Agenda Item 4.4 GF 02/7

Second FAO/WHO Global Forum for Food Safety Regulators

Bangkok, Thailand, 12–14 October 2004

How Official Services Foster and Enforce the Implementation of HACCP1 by Industry and Trade

(Prepared by Sirilak Suwanrangsi2 and Suwimon Keerativiriyaporn 3, Thailand)

1. Introduction and Background on HACCP Implementation

HACCP is a systematic and preventive approach to achieve food safety standards. Originally developed in the United States to guarantee the safety of astronauts’ food in space, HACCP is now being adopted worldwide as a scientific, systematic and effective approach to enhance food safety. Internationally, it is recognized that the application of the HACCP system to food production and preparation has clear benefits, including the potential of enhancing food safety and preventing many cases of food borne diseases.

HACCP is becoming the international norm for food safety assurance. Regulatory Food Control Authorities in many countries require HACCP implementation by food processing industries to ensure hygienic practices and safe products. This system has been adopted by many countries around the world and is mandatory in some countries. The requirements apply to various sectors in the food supply chain including domestic, exported and imported food products. The European Union and Japan require HACCP for specific products. In addition, many multinational food distribution chains now require a working HACCP programme as a prerequisite for becoming an accepted supplier.

Many Government agencies responsible for food safety control are shifting their agency's focus to prevention rather than inspection by encouraging the use of HACCP. Accordingly, HACCP-based control programmes are increasingly adopted by food control agencies.

Government programmes to enhance the application of HACCP in small scale food processing establishments and in domestic and export markets have been the key to success of HACCP implementation by the food industry. In addition, in many countries, industry has taken the lead in developing in-house HACCP programmes and hiring and training personnel who are skilled in preventative quality control.

The HACCP approach can be used by all segments of the food production continuum and can be tailored to any individual product or process line. The advantage of using the HACCP system lies in the constant control it provides over food safety in the processing plant, from receiving raw materials to shipping the final products. HACCP is now applied to milk, fresh fruits, pasteurized juice and vegetables as well as meat, poultry and seafood.

In many cases, the move to introducing HACCP systems has been led by industry. The stimulus may have come from the firms themselves where, for enhancing food safety and/or quality or for market reasons, the decision was made to adopt HACCP. Food industries experienced in food safety management systems are more likely to appreciate the need to move to HACCP. Generally, they recognize the importance of HACCP in allowing them to gain access to domestic and foreign markets, to protect their reputation and to satisfy customer demand.

2. Government role in HACCP implementation

Governments in most countries play vital roles in promoting HACCP application through successful cooperation with all stakeholders in the food supply chain including industry associations, academia, individual processors and producers, suppliers of raw materials, exporters and importers.

Government agencies have both a strategic role in the implementation of HACCP, as well as an operative role in organizing the effective and ongoing assessment of HACCP systems of the food industry. A key role of government agencies is to demonstrate leadership by promoting and facilitating the implementation of HACCP. The type of activities that government agencies need to consider have been described in other FAO and WHO documents.4,5 In summary, these could include the following:

2.1 Commitment

Government commitment is probably the single most important factor in the development and implementation of a successful HACCP initiative. In this respect, one of the most important tasks of governments is to raise the awareness of industry to the benefits of and need to introduce HACCP to produce safe food. To promote HACCP and secure the commitment of those involved, governments need to draw the attention of food enterprises to the following: the benefits achieved in rationalization of food safety management; risks inherent in certain foodstuffs or production processes; costs, including compensation costs resulting from production failure; and value of HACCP in safeguarding the enterprise’s image from any associated outbreaks and/or product recalls.

2.2 Programme Requirements

To promote and facilitate HACCP initiatives, governments may need to consider implementing mandatory measures, as appropriate. Countries that have established mandatory HACCP schemes for specific products include: Australia, Canada, Japan, USA and the European Union. In some countries, control authorities have developed voluntary schemes and then sought participation by individual firms. For example, the Thai Department of Fisheries has used voluntary HACCP programmes to enhance the food safety practices, standards and the process for approval of fishery products for export. Whether the programme is mandatory or voluntary, clear guidelines should be provided for uniform application and scientific integrity.

