Hazard Analysis and Critical Control Points
Encyclopedia
Hazard analysis and critical control points, or HACCP (English
English language
English is a West Germanic language that arose in the Anglo-Saxon kingdoms of England and spread into what was to become south-east Scotland under the influence of the Anglian medieval kingdom of Northumbria...

, pronounced ˈhæsʌp), is a systematic preventive approach to food safety
Food safety
Food safety is a scientific discipline describing handling, preparation, and storage of food in ways that prevent foodborne illness. This includes a number of routines that should be followed to avoid potentially severe health hazards....

 and pharmaceutical safety that addresses physical, chemical
Chemical hazard
A chemical hazard arises from contamination of an area with harmful or potentially harmful chemicals. Possible sources of chemical hazards include the burning of fossils, materials and chemicals used in construction and industry, pollution of the environment and water supply, chemical spillages,...

, and biological
Biological hazard
Biological hazards, refer to biological substances that pose a threat to the health of living organisms, primarily that of humans. This can include medical waste or samples of a microorganism, virus or toxin that can impact human health. It can also include substances harmful to animals...

 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 can be taken to reduce or eliminate the risk of the hazards being realized. The system is used at all stages of food production
Food processing
Food processing is the set of methods and techniques used to transform raw ingredients into food or to transform food into other forms for consumption by humans or animals either in the home or by the food processing industry...

 and preparation processes including packaging, distribution, etc. The Food and Drug Administration (FDA) and the United States Department of Agriculture
United States Department of Agriculture
The United States Department of Agriculture is the United States federal executive department responsible for developing and executing U.S. federal government policy on farming, agriculture, and food...

 (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.

A forerunner to HACCP was developed in the form of production process monitoring during World War II
World War II
World War II, or the Second World War , was a global conflict lasting from 1939 to 1945, involving most of the world's nations—including all of the great powers—eventually forming two opposing military alliances: the Allies and the Axis...

 because traditional "end of the pipe" testing was not 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.

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
Quality control
Quality control, or QC for short, is a process by which entities review the quality of all factors involved in production. This approach places an emphasis on three aspects:...

 methods which are less successful and inappropriate for highly perishable foods. In the US, HACCP compliance is regulated by 21 CFR
Title 21 of the Code of Federal Regulations
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 , the Drug Enforcement Administration , and the Office of National Drug Control Policy ....

 part 120 and 123. Similarly, FAO
Fão
Fão is a town in Esposende Municipality in Portugal....

/WHO
Who
Who may refer to:* Who , an English-language pronoun* who , a Unix command* Who?, one of the Five Ws in journalism- Art and entertainment :* Who? , a 1958 novel by Algis Budrys...

 published a guideline for all governments to handle the issue in small and less developed food businesses.

History

On 4 October 1957, the Soviet Union
Soviet Union
The Soviet Union , officially the Union of Soviet Socialist Republics , was a constitutionally socialist state that existed in Eurasia between 1922 and 1991....

 launched Sputnik, the world's first satellite
Satellite
In the context of spaceflight, a satellite is an object which has been placed into orbit by human endeavour. Such objects are sometimes called artificial satellites to distinguish them from natural satellites such as the Moon....

. American president
President of the United States
The President of the United States of America is the head of state and head of government of the United States. The president leads the executive branch of the federal government and is the commander-in-chief of the United States Armed Forces....

 Dwight D. Eisenhower
Dwight D. Eisenhower
Dwight David "Ike" Eisenhower was the 34th President of the United States, from 1953 until 1961. He was a five-star general in the United States Army...

 responded by committing the United States
United States
The United States of America is a federal constitutional republic comprising fifty states and a federal district...

 to the space race
Space Race
The Space Race was a mid-to-late 20th century competition between the Soviet Union and the United States for supremacy in space exploration. Between 1957 and 1975, Cold War rivalry between the two nations focused on attaining firsts in space exploration, which were seen as necessary for national...

. 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.

