Food Safety Plan Development & Implementation
Compliant with 21 CFR §117.126 — Food Safety Plan Requirements
To establish and maintain a written and audit-ready Food Safety Plan (FSP) in compliance with 21 CFR §117.126 of the Preventive Controls for Human Food regulation. The service ensures the plan is developed or overseen by a Preventive Controls Qualified Individual (PCQI) and includes all required program components, monitoring systems, and recordkeeping protocols.
Deliverables
1. Written Food Safety Plan (FSP) Development
- • Created or reviewed by a certified PCQI
- • Includes signature/date log and version tracking
2. Hazard Analysis (as per §117.130)
- • Identification and evaluation of known or reasonably foreseeable hazards
- • Written analysis regardless of outcome
3. Preventive Controls (as per §117.135)
- • Identification and documentation of process, allergen, sanitation, and other applicable controls
- • Written preventive controls customized per product/process
4. Supply-Chain Program Integration (as per Subpart G)
- • Supply-chain-applied control determination
- • Supplier approval and verification planning
5. Recall Plan (as per §117.139)
- • Step-by-step procedures
- • Assigned responsibilities and communication protocols
6. Monitoring Procedures (as per §117.145)
- • Frequency and method of monitoring for each preventive control
- • Log templates included
7. Corrective Action Procedures (as per §117.150)
- • Defined action steps for implementation failure or non-conformance
- • Immediate correction vs. corrective action pathway
8. Verification Procedures (as per §117.165)
- • Documented reanalysis, calibration, product/environmental testing
- • Review schedules and PCQI oversight logs
9. Records Management Support
- • All FSP documents aligned with Subpart F recordkeeping requirements
- • Templates provided for required records (e.g., monitoring logs, verifications, signatures)
Fees and Subscriptions
Service Fee Structure
| Plan | Description | One-Time Setup | Monthly Maintenance |
|---|---|---|---|
| Core Compliance | Includes initial plan development for 1 facility with basic PCQI support | $2,500 | $750/month |
| Full Compliance Suite | Includes initial plan, monthly PCQI oversight, plan reanalysis, audit readiness | $3,800 | $1,250/month |
| Multi-Site Enterprise | Tailored for facilities with multiple locations or co-packing partners | Custom Quote | Custom Quote |
All plans include FDA inspection preparedness tools, editable templates, and annual plan reanalysis.
Ideal For:
- • U.S.-based or foreign food facilities seeking FSMA compliance
- • Startups and small processors building preventive controls from scratch
- • Co-packers and private labelers needing traceable, qualified programs
- • Companies under inspection risk or FDA 483 corrective orders