2.3 Training

Adequate training is important for overcoming barriers related to human resources in both government and industry. Governments need to take a leading role in training programmes. The support of academia and industry associations is vital. Training should include both industry employees and enforcement officials at different levels.

2.4 Technical Support

Industries, particularly those of small size, often lack the technical expertise required to implement HACCP and may therefore need external support. The capacity of governments and industry/trade associations and academia to provide adequate technical support is a critical factor in the successful implementation of HACCP. The type of technical support that could be offered by governments, academia or industry/trade associations may include:

2.5 Infrastructure and Facilities

Implementation of HACCP may require improvements in the infrastructure and facilities, both within the community and in the business itself. In this regard, governments have a role and, in some instances, even an obligation to ensure that the appropriate infrastructure (electricity, roads, safe water supply, sewage facilities, etc) is in place and that environmental pollution is minimized. The major role of the government is to ensure sufficient infrastructure and the compliance of facilities with food hygiene requirements.

2.6 Communications

Inadequate communications between the government and businesses and between businesses can impede the introduction of HACCP. Government agencies have a duty to clearly communicate all health and safety standards, regulations, guidelines, and other requirements to the food industry. Communication strategies need to be part of any HACCP initiative. To ensure a common understanding, it is important to use consistent and accurate terminology, such as that contained in Codex documents. The use of appropriate and effective channels for communication is also important for effective communication.

2.7 Evaluation

Once established, the HACCP programme should be evaluated to assess cost-effectiveness, compliance with legislation (if appropriate), adherence to schedule and how improvements could be made. Governments play a crucial role in HACCP evaluation by ensuring that the programme meets food safety objectives and by seeking its further development and improvement. Governments also have a role in enhancing the programme evaluation for the industry (internal audits) and in advising on how improvements can be made.

The impact of HACCP initiatives on the enhancement of food safety can be measured directly (e.g. through data collected from programmes for surveillance of food borne diseases or monitoring contamination of food) or indirectly (e.g. through data collected in industries on the results of auditing or inspection of design and implementation of HACCP).

3. Fostering success of HACCP implementation 

Governments have multiple roles to play in food safety control systems. These include promoting, assisting and checking that manufacturers have appropriate control measures for potential hazards and properly maintaining their implementation. In some cases, industry may take the lead in HACCP application, especially in large companies and export-oriented food businesses.

It is of utmost importance that government authorities have the capabilities to perform the necessary tasks, especially when industry relies solely on the judgment of the regulatory authorities. Thus, governments have to re-organize the activities and work force to support the industry, particularly in the following areas:

Organization management: To strengthen the workforce capabilities, personnel management should be addressed first. This may include increasing the number of staff and upgrading their competencies to carry out the jobs assigned. Assessors who have been familiar with traditional GMP inspections and are not able to shift to HACCP-based assessment may have to limit their tasks to those related to GMPs. Many agencies have coped with the problem through recruitment and training of new employees. When recruitment is not possible, management of personnel should be given critical attention.

Knowledge and skills: Food control agencies should ensure that assessors have sufficient knowledge of HACCP and of the relevant processing technology. The potential food safety hazards that are likely to occur must be controlled. Assessors should have sufficient knowledge and experience to identify hazards relevant to raw materials and processing technologies. Ability to determine appropriateness of the established control measures, which are directly linked to the HACCP requirements, is also vital.

Training is therefore important to provide knowledge and experience to assessors. However, attention should be paid to the context and delivery technique of the courses, particularly for those who are new learners. Training should not only focus on obtaining theoretical understanding, but also practical skills and auditing skills, for example, the ability to seek evidence and evaluate findings. Proper training helps to maintain consistent performance of the assessors.

Minimum training for assessors should include the following subjects:

While training their own workforces to enforce HACCP implementation, government agencies have been providing support to the industry in order to successfully implement the programme. Such support includes the following:

3.1 Technical support

Governments play a leading role in the provision of the following:

Information package: In addition to laying down laws, requirements or rules, guidance materials or application manuals have been developed to describe regulatory requirements and the government’s role in the recognition and auditing of HACCP systems. General information is also given on HACCP and documentation requirements.

