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including all raw material sources; (4) shipping and receiving; (5) storage; (6) water and ice supply; (7) mail handling; (8) personnel security; and (9) transportation, shipping, and receiving.
9.1.1 FDSS. When required in the solicitation, contract, or purchase order, a FDSS shall be conducted by USDA, AMS, PPD. The FDSS verifies that operators of food establishments have implemented measures to minimize the risk of tampering or other criminal actions against the food under their control. (An AMS, FDSS verifies the participating company's adherence to the FDA's "Guidance for Industry - Food Producers, Processors, and Transporters: Food Security Preventive Measures Guidance.") For further information, see section 12.1 and 12.3.2.
9.1.2 Food Defense Addendum to Plant Systems Audit (PSA). When required in the solicitation, contract, or purchase order, a Food Defense addendum shall be conducted by USDA, AMS, PPD auditors. This verifies that operators of food establishments have implemented measures to minimize the risk of tampering or other criminal actions against the food under their control. (An AMS, FDSS verifies the participating company's adherence to the
FDA's "Guidance for Industry - Food Producers, Processors, and Transporters: Food Security
Preventive Measures Guidance.") For further information, see section 12.1 and 12.3.2.
9.2 Manufacturer's quality assurance. When required in the solicitation, contract, or purchase order, the product manufacturer shall be required to provide evidence, by certificate, that the manufacturing plant has undertaken one of the following quality assurance measures within 12 months prior to providing a bid, or no later than 10 business days from the date of awarding of the contract. Failure to provide this documentation within the proper time frame may result in the contract being terminated for cause.
9.2.1 PSA. A PSA conducted by USDA, AMS, or other audit performed by a third party auditing service and is required within 12 months prior to the date of the awarding of the contract. (An AMS PSA verifies the manufacturer's capability to produce products in a clean, sanitary environment in accordance with 21 CFR Part 110 - Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food, and verifies that the
manufacturer has in place an internal quality assurance program.) (Perform with Food Defense addendum when required).
9.2.2 Plant survey. A plant survey conducted by USDA, AMS, or other survey performed by a third party auditing service is required within 12 months prior to the date of the awarding of the contract. (An AMS plant survey audit verifies that at the time of the survey, the manufacturer produces products in a clean sanitary environment in accordance with 21 CFR Part 110 - Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food.)
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