HACCP/ Food Safety Toolkit
Program Validation and Maintenance
A Project of Brewers Association of Canada HACCP Working Group Revision Date: November 2009 www.brewers.ca
BAC/HACCP - FS Validation/Maintenance Page 2 of 11 Revision Date; November 2009 BAC/HACCP - FS Validation/Maintenance Page 3 of 11 Revision Date; November 2009 Table of Contents
Monitoring, Verification & Internal Audits...... 5
Validation...... 5
Reassessment of the HACCP System...... 7
Changes to the Food Safety System...... 9
BAC/HACCP - FS Validation/Maintenance Page 4 of 11 Revision Date; November 2009 BAC/HACCP - FS Validation/Maintenance Page 5 of 11 Revision Date; November 2009 Introduction
After developing and implementing the prerequisite programs and HACCP Plan(s), each brewery will be required to validate and maintain these programs and plans.
Plans for validation, monitoring, verification and corrective action, re-validation and reassessment should be developed and implemented.
Monitoring, Verification & Internal Audits
Ongoing monitoring and verification can provide information that demonstrates the food safety system is working as planned. This information may also lead to required changes to the system. Trends toward loss of control may also be detected through monitoring.
Monitoring, verification and corrective action tasks must be planned documented and must be performed throughout the life of the food safety program. Record keeping must be continually performed.
At a minimum, each brewery should conduct an internal audit of the prerequisite programs and HACCP plans each year. Internal audit activities may be scheduled throughout the year and do not need to be completed all at once.
Breweries may require assistance from experts during the development of a validation protocol and review of results.
Validation
Validation of food safety control measures is different from both verification and monitoring. Validation focuses on the collection and evaluation of scientific, technical and observational information to determine whether the control measures are capable, if implemented, of controlling the hazard to the appropriate level and whether this level of control can be achieved consistently.
BAC/HACCP - FS Validation/Maintenance Page 6 of 11 Revision Date; November 2009 This is in contrast to monitoring and verification, which both take place only after the validated control measures have been implemented.
Each brewery should validate the adequacy of the HACCP system in controlling the food safety hazards identified during the hazard analysis and verify that the system is being implemented effectively.
Upon completion of the hazard analysis and development of the HACCP plan, the brewery should conduct activities designed to determine whether the HACCP plan is functioning as intended. During this HACCP plan validation period, the brewery will repeatedly test the adequacy of the CCP's critical limits, the monitoring and record keeping procedures, and the corrective actions set forth in the HACCP plan. Validation also encompasses reviews of the records themselves, routinely generated by the HACCP system, in the context of other validation activities.
Validation of the prerequisites is accomplished through initial self-evaluation and ongoing reassessment of the HACCP system.
Need for Re-Validation
There are many changes that could lead to a need to re-validate a control measure, a combination of control measures or the entire food safety control system.
For example, the introduction into the food control system of a new product line, process step, control measure, technology or piece of equipment that impacts the control of the hazard means that part or all of the system may need to be re- validated. Similarly, changes made in product formulation or the application of current control measures may result in the need for re-validation of control measures. While minor changes are less likely to require re-validation of the control measures, multiple minor changes will almost certainly mean that re- validation is needed.
BAC/HACCP - FS Validation/Maintenance Page 7 of 11 Revision Date; November 2009 The hazard(s) associated with a food or ingredient change as a result of (i) higher concentrations of a pathogen or pathogens than originally encountered and accounted for in the design, (ii) a change in the response of a hazard to control (e.g. adaptation), (iii) the emergence of a previously unidentified hazard, or (iv) new information indicating that the hazard is not being controlled to the level specified (e.g. new epidemiological findings or new analytical technologies). Any of these changes may result in the need for re-validation.
If monitoring or verification identifies failures that are above a pre-established rate and for which a process deviation cause cannot be identified, re-validation may be needed. Non-compliance with monitoring or verification criteria may indicate a change in the parameters (i.e. the selection and specification of the control measures) on which the design of the food safety control system is based.
CFIA reference http://www.inspection.gc.ca/english/fssa/polstrat/haccp/manue/ch2sec5e.shtml
Reassessment of the Food Safety System
Every brewery will be required to reassess the adequacy of the food safety system at least annually and whenever any changes occur that could affect the hazard analysis or alter the food safety system.
Your brewery must have in place written procedures that indicate how the company annually reviews and updates its entire food safety system. These written reassessment procedures may specify that the brewery will conduct its required activities at various times over the course of a year.
The food safety reassessment plan must specify regular procedures for maintaining your food safety system. Outline the procedures that the company will follow when a deviation is found during the review. Include actions to prevent reoccurrence of these deviations.
BAC/HACCP - FS Validation/Maintenance Page 8 of 11 Revision Date; November 2009 Reassessment procedures include the following:
1. Procedures to ensure that all changes to the HACCP system are documented.
2. Procedures to review all sub-elements in the prerequisite program to ensure that the procedures reflect current processes and equipment at your brewery, as well as regulatory requirements, and that they continue to be effective.
3. Procedures to review the accuracy of the product descriptions, lists of incoming ingredients, process flow diagrams and schematic diagrams in your HACCP system.
4. Procedures to review all hazards identified in the HACCP system, in order to ensure that they are accurate and reflect your brewery's current processes, equipment and operating procedures. When new hazards are identified, your HACCP team must analyze them appropriately in accordance with to your HACCP system. Hazards that are not controlled by CCPs should continue to be controlled by other measures identified in the HACCP system (e.g. prerequisite programs, letters of guarantee, etc.).
5. Procedures to review each CCP (including validation studies such as microbiological sampling, challenge studies and process validation) to ensure that it continues to control the identified hazard(s).
6. Procedures to evaluate critical limits to ensure that they meet current program and regulatory requirements.
7. Procedures to review the monitoring, deviation and verification procedures for each CCP, in order to ensure that they continue to be implemented effectively.
CFIA reference http://www.inspection.gc.ca/english/fssa/polstrat/haccp/manue/ch2sec5e.shtml
BAC/HACCP - FS Validation/Maintenance Page 9 of 11 Revision Date; November 2009 Changes to the Food Safety System
When a brewery changes its food safety system (e.g. removes a CCP), it should enter the changes in a log and support the rationale with scientific data. http://www.inspection.gc.ca/english/fssa/polstrat/haccp/manue/ch4sec1-5e.shtml#4.5
System Communication, Maintenance & Improvement
The brewery should ensure that there is effective review and improvement to the food safety system. This may be facilitated by team meetings and internal communication. Employees should be made aware of the requirement to report food safety related issues to the Food Safety/ HACCP Team Leader directly or to their supervisor or a member of the food safety Team.
Management will ensure that changes that directly impact, or could possibly affect, food safety will be communicated to the food safety team in a timely manner. These changes include, but are not limited to:
products, or addition of new products raw materials, ingredients and services production systems and equipment production premises, location of equipment, and surrounding environment cleaning & sanitation programs packaging, storage and distribution systems personnel qualification levels and or allocation of responsibilities and authorizations statutory and regulatory requirements knowledge regarding food safety hazards and control measures customer, sector and other requirements that the organization observes relevant enquiries from external interested parties complaints indicating food safety hazards associated with the product other conditions that have an impact on food safety
BAC/HACCP - FS Validation/Maintenance Page 10 of 11 Revision Date; November 2009 The food safety team should ensure the information is included in the updating of the food safety system. Recommendations or updates of the food safety system are communicated to Management.
Associated corrective and improvement actions should be performed according to established brewery procedures.
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