RISK MANAGEMENT HACCPAN INTRODUCTION TO The Hazard Analysis & Critical Control Point System for Food Processors By A.V. RISWADKAR ccording to a 1996 U.S. Dept. marily on finished product testing and to distribution. Even potential consumer of Agriculture (USDA) report, general sanitation; these have proven to abuse and misuse can be considered foodborne microbiological be inadequate in controlling many food- under HACCP principles. contamination in the U.S. borne illnesses, such as salmonellosis, With HACCP in place, a food proces- causes an estimated 9,000 e-coli and listeriosis in meat and dairy sor can identify and monitor specific deaths and 33 million human products. Meanwhile, the Food and Drug foodborne hazards that are biological, illnesses annually. The cost of Administration (FDA), USDA and other chemical or physical in nature. A system- AtheseA human illnesses and lost productivi- food regulatory agencies are seeking atic hazard analysis is used to identify ty is estimated to be $9.3 to $12.9 billion alternative approaches that will effective- critical control points (CCPs) in the proc- annually (Bacterial Foodborne Diseases). ly and comprehensively evaluate a food ess; these points must be controlled in Recent headlines have reported food plant’s ability to produce consistently order to ensure food safety and prevent safety problems. “Hot dogs blamed for safe, high-quality foods. adverse health impact on the consumer. Listeria outbreak” (AP-Detroit, MI, June This enables the processor to focus con- 1999). “12th death is linked to tainted HAZARD ANALYSIS & CRITICAL CONTROL POINT trol efforts on specific critical points, meat at plant” (New York Times, Jan. 27, The Hazard Analysis and Critical which also prevents the inefficiency asso- 1999). “Armed with E-coli horror stories, Control Point (HACCP) system is one ciated with overapplication of extraordi- consumer groups demand safer meat” such alternative. It focuses on identifying nary sanitation measures. (CNN, Nov. 10, 1999). and preventing hazards that could cause In the drive to ensure food safety, Due to this increased attention, con- foodborne illnesses rather than relying on HACCP is becoming a necessity for all sumer expectations about food quality spot-checks of manufacturing processes food processors; it is now widely accepted and safety have grown, prompting food and random sampling of finished food as an effective part of a total quality pro- processors to seek systems and programs products to ensure safety. Combined with gram. In addition, FDA has incorporated that will both bolster consumer confi- an effective hazard analysis technique, HACCP into its 1999 Food Code, a guid- dence and improve food safety. HACCP allows safety and quality to be ance document that is a model regulation Traditional quality assurance pro- built into each step within the process— for state and local agencies responsible for grams and facility inspections focus pri- from product formulation specifications licensing and inspecting food service

AMERICAN SOCIETY OF SAFETY ENGINEERS JUNE 2000 33 HACCP follows a basic risk management philosophy. By identifying critical risk factors, a firm can focus its prevention and mitigation resources to maximize its risk management efforts. establishments, retail food stores and approach to HACCP systems is taking the words, one cannot depend on the advan- vending operations. USDA now requires form of workshops, manuals and training tage of consumer cooking to eliminate all meat and poultry processors to imple- videos developed under the sponsorship remaining microbiological hazards. ment an effective HACCP system and of the International Dairy Foods Assn., Based on these factors, food risk cate- reassess its adequacy at least annually. National Cheese Institute and American gories are assigned as “0” to “VI,” with Butter Institute. Many generic HACCP “VI” being the highest risk. Foods that HISTORY OF HACCP programs have also been developed; for fall into risk factor “A” (e.g., infant for- HACCP emerged as the result of sever- example, FSIS has developed several mula, baby food) automatically become a al joint projects conducted during the generic HACCP models. risk category “VI,” while foods with no 1960s to develop food for the space pro- risk factors (B-F) are categorized as “0.” gram. The approach was presented at the THE SEVEN PRINCIPLES Foods with one risk factor (other than 1971 Conference on Food Protection, Conduct Hazard Analysis & Risk Assessment “A”) are risk category “I.” Those with where it was viewed as a solution to micro- This first principle may be the most two factors (other than “A”) are category biological problems with low-acid canned important. Effective controls cannot be “II” and so on. foods, particularly mushrooms. This led to considered until hazards have been iden- Risk categories can also be assigned to promulgation of Low-Acid Canned Foods