HACCP enforcement in New Zealand
9.3 Assessment of the HACCP system
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
when carrying out a compliance audit has led to some problems in the interpretation of HACCP plan deficiencies. The level of HACCP awareness among compliance audit staff is, however, currently under review and strong recommendations have been made to upskill these HACCP plan compliance auditors.
The HACCP plan audit focuses on effective control of food safety hazards.
The depth of the audit will be determined by performance. However, the following outcomes are generally sought regardless of the frequency of the audit:
• determination as to whether all required elements are present in the HACCP plan and that they are addressed adequately
• determination as to whether the procedures are effective with respect to achieving acceptable food safety outcomes for the product/process on an ongoing basis
• determination as to whether actual events comply with validated documented procedures.
A recommended audit approach has been issued by MAF and is included in HACCP guides available to the industry. Essentially, the audit approach follows that suggested and outlined in ISO Standards 10011-1:199214 and 10011-3:199215and includes the following main headings:
• decide the type of audit, e.g. full or partial, including the specifications against which the HACCP plan is to be assessed
• notify the auditee
• obtain information prior to the premises audit
• assess the pre-audit information (either on-site or off-site) and if necessary target specific concerns to be addressed prior to the audit or for further evaluation on-site
• select the audit team
• brief the audit team
• visit the premises and carry out the entry meeting
• carry out the audit; all observations and non-conformances should be acknowledged by the auditee
• carry out the exit meeting and deliver the conclusions of the audit, deciding how to accept corrective actions (if required) and how to verify those corrective actions
• write formal report.
9.3.2 Relationship of prerequisite programmes
It is essential that the auditor appreciates the intimate relationship that PRPs have to the HACCP plan and are prompted to investigate the performance of the PRPs prior to beginning the HACCP plan audit.
There are several ways that the auditor can obtain information about the performance of the PRPs. They should check which PRPs are present at each
individual premises and determine whether these programmes fall outside the scope of the HACCP plan. PRPs are expected to be authorised by a responsible company person. There should be evidence of an ongoing acceptable level of compliance with the documented programmes from several sources, for example:
• ongoing monitoring records
• internal audit/review
• extrinsic audits
• non-conformance records.
The auditor also should examine records from a selected sample of PRPs deemed relevant to the HACCP plan under audit. The outcome from evaluating the PRPs may well determine whether the audit for recognition of a HACCP plan (initial audit) or compliance audit of a HACCP plan will continue.
9.3.3 Recognition of a validated HACCP plan
Under the current HACCP standard,7 recognition of a HACCP plan that the premises has validated is the first requirement prior to implementation and, where relevant, prior to gaining access to overseas markets. The recognition audit is carried out by a MAF VA auditor with the appropriate qualification as mentioned in section 9.2. Recognition of the HACCP plan must start with an appreciation as to how effective the PRPs are, as discussed above. This is followed by evaluation of documentation comprising the validated HACCP plan, including evidence to substantiate:
• hazard identification and analysis
• CCP determination
• critical limit determination
• validation.
Essentially the auditor must be satisfied that all eleven elements required in the HACCP plan are present, that they have been applied in a relevant manner applicable to the product and process and that they have been validated appropriately in line with acceptable food safety objectives for the product.
There must be enough evidence to demonstrate that the food safety objectives can be achieved on a consistent basis.
Once the evaluation of documentation has been completed, the auditor must then check that what is actually occurring during processing fits with the documented procedures. A record review is an essential part of this reality check. This latter activity also forms the primary part of any compliance audit carried out by MAF VA on a recognised HACCP plan.
In some cases, e.g. where a new premise starts up or a company decides to begin a new product, information is not available for the food premises HACCP-competent person to complete validation. Thus the premises must seek provisional recognition of the documented HACCP plan by MAF VA prior to
commencing production. Completion of the validation process is then allowed to occur once the process is implemented and information can be collected. This occurs over a set time period, usually the equivalent of two working weeks. The MAF VA auditor is then able to complete the recognition of validation of the HACCP plan.
9.3.4 Using a check-list
Check-lists have been found to be very useful in carrying out HACCP plan audits. They assist greatly in ensuring a consistent approach by auditors, helping to focus the auditor on the key outcomes to be obtained from a HACCP plan.
Examples of recommended check-lists6 can be seen in Tables 9.1 and 9.2 covering pre-audit activities and HACCP plan audit activities respectively.
However, check-lists can never be all inclusive as each HACCP plan is developed and implemented on a premises-specific basis. Therefore the auditor must be mindful that the check-list is just a useful tool and that the final judgement call(s) will always rest with the individual auditor or audit team.
9.3.5 Dealing with outcomes of HACCP plan audits
The MAF VA auditor, on completion of the audit as described above, collates all findings, both pre-audit and HACCP audit, to determine the audit outcome. The check-lists will provide a useful starting point for this exercise. The auditor will decide if the HACCP plan is working effectively, taking into consideration the aims of the audit process which focus on the following outcomes (depending on whether the audit is an initial recognition of validation audit or an ongoing compliance audit):
• determination as to whether all required elements are present in the HACCP plan and that they are addressed adequately
• determination as to whether the procedures are effective with respect to achieving acceptable food safety outcomes for the product/process on an ongoing basis
• determination as to whether actual events comply with validated documented procedures.
Conformance
The HACCP plan is deemed to be conforming (effective) when all the following have been met:
• all necessary PRPs are in place and are operating substantially in compliance with regulatory requirements
• all eleven elements of the HACCP plan are present, have been applied correctly and have been documented
Continued on page 161.
Table 9.1 Pre-audit check-list
Note: This check-list provides a detailed guideline to assist the auditor in assessing pre-audit information.
Pre-audit check-list Comments