Proposed SEC 507.45(c) would establish that the purpose of the review of records would be to ensure that the records are complete, the activities reflected in the records occurred in accordance with the food safety plan, the preventive controls are effective, and appropriate decision were made about corrective actions. The Agency tentatively concludes that review of the records required by proposed SEC 507.45(c)(1)(i) and (ii) would accomplish these purposes. Reviewing monitoring records can reveal whether they contain information on all the parameters that were to be monitored to determine whether a process is delivered in accordance with the food safety plan. For example, if the size of the animal food to be baked and the temperature and the time of baking are critical to the safety of the animal food, review of the monitoring records would demonstrate whether all three parameters were monitored and whether the values were within specified parameter values. Reviewing monitoring records can reveal whether a process followed the procedures specified in the facility's food safety plan (e.g., if the monitoring records show the temperature of every other batch of a baked animal food when the plan specified the measurement of every batch). Review of monitoring records also can reveal whether any information is missing, e.g., a designated lot number, so that the missing information can be quickly identified and added to the record if necessary. The Agency seeks comment on this proposal.
If the review of the records reveals that the records do not contain all information specified by the food safety plan, or that the procedure in the food safety plan was not followed, the facility will not be able to conclude that its preventive controls were implemented in accordance with its food safety plan for those activities. Because the food safety plan establishes the procedures needed to ensure preventive controls are effective, if the records review indicates that the plan is not being followed, e.g., the records are missing critical information or the activities were not performed as specified in the plan, the facility will not be able to conclude its preventive controls were effective. For example, if the records show that animal food particle size is not being determined or that the particles are too large, the minimum temperature of all parts of the particle may not occur to ensure control of pathogens such as Salmonella spp. If the plan requires determination of the baking temperature and time of each batch of product but the records do not show that the temperature was measured on all batches, the facility cannot be sure that the internal temperature of those batches is correct, again posing a potential risk from Salmonella spp. As a result, the facility would not be able to verify 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.
Review of records can also reveal whether appropriate decisions were made about corrective actions. The review should determine whether all the corrective action procedures required by proposed SEC 507.42(a) have been followed, e.g., that actions are taken to prevent recurrence of the problem, that affected animal food has been evaluated for safety, and that affected animal food is prevented from entering commerce unless it can be determined that the animal food is not adulterated under section 402 of the FD&C Act. For example, a food safety plan may require that each package of product pass through a properly functioning metal detector and that the operator determine every two hours whether metal test pieces of a specified type and size are rejected when passed through the metal detector. If one of the test pieces was not rejected but production continued until a supervisor doing a verification check noted the problem, then corrective actions should have been taken and a corrective action record produced. A review of the corrective action records should reveal that all packages of product that passed through the metal detector since the last test showing the metal detector was functioning appropriately were held and passed through a functioning metal detector before being released into commerce. The records should also show that the metal detector was adjusted to reject the metal test pieces before it was used again to check product during production.
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