The FSMA Preventive Controls Add-On is an optional BRCGS module designed to help facilities meet the regulatory requirements of the U.S. Food and Drug Administration’s (FDA) Food Safety Modernization Act (FSMA), specifically under 21 CFR Part 117: Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food.
This add-on supports FDA compliance by integrating preventive controls, supply-chain controls, recall procedures, and qualified individual responsibilities into your BRCGS-certified Food Safety Plan.
Ideal for companies exporting to the United States or preparing for FDA inspections.
BRCGS for Storage & Distribution requires that products moved via cross-docking are traceable and controlled at all times, even when they are not held in storage for extended periods.
Clause 4.3.1: “The company shall ensure that traceability is maintained at all stages, including during cross-docking operations.”
Clause 4.3.3: “Procedures shall be in place to ensure that all products handled, including those not stored on-site, remain under control and are not subject to contamination or substitution.”
Cross-docking operations must not compromise product traceability, safety, or integrity. Even with minimal handling and temporary presence, each product must be accurately identified, documented, and protected.
Audit Finding | Recommended Action |
---|---|
No HARPC-based hazard analysis | Update hazard analysis to meet FSMA expectations |
PCQI role not clearly assigned or documented | Designate a trained PCQI and maintain qualification documentation |
Recall plan missing FSMA-specific requirements | Update to include FDA-mandated elements (responsibilities, steps) |
No supply-chain program for controlled hazards | Conduct supplier verification and maintain audit/test records |
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