Preventive Control Monitoring & Management Program
Compliant with 21 CFR §117.140–§117.145 – Monitoring, Corrective Actions, and Verification of Preventive Controls
To establish and implement an integrated Preventive Control Management System ensuring the effectiveness of written food safety controls through structured Monitoring, Corrective Actions, and Verification in alignment with FSMA and §117 Subpart C requirements.
Deliverables
1. Preventive Control Management Plan
- • Identification of relevant preventive controls requiring oversight
- • Assignment of management components based on control type (e.g., CCPs, allergen controls, sanitation)
2. Written Monitoring Procedures
- • Development of step-by-step procedures for monitoring each preventive control
- • Defined frequencies and responsibilities for monitoring tasks
- • Integration of exception record protocols (e.g., refrigeration logs)
3. Monitoring Records Templates
- • Custom logbooks or digital formats for daily, weekly, or batch-based monitoring
- • Pre-filled templates for high-risk controls (e.g., temperature, pH, cleaning validation)
4. Corrective Actions & Corrections Guidance
- • Definition of deviations vs. minor corrections
- • Template for documenting non-conformances, product holds, and release decisions
- • Instructions for retraining, root cause investigation, and preventive measures
5. Verification System
- • Scheduled internal checks of monitoring records
- • Outline of validation/revalidation triggers
- • Checklist for cross-verification of supply-chain-related hazards (if applicable)
6. Exception Records Management
- • Implementation of affirmative or exception-based recordkeeping for time/temperature controlled foods
- • Guidance on acceptable substitute logs under specific operational conditions
7. Training Module: Preventive Control Oversight
- • Staff training deck and SOP integration on how to implement, document, and respond to preventive control deviations
- • Quiz and competency form for food safety team
Fees and Subscriptions
Initial Setup Fees
| Plan | Description | One-Time Fee |
|---|---|---|
| Basic Monitoring Kit | Setup for 1 preventive control with forms & SOPs | $750 |
| Standard Oversight Package | Management plan for 3–5 controls | $1,950 |
| Comprehensive Facility Program | Full oversight of 6+ controls + audit prep | $3,500 |
Monthly Maintenance Fees
| Plan | Monthly Maintenance | Monthly Fee |
|---|---|---|
| Basic | Annual review support + quarterly record review | $200/month |
| Standard | Bi-monthly record review + email support + refresher updates | $450/month |
| Comprehensive | Monthly file review, retraining access, audit prep calls, and CAPA log reviews | $750/month |
Monthly Maintenance Coverage Includes
- • Ongoing recordkeeping compliance checks
- • Quarterly refresher training module updates
- • Corrective action guidance and feedback on implementation
- • Review of exception logs and supply-chain PC oversight
- • Email support for compliance questions and audit readiness
- • Alerts on regulatory updates impacting §117 Subpart C
Ideal For:
- • Facilities implementing or updating a FSMA-compliant food safety system
- • Contract manufacturers seeking to align with HARPC and PCQI best practices
- • QA Managers needing structured documentation for FDA or third-party audit readiness
- • Businesses managing high-risk or RTE foods requiring ongoing monitoring and proof of control