The Hazard Analysis and Critical Control Point System in Food Safety

Anavella Gaitan Herrera

1. Introduction

The Hazard Analysis and Critical Control Point (HACCP) system is a preventive method of ensuring food safety. Its objectives are the identification of consumer safety hazards that can occur in the production line and the establishment of a control process to guarantee a safer product for the consumer; it is based on the identification of potential hazards to food safety and on measures aimed at preventing these hazards. HACCP is the system of choice in the management of food safety (1-3). The principles of HACCP are applicable to all phases of food production (4), including basic husbandry practices, food preparation and handling, food processing, food service, distribution systems, and consumer handling and use (5-13). The HACCP system is involved in every aspect of food safety production (according to the UN Food and Agriculture Organization [FAO] and the International Commission on Microbiological Specifications for Foods [ICMSF]) (14-18).

The most basic concept underlying the HACCP system is that of prevention rather than inspection. The control of processes and conditions comprises the critical control point (CCP) element (see Note 1). HACCP is simply a methodical, flexible, and systematic application of the appropriate science and technology for planning, controlling, and documenting the safe production of foods (6-11,19,20) (see Note 2).

The successful application of HACCP requires the full commitment and involvement of management and the workforce, using a multidisciplinary approach that should include, as appropriate, expertise in agronomy, veterinary health, microbiology, public health, food technology, environmental health (21), chemistry, engineering, and so on according to the particular situation (22,23). Application of the HACCP system is compatible with the implementation of total quality management (TQM) systems such as the ISO 9000 series (15-17).

From: Methods in Molecular Biology, vol. 268: Public Health Microbiology: Methods and Protocols Edited by: J. F. T. Spencer and A. L. Ragout de Spencer © Humana Press Inc., Totowa, NJ

As stated previously, international food commerce is regulated by the World Trade Organization (WTO), which ensures that all economic relations involving foods are regulated by the norms, guidelines, and recommendations of the Codex Alimentarius Commission, Office of International Epizootics (OIE) and of the International Phytosanitary Protection Convention (IPPC) (24,25) (see Note 3). Thus, food-exporting countries may require additional resources to enhance the ability of their food industries to meet the requirements. Adequate steps should be taken to facilitate food trade, such as training of personnel, technology transfer, and strengthening of the national food control system (15,16).

The HACCP system covers all types of potential risks or hazards to food safety, whether biological, chemical, or physical, occurring naturally in the food or environment or caused by errors in food processing (26,27). HACCP is not a zero-risk system, but it is designed to minimize the risk of food safety hazards. The growing acceptance of the HACCP system worldwide by industry, governments, and consumers makes it likely that it will be the most universal tool for guaranteeing food safety in the twentieth century (28-34).

Theories of quality management were regarded as a major factor in increasing the quality of Japanese products in the 1950s. Dr. W. E. Deming and others were active in developing TQM systems.

In the 1960s, the Pillsbury Company, the US Army, and the US National Aeronautics and Space Administration (NASA) developed a program for the production of safe foods for the US space program. NASA had two principal safety issues: the potential problems with food particles in the space capsule under conditions of zero gravity and the protection of food from all pathogens and biological toxins.

The US Army's Natick Laboratories were able to predict what might be wrong (a hazard), as well as how and where the problem could occur in the food production process. Thus it was possible to select points at which measurements and/or observations could be made; these points were called critical control points.

The Pillsbury Company introduced and adopted the HACCP system to guarantee the greatest safety possible while reducing end-product inspection and testing. Pillsbury presented the HACCP system to the public for the first time in 1971 at a food safety conference in the United States. In 1973, the Pillsbury Company published Food Safety Through the Hazard Analysis and Critical Control Point System, the first document detailing the HACCP technique. It later served as the basis for US Food and Drug Administration (FDA) inspector training programs (35,36).

The US National Academy of Sciences recommended in 1985 that the HACCP approach be adopted in food processing establishments to ensure food safety. In 1988, ICMSF published a book recommending the HACCP system as a basis of quality control with regard to hygiene and microbiology, and the International Association of Milk, Food, and Environmental Sanitarians (IAMFES) has recommended the broad application of HACCP to food safety (16).

The Guidelines for the Application of Hazard Analysis and Critical Control Point (HACCP) System of the Codex Alimentarius has become the point of reference for international food safety requirements. The Codex Alimentarius Commission adopted the Guidelines (ALINORM 93/13a, Appendix II) at its 20th session, held in Geneva, in 1993. The revised Recommended International Code of Practice—General Principles of Food Hygiene (CAC/RCP 1-1969, Rev. 3 [1997]) was adopted by the Codex Alimentarius Commission during its 22nd session in June of 1997 (15-17,37,38).

1.2. Foodborne Diseases

A foodborne disease outbreak is defined by the US Centers for Disease Control and Prevention as an incident in which two or more persons experience a similar illness after ingestion of a common food and epidemiological analysis implicates the food as the source of the illness.

The foods most frequently involved are foods of animal origin. In 48% of the outbreaks between 1973 and 1987 in the United States in which the vehicle was identified, beef, chicken, eggs, pork, finfish, shellfish, turkey, or dairy products were involved. For a foodborne illness to occur, the pathogen or its toxin(s) must be present in the food. The mere presence of a pathogen, however, does not necessarily result in foodborne disease (26,27,39).

Foodborne illnesses are generally classified as:

1. Foodborne infection: a disease that results from ingesting food containing living harmful microorganisms, such as Salmonella, Shigella, hepatitis A virus, and Trichinella spiralis (40).

2. Foodborne intoxication: toxins or poisons from bacteria or mold growth are present in the ingested food (26).

3. Foodborne toxin infection: results from eating a food containing a large amount of disease-causing microorganisms that are capable of producing or discharging toxin once they are ingested, e.g., Vibrio cholerae and Clostridiumperfringens, respectively (26,39).

1.3. Definitions

Control (noun) To state wherein correct procedures are being followed and criteria are being met.

Control (verb) To take all necessary actions to ensure and maintain compliance with criteria established in the HACCP plan.

Control measure Any action and activity that can be used to prevent or eliminate a food safety hazard or reduce it to an acceptable level.

Corrective action Any action to be taken when the results of monitoring at the CCPs indicates a loss of control.

Critical control A step at which control can be applied and is essential point (CCP) to prevent or eliminate a food safety hazard or reduce it to an acceptable level.

Critical limit A criterion that separates acceptability from unacceptability.

Deviation Failure to meet a critical limit.

Flow diagram A systematic representation of the sequence of steps or operations used in the production or manufacture of a particular food item.

HACCP A system that identifies, evaluates, and controls hazards that are significant for food safety.

HACCP plan

A document prepared in accordance with the principles of the HACCP system to ensure control of hazards that are significant for food safety in the segment of the food chain under consideration. A biological, chemical, or physical agent in, or condition of, food with the potential to cause an averse health effect. The process of collecting and evaluating information on hazards and conditions leading to their presence to decide which are significant for food safety and therefore should be addressed in the HACCP plan.

The act of conducting a planned sequence of observations or mea surements of control parameters to assess whether a CCP is under control.

A point, procedure, operation, or stage in the food chain including raw materials, from primary production to final consumption. Obtaining evidence that the elements of the HACCP plan are effective. The application of methods, procedures, tests, and other evaluations, in addition to monitoring to determine compliance with the HACCP plan (Hazard Analysis and Critical Control Point (HACCP) System and Guidelines for its Application (Annex to CAC/RCP 1-1969, Rev 3 [1997]), are reproduced in Subheading 1.4. (1-3,16,37,41).


Hazard analysis



Validation Verification

1.4. Principles of the HACCP System (1-4)

The HACCP system consists of the following seven principles:

1. Conduct a hazard analysis. Identify the potential hazard(s) associated with food production at all stages, from primary production, processing, manufacture, and distribution until the point of consumption. Assess the likelihood of occurrence of the hazard(s) and identify the measures for their control.

2. Determine the CCPs. Determine the points, procedures, or operational steps that can be controlled to eliminate the hazard(s) or minimize its (their) likelihood of occurrence (42). A "step" means any stage in food production and/or manufacture including the receipt and/or production of raw materials, harvesting, transport, formulation, processing, storage, and so forth (see Note 4).

3. Establish critical limit(s). Establish critical limit(s) that must be met to ensure the CCPs are under control.

4. Establish a system to monitor control of the CCPs. Establish a system to monitor control of the CCPs by scheduled testing or observations.

5. Establish the corrective action to be taken when monitoring indicates that a particular CCP is not under control.

6. Establish procedures for verification to confirm that the HACCP system is working effectively.

7. Establish documentation concerning all procedures and records appropriate to these principles and their application.

1.5. Application of the HACCP Principles

The application of HACCP principles consists of the following tasks as identified in the Logic Sequence for Application of HACCP (4,42a,43):

1. Assemble HACCP team.

2. Describe product.

3. Identify intended use.

4. Construct flow diagram.

5. On-site verification of flow diagram.

6. List all potential hazards associated with each step, conduct a hazard analysis, and consider any measures to control identified hazards (see principle 1, Subheading 1.4.).

7. Determine CCPs (see principle 2).

8. Establish critical limits for each CCP (see principle 3).

9. Establish a monitoring system for each CCP (see principle 4).

10. Establish corrective actions (see principle 5).

11. Establish verification procedures (see principle 6).

12. Establish documentation and record keeping (see principle 7).

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