citation, must report this information to their management within 24 hours of the arrest or 24 hours of the receipt of a citation, whichever occurs earlier. Failure to do so may result in disciplinary action, including termination. Upon conviction of a DUI/DWI, the driver must again notify his/her management regarding license suspension, or driving restrictions.
• If stopped for a DUI, drivers must comply with blood alcohol content (BAC) testing as required by law. Should a driver receive a DUI citation, driving of the company vehicle must be immediately suspended until further assessment is completed. In some countries, the assessment will be performed by the Employee Assistance Professional and the Occupational Health Nurse. If the driver loses his/her driver’s license, he/she will lose fleet vehicle use until the license is reinstated and the driver is cleared to drive per J&J affiliate review and assessment processes.
WW EHS Standards 180 Version 7 August 2012
25B.2.5b Alcohol/Drug Screening
For Cause Employees and other Authorized drivers who are involved in serious driving incidents may be requested to take a drug or alcohol screening as part of the incident investigation process. This practice may vary according to local affiliate policies and regulations.
For Safety Driving a company vehicle is considered a safety-sensitive activity, and as such, drug screening for safety reasons may be a required condition for hiring. (A "safety-sensitive activity" is one deemed by the corporation to present significant risks should the employee's judgment or skill be impaired by the use of alcohol or drugs.). This practice (i.e., drug screening) will vary according to local policies, laws and regulations.
Please refer to the SAFE Fleet website and click on the “Standards” tab for links to the U.S. and Global Alcohol and Drug Policies: http://ehs.jnj.com/safefleet.
25B.2.6 Medication Medication should only be used when taken under the prescribed advice of a physician. Employees should discuss safety concerns (e.g., impairment) regarding the use of prescription drugs with their physicians or company medical personnel. Drivers are responsible for knowing the side effects of any medications (either prescribed or over-the-counter) which may impair their ability to drive (e.g., cause drowsiness, etc.). If medication that may cause drowsiness or other impairment must be used, then the employee and Authorized driver must refrain from driving.
25B.2.7 Driver Alertness Employees and other Authorized drivers shall not operate a vehicle in a state of fatigue that may adversely impact their ability to safely operate the vehicle. It is the responsibility of the J&J affiliate to inform drivers of how to identify fatigue and alertness problems and the appropriate means for addressing these situations. The Global SAFE Fleet team has educational on-line training related to such topics. It is the responsibility of the driver not to drive when fatigued.
25B.2.8 Securing of Loose Articles Employees and other Authorized drivers must properly secure all loose articles (including, but not limited to, company assets such as equipment, samples, brochures, tools, cell phones, computers etc.) to protect vehicle occupants from injury in the event of sudden stops, turns or impact. Safety screens must be installed in mini-vans and station wagons/combis used to carry cargo loads according to local policy or regulations. Drivers must consider vehicle load capacity and properly secure their loads in their vehicles.
WW EHS Standards 181 Version 7 August 2012
25B.2.9 Journey Management and Driver Fatigue Employees and other Authorized drivers must take safe journey planning into consideration before each trip. This includes (but is not limited to) assessing the need to travel, the mode of transport (e.g. train, bus or taxi as opposed to car), the amount and distance of travel required with rest stops scheduled every 2 hours, choice of route, avoiding drowsy driving.
25B.3 Driver Training and Coaching
25B.3.1 All J&J and affiliate employees driving a company vehicle shall:
• Participate in a new driver orientation to review Fleet Safety standards and other related training or policies established by the J&J affiliate; • Ensure general driver safety information is regularly disseminated; and, • Complete a coaching session with the supervisor after any crash to analyze and identify causal factors and agree on preventative training or other actions.
25B.4 Vehicle Use, Maintenance and Condition
25B.4.1 There must be a written policy in place that outlines where vehicles can be driven, who can be transported and what can be transported.
25B.4.2 All company vehicles are required to undergo preventative maintenance as recommended by the manufacturer, leasing company or J&J affiliate at designated mileage or kilometer intervals, with all service activities recorded.
25B.4.3 A process must be established for monitoring and recording overall vehicle condition (exterior and interior) on a regular basis.
25B.4.4 J&J affiliates may hold drivers financially accountable for any damage, to company owned or leased vehicles, resulting from negligence (e.g., being involved in highly preventable crashes, such as parking and backing).
25B.4.5 Vehicles found to be unfit for safe driving should be removed by the J&J affiliate from the road network.
25B.5 Vehicle Safety Features
25B.5.1 The following minimum vehicle safety features are required in all company purchased or leased passenger vehicles:
WW EHS Standards 182 Version 7 August 2012 • 4 or 5 star ratings based on reputable new car rating systems (e.g., NHTSA, IIHS, ANCAP, Euro NCAP, and other established organizations that publish vehicle safety ratings.) • Safety belts (three-point) for driver and all passengers, front and back seats • Anti-lock brakes (ABS) • Dual front driver and passenger airbags
Note: These vehicle safety features may not be available on other types of motorized vehicles utilized at the company site. In these cases, the J&J affiliate must ensure that minimum local regulatory requirements related to that particular vehicle type are satisfied.
WW EHS Standards 183 Version 7 August 2012 26. Warehouses & Storage Areas [TOC]
INTRODUCTION
This standard provides minimum EHS requirements for warehouses and storage areas that fall into two categories – those associated with manufacturing operations and separate facilities commonly known as “stand-alone warehouses.”
Part A describes requirements for warehouses and storage areas attached to manufacturing facilities. Since these areas are typically included in the site’s MAARS program and other topics in this manual are already considered, Part A describes additional elements that are specific to warehouses and storage areas.
Part B provides requirements for stand-alone warehouses where the MAARS process is not currently applied. Information is more detailed to highlight all the portions of this manual that need to be considered.
