Hazard Analysis Critical Control Points
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Hazard analysis and critical control points, or HACCP (), is a systematic preventive approach to
food safety Food safety (or food hygiene) is used as a scientific method/discipline describing handling, preparation, and storage of food in ways that prevent food-borne illness. The occurrence of two or more cases of a similar illness resulting from t ...
from
biological Biology is the scientific study of life. It is a natural science with a broad scope but has several unifying themes that tie it together as a single, coherent field. For instance, all organisms are made up of cells that process hereditary in ...
, chemical, and physical
hazards A hazard is a potential source of harm. Substances, events, or circumstances can constitute hazards when their nature would allow them, even just theoretically, to cause damage to health, life, property, or any other interest of value. The probabi ...
in production processes that can cause the finished product to be unsafe and designs measures to reduce these risks to a safe level. In this manner, HACCP attempts to avoid hazards rather than attempting to inspect finished products for the effects of those hazards. The HACCP system can be used at all stages of a food chain, from
food production The food industry is a complex, global network of diverse businesses that supplies most of the food consumed by the world's population. The food industry today has become highly diversified, with manufacturing ranging from small, traditional, ...
and preparation processes including packaging, distribution, etc. The
Food and Drug Administration The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is respon ...
(FDA) and the
United States Department of Agriculture The United States Department of Agriculture (USDA) is the United States federal executive departments, federal executive department responsible for developing and executing federal laws related to farming, forestry, rural economic development, ...
(USDA) require mandatory HACCP programs for juice and
meat Meat is animal flesh that is eaten as food. Humans have hunted, farmed, and scavenged animals for meat since prehistoric times. The establishment of settlements in the Neolithic Revolution allowed the domestication of animals such as chic ...
as an effective approach to
food safety Food safety (or food hygiene) is used as a scientific method/discipline describing handling, preparation, and storage of food in ways that prevent food-borne illness. The occurrence of two or more cases of a similar illness resulting from t ...
and protecting
public health Public health is "the science and art of preventing disease, prolonging life and promoting health through the organized efforts and informed choices of society, organizations, public and private, communities and individuals". Analyzing the det ...
. Meat HACCP systems are regulated by the USDA, while
seafood Seafood is any form of sea life regarded as food by humans, prominently including fish and shellfish. Shellfish include various species of molluscs (e.g. bivalve molluscs such as clams, oysters and mussels, and cephalopods such as octopus an ...
and juice are regulated by the FDA. All other food companies in the
United States The United States of America (U.S.A. or USA), commonly known as the United States (U.S. or US) or America, is a country primarily located in North America. It consists of 50 states, a federal district, five major unincorporated territorie ...
that are required to register with the FDA under the
Public Health Security and Bioterrorism Preparedness and Response Act Signed into effect on 12 June 2002, the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, (PHSBPRA) was signed by the President, the Department of Health and Human Services ( DHHS) and the U.S. Department of Agriculture ...
of 2002, as well as firms outside the US that export food to the US, are transitioning to mandatory hazard analysis and risk-based preventive controls (HARPC) plans. It is believed to stem from a production process monitoring used during
World War II World War II or the Second World War, often abbreviated as WWII or WW2, was a world war that lasted from 1939 to 1945. It involved the vast majority of the world's countries—including all of the great powers—forming two opposin ...
because traditional "end of the pipe" testing on artillery shells' firing mechanisms could not be performed, and a large percentage 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 The National Aeronautics and Space Administration (NASA ) is an independent agency of the US federal government responsible for the civil space program, aeronautics research, and space research. NASA was established in 1958, succeeding th ...
(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 by establishing and auditing safe food production practices. In 1994, the organization
International HACCP Alliance International is an adjective (also used as a noun) meaning "between nations". International may also refer to: Music Albums * ''International'' (Kevin Michael album), 2011 * ''International'' (New Order album), 2002 * ''International'' (The T ...
was established, initially to assist the US meat and poultry industries with implementing HACCP. As of 2007, its membership spread over other professional and industrial areas. 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 based on science, differs from traditional "produce and sort"
quality control Quality control (QC) is a process by which entities review the quality of all factors involved in production. ISO 9000 defines quality control as "a part of quality management focused on fulfilling quality requirements". This approach places ...
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 health safety issues of a product and not the quality of the product, yet HACCP principles are the basis of most food quality and safety assurance systems. In the
United States The United States of America (U.S.A. or USA), commonly known as the United States (U.S. or US) or America, is a country primarily located in North America. It consists of 50 states, a federal district, five major unincorporated territorie ...
, HACCP compliance is regulated by
21 CFR Title 21 is the portion of the Code of Federal Regulations that governs food and drugs within the United States for the Food and Drug Administration (FDA), the Drug Enforcement Administration (DEA), and the Office of National Drug Control Policy (O ...
part 120 and 123. Similarly, FAO and WHO published a guideline for all governments to handle the issue in small and less developed food businesses.