Application manual: The manual explaining HACCP principles, its application to specific processes and products and the principal programme components required by control agencies (i.e. prerequisite control, hygiene control programme, generic HACCP model) is vital for successful application of HACCP by industry. The manual is an aid to the official inspection workforce and to management and employees in industry. The manual is intended for use during the implementation phases of HACCP.

Industrial seminars: Communication to industry through meetings and seminars has become a useful tool for governments to explain HACCP requirements, initiatives, benefits, and programme objectives at the initial stages of the programme. Promotion materials (i.e. handbooks, leaflets, videos) are also helpful starters. Today, they are often replaced by web- based information, which is a readily- available source of information.

Hazard identification and control guides: A handbook describing hazards associated with specific raw materials, processes or products is necessary to provide science- based information for hazard analysis and development of effective control measures. An example of such a document is the USFDA Hazard and Control Guides for Fish and Fishery Products, which provides a basic scientific foundation for industry application of HACCP. Specific hazard and control guides for raw materials and processes have been developed by many government agencies to meet particular needs in the countries.

Generic HACCP Models: Generic HACCP models have been developed by technical staff of governments to be used as a basis for HACCP plan development. These have been developed as guides for the design of specific HACCP systems for food establishments.

Scientific information: Since the HACCP system is designed for food safety, control measures selected should be based on scientific information. Some control measures have already been set by regulatory authorities. Where specific data on the results of control measures and other important information is not available, appropriate studies should be undertaken. The studies may involve risk assessment to identify hazards and appropriate control measures. In addition, methods for validation and the need for validation of critical limits established for CCPs are necessary. However, it is not always possible for processors to carry out these activities, particularly small processors who do not have adequate personnel, knowledge, and skills. Governments should take the lead to conduct studies and provide necessary information to industries.

3.2 Training initiatives

Training programmes for industry/employees were initially a key role of government; however, this activity has since been taken over by academia, trade associations or private consultants. The aims of training initiated by governments are to enhance competency; enable uniform, science- based application; ensure compliance; and to create confidence in one’s ability, and thus confidence in the safety of the food supply.

Training in the initial stages of HACCP implementation is normally designed to provide processors with the kind of information necessary to develop and operate HACCP systems that would be in compliance with relevant regulations. During the implementation stage, on-going training should be conducted to strengthen weaknesses in certain areas, such as hazard analysis, internal auditing, validation, and how to maintain HACCP effectively.

Since the competence of the HACCP team is one of the driving forces affecting the success of HACCP implementation, the team members should receive adequate training to facilitate the implementation and maintenance of their company’s HACCP system. In particular, the team leader may need advanced training. Training should not only focus on theoretical study, but also provide practical experience to facilitate a fuller understanding.

In some developed countries (i.e. Australia, Canada and the U.S.A.), training packages have been formulated for industry and regulatory officers by the government and by joint government/ academia/industry teams, while developing countries have initially been assisted by international organizations in training their officials in the application of HACCP. Train- the- trainer courses funded by FAO and WHO have been the initial training efforts in many developing countries. Thailand has invested resources in training officials and industries to strengthen competencies in hazard analysis, programme application, programme assessment and audit and have worked with FAO and WHO in developing materials and training programmes for other countries in Asia.

Training programmes that conform to national standards, Codex requirements and importing country requirements have been developed and tailored to meet the needs of different sectors of industry, in particular small and less developed businesses (SLDBs). HACCP Curriculum Guidelines, intended to assist providers who are considering the delivery of HACCP training courses, have been developed in various countries, through government initiatives and the support of academia and industry associations.

3.3 Hygiene improvements

As HACCP is not a stand- alone system, it requires basic hygienic conditions and Good Manufacturing Practices (GMPs) to support the advancement of the programme. Prior to HACCP implementation, governments must provide the necessary assistance for hygiene improvements. Guidance for hygienic practices and GMPs for specific processes and products must be provided. The government must constantly review hygiene conditions with industry and develop a plan to encourage improvements and maintenance.

A programme to accelerate improvements of hygienic conditions and practices, such as good agriculture and aquaculture practices, a survey of hygienic conditions, training, on-site technical advice, and support of monitoring activities for primary and small scale processors has recently been initiated in Thailand.

