Abstract
Hazard analysis and critical control points, or HACCP, are a systematic, organized approach to the identification, evaluation, and control of food safety hazards (FDA 1997a). HACCP manages food safety through the analysis and control of certain hazards during all facets of the food supply chain: from the production of raw materials to handling, manufacturing, shipping/transportation, and consumption (FDA 2013a).
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Notes
- 1.
USDA lists recordkeeping as Principle 6 and verification procedures as Principle 7.
References
Food and Agriculture Organization of the United Nations (1997) Hazard analysis and critical control point (HACCP) system and guidelines for its application. http://www.fao.org/docrep/005/y1579e/y1579e03.htm. Accessed 18 Dec 2014
Food and Agriculture Organization of the United Nations and World Health Organization (2006) FAO/WHO guidance to governments on the application of HACCP in small and/or less-developed food businesses. http://www.fao.org/docrep/009/a0799e/a0799e00.htm. Accessed 18 Dec 2014
National Advisory Committee on Microbiological Criteria for Foods (1997) Journal of Food Protection 1998;61(9):1246–1259. http://www.fsis.usda.gov/wps/wcm/connect/dccfe894-36bb-4bd9-b27a-a7f5275a22cd/JFP0998.pdf?MOD=AJPERES. Accessed 8 Jul 2014
U.S. Department of Agriculture, Food Safety and Inspection Service (1998) Key facts: the seven HACCP principles. http://www.fsis.usda.gov/Oa/background/keyhaccp.htm. Accessed 18 Dec 2014
U.S. Food and Drug Administration (1997a) HACCP principles & application guidelines. http://www.fda.gov/Food/GuidanceRegulation/HACCP/ucm2006801.htm. Accessed 18 Dec 2014
U.S. Food and Drug Administration (1997b) 1997 Food Code—Annex 5: HACCP guidelines. http://www.fda.gov/Food/GuidanceRegulation/RetailFoodProtection/FoodCode/ucm054471.htm. Accessed 18 Dec 2014
U.S. Food and Drug Administration, Center for Food Safety and Applied Nutrition (2006) Managing food safety: a manual for the voluntary use of HACCP principles for operators of food service and retail establishments. http://seafood.oregonstate.edu/.pdf%20Links/Managing%20Food%20Safety%20-%20A%20Manual%20for%20the%20Voluntary%20Use%20of%20HACCP%20Principles%20for%20Operators%20of%20Food%20Service.pdf. Accessed 9 Jul 2014
U.S. Food and Drug Administration, Center for Food Safety and Applied Nutrition (2006) Managing food safety: a manual for the voluntary use of HACCP principles for operators of food service and retail establishments. http://www.fda.gov/downloads/Food/Guidance Regulation/HACCP/UCM077957.pdf Accessed 27 Feb 2014
U.S. Food and Drug Administration (2013a) Hazard analysis & critical control points (HACCP). http://www.fda.gov/food/guidanceregulation/haccp/default.htm. Accessed 18 Dec 2014
U.S. Food and Drug Administration (2013b) FDA Food Code 2009: Annex 4—Management of food safety practices—achieving active managerial control of foodborne illness risk factors. http://www.fda.gov/Food/GuidanceRegulation/RetailFoodProtection/FoodCode/ucm188363.htm. Accessed 18 Dec 2014
U.S. Food and Drug Administration (2013c) FDA Food Safety Modernization Act. Frequently asked questions and answers. http://www.fda.gov/downloads/Food/GuidanceRegulation/UCM345224.pdf. Accessed 18 Dec 2014
U.S. Food and Drug Administration (2013d) 2013 Food Code, Chapter 3. http://www.fda.gov/downloads/Food/GuidanceRegulation/RetailFoodProtection/FoodCode/UCM374510.pdf. Accessed 9 Jul 2014
U.S. Food and Drug Administration (2014) Guidance for industry: juice HACCP hazards and controls guidance first edition; Final guidance. http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/Juice/ucm072557.htm. Accessed 12 Jun 2014
Additional Resources
21 CFR 110. Current good manufacturing practice in manufacturing, packing, or holding human food
9 CFR 416. Sanitation
U.S. Food and Drug Administration (2001) Guidance for industry: the juice HACCP regulation—questions & answers. http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/Juice/ucm072981.htm. Accessed 19 May 2014
U.S. Food and Drug Administration, Center for Food Safety and Applied Nutrition (2011) Fish and fishery products hazards and controls guidance. http://www.fda.gov/downloads/food/guidanceregulation/ucm251970.pdf. Accessed 27 Feb 2014
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Appendices
Take-Home Message
HACCP is a worldwide standard food safety system that can adapt to new hazards and new controls, can apply to operations of all sizes, and can apply to virtually every operation within the farm-to-fork supply chain. The HACCP approach in identifying and controlling food safety hazards is essential to preventing foodborne illnesses and instilling consumer confidence in the safety of the food supply.
Activity
For each step in the HACCP process, indicate whether each question is true or false.
The questions listed below are based on FDA and USDA FSIS HACCP publications referenced in previous paragraphs, as well as information accessible through the FDA website provided in the publication titled “A Model HACCP Plan for Small-Scale, Fresh-Squeezed (Not Pasteurized) Citrus Juice Operations” from the Institute of Food and Agricultural Sciences, Cooperative Extension Service, University of Florida. The publication is available at: http://university.uog.edu/cals/people/Pubs/FS07500.PDF
Pre-HACCP
-
1.
