FSMA Preventive Controls
Aligned with FSSC 22000 – Optional Compliance Enhancement for U.S. FDA FSMA
Requirement Overview
The FSMA Preventive Controls Add-On is an optional enhancement for food facilities certified under FSSC 22000, aimed at aligning your system with the U.S. FDA’s Food Safety Modernization Act (FSMA), specifically 21 CFR Part 117: Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food.
This module complements your ISO 22000-based Food Safety Management System (FSMS) with FSMA-specific requirements—integrating hazard analysis, preventive controls, recall planning, supply-chain controls, and documentation—essential for U.S. exports and FDA inspections.
Ideal for:
Food facilities exporting to the United States, preparing for FDA inspections, or seeking FSMA alignment within their existing FSSC 22000-certified system.
Aligned with BRCGS for Storage & Distribution Issue 4 – Clause 4.3.1 & 4.3.3
Requirement Overview
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.
Key Compliance Objectives
-
✓ Map FSMA-specific controls into your FSSC 22000 FSMS
✓ Demonstrate 21 CFR 117 alignment during FDA inspections
✓ Implement Hazard Analysis and Risk-Based Preventive Controls (HARPC)
✓ Define qualified roles and maintain compliant records
Step-by-Step Compliance Implementation
1. Conduct a HARPC-Based Hazard Analysis
-
Activities:
-
• Identify known or reasonably foreseeable hazards (biological, chemical, physical, radiological, economically motivated adulteration)
• Evaluate severity and likelihood
Evidence to Maintain:
-
• FSMA-aligned hazard analysis documentation
• Justifications for exclusion/inclusion of hazards
• Qualified Individual (QI/PCQI) signature
- • Identify known or reasonably foreseeable hazards (biological, chemical, physical, radiological, economically motivated adulteration) • Evaluate severity and likelihood
- • FSMA-aligned hazard analysis documentation • Justifications for exclusion/inclusion of hazards • Qualified Individual (QI/PCQI) signature
2. Identify and Implement Preventive Controls
-
Controls May Include:
-
• Process controls (e.g., temperature, pH)
• Sanitation and allergen controls
• Supply-chain controls
• Recall plans meeting FSMA standards
Records to Maintain:
-
• Monitoring and verification records
• Corrective actions
• Documented recall procedures in compliance with 21 CFR 117.139
- • Process controls (e.g., temperature, pH) • Sanitation and allergen controls • Supply-chain controls • Recall plans meeting FSMA standards
- • Monitoring and verification records • Corrective actions • Documented recall procedures in compliance with 21 CFR 117.139
3. Designate a Preventive Controls Qualified Individual (PCQI)
-
PCQI Responsibilities:
-
• Oversee FSMA elements of the FSMS
• Validate and reanalyze controls
Evidence to Maintain:
-
• PCQI training certificate or documentation
• Food safety plan signed by PCQI
• Review logs and change records
- • Oversee FSMA elements of the FSMS • Validate and reanalyze controls
- • PCQI training certificate or documentation • Food safety plan signed by PCQI • Review logs and change records
4. Establish a FSMA-Compliant Supply-Chain Program
-
If receiving ingredients requiring control:
-
• Verify suppliers via audits, COAs, sampling, or approved documentation
• Keep supplier verification and approval records
Evidence to Maintain:
-
• Supplier risk assessments
• Audit results and control documentation
• Justifications for exemptions
- • Verify suppliers via audits, COAs, sampling, or approved documentation • Keep supplier verification and approval records
- • Supplier risk assessments • Audit results and control documentation • Justifications for exemptions
5. Maintain FSMA Recordkeeping and Reanalysis
-
Plan Components:
-
• Keep records for a minimum of 2 years
• Ensure quick access during FDA inspection
• Conduct reanalysis at least every 3 years or upon significant changes
Evidence to Maintain:
-
• Controlled records aligned with 21 CFR 117 Subparts C & G
• Reanalysis logs
• Traceability of decisions and updates
- • Keep records for a minimum of 2 years • Ensure quick access during FDA inspection • Conduct reanalysis at least every 3 years or upon significant changes
- • Controlled records aligned with 21 CFR 117 Subparts C & G • Reanalysis logs • Traceability of decisions and updates
Common Audit Findings & Recommended Fixes
| Audit Finding | Recommended Action |
|---|---|
| No HARPC-based hazard analysis | Update your hazard analysis to align with FSMA |
| PCQI role not assigned or documented | Assign and train a PCQI, keep documentation |
| Recall plan missing FSMA elements | Revise to include FDA-mandated responsibilities |
| No supply-chain program for controlled hazards | Implement supplier verification and maintain proof |