BASIC RESPONSIBILITY
The organization shall ensure that a comprehensive EHS management process is applied to:
1. Warehouses owned and operated by Johnson & Johnson employees, and 2. Leased warehouses that are operated by Johnson & Johnson employees and/or operated by contract employees supervised by Johnson & Johnson employees.
For the purpose of this standard a warehouse is defined as:
• any location where goods are stored outside of an office area, and • where there is at least one Johnson & Johnson employee working full time on site who is conducting non-administrative tasks, and • where powered handling equipment is used.
MINIMUM REQUIRED ELEMENTS
A. Manufacturing-attached Warehouses covered by the MAARS process 26A.1 Powered Industrial Vehicles 26A.2 Asset Protection 26A.3 Trailer safety/wheel chocks and trailer restraints 26A.4 Dock safeguards 26A.5 Segregation of pedestrians and traffic 26A.6 Housekeeping 26A.7 No Idling Policy
WW EHS Standards 184 Version 7 August 2012 B. Stand-alone Warehouses 26B.1 Management System 26B.2 Powered Industrial Vehicles 26B.3 Asset Protection 26B.4 Ergonomics 26B.5 Work Practices 26B.6 Fall Prevention 26B.7 Chemicals 26B.8 Machine Safety 26B.9 Waste Management 26B.10 No Idling Policy 26B.11 Program Review
WW EHS Standards 185 Version 7 August 2012 26A. MANUFACTURING-ATTACHED WAREHOUSES The requirements in this section apply to manufacturing-attached warehouses and storage areas that are covered by the MAARS process
26A.1 Powered Industrial Vehicles
26A.1.1 Powered industrial vehicle (PIV) operators shall be 18 years of age or older.
26A.1.2 The organization shall establish, implement, and maintain a theoretical & practical training/re-training program for PIV operators. The training shall be delivered by qualified instructors and take into account typical features of such equipment.
26A.1.3 The organization shall establish, implement, and maintain a process/system to ensure that only suitably qualified personnel can operate powered industrial vehicles.
26A.1.4 The organization shall establish, implement, and maintain a PIV Operator Medical Surveillance Program in accordance with the requirements of WWEHS Standard 18, Occupational Health. Specific elements shall include:
• Medical surveillance inclusion criteria
• Medical surveillance/periodic evaluation that is conducted at least every 3 years
• Post-exposure and per request evaluations
• Trending and recordkeeping
26A.1.5 The organization shall establish, implement, and maintain a documented process for pre-shift operational readiness assessments and regular maintenance of each PIV.
26A.1.6 The organization shall establish, implement, and maintain a documented process to identify the hazards associated with battery charging areas and battery charging, assess the risks and implement appropriate controls to manage these risks. This assessment shall take into consideration the following:
• An evaluation of room ventilation to assure it is capable of diluting the hydrogen accumulation to less than 1% by volume in an air mixture;
• Availability of clearly displayed instructions relating to charging and authorized maintenance inside the battery-charging room;
WW EHS Standards 186 Version 7 August 2012
• Procedures to clean up any spilled electrolyte; and,
• Availability of, and unobstructed access to, emergency equipment such as eye-wash stations and emergency showers.
26A.2 Asset Protection
26A.2.1 The organization shall establish, implement, and maintain a documented process for racking structure inspections. Specific elements shall include:
• At least every 3 years, a thorough inspection shall be carried out by a competent person who understands the impact of racking structure damage or missing components as it relates to mechanical integrity; and,
• Routine, periodic integrity inspections shall be conducted by in house personnel. When trend analyses indicate significant deviations, a more in-depth inspection shall be conducted.
26A.2.2 Racking structures shall be appropriate for the commodities stored and must be designed, installed or modified under supervision of a competent person.
26A.3 Trailer Safety & Wheel Chocks/Trailer Restraints
26A.3.1 The organization shall implement the most appropriate trailer safety controls based on a documented risk assessment.
26A.3.2 The organization shall select the most appropriate control measure to prevent trailer creep, dock walk or landing gear collapse. This measure shall take into account the amount, type(s) of traffic, and the probability that the selected measure will be applied properly.
26A.4 Dock Safeguards
26A.4.1 The organization shall establish, implement and maintain a documented process to identify the hazards associated with dock work, assess the risks and implement appropriate controls to manage these risks. This assessment shall take into consideration the loading and unloading activities, types of material handling equipment being used, types and numbers of vehicles at the dock, and the intended storage capacity at the warehouse.
26A.4.2 The organization shall ensure the following related to Dock Plates/Dock Levelers:
WW EHS Standards 187 Version 7 August 2012 • Where dock levelers are used, the organization shall conduct a documented review on the need to integrate the dock levelers and locking devices into signal lights that would then communicate to workers and truckers when it is safe to load and when it is safe to move the trailer.
• Where dock levelers are installed or dock plates are used, the organization shall review, implement and maintain these devices to their original design intent.
26A.4.3 To ensure a safe working environment, loading dock operators and maintenance personnel shall be trained in the proper handling and use of all dock equipment and associated safety procedures. Training records shall be maintained.
26A.5 Segregation of Pedestrians and Traffic
26A.5.1 The organization shall select the most appropriate manner to segregate pedestrians and traffic. Where segregation is impractical, walkways, crosswalks, mirrors on blind corners etc. shall be used.
26A.5.2 The organization shall establish, implement, maintain and enforce traffic rules in the warehouse and ensure that warehouse employees, visitors, contractors etc. are trained in their application.
26A.6 Housekeeping
26A.6.1 The organization shall establish, implement and maintain a housekeeping program that includes both the responsibilities of the organization and the employees.
