The FDA Food Safety Modernization Act Preventive Controls for Human Food identifies four types of preventive controls. The first type of preventive controls is Process Preventive Controls.

When developing a Food Safety Plan for Preventive Controls for Human Food, after the preliminary steps (product description, flow diagram and process descriptions) and the Hazard Analysis (identifies known or reasonably foreseeable biological, chemical or physical hazards) have been completed, the next step is to address the process preventive controls. Much of the information in Process Preventive Controls is similar to what you find in HACCP Plans.

Process Preventive Controls focuses on controls required at process steps that are critical for the safety of the food. Process preventive controls include parameters and limits (minimum or maximum values) associated with the control of a hazard that has been identified in the Hazard Analysis. These science-based parameters and limits are quite specific and are commonly called critical limits. They are applied at processing steps which are frequently called Critical Control Points (CCPs). A Critical Control Point (CCP) is a point, step or procedure in a food process at which control can be applied and is essential to prevent or eliminate a food safety hazard or reduce such hazard to an acceptable level (21CFR. 117.3).

The critical limit must be met at each CCP or the process step is out of control. Examples of process steps that may have critical limits include time, temperature, flow rate, line speed, product bed depth, weight, viscosity, moisture level, water activity, salt concentration and pH.

The process must be monitored to assure that each CCP is met. Monitoring is defined as; to conduct a planned sequence of measurements to assess whether control measures are operating as intended (21CFR 117.3). Monitoring requires four elements: 1) what measurements or observations will be used to monitor, 2) how to conduct the monitoring, 3) what frequency will be used for monitoring, and 4) who will do the monitoring.

When something goes wrong corrective action must be performed. Written corrective action procedures must describe steps taken to: 1) identify and correct the problem, 2) reduce likelihood of it happening again, 3) evaluate affected food for safety, and 4) prevent affected food from entering commerce if you cannot ensure the food is not adulterated.

In future columns the other three types of preventive controls will be addressed; Food Allergen Preventive Controls (November, 2016), Sanitation Preventive Controls (December, 2016) and Supply Chain Preventive Controls (January, 2016).

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