Editor’s Note: The author would like to thank William Sperber, PhD, for the insight he provided on the development of HACCP during the 1980s.
As it approaches its 50th anniversary, hazard analysis and critical control point (HACCP) has repeatedly shown itself to be the most effective system to ensure food safety. The principles can be applied in a variety of venues, from agricultural production to food service, from multinational corporations to small processors in developing countries. It is a systematic approach to building safety.
The HACCP concept has continually evolved over the years. The changes that it has undergone have built a complete food safety management system (FSMS) with increased efficiency and effectiveness.
HACCP was developed in the late 1950s by a team of food scientists and engineers from The Pillsbury Company, the Natick Research Laboratories, and the National Aeronautics and Space Administration. The team developed a system designed to build quality into the product to ensure food safety for the manned space program.
In 1971, Pillsbury presented this concept at the National Conference on Food Protection sponsored jointly by the Food and Drug Administration (FDA) and the American Public Health Association. Initially, HACCP consisted of three principles:
- identification and assessment of hazards associated with food from farm to fork;
- determination of the critical control points to control any identified hazard; and
- establishment of a system to monitor the critical control points.
Changes have been made to HACCP to simplify the concept, to make it easier to implement and maintain an FSMS, and to make the FSMS more effective. The initial concept of HACCP, however, has never changed.
The FDA incorporated the concepts of HACCP into its low acid and acidified food regulations in 1974. These regulations were developed in response to outbreaks of Clostridium botulinum poisoning in commercially canned food and have effectively prevented such occurrences since their implementation. Recent outbreaks in commercially canned food have occurred in the products of companies that did not precisely follow the regulations. During the late 1970s, general interest in HACCP waned. Yet during this time, HACCP was implemented and used by several large food processing companies.
HACCP Takes Over
Toward the end of the 1980s, a number of publications were instrumental in making HACCP the predominant food safety system. In 1985, the National Research Council of the National Academy of Sciences published An Evaluation of the Role of Microbiological Criteria for Foods and Food Ingredients. This publication, also known as the green book, recommended that the food processing industry and governmental agencies use HACCP, describing it as the most effective means to ensure the safety of the U.S. food supply. The expert committee stated that HACCP would have to be made a regulatory requirement to ensure widespread use.
It is interesting to note that the use of HACCP in the United States was driven by the marketplace rather than by regulations. Customers like McDonald’s required all of their suppliers to implement HACCP to ensure the safety of the food sold in their restaurants. Other suppliers soon followed suit.
In 1989, The National Advisory Committee on Microbiological Criteria for Foods (NACMCF) published the first HACCP document. This standard codified the practice of HACCP to date, including the seven principles of HACCP.
Also in 1989, the International Commission on Microbiological Specifications for Foods (ICMSF) published Microorganisms in Foods 4: Application of the Hazard Analysis Critical Control Point (HACCP) System to Ensure Microbiological Safety and Quality. The book described the application of HACCP to the entire food chain from the farm through food preparation in the restaurant and home. Hazard analysis was based on a combination of risk and the severity of the hazard. As part of the hazard analysis process, the microbiologist was to ask a number of critical questions related to the product’s manufacture, composition, and distribution.
The ICMSF book included the concepts of CCP1 and CCP2. CCP1 is a point at which control can be applied to prevent or eliminate a food safety hazard or to reduce the hazard to an acceptable level. CCP1 evolved into what is currently known as CCP. CCP2 is a point at which a hazard can be minimized but not controlled. The concept of CCP2 also changed over the years, and most CCP2s were eliminated through the prerequisite programs (PRPs). Any remaining CCP2s were designated control points (CP).
The publication also identified the initial concepts of the PRPs. Systems that were critical to a successful HACCP program included hygienic design of the plant and equipment, cleaning and sanitizing, health and hygiene of personnel, and training.
Initially, PRPs were good manufacturing practice programs. The concept then evolved; PRPs were used to form the underlying system for a successful HACCP program. A list of PRPs was classified as essential for HACCP programs as of 1998 (see “Essential Prerequisite Programs as of 1998,” left).
The 1990s were an exciting time for HACCP. In 1993, the Codex Alimentarius Commission issued its first HACCP standard, which provided the first international definition for HACCP. In the same year, NACMCF revised its guidance standard, thus codifying the currently used five preliminary steps and seven principles of HACCP.
The five preliminary steps were a critical addition to HACCP. The first step required that HACCP be developed by a cross-functional team. Preliminary steps two through five enabled the team to develop a detailed understanding of the customer, product, and process used to manufacture the product. This information would provide critical input into the hazard analysis process. Many HACCP auditors report that most working flow diagrams are weak and contain insufficient detail regarding areas where hazards can occur in the manufacturing process. Information that can be included in the flow diagrams includes flow of materials, byproducts, rework, waste, and personnel.
In 1997, both Codex and NACMCF revised their standards. As part of the revision process, NACMCF harmonized the U.S. definition of HACCP with the Codex definition. PRPs were identified as necessary for the successful implementation and maintenance of the HACCP process.
The acceptance of HACCP changed third party audit systems internationally. In the United States, the “sanitation audit” was expanded to include PRPs and HACCP. In Europe, private food safety audit schemes were developed. These schemes included the preliminary steps and principles of HACCP, along with PRPs and elements from the 1994 version of ISO (International Organization for Standardization ) 9001, a standard that described the requirements of an FSMS.
