18 1/2016 eFOOD-Lab international New US Legislation 2) Documentation of audit procedures; 3) The date(s) the audit; 4) Audit conclusions; 5) Corrective actions taken by the supplier or food plant in response to significant deficiencies identified during the audit. d. Imported Raw Materials: A Supply Chain program for imported raw materials and ingredients needs to include documentation that the foreign supply plant is in compliance with the FSMA Foreign Supplier Verification Program or have the following information available for an FDA inspection: 1) Documentation of the approval of a supplier; 2) W ritten procedures for receiving raw materials and other ingredients; 3) Records supporting the written procedures for receiving raw materials and other ingredients; 4) Records verifying the supplier’s verification activities for raw materials and other ingredients; 5) Records of the on-site audit of the foreign supplier must document: • The name of the supplier; • Audit procedures; • Date(s) of the audit; • Audit conclusions; • Corrective actions taken by the supplier or food plant in response to significant deficiencies identified during the audit; • Sampling and testing conducted as a supplier verification activity; and • Review of the supplier’s relevant food safety records that list the name of the supplier whose records were reviewed, the date(s) of review, the general nature of the records reviewed and the conclusions of the review; and corrective actions taken in response to significant deficiencies identified during the review; 5. Recall Plan. The food plant’s recall program is a preventive control under PCHF and must be written with mock recalls conducted by the plant. 6. Other controls. A preventive control is also any other control necessary to deliver food safety and could include establishing segregated hygiene areas, employee hygiene training, employee traffic management, proper employee hygiene, captive shoe program and/or foot baths or foamers, etc. Monitoring preventive controls The food plant must have a written program on how preventive controls will be monitored with supporting records that include the name of the monitor record and the frequency of monitoring. Corrective action and correction procedures The food plant needs a written program to address what happens when a preventive control is not implemented, implemented improperly or cannot be verified by supporting records. At a minimum, a food plant’s corrective action plan should include the following steps: a. Segregate and hold the affected product. b. Determine the acceptability of the product for distribution. c. T ake corrective action to assure that injurious or adulterated product does not enter commerce. d. Correct the cause of the deviation. e. Determine whether modification of the HACCP plan is necessary Verification of preventive controls A food plant’s food safety program that includes the preventive controls must be verified internally. The PCHF regulation states that verification includes as appropriate: a. Calibration of process monitoring instruments and verification instruments (or checking them for accuracy) that includes the method and frequency of the calibration activity. b. Product testing (could include raw material and ingredient testing, in-process product testing, or end-product testing for a pathogen (or appropriate indicator organism) or other hazard; 1) Be scientifically valid; 2) Identify the test microorganism(s) or other analyte(s); 3) Specify the procedures for sample identification and linkage to the source lot; 4) Sampling schedule that includes the number of samples, what is to be sampled and the sampling frequency; 5) Specific test(s) to be conducted, including the reference analytical method(s) used; 6) Identify of the laboratory conducting the test; and 7) Corrective action if test results indicate a problem. c. E nvironmental monitoring for an environmental pathogen or indicator organism is required if contamination of a ready-to-eat food with an environmental pathogen is a hazard requiring a preventive control. The amount of samples, sample locations, and frequency must be adequate to determine whether preventive controls are effective. If conducted by a food plant, an environment monitoring program must address the following: 1) Be scientifically valid; 2) Identify the test microorganism(s), the test(s) conducted, the analytical method(s) used and the laboratory conducting the testing 3) Have a map of the facility with sampling locations or a list that identifies all sample locations. 4) Schedule that includes the number of samples, what is to be sampled and the sampling frequency. 5) Have corrective action procedures if a environmental sampling test result comes back “positive” d. Records Review under the oversight of a PCQI to ensure that the records for the food safety plan and preventive controls are complete, effective, and the corrective actions are preventing food safety hazards from getting into finished product. At a minimum, a food plant’s records review program frequency needs to be: 1) 7 days after the records were created for records supporting the food plant’s food safety. If more than 7 working days is needed, written justification must exist from the PCQI. 2) “Reasonable time” for records of calibration, testing (e.g., product testing, environmental monitoring), supplier and supply-chain verification activities, and other verification activities Validation of preventive controls The PCQI is the only party at the food plant that will be recognized by FDA as having the qualifications, training and knowledge to validate any identified preventive control. Fortunately, the PCHF states that the food allergen controls, sanitation controls, the recall plan, the supply-chain program and the “Other Controls” programs do not require validation.
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