Chapter 3, Subject 4
QMP Reference Standard and Compliance Guidelines
Appendix G
Guidelines for the Verification and Maintenance of the QMP

Purpose

This document provides guidelines about the requirements set out by Element 6 of the QMP Reference Standard - Verification and Maintenance of the QMP Plan; and specific requirements set out by Element 5 of the QMP Reference Standard - the HACCP plan.

Key Criteria

The objective in developing a verification and maintenance program is to use all available information to confirm that the QMP meets the needs of the fish processor in producing a safe, wholesome and fairly traded product. The key criteria for such a program are:

1. Written outline - The plan must have enough detail to clearly outline the "what" and "how" actions that will be completed when assessing each Verification and Maintenance element component. The plan should also outline "who" is responsible for carrying out the plan.
2. Appropriate timing - Verification and Maintenance activities should be timed so that changes can be made and implemented to ensure the QMP functions correctly and remains effective during production. The frequency of each Verification and Maintenance activities should be linked to the amount of change occurring in the operation (i.e., more often for rapidly changing products versus more stable production).
3. Records - Records must be kept for all verification and maintenance activities to demonstrate what took place, the extent of these activities, and the results.
4. Amendments - the processor must keep a list of all amendments made to the QMP (i.e., amendment log).

Compliance Guidelines

There are 4 main requirements to be met:

1. Complete review of QMP prior to implementation
2. Validation - before starting a process and when changes are made to the process
3. HACCP Verification while operating (Codex HACCP Principle 6)
4. Verification/maintenance activities for the entire QMP plan with specific requirements for the HACCP plan.

1) Complete Review

When submitting a QMP Plan for System Verification, the processor must provide evidence that the QMP Plan has been reviewed to confirm that it is complete and all the necessary controls and documentation for all elements of the Reference Standard are in place. One way to ensure this is accomplished is by using a checklist completed in sufficient detail to demonstrate that an assessment was carried out and the plan met the criteria (an example is available in Chapter 2, Subject 1, Appendix C of this manual).

2) Validation

Before implementation of the QMP, validation of HACCP controls and CCP critical limits must be completed and submitted as part of the initial QMP submission for System Verification. There are two parts to this validation:

1. scientific evidence - must be collected to establish that the parameters for the critical limits for each CCP are sufficient to prevent, eliminate or reduce to an acceptable level, the food safety hazards in the final product (examples of scientific evidence include a process authority (NFPA), published research data, Health Canada regulatory standard).
2.  in-plant testing - sufficient tests and measurements must be conducted during test trials of the process to clearly demonstrate that the process is able to consistently meet the chosen critical limits.

Once production has started, revalidation of HACCP controls or CCP critical limits is required where changes are made to raw materials, products, or processes, or in response to adverse audit findings, recurring deviations, new information on hazards or new distribution and consumer-handling practices where potential hazards may be encountered:

For each Critical Control Point on the production line, the critical limits are based on stable conditions, i.e., the raw materials, the equipment and all the process steps remain the same. If any of these change, control measures must be evaluated to confirm they are still effective, and critical limits must be re-validated to ensure safe food is still being produced.

Other events such as, but not limited to, the following may point to a need to re-validate QMP controls or CCP critical limits:

• adverse findings from a CV or other external audit which found problems with the process or controls.
• deviations from critical limits which keep occurring and cannot be eliminated.
• a new hazard is identified or a new time/temperature process is published by a process authority.
• changes to distribution/marketing, e.g., extended shelf life or consumer packaging (oxygen permeable packaging).

3) Codex HACCP Principle 6 - verification during production (Reference Standard 5.1.6)

Once production is underway the processor is required to perform two ongoing verification procedures to confirm that the HACCP system is working effectively (Principle 6 - Codex HACCP model). These activities would normally be completed by someone not directly involved in the production process, such as a supervisor, manager or some other person (e.g., Quality Control) with the authority to review the production.

a) Records Review of the monitoring actions for CCP critical limits and corrective actions taken must be verified frequently to confirm they are occurring as described in the plan. This includes calibration records of instruments used in the measurement of Critical Control Point parameters (e.g., temperatures, pH, weight, flow rate).

The Records Review is intended to verify that:

• monitoring activities were performed at the frequency required by the HACCP plan and all results were within the Critical Limits;
• no monitoring activities were missed and all records were completed accurately and correctly;
• all deviations were followed up immediately with Corrective Actions.

