Deviation Management

A thermal process deviation is defined as a thermal process that is less than scheduled and/or in which one or more of the critical factors has not been satisfied. The corrective action taken and the specific procedures required to handle the deviation will depend on the regulatory agency involved. The FDA regulations concerning the handling of low-acid deviations are located in 21 CFR part 113.89. The corresponding regulations for the USDA are found in 9 CFR 318.308 and 381.308.

Deviations that are discovered prior to or during the thermal process may be corrected, thus eliminating the need to handle the thermal process as a deviation. All deviations must be completely documented on the thermal processing records. If it is not possible to correct a problem on the spot, or if the deviation is discovered after the fact, all product involved with the deviation must be placed on hold with one of the following options undertaken:

1. The deviant product may be reprocessed if a suitable reprocess is available from a processing authority.

2. The deviant process could be evaluated by a processing authority.

3. The deviant product could be destroyed. Records must be kept that delineate the disposition of the destroyed product.

All thermal processing, product disposition, and deviation evaluation records pertaining to a specific deviation need to be kept in a separate file. Alternatively a log may be kept that identifies all deviations.

The best way to manage deviations is to prevent them from occurring. This may be accomplished by training the retort operators and employees assigned to monitor critical factors to recognize the potential for the occurrence of a deviation and be familiar with corrective action.

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