Hazard Analysis and Critical Control Points

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Terms
Foodborne illness
HACCP
Critical control point
Critical factors
FAT TOM
pH
Water activity (Wa)
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E. coli
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Hazard Analysis Critical Control Point (HACCP) is a systematic preventive approach to food safety and pharmaceutical safety that addresses physical, chemical, and biological hazards as a means of prevention rather than finished product inspection. HACCP is used in the food industry to identify potential food safety hazards, so that key actions, known as Critical Control Points (CCPs) can be taken to reduce or eliminate the risk of the hazards being realized. The system is used at all stages of food production and preparation processes including packaging, distribution, etc. The Food and Drug Administration (FDA) and the United States Department of Agriculture (USDA) say that their mandatory HACCP programs for juice and meat are an effective approach to food safety and protecting public health. Meat HACCP systems are regulated by the USDA, while seafood and juice are regulated by the FDA. The use of HACCP is currently voluntary in other food industries.[1]

A forerunner to HACCP was developed in the form of production process monitoring during World War II because traditional "end of the pipe" testing wasn't an efficient way to ferret out artillery shells that would not explode. HACCP itself was conceived in the 1960s when the US National Aeronautics and Space Administration (NASA) asked Pillsbury to design and manufacture the first foods for space flights. Since then, HACCP has been recognized internationally as a logical tool for adapting traditional inspection methods to a modern, science-based, food safety system. Based on risk-assessment, HACCP plans allow both industry and government to allocate their resources efficiently in establishing and auditing safe food production practices. In 1994, the organization of International HACCP Alliance was established initially for the US meat and poultry industries to assist them with implementing HACCP and now its membership has been spread over other professional/industrial areas.[2]

Hence, HACCP has been increasingly applied to industries other than food, such as cosmetics and pharmaceuticals. This method, which in effect seeks to plan out unsafe practices, differs from traditional "produce and test" quality control methods which are less successful and inappropriate for highly perishable foods. In the US, HACCP compliance is regulated by 21 CFR part 120 and 123. Similarly, FAO/WHO published a guideline for all governments to handle the issue in small and less developed food businesses.[3]

History

On 4 October 1957, the Soviet Union launched Sputnik, the world's first satellite.[4] American president Dwight D. Eisenhower responded by committing the United States to the space race.[4] Eisenhower signed the National Aeronautics and Space Act on 29 July 1958 that created the National Aeronautics and Space Administration (NASA) to put an American satellite in orbit and to get a person in space.[4]

Food played a critical part in the manned space program. The initial group involved in this were Herbert Hollander, Mary Klicka, and Hamed El-Bisi of the United States Army Laboratories in Natick, Massachusetts and Dr. Paul A. Lachance of the Manned Spaceflight Center (Johnson Space Center since February 1973) in Houston, Texas.[4] Pillsbury joined the program as a contractor in 1959 with Howard E. Baumann representing the company as its lead scientist.[4] The main goal was to produce food that would not crumble under zero gravity, but also be safe to eat.[4] Lachance imposed strict microbial requirements, including pathogen limits (including E. coli, Salmonella, and Clostridium botulinum) on all foods destined for space travel.[4] All personnel involved realized that traditional quality control methods would be inadequate because there would be so much product testing involved for actual product to be used.[4] NASA own requirements for Critical Control Points (CCP) in engineering management would be used as a guide for food safety.[4] CCP derived from Failure mode and effects analysis (FMEA) from NASA via the munitions industry to test weapon and engineering system reliability.[4] Using that information, NASA and Pillsbury required contractors to identify "critical failure areas" and eliminate them from the system, a first in the food industry then.[4] Baumann, a microbiologist by training, was so pleased with Pillsbury's experience in the space program that he advocated for his company to adopt what would become HACCP at Pillsbury.[4]

