Sage Advice US

Preventive Controls in the new FSMA

Are you in compliance?

The new Food Safety Modernization Act (FSMA) gives the FDA broad authority to manage recalls, and to minimize the likelihood of a recall, the rules require companies to establish and implement a food safety system that includes an analysis of hazards and risk-based preventive controls. Are you doing all that is necessary to ensure your organization remains in compliance? In our continuing series covering relevant FSMA topics, we take a look at the key requirements in the rules surrounding preventive controls.

Identify the hazards

The first step is in preventive control is hazard identification, with hazards being any known or reasonably foreseeable biological, chemical, and physical dangers. These hazards could be present because they occur naturally, are unintentionally introduced, or are intentionally introduced.

Develop preventive controls

These measures are required to ensure that hazards requiring a preventive control will be minimized or prevented. They include process, food allergen, and sanitation controls, as well as supply-chain controls, and a recall plan.

Oversight and management of preventive controls

Once your hazards are identified and you’ve put a plan in place to minimize or prevent the danger, you have to enact and monitor that plan. There are three steps in this process:

  1. Monitoring: You must document your efforts to provide assurance that preventive controls are consistently performed. An example of this would be the monitoring of a heat process used to kill pathogens, where actual temperature values are recorded on a stated schedule.
  2. Corrections and corrective actions: Corrections are steps taken to timely identify and correct a minor, isolated problem occurring during food production. Corrective actions include actions to, to reduce the likelihood the problem will recur, evaluate affected food for safety, and prevent it from entering the food chain. Both must be documented with records.
  3. Verification: Verification is required to ensure that your preventive controls are consistently implemented and effective. Such verification might include validating with scientific evidence that a certain preventive control is capable of effectively controlling an identified hazard; the calibration of process monitoring and verification instruments, and reviewing records to verify that monitoring and any necessary corrective actions are being conducted.

It’s clear that documentation and testing, along with quick and decisive data-backed decisions, will be necessary to obtain and retain compliance with the FSMA.

Special thanks to our partners at NexTec Group for contributing to this series.