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

  • 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

  • Key Activities:

    • 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:

    • FSMA-aligned hazard analysis

      Justification for hazard inclusion/exclusion

      Qualified Individual signature and verification

2. Identify and Implement Preventive Controls

  • Preventive Controls May Include:

    • Process controls (e.g., cooking, cooling, pH)

      Allergen controls

      Sanitation controls

      Supply-chain controls

      Recall plan implementation

    Evidence to Maintain:

    • 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)

  • PCQI Responsibilities:

    • 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:

    • PCQI training certificate or qualification documentation

      Signed food safety plan

      Record of periodic reviews and reanalysis

4. Establish Supply-Chain Program Requirements

  • If Receiving Ingredients Requiring Controls:

    • Verify suppliers via audits, sampling/testing, or review of supplier records

      Maintain supplier approval and verification records

      Justify exemptions if applicable

    Evidence to Maintain:

    • Approved supplier list and risk assessments

      Supplier audit reports and verification results

      Records of ingredient sourcing and control

5. Maintain Recordkeeping and Reanalysis Requirements

  • FSMA Requires:

    • 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:

    • 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

Auditor Verification Checklist

During an audit or FDA inspection, be ready to show:

  • FSMA-aligned food safety plan and hazard analysis

    Preventive controls procedures and monitoring records

    PCQI designation and training verification

    Supply-chain program evidence for hazard control

    Recall plan in compliance with 21 CFR 117.139

Implementation Roadmap

Build Your Program

  • Perform HARPC-compliant hazard analysis

    Designate and train your PCQI

Train and Apply

  • Implement preventive and supply-chain controls

    Maintain records in line with FSMA expectations

Monitor and Review

  • Conduct internal FSMA audits and document results

    Reanalyze the plan as required or after changes

Strengthen Continuously

  • Update food safety plans with audit findings

    Conduct regular PCQI training refreshers and plan reviews

Why This Matters?

  • Supports dual compliance: BRCGS + U.S. FDA FSMA

    Enhances export readiness for U.S. food markets

    Helps avoid FDA Form 483 observations and enforcement actions

    Demonstrates proactive global food safety leadership

Support Tools Available

Food Safety Systems provides:

  • FSMA-compliant hazard analysis templates

    Preventive control procedures and PCQI training guides

    Supply-chain verification logbooks

    FDA-compliant recall plan templates and training