26A.6.2 The housekeeping program shall be based on inspections and include:
• Docking areas: to avoid accumulation of debris;
• Pallets: to ensure that products are secured and the absence of loose material for transportation and storage;
• Storage of empty pallets: in accordance with Factory Mutual Global guidelines that idle/empty pallets should not be stored in a warehouse but, when no alternative exists, require them to be stored at a height no greater than 6 ft/1.8 m unless Early Suppression Fast Response (ESFR) sprinkler heads are installed;
• Ladder and access equipment: to ensure they are in good working condition;
WW EHS Standards 188 Version 7 August 2012
• Hazardous waste and chemical storage areas: to ensure their recipients (drums, boxes, containers, etc.) are intact, labeled and stored properly. The frequency of inspections shall be established by the organization using a risk-based approach. Frequency shall not exceed that required by local regulations. If regulatory requirements do not exist, the minimum inspection interval shall be monthly; and,
• Emergency equipment: to ensure they are in good order and readily accessible.
26A.6.3 The frequency of inspections shall be in compliance with applicable country legislation or based on experience.
26A.6.4 The organization shall ensure that the warehouse floor remains free of debris at all times to maintain a safe working environment. Particular attention should be given to the timely removal of packaging materials (e.g. wrapping, pallets, boxes, etc.).
26A.6.5 The organization shall establish, implement and maintain a documented training program to assure appropriate orientation of new personnel and to reacquaint existing personnel with the warehouse safety procedures.
26A.7 No Idling Policy
26A.7.1 The organization shall establish, implement, and maintain a “No Idling Policy” that requires motor vehicle engines to be shut-down when the vehicle is stopped and there is no operational or safety need for engine power.
WW EHS Standards 189 Version 7 August 2012 26B. STAND-ALONE WAREHOUSES The requirements in this section apply to stand-alone warehouses that are not covered by the MAARS process.
26B.1 Management System
Organization
26B.1.1 The organization shall apply requirements provided in Section 1.1 of Worldwide EHS Standards Chapter 1 – EHS Management System.
26B.1.2 Management at each organization shall:
• Ensure the availability of resources essential to establish, implement, maintain and continually improve its EHS management system(s).
• Appoint (a) specific EHS management representative(s) with the authority and responsibility for:
A. Ensuring that the organization’s EHS management system(s) is established, implemented, maintained and periodically evaluated; and,
B. Reporting to management on the performance of the organization’s EHS management system(s), including recommendations for improvement.
26B.1.3 Roles, responsibilities and authorities shall be defined, documented, and communicated in order to facilitate effective EHS management, including the expectation that management will support and promote the importance of safe and environmentally conscious behaviors in the performance of all work.
Hazard Identification, Risk Assessment & Control
26B.1.4 The organization shall establish, implement, and maintain a documented process to systematically:
• Identify and assess the EHS aspects and hazards of its activities, processes, products and services over which it has control and influence, taking into account planned or new developments, or new or modified activities, processes, products, and services;
• Determine those aspects that have or can have significant impact(s) on the environment and the hazards that pose or can pose a risk(s) to the health & safety of its employees, including
WW EHS Standards 190 Version 7 August 2012 behaviors that can create unacceptable risk for employees, contractors, visitors, and/or the environment; and,
• Document and maintain an up to date assessment regarding the organization’s EHS aspects & hazards and impacts & risks.
26B.1.5 The organization shall establish, implement, and maintain a documented process to control risks and impacts. Specific elements shall include:
• The establishment, implementation, and maintenance of appropriate EHS rules and procedures;
• Criteria to control the identified significant EHS aspects and hazards associated with:
A. Work processes used by the organization. The defined criteria shall be based on the hierarchy of controls emphasizing process and engineering controls above personal protective equipment (PPE) and administrative controls.
B. Goods and services used by the organization. Applicable procedures and requirements shall be communicated to suppliers, including contractors.
26B.1.6 All identified risks/impacts that cannot be corrected immediately shall be incorporated into the organization’s Management Action Plan (MAP) for follow-up. Appropriate corrective actions shall be initiated immediately and a state of compliance shall be returned as soon as possible.
Regulatory Compliance
26B.1.7 The organization shall apply requirements provided in Sections 1.2.3 to 1.2.9 of Worldwide EHS Standards Chapter 1 – EHS Management System.
Communication & Consultation
26B.1.8 The organization shall apply requirements provided in Sections 1.3.8 to 1.3.10 of Worldwide EHS Standards Chapter 1 – EHS Management System.
Nonconformity, Corrective and Preventive Actions
26B.1.9 The organization shall apply requirements provided in Sections 1.4.5 to 1.4.6 of Worldwide EHS Standards Chapter 1 – EHS Management System.
WW EHS Standards 191 Version 7 August 2012 Johnson & Johnson Corporate Reporting
26B.1.10 The organization shall apply requirements provided in Sections 1.4.7 to 1.4.9 of Worldwide EHS Standards Chapter 1 – EHS Management System.
Emergency Planning & Response
26B.1.11 The organization shall apply requirements provided in Worldwide EHS Standards Chapter 3 – Emergency Planning & Response.
26B.2 Powered Industrial Vehicles
26B.2.1 The organization shall apply requirements provided in Section 26A.1 of Worldwide EHS Standards Chapter 26 – Warehouses & Storage Areas.
26B.3 Asset Protection
26B.3.1 The organization shall apply requirements provided in Section 26A.2 of Worldwide EHS Standards Chapter 26 – Warehouses & Storage Areas.
26B.3.2 The organization shall apply requirements provided in Worldwide EHS Standards Chapter 20 – Fire and Explosion Prevention.
