Food Safety Plan Reanalysis & Update Service
Compliant with 21 CFR §117.170 — Food Safety Plan Reanalysis
Maintaining an up-to-date Food Safety Plan (FSP) is a regulatory requirement under 21 CFR §117.170, requiring facilities to conduct reanalysis whenever significant changes occur or at least once every three years to ensure the continued effectiveness of preventive controls, and this service provides structured, PCQI-led reanalysis and update support to ensure your Food Safety Plan remains compliant, validated, and audit-ready under the Food Safety Modernization Act (FSMA) Preventive Controls Rule.
Program Objective
The purpose of the Food Safety Plan reanalysis process is to:
- • Ensure ongoing effectiveness of hazard analysis and preventive controls.
- • Identify new or emerging food safety risks.
- • Align the Food Safety Plan with current operations and regulatory updates.
- • Provide defensible documentation for FDA inspections and audits.
- • Maintain PCQI oversight and certification of all reanalysis activities.
Scope of Work
Reanalysis Triggers & Conditions
Reanalysis is conducted under the following required and risk-based scenarios:
1. Scheduled Reanalysis (Every 3 Years)
The reanalysis process includes:
- • Comprehensive review of the entire Food Safety Plan.
- • Verification of continued hazard identification and control effectiveness.
- • Alignment with current operations, products, and processes.
2. Event-Triggered Reanalysis
Reanalysis is required under the following conditions:
- • Significant changes in facility operations, equipment, or processes.
- • Introduction of new products or ingredients.
- • Emergence of new hazard-related scientific or regulatory information.
- • Occurrence of unanticipated food safety events (e.g., contamination, recall, deviation trends).
- • Audit findings indicating gaps or non-conformances.
- • Determination that preventive controls are ineffective.
3. Regulatory or FDA-Directed Reanalysis
Regulatory-driven reanalysis includes:
- • Updates driven by new FDA guidance or regulatory changes.
- • Required modifications based on scientific developments.
- • FDA inspection findings or formal regulatory actions requiring plan updates.
Deliverables
- • Comprehensive gap assessment and risk-based evaluation of the existing Food Safety Plan.
- • Updated hazard analysis reflecting current risks and conditions.
- • Revision of preventive controls, monitoring, corrective actions, and verification procedures as needed.
- • Validation of new or modified preventive controls.
- • Documented reanalysis report with PCQI review and certification.
- • Justification documentation for reanalysis timelines (including cases exceeding 90 days from trigger event).
- • FDA inspection preparedness and compliance summary report.
Service Fee Structure
| Plan | Description | Monthly Fee |
|---|---|---|
| Standard | Scheduled triennial reanalysis support and PCQI oversight | $950/month |
| Premium | Includes mid-cycle reanalysis, validation updates, and FDA event response | $1,600/month |
| Enterprise | Custom plan for multi-site compliance, centralized PCQI, and multi-product reanalysis | Starting at $2,500/month |
This service ensures your food safety plan stays current, validated, and defensible during inspections.
Ongoing Program Support
- • Annual performance review of the Food Safety Plan.
- • Continuous monitoring of regulatory updates and emerging risks.
- • Trigger-based alerts for required reanalysis activities.
- • Scheduled consultation with a Preventive Controls Qualified