tified and their risks assessed. This can be ingredients, incoming raw materials, in- regulation by the FDA in 1974. an involved process, since all potential process foods and finished products. These The original HACCP (1971) was based hazards should be evaluated. Further- categories are useful indicators for priority on three principles: more, failure to recognize a potential haz- identification in the next task—the specific 1) Comprehensive hazard analysis ard can lead to an unacceptable risk, even hazard identification and analysis. and risk assessment. if controls and monitors for identified The focus on consumer safety is funda- 2) Determination and identification of hazards are implemented correctly. mental to HACCP. However, the program CCPs. In 1992, in its “Hazard Principles for can be effectively extended to include other 3) Monitoring of CCPs. Food Production” report, NACMCF de- potential problem types, provided food By 1986, subcommittees of both the fined a hazard as “any chemical, physical safety hazards remain separate and distinct National Conference on Food Protection or biological property that could cause an from those unrelated to food safety. A flow and National Academy of Sciences had unacceptable consumer health risk.” This diagram can be used to document the pro- recommended that the HACCP approach report introduced a food risk categoriza- duction and distribution processes and be adopted by both the U.S. food industry tion process that forms a basis for this first help identify hazards at each step. and regulatory agencies. These recommen- principle. To ensure uniformity, food risk Risk hazard analysis helps identify dations led to formation of the National assessment should encompass the follow- potential types of hazards and their Advisory Committee on Microbiological ing six hazard characteristics. sources. Biological hazards in food proc- Criteria for Foods (NACMCF) in 1987. This A) Food intended for consumption by essing include bacterial, viral, or enteric committee expanded the HACCP protocol at-risk population. This category accounts and parasitic organisms. Chemical hazards to include the seven principles now wide- for risk factors introduced when con- include naturally occurring elements (such ly accepted as the standard. sumers are very young, elderly or other- as mycotoxins from mold), toxic mush- 1) Conduct hazard analysis and risk wise unusually susceptible to potential rooms, plant toxins and chemicals added assessment. hazards of the evaluated food product. during food processing (such as pesticide 2) Identify critical control points in B) Product contains sensitive ingredi- residues, food additives and lubricants). food preparation. ent(s). This accounts for any ingredient Physical hazards come in different forms, 3) Establish critical limits for each CCP. that may be a source of a hazard or might such as glass, stones or metal fragments, 4) Establish procedures for monitoring be a carrier of a microbiological hazard with the most likely outcomes ranging the CCPs. (e.g., eggs). from a chipped tooth to choking. 5) Establish corrective action protocol C) No process step to eliminate haz- for each CCP. ard. For example, raw milk is still sold in Identify CCPs in Food Preparation 6) Establish procedures for effective the U.S. Elimination of the pasteurizing Many points in food processing can be recordkeeping. step is an example of this factor. considered control points, but few are 7) Establish procedures for an effective D) Recontamination potential before critical control points (CCPs). According verification (audit). packaging. Aseptic packaging has sever- to NACMCF, a CCP is any controllable Today, many HACCP programs and al control advantages over traditional point in a specific process where loss of studies are in progress. One of the system’s packaging. One key benefit is the reduc- control may result in unacceptable risk. It greatest strengths is its adaptability to tion of the recontamination potential. is a point, step or procedure in food widely varied processes. For example, E) Potential for product abuse. Does preparation where a food safety hazard USDA’s Food Safety and Inspection Ser- a real potential exist for abuse to the can be prevented, controlled, reduced or vice (FSIS) is applying HACCP principles product during distribution or consumer eliminated. For example, time-tempera- to meat and poultry product safety. These handling that could lead to an unsafe ture relation in pasteurization is a CCP. principles are also the center of an ongoing product? As noted, NACMCF defined CCPs joint seafood inspection program of F) No terminal heat process. This based on the need to protect the con- the FDA and the National Marine Fisheries encompasses ready-to-eat foods that typ- sumer. Other control points have also service (NMFS). The dairy industry’s ically do not require reheating. In other been identified.