26B.4 Ergonomics
Ergonomics Risk Recognition
26B.4 1 The organization shall conduct site-wide ergonomics risk assessments for activities listed below. Use of the Johnson & Johnson tool referenced in each section is preferred.
• Packaging-related activities using the EJA (Ergonomics Job Analyzer)
• Manual handling of loads tasks using the MHEJA (Manual Handling Ergonomics Job Analyzer)
• Workstations using display screens using the CWEJA (Computer Workstation Ergonomics Job Analyzer)
Intervention
26B.4.2 The organization shall establish, implement, and maintain an action plan to mitigate high and moderate risk tasks to the lowest possible level with preference given to engineering controls over administrative controls.
WW EHS Standards 192 Version 7 August 2012 Prevention
26B.4.3 The organization shall conduct an ergonomics evaluation of new and/or modified equipment, preferably during the design but certainly prior to use at the site, to ensure that ergonomics risks are not introduced to the facility.
Note: The ERGO Engineering Design Guidelines is the most appropriate tool to support a site with these ergonomic reviews.
Training and Education
26B. 4.4 The organization shall provide appropriate ergonomics education and training to all employees.
Ergonomics Medical Surveillance and Recordkeeping
26B.4.5 The organization shall establish, implement, and maintain a process for medical surveillance and recordkeeping on ergonomics-related issues in accordance with the requirements in the Global Health Guideline on Ergonomics Medical Surveillance.
Ergonomics Injury/Illness Investigation & Recordkeeping
26B.4.6 The organization shall establish, implement, and maintain a process to investigate all ergonomics-related Lost Work Day Cases and/or Serious Injuries and Illnesses using the “Learning to Look for Ergonomics” methodology or an equivalent method. A record should be kept of all ergonomics-related injuries in order to establish trends.
26B.5 Work Practices
26B.5.1 The organization shall apply requirements provided in Sections 26A.3 to 26A.6 of Worldwide EHS Standards Chapter 26 – Warehouses & Storage Areas.
26B.6 Fall Prevention
26B.6.1 The organization shall apply requirements provided in Sections 19.1 to 19.5 of Worldwide EHS Standards Chapter 19 – Fall Prevention.
26B.7 Chemicals
26B. 7.1 The organization shall establish, implement, and maintain a documented, systematic process to receive, label and store chemicals in the warehouses. Specific elements shall include but not be limited to:
WW EHS Standards 193 Version 7 August 2012 • When receiving goods on site, labels shall provide specific information concerning EHS risks.
• When stored, and following the storage model, the organization shall implement and maintain a process to prevent storage of incompatible products next to each other.
• The organization shall develop, implement and maintain a documented process to receive, label and store all returned goods.
• The organization shall develop, implement and maintain a systematic inspection process to validate, before storage, that received goods are in good condition.
• For all chemicals containing sensitive receptors or those with the potential to contaminate soil the organization needs to provide secondary containment.
26B.8 Machine Safety
26B.8.1 The organization shall establish, implement, and maintain programs and processes to ensure machinery and equipment are purchased, built, operated, and serviced in accordance with the Johnson & Johnson Machine Safety philosophy. Specific elements shall include:
• Zero Access: Apply requirements provided in Sections 22.1.1 to 22.1.2 of Worldwide EHS Standards Chapter 22 – Machinery, Electrical and Powered Industrial Vehicle Safety.
• Hazardous Energy Control (Lock Out/Tag Out) Program: Apply requirements provided in Section 22.2 of Worldwide EHS Standards Chapter 22 – Machinery, Electrical and Powered Industrial Vehicle Safety.
• Bypassing of safety devices: The organization shall establish, implement, and maintain a process to eliminate unauthorized bypassing of safety systems.
• Electrical Safety: Apply requirements provided in Section 22.3 of Worldwide EHS Standards Chapter 22 – Machinery, Electrical & Powered Industrial Vehicle Safety.
26B.8.2 The organization shall establish, implement, and maintain a training program for:
WW EHS Standards 194 Version 7 August 2012 • Machinery/equipment operators, maintenance and supervisory personnel, on the operation and service of machinery and equipment in accordance with manufacturer’s and Johnson & Johnson instructions.
• "Affected" employees and other employees who may encounter locked out/tagged out machinery or equipment, on the Hazardous Energy Control Program including the roles and responsibilities of "Authorized" employees.
• Employees and their supervisors who are potentially exposed to injury due to electrical hazards, on the electrical safe work practices including the roles and responsibilities of “Qualified” and “Unqualified” persons.
26B.9 Waste Management
26B.9.1 The organization shall develop, implement, and maintain a program to properly and safely manage its waste, from generation through identification, characterization, collection, storage, transportation, until ultimate disposal.
Identification and Characterization for Disposal
26B.9.2 An inventory of all waste generated on site shall be established and maintained up to date. It shall contain adequate information for sound management with the following minimum information for each waste type:
• Origin of the waste (warehouse activity that created the waste);
• Classification of the waste (e.g., nonhazardous, universal, hazardous, biological, damage goods, products for disposal, off- spec products and radioactive as defined by local regulations);
• Hazardous characteristics of the waste, if applicable (e.g., corrosive, flammable, biological, infectious, radioactivity level, etc.);
• Typical annual generation rate; and,
• Current disposal method including final destination.
Storage and Handling
26B.9.3 Hazardous and non-hazardous waste shall be clearly segregated from the time of generation until removal for off-site disposal and their respective accumulation and storage areas shall be clearly designated.
WW EHS Standards 195 Version 7 August 2012 Non-Hazardous Waste
26B.9.4 To the extent practicable, non-hazardous waste shall be segregated as either recyclable or non-recyclable and into general types of recyclable materials (for example, metals, cardboard, glass, and paper) to promote recycling.