Soon thereafter, Pillsbury was confronted with a food safety issue of its own when glass was found contaminated in farina, a cereal commonly used in infant food.[4] Baumann's leadership promoted HACCP in Pillsbury for producing commercial foods, and applied to its own food production.[4] This led to a panel discussion at the 1971 National Conference on Food Protection that included examing CCPs and Good Manufacturing Practices in producing safe foods.[4] Several botulism cases were attributed to under-processed low-acid canned foods in 1970-71 that the United States Food and Drug Administration (FDA) asked Pillsbury to organize and conduct a training program for FDA inspectors to served as an inspection basis for canned foods.[4] This 21 day program was first held in September 1972 with 11 days of classroom lecture and 10 days of canning plant evaluations.[4] Canned food regulations (21 CFR 108, 21 CFR 110, 21 CFR 113, and 21 CFR 114)[5] were first published in 1973.[4] Pillsbury's training program to the FDA in 1972, titled "Food Safety through the Hazard Analysis and Critical Control Point System", was the first time that HACCP was used.[4]

HACCP was initially set on three principles, now shown as principles one, two, and four in the section below.[4] Pillsbury quickly adopted two more principles, numbers three and five, to its own company in 1975.[4] It was further supported by the National Academy of Sciences (NAS) that governmental inspections by the FDA go from reviewing plant records to compliance with its HACCP system.[4] A second proposal by the NAS led to the development of the National Advisory Committee on Microbiological Criteria for Foods (NACMCF) in 1987.[4] NACMCF was initially responsible for defining HACCP's systems and guidelines for its application and were coordinated with the Codex Committee for Food Hygiene, that led to reports starting in 1992 and further harmonization in 1997.[4] By 1997, the seven HACCP principles listed below became the standard.[4] A year earlier, the American Society for Quality offered their first certifications for HACCP Auditors.[6] (First known as Certified Quality Auditor-HACCP, they were changed to Certified HACCP Auditor (CHA) in 2004.[7]

HACCP expanded in all realms of the food industry, going into meat, poultry, seafood, dairy, and has spread now from the farm to the fork.[4]

The HACCP seven principles

Principle 1: Conduct a hazard analysis. - Plans determine the food safety hazards and identify the preventive measures the plan can apply to control these hazards. A food safety hazard is any biological, chemical, or physical property that may cause a food to be unsafe for human consumption.

Principle 2: Identify critical control points. - A Critical Control Point (CCP) is a point, step, or procedure in a food manufacturing process at which control can be applied and, as a result, a food safety hazard can be prevented, eliminated, or reduced to an acceptable level.

Principle 3: Establish critical limits for each critical control point. - A critical limit is the maximum or minimum value to which a physical, biological, or chemical hazard must be controlled at a critical control point to prevent, eliminate, or reduce to an acceptable level.

Principle 4: Establish critical control point monitoring requirements. - Monitoring activities are necessary to ensure that the process is under control at each critical control point. In the United States, the FSIS is requiring that each monitoring procedure and its frequency be listed in the HACCP plan.

Principle 5: Establish corrective actions. - These are actions to be taken when monitoring indicates a deviation from an established critical limit. The final rule requires a plant's HACCP plan to identify the corrective actions to be taken if a critical limit is not met. Corrective actions are intended to ensure that no product injurious to health or otherwise adulterated as a result of the deviation enters commerce.

Principle 6: Establish record keeping procedures. - The HACCP regulation requires that all plants maintain certain documents, including its hazard analysis and written HACCP plan, and records documenting the monitoring of critical control points, critical limits, verification activities, and the handling of processing deviations.

Principle 7: Establish procedures for ensuring the HACCP system is working as intended. - Validation ensures that the plants do what they were designed to do; that is, they are successful in ensuring the production of safe product. Plants will be required to validate their own HACCP plans. FSIS will not approve HACCP plans in advance, but will review them for conformance with the final rule.

Verification ensures the HACCP plan is adequate, that is, working as intended. Verification procedures may include such activities as review of HACCP plans, CCP records, critical limits and microbial sampling and analysis. FSIS is requiring that the HACCP plan include verification tasks to be performed by plant personnel. Verification tasks would also be performed by FSIS inspectors. Both FSIS and industry will undertake microbial testing as one of several verification activities.

