Supply-Chain Program Compliance Management for Receiving Facilities
Compliant with 21 CFR Part 117 Subpart G — Supply-Chain Program Requirements
This program provides a complete framework for establishing and maintaining a risk-based supply-chain program in accordance with 21 CFR Part 117 Subpart G, ensuring that raw materials and ingredients requiring supply-chain-applied controls are properly sourced, verified, and documented in compliance with the Food Safety Modernization Act (FSMA).
Program Objective
To develop and manage a compliant Supply-Chain Program that:
- • Ensures supplier controls are effective and properly verified
- • Establishes risk-based supplier approval and monitoring systems
- • Documents verification activities aligned with FSMA requirements
- • Supports FDA inspection readiness and audit defensibility
- • Maintains traceable and organized supplier compliance records
Deliverables
1. Written Supply-Chain Program
- • Development of a customized written program for raw materials and ingredients
- • Definition of supplier performance criteria and risk-based control procedures
- • Integration with the Food Safety Plan and preventive controls
2. Supplier Approval & Documentation System
- • Evaluation and documentation of supplier eligibility, including:
- ◦ Qualified facilities
- ◦ Farms and agricultural suppliers
- ◦ Shell egg producers and exempt entities
- • Development of supplier approval forms and compliance declarations
- • Annual re-evaluation templates and documentation
3. Supplier Verification Activity Management
- • Determination of appropriate verification activities, including:
- ◦ Onsite audits
- ◦ Product testing
- ◦ Document review and COA verification
- ◦ Risk-based scheduling and frequency planning
- • Documentation of verification outcomes and follow-up actions
4. Onsite Audit Coordination & Support
- • Identification of audit requirements for high-risk hazards (e.g., SAHCODHA hazards)
- • Coordination or support for audits conducted by qualified auditors
- • Provision of audit checklists and corrective action documentation templates
5. Third-Party Assurance & Supply Chain Review
- • Evaluation of verification activities conducted by upstream entities
- • Documentation of reliance on third-party controls where applicable
- • Verification records for controls applied outside direct supplier relationships
6. Alternative Verification Programs
- • Development of written assurance templates for qualified facilities and exempt suppliers
- • Recordkeeping systems for annual or biennial compliance requirements
- • Monitoring tools for exemption status and compliance tracking
7. Recordkeeping & Compliance Tracking System
- • Development of a structured recordkeeping system aligned with FDA Subpart F
- • Centralized tracking of:
- ◦ Supplier approvals
- ◦ Verification activities
- ◦ Non-conformances and corrective actions
- • Dashboard setup for real-time compliance monitoring and reporting
Fees and Subscriptions
Service Fee Structure
| Package | Description | One-Time Set-Up | Monthly Maintenance |
|---|---|---|---|
| Standard | Up to 5 suppliers and one production category | $1,900 | $950/month |
| Professional | Up to 15 suppliers and up to 3 production categories | $3,200 | $1,500/month |
| Enterprise | Unlimited suppliers and multiple categories | Custom Quote | Custom Quote |
Each plan includes document templates, compliance dashboard access, monthly support, and update services.
Ongoing Program Support
- • Food manufacturers or co-packers handling high-risk ingredients
- • Continuous supplier performance monitoring and documentation updates
- • Review of verification records and corrective action follow-up
- • Updates based on regulatory changes and FDA guidance
- • Support for FDA inspections and third-party audit preparation
- • Ongoing advisory for supplier risk management and compliance strategy
Ideal For
- • Food manufacturers or co-packers handling high-risk ingredients
- • U.S. importers managing multiple suppliers under FSVP requirements
- • Facilities outsourcing supplier verification and compliance management
- • Companies preparing for FDA inspections or GFSI-recognized audits
- • Multi-supplier operations requiring centralized compliance control systems
Program Value
- • Ensures full compliance with FSMA supply-chain program requirements
- • Strengthens supplier verification and risk management processes
- • Improves traceability and accountability across the supply chain
- • Enhances audit readiness with structured documentation and records
- • Supports scalable compliance for growing supplier networks