34 PROFESSIONAL SAFETY Hazard Analysis Questions Appendix C of the “Hazard Analysis and Critical Control Point Principles and Application Guidelines,” adopted Aug. 14, 1997, by the National Advisory Committee on Microbiological Criteria for Foods, contains a list of questions to be considered when conducting a hazard analysis. Examples are printed below. INGREDIENTS 1) Does the food contain any sensitive ingredients that may present microbiological hazards, chemical hazards or physical hazards? 2) Are potable water, ice and steam used in formulating or handling the food? INTRINSIC FACTORS 1) What hazards may result if the food composition is not controlled? 2) Does the food permit survival or multiplication of pathogens and/or toxin formation in the food during processing? During sub- sequent steps in the food chain? PROCESSING PROCEDURES •CCP1 and CCP2. The International 1) Does the process include a controllable processing step that destroys pathogens? Commission on Microbiological Specifica- If so, which pathogens? tions for Foods (ICMSF) divides CCPs into 2) If the project is subject to recontamination between processing (e.g., cooking, pas- “major” (1) and “minor” (2). CCP1 re- teurizing) and packaging, which biological, chemical or physical hazards are like- quires that a hazard be completely elimi- ly to occur? nated to ensure food safety, whereas CCP2 requires that a hazard be reduced to ensure MICROBIAL CONTENT OF FOOD control. CCP2 is less critical to food safety 1) What is the normal microbial content of the food? and, thus, requires less monitoring. 2) Does the microbial population change during the normal time the food is stored •Universal CCPs. As applied in the prior to consumption? ABI/NCI Total Quality Systems Handbook, FACILITY DESIGN these refer to potential hazards that are 1) Does the facility’s layout provide an adequate separation of raw materials from universal to all manufacturing sites. ready-to-eat (RTE) foods (if this is important to food safety)? If not, what hazards Specifically, these are hazards that may be should be considered as possible contaminants of the RTE products? common throughout a plant rather than 2) Is the traffic pattern for people and moving equipment a significant source of located specifically within a single proc- contamination? ess or piece of equipment. Sanitation is a EQUIPMENT DESIGN & USE universal CCP. 1) Is the equipment properly sized for the volume of food that will be processed? •Physical hazard CCPs. Also defined 2) Is the equipment reliable or is it prone to frequent breakdowns? by the ABI/NCI Handbook, physical haz- ards in the production process within the PACKAGING food industry are often controlled through 1) Does the package include instructions for the safe handling and preparation of filtering, metal detection or visual inspec- the food by the end user? tion. This type of control point has been 2) Are tamper-evident packaging features used? designated to differentiate it from microbi- EMPLOYEE HEALTH, HYGIENE & EDUCATION ological CCPs that typically cannot be eas- 1) Can employee health or personal hygiene practices impact the safety of the food ily monitored during production. being processed? •Manufacturing, economic, produc- 2) Do employees understand the process and the factors they must control to ensure tion, quality, regulatory CCPs. These can the preparation of safe foods? be defined as any controllable point at which failure to control may result in To obtain a complete copy of the guidelines, visit http://vm.cfsan.fda.gov/~comm/nacmcfp.html. unacceptable quality; improper portion control or waste; or productivity, yield or regulatory problems. However, since Examples of criteria used for CCPs used to document the monitoring process. these points are not usually food-safety- include time, temperature, humidity, Monitoring tracks the process and detects related, most HACCP programs do not water activity and pH level. adverse trends that, left uncorrected, could encompass them. lead to loss of control. Signatures and ini- Establish Procedures for Monitoring of CCPs tials on monitoring records protect the Establish Critical Limits (Specifications) Monitoring is defined as a planned integrity of the process. for Each CCP sequence of observation, testing or mea- Critical limits must be established for surement to ensure that the CCP is under Establish Corrective Action Protocol for Each CCP each CCP to ensure that the system effec- control. Monitoring requirements should This protocol is implemented when tively controls identified hazards. Critical be carefully defined; responsibility for monitoring indicates that deviation at a limits are the tolerance limits or safety observation or testing clearly assigned; CCP has exceeded the critical tolerance margins for each CCP to ensure preven- and test results accurately recorded for limit. A critical deviation (CD) is a defi- tion or control of a hazard. These limits future verification. Monitoring can be per- ciency that could result in an unaccept- may be derived experimentally through formed at defined time intervals or contin- able consumer health risk and must be validation process, regulatory standards uously, and visual observation, calibrated addressed promptly. This may involve and codes, or by other reliable sources. instruments and recording charts may be adjustment to the process upstream or