By 2000, there were many private and national food safety standards. Although the standards were similar, significant differences among them led to problems in third-party certifications. As a result, Danish Standards petitioned ISO to develop a standard that would define the requirements for an FSMS.
Because HACCP is an evolving system, ISO 22000 describes the state-of-the-art practices of HACCP and food safety. ISO 22000 has made major contributions to FSMS programs. ISO 22000 is designed for any organization in the food chain, including producers, suppliers, manufacturers, distributors, retailers, and food service organizations.
The structure of ISO 22000 is based on the 2000 version of ISO 9001, which differs significantly from the 1994 version. ISO 9001:2000 was developed with a systems approach, which linked all of the elements of an FSMS. In addition, like ISO 9001:2000, ISO 22000:2005 reduced the amount of required documentation.
In 2007, an ISO joint working group made up of ISO Technical Committee 34 (food products) and the ISO’s Committee on Conformity Assessment developed ISO/TS 22003. This technical specification lays out the rules for auditing and certifying organizations to ISO 22000. As part of these requirements, auditors must be knowledgeable in both the food-processing sector they are auditing and in managing system audits. ISO 22003:2007 also contains requirements for both the certification and accreditation bodies. These requirements are designed to give customers information and confidence about the way suppliers earn certification.
One major contribution of these newer standards is the separation of validation and verification. Traditionally, HACCP classified validation under verification. Validation is now seen as a separate function. The following definitions can be used to clarify the differences among validation, verification, and monitoring.
Validation: Obtaining evidence that the control measures managed by the HACCP plan and the operational PRPs are effective. This is an assessment conducted prior to starting operations.
Verification: Confirming through the provision of objective evidence that the specified requirements have been fulfilled. This is an assessment carried out during and after operations.
Monitoring: Conducting a planned sequence of observations or measurements to assess whether control measures are operating as intended. This is an activity undertaken during operations.
Food safety is still evolving. The American Society for Quality (ASQ) has developed HACCP Auditor Certification (ASQ 2008), training designed to ensure that professionals understand the HACCP standards and the principles of auditing a HACCP-based FSMS.
Recently, the British Standards Institution issued a publicly available specification known as PAS 220:2008. Non-governmental organizations, ISO 22000 certification bodies, and food manufacturers developed this specification to provide additional detailed requirements for PRPs defined in ISO 22000, clause 7.2. Part of the reason for the development of this standard is to allow for the approval of the ISO 22000 scheme by the Global Food Safety Initiative. There are a number of elements for this standard (see “Elements of PAS 220:2008 …,” above). The working group that will revise ISO 22000 will consider the elevation of PAS 220 to an ISO standard.
In the future, we expect to see further improvement that will allow the U.S. food processing industry to deliver safe food products to their consumers anywhere in the global marketplace. n
Dr. Surak is the principal of Surak and Associates. Reach him at [email protected].
- American Society for Quality (ASQ). HACCP Auditor Certification – CHA [ASQ Store Web site]. Available at: www.asq.org/certification/haccp-auditor/. Accessed January 23, 2009.
- British Standards Institution (BSI). PAS 220:2008. Prerequisite programmes on food safety for food manufacturing. London, U.K.; 2008.
- Centers for Disease Control and Prevention (CDC). Update on Multi-State Outbreak of E. coli O157:H7 Infections from Fresh Spinach, October 6, 2006 [CDC Web site]. Available at: http://www.cdc.gov/foodborne/ecolispinach/ 100606.htm. Accessed January 23, 2009.
- Codex Alimentarius Commission (CAC). CAC/GL 69-2008. Proposed draft guidelines for the validation of food safety control measures. Rome, Italy; 2008.
- International Commission on Microbiological Specifications for Foods (ICMSF). Microorganisms in Foods 4: Application of the Hazard Analysis Critical Control Point (HACCP) System to Ensure Microbiological Safety and Quality. Boston: Blackwell Scientific Publications, Ltd.; 1989.
- International Organization for Standardization (ISO). ISO 9001:1994. Quality systems – Model for quality assurance in design, development, production, installation and servicing. Geneva, Switzerland; 1994.
- International Organization for Standardization (ISO). ISO 9001:2000. Quality management systems—requirements. Geneva, Switzerland; 2000.
- International Organization for Standardization (ISO). ISO 22000:2005. Food safety management systems—requirements for any organization in the food chain. Geneva, Switzerland; 2005.
- International Organization for Standardization (ISO). ISO/TS 22003:2007. Food safety management systems—requirements for bodies providing audit and certification of food safety management systems. Geneva, Switzerland; 2007.
- National Advisory Committee on Microbiological Criteria for Foods (NACMCF). Hazard analysis and critical control point principles and application guidelines. August 14, 1997. Available at: www.cfsan.fda.gov/~comm/nacmcfp.html. Accessed January 23, 2009.
- National Research Council (NRC). An Evaluation of the Role of Microbiological Criteria for Foods and Food Ingredients. Washington, D.C.: National Academy Press; 1985.
- Sperber W H, Stevenson KE, Bernard DT, et al. The role of prerequisite programs in managing a HACCP system. Dairy Food Environ Sanit. 1998;18(7):418-423.