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Risk Management Programme Manual for Animal Product Processing

4 Checks and Validation

Amendment 3

October 2009

4.1 Introduction

This section discusses what you need to do once you have developed your RMP²³.

You must check that the:

• RMP documentation is complete and complies with all relevant legislation under the APA

• premises and equipment are ready to operate; and

• RMP will be capable of consistently producing animal material or animal product that is fit for its intended purpose.

To demonstrate that the RMP will be capable of consistently producing animal material or animal product that is fit for its intended purpose, you must show that GOP requirements are being met. If there are regulatory and or operator-defined limits applicable to your product or process, you may also need to validate the RMP to confirm its effectiveness to consistently achieve those limits.

If there is insufficient evidence to demonstrate the effectiveness of the RMP at the time of application for registration (e.g. for new businesses or new process), you may need to document a protocol for the collection of evidence, refer to section 4.4.

The requirements for checks and validation are summarised in Table 4A and explained in detail in the following sections.

(Section 16, 17 (2) (b) and 20 of the Animal Products Act)

Table 4A: Summary of Requirements for Demonstrating Effectiveness of the RMP

Requirements for demonstrating effectiveness of the RMP	Evidence for demonstrating effectiveness of the RMP	When is the evidence required	Is a protocol needed?
1. Checks
a. RMP documentation
• is complete; and • complies with all relevant legislative requirements	• RMP document; • the use of a checklist is recommended to indicate where the relevant legislative requirements have been addressed within the RMP	Before application for registration of RMP	NA.
b. Premises and equipment
Ready to operate	Actual design and construction of premises is complete; equipment is available and ready to operate	Before application for registration of RMP24	NA
	Commissioning reports for certain equipment (e.g. retort, drier)	Before or after registration of RMP	Yes, if commissioning after registration
c. GOP check
Achievement of GOP requirements	Records of compliance to: • documented procedures (e.g. monitoring records, internal audit reports); and • measurable GOP requirements (e.g. product load out temperatures)	Before or after registration Any existing evidence should be made available to the evaluator before registration	A protocol is not required for most GOP operations See Appendix F for those operations that would require a protocol
2. Validating the RMP
1. Validating the regulatory limits	Records of data collected that show compliance with regulatory limits and relevant critical limits	Before or after registration	When there is insufficient evidence at the time of application for registration, the operator must provide a written protocol for collection of this evidence
2. Validating the operator-defined limits	Records of data collected that show compliance with operator-defined limits and relevant critical limits; and/or Records of compliance to acceptable procedures that ensure that resulting products comply with the relevant operator-defined limit	Before or after registration	When there is insufficient evidence at the time of application for registration, the operator must provide a written protocol for collection of this evidence

4.2 Checks

4.2.1 RMP Documentation

You must check that all of the required components of an RMP have been documented and are complete. You must also check that the RMP documentation meets all relevant legislative requirements including any regulatory limits and GOP requirements contained within specifications or approved criteria, by systematically checking it against the legislation. This must be completed before the application for registration of the RMP.

To assist the evaluation process (refer section 5) it is recommended that you prepare a checklist that lists the relevant legislation and references where these requirements are addressed in the RMP.

4.2.2 Premises and Equipment are Ready to Operate

You must ensure that the design and construction of premises and equipment meets the requirements of the APA. The premises must be complete and all equipment necessary for the processes described in the RMP must be available, ready to start processing and have been viewed by the evaluator as part of the evaluation before registration of the RMP.

Certain equipment (e.g. retorts, rendering driers, pasteurisers) may require commissioning by a competent person. If this activity is to be done after registration, then the commissioning must be included in the protocol (see section 4.4). A commissioning report should be made available to the evaluator when required.

4.2.3 Demonstration of Compliance with GOP Requirements

You must demonstrate that the RMP meets regulatory requirements for GOP. Procedures for meeting these requirements should be documented in the supporting systems, e.g. hygiene and maintenance, personnel health, approved chemicals, water quality. In most cases the checks referred to in section 4.2 will be sufficient evidence but in some cases data will be needed (refer to Appendix F for those supporting systems that require data as evidence for demonstrating effectiveness). Where this is needed you should make any existing compliance records available to the evaluator and if such evidence is not available during the evaluation (e.g. new processes or operations), a protocol will be required (see section 4.4).