3.4 Primary production controls

Even though HACCP is a tool for processors that is applied to manage food safety, some hazards existing in raw materials are environmental-related problems, for instance, heavy metal contamination, pathogenic bacterial contamination and other types of pollution which are normally beyond the control of food processors alone. In this regard, a nationwide food safety programme should be conducted throughout the food chain. This includes control of the harvesting environment (whether in the wild or on farms), control of good handling practices prior to the processing establishments, etc. Government agencies should take the lead in these tasks.

3.5 Develop schemes that recognize HACCP systems

To accelerate effective HACCP implementation, development of schemes that recognize HACCP systems is necessary. This may include 1) the review of regulations and requirements to shift from end-point testing alone to a safety management system approach, and 2) applying reduced inspection rates where HACCP is effectively applied.

Regulatory audit: As the implementation of the HACCP system is making headway in food safety management systems of food industries, the traditional role of food control agencies, including that of food inspectors, is also changing, particularly in countries where the application of the HACCP system is mandatory. In addition to the inspection of food industries for compliance with GMPs and other regulatory requirements, government officials have to assume new responsibilities, including the assessment of industry-designed and implemented HACCP systems.

Government authorities should define clear policy and procedures for audits to ensure uniformity and technical integrity. The role of government in HACCP audits is described internationally.6 A curriculum for audit training, including audit manuals, has been developed for government use. Assessment tools have been designed for assessing and ensuring competency and consistency. Government assessment includes the following:

Programme evaluation: Pre-approval of the HAACP programme by governments leads to the improvement of HACCP application by industry, as it ensures that the programme meets legal requirements and food safety objectives. Control authorities usually require processing establishments to have HACCP plans, but some do not require processors to have them pre-approved; thus there is no way of knowing whether a processing plant's HACCP plan is in accordance with the agency's requirements until it inspects the plant. Pre-approval also validates that the programme is sufficient to ensure food safety and guides the processors in their application.

On- site compliance audit: The on-site audit should assess the adequacy of implementation, i.e. whether the HACCP plan and the prerequisites for HACCP have actually been implemented in the food business, are being maintained and are functioning correctly.

List of recognized establishments: Government authorities usually set HACCP requirements or compliance standards. Once these conditions are met, which are verified through audit, processors are included in the approved list. These lists are exchanged between authorities having jurisdiction for control of import and export, thus providing market access to companies that have systems meeting agreed standards.

Certification: Certification is one of the tools used to provide assurance that industries have an effective HACCP system in place to ensure food safety and regulatory compliance. Many governments are not fond of the use of certificates, but it is still a common practice used to ensure compliance. Governments can establish a HACCP certification scheme to assure that food processors comply with HACCP requirements. The main purpose of these schemes is to facilitate trade.

3.6 Others:

Financial support: Governments may provide financial support to promote HACCP application through funding of hygiene improvements, infrastructure development, training and consultancy services.

4. Problems encountered in the application of HACCP

Although the HACCP system has been utilized for nearly 10 years, difficulties in HACCP implementation for both the industry and regulators are still obvious in many countries. One of the main reasons for this may be that the effective control of food safety hazards, such as through a HACCP system, require a scientific-based design and in- depth understanding of the management system. HACCP is not a one-dimensional management system, but requires a process of analytical thinking to ensure that proper control is established. Such a process needs to be reviewed either during the stages of HACCP development by processors or assessments by regulators.

Some of the problems encountered in HACCP application are as follows:

4.1 Regulatory agency

4.1.1 Government support

Government commitment is a vital driving force of the success of a HACCP programme. A clear policy on food safety should be elaborated and turned into strategic plans for actual practices. In many instances, strong commitment from governments is still lacking, as reflected in the lack of real support at the operational level. Such support includes financial funding and manpower.

4.1.2 Legal requirements

In many countries, HACCP is widely applied only to exported products while domestic products are not dealt with, as there is no legal framework to enforce and assess HACCP systems in domestic products. Regulatory authorities face many time-consuming challenges in convincing processors to apply HACCP, especially small processors who already experience difficulties in complying with GMP requirements.

