The HACCP approach

Hazard Analysis Critical Control Point (HACCP) is recognised internationally as a scientifically based system for the production of safe food centred on the prevention of contamination. However, its use is not limited to the food industry and there is increasing interest from other sectors. Indeed, the International Conference on Harmonisation’s recent Codification on Risk Management (Q9, Nov 2005), endorses HACCP as a useful tool for risk management in the production of pharmaceuticals.

Within the food industry, HACCP is now well established and is a legal requirement within Europe. The food manufacturing sector is, therefore, generally fairly comfortable with the technique, although smaller, non-process based sections of the food industry, such as catering, are less well practised.

Within manufacturing, however, there are dangers in being complacent and there continue to be weaknesses in the food safety management systems as a result. Even those HACCP-based food safety management systems that are effective in delivering a safe product are not always as good as they might be, and there is frequently opportunity for improvement.

Companies often make the mistake of using the framework provided by HACCP principles to document existing controls and monitoring activities. This will perpetuate errors inherent in historically evolved systems. However, by using the principles of HACCP as they were originally intended, manufacturers are obliged to look at the process objectively and scientifically in order to develop a food safety system that is robust and effective. This approach may also result in benefits such as reduced costs and improved utilisation of labour.

Back to basics

Many people consider that they understand the application of HACCP but it does no harm, periodically, to go back to basic principles. Any food safety management system needs to be built on sound foundations and, in respect of HACCP, these foundations are not always given the attention required. If the “Pre-Requisite Programmes” or Good Manufacturing Practices (cleaning, maintenance, personal hygiene) are not well designed and managed, the foundations for the HACCP system will be weak and may fail, even where the system is considered to be working.

HACCP is intended to be applied to a production process and it is vital that the process is managed in a manner that minimises the potential for product contamination. If the “Pre-Requisites” are not fully effective and these issues are not recognised, then the effectiveness of the HACCP system may be undermined.

The pre-requisites include disciplines such as cleaning and sanitation, maintenance, personnel hygiene and training, pest control and even procedures for traceability and recall. In effect, the pre-requisite programme is general rather than product/process specific, but its general nature should not undermine its importance to the HACCP programme.

Once the pre-requisites are in place there is some preparatory work required to train staff, assemble the HACCP team and ensure that the processes and procedures that the facility carries out are actually those that are defined in the company’s manual and specifications. After all, there is no point in designing a HACCP system around actions and events that do not actually take place or equipment that is never used!

There are seven principles of HACCP on which a food safety management system is based. The important first principle is to identify the hazards and their causes or sources. This will mean evaluating every aspect of the operation from purchasing and delivery of ingredients, through to storage, preparation, processing and packaging.

The idea is to identify what can go wrong and to understand the reasons – for example, inappropriate storage leading to cross contamination with Salmonella (biological hazard); incorrect dilution of cleaning solutions (chemical hazard) due to lack of training; or the possibility that glass packaging might fracture (physical hazard) due to excessive filling speed on the filler.

The second principle is to determine the critical control points (CCPs) in the operation where it is imperative the hazards are controlled adequately: for example, cooking beef burgers to a minimum of 70°C for two minutes will kill E. coli O157 and other pathogens.

Related to this is the third principle, which is to establish critical limits. This makes it possible to identify when a CCP is out of control, provided that the fourth principle is observed, which is to establish a system for monitoring control of the CCP. Monitoring will typically, involve measuring parameters associated with the control measures, such as temperature and time. Monitoring should be simple, clear, easy to apply and give rapid results, e.g. recording the final cooking temperature and time for a burger.

Should monitoring indicate that a particular CCP is not under control, corrective action will need to be taken (principle 5). This may involve destruction or re-processing of any potentially affected material, as well as correcting the fault with the equipment that caused the problem. It is also vital that the system developed using the principles of HACCP is validated to demonstrate scientifically that it is capable of producing a safe product.

The sixth principle requires the system to be verified. This means a periodic review to ensure it is working properly and meeting expectations. This may involve routine testing of products to demonstrate that the controls continue to be effective and testing of ingredients to ensure that they meet their specification. It should also include checks on monitoring devices to ensure they are working properly, auditing the systems to establish whether all the elements are working correctly and reviewing the information generated by the system, e.g. CCP monitoring records.

Finally, it is important to document the system (principle 7). For the successful implementation of HACCP, appropriate records must be kept and be readily available. Examples include records of cooking temperatures, of change to the systems, validation information and verification records.

It is unrealistic to operate HACCP or to demonstrate compliance with the current legislation without providing evidence such as written records. As with HACCP itself, the complexity of the record keeping will very much depend on the nature and complexity of the business. The aim should be to ensure control is maintained without generating excessive paperwork.

If an effective HACCP system is to be developed then there must first be commitment from the senior management so that the required resources are available and that support is given, from initiation of the project through to verification and maintenance of the live system.

For the HACCP system to be effective, the people who carry out each HACCP study must have the correct blend of training and experience. It should not be the responsibility of one person, but rather a multi-disciplinary team effort. The members of the HACCP team will require thorough training in HACCP techniques and between them should have experience in all areas relevant to the safety of the product so that all hazards can be identified and controlled. Generally this will involve representatives from QA and technical, operations and engineering, although other functions within the organisation may also be included; for example, r&d and raw material sourcing. If the correct blend of experience is not available internally, technical experts may be called in and companies often find it helpful to use an external HACCP expert as a facilitator for their first HACCP implementation.

Hazard awareness training will be required at all levels so that everyone understands the importance of the project. Specific training will be required for all individuals who will be expected to monitor CCPs and the people responsible for setting and running the HACCP programme may also need specialist training. Courses in HACCP appropriate for these different types of employee are offered by a number of organisations. However, standards do vary, and only courses able to provide examination for the Royal Institute of Public Health qualification should be considered.

The other important resource issue is time. It must be realised that a HACCP system cannot be put in place overnight and the entire project should be carefully planned. Sufficient time must be included for all training requirements, development and validation of the system by the HACCP team, and the implementation of CCPs throughout the process. Then, when the system is fully operational, time will be required on an ongoing basis for system verification and maintenance.

It is vital that the system designed can be proven to work. Validation is frequently confused with verification, but the two play entirely separate roles. Validation is about being able to prove scientifically that the elements within the HACCP (primarily control measures and critical limits) can deliver a safe product. Verification is essentially retrospective and requires the business to carry out various activities to demonstrate that a safe product has been produced, thus confirming that the safety system has “delivered”. Verification therefore provides a “final check” and gives confidence that the products are safe.

When food safety issues are investigated, it is often the case that the problem is something that could have been foreseen and the incident is the result of one of more failures of the systems in place – whether pre-requisite-based or as a result of failure of the HACCP system. A well-designed food safety system that is well applied and well managed will overcome these problems.

Certainly, as far as the food industry is concerned, HACCP has gained widespread approval and acceptance. Because the HACCP approach is logical and individually applied to specific situations, it is relevant to a wide variety of sectors. And as it requires safety to be “designed in” and is preventative in nature, it is of more value in protecting consumers than traditional approaches based on detection and “cure”.