HARPC Compliance Management Program
Hazard Analysis & Risk-Based Preventive Controls (HARPC) | 21 CFR Part 117 Subpart C
The HARPC (Hazard Analysis and Risk-Based Preventive Controls) Compliance Management Program provides a comprehensive framework for developing, implementing, and maintaining a Food Safety Plan in full accordance with 21 CFR Part 117 Subpart C, ensuring that all required components—including hazard analysis, preventive controls, monitoring, corrective actions, verification, and recordkeeping—are properly established and overseen by a Preventive Controls Qualified Individual (PCQI) under the Food Safety Modernization Act (FSMA).
Program Objective
To design and manage a fully compliant HARPC-based Food Safety System that:
• Identifies and evaluates food safety hazards across all operations
• Establishes risk-based preventive controls for each hazard
• Implements monitoring, corrective action, and verification procedures
• Maintains complete, audit-ready documentation
• Ensures continuous compliance with FDA Preventive Controls requirements
• Identifies and evaluates food safety hazards across all operations
• Establishes risk-based preventive controls for each hazard
• Implements monitoring, corrective action, and verification procedures
• Maintains complete, audit-ready documentation
• Ensures continuous compliance with FDA Preventive Controls requirements
Scope of Work
1. Food Safety Plan Development (21 CFR §117.126)
- • Development or oversight of a complete written Food Safety Plan by a PCQI
- • Integration of all required components, including
- ◦ Hazard analysis
- ◦ Preventive controls
- ◦ Monitoring procedures
- ◦ Corrective actions
- ◦ Verification activities
- ◦ Recall plan
- ◦ Supply-chain program
2. Hazard Analysis (21 CFR §117.130)
- • Identification and evaluation of:
- ◦ Biological hazards
- ◦ Chemical hazards (including allergens)
- ◦ Physical hazards
- ◦ Economically motivated hazards (food fraud)
- • Risk assessment based on severity and probability
- • Evaluation across product types, processing steps, and storage conditions
3. Preventive Controls Plan (21 CFR §117.135)
- • Development of risk-based preventive controls, including:
- ◦ Process controls
- ◦ Allergen controls
- ◦ Sanitation controls
- ◦ Supply-chain controls
- • Definition of critical parameters, limits, and control procedures
- • Documentation tailored to facility operations and product categories
4. Recall Plan (21 CFR §117.139)
- • Development of written recall procedures
- • Assignment of roles and responsibilities
- • Communication protocols for regulatory authorities and customers
- • Effectiveness checks and product disposition procedures
5. Monitoring, Corrective Actions & Verification (21 CFR §117.145–§117.165)
- • Establishment of monitoring procedures and documentation logs
- • Development of corrective action workflows for deviations and failures
- • Verification activities including:
- ◦ Calibration
- ◦ Product testing
- ◦ Environmental monitoring
- ◦ Record review
- • Structured recordkeeping system for compliance tracking
6. Validation & Reanalysis (21 CFR §117.160–§117.170)
- • Validation of preventive controls where required
- • Scheduled reanalysis (minimum every three years)
- • Trigger-based reanalysis procedures for operational or hazard changes
- • Documentation of PCQI oversight, justifications, and timelines
7. PCQI & Training Documentation (21 CFR §117.180)
- • Verification that PCQIs and relevant personnel meet qualification requirements
- • Maintenance of training records and competency documentation
- • Documentation of PCQI oversight and responsibilities
8. Implementation Records System (21 CFR §117.190)
- • Development of compliant monitoring, verification, and corrective action records
- • Creation of standardized templates and logs
- • Organization of digital or physical recordkeeping systems for audit readiness
Deliverables
- • Fully developed FDA-compliant HARPC Food Safety Plan
- • Written Hazard Analysis and Preventive Controls Program
- • Monitoring, Corrective Action, and Verification SOPs
- • Recall Plan with audit and effectiveness check templates
- • Training records and PCQI qualification tracking documentation
- • Structured digital or physical recordkeeping system
- • Ongoing compliance reports and performance scorecards
- • Certificate of program implementation
Ongoing Program Support
- • PCQI-led review of monitoring and corrective action records
- • Evaluation of product testing and environmental monitoring results
- • Continuous SOP refinement and preventive control updates
- • Reanalysis trigger monitoring and validation support
- • Recall simulations and internal audit reviews
- • Periodic verification reports and compliance assessments
- • FDA inspection readiness monitoring and preparation
- • Ongoing PCQI advisory support for compliance issues and control failures
Ideal For:
- • FDA-regulated food manufacturers, processors, and co-packers
- • U.S. importers implementing HARPC programs for foreign suppliers
- • Contract manufacturers requiring documented food safety systems
- • Facilities producing RTE foods, dairy, baked goods, supplements, or frozen products
- • Companies preparing for FDA inspections or FSMA compliance audits