Prior to developing a HACCP plan, it is important to assemble a HACCP team that has thorough knowledge of all stages of the establishment’s food production process. T___ F___
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2.
The HACCP team should develop a “flow diagram” of all steps in the production process so that the HACCP team can make an accurate assessment of all hazards reasonably likely to occur in the production process. T___F___
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3.
Typically, the first step in a “flow diagram” is “receiving.” T___F___
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4.
Pre-HACCP activities might include evaluations of the effectiveness of the establishment’s “sanitation plan.” T___F___
HACCP Implementation Steps (note: the term, “step” is interchangeable with “principle”)
-
1.
There are six important steps of HACCP implementation plus one that is not very important. T___F___
Step One—Conduct a Hazard Analysis
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1.
The hazard analysis is concerned with two main hazards reasonably likely to occur: biological and chemical hazards. T___F___
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2.
In the hazard analysis process, physical hazards are not as important as biological or chemical hazards. T___F___
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3.
Many biological hazards can survive the food production process and cause a foodborne illness to consumers. T___F___
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4.
Chemical hazards are toxic substances such as pesticides, certain toxins, cleaning compounds, accidentally or intentionally introduced into the production process, that can cause food-borne illness. T___F___
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5.
While small pieces of metal are not considered significant physical hazards, pieces of glass are. T___F___
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6.
While the HACCP team may use multiple sources (scientific literature, expert opinion, laboratory records, illness data) when evaluating hazards of significance or those hazards reasonably likely to occur in a specific production process, it is not really necessary. T___F___
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7.
It is not relevant for the HACCP team to consider factors (pH and temperature) which influence growth of common foodborne pathogens. T___F___
Step Two—Determine the Critical Control Points (CCPs)
-
1.
A critical control point (CCP) is a point, step, or procedure in a food process at which a control measure can be applied, and, as a result, a food safety hazard can be prevented, eliminated, or reduced to acceptable levels. T___F___
-
2.
Examples of clearly defined CCPs could include pasteurization of milk and the use of metal detector systems designed to remove metal fragments from food products. T___F___
Step Three—Establish Critical Limits
-
1.
A critical limit is the maximum or minimum value (safe tolerance levels) to which a physical, biological, or chemical hazard must be controlled at a critical control point to prevent, eliminate, or reduce it to an acceptable level. T___F___
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2.
Exceeding critical limits indicate that a health hazard may exist or could develop. T___F___
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3.
Critical limits pertain to temperature controls only. Time is not a factor. T___F___
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4.
CCP limits must be scientifically-based. T___F___
Step Four—Establish Monitoring Procedures
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1.
Monitoring is not necessarily a scheduled task. T___F___
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2.
Critical limits of a CCP are monitored to determine if the CCP is under control, but it is not necessary to record the values. T___F___
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3.
Anyone can perform CCP monitoring including new employees not familiar with the production process. T___F___
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4.
The critical monitoring philosophy is “Close is good enough for me.” T___F___
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5.
Continuous monitoring devices such as time/temperature recording thermometers are acceptable. T___F___
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6.
In addition to time and temperature, monitoring measurements could include visual observations and pH levels. T___F___
Step Five—Establish Corrective Actions
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1.
Corrective actions are taken when monitoring activities indicate that critical limits or tolerances are not met. T___F___
-
2.
Corrective actions do not have to be taken when values for critical limits are close. T___F___
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3.
For severe hazards, a corrective action could include stopping the production line. T___F___
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4.
Corrective actions do not have to be identified and documented. T___F___
-
5.
Corrective action responsibility and authority must be clearly identified in the HACCP plan. T___F___
Step Six—Establish Verification Procedures
-
1.
The HACCP plan is reviewed to determine if any changes are needed in CCPs, critical limits, or other procedures. T___F____
-
2.
Verification activities can include an evaluation of equipment calibration procedures. T___F___
Step Seven—Establish Recordkeeping and Documentation Procedures
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1.
An adequate recordkeeping system is an integral part of the HACCP plan. T___F___
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2.
Records should be designed to document the effectiveness of the HACCP plan. T___F___
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3.
Process control records should be readily accessible to record critical limit observations/values. T___F___
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4.
Records in which values for critical limits for CCPs are made do not have to be signed or initialed. T___F___
-
5.
Records that document critical limit values do not have to be reviewed by a designated, responsible establishment employee. T___F___
Answer Key
Pre-HACCP
(1) True (2) True (3) True (4) True
HACCP Implementation Steps
(1) False
Step One—Conduct a Hazard Analysis
(1) False (2) False (3) True (4) True (5) False (6) False (7) False
Step Two—Determine the Critical Control Points (CCPs)
(1) True (2) True
Step Three—Establish Critical Limits
(1) True (2) True (3) False (4) True
Step Four—Establish Monitoring Procedures
(1) False (2) False (3) False (4) False (5) True (6) True
Step Five—Establish Corrective Actions
(1) True (2) False (3) True (4) False (5) True
Step Six—Establish Verification Procedures
(1) True (2) True
Step Seven—Establish Record Keeping and Documentation Procedures
(1) True (2) True (3) True (4) False (5) False
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Nummer, B., Gump, D., Wells, S., Zimmerman, S., Montalbano, A. (2015). Hazard Analysis and Critical Control Points (HACCP). In: Bradsher, J., Wojtala, G., Kaml, C., Weiss, C., Read, D. (eds) Regulatory Foundations for the Food Protection Professional. Springer, New York, NY. https://doi.org/10.1007/978-1-4939-0650-5_11
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