HACCP

HAZARD ANALYSIS AND CONTROL POINTS

Hazard analysis and critical control points, or HACCP is a systematic preventive approach to food safety and pharmaceutical safety that identifies physical, allergenic, chemical, and biological hazard in production process that can cause the finished product to be unsafe, and designs measurements to reduce these risks to a safe level. In this manner, HACCP is referred as the prevention of hazards rather than finished product inspection. The HACCP system can be used at all stages of a food chain, from food production and preparation process including packaging, distribution, etc. The Food and Drug Administration (FDA) and the United Stated Department of Aqriculture (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 curently voluntary in other food industries.

HACCP is believed to stem from of a production process monitoring used during World War II because traditional "end of the pipe" testing on artillery shell's firing mechanisms could not be performed, and a large  percent of the artillery shells made at the time were either duds or misfiring. 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 Alliiance was established initially for the US meat and poultry industries to assist them implementing HACCP and now its membership has been spread over other professional/industries areas.

Hence, HACCP has been increasingly applied to industries other than food, such as cosmetics and pharmaceutical. This method, which in effect seeks to plan out unsafe practices based on science, differs from traditional "produce and sort" quality control methods that do nothing to prevent hazards from occurring  and must identify them at the end of the process. HACCP is focused only on the heath safety issues of a product and not the quality of the product, yet HACCP principles are the basic of most food quality  and safety assurance system, and the United States, HACCP compliance is regulated by 21 CFR part 120 and 123. Similarly, FAO/WHO published a guideline for government to handle the issue in small and less developed food business.

History
In the early 1960's a collaborated effort between the Pillsbury Company, NASA, and the U.S Army Laboratories began with the objective to provide safe food for space expeditions. Persons involved in this collaboration included Herbert Hollander, Mary Klicka, and Hamed El Bisi of the United State Army Laboratories in Natick Massachusetts, Dr.Paul A. Lachance of the Manned Spacecraft Center in Houston, Texas and Howard E. Baumann representing the Pillsbury as its lead scientist.

In order to insure that the food that would be sent to space was safe, Lachance imposed strict microbial requirements, including pathogen limits (including E.coli, Salmolina, and Clostridium botulinum). Using the traditional end product testing method, it was soon realized that almost all of the food manufactured was being used on testing and very little was left for actual use. It was realized that a new approach was needed.

Nasa own requirements for Critical Control Points (CCP) in engineering management would be used as a guide for food safety. CCP derived from Failure mode and effects analysis (FMEA) from NASA via the munitions industry to test weapon and engineering system reliability. 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. Baumann, a microbiologist by training, was so pleased with Phillbury's experience in the space program the he advocated for his company to adopt what would become HACCP at Phillsbury.

Soon thereafter, Phillsbury was confronted with a food safety issue of its own when glass was found contaminated in farina, a cereal commonly used in infant food. Baumann's leadership promoted HACCP in Phillsbury for producing commercial foods, and applied to its own food production. This led  to a panel discussion at the 19721 National Conference on Food that including examining CCPs and Good Manufacturing Practices in producing safe foods. Several botulism cases were attributed to under-processed low-acid canned foods in 1970-71. The United Stated Food and Drug Administration (FDA) asked Phillsbury to organize and conduct a training program on the inspection of canned foods for FDA inspectors. This 21 day program was first held in September 1972 with 11 day of classroom lecture and 10 days of canning plant evaluations. Canned food regulations (21CFR 108, 21CFR 110, 21 CFR 113, and 21 CFR 114) were first published in 1973. Phillsbury's training program to the FDA in 1972, titled 'Food Safety through the Hazard Analysis and Control Point System', was the first time that Haccp was used.

HACCP was initially set on three principle, now shown as principles one, two, and four in the section below. Pillsbury quickly adopted two more principle, number three and five, to its own company in 1975. 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. A second proposal by the NAS led to the development of the National Advisory Committe on Microbiological Criteria for Food (NACMCF) was initially responsible for defining HACCP's system 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. By 1997, the seven HACCP principles listed below become the standard. A year earlier, the American Society for Quality offered their first certifications for HACCP Auditors. (First known as Certified Quality Auditor-HACCP, they were changed to Certified HACCP Auditor (CHA) in 2004. 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.

The HACCP seven principle

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 proceduce 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 requirement.
Monitoring activities are necessary to ensure that the process is under control at each critical control point. In the United State, 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 procedures for ensuring the HCCP 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 a 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 my 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 to 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).

Principle 7- Establish record keeping procedures.
The HCCP 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 process deviations- wikipedia