HACCP enforcement in New Zealand
9.2 Developing HACCP assessment
9.2.3 Developing a HACCP standard
A HACCP standard is required once the decision is made to mandate HACCP.
The standard6 is developed in consultation with industry, using the CAC HACCP guideline4as the starting point. The expectation is that the food industry has already established good hygienic practice prior to the development of the HACCP plan(s) for their operations and can effectively demonstrate this with documented systems. These systems are known as ‘prerequisite programmes’
(PRPs).
PRPs, based on good hygienic practice and meeting individual countries’
food legislative and market access requirements, are the internationally recognised norm to an otherwise overwhelming task of hazard identification and analysis of everything associated with the food. However, there is considerable benefit in returning to those PRPs at a later stage to ascertain what they deliver in terms of contribution to achieving food safety outcomes directly associated with the product. In fact, in some cases, PRPs or their equivalent have not been established adequately as effective documented systems by a food business prior to HACCP implementation, but this may have been ignored to some degree, in favour of promoting HACCP. In these cases, HACCP progress is inevitably hindered by the inadequate performance of those PRPs.
Common PRPs present at food premises in New Zealand include, but are not limited to, the following:
• sanitary design
• potable water quality
• sanitation and clean-up procedures for edible areas and food contact surfaces (pre-operational and operational)
• personal hygiene (protective clothing requirements, personal equipment and use of amenities)
• training
• hygienic dressing or processing (dressing/processing techniques and procedures, cleaning and sterilisation of equipment)
• food contact materials (specifications, handling and storage)
• repairs and maintenance of equipment
• control of chemicals
• vermin control
• waste management
• condition and welfare of stock
• handling and disposition of detained and non-conforming products.
The HACCP standard7 applies to those premises where any food safety hazard(s) that may be reasonably associated with each product and process exists. Where no food safety hazards are identified, the premises is expected to reassess the product(s) and process(s) whenever significant changes occur.
Examples of ‘significant change’ include change to product, intended use of product, process, premises and food safety objectives. Where one or more food safety hazards and, consequent to hazard analysis and CCP determination, one or more CCPs are identified, a HACCP plan is required.
New Zealand experience has shown that from a practical point of view, the internationally recognised seven principles of HACCP are insufficient to produce a meaningful HACCP plan by themselves. Another four elements have therefore been added to these principles to give eleven essential elements for each HACCP plan. These four elements are:
1. Scope of the HACCP plan.
2. Description of the product, its intended use and the intended consumer.
3. Food safety objectives.
4. Description of the process.
These are followed by the seven essential principles of HACCP:
1. Hazard identification and analysis.
2. Identification of the CCPs, if any, needed to control or eliminate those hazards found to be unacceptable in relation to food safety objectives set.
3. Critical limits that have been established for each CCP.
4. Monitoring procedures for each CCP.
5. Corrective action procedures (including measures to restore control, deal with affected product and prevent recurrence), developed for any non-compliance with critical limits.
6. Verification procedures including validation, ongoing review/audit and revalidation when significant changes occur.
7. Documentation and record keeping appropriate to the above elements.
Scope
Defining the scope of a HACCP plan is an essential element of a HACCP plan because it provides a clear message as to what the plan incorporates. It will inform the reader (both user and auditor) of the following:
• what the HACCP plan covers and what it does not, i.e. what can be expected to be covered elsewhere by PRPs
• whether the application of the HACCP plan is only for food safety or is wider than food safety
• the boundaries of application of the HACCP plan, i.e. the start and end point of the process, thus also defining the scope of hazard identification.
Description of the product, its intended use and the intended consumer Describing the product, its intended use and the intended consumer is an essential element of a HACCP plan because it provides information needed to make decisions on expected food safety outcomes for the product in relation to the intended consumer. This will increase in importance as applied risk analysis gives us more information in the future about the relationship between individual hazards and their effect on the consumer population.
