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Risk Management Programme Manual for Animal Product Processing
5 Evaluation
Amendment 3
October 2009
5.1 Introduction
(Section 20 of the Animal Products Act)
This section describes the evaluation process. Evaluation leads to the recognition of validity of your RMP so that it can be recommended for registration. Evaluation is necessary for most RMPs, however the Director-General may waive or modify the requirement for evaluation if:
• your RMP is fully based on a template, model, or code of practice approved under section 12(3A) of the APA
For a list of RMP templates for which evaluation has been waived see : http://www.nzfsa.govt.nz/dairy/publications/cop/farm-rmp-template/waiver-of-the-requirement-to-provide-an-independant-evaluation-report.pdf and
http://www.nzfsa.govt.nz/dairy/legislation/waiver.pdf
• your RMP is a multi-business RMP approved by the Director-General in accordance with section 17A; or
• the risks to human or animal health are negligible, and the Director-General is satisfied that the nature of your business does not require an independent evaluation report to ensure validity in terms of sections 12 and 17 of the APA.
You must contract an independent evaluator recognised under the APA to evaluate your RMP.
Figure 5A shows the sequence of events and linkages between evaluation and registration (also see section 6).
NZFSA have issued documents relating to evaluation which are available on the NZFSA web site at:
Legislation:
http://www.nzfsa.govt.nz/animalproducts/legislation/notices/agencies-persons.htm (non dairy)
http://www.nzfsa.govt.nz/dairy/publications/specifications/index.htm (dairy)
Evaluators' Manual for Risk Management Programmes:
http://www.nzfsa.govt.nz/animalproducts/publications/manualsguides/eval-man-rmp/index.htm (non dairy)
Dairy Operational Guidelines:
http://www.nzfsa.govt.nz/dairy/publications/guidelines/index.htm
5.2 Selection of Recognised Evaluator
You must contract a recognised evaluator with competencies appropriate to your operation. Specific competencies may be shown in the register of recognised evaluators by an activity endorsement applied to their recognition. In some cases it is mandatory to use an evaluator with the appropriate activity endorsement e.g. low acid canned foods, or dairy heat treatment. In any case it is your responsibility to check that the evaluator has the required competencies. A list of all recognised evaluators and their activity endorsements is available on the website at the following address: http://www.nzfsa.govt.nz/registers-lists/.
You cannot use the same person to develop and evaluate your RMP as this would be a conflict of interest.
The evaluator may obtain technical assistance from other recognised evaluators or technical experts as necessary.
You are responsible for costs associated with evaluation.
5.3 Evaluation Prior to RMP Registration
5.3.1 Desk-top Review
The evaluator carries out a desk-top review of all documentation to ensure that it is complete, meets all the relevant regulatory requirements and that the proposed controls will deliver animal product that is fit for its intended purpose. This would typically occur prior to the on-site assessment. Dairy evaluators review the reports from the heat treatment and premises evaluators as part of the evaluation.
5.3.2 On-site Assessment
2. On site assessment
The operator must ensure that an on-site assessment, in relation to the evaluation report required under section 20(2)(b) of the Act, is performed when the premises and equipment are ready to operate in accordance with the risk management programme and legislative requirements.
During the on-site assessment the evaluator will:
• conduct a reality check of your operation against the documented RMP including discussions with staff
• confirm that the scope of your RMP is appropriate (including the physical boundaries)
• check the design and construction of your facilities and equipment and confirm that they are suitable and ready to operate. (Note, dairy evaluators get this information from heat treatment and premises evaluation reports)
• talk to key staff to ensure an acceptable level of understanding of the RMP
• check relevant documents and records, including any validation evidence.
An on-site assessment may require more than one visit.
In the case of mobile premises, fishing vessels or dairy transporters, the on-site assessment may be done at the home base or home port.
If your RMP covers a number of businesses or sites, depending on the nature of operations, the evaluator may only need to visit selected sites. The evaluator must consult NZFSA regarding this prior to the on-site assessments to determine whether this is acceptable.
If your premises is not operational at the time of evaluation e.g. in the case of a new premises or new process, you must make reasonable attempts to demonstrate or explain normal operations.
5.3.3 Resolving RMP Deficiencies
It is your responsibility to resolve any deficiencies identified by the evaluator. If changes are made, you should check whether any consequential changes to the RMP are necessary to ensure consistency, e.g. to other procedures, the document list, version numbers etc.
If your RMP is found to be unsatisfactory, the evaluator may provide you with feedback in general terms stating where the programme is deficient. To ensure impartiality and independence is maintained the evaluator must not provide solutions to the deficiencies if they wish to remain as your evaluator.
5.4 Reporting and Registration Documentation
When your RMP is satisfactory, the evaluator must prepare an evaluation report which recommends the RMP for registration. The evaluator must endorse the RMP or the outline.
You must submit the evaluation report, the endorsed RMP or outline (see section 6.2.1) and any other required documents (see section 6.2) to NZFSA with your application for registration.
The evaluation report is only valid for 6 months. The evaluation must be repeated if this timeframe is exceeded. For this reason you should apply for registration as soon as possible after evaluation.
5.5 Validation after Registration
If your RMP is not valid at the time of registration, you must complete the validation in accordance with your validation protocol (see section 4.4). You must provide a report and any significant amendments to the evaluator.
The report and any RMP amendments are evaluated and this may require an on-site assessment. Deficiencies should be resolved in accordance with section 5.3.3.
Once the evaluator is satisfied that validation is complete, the final evaluation report is prepared. You must forward this report, together with any endorsed RMP amendments to the NZFSA to satisfy the registration conditions.
5.6 Evaluation of Significant Amendments
Significant amendment of a registered RMP follows the evaluation process as described in this section. An on-site assessment may not be necessary depending on the nature of the amendment and this must be justified in the evaluation report. See section 7.5.1 for further information on significant amendments.
5.7 Linkage between Evaluation and Registration
Figure 5A: Evaluation and Registration Process
New Zealand Food Safety Authority
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