History

In the early 1960s, 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. People involved in this collaboration included Herbert Hollander, Mary Klicka, and Hamed El-Bisi of the United States Army Laboratories in
Natick, Massachusetts Natick ( ) is a town in Middlesex County, Massachusetts, United States. It is near the center of the MetroWest region of Massachusetts, with a population of 37,006 at the 2020 census. west of Boston, Natick is part of the Greater Boston area. ...
, Paul A. Lachance of the Manned Spacecraft Center in
Houston, Texas Houston (; ) is the most populous city in Texas, the most populous city in the Southern United States, the fourth-most populous city in the United States, and the sixth-most populous city in North America, with a population of 2,304,580 in ...
, and Howard E. Baumann representing Pillsbury as its lead scientist. To ensure that the food sent to space was safe, Lachance imposed strict
microbial A microorganism, or microbe,, ''mikros'', "small") and ''organism'' from the el, ὀργανισμός, ''organismós'', "organism"). It is usually written as a single word but is sometimes hyphenated (''micro-organism''), especially in olde ...
requirements, including
pathogen In biology, a pathogen ( el, πάθος, "suffering", "passion" and , "producer of") in the oldest and broadest sense, is any organism or agent that can produce disease. A pathogen may also be referred to as an infectious agent, or simply a germ ...
limits (including ''
E. coli ''Escherichia coli'' (),Wells, J. C. (2000) Longman Pronunciation Dictionary. Harlow ngland Pearson Education Ltd. also known as ''E. coli'' (), is a Gram-negative, facultative anaerobic, rod-shaped, coliform bacterium of the genus ''Escher ...
'', ''
Salmonella ''Salmonella'' is a genus of rod-shaped (bacillus) Gram-negative bacteria of the family Enterobacteriaceae. The two species of ''Salmonella'' are ''Salmonella enterica'' and ''Salmonella bongori''. ''S. enterica'' is the type species and is fur ...
'', and '' Clostridium botulinum''). Using the traditional end product testing method, it was soon realized that almost all of the food manufactured was being used for testing and very little was left for actual use. Therefore, a new approach was needed. NASA's own requirements for critical control points (CCP) in
engineering management Engineering management is the application of the practice of management to the practice of engineering. Engineering management is a career that brings together the technological problem-solving ability of engineering and the organizational, admini ...
would be used as a guide for food safety. CCP derived from failure mode and effects analysis (FMEA) from NASA via the
munition Ammunition (informally ammo) is the material fired, scattered, dropped, or detonated from any weapon or weapon system. Ammunition is both expendable weapons (e.g., bombs, missiles, grenades, land mines) and the component parts of other weapo ...
s 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 Pillsbury's experience in the space program that he advocated for his company to adopt what would become HACCP at Pillsbury. Soon, Pillsbury was confronted with a food safety issue of its own when
glass Glass is a non-crystalline, often transparent, amorphous solid that has widespread practical, technological, and decorative use in, for example, window panes, tableware, and optics. Glass is most often formed by rapid cooling (quenching) of ...
contamination was found in farina, a
cereal A cereal is any Poaceae, grass cultivated for the edible components of its grain (botanically, a type of fruit called a caryopsis), composed of the endosperm, Cereal germ, germ, and bran. Cereal Grain, grain crops are grown in greater quantit ...
commonly used in
infant An infant or baby is the very young offspring of human beings. ''Infant'' (from the Latin word ''infans'', meaning 'unable to speak' or 'speechless') is a formal or specialised synonym for the common term ''baby''. The terms may also be used to ...
food. Baumann's leadership promoted HACCP in Pillsbury for producing commercial foods, and applied to its own food production. This led to a panel discussion at the 1971 National Conference on Food Protection that included examining CCPs and
