the hazard, control, and role in the food safety system. Sites should reanalyze all identified preventive controls and consider the need for validation where this is not presently documented. 13 117.165 (a) The PCQI (or authorized The review of records related to the designee) reviews the implementation and management of preventive monitoring and corrective controls is defined as a core verification activity in action records within 7 days. the regulation. The PCQI has overall responsibility Where an alternate for it to ensure that any failure in implementing timeframe exceeding 7 days preventive controls is identified within an is used, the PCQI must appropriate timeframe to prevent adulterated document justification. product from reaching consumers. 21 CFR § 117.165 requires the PCQI to conduct (or oversee) record reviews for monitoring and The PCQI (or their corrective action records within 7 days and all authorized designee) verification records within a reasonable timeframe. reviews the verification This requirement is consistent with the monitoring records for all preventive expectations for record review, as defined in BRC controls (e.g., calibration clause 2.10.2. Consideration should be given to records, product testing, the 7-day timeframe; where a timeline exceeding supply-chain audits) within a 7 days is used, the PCQI must document reasonable timeframe after justification. the record has been created. Requirements for the review of corrective action and verification records are implied in BRC clauses 2.12.1 and 3.7.2. The corrective action and verification procedures related to the food safety plan should be evaluated and updated as necessary to ensure there is provision for records to be reviewed by the PCQI or their designee.
the hazard, control, and role in the food safety system. Sites should reanalyze all identified preventive controls and consider the need for validation where this is not presently documented. 13 117.165 (a) The PCQI (or authorized designee) reviews the monitoring and corrective action records within 7 days. Where an alternate timeframe exceeding 7 days is used, the PCQI must document justification. The PCQI (or their authorized designee) reviews the verification records for all preventive controls (e.g., calibration records, product testing, supply-chain audits) within a reasonable timeframe after the record has been created. The review of records related to the implementation and management of preventive controls is defined as a core verification activity in the regulation. The PCQI has overall responsibility for it to ensure that any failure in implementing preventive controls is identified within an appropriate timeframe to prevent adulterated product from reaching consumers. 21 CFR § 117.165 requires the PCQI to conduct (or oversee) record reviews for monitoring and corrective action records within 7 days and all verification records within a reasonable timeframe. This requirement is consistent with the monitoring expectations for record review, as defined in BRC clause 2.10.2. Consideration should be given to the 7-day timeframe; where a timeline exceeding 7 days is used, the PCQI must document justification. Requirements for the review of corrective action and verification records are implied in BRC clauses 2.12.1 and 3.7.2. The corrective action and verification procedures related to the food safety plan should be evaluated and updated as necessary to ensure there is provision for records to be reviewed by the PCQI or their designee.
vm005-brc-fsma-self-assessment-tool-3152016-3.docx