Food safety objectives
Food safety objectives are considered one of the most important elements within the HACCP plan. They provide a measurable ‘food safety’ outcome for the product, often in qualitative terms as not enough information is available to associate the level of control of hazards within a HACCP plan to the level of risk to the consumer population, especially with raw foods. The Guide to HACCP Systems in the Meat Industry6defines a food safety objective as ‘A statement based on a risk analysis process, which expresses the level of a hazard in a food that is tolerable in relation to an appropriate level of consumer protection. When justified by either a qualitative or quantitative risk assessment, the food safety objective should express the level of the hazard as its maximum tolerable concentration and/or frequency.’
Thus food safety objectives give new meaning to internationally accepted phrases seen in many a HACCP guideline, text or HACCP standard such as ‘unacceptable levels of hazards’ (or conversely ‘acceptable levels’), referred to in hazard analysis and CCP determination, and ‘critical limits’.
Critical limits deliver directly or contribute cumulatively to a certain food safety outcome, i.e. the food safety objective. An example of a direct relationship between a critical limit and a food safety objective can be shown with a food safety objective relating to metal detection, e.g. to remove metal from the product to a specified target level. The targets are the critical limits and these are the specifications of the metal detector.
Critical limits that contribute cumulatively to achieving a food safety objective are often associated with a microbiological food safety outcome.
Consider the following two examples of food safety objectives for a slaughter and dressing process and a canning process respectively:
1. To minimise transfer of microbiological hazards from the gastrointestinal tract and the hide to the carcass, and their redistribution, to levels not exceeding specified microbiological targets.
2. To ensure commercial sterility of product by destruction of all viable micro-organisms of public health significance as well as those capable of reproducing under non-refrigerated conditions of storage and distribution.
In both cases, critical limits are measurable visual criteria at one or more process steps, e.g. visual observations of operators at key hide removal steps (slaughter and dressing), and seaming under vacuum and heat processing steps (canning).
Achievement of these critical limits collectively within each process leads to the food safety objective being achieved for the product.
Food safety objectives have been readily accepted by the New Zealand meat and seafood export industry as an integral part of their HACCP plans but other food industries have yet to be exposed to this concept and the value that it can offer to application of HACCP. Internationally, the concept also is under consideration particularly in association with the determination of parameters surrounding equivalency agreements between trading countries.
One of the most successful applications of food safety objectives in New Zealand has been in association with the implementation of a standardised microbiological monitoring programme8,9,10 for all US-listed bovine and ovine meat slaughter premises and packing houses. This programme enables the participating premises to use summary data so that they can individually assess their microbiological performance on a premises-by-premises basis and in relation to the national performance. These data are often used as a basis for establishing individual microbiological targets for HACCP plans for slaughter and dressing.
In summary, the main benefits for industry from application of food safety objectives11include the provision of:
• a description of the expected/desired extent of control of foodborne hazards resulting from application of a sanitary measure
• a target that ensures that HACCP plans are outcome focused, achieve expected food safety goals and have inherent flexibility
• an expression of due diligence by reflecting expectations with respect to specific processes
• clear identification of any limitations that a HACCP plan may have in terms of what can be achieved in controlling hazards.
This is a considerable advance on stating that a HACCP plan will deliver ‘safe’
food without qualifying what ‘safe’ actually means.
Description of the process
A description of the process is an essential component of the HACCP plan. It may be done in conjunction with hazard identification and analysis or separately. The main thing is that it is done thoroughly and accurately. It provides a reality check for those involved directly or indirectly with the process, reinforcing what is actually occurring. The accurate process description will remind the HACCP team of all factors to be considered.
Validation as part of the verification process
In New Zealand, validation of the HACCP plan is seen as the essential first part of the industry’s verification programme and is specifically mentioned as part of the verification element in the HACCP standard. Validation is the responsibility of the food industry and must be under the guidance of the premises’ HACCP-competent person.
Validation consists of two components: first, the initial confirmation that the HACCP plan is complete in that it has satisfactorily covered and documented all the required elements, and second, that the implemented plan will achieve food safety objectives. Validation has been a difficult process for regulators to define clearly, given the wide range of processes, and for industry to understand. With this in mind, MAF has published guidance on validation,6 including it as an integral part of comprehensive generic HACCP plans available on the Internet (http://www.maf.govt.nz) to assist in development of premises-specific valida-tion procedures.12