HACCP plans rely on accurate measurements (e.g., temperatures, pH, weight, flow rate) to ensure the CCPs are operating within critical limits. The instruments or equipment that require calibration for accurate CCP monitoring should be described in the HACCP plan. The recommended frequency of calibration is dependant on the likelihood that the instrument will go out of calibration and, if it does, the likelihood that a Critical Limit will not be met.

b) Independent checks must be completed to verify that the control measures implemented at each CCP are adequate and effective. This verification step must be done on a routine basis, at an appropriate frequency so that corrective action could be successfully initiated and final product controlled if a problem were to be discovered.

Independent Checks are observations, measurements, analytical tests, samples, etc. These are completed separately from the monitoring activities and are intended to be an additional level of control to demonstrate that the identified hazard is being controlled adequately. Observations might involve a second individual watching the monitoring activity being performed. Measurements might involve a second individual performing the monitoring activity separately from the production monitoring.

The verification plan must include a description of the independent checks, the timing of the activity, the individual performing the checks, and the corrective action to be taken if the results indicate a problem with the monitoring.

4) Specific requirements for the HACCP plan and verification/ maintenance activities for the rest of the QMP

a) Specific requirements for the HACCP plan

The purpose of a HACCP is to prevent food safety hazards from occurring and to accomplish this, the entire HACCP plan must be evaluated at least once each year to confirm that it:

• is complete;
• accurately reflects current products and processes;
• has effective controls over all significant hazards;
• has monitoring of the critical limits at frequencies sufficient to ensure that products remain in compliance; and
• has corrective action procedures that work efficiently and effectively.

For processes that do not currently have significant hazards, it is crucial that the Hazard Analysis is reviewed to confirm that there have been no changes in the product formulation or process steps that might require a re-evaluation of hazards for significance.

b) Verification/maintenance activities for the rest of the QMP

The processor must review all other elements of the QMP Plan, (i.e., Management Roles and Responsibilities, Product Descriptions, Process Flow Diagram, Prerequisite Programs, RAP Controls) at least once every year. This review must verify that the QMP Plan is current, complete and accurate, such that the written document matches what is actually occurring during production.

This review would confirm that all corrective actions and any problems or consumer complaints that occurred over the year have been analysed with written amendments or other appropriate changes made to the QMP Plan.

The processor should consider their yearly operating schedule in order to best schedule the annual review of the QMP Plan. Some review activities require the establishment to be in full production mode in order to assess (for example, swab samples for microbiological analysis), while other review activities, such as equipment or instrument calibrations may better be scheduled during shutdown periods. All elements must be reviewed in the course of each year, but they need not all be reviewed at the same time.

The types of Annual Review activities can be found in Table 1.

Table 1 - Types of Review Activities

Examples of verification and maintenance activities include, but are not limited to, the examples provided in the following table.

Types of Review Activities

QMP Element	What	How (Activities)
1. Management Roles and Responsibilities	Changes: Organization New Staff	Review responsibility for QMP and decision- making process.
2. Background Product and Process Information	Changes: Existing products (suppliers, formula, etc.) New products Problems: Corrective actions to resolve problems and/or non-conformities. Review One or more products with attention to those with significant hazards.	- Compare and review product descriptions with processed products in plant. - Examine records - Compare diagram and/or floor plan with actual layout of the production floor.
3. Pre-Requisite Plan	Changes: New equipment New sanitation products New procedures New work shift New employees New requirements Problems Deficiencies Corrective actions Non-conformities Review Sub-elements such as construction, sanitation program, pest control, product accountability and notification.	- Examine records - Recall simulation - Inspect facilities and equipment - Observe procedures - Verify effectiveness of cleaning (e.g., swabs, ATP testing) - Check effectiveness of training - Check for updates (e.g., FIR, standards)
4. Regulatory Action Point (RAP) Plan	Changes New supplier New label Coding New standard/ requirement New employees New procedures Production volume Problems Deficiencies Corrective actions Non-conformities Complaints Review Sub-elements (e.g., minimum acceptable product quality, ingredients, packaging, labelling and coding)	- Examine records - Confirm training - Check for updates - Observe procedures - Inspect product and labels - Check calibration records for completeness
5. HACCP Plan	Changes New hazard New employee Critical limit change New procedure SQA changes Change in production volume Problems Deficiencies Corrective actions Non-conformities Complaints Review Hazard analysis and HACCP Plan for a selected product	- Examine records - Confirm training - Literature search, check for updates - Review data to validate critical limits - Sampling to test for specific hazards (biological, chemical and/or physical) - Observations (ensure all hazards have been considered)

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