Establish Verification Procedures Principle

3.8.1. Verification

The Codex guidelines define verification as "the application of methods, procedures, tests and other evaluations, in addition to monitoring to determine compliance with the HACCP plan." Verification and auditing methods, procedures, and tests, including random sampling and analysis, can be used to determine whether the HACCP system is working correctly (20,47).

3.8.2. Description of Verification Activities

Each HACCP plan should include verification procedures for individual CCPs and for the overall plan.

3.8.2.1. HACCP Plan Validation

Validation is the act of assessing whether the HACCP plan for the particular product and process adequately identifies and controls all significant food safety hazards or reduces them to an acceptable level. HACCP plan validation should include:

• Review of the hazard analysis.

• CCP determination.

• Justification for critical limits, based for example on current good science and regulatory requirements.

• Determination of whether monitoring activities, corrective actions, record-keeping procedures, and verification activities are appropriate and adequate.

The process of validating an existing HACCP plan should also include:

• Review of HACCP audit reports.

• Review of changes to the HACCP plan and the reasons for those changes.

• Review of past validation reports.

• Review of deviation reports.

• Assessment of corrective action effectiveness.

• Review of information on consumer complaints.

• Review of linkages between the HACCP plan and GMP programs.

3.8.2.2. HACCP System Audits

Audits are systematic and independent examinations involving on-site observations, interviews, and reviews of records to determine whether the procedures and activities stated in the HACCP plan are implemented in the HACCP system.

Records to be reviewed during auditing of the HACCP plan include, for example, those demonstrating that:

• Monitoring activities have been performed at the locations specified in the HACCP plan.

• Monitoring activities have been performed at the frequencies specified in the HACCP plan.

• The affected product has been controlled and corrective actions have been taken whenever monitoring has indicated the occurrence of a deviation from critical limits.

• Equipment has been calibrated at the frequencies specified in the HACCP plan. Audits should occur frequently enough to ensure that the HACCP plan is being followed continuously. This frequency depends on a number of conditions, such as the variability of the process and product.

3.8.2.3. Calibration

Calibration involves checking instruments or equipment against a standard to ensure accuracy. Calibration should be documented, and the records should be available for review during verification.

Calibration of CCP monitoring equipment is important; if the equipment is out of calibration, then monitoring results will not be accurate and may be completely unreliable.

3.8.2.4. Targeted Sample Collection and Testing

Verification may also include targeted sampling and testing and other periodic activities. Targeted sampling and testing involves taking product samples periodically and testing them to ensure that critical limits are appropriate for product safety. When sampling and testing are used as a verification tool, the usefulness of the test often depends on how the material is sampled. The risk and level of confidence needed will determine the sample size and the method of sample collection.

3.8.3. Role of Microbiological Testing in HACCP Verification

Microbiological testing is seldom effective for monitoring CCPs and cannot be used as a means of process control because of the lengthiness of analytical procedures and the inability to provide results in real time (39).

Microbiological testing does have a role in HACCP verification, however: when critical limits are established for the elimination of pathogens or their reduction to an acceptable level, microbiological testing can be used to verify the HACCP plan's effectiveness and to ensure that the identified microbiological limits have not been exceeded.

3.8.4. Verification Frequency

Verification activities should be performed according to a pre-established schedule described in the HACCP plan or whenever there are indications that the food safety status may have changed. These indications may include:

• On-line observations that CCPs may not be operating within critical limits.

• Record reviews indicating inconsistent monitoring.

• Record reviews indicating that CCPs are repetitively operated outside critical limits.

• Consumer complaints or product rejections by customers.

• New scientific data

3.8.5. Records of Verification

Records of verification should include methods, date, individuals and/or organizations responsible, results or findings, and action(s) taken.

3.8.6. Regulatory Verification

The reasons for regulatory verification activities include, among others: government obligation in consumer protection, support to the food industry (particularly medium- and small-scale food industry), and assistance to industry in trade opportunities when certification is required.

The inspector should document the existence and implementation of the HACCP plan. Regulatory verification should also involve review and/or audit of the adherence of the processor's HACCP system to its HACCP plan. In particular, the inspector should focus on the following:

• Review of the hazard analysis.

• Review of the CCP determination.

• Verification that the critical limits are based on good science and meet regulatory requirements.

• Review of the deviation and corrective action procedures.

• Review of the verification procedures.

• Review of records to verify that the HACCP plan is being followed effectively at all times.

• Verification of the accuracy of CCP monitoring equipment.

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