JUNE 2000 35 addition of corrective steps in the subse- ment has been performed and the pro- Successful food processors under- quent process. In addition, the plan must gram customized to meet site-specific stand the importance of their reputation address disposition of any product pro- needs. However, the HACCP principles and “brand value” in the marketplace. duced during CD. In some cases, the do not mandate or suggest any particular This status can be best protected through product must be placed “on hold” pend- methodology for hazard analysis. a well-implemented “total quality” sys- ing investigation and appropriate correc- In the author’s experience, one effec- tem focused on prevention. Ⅲ tive action. Additional monitoring and tive technique is to use a team-based sampling may be necessary to ensure gross hazard analysis method that sys- REFERENCES implementation of corrective action. tematically identifies hazards and their U.S. Dept. of Agriculture. Bacterial trigger mechanisms, and assesses their Foodborne Diseases: Medical and Productivity Establish Procedures for Recordkeeping associated effects in terms of likelihood Losses. Agriculture Economic Report No. Future regulatory inspections will and severity. This information is recorded 741. Washington, DC: USDA, Food and likely shift from physical plant/product to create a hazard catalog. Consumer Economics Div., Economic inspection to review of the HACCP sys- Each hazard can then be assessed Research Service, 1996. tem and associated documentation. It is qualitatively for its relative risk, includ- Microorganisms in Foods. Application of already a key component of the volun- ing comparative probability of occur- the Hazard Analysis Critical Control Point tary FDA/National Oceanic and Atmos- rence and severity of effects, with due (HACCP) System to Ensure Microbiological pheric Administration’s Fish and Fishery consideration for effectiveness of down- Safety and Quality. Oxford, England: Black- Products Program. stream controls. For example, the poten- well Scientific Publications Ltd., 1992. Documentation should be systematic tial detrimental effect of a specific hazard National Advisory Committee on Mi- and thorough. It should include the in milk production (e.g., inadequate stor- crobiological Criteria for Foods. “HACCP HACCP-based plan; modifications to the age temperature and potential for tem- Principles for Food Production.” Washing- process or the plan; raw material procure- perature abuse of raw milk) may be ton, DC: NACMCF, Food Safety Inspection ment records; CCP limits and monitoring somewhat reduced if the downstream Service, U.S. Dept. of Agriculture, 1989. records; records of action taken to address process includes a pasteurization step. Pierson, M.D. and D.A. Corlett Jr., eds. CDs; disposition of products affected by The assessor must then determine the HACCP: Principles and Applications. New CDs; quality assurance/control records; desired risk tolerance level and compare York: Van Nostrand Reinhold, 1992. and consumer complaint records. Appro- this level to the potential frequency and Scarlett, T. “An HACCP Approach to priate monitoring records should be docu- severity of catalogued hazards in order to Product Liability.” Food Technology. June mented with signature as necessary. determine unacceptable risks. The result is 1991: 128-134. The level of detail in recordkeeping a risk profile, which facilitates the identifi- Sperber, W.H. “The Modern HACCP will vary according to the complexity of cation of CCPs with unacceptable risks to System.” Food Technology. June 1991: 116- the food preparation process. For efficien- help the facility set priorities; it also simpli- 120. cy, HACCP documentation may be inte- fies completion of the HACCP program. Tisler, J.M. “The Food and Drug grated into operational recordkeeping. Administration’s Perspective on HACCP.” CONCLUSION Food Technology. June 1991: 125-127. Establish Procedures for an Effective Verification An effective HACCP program provides U.S. Food and Drug Administration. These procedures ensure that the a systematic approach to food safety. With “HACCP Guidelines.” Annex 5, 1997 HACCP-based system implemented com- dramatic increases in the variety of pre- Food Code. Washington, DC: U.S. Dept. plies with the HACCP plan designed for pared foods, an effective food safety pro- of Health and Human Services, Public that process. Verification may include doc- gram is an important element of public Health Service, FDA, 1997. umentation checks as well as testing, and health protection. FDA has already added the manufacturer or regulatory agency HACCP to its Food Code and is recom- may perform audits. Verification activities mending HACCP system implementation and procedures may include review of throughout the food industry. USDA has CCPs and monitoring records, deviations introduced HACCP into its regulations for A.V. Riswadkar, CSP, ARM, is product liability and corrective actions, as well as periodic meat and poultry processors. manager in the Risk Engineering Div. of Zurich verification inspections. Focused verifi- HACCP follows a basic risk manage- Services Corp., Schaumburg, IL. He holds a B.S. in cation can be initiated to investigate and ment philosophy with an emphasis on Mechanical Engineering and an M.S. in Industrial follow-up specific foodborne disease out- reducing the potential hazards inherent Engineering. Riswadkar is an American Society for Quality certified quality engineer and certified breaks and other incidents. in food safety. By identifying critical risk auditor. In addition, he has extensive consulting In addition to a periodic program factors, a firm can direct its prevention experience in loss prevention. Riswadkar is a mem- review and audit, it may be necessary to and mitigation resources to maximize its ber of ASSE’s Northeastern Illinois Chapter. review and verify the integrity and scien- risk management efforts. tific basis for critical limits established for HACCP principles are not limited to each CCP. Any significant change in the food safety; they can be applied to other process, materials or packaging will re- products and processes as well. For quire an appropriate review. The key is to example, in 1985, the National Academy ensure that the program remains effective of Sciences recommended that all regula- READER FEEDBACK and current. tory agencies adopt HACCP principles. FDA’s Center for Devices and Radiologi- Did you find this article interesting CRITICAL CONTROL POINTS & RISK ASSESSMENT cal Health is working on adopting and useful? Circle the corresponding Due to lack of expertise or adequate HACCP for the medical device industry. number on the reader service card. training in comprehensive risk assess- In 1995, former FDA Commissioner ment, many food processors rely on off- David Kessler stated, “Our safety inspec- YES 41 the-shelf generic HACCP systems. While tions should focus on prevention rather SOMEWHAT 42 this is a good start, full benefits of an than on chasing the horses after they are NO 43 effective HACCP program cannot be real- out of the barn. HACCP is the system that ized until a comprehensive risk assess- will make that possible.”

36 PROFESSIONAL SAFETY