Verification also includes 'validation' - the process of finding evidence for the accuracy of the HACCP system (e.g. scientific evidence for critical limitations).

Standards

The seven HACCP principles are included in the international system ISO 22000. This standard is a complete food safety management system incorporating the elements of prerequisite programmes for food safety, HACCP and quality management system which together form an organization’s Total Quality Management.

HACCP training

HACCP management system trainings are only offered by several commercial enthusiasts.[8][9] However, ASQ does provide Trained HACCP Auditor (CHA) exam to individuals seeking the professional training.[10] In the UK the Chartered Institute of Environmental Health (CIEH) [11] offer a HACCP for Food Manufacturing qualification accredited by the QCA (Qualifications and Curriculum Authority) [12]

HACCP application (USA)

  • Fish and fishery products [13]
  • Fresh-cut produces [14]
  • Juice and nectary products [15]
  • Food outlets [16]
  • Meat and poultry products [17]
  • School food and services [18]

HACCP implementation

It involves monitoring, verifying and validating of the daily work that is compliant with regulatory requirements in all stages all the time. The differences among those three types of work are given by Saskatchewan Agriculture and Food [19]

Notes

  1. Food Safety Research Information Office."A Focus on Hazard Analysis and Critical Control Points". Created June 2003, Updated March 2008.
  2. International HACCP Alliance. "International HACCP Alliance" (PDF). Retrieved 12 October 2007. 
  3. FAO/WHO. "FAO/WHO guidance to governments on the application of HACCP in small and/or less-developed food businesses" (PDF). Retrieved 14 October 2007. 
  4. 4.00 4.01 4.02 4.03 4.04 4.05 4.06 4.07 4.08 4.09 4.10 4.11 4.12 4.13 4.14 4.15 4.16 4.17 4.18 4.19 4.20 4.21 4.22 4.23 4.24 4.25 Sperder, William H. and Richard F. Stier. "Happy 50th Birthday to HACCP: Retrospective and Prospective". FoodSafety magazine. December 2009-January 2010. pp. 42, 44-46.
  5. FDA.gov Regulations on acidified and low-acid canned foods. - accessed 10 January 2010.
  6. Newcomb, Wiiliam O. "ASQ Certification: A Brief History". Quality Progress. January 2010. p. 43.
  7. American Society for Quality Certified HACCP Auditor brochure. - accessed 9 January 2010.
  8. TQ Vision. "Welcome to TQ Vision". Retrieved 9 October 2007. 
  9. International Certifications Limited. "International Certifications". Retrieved 9 October 2007. 
  10. American Society for Quality. "HACCP Auditor Certification - CHA". Retrieved 9 October 2007. 
  11. CIEH. "Chartered Institute of Environmental Health (CIEH)". Retrieved 25 March 2009. 
  12. CIEH. "Qualifications Curriculum Authority". Retrieved 25 March 2009. 
  13. Food and Drug Administration. "Fish and fisheries products hazards and controls guidance, third edition". Retrieved 14 October 2007. 
  14. Food and Drug Administration. "(draft) Guide to minimize microbial food safety hazards of fresh-cut fruits and vegetables" (PDF). Retrieved 14 October 2007. 
  15. Food and Drug Administration. "Guidance for Industry: Juice HACCP Hazards and Controls Guidance, First Edition". Retrieved 14 October 2007. 
  16. Food and Drug Administration. "Managing Food Safety: A HACCP Principles Guide for Operators of Food Establishments at the Retail Level (Draft)". Retrieved 14 October 2007. 
  17. Food Safety and Inspection Service. "FSIS Microbiological Hazard Identification Guide For Meat And Poultry Components Of Products Produced By Very Small Plants". Retrieved 14 October 2007. 
  18. United States Department of Agriculture. "Guidance for school food authorities: developing a school food safety program based on the process approach to HACCP principles" (PDF). Retrieved 14 October 2007. 
  19. Saskatchewan Agriculture and Food. "Monitoring, Verification and Validation". Retrieved 20 March 2008. 

See also

External links

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