4.3 Validation

You must provide evidence to demonstrate that when the RMP is implemented as documented, the criteria defining the product’s fitness for intended purpose, and particularly the regulatory limits and operator-defined limits are consistently met.

This will generally involve product testing and/or the measurement of process parameters.

Where available, historical data may be used to show that a process is consistently able to meet the criteria (e.g. microbiological databases, final product testing results). An advantage of using historical data, particularly if it has been collected over a long period, is that product/process variability due to factors such as season, raw material sources, and work shifts will be reflected in the results.

When using historical data, consider how applicable it is to the process covered by the RMP as it may have been collected for a different purpose and under different conditions. For example, if raw materials have changed or if the data collection methodology has changed it may be inappropriate to use historical data to validate current procedures.

You must consider the following when undertaking validation:

• any hazards that may already be controlled by the supplier when establishing incoming hazard levels

• the use of calibrated equipment when any critical measurements are taken

• statistical sampling of each batch for a number of batches, including inputs as well as final product

• the use of challenge tests ²⁵ where appropriate

• if there is high variability within the operation then more sampling will be required to ensure that the process design is capable of dealing with all variables likely to be encountered

• if initial test results are unsatisfactory (i.e. outside an acceptable limit) it is not acceptable to simply retest the same batch or the same product samples until a satisfactory result is achieved.

You may use an external competent person (e.g. consultant) to undertake validation including preparing the validation report and where necessary a protocol.

4.3.1 Achievement of Regulatory Limits

You must collect evidence to demonstrate that the relevant regulatory limits are being met.

Regulatory limits may be expressed as product requirements (such as water activity), performance criteria (such as a certain log reduction of a pathogen) or process parameters (such as thermal processing parameters). See section 3.6.3.1 for a further explanation of regulatory limits. The type of data required will depend on how the regulatory limit has been expressed. If a regulatory limit is expressed as the level of hazard in a final product, then results of end product testing will be needed. If the limit is expressed as a process parameter, then measurements of the particular process parameter will be expected.

If there is insufficient evidence when applying for RMP registration, you must provide a protocol that describes how data will be collected to demonstrate achievement of the regulatory limit (see section 4.4).

Further guidance on validation requirements for specific processes can be found in NZFSA COPs. For example, guidance on the validation of uncooked comminuted fermented meats is given in the Guidelines for the Production of Uncooked Comminuted Fermented Meat (UCFM) Products, and guidance on the validation of further processing operations for non dairy products is given in the Further Processing code of practice.

4.3.2 Achievement of Operator-defined Limits

To demonstrate the achievement of an operator-defined limit, you must first collect evidence to demonstrate that this limit has been appropriately set for that product, and then you must provide evidence that it will be met.

Operator-defined limits may be expressed as product requirements (such as pH), performance criteria (such as a certain log reduction of a pathogen) or process parameters (such as cooking parameters to ensure a specified microbiological level is achieved). See section 3.6.3.2 for a further explanation of operator-defined limits. The type of data required will depend on how the operator-defined limit has been expressed. If an operator-defined limit is expressed as the level of hazard in a final product, then results of end product testing will be needed. If the limit is expressed as a process parameter, then measurements of the particular process parameter will be expected.

If there is insufficient evidence when applying for RMP registration, you may need to provide a protocol that describes how data will be collected to demonstrate achievement of the operator-defined limit (see section 4.4).

A protocol is not required when the evidence only involves demonstrating compliance to documented procedures (i.e. no data is collected). A protocol is also not required for any operator-defined limits related to wholesomeness.

4.3.3 Resources to Assist in Validation

The following resources may be used to assist in the validation process, either when demonstrating the appropriateness of a limit or when collecting evidence to demonstrate that a limit will be met:

• references from reputable scientific literature etc (e.g. COPs, international standards, journal articles)

• mathematical modelling programmes.

• previous validation studies or historical knowledge on performance of the control measure. For this to be possible you must ensure that the conditions (e.g. raw materials, relevant hazards, combinations of control measures, intended use, distribution) in their particular operation do not differ from the conditions under which the control measure was previously validated

• validation trials and experimentation

• challenge testing

• NZFSA COPs

4.4 Development and Implementation of the Protocol

When there is insufficient evidence to demonstrate the effectiveness of the RMP at the time of application for registration (e.g. for a new businesses or a new process), you may need to document a protocol for collection of evidence.

A protocol is not required for most GOP procedures.

