Hazard Analysis Critical Control Point (HACCP) system is based on the principle that food safety issues can be eliminated or minimised by prevention during production rather than detection in the finished product. The concept of Hazard and Operability (HAZOP) is used to identify hazardous working conditions in specific steps of a processing system that jeopardises the safety of employees. The design of a PEF facility based on the HACCP concepts is a preliminary step toward approval by regulatory agencies such as the US Food and Drug Administration (FDA) and the US Department of Agriculture (USDA).
The concept of HACCP emerged as a result of an effort of the Pillsbury Company to manufacture safe food products for the National Aeronautics and Space Administration (NASA) who wanted a “zero defects” programme to guarantee safety in the foods, astronauts consume in the space. HACCP system guarantees food safety while reducing or eliminating the need for sample testing the finished product by eliminating microbiological, chemical and physical hazards through anticipation and prevention rather than inspection. To establish and design an effective HACCP programme, the following requirements must be fulfilled (National Food Processors Association, 1992):
?Management, leadership, and commitment
?Expert knowledge of design of a HACCP programme
?Employee training and operator control
?Effective verification programme
HACCP - A new approach
This would require control over the raw materials, the process, and the environment, personnel, storage and distribution beginning as early in the system as possible. It was felt certain that if this type of control could be established, along with appropriate record keeping, that a product that could be said to be safe with a high degree of assurance should be able to be produced. For all practical purposes, if it was done correctly, it should not require any testing of the final packaged product other than for monitoring purposes.
HACCP - A preventative system
HACCP is a preventative system for food control. The system when properly applied can be used to control any area or point in the food system that could contribute to a hazardous situation, whether it be from contaminants, pathogenic microorganisms, physical objects, chemicals, raw materials, a process, user directions for the consumer or storage conditions. The hazard analysis portion of HACCP (Fig.1) involves a systematic study of the ingredients, the food product, and the conditions of processing, handling, storage, packaging, distribution and consumer use. This analysis allowed the identification in the process flow of the sensitive areas that might contribute to a hazard. From this information the Critical Control Points (CCP) in the system that had to be monitored could be determined. The definition of a CCP is any point in the chain of food production, from raw materials to finished products, where loss of control could result in an unacceptable food safety risk.
Figure 1. Preliminary Tasks in the Development of the HACCP Plan
History of HACCP
HACCP has become synonymous with food safety. It is a worldwide-recognised systematic and preventive approach that addresses biological, chemical and physical hazards through anticipation and prevention, rather than through end-product inspection and testing (http://www.fao.org/).
The HACCP system for managing food safety concerns grew from two major developments. The first breakthrough was associated with W E Deming, whose theories of quality management are widely regarded as a major factor in turning around the quality of Japanese products in the 1950s. Dr Deming and others developed total quality management (TQM) systems which emphasised on a total systems approach to manufacturing that could improve quality while lowering costs. The second major breakthrough was the development of the HACCP concept itself.
The HACCP concept was pioneered in the 1960s by the Pillsbury Company, the United States Army and NASA as a collaborative development for the production of safe foods for the United States space programme. NASA wanted a "zero defects" programme to guarantee the safety of the foods that astronauts would consume in space. Pillsbury therefore introduced and adopted HACCP as the system that could provide the greatest safety while reducing dependence on end-product inspection and testing. HACCP emphasised control of the process as far upstream in the processing system as possible by utilising operator control and/or continuous monitoring techniques at critical control points. Pillsbury presented the HACCP concept publicly at a conference for food protection in 1971. The use of HACCP principles in the promulgation of regulations for low-acid canned food was completed in 1974 by the United States Food and Drug Administration (FDA). In the early 1980s, the HACCP approach was adopted by other major food companies.
The United States National Academy of Science recommended in 1985 that the HACCP approach be adopted in food processing establishments to ensure food safety. More recently, numerous groups, including for example the International Commission on Microbiological Specifications for Foods (ICMSF) and the International Association of Milk, Food and Environmental Sanitarians (IAMFES), have recommended the broad application of HACCP to food safety.
Seven Principles of the HACCP System
The HACCP system consists of the following seven principles (Fig. 2)
Principle 1
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.
Principle 2
Determine the points, procedures or operational steps that can be controlled to eliminate the hazard(s) or minimise its (their) likelihood of occurrence. 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, etc.
Principle 3
Establish critical limit(s) which must be met to ensure the CCP is under control.
Principle 4
Establish a system to monitor control of the CCP by scheduled testing or observations.
Principle 5
Establish the corrective action to be taken when monitoring indicates that a particular CCP is not under control.
Principle 6
Establish procedures for verification to confirm that the HACCP system is working effectively.
Principle 7
Establish documentation concerning all procedures and records appropriate to these principles and their application.
