FSMA Preventive Controls Add-On
Aligned with BRCGS Food Safety Issue 9 – Optional Add-On Module (U.S. FDA FSMA Compliance)
Requirement Overview
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.
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
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✓ Address FSMA-specific requirements within your existing BRCGS Food Safety Plan
✓ Demonstrate readiness for FDA inspections and 21 CFR 117 compliance
✓ Integrate hazard analysis and risk-based preventive controls (HARPC)
✓ Establish roles and records required under U.S. regulations
Step-by-Step Compliance Implementation
1. Conduct a HARPC-Based Hazard Analysis
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Key Activities:
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• Identify biological, chemical, and physical hazards (including radiological and economically motivated adulteration)
• Evaluate known or reasonably foreseeable hazards
• Assess severity and probability
Evidence to Maintain:
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• FSMA-aligned hazard analysis
• Justification for hazard inclusion/exclusion
• Qualified Individual signature and verification
- • Identify biological, chemical, and physical hazards (including radiological and economically motivated adulteration) • Evaluate known or reasonably foreseeable hazards • Assess severity and probability
- • FSMA-aligned hazard analysis • Justification for hazard inclusion/exclusion • Qualified Individual signature and verification
2. Identify and Implement Preventive Controls
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Preventive Controls May Include:
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• Process controls (e.g., cooking, cooling, pH)
• Allergen controls
• Sanitation controls
• Supply-chain controls
• Recall plan implementation
Evidence to Maintain:
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• Preventive control procedures with monitoring, verification, and corrections
• Records of preventive control verification
• Documented recall plan meeting FSMA criteria
- • Process controls (e.g., cooking, cooling, pH) • Allergen controls • Sanitation controls • Supply-chain controls • Recall plan implementation
- • Preventive control procedures with monitoring, verification, and corrections • Records of preventive control verification • Documented recall plan meeting FSMA criteria
3. Designate a Preventive Controls Qualified Individual (PCQI)
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PCQI Responsibilities:
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• Prepare or oversee the food safety plan
• Validate and review preventive controls
• Conduct reanalysis at least every 3 years or after significant changes
Evidence to Maintain:
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• PCQI training certificate or qualification documentation
• Signed food safety plan
• Record of periodic reviews and reanalysis
- • Prepare or oversee the food safety plan • Validate and review preventive controls • Conduct reanalysis at least every 3 years or after significant changes
- • PCQI training certificate or qualification documentation • Signed food safety plan • Record of periodic reviews and reanalysis
4. Establish Supply-Chain Program Requirements
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If Receiving Ingredients Requiring Controls:
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• Verify suppliers via audits, sampling/testing, or review of supplier records
• Maintain supplier approval and verification records
• Justify exemptions if applicable
Evidence to Maintain:
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• Approved supplier list and risk assessments
• Supplier audit reports and verification results
• Records of ingredient sourcing and control
- • Verify suppliers via audits, sampling/testing, or review of supplier records • Maintain supplier approval and verification records • Justify exemptions if applicable
- • Approved supplier list and risk assessments • Supplier audit reports and verification results • Records of ingredient sourcing and control
5. Maintain Recordkeeping and Reanalysis Requirements
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FSMA Requires:
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• Retention of records for at least 2 years
• Availability of digital or physical records for FDA review
• Reanalysis of food safety plan as needed
Evidence to Maintain:
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• Controlled records for each FSMA-required activity
• Change control logs and reanalysis justifications
• Traceable documentation aligned with 21 CFR 117 Subparts C & G
- • Retention of records for at least 2 years • Availability of digital or physical records for FDA review • Reanalysis of food safety plan as needed
- • Controlled records for each FSMA-required activity • Change control logs and reanalysis justifications • Traceable documentation aligned with 21 CFR 117 Subparts C & G
Common Audit Findings & Recommended Fixes
| 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 |
