Overview of the Suppliers Form:

There should be a vetting process within your company for supplier approval. You may want to consider having the team include a Purchasing, R&D, and Manufacturing. Be confident that the supplier can safely manufacture what you are specifying. If a material requires a supply-chain-applied preventive control it is especially important to have procedures and documentation regarding the measures taken to minimize risks associated with the ingredient.

Understanding the potential hazards associated with your supply chain helps to determine preventive controls needed to control those hazards, either within your facility or at the supplier.

Supplier Form Instructions:

Include in this category any sanitation/chemical suppliers as well as pest control services.

Suppliers Form Tips:

Know your supplier. If a food safety issue occurs with your product, review your supplier program, including verification activities, to ensure that program inadequacy was not the cause.

Some suppliers are routinely inspected by FDA or other recognized government agencies. You may be able to rely on the results of these inspections instead of a private party audit and obtain information on these inspections annually from the supplier.

FSPCA Manual p12-10. Once approved suppliers are identified, you must identify and implement appropriate verification activities to ensure that the supplier actually controls the hazard requiring a supply-chain-applied control.

Appropriate Supplier Verification Activities
Conduct one or more of the following verification activities before using and periodically thereafter:

  • Onsite audit (should be done with a trained auditor who knows what to look for)
  • Review supplier’s food safety records for the ingredient (processing times and temperatures)
  • Sampling and testing - by the supplier or the receiving activity
  • Other if applicable

21 CFR 117.3 Definitions:

Supplier means the establishment that manufactures/processes the food, raises the animal, or grows the food that is provided to a receiving facility without further manufacturing/processing by another establishment, except for further manufacturing/processing that consists solely of the addition of labeling or similar activity of a de minimis nature.

Receiving facility – A facility that is subject to subparts C (Preventive Controls) and G (Supply-chain Program) of this part and that manufactures/processes a raw material or other ingredient that is receives from a supplier.

Supply-chain-applied control means a preventive control for a hazard in a raw material or other ingredient when the hazard in the raw material or other material is controlled before its receipt.

For any Sampling and Testing that is done in connection to Supply Chain preventive controls the following information must be included:

  • Identification of the raw material or other ingredient, including lot number, as appropriate, and number of samples tested
  • Test(s) conducted, including analytical method used
  • Date the test was conducted and date of the report
  • Results of the test
  • Corrective actions taken in response to detection of hazards
  • Identifying the laboratory conducting the test

21 CFR 117.415 Responsibilities of the receiving facility:

(a)(1)The receiving facility must approve the suppliers. There should be some vetting process from the receiving facility that has the acceptable criteria that supplier should follow to be approved to ship materials.

As documented in 21 CFR 117.415, the receiving facility must approve their suppliers. Keep in mind, other entities can determine and conduct other activities, such as a broker. The broker may perform supplier verification activities for review and assessment by the receiving facility.

Supply-chain Program General Requirements

  • Use approved suppliers
  • Determine Supplier verification activities
  • Conduct supplier verification activities
  • Document supplier verification activities
  • When applicable, verify a supply-chain-applied control applied by an entity other than your supplier.