Food
Food
Food is any substance consumed to provide nutritional support for the body. It is usually of plant or animal origin, and contains essential nutrients, such as carbohydrates, fats, proteins, vitamins, or minerals...

 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
Natick, Massachusetts
Natick is a town in Middlesex County, Massachusetts, United States. Natick is located near the center of the MetroWest region of Massachusetts, with a population of 33,006 at the 2010 census. Only west from Boston, Natick is considered part of the Greater Boston area...

 and Dr. Paul A. Lachance of the Manned Spacecraft Center
Lyndon B. Johnson Space Center
The Lyndon B. Johnson Space Center is the National Aeronautics and Space Administration's center for human spaceflight training, research and flight control. The center consists of a complex of 100 buildings constructed on 1,620 acres in Houston, Texas, USA...

 (Johnson Space Center since February 1973) in Houston, Texas
Houston, Texas
Houston is the fourth-largest city in the United States, and the largest city in the state of Texas. According to the 2010 U.S. Census, the city had a population of 2.1 million people within an area of . Houston is the seat of Harris County and the economic center of , which is the ...

. Pillsbury joined the program as a contractor in 1959 with Howard E. Baumann representing the company as its lead scientist. The main goal was to produce food that would not crumble under zero gravity, but also be safe to eat. Lachance imposed strict microbial
Microbiology
Microbiology is the study of microorganisms, which are defined as any microscopic organism that comprises either a single cell , cell clusters or no cell at all . This includes eukaryotes, such as fungi and protists, and prokaryotes...

 requirements, including pathogen
Pathogen
A pathogen gignomai "I give birth to") or infectious agent — colloquially, a germ — is a microbe or microorganism such as a virus, bacterium, prion, or fungus that causes disease in its animal or plant host...

 limits (including E. coli, Salmonella
Salmonella
Salmonella is a genus of rod-shaped, Gram-negative, non-spore-forming, predominantly motile enterobacteria with diameters around 0.7 to 1.5 µm, lengths from 2 to 5 µm, and flagella which grade in all directions . They are chemoorganotrophs, obtaining their energy from oxidation and reduction...

, and Clostridium botulinum
Clostridium botulinum
Clostridium botulinum is a Gram-positive, rod-shaped bacterium that produces several toxins. The best known are its neurotoxins, subdivided in types A-G, that cause the flaccid muscular paralysis seen in botulism. It is also the main paralytic agent in botox. C. botulinum is an anaerobic...

) on all foods destined for space travel. All personnel involved realized that traditional quality control
Quality control
Quality control, or QC for short, is a process by which entities review the quality of all factors involved in production. This approach places an emphasis on three aspects:...

 methods would be inadequate because there would be so much product testing involved for actual product to be used. NASA own requirements for Critical Control Points (CCP) in engineering management
Engineering management
Engineering Management or Management Engineering is a specialized form of management and engineering that is concerned with the application of engineering principles to business practice...

 would be used as a guide for food safety. CCP derived from Failure mode and effects analysis
Failure mode and effects analysis
A failure modes and effects analysis is a procedure in product development and operations management for analysis of potential failure modes within a system for classification by the severity and likelihood of the failures...

 (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 Pillsbury's experience in the space program that he advocated for his company to adopt what would become HACCP at Pillsbury.

Soon thereafter, Pillsbury was confronted with a food safety issue of its own when glass
Glass
Glass is an amorphous solid material. Glasses are typically brittle and optically transparent.The most familiar type of glass, used for centuries in windows and drinking vessels, is soda-lime glass, composed of about 75% silica plus Na2O, CaO, and several minor additives...

 was found contaminated in farina
Farina (food)
Farina is a cereal food, frequently described as mild-tasting, usually served warm, made from cereal grains. In contemporary American English use, the word usually refers to Cream of Wheat made from soft wheat. Wheat farina is a carbohydrate-rich food, often cooked in boiling water and served warm...

