The FDA Food Safety Modernization Act Preventive Controls for Human Food identifies four types of preventive controls. The first three types of preventive controls; Process Preventive Controls, Food Allergen Preventive Controls and Sanitation Preventive Controls were discussed in my October, November and December columns respectively.

The Preventive Controls for Human Food regulation also requires documented Supply Chain Preventive Controls.

The safety of your product depends on more than just what you control in your facility. Use of a particular ingredient may require a supply-chain program as a preventive control. (The term ingredient means raw materials and other ingredients used in the manufacture of an item.)

The hazard analysis process determines when a hazard requiring a supply-chain-applied control exists. Some ingredients may not have hazards that require a preventive control and are controlled with GMPs. You do not need a supply-chain preventive control if you implement a preventive control for the hazard within your facility. However, if the hazard is controlled before you receive the ingredient a supply-chain program is required.

To understand supply-chain program requirements it is important to understand the definition of a supplier, receiving facility and customer in the context of the regulation.

Supplier: 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.

Receiving Facility: A facility that manufactures/processes a raw material or other ingredient that it receives from a supplier.

Customer: The entity the receiving facility sells to. May or may not be subject to the requirements for hazard analysis and risk-based preventive controls and may manufacture, process, or prepare the food in accordance with applicable food safety requirements.

Another definition that is important to understand is;

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

When you are the receiving facility you must document and implement a supply-chain program when hazards requiring a supply-chain-applied control are identified through hazard analysis.

The general requirements of a Supply-chain Program are;

  • 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

Documentation is a key element of supply-chain control.

For additional information on FDA’s Preventive Controls for Human Food go to the Food Safety Preventive Controls Alliance (FSPCA) website,