Hazardous (including Biological, Low Level Radioactive, and Liquid Non- Hazardous) Waste
26B.9.5 Hazardous waste shall be stored in leak-proof containers that are clearly labeled and kept closed, except when adding or removing waste. The label shall identify that the material in the container is waste, what the waste material is (e.g. toluene, mixed chlorinated solvents, used oil etc.), and the hazardous characteristic(s) of the waste (e.g. flammable, corrosive, etc.).
26B.9.6 The hazardous waste storage area(s) shall be secured and managed as follows, to prevent releases to the environment:
• Located indoors or within a covered structure that prevents direct contact with rain water;
• Have an impervious floor (such as chemical resistant coating or chemical resistant material) that has been fitted with a secondary containment. This structure shall be of sufficient size so that it totally surrounds the primary containment, and it shall be capable to contain a spill equivalent to at least 110 percent of the capacity of the largest container stored;
• Have suitable fire fighting, communication system, safety shower and eyewash equipment, and spill control equipment located in or near the storage area;
• If applicable, have appropriate containment measures to prevent contaminated discharged fire sprinkler water from entering the environment;
• Avoid the use of underground spill collection sumps, troughs, and piping, whenever possible; otherwise, all underground piping and sumps shall be evaluated for integrity every five years and a system shall be in place to quickly detect the presence of spilled liquid in the sumps;
• Provide separation of incompatible waste so that in the event of a spill, incompatible chemicals will not mix; and,
WW EHS Standards 196 Version 7 August 2012 • Provide sufficient space between containers to enable the identification of each container’s label and the inspection of each container’s condition.
26B.9.7 Hazardous waste shall be removed from site as soon as practicable. Local regulatory requirements shall determine the maximum holding time without requiring a permit or special regulatory approval. Holding waste for longer than 12 months shall be reviewed with Worldwide EHS, unless it is low- level radioactive waste being stored for decay purposes and allowed by regulatory authorities.
26B.9.8 If the organization generates low-level radioactive waste, it shall implement the following additional requirements:
• Segregate low-level radioactive waste with long half-lives from those with short half-lives;
• Store and accumulate low-level radioactive waste with short half lives in a secured area until they are non-radioactive or their radioactivity levels are below regulatory thresholds for sewer discharge or disposal as non-radioactive waste, as applicable and allowed by laws and/or regulations; and,
• Avoid the mixing of low-level radioactive waste with hazardous or solid waste.
26B.9.9 If the organization generates biological waste, it shall ensure that the waste is properly incinerated, or rendered non-infectious and non-recognizable prior to final disposal other than incineration.
Treatment and Disposal
26B.9.10 All waste transport transactions and shipments shall be documented per regulatory requirements and with the following minimum information: date of shipment, identity and weight/volume of waste shipped, name and address of the receiving facility, and the method of treatment or disposal.
Used Container Management
26B.9.11 The organization shall establish, implement, and maintain a program to minimize the use of containers and properly manage used containers. This program shall include all types of shipping containers and is intended to prevent environmental contamination from improper disposal and the misuse of used containers by unauthorized personnel. The organization shall ensure that all labels and/or markings that identify Johnson & Johnson or its affiliate companies are removed and that used containers are not given to employees or the community.
WW EHS Standards 197 Version 7 August 2012
Training & Supervision
26B.9.12 The organization shall establish, implement, and maintain a documented annual training and supervision program to ensure that appropriate facility personnel including contractors are properly trained and supervised in the handling and management of waste, during routine operations and emergency situations.
26B.10 No Idling Policy
26B.10.1 The organization shall apply requirements provided in Section 26A.7 of Worldwide EHS Standards Chapter 26 – Warehouses & Storage Areas
26B.11 Program Review
26B.11.1 All elements of the program shall undergo a documented multidisciplinary review at least once per year to ensure efficacy in managing the warehouse EHS risks.
WW EHS Standards 198 Version 7 August 2012 27. Environmental, Health and Safety Standards for Office Organizations [TOC]
INTRODUCTION
This chapter specifies minimum EHS requirements for office organizations that fall into two categories – those associated with manufacturing operations and separate office facilities.
Part A describes requirements for office areas attached to manufacturing or R&D facilities. Since these areas are typically included in the site’s MAARS program and other standards in this manual are already considered, Part A describes additional requirements that are specific to office areas.
Part B provides requirements for stand-alone office locations where the MAARS process is not currently applied. Information is more detailed to highlight all the portions of this manual that need to be considered.
BASIC RESPONSIBILITY
The organization shall establish, document, implement, maintain and continually improve an environmental, health and safety management system to fulfil the requirements of its policy and this standard, as well as all applicable regulatory requirements.
MINUMUM REQUIRED ELEMENTS
A. Manufacturing-attached Offices 27A.1 Environmental, Health and Safety Management System
B. Stand-alone Offices 27B.1 Environmental, Health and Safety Management System 27B.2 Occupational Safety 27B.3 Global Health 27B.4 Environmental Management 27B.5 Emergency Planning
WW EHS Standards 199 Version 7 August 2012 27A. MANUFACTURING-ATTACHED OFFICES The requirements in this section apply to manufacturing or R&D-attached office areas that are currently covered by the MAARS process
27A.1 Environmental, Health and Safety Management Systems
27A.1.1 The organization shall include the office areas in the Environmental, Health and Safety Management Systems for the manufacturing and/or R&D operations.