4.1.3 Manpower

A limited number of technical officers to provide technical assistance to the industry and regulatory assessors are available in some agencies, especially where the inspection system has shifted towards the HACCP approach. As it is more appropriate if there is a functional separation between government adviser and regulator roles, personnel needs increase. Also, HACCP- based assessment is more time consuming than traditional GMP assessment as HACCP assessment demands proper planning for audit, document and record reviews, as well as observing current practices during the process. Traditional GMP inspections mainly involve only evaluation of cleanliness and hygiene against set standards, which simply observe conditions and performance.

4.1.4 Assessor competency

Knowledge of HACCP: Government officers need to have sound knowledge of HACCP in order to assist industry in designing and implementing the programme, and to be able to address questions that may arise. Regulatory assessment of HACCP requires a consistent performance. Hence competency of auditors is an important key to achieve this. The competent HACCP officers and auditors must understand the 7 HACCP principles and how to correctly (scientifically) apply them. The ability to identify potential hazards that may occur during processing and to assess the appropriateness of their specific controls is essential. Knowledge required also includes (but is not limited to) hazards associated with different raw materials and processing technology, for example canning and freezing have different hazards and hence different controls should be applied.

Inadequate HACCP assessment influences the safety of foods produced if potential hazards and controls are missed. On the other hand, processors may also become discouraged to maintain HACCP if unnecessary hazards are too difficult to control. For example, if histamine is mistakenly determined as requiring control in non-histamine forming fish, the processor may be required to record fish temperature, have a certification of analysis from the fish supplier, or test for histamine in every incoming lot. Some processors have a tendency to think that more controls in a HACCP plan will promote safer food. However, too many controls may instead create a burden for the processor, especially when a deviation occurs and corrective action is necessary. Although nothing is wrong with these HACCP plans, processors may be unable to maintain the overall HACCP system, since more time is spent on unnecessary controls rather than significant hazards that are likely to occur.

Assessment technique: Apart from the basic assessment procedures, the greatest challenge to an assessor is the ability to collect sufficient evidence to support the judgment of HACCP compliance. Different processors may have different control approaches to the same hazards and may also provide different information for assessment. Therefore, assessors must utilize appropriate techniques to obtain the needed information in each situation. Some employers are very cooperative with the assessors, while others are not. Too much restriction with the assessment guides or generic HACCP models provided without flexibility to the situation may result in non-compliance to HACCP plans. On the other hand, inability to seek the right evidence may cause processors to lose control of potential hazards and risk the production of unsafe food.

4.2 Food industry

4.2.1 Technical difficulties

Hazard analysis (HA): Since the introduction of the HACCP system, applying hazard analysis has always been a hurdle, even for larger companies. The process requires specific expertise and knowledge of chemical and microbiological hazards and their attached risks, which is often not available. For this reason, proper HA application is always an important focus in good quality training programmes.

Validation of critical limits: Critical limits are borderlines to define acceptability and unacceptability of the product. Unfortunately, not all borderlines are defined by figures that are easy for industry to use. In this case, validation is vital. If the critical limits set for controlling hazards are not properly validated (for example, temperature and time used for pasteurization or cooking of the product), the HACCP plan will not be able to ensure safe food. Such processes need to prove their sufficiency to reduce the targeted bacteria to an acceptable level. In some cases, scientific support for all critical limits selected is not available and the support, if any, is not relevant to the processing conditions present in the facility. Large factories usually have their own equipment and experienced personnel to establish the process or can hire external experts to perform the studies. Validation is especially a problem for small processors who have limited financial resources and qualified staff. Difficulties still arise, even if the test is done by an external institute, if the processor does not fully understand how to utilize the study results.

Inconsistent implementation of HACCP: The implementation stage of HACCP involves monitoring, corrective action, and verification activities. At times, it is found that the documented HACCP plans have not actually been put into place or monitoring is not conducted as established. Corrective action is not always taken when the critical limit is deviated. Problems particularly arise with HACCP plans that are too restrictive to control, as many deviations can occur and corrective actions may be taken during daily operations. In the worst case, if processors are not very happy with this situation as it could cause an increase in production costs, they may choose to not follow the impractical HACCP plans. This is often the case when an external consultant prepares HACCP documents for a company without any involvement from the company’s staff. Any further changes made, for any reason, to the first developed HACCP plan are often difficult for the processor to implement.

