FSMA Preventive Controls Rule
Core FDA framework establishing preventive, risk-based food safety requirements, including hazard analysis, supplier verification, monitoring, and corrective actions.
What You Can Expect
Practical insights you can apply right away.
Hazard Analysis Is the Foundation
Facilities must identify known or reasonably foreseeable biological, chemical, and physical hazards in their products and processes. Where hazards are identified, written preventive controls must be implemented to significantly minimise or prevent them.
Four Types of Preventive Controls
The rule defines four categories of preventive controls: process controls, food allergen controls, sanitation controls, and other controls. Each must be monitored, verified, and supported by corrective action procedures with documented records.
Supply Chain Accountability
If a hazard is controlled by a supplier rather than in-house, facilities must have a risk-based supply chain program to verify that suppliers are effectively controlling the hazard before raw materials are accepted for use.