27A.1.2 The organization shall establish a specific process to identify and assess significant impacts of the office environment and the hazards that can pose a risk to the health and safety of its office employees, including behaviours that can put others at risk. An action plan shall be established to reduce the identified impacts and risks. This process shall include, but not limited to:
• Computer workstations, using the Computer Workstation Ergonomics Job Analyser (CWEJA);
• Slips, trips and falls prevention approach;
• Biosafety hazards for first aid employees and employees who work in clinical settings or manage returned and potentially contaminated products;
• Ionizing and non-ionizing radiation for employees who work in clinical settings, where there is potential exposure; and/or
• Fire hazards related to the use of electrical equipment, the use of flammable products for decoration purposes and the storage of flammable materials, such as office paper.
WW EHS Standards 200 Version 7 August 2012 27B. STAND-ALONE OFFICES The requirements in this section apply to stand-alone offices that are not currently covered by the MAARS process.
27B.1 Environmental, Health and Safety Management Systems
Policy
27B.1.1 The organization shall develop, authorize and publish an Environmental, Health and Safety Policy which at a minimum includes a commitment to reduce the impact on the environment, create a healthy and safety work environment for its employees and contractors, promote healthy lifestyles, and a commitment to continuous improvement.
Planning
27B.1.2 The organization shall establish a process to identify the aspects that can have a significant impact on the environment and the hazards that can pose a risk to the health and safety of its employees, including behaviours that can put employees, contractors and visitors at risk. The risk assessments shall include, where necessary, identifying and assessing risks to pregnant women, from psychological stressors, and during customer visits (such as slips, trips and falls). An action plan shall be established to manage and reduce the identified impacts and risks.
27B.1.3 The organization shall assign the coordination of environmental, health and safety management to one or more employees in the organization.
27B.1.4 The organization shall establish an Environmental, Health and Safety Steering Committee, consisting of relevant representatives, who meet at a minimum quarterly to propose, establish and measure the progress of specific goals and objectives for environmental, health and safety management, such as – but not limited to – safety incident numbers, pollution prevention and global health data.
Implementation
27B.1.5 The organization shall perform an annual self assessment to measure the level of implementation of the J&J Worldwide Environmental, Health and Safety Office Standards.
27B.1.6 The organization shall establish and maintain a Management Action Plan to correct any observations identified during the self assessment or any other environmental, health and safety or Global Health related inspection or audit.
WW EHS Standards 201 Version 7 August 2012 Checking
27B.1.7 The organization shall establish, implement and maintain specific processes to assess regulatory compliance and to collect and validate data for reporting on Johnson and Johnson worldwide environmental, health and safety goals.
Management Review
27B.1.8 The organization’s senior management shall review the progress of its environmental, health and safety goals and objectives at least annually. If senior management is represented on the organization’s EHS Steering Committee per Section 27B.1.3, then those quarterly meetings will suffice.
Investigation of Incidents and Reporting of Data
27B.1.9 The organization shall assign the reporting of all relevant environmental, health and safety data to one or more specific persons in the organization. These persons shall be adequately trained to use the data gathering systems and have access to all necessary information to report the relevant data.
27B.1.10 The organization shall establish a process to investigate and report, within 72 hours, all incidents listed in Section 1.4.8, and escalate major incidents per Section 1.4.9.
27B.1.11 The on-time completion of data reporting shall be monitored by the Environmental, Health and Safety Steering Committee.
Communication
27B.1.12 The organization shall establish, implement and maintain a system to communicate any environmental, health and safety programs, relevant publications or other data to its employees.
27B.1.13 A system shall be established for employees to express specific concerns about work related hazards.
27B.1.14 The organization shall establish a system to engage the employees in any relevant safety and environmental or health and wellness program.
Verification
27B.1.15 Periodically (preferably every three years), the organization shall perform an assisted self assessment, in which the assessment is carried out by the Environmental, Health and Safety coordinator/team
WW EHS Standards 202 Version 7 August 2012 with the assistance of an external Office EHS Subject Matter Expert to verify the identified corrective actions and exchange best practices.
27B.2 Occupational Safety
Training
27B.2.1 All employees (including temporary staff) shall receive a general environmental, health and safety introduction training, including – but not limited to – emergency response activities, incident reporting and good housekeeping practices.
27B.2.2 All employees shall receive an annual reminder training – in any chosen format – around good housekeeping practices, slips, trips and falls, ergonomics and emergency response.
Ergonomics
27B.2.3 The organization shall assess all computer workstations for ergonomic risks using the Computer Workstation Ergonomics Job Analyser (CWEJA). A corrective action plan shall be developed to reduce the identified risks to as low as reasonable practical and in a timely manner.
27B.2.4 All employees who work over 4 hours at a computer workstation shall receive specific ergonomics training, consisting of – but not limited to – the seating and display screen position.
Biosafety (Blood Borne Pathogens)
27B.2.5 The organization shall establish a risk assessment process to identify the biosafety hazards for first aid employees and employees who visit clinical settings or manage returned and potentially contaminated products. This risk assessment shall lead to adequate prevention and protection measures.
Ionizing and Non-ionizing Radiation
27B.2.6 The organization shall establish a risk assessment process to identify the ionizing and non-ionizing radiation hazards for employees who are potentially exposed to these hazards (e.g. employees visiting hospitals in X-ray environments) and take adequate measures to reduce these risks and at a minimum ensure compliance with country regulations.
Slips, Trips and Falls
27B.2.7 The organization shall assess the risk of slips, trips and falls in the facility and all other areas frequently used by employees (such as WW EHS Standards 203 Version 7 August 2012 parking lots or shared catering facilities). The organization shall develop a corrective action plan to reduce these risks and have a program in place to create slips, trips and fall risk awareness for employees, focusing particularly on field personnel.
Office Housekeeping
27B.2.8 The organization shall develop, implement and maintain an office housekeeping program.
27B.3 Global Health
Occupational Health – if the organization uses an external occupational health service provider, the specific Johnson and Johnson program requirements shall be communicated in order to ensure understanding and support of the medical surveillance required.
