B

Maximum time lapse between closing and retort up, minimum IT, minimum time, and temperature for vent and cook as specified in the scheduled process Heat-sensitive indicator changes color

Postprocess contamination of product from cooling water

Detectable residual chlorine levels to 2 ppm in the cooling water

QC to check on time lapse between closing and retort up (at least once per period) Retort operator to check on IT, time, and temperature for vent and cook and thermograph Busse unloader to check heat-sensitive indicator tape Busse unloader to segregate product if no indicator tape or no color change of indicator tape Chlorine checks every hour at exit of cooling water date:

approve by:

HEM, harmful extraneous materials; QC, quality control. aNumbers are from flow diagram in Table 11.

3.7.2.3. Evaluation of Affected Product

Evaluation of the affected product should be adequate to detect potential hazards, i.e., it should be ensured that sampling is adequate to identify the extent of the problem, that the tests are appropriate, that the judgment is based on sound science, and that the product is not released until the evaluation has determined that no potential hazard exists.

3.7.3. Corrective Action Procedures

Corrective action should be taken following any deviation to ensure the safety of the product and to prevent recurrence of the deviation.

Corrective action procedures are necessary to determine the cause of the problem, take action to prevent recurrence, and follow up with monitoring and reassessment to ensure that the action taken is effective. If the corrective action does not address the root cause of the deviation, the deviation could recur.

The producer's corrective action program should include the following:

• Investigation to determine the cause of the deviation.

• Effective measures to prevent recurrence of the deviation.

• Verification of the effectiveness of the corrective action taken.

3.7.4. Deviation and Corrective Action Records

Records should be available to demonstrate the control of products affected by the deviation and the corrective action taken.

3.7.4.1. Deviation

• Date produced/held/released.

• Amount of product held.

• Results of evaluation: amount analyzed, analysis report, number and nature of defects.

• Signature of personnel responsible for hold and evaluation.

• Disposition of held product (if appropriate).

• Signed authorization for disposition.

3.7.4.2. Corrective Action

• Corrective action taken to correct deficiency.

• Follow-up/assessment of effectiveness of corrective action

• Signature of person responsible.

3.7.5. Deviation Procedures

The following are some examples of deviation procedures for different products.

Antibiotics in incoming raw milk are detected by a rapid screening test. The detected level exceeds the established critical limit. The milk receiver refers to the deviation procedure.

The deviation procedure states that the milk is to remain in the truck and not be unloaded. The procedure also describes the follow-up action. The processor will follow up with the milk supplier involved. All corrective actions are recorded (35,55-58).

3.7.5.2. Cooked Sausages

Cooked sausages are sliced with equipment that has not been cleaned with the specified frequency. The supervisor notices that the slicer has excessive product buildup and believes that the sausages are being subjected to excessive bacterial contamination.

The deviation procedure states that the supervisor must hold all product produced since the last recorded clean-up. The product under hold is subjected to microbiological testing and is not released until the laboratory results are received. The deviation procedure also states that the employee responsible for equipment cleaning should be questioned as to the reason for the deviation from the specified procedure and be retrained as necessary.

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