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Food Safety Plan Development & Implementation

Compliant with 21 CFR §117.126 — Food Safety Plan Requirements

A compliant Food Safety Plan (FSP) serves as the foundation of the Preventive Controls framework under 21 CFR §117.126, ensuring that your facility maintains a written, hazard-based, and audit-ready system that effectively identifies risks, implements preventive controls, and preserves all required documentation, with all plans developed or overseen by a Preventive Controls Qualified Individual (PCQI) in full alignment with the Food Safety Modernization Act (FSMA).

Program Objective

To develop, implement, and maintain a comprehensive Food Safety Plan (FSP) that:
  • • Identifies and evaluates food safety hazards across products and processes
  • • Establishes risk-based preventive controls
  • • Defines monitoring, corrective action, and verification systems
  • • Ensures full compliance with FSMA Preventive Controls requirements
  • • Provides complete, audit-ready documentation for FDA inspections

Deliverables

1. Written Food Safety Plan (FSP) Development

  • • Development or review by a certified PCQI
  • • Formalized document structure with version control, signatures, and approval records
  • • Facility-specific and product-specific customization

2. Hazard Analysis (21 CFR §117.130)

  • • Identification of known or reasonably foreseeable hazards, including:
    • ◦ Biological hazards (e.g., pathogens)
    • ◦ Chemical hazards (e.g., allergens, residues)
    • ◦ Physical hazards
  • • Written hazard analysis regardless of outcome
  • • Risk evaluation based on severity and probability

3. Preventive Controls (21 CFR §117.135)

  • • Identification and documentation of applicable controls, including:
    • ◦ Process controls
    • ◦ Allergen controls
    • ◦ Sanitation controls
  • ◦ Supply-chain controls
  • • Preventive controls tailored to specific products, processes, and facility conditions

4. Supply-Chain Program Integration (Subpart G)

  • • Determination of supply-chain-applied controls
  • • Supplier approval and verification program development
  • • Documentation of supplier compliance and risk-based verification activities

5. Recall Plan (21 CFR §117.139)

  • • Written recall procedures with step-by-step execution framework
  • • Assignment of roles and responsibilities
  • • Communication protocols for regulatory authorities, customers, and internal teams

6. Monitoring Procedures (21 CFR §117.145)

  • • Defined monitoring activities for each preventive control
  • • Frequency, method, and responsible personnel identified
  • • Standardized log templates for consistent recordkeeping

7. Corrective Action Procedures (21 CFR §117.150)

  • • Defined response procedures for deviations and control failures
  • • Distinction between immediate corrections and corrective actions
  • • Documentation requirements for incident handling and resolution

8. Verification Procedures (21 CFR §117.165)

  • • Verification activities including:
    • ◦ Calibration of instruments
    • ◦ Product testing and environmental monitoring
    • ◦ Record review and validation
  • • Scheduled reanalysis and PCQI oversight documentation

9. Records Management System (Subpart F)

  • • Alignment with FSMA recordkeeping requirements
  • • Provision of templates for: ◦ Monitoring logs
    • ◦ Verification records
    • ◦ Corrective action documentation
    • ◦ Sign-off and review records
  • • Structured documentation system for audit readiness

Ongoing Program Support

  • • PCQI oversight and Food Safety Plan maintenance
  • • Support for required plan reanalysis and updates
  • • FDA inspection preparedness and documentation review
  • • Continuous improvement based on audit findings and regulatory updates
  • • Integration with corrective action, training, and supplier compliance programs

Ideal For

  • • U.S.-based and foreign food facilities subject to FSMA Preventive Controls
  • • Startups and small processors developing Food Safety Plans from the ground up
  • • Co-packers and private label manufacturers requiring documented compliance systems
  • • Companies preparing for FDA inspections or responding to FDA Form 483 observations

Need Expert PCQI Support?

Partner with our experienced Preventive Controls Qualified Individuals (PCQIs) for practical FDA compliance guidance, documentation support, Food Safety Plan development, regulatory consulting, and ongoing compliance services tailored to your operation.