27B.3.1 The organization shall establish an Occupational Health program, including the following aspects:
• Medical surveillance program based upon the Johnson and Johnson Health and Wellness Policy and applicable country regulations. The outcome of the medical surveillances shall be tracked and reported according to the corporate requirements;
• Where legally possible, a process to medically screened new employees to ensure that they are fit for duty, including sales and marketing employees who use a vehicle on company business;
• Process that supports the early recognition and management of the most common occupational musculoskeletal injuries;
• Promotion of a drug free workplace; and,
• Process for medical record management, including control of access to medical records.
27B.3.2 The organization shall establish the following Global Health programs:
• Mental Wellbeing, including the following aspects ‐ Employee Assistance Program availability ‐ Stress management and resilience training
• Wellness & Health Promotion, including the following aspects ‐ General health promotional programs as identified by the aggregate feedback of Health Profile data
WW EHS Standards 204 Version 7 August 2012 ‐ Deployment of the Tobacco Free Workplace Policy and smoking cessation programs ‐ Deployment of the HIV/AIDS in the Workplace Policy ‐ Promotion of physical activity ‐ Promotion of Healthy Eating/Healthy Cafeteria principles ‐ Establishing cancer awareness
• Travel Health, providing access to employees travelling for business reasons that include appropriate and up-to-date travel vaccination and general travel health advice
• Absence and Disability Management, including ‐ Medical Case Management ‐ Occupational rehabilitation
27B.3.3 The organization shall have access to a well equipped medical centre and occupational health support, either on site or off site.
Further details can be found in the Office EHS Global Health and Wellness Guideline.
27B.4 Environmental Management
Recycling
27B.4.1 The organization shall have a recycling program in place for paper, glass, cardboard, plastic, batteries and other materials – if these wastes can be managed as separate waste streams.
Procurement
27B.4.2 The organization shall develop specific guidelines for the procurement of environmentally best options (e.g. low energy use equipment). Where available, the organization shall procure office paper from a sustainable source, containing more than 30% Post Consumer Recycled content or paper sourced from sustainable forestry (and certified as such).
Energy
27B.4.3 The organization shall establish an energy conservation program, which consists as a minimum of automatic lighting systems (switching off during non-occupancy), adjustable heating or cooling per room or area and employee awareness.
Water
WW EHS Standards 205 Version 7 August 2012
27B.4.4 The organization shall establish a water conservation program, which consists as a minimum of an awareness program and discouragement to use water bottles (where other safe means of drinking water are available).
Waste Management
27B.4.5 The organization shall establish a program to reduce waste as much as possible. The organization shall, where applicable, develop, implement and maintain a process for managing hazardous waste in compliance with country regulations.
Resource Reduction
27B.4.6 The organization shall establish programs to reduce the use of natural resources, including:
• Encourage car pooling and use of public transportation for employees commute;
• Set up double sided printing as default on all printers;
• Where possible, serve all food and drinks in reusable cups, plates or containers.
27B.5 Emergency Planning
Emergency Plan
27B.5.1 The organization shall establish an emergency plan and communicate the plan to all employees. This plan shall include, at a minimum, an evacuation plan, first aid and emergency notification numbers.
Evacuation Drills
27B.5.2 The organization shall organize an evacuation drill at least annually. This drill shall involve a significant majority of all employees. The drill shall be evaluated with senior management and adjusted where necessary. The evacuation process shall include a plan to account for all employees impacted by the evacuation.
27B.5.3 The evacuation drill coordinators shall be trained at least annually – which includes an update of the area for which they are responsible.
WW EHS Standards 206 Version 7 August 2012 Emergency Equipment
27B.5.4 Every office building shall be protected by an automatic sprinkler system, unless an exemption has been granted by the management board of the main (J&J) occupant of the building and submitted to J&J Corporate Risk Management.
27B.5.5 Fire extinguishers and any other required emergency equipment (such as fire blankets) shall be inspected at least annually and replaced if necessary.
First Aid
27B.5.6 The organization shall establish a first aid team and provide training (and certification) to the assigned first aiders as required by country standards.
27B.5.7 The organization shall provide adequate first aid equipment and inspect this equipment (specifically first aid boxes) routinely and restock where necessary. The provision of an automatic electronic defibrillator on site shall be considered.
WW EHS Standards 207 Version 7 August 2012 Appendix I [TOC]
PROCESS HAZARD SCREENING TOOL Version 1.08 July 19, 2012
COMPANY NAME: SITE/LOCATION: COMPLETED BY:
PROCESS NAME: PROCESS OVERVIEW:
PROCESS MEANS ANY MANUFACTURING OR R&D ACTIVITY INVOLVING THE USE OR IN-PROCESS STORAGE OF A HAZARDOUS SUBSTANCE. CHEMICAL WAREHOUSES & BOILER FUEL STORAGE USED FOR HVAC ARE EXEMPT FROM THIS TOOL. ITEM PROCESS HAZARD SCREENING TOOL QUESTIONS YES NO
J&J PSM Tier I Designation – Only if a “yes” response is indicated for question 1 is the facility a Tier I. If a “no” response is given for question 1 and a “yes” response to any other question listed below designates the site as a Tier II facility.
Do any of the following process safety management conditions apply to your site?
a. Does the site employ a process whose system (e.g. storage vessels, process vessels, mobile tanks) are interconnected with piping and may contain in total 4536 kilograms (10,000 pounds) or more of any flammable liquids at any given time? b. Is the site a JSC Active Pharmaceutical Ingredient Chemical manufacturing facility or a Consumer Listerine manufacturing 1. facility? c. Is the site covered under the OSHA PSM standard or the EU Seveso II Directive?