Improper conducting of internal verification is also another weakness of HACCP application. Much confusion arises during monitoring, verification, and validation methodology as some processors cannot differentiate the activities concerned with these three procedures. The overall system verification is sometimes misleading and may be limited to only a conduct of sanitation and GMP checks, rather than observing the overall HACCP- related activities and reviewing documents as well as records. Verification is an important tool to check if the HACCP system is functioning properly. A lack of such activity may subsequently lead to the inconsistent implementation of HACCP.

Another technical issue concerning industry is the utilization of data obtained from monitoring and HACCP- associated activities. HACCP application generates many important records which will be useful in providing the trend analysis, which contributes significantly to improving the HACCP system. However, to be able to carry out analysis also requires knowledgeable personnel who understand the process of trend analysis and know how to evaluate and utilize the results obtained afterwards, which is often lacking in small-scale processors.

4.2.2 Human resources

Limited qualified personnel is one of the constraints for the success of HACCP. Large plants, where personnel management is well handled, can minimize the problem. However, small processing plants, where the turnover of key staff is often high, have more difficulties in developing and maintaining a HACCP system.

In order to maintain the effectiveness of HACCP, it is necessary for the company to have at least one person who has knowledge of and experience with HACCP. In many instances, the processing personnel give much more attention to provide adequate personnel to meet the daily production demands, whereas the technical personnel are often not considered to implement its HACCP system. This also includes personnel associated with HACCP activities, for example, CCP monitors. Lack of personnel or limited time available for performing monitoring as frequently as designed may result in inconsistent control of hazards.

4.2.3 Financial capabilities

Financial concerns is a restriction particularly for the small establishments, where the majority of food in many countries is produced. As food hygiene standards are prerequisites to HACCP, basic environmental processing conditions must be achieved. For some processors this may be a large amount of capital as they have made considerable efforts to upgrade their premises prior to implementing HACCP. Besides the upgrading costs, HACCP also creates additional costs of recruiting new employees, increased paper work, consultant fees, training, etc. Due to such reasons, many establishments are delaying HACCP implementation if it is a voluntary programme and its products are still marketable.

Beyond HACCP:
How can the present food safety systems be improved at all points along the food chain?

Application of HACCP principles in various sectors of the food supply chain, from production of raw materials to processing, is necessary to ensure safe food, but more is necessary. It is recognized that HACCP is one of the risk management tools available to the food industry. HAACP alone cannot resolve food safety problems, which is why it must be complimented by other control measures such as traceability, labeling and laboratory analysis. The latter should be directed towards monitoring programmes for agriculture chemicals, pollutants, contaminants and natural toxins, rather than end product inspection.

1 Hazard Analysis and Critical Control Point

2 Ms. Sirilak Suwanrangsi, Minister Counsellor (Agriculture), Office of Agricultural Affairs, Royal Thai Embassy Tokyo, Japan

3 Ms. Suwimon Keerativiriyaporn , Director, Fish Inspection Center (Samutsakorn), Fish Inspection and Quality Control Division, Department of Fisheries, Thailand.

4 WHO. HACCP: Introducing the Hazard Analysis and Critical Control Point System. WHO document WHO/FSF/FOS/97.2. Geneva, World Health Organization, 1997 (based on the Report of the WHO Consultation on Hazard Analysis Critical Control Point System: Concept and Application, with the participation of FAO, Geneva, 29-31 May 1995. WHO document WHO/FNU/FOS/95.7).

5 FAO. The use of hazard analysis critical control point (HACCP) principles in food control. Report of an FAO Expert Technical Meeting, Vancouver, Canada, 12-16 December 1994. FAO Food and Nutrition Paper 58. Rome, Food and Agriculture Organization of the United Nations, 1995.

6 Guidance on Regulatory Assessment of HACCP. Report of a Joint FAO/WHO Consultation on the Role of Government Agencies in Assessing HACCP. WHO document WHO/FSF/FOS/98.5, pp 25-28. World Health Organization, Geneva, 1998.