Preventive Controls Program Development
Compliant with 21 CFR §117.135 – Hazard-Based Preventive Controls
To develop, document, and implement risk-based Preventive Controls that significantly minimize or prevent hazards requiring control. This includes identifying Critical Control Points (CCPs) and implementing written controls tailored to the facility’s food safety system, in accordance with the Food Safety Modernization Act (FSMA).
Deliverables
1. Preventive Controls Identification & Implementation Plan
- • Evaluation of process flow to identify hazards requiring control
- • Determination of Critical Control Points (CCPs), if any
- • Development of controls other than CCPs (e.g., allergen, sanitation, supplier, etc.)
2. Written Preventive Controls Program
- • Required written procedures for each control type
- • Integration with the Food Safety Plan under §117.126
- • Facility- and product-specific control alignment
3. Process Controls
- • Development of procedures to manage critical parameters (e.g., time, temperature, pH)
- • Identification of minimum/maximum values required to control hazards
- • Sample documentation and monitoring forms
4. Food Allergen Controls
- • Assessment of cross-contact risks during receiving, storage, processing, and packaging
- • Label control protocols to prevent misbranding under §403(w)
- • Visual tools, signage, and staff procedures to maintain allergen segregation
5. Sanitation Controls
- • Procedures for cleaning/sanitizing food-contact surfaces and tools
- • Employee hygiene practices and contamination prevention
- • Cross-contact and cross-contamination mitigation protocols
6. Supply-Chain Controls
- • Integration of supply-chain program from Subpart G (§117.405–§117.475)
- • Identification of supply-chain-applied controls and supplier verification plans
7. Recall Plan Integration
- • Development or review of the written recall plan under §117.139
- • Clarification of triggers, roles, and traceability requirements
8. Other Controls
- • Development of Good Manufacturing Practice (GMP) based controls
- • Hygiene training protocols and verification processes
Fees and Subscriptions
Service Fee Structure
| Plan | Description | One-Time Fee | Included Support |
|---|---|---|---|
| Foundational Plan | Preventive Controls for 1 Product Line | $1,750 | Includes process, allergen, and sanitation controls |
| Standard Facility Package | Controls for Multi-Line Facility (Up to 5 SKUs) | $3,200 | Includes supplier controls, monitoring templates, and CCP documentation |
| Enterprise Compliance Suite | Facility-wide control systems + audit simulation | Custom Quote | Includes validation aid, training module, and recall plan development |
Ideal For:
- • FDA-regulated food facilities establishing a compliant Preventive Controls system
- • Contract manufacturers, private labelers, and co-packers seeking FSMA audit readiness
- • Facilities transitioning from HACCP to HARPC compliance
- • U.S. importers needing preventive control support under FSVP