4.4.1 Developing the Protocol

The protocol must contain:

• details of the evidence required and how it is to be collected

• a proposal for the disposition of animal material or product produced during implementation of the protocol; and

• a timeframe for completion of the protocol.

You may use an external competent person to design and document the protocol or parts of it, e.g. to design sampling plans or to confirm the capability of complex machinery such as retorts and rendering dryers.

The protocol will need to be submitted to the recognised evaluator as part of the evaluation, and NZFSA when applying for registration.

4.4.1.1 Contents of a protocol

The protocol should include the following information, as appropriate:

1. Scope/purpose

• person responsible for protocol

• description of the specific aspects of the process(es) or operation(s) to be validated

• product to be produced.

2. Competencies

• mandatory qualifications, when appropriate (e.g. thermal processing)

• intended use of any technical expert and details about the expert’s competence.

3. Commissioning of equipment

• details of the equipment that will be commissioned and how this will be done.

4. Criteria against which the effectiveness will be determined:

• regulatory limits (if any)

• operator-defined limits (if any)

• critical limits (if any)

• GOP requirements (for procedures requiring validation as listed in Appendix F).

5. Trial design

You should consider the following trial design parameters and incorporate variations where necessary to cover likely trial outcomes (valid, not yet fully valid, not valid) when developing the protocol:

• specific process step(s) that will be studied

• specific trial conditions to be used including processing variables (e.g. throughput, size and configuration of product, equipment settings, ingredients) and other variables that impact on the operation, e.g. season, work-shift, processing days

• the data to be collected (e.g. time, temperature, humidity, moisture content, specific microorganisms)

• sampling plan:
The sampling plan should indicate where, when and how the samples are to be taken. Ideally, statistical-based sampling plans should be used. However, it is recognised that for practical reasons such as cost, time, etc this may not be feasible. You must at least develop a sampling plan that specifies a sufficient number of samples and/or process runs/batches to provide assurance of the effectiveness of the RMP

• test methods (details as appropriate), laboratory that will do the testing

• the proposed trial start and completion dates. It is generally expected that validation is completed within four working weeks unless the processing schedule makes this impractical. Where processing is discontinuous or production volume is low, the validation may be completed over the equivalent of ten processing days, and without unnecessary delay; and

• method for analysing results.

6. Product disposition

• how the product resulting from the trials is to be disposed of. Disposition options include release as is, restricted release, rework, dump or burn, and will depend on the results of the trial.

4.4.2 Implementation of the Protocol

Once the RMP is registered, operations producing product for trade can commence.

You must follow the protocol and any conditions imposed by NZFSA at registration, and collect data over the stated period. If the protocol needs to be changed, e.g. because the design is not practical or the proposed process is not producing acceptable results, you should discuss this with the evaluator and, if required, provide them with further documentation to support the agreed changes.

The external RMP verifier will check that the protocol is being followed and is completed during any verification visit.

4.4.3 Reporting Protocol Results

Immediately after completion of the protocol, you should prepare a report and submit this to the evaluator for assessment. The report should include the following:

• results from process records, test results, certificates of analysis, and other records collated in an appropriate way for easy review (e.g. tabulated, graphed)

• analysis or interpretation of the results

• conclusion regarding the effectiveness of the RMP to achieve the criteria

• confirmation that product disposition occurred as agreed; and

• any significant amendments to the RMP (see section 7.5.1).

Refer to section 5.5 for the procedures to be followed to complete the registration process.

4.5 Validation Examples

The following provides examples of how a regulatory limit or operator-defined limit may be validated²⁶.

4.5.1 Evidence to Show Achievement of Regulatory Limits

4.5.1.1 Where the regulatory limit is a product requirement:

Example 1: Limit for a biological hazard (e.g. absence of Listeria monocytogenes in 25 g of packaged heat treated meat paste)

a. Conduct a hazard identification and analysis. Identify the regulatory limit appropriate to the hazard and the product. Identify any other regulatory limits, that assist in achievement of this product regulatory limit, e.g. such as performance criteria (log reduction) or process parameters (time/ temperatures).

Also consider other microbiological hazards associated with your product and process at this stage, and whether they have a regulatory limit and or/similar control measures that may be able to be validated together.

b. Reference New Zealand or international literature that confirms that the chosen measures are capable of and appropriate for achieving the regulatory limit. Codes of Practice may be useful in obtaining information for validation

c. Determine own performance criteria by the following steps, as appropriate:

• establish incoming microbiological load of the pathogen, unless already well established within food sector

• establish reduction of microbiological pathogens required to meet regulatory limit for product

• develop process to meet product requirements (including establishment of key process parameters for intervention(s))

• prove achievement of regulatory limit.