good manufacturing practice Current good manufacturing practices (cGMP) are those conforming to the guidelines recommended by relevant agencies. Those agencies control the authorization and licensing of the manufacture and sale of food and beverages, cosmetics, pharmaceutica ...
s in producing safe foods. Several botulism cases were attributed to under-processed low-acid canned foods in 1970–71. The United States Food and Drug Administration (FDA) asked Pillsbury 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 days of classroom lecture and 10 days of canning plant evaluations. Canned food regulations ( 21 CFR 108, 21 CFR 110, 21 CFR 113, and 21 CFR 114) were first published in 1969. Pillsbury's training program, which was submitted to the FDA for review in 1969, entitled "Food Safety through the Hazard Analysis and Critical Control Point System" was the first use of the acronym HACCP. HACCP was initially set on three principles, now shown as principles one, two, and four in the section below. Pillsbury quickly adopted two more principles, numbers three and five, to its own company in 1975. It was further supported by the
National Academy of Sciences The National Academy of Sciences (NAS) is a United States nonprofit, non-governmental organization. NAS is part of the National Academies of Sciences, Engineering, and Medicine, along with the National Academy of Engineering (NAE) and the Nati ...
(NAS) when they wrote that the FDA inspection agency should transform itself from reviewing plant records into an HACCP system compliance auditor. Over the period 1986 to 1990, a team consisting of
National Sea Products High Liner Foods Inc. is a Canadian processor and marketer of frozen seafood. High Liner Foods' retail branded products are sold throughout the United States, Canada, and Mexico under the High Liner, Fisher Boy, Mirabel, Sea Cuisine and C. Wirthy ...
and the
Department of Fisheries and Oceans Fisheries and Oceans Canada (DFO; french: Pêches et Océans Canada, MPO), is a department of the Government of Canada that is responsible for developing and implementing policies and programs in support of Canada's economic, ecological and sc ...
developed the first mandatory food inspection programme based on HACCP principles in the world. Together, these Canadian innovators developed and implemented a Total Quality Management Program and HACCP plans for all their
groundfish trawlers Bottom trawling is trawling (towing a trawl, which is a fishing net) along the seafloor. It is also referred to as "dragging". The scientific community divides bottom trawling into benthic trawling and demersal trawling. Benthic trawling is towin ...
and production facilities. A second proposal by the NAS led to the development of the National Advisory Committee on Microbiological Criteria for Foods (NACMCF) in 1987. NACMCF was initially responsible for defining HACCP's systems and guidelines for its application and were coordinated with the
Codex Alimentarius The Codex Alimentarius () is a collection of internationally recognized standards, codes of practice, guidelines, and other recommendations published by the Food and Agriculture Organization of the United Nations relating to food, food production ...
Committee for Food Hygiene A committee or commission is a body of one or more persons subordinate to a deliberative assembly. A committee is not itself considered to be a form of assembly. Usually, the assembly sends matters into a committee as a way to explore them more ...
, that led to reports starting in 1992 and further harmonization in 1997. By 1997, the seven HACCP principles listed below became the standard. A year earlier, the American Society for Quality offered their first certifications for HACCP Auditors.Newcomb, William O. "ASQ Certification: A Brief History". ''Quality Progress''. January 2010. p. 43. First known as Certified Quality Auditor-HACCP, they were changed to Certified HACCP Auditor (CHA) in 2004.American Society for Quality Certified HACCP Auditor brochure.
– accessed 9 January 2010.
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.


