Preventive Controls Program Development

Compliant with 21 CFR §117.135 — Hazard-Based Preventive Controls

A compliant Preventive Controls Program is a core requirement of a Food Safety Plan under 21 CFR §117.135, ensuring that identified hazards are effectively controlled through risk-based, scientifically supported measures, and this service provides a structured, PCQI-led approach to developing and implementing preventive controls aligned with the Food Safety Modernization Act (FSMA), fully integrated into your overall Food Safety Plan.

Program Objective

To develop and implement a comprehensive Preventive Controls Program that:

• Identifies hazards requiring control based on hazard analysis
• Establishes risk-based preventive controls tailored to products and processes
• Defines monitoring, corrective action, and verification requirements
• Ensures compliance with FSMA Preventive Controls regulations
• Maintains audit-ready documentation for FDA inspections

Deliverables

1. Preventive Controls Identification & Implementation Plan

• Evaluation of process flow to identify hazards requiring preventive controls
• Determination of Critical Control Points (CCPs) where applicable
• Development of additional controls, including:
- ◦ Allergen controls
- ◦ Sanitation controls
- ◦ Supply-chain controls
• Alignment with facility operations and product risks

2. Written Preventive Controls Program

• Development of required written procedures for each control type
• Integration with the Food Safety Plan under 21 CFR §117.126
• Customization based on facility processes and product categories

3. Process Controls

• Development of procedures to manage critical process parameters, including:
- ◦ Time and temperature
- ◦ pH and water activity
• Establishment of minimum and maximum critical limits
• Monitoring forms and documentation templates

4. Food Allergen Controls

• Assessment of allergen cross-contact risks across all operations
• Development of label control procedures to prevent misbranding under FD&C Act Section 403(w)
• Implementation of visual controls, segregation practices, and staff procedures

5. Sanitation Controls

• Procedures for cleaning and sanitizing food-contact surfaces and equipment
• Employee hygiene and contamination prevention protocols
• Controls to prevent cross-contamination and environmental risks

6. Supply-Chain Controls

• Integration of supply-chain program requirements under Subpart G
• Identification of supply-chain-applied controls
• Development of supplier approval and verification procedures

7. Recall Plan Integration

• Development or review of recall procedures in accordance with 21 CFR §117.139
• Definition of recall triggers, responsibilities, and communication protocols
• Integration with traceability and product disposition systems

8. Additional Preventive Controls & GMP Integration

• Development of GMP-based operational controls
• Hygiene and training procedures for personnel
• Verification processes to ensure consistent implementation

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