(If yes to any of the above, the site is required to participate in a PSM audit on a three year cycle)
Note* Chemical density and the process volume in liters (or gallons) is used to determine the total weight of the chemical in question, e.g. 0.964g/ml x 5,000liters = 4820 kilograms
Flammability Hazards:
Does the process contain more than 200 L or 55 gal of a material with a NFPA Flammability Rating of 4? [Ethylene oxide used for sterilization manufacturing processes should be captured here 2. regardless of quantities.] (Material is classified as severe hazard, the flash-point is less than 73 0F or 23 0C and & boiling point <1000F or 380C)
WW EHS Standards 208 Version 7 August 2012
Does the process contain more than 1000 L of a flammable material with a NFPA Flammability Rating of 3? (Material is classified as 3. serious hazard, the flash-point is less than 730F(230C) and boiling point >1000F(380C) or the flash-point is greater than 730F(230C) and boiling point is less than 1000F(380C))
Does the production process contain more than 200 L or 55 gal of a material that is above its flash point while in use in the process and operates at a pressure greater than 5 PSIG (0.35 barg)? This does 4. not include inertion pressurization, e.g. nitrogen (headspace) or pressure created for reasons of transfer of the material. Note* Process means any manufacturing or R&D activity involving the use or in-process storage of a hazardous substance.
Explosion Hazards:
Are powders handled in quantities greater than 220 pounds or 100 Kg in a process with any of the following characteristics: a) KSt Value > 201 or Dust Explosion Class St 2 or 3 b) Volume resistivity greater 1010 ohm.m 5. c) Minimum Ignition Energy (MIE) less than or equal to 10 mJ d) Burning Class rating of 4 or greater e) Capable of detonation upon impact Note* The addition of any powders to vessels containing flammable solvents should be reviewed with the Sector PSM leads.
Reactivity Hazards:
Does the process contain more than 11 lbs. (5 kg) of a material with a NFPA Reactivity Rating of 4? (Materials that in themselves are readily capable of detonation or 6. explosive decomposition or explosive reaction at normal temperatures and pressures; materials sensitive to localized thermal or mechanical shock at normal temperatures and pressures)
Does the process contain more than 44 lbs. (20 kg) of a material with a NFPA Reactivity Rating of 3? (Materials that in themselves are capable of detonation or explosive decomposition or explosive reaction but that require a strong initiating source or that must be 7. heated under confinement before initiation; materials that are sensitive to thermal or mechanical shock at elevated temperatures and pressures or that react explosively with water without requiring heat or confinement)
Does the process contain more than 1,100 lbs. (500 kg) of a material with any of the following characteristics: 8. a) NFPA Reactivity Rating of 2? (Materials that readily undergo violent chemical change at elevated temperatures and pressures; materials that exhibit an exotherm at temperatures less than or equal to 1500C when tested by differential WW EHS Standards 209 Version 7 August 2012 scanning calorimetry; materials that may react violently with water or form potentially explosive mixtures with water.) b) NFPA Specialty rating of Oxidizing Substance? (Material is classified as Oxidizing material; any solid or liquid that readily yields oxygen or other oxidizing gas, or that readily reacts to oxidize combustible materials: a list of typical oxidizing materials is in the glossary) c) NFPA Specialty rating of Water Reactive? (Material is classified as Materials that react so violently with water that a possible hazard results when they come in contact with water, as in a fire situation. Similar to NFPA Reactivity Rating 2.
Runaway Chemical Reaction Hazards:
Is the process volume 50 liters (13.2 gallons) or more that utilizes chemicals / materials that have the potential to cause or undergo 9. uncontrolled decomposition or reaction during normal operation or inadvertent mixing?
General:
Is there a process or sub-process utilizing quantities of these target materials at levels BELOW the thresholds in this form that, in your professional judgment, should be further evaluated to prevent a PSM accident? 10. PSM accident is defined as an occurrence (including in particular, a major emission, fire or explosion) resulting from uncontrolled developments in the course of the operation of any establishment and leading to serious danger to human health or the environment, immediate or delayed, inside or outside the establishment, and involving one or more dangerous substances.) Please consult your sector or WWEHS PSM lead.
Additional Considerations: (e.g. severity/complexity of process conditions or previous incident history)
Conclusion of the Analysis: Hazardous Process Non-Hazardous Process If Hazardous, provide time line to perform an in depth Process Hazard Analysis (including the application of Risk Ranking per identified risk).
Date: Analysis Conducted by: Date: Reviewed/Approved by:
Note: The above Process Hazard Screening tool applies unless local, country or regional regulations are more stringent, in which case, the more stringent regulations apply.
WW EHS Standards 210 Version 7 August 2012 Appendix II [TOC]
WW EHS Standards 211 Version 7 August 2012 Incidents that shall be escalated include:
J&J Organization
• Work-related fatality of an employee, temporary worker, or contractor (including sub-contractor);
• Amputation;
• Major spill/release (that results in significant environmental damage, e.g. fish kill or local community impact);
• Knowledge of possible major fine (i.e. >US$50K);
• Hospitalization of an employee, temporary worker, or contractor (including sub-contractor) for a significant period of time (>3 days) as a result of a work-related injury or illness;
• Hospitalization of 2 or more employees, temporary workers, or contractors (including sub-contractors) as a result of a single work- related event;
• Fire resulting in loss of life or hospitalization per the criteria above; or,
• Any EHS incident that results in media attention or cessation of operations.
J&J High Priority Supplier
• Work-related fatality;
• Major spill/release (that results in significant environmental damage, e.g. fish kill or community impact); or,
• Any EHS incident that is likely to receive media attention or result in cessation of operations.
WW EHS Standards 212 Version 7 August 2012