, a cereal
Cereal
Cereals are grasses cultivated for the edible components of their grain , composed of the endosperm, germ, and bran...

 commonly used in infant
Infant
A newborn or baby is the very young offspring of a human or other mammal. A newborn is an infant who is within hours, days, or up to a few weeks from birth. In medical contexts, newborn or neonate refers to an infant in the first 28 days after birth...

 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 examing CCPs and Good Manufacturing Practice
Good Manufacturing Practice
"Good manufacturing practice" or "GMP" are practices and the systems required to be adapted in pharmaceutical manufacturing, quality control, quality system covering the manufacture and testing of pharmaceuticals or drugs including active pharmaceutical ingredients, diagnostics, foods,...

s in producing safe foods. Several botulism
Botulism
Botulism also known as botulinus intoxication is a rare but serious paralytic illness caused by botulinum toxin which is metabolic waste produced under anaerobic conditions by the bacterium Clostridium botulinum, and affecting a wide range of mammals, birds and fish...

 cases were attributed to under-processed low-acid canned
Canning
Canning is a method of preserving food in which the food contents are processed and sealed in an airtight container. Canning provides a typical shelf life ranging from one to five years, although under specific circumstances a freeze-dried canned product, such as canned, dried lentils, can last as...

 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
Title 21 of the Code of Federal Regulations
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 , the Drug Enforcement Administration , and the Office of National Drug Control Policy ....

 CFR
Code of Federal Regulations
The Code of Federal Regulations is the codification of the general and permanent rules and regulations published in the Federal Register by the executive departments and agencies of the Federal Government of the United States.The CFR is published by the Office of the Federal Register, an agency...

 108, 21 CFR 110, 21 CFR 113, and 21 CFR 114) were first published in 1973. 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.

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
United States National Academy of Sciences
The National Academy of Sciences is a corporation in the United States whose members serve pro bono as "advisers to the nation on science, engineering, and medicine." As a national academy, new members of the organization are elected annually by current members, based on their distinguished and...

 (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 Committee on Microbiological Criteria for Foods
National Advisory Committee on Microbiological Criteria for Foods
The National Advisory Committee on Microbiological Criteria for Foods was established in 1987 to advise the Secretaries of Agriculture and Health and Human...

 (NACMCF) in 1987. 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. By 1997, the seven HACCP principles listed below became the standard. A year earlier, the American Society for Quality
American Society for Quality
American Society for Quality , formerly known as American Society for Quality Control , is a knowledge-based global community of quality control experts, with nearly 85,000 members dedicated to the promotion and advancement of quality tools, principles, and practices in their workplaces and in...

 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 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
Critical Control Point
Critical control point is a point, step or procedure at which controls can be applied and a food safety hazard can be prevented, eliminated or reduced to acceptable levels...

 (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 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 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
Verification and Validation
In software project management, software testing, and software engineering, verification and validation is the process of checking that a software system meets specifications and that it fulfills its intended purpose...

 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).

Principle 7: 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.

Standards

The seven HACCP principles are included in the international standard ISO 22000 FSMS 2005. This standard is a complete food safety and quality 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.

HACCP training

HACCP management system trainings are only offered by several commercial enthusiasts. However, ASQ
American Society for Quality
American Society for Quality , formerly known as American Society for Quality Control , is a knowledge-based global community of quality control experts, with nearly 85,000 members dedicated to the promotion and advancement of quality tools, principles, and practices in their workplaces and in...

 does provide Trained HACCP Auditor (CHA) exam to individuals seeking the professional training.
In the UK the Chartered Institute of Environmental Health (CIEH) offer a HACCP for Food Manufacturing qualification accredited by the QCA (Qualifications and Curriculum Authority).

Applied range

It can apply to several food categories; sea food, bulk milk production line, Bulk Cream and Butter Production Line, animal meat industry, Organic Chemical Contaminants in Food, Corn Curl Manufacturing Plant, etc.

