Proposed SEC 507.45(c) would require that the review of records be performed by (or under the oversight of) a qualified individual (see the discussion in section X.I regarding the activities that must be performed (or overseen) by a qualified individual as would be established in proposed SEC 507.50). The review of records is critical to assessing the facility's application of the preventive controls system and, thus, is fundamental to ensuring its successful operation.
Proposed SEC 507.45(c)(1)(i) would require review of the monitoring and corrective action records within a week after the records are made. Although proposed SEC 507.45(c)(1)(i) would establish a more frequent review of these records than recommended in the NACMCF guidelines (which recommend monthly verification of monitoring records and corrective action records), it is consistent with the Agency's HACCP regulations for seafood ( SEC 123.8(a)(3)(i) and (ii)) and juice ( SEC 120.11(a)(1)(iv)(A) and (B)), which require that the review of monitoring records and corrective action records occur within one week of the day that the records are made. Even for shelf-stable foods (e.g., low-acid canned foods and acidified foods) the Agency's experience has demonstrated that review of these kinds of records is a critical verification tool (60 FR 65096 at 65133,
Proposed SEC 507.45(c)(1)(ii) would require review of the records related to calibration, within a reasonable time after the records are made. The review of calibration records will depend in part on the frequency with which calibrations occur, which will be established in the food safety plan. If calibrations occur daily, it would be reasonable to review these records weekly. Where several instruments are calibrated each month, a monthly review of all the calibrations would be reasonable. Consequently, FDA tentatively concludes that setting a specific frequency for review of these records is not warranted.
As noted previously, proposed SEC 507.45(c) would require a review of records in part to determine whether the preventive controls are effective. A review should determine whether monitoring and corrective actions have been done in accordance with the food safety plan and whether the instruments used in monitoring and verification were properly calibrated. If food safety activities appropriate to the facility have been conducted in accordance with the plan and this is reflected in the records, the facility thus verifies the preventive controls are effective, i.e., that its preventive controls are effectively and significantly minimizing or preventing the occurrence of identified hazards as required by Section 418(f) of the FD&C Act.
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