Principles

#Conduct a hazard analysis #:Plan to 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. #Identify critical control points #:A
critical control point Critical Control Point (CCP) is the point where the failure of Standard Operation Procedure (SOP) could cause harm to customers and to the business, or even loss of the business itself. It is a point, step or procedure at which controls can be app ...
(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. #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 that hazard to an acceptable level. #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 requires that each monitoring procedure and its frequency be listed in the HACCP plan. #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 is injurious to health or otherwise adulterated as a result if the deviation enters commerce. #Establish procedures for ensuring the HACCP system is working as intended #:Validation ensures that the plans 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 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). #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. Implementation 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.


Standards

The seven HACCP principles are included in the
international standard international standard is a technical standard developed by one or more international standards organizations. International standards are available for consideration and use worldwide. The most prominent such organization is the International Or ...
ISO 22000. This standard is a complete food safety and qualityISO 22000 FSMS 2005 management system incorporating the elements of prerequisite programmes(GMP & SSOP), HACCP and the quality management system, which together form an organization's Total Quality Management system. Other schemes with recognition from the Global Food Safety Initiative (
GFSI The Global Food Safety Initiative (GFSI) is a private organization working as a "Coalition of Action" from The Consumer Goods Forum (CGF) bringing together retailers and brand owners (manufacturers) from across the CGF membership operating as multis ...
), such as Safe Quality Food Institute's SQF Code, also relies upon the HACCP methodology as the basis for developing and maintaining food safety (level 2) and food quality (level 3) plans and programs in concert with the fundamental prerequisites of
good manufacturing practice Current good manufacturing practices (cGMP) are those conforming to the guidelines recommended by relevant agencies. Those agencies control the authorization and licensing of the manufacture and sale of food and beverages, cosmetics, pharmaceutica ...
s.


Training

Training for developing and implementing HACCP food safety management system are offered by several quality assurance companies. However, ASQ does provide a Trained HACCP Auditor (CHA) exam to individuals seeking professional training. In the UK the
Chartered Institute of Environmental Health The Chartered Institute of Environmental Health (CIEH) is a professional membership body concerned with environmental health and promoting standards in the training and education of environmental health professionals. History The history of the ...
(CIEH) and Royal Society for Public Health offer HACCP for Food Manufacturing qualifications, accredited by the QCA (Qualifications and Curriculum Authority).


Application

* Fish and fishery products Consequent to the promulgation of US Seafood Regulation on HACCP on 18th December 1995, it became mandatory that every processor exporting to USA to comply with HACCP with effect from 18.12.1997. The Marine Products Export Development Authority of India (MPEDA) constituted an HACCP Cell in early 1996 to assist the Indian seafood industry in the effective implementation of HACCP. Technical personnel of MPEDA are trained in India and abroad on various aspects of HACCP including HACCP Audit. Seafood Exporters Association of India has eight regional offices to monitor compliance and members use the latest sustainable aquaculture practices and a high-tech hatchery that provides disease-resistant baby shrimp and fingerlings to its own farm, and to hundreds of farmers who supply raw shrimp to major brands Falcon Marine, Devi Seafoods, Ananda Group, Gadre Marine and Mukka Seafood. Devi Seafood now one of India’s largest shrimp exporters and Sysco’s 2018 Gold Supplier for Seafood, benchmarks latest HACCP practices. Its farm-to-fork traceability, commitment to environmental and social responsibility and meticulous standard for food safety and quality have made it a great partner to Sysco for more than 10 years. “We are an integrated seafood company, with our own farms and processing plants,” says Sree Atluri, Director of Operations. “We work closely with Sysco in adding new items and supporting sustainability.” * Fresh-cut produce * Juice and nectar products * Food outlets * Meat and poultry products * School food and services


Water quality management

The use of HACCP for water
quality management Quality management ensures that an organization, product or service consistently functions well. It has four main components: quality planning, quality assurance, quality control and quality improvement. Quality management is focused not only ...
was first proposed in 1994. Thereafter, a number of water quality initiatives applied HACCP principles and steps to the control of
infectious disease An infection is the invasion of tissues by pathogens, their multiplication, and the reaction of host tissues to the infectious agent and the toxins they produce. An infectious disease, also known as a transmissible disease or communicable dise ...
from
water Water (chemical formula ) is an inorganic, transparent, tasteless, odorless, and nearly colorless chemical substance, which is the main constituent of Earth's hydrosphere and the fluids of all known living organisms (in which it acts as a ...
, and provided the basis for the Water Safety Plan (WSP) approach in the third edition of the WHO ''Guidelines for Drinking-water Quality'' report. This WSP has been described as "a way of adapting the HACCP approach to drinking water systems".


Water quality management programme guidelines

Program Modernization: According to Ongley, 1998, a series of steps could be taken to execute a more useful transition – from technical programmes to policy to management decisions. Various aspects of the modernization process have been discussed by Ongley in ESCAP (1997): *Policy reform – A consultative process must define all the policy tenets and should review the execution of the said policy tenets. *Legal reform – Legal reform with respect to water quality management is one of the most crucial elements. This could be addressed by the creation of national data standards as well as the creation of a national process to analyze and review collected data. *Institutional reform – This is a complex issue and has no simple answers. Still, there are some key principles that can be helpful for institutional reform in light of water quality management. One of them is water quality monitoring as a service function. Apart from that, both technical efficiency and capacity issues emerge as major factors in reformed water quality programs. *Technical reform – This is the area that garners the most attention as well as investment. Such a reform targets facility modernization, including other co-factors like data programmes/networks, technical innovation, data management/data products and remediation.