USA

  • Fish and fishery products
  • Fresh-cut produce
  • Juice and nectary products
  • Food outlets
  • Meat and poultry products
  • School food and services

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.

HACCP versus ISO 22000

ISO 22000
ISO 22000
ISO 22000 is a standard developed by the International Organization for Standardization dealing with food safety. This is a general derivative of ISO 9000.-Food safety:...

 is the new standard bound to replace HACCP on issues related to food safety. Although several companies, especially the big ones, have either implemented or are on the point of implementing ISO 22000, there are many others which are rather timid and/or reluctant to implement it. 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, from abstract of case study.

ISO 22000 will not replace HACCP. The requirements for HACCP are set with global agreement by the United Nations Codex Alimentarius Commission - and these are the basis for international trade and national legislation around the world. HACCP is a system - ISO 22000 is a standard. ISO 22000 can be used to measure the success of a company's implementation of HACCP, as well as pre-requsites to HACCP and quality systems. There are other standards that can also be used - ISO 22000 is not the only one.

See also

  • Failure mode and effects analysis
    Failure mode and effects analysis
    A failure modes and effects analysis is a procedure in product development and operations management for analysis of potential failure modes within a system for classification by the severity and likelihood of the failures...

  • Failure Mode, Effects, and Criticality Analysis
  • Fault tree analysis
    Fault tree analysis
    Fault tree analysis is a top down, deductive failure analysis in which an undesired state of a system is analyzed using boolean logic to combine a series of lower-level events...

  • Food safety
    Food safety
    Food safety is a scientific discipline describing handling, preparation, and storage of food in ways that prevent foodborne illness. This includes a number of routines that should be followed to avoid potentially severe health hazards....

  • Design Review Based on Failure Mode
    Design Review Based on Failure Mode
    Design Review Based on Failure Mode is a tool originally developed by the Toyota Motor Corporation. This tool was developed based on the philosophy that design problems occur when changes are made to existing engineering designs that have already been proven successful.-Methodology:DRBFM...

  • Fast food restaurant
    Fast food restaurant
    A fast food restaurant, also known as a Quick Service Restaurant or QSR within the industry itself, is a specific type of restaurant characterized both by its fast food cuisine and by minimal table service...

  • ISO 22000
    ISO 22000
    ISO 22000 is a standard developed by the International Organization for Standardization dealing with food safety. This is a general derivative of ISO 9000.-Food safety:...


  • Hazard analysis
    Hazard analysis
    A hazard analysis is used as the first step in a process used to assess risk. The result of a hazard analysis is the identification of risks. Preliminary risk levels can be provided in the hazard analysis. The validation, more precise prediction and acceptance of risk is determined in the Risk...

  • Hazop
    Hazop
    A hazard and operability study is a structured and systematic examination of a planned or existing process or operation in order to identify and evaluate problems that may represent risks to personnel or equipment, or prevent efficientoperation....

  • Hygiene
    Hygiene
    Hygiene refers to the set of practices perceived by a community to be associated with the preservation of health and healthy living. While in modern medical sciences there is a set of standards of hygiene recommended for different situations, what is considered hygienic or not can vary between...

  • Sanitation
    Sanitation
    Sanitation is the hygienic means of promoting health through prevention of human contact with the hazards of wastes. Hazards can be either physical, microbiological, biological or chemical agents of disease. Wastes that can cause health problems are human and animal feces, solid wastes, domestic...

  • Sanitation Standard Operating Procedures
    Sanitation Standard Operating Procedures
    Sanitation Standard Operating Procedures is the common name give 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 in conjunction with 21 CFR part 178.1010...

  • Codex Alimentarius
    Codex Alimentarius
    The Codex Alimentarius is a collection of internationally recognized standards, codes of practice, guidelines and other recommendations relating to foods, food production and food safety. Its name derives from the Codex Alimentarius Austriacus...

  • Total quality management
    Total Quality Management
    Total quality management or TQM is an integrative philosophy of management for continuously improving the quality of products and processes....



External links

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