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