HACCP for building water systems

Hazards associated with water systems in buildings include physical, chemical and microbial hazards. In 2013, NSF International, a public health and safety NGO, established education, training and certification programs in HACCP for building water systems. The programs, developed with the guidance of subject matter experts Aaron Rosenblatt and William McCoy center on the use of HACCP principles adapted to the specific requirements of domestic (hot and cold) and utility (HVAC, etc.) water systems in buildings, to prevent plumbing-associated hazards from harming people. Hazards addressed include scalding, lead, and disinfection byproducts as well as a range of clinically important pathogens, such as '' Legionella'', '' Pseudomonas'', nontuberculous mycobacteria (NTM), '' Acinetobacter'', ''
Elizabethkingia ''Elizabethkingia'' is a genus of bacterium described in 2005, named after Elizabeth O. King, the discoverer of the type species. Before this genus being formed in 2005, many of the species of ''Elizabethkingia'' were classified in the ''Chryse ...
'', and '' Naegleria''. Early adopters of HACCP for building water systems include leading healthcare institutions, notably the
Mayo Clinic The Mayo Clinic () is a nonprofit American academic medical center focused on integrated health care, education, and research. It employs over 4,500 physicians and scientists, along with another 58,400 administrative and allied health staff, ...
in
Rochester, Minnesota Rochester is a city in the U.S. state of Minnesota and the county seat of Olmsted County. Located on rolling bluffs on the Zumbro River's south fork in Southeast Minnesota, the city is the home and birthplace of the renowned Mayo Clinic. Acco ...
.


ISO 22000 Food Safety Management System

ISO 22000 is a standard designed to help augment HACCP on issues related to food safety. Although several companies, especially big ones, have either implemented or are on the point of implementing ISO 22000, there are many others which are hesitant to do so. The main reason behind that is the lack of information and the fear that the new standard is too demanding in terms of bureaucratic work. ISO 22000 references the
Codex Alimentarius The Codex Alimentarius () is a collection of internationally recognized standards, codes of practice, guidelines, and other recommendations published by the Food and Agriculture Organization of the United Nations relating to food, food production ...
General Principles of Food Hygiene, CXC 1-1969 which includes HACCP principles and 12 HACCP application steps. This is explained in a joint publication from
ISO ISO is the most common abbreviation for the International Organization for Standardization. ISO or Iso may also refer to: Business and finance * Iso (supermarket), a chain of Danish supermarkets incorporated into the SuperBest chain in 2007 * Iso ...
and
United Nations Industrial Development Organization The United Nations Industrial Development Organization (UNIDO) (French: Organisation des Nations unies pour le développement industriel; French/Spanish acronym: ONUDI) is a specialized agency of the United Nations that assists countries in e ...
(UNIDO) which provides guidance to assist all organizations (including small and medium-sized) that recognize the potential benefits of implementing a Food Safety Management System.


See also

* Failure mode and effects analysis * Failure mode, effects, and criticality analysis * Fault tree analysis *
Food safety Food safety (or food hygiene) is used as a scientific method/discipline describing handling, preparation, and storage of food in ways that prevent food-borne illness. The occurrence of two or more cases of a similar illness resulting from t ...
* Design Review Based on Failure Mode * Fast food restaurant * ISO 22000 * Hazard analysis * Hazard analysis and risk-based preventive controls * Hazop * Hygiene *
Sanitation Sanitation refers to public health conditions related to clean drinking water and treatment and disposal of human excreta and sewage. Preventing human contact with feces is part of sanitation, as is hand washing with soap. Sanitation systems ...
*
Sanitation Standard Operating Procedures Sanitation Standard Operating Procedures is the common name, in the United States, given to the sanitation procedures in food production plants which are required by the Food Safety and Inspection Service of the USDA and regulated by 9 CFR part 416 ...
* ''
Codex Alimentarius The Codex Alimentarius () is a collection of internationally recognized standards, codes of practice, guidelines, and other recommendations published by the Food and Agriculture Organization of the United Nations relating to food, food production ...
'' * Total quality management


References

{{Authority control Food safety Food technology Quality management Hazard analysis United States Department of Agriculture Drinking water