Supply Chain Verification and Compliance
Supply Chain risks continue to be one of the fastest-growing threats for food companies. If supply chain risks are not managed appropriately they can result in a crisis. Whether you are approving a new supplier, assessing an existing supplier, or developing your Foreign Supplier Verification Program (FSVP), ensuring your suppliers are supplying your facility(s) with ingredients and materials that are safe is critical to ensuring the products you produce are safe.
What is Supplier Verification or Supply Chain Program?
Manufacturers must have and implement a risk-based supply chain program if the hazard analysis required by FSMA in relation to a manufacturer’s Food Safety Plan identifies a hazard that (1) requires a preventive control and (2) the control will be applied in the facility’s supply chain.
- Facilities do not need to have a supply-chain program if they control the hazard in their own facility, or if a subsequent entity (such as another processor) will control the hazard, and the facility follows applicable requirements.
- Manufacturers are responsible for ensuring that raw materials and other ingredients requiring a supply-chain-applied control are received only from approved suppliers, or on a temporary basis from unapproved suppliers whose materials are subject to verification activities before being accepted for use. (Suppliers are approved by the facility after the facility considers several factors, such as a hazard analysis of the food, the entity that will be controlling that hazard, and supplier performance.)
- Another entity in the supply chain, such as a broker or distributor, can conduct supplier verification activities, but the receiving facility must review and assess that entity’s documentation that they verified the supplier’s control of the hazard.
What is the FDA’s Foreign Supplier Verification Program rule?
The Foreign Supplier Verification Programs (FSVP) final rule, established through the FDA Food Safety Modernization Act (FSMA) went into effect on January 26, 2016. FSVP equires importers to verify that the food they are importing into the United States has been produced in a manner that meets applicable U.S. food safety standards. To do this, importers are required to develop, implement, and maintain a Foreign Supplier Verification Program which includes verification activities and records of those activities for each imported food from each foreign supplier.
The FDA has increased focus on FSVP during inspections in recent years. The absence of an FSVP has been the most cited observation on FDA form 483 by FDA investigators during inspections in recent years, making up 14% to 20% of the citations.
What is an Importer?
The U.S. owner or consignee of an article of food that is being offered for import into the United States. If there is no U.S. owner or consignee of an article of food at the time of U.S. entry, the importer is the U.S. agent or representative of the foreign owner or consignee at the time of entry, as confirmed in a signed statement of consent to serve as the importer. This has been a confusing issue for food manufacturers since the FSVP rule went into effect January 26, 2016. Many food manufacturers source ingredients through food brokers. Depending on the contract a food manufacturer has with the food broker may determine who the actual importer on record is. This has and continues to be a confusing issue for both food brokers and manufacturers. It is important for both parties to understand who the importer is and for the agreement between the two parties to reflect the agreement. Records must be maintained by both parties and be made available to the FDA if required. Ultimately, it is critical to assure the ingredients are sourced from a supplier that has been verified to ensure the safety of the food in question.