Example 2: Limit for a chemical hazard e.g. 10mg/kg sulphite in dried apricots, 125µg/200ml Vitamin A in vitamin fortified milk powders, the level of histamine in fish or fish products must not exceed 200 mg/kg.

a. Identify the regulatory limit appropriate to the hazard and the product.

b. Reference any New Zealand or international literature that confirms that the chosen measures are capable of and appropriate for achieving the regulatory limit.

Literature searches may assist in validation using NZFSA or international information, e.g. temperature controls to limit toxin development, chemical degradation curves, processing losses.

c. Where the chemical is an additive, calculate the ingoing level from all sources/ingredients, expected losses during processing and final product levels of chemical. Consider the impact of either manual or automated delivery systems on accuracy and homogeneity of mixing.

d. Prove achievement of the regulatory limit. Samples (taken from commercial production runs) must be tested or achievement demonstrated by other acceptable means to NZFSA, e.g. for histamine.

Where sampling occurs, it is recommended that 3-5 production batches are tested taking:

• at least 3 samples per batch of homogenous material;

• at least 8 samples per batch of non-homogenous material.

4.5.1.2 Where the regulatory limit is a performance criterion:

Example: Limit for a biological hazard (e.g. 6 log reduction for Listeria)

a. Conduct a hazard identification and analysis. Identify the regulatory limit appropriate to the hazard and the product.

Reference any other regulatory limits if applicable, that assist in achievement of this performance regulatory limit, such as process parameters to be applied at a process step to achieve this log reduction.

Also consider other microbiological hazards associated with your product and process at this stage, and whether they have a regulatory limit and or/similar control measures that may be able to be validated together.

b. Reference New Zealand or international literature that confirms that the chosen measures are capable of and appropriate for achieving the regulatory limit.

Establish incoming microbiological load of the pathogen unless already well established within food sector.

Develop process to meet performance criterion (including establishment of key process parameters for intervention(s)).

Prove achievement of the regulatory limit e.g. by establishing the pathogen microbiological load in the food post-intervention to determine the effectiveness of the intervention, or using a predictive modelling programme to demonstrate that the required reduction is achieved (e.g. Tom Ross Model for UCFM).

4.5.1.3 Where the regulatory limit is a process parameter

Example: Limits for a biological hazard to eliminate Listeria monocytogenes: by application of time and temperature requirements for cooking raw poultry meat.

a. Conduct a hazard identification and analysis. Identify the regulatory limit(s) appropriate to the product.

b. Develop process and include the regulatory limits (or equivalent alternatives where permitted).

c. Prove achievement of the regulatory limit e.g., achievement of those parameters using calibrated equipment.

4.5.2 Evidence to Justify Operator-defined Limits

You must decide whether an operator-defined limit is needed for any of the hazards identified during the HACCP application. Operator-defined limits should only be considered if there is no regulatory limit for that hazard, and control of that hazard is essential for food safety. For example setting a limit for water activity in dried product, or a microbiological limit for RTE product where there is no limit in the legislation.

You must document the basis for selection of an operator-defined limit, including:

• where the limit came from (e.g. industry or NZFSA COP, literature, an overseas regulatory agency, own trials)

• what hazard and food the limit applies to

• why the limit is set at the particular level.

4.5.3 Evidence to Show Achievement of Operator-defined Limits

The evidence will be the same as described for regulatory limits.

4.6 Amendments to the RMP

When amending an RMP you must consider whether validation is needed and where it is necessary, ensure that it is undertaken in accordance with the requirements of this section. For further information on the requirements when amending an RMP refer to section 7.

²³ Currently validation may operate slightly differently for dairy operators in that engineers may be used as part of the process. It is intended that this be aligned with the non-dairy requirements with any amendment to the specification for recognised agencies and persons.

²⁴ Also see section 6.3.1 Pre-registration Assessment, for the pre-assessment procedure of RMP documentation before the premises is complete.

²⁵ Challenge testing generally involves subjecting a product with a known level of hazard to the intended process to determine whether the required hazard reduction is achieved.

²⁶ Also see more detailed validation guidance in product specific NZFSA COPs, e.g. the Further Processing COP.