Figure 2: Pie-chart showing the seventh principles of HACCP
Hazard Analysis
Hazards were assessed by ranking each product according to six hazard characteristics (Table1), followed by the assignment of risk category. This was conducted after the participants determined the types of raw materials and ingredients required for product preparation. The agency followed the guidelines established by NACMCF (1989) in their HACCP paper. Furthermore, this revised paper is similar to the internationally agreed upon HACCP principles developed by the Food Hygiene Committee of the Codex Alimentarius Commission.
Physical Hazards
Illness and injury can result from hard foreign objects in food. These physical hazards can result from contamination and/or poor practices at many points in the food chain from harvest to consumer, including those within the food establishment.
Table 1: Examples of physical hazards
| Material | Injury potential | Sources |
| Glass | Cuts, bleeding; may require surgery to find or remove | Bottles, jars, light fixtures, utensils, gauge covers, etc. |
| Wood | Cuts, infection, choking; may require surgery to remove | Field sources, pallets, boxes, building materials |
| Stones | Choking, broken teeth | Fields, buildings |
| Metal | Cuts, infection; may require surgery to remove | Machinery, fields, wire, employees |
| Insulation | Choking; long-term if asbestos | Building materials |
| Bone | Choking | Improper processing |
| Plastic | Choking, cuts, infection; may require surgery to remove | Packaging, pallets, equipment |
| Personal effects | Choking, cuts, broken teeth; may require surgery to remove | Employees |
Critical Control Points
Following the first principle is critical (Fig.3) to applying the others. Before beginning the hazard analysis, an HACCP team consisting of individuals who have specific knowledge and expertise appropriate to the product and process must be formed. It is the responsibility of the team to describe the food and method of its distribution, identify the intended use and consumers of the food, and develop a flow diagram with the actual processes occurring in the facility.
In the application of the HACCP, the use of microbiological testing is seldom an effective means of monitoring the results. In most instances, monitoring can best be accomplished through the use of physical and chemical tests, visual observations, or rapid methods of microbial detection when applicable.
In accordance with the National Academy of Sciences recommendation, the HACCP system must be developed by each food establishment and tailored to its individual products, processing and distribution conditions (NACMCF, 1992). Each generic model included CCPs for chemical, microbiological and physical hazards at appropriate steps of production. The critical control points for raw beef are listed below:
Raw Beef Critical Control Points
1.Sanitation: microbiological, chemical, physical;
2.Meat receiving: microbiological, physical;
3.Non-meat receiving: chemical;
4.Storage: microbiological;
5.Assemble/pre-weigh/ pre-grind: microbiological, chemical, physical;
6.Final grind: physical;
7.Packaging/labelling: microbiological, chemical, physical;
8.Storage: microbiological; and
9.Shipping: microbiological.
Figure 3: Critical Control Point Decision Tree
Record Keeping
It is extremely essential to maintain written documentation of the daily events related to processing. Record keeping (Fig. 4) should cover all the processing steps, from receipt of the raw material to distribution of the finished product. Vega-Mercado et al. (1996), in combination with setup and CCP monitoring procedures. Records utilised in the HACCP system must include the following (NACMCF, 1992):
Record of the HACCP plan: A listing of the HACCP team and assigned responsibilities, description of the product and its intended use, flow diagram of the entire manufacturing process indicating the CCPs, hazards associated with each CCP and preventive measures, critical limits, monitoring system, corrective action plans for deviations from the critical limits, record keeping procedures, and procedures for verification of the HACCP system.
Record of raw materials: Name of the supplier, date of the supplier, date received, condition of the raw material when received, storage temperature, and shelf-life.
Record of processing: Data of all monitored CCPs to established the safe shelf-life of the product and prove the adequacy of the process to manufacturing safe foods.
Record of packaging: Record to indicate compliance with packaging material and sealing specifications.
Record of storage and distribution: Temperature data and records indicating when temperature-sensitive products where shipped.
Record of deviation(s) and corrective action(s)
Record of HACCP system validation: Modification of the HACCP plan (if any) indicating approved revisions and changes in ingredients, formulations, processing, packaging, and distribution as needed.
Record of employee training: The verification step is an important component of the HACCP system. Verification procedures including ensuring that the critical limits of the CCPs are satisfactory, the HACCP plan is functioning effectively, documented periodic revalidation remains free of audits, and the HACCP system is functioning in compliance with government regulations (NACMCF, 1992). This step may also include consideration of any consumer complaints about the food in question (Notermans et al., 1994).
Figure 4: Record-keeping of HACCP System
Cost of Implementing and Operating HACCP
The cost of HACCP is associated with the initial analysis of the individual company and the standards to which they operate prior to development and implementation of the system. Some of the costs involved during the implementation and maintenance of HACCP are as follows:
Implementation Costs
- Consultant fees
- Investment in new equipment
- Staff training
- Structural changes to the plant
- Staff time in documenting the system
- Operational Costs
- Record keeping and Product testing
- Staff training
- Managerial or supervisory time
Although the main goal of HACCP is food protection, there are other benefits acquired through HACCP implementation, such as (http://www.gov.mb.ca/; http://www.ready-haccp.com/):
- Increase customer and consumer confidence
- Maintain or increase market access
- Improve control of production process
- Reduce costs through reduction of product losses and rework
- Increase focus and ownership of food safety
- Business liability protection
- Improve product quality and consistency
- Simplify inspections primarily because of the recordkeeping and documentation
- Alignment with other management systems (ISO 22000)
- Focusses on identifying and preventing hazards from contaminating food
- Permits more efficient and effective government oversight, by the recordkeeping
- Places responsibility for ensuring food safety appropriately on the food manufacturer or distributor
- Helps food companies compete more effectively in the world market
- Reduces barriers to international trade.
Drawbacks of HACCP
If HACCP is not properly applied, then it may not result in an effective control system.
This may be due to improperly trained or untrained personnel not following the principles correctly; it maybe the outcome of the HACCP study is not implemented within the workplace; or it may be that the implemented system fails though lack of maintenance, e.g. if a company implements a system and stops there paying little or no heed to changes that occur in the operation, then new hazards may be dismissed (http://www.food-safety-issue.com/).
HACCP is compatible with existing quality management systems but you must ensure that product safety is always given priority and that HACCP findings are not changed because they differ from existing operational limits.
Other problems may arise if HACCP is carried out by only one person, rather than a multi-disciplinary team or where it is done at the corporate level with little or no input from the processing facility.
HACCP and trade
Significant implications for the Codex Alimentarius Commission arise from the Final Act of the Uruguay Round: the Agreement on the Application of Sanitary and Phytosanitary Measures (SPS Agreement) and the Agreement on Technical Barriers to Trade (TBT Agreement). The purpose of the SPS Agreement is to ensure that measures established by governments to protect human, animal and plant life and health, in the agricultural sector only, are consistent with obligations prohibiting arbitrary or unjustifiable discrimination on trade between countries where the same conditions prevail and are not disguised restrictions on international trade. The SPS Agreement is particularly relevant to food safety, providing a framework for the formulation and harmonisation of sanitary and phyto-sanitary measures. It requires that such measures be based on science and implemented in an equivalent and transparent manner. They cannot be used as an unjustifiable barrier to trade by discriminating among foreign sources of supply or providing an unfair advantage to domestic producers.
To facilitate safe food production for domestic and international markets, the SPS Agreement encourages governments to harmonise their national measures or base them on international standards, guidelines and recommendations developed by international standard-setting bodies.
The purpose of the TBT Agreement is to prevent the use of national or regional technical requirements, or standards in general, as unjustified technical barriers to trade. The agreement covers all types of standards including quality requirements for foods (except requirements related to sanitary and phyto-sanitary measures), and it includes numerous measures designed to protect the consumer against deception and economic fraud. The TBT Agreement also places emphasis on international standards. WTO members are obliged to use international standards or parts of them except where the international standard would be ineffective or inappropriate in the national situation.
The application of HACCP as a public policy requires definition of the role of government in the utilisation of the HACCP process. Food-exporting countries may require additional resources to enhance their food industries to meet the requirements. Adequate steps should be taken to facilitate food trade, such as assessment of food safety, training of personnel, technology transfer and strengthening of the national food control system.
Training
Food industries and food control regulatory agencies worldwide have shown interest in implementing the HACCP system. A common understanding about terminology and approaches for application will greatly enhance its adoption and will lead to a harmonised approach to food safety among countries all over the world. Many countries have integrated or are in the process of integrating the HACCP system into their regulatory mechanisms. In many countries, application of the HACCP system to foods may become mandatory. As a result, there is a tremendous demand, particularly in developing countries, for training in the HACCP system and for the development and assembly of reference materials to support this training. It is in this context that FAO has prepared this training package on the Codex General Principles of Food Hygiene and the guidelines for the application of the HACCP system (Fig.5).
Application of HACCP
While the application of HACCP to all segments and sectors of the food chain is possible, it is assumed that all sectors should be operating according to good manufacturing practices (GMPs) and the Codex General Principles of Food Hygiene. The ability of an industry segment or sector to support or implement the HACCP system depends on the degree of its adherence to these practices.
The successful application of HACCP requires the full commitment and involvement of management and the workforce. It requires a multidisciplinary approach which should include, as appropriate, expertise in agronomy, veterinary health, microbiology, public health, food technology, environmental health, chemistry, engineering, etc. according to the particular situation. The application of the HACCP system is compatible with the implementation of TQM systems such as the ISO 9000 series. However, HACCP is the system of choice in the management of food safety within such systems.
