Manufacturers - 1
any LACF, the processor must either fully reprocess the affected product, keeping complete records of the processing conditions; or set aside the affected production for evaluation by a recognized processing authority. Unless the evaluation demonstrates the product has been given a process rendering it free of organisms of potential public health significance the product must be reprocessed or destroyed. A record of the procedures used for the evaluation and the results must be recorded. Affected product may only be shipped from the establishment upon obtaining documentation that the deviation represents no potential health hazard; or upon complete reprocessing to commercial sterility.
Processors are required to maintain a file or log identifying appropriate data detailing the processing deviation and the actions taken.
When a deviation is detected in progress, the affected product need not be held if the corrective action executed is to apply the original scheduled process, implement an alternate process, or reprocess in accordance with a process recommended in writing from a processing authority. After the corrective action is applied, the processor must assure the application has been satisfactorily implemented and documented on batch records and in the deviation file. For example, if a retort temperature drop occurred and an alternate process was applied to satisfy the lowest retort temperature, the corrective action may have been adequate if the cause of the drop was simply a loss in steam. However, if the cause of the drop was due to a retort malfunction such as a leaking or cracked cold water valve or a leaking or cracked air valve, or operator error, the application of the alternate process may not sufficiently correct the deviation. Temperature distribution test simulations may be required to evaluate the deviation. However, in many cases, simulation testing may not be reliable since the extent of the problem may not be known. Often simulations must be based on a worst possible scenario.
Processors may contact a processing authority while a processing deviation is occurring and request calculations of emergency alternate schedules. Although this remedy is often successful in preventing under processing or over processing, the process must be evaluated and the results must be documented. Processing conditions (which form the basis of any proposed corrective action) provided to the processing authority, may change before the end of the process. Therefore the cause, as well as complete records of the processing deviation, need to be examined by the processing authority to confirm the adequacy of the alternate process.
FDA has observed incidents where processing authorities supplied emergency alternate schedules by phone, FAX or modem. Some processors fail to follow-up implementation of the emergency recommendations with a request for a written evaluation of the processing deviation, as required by the regulations.
Corrective actions may also be based on calculations or programs that calculate processes for retort temperature drops. However, the processing deviation must be evaluated by a processing authority, and documented in the deviation file.
A common problem deals with corrective actions when there is a loss of steam retort pressure and the temperature drops to below the boiling point of water (2120F at sea level). Once the minimum retort temperature is regained, operators may incorrectly begin to time the process again without re-venting the retort. Failure to re-vent the retort may make an evaluation by a processing authority impossible.
Reprocessing of products is performed routinely by processors. Plant personnel do not always realize that unless the scheduled process has been designed specifically for the product to be reprocessed, its use for reprocessing is not valid. Test conditions utilized to establish the scheduled process are usually specific to products which have not been previously thermally processed. There are numerous examples of products which heat slower upon reprocessing, or heat slower depending on storage time between the original process and the reprocess. Products of concern are those containing starches, binders, extenders and the like. To optimize product quality, condensed soups or sauces are often formulated with thickeners that activate late in the thermal process or during cooling. Some products experience thickening of the sauce component during storage. If changes during storage have not been considered, the reprocess may be inadequate when applied. In one case, a product which had an original process 110 minute cook time, when reprocessed had to be subjected to a 180 minute cook time.
Timeliness of reprocessing may also be important depending on the severity of the original processing deviation. If the product is severely under processed, there may be a concern for the failure to destroy Staphylococcus aureus. If this organism survives in the product prior to reprocessing, and sufficient time permits growth and production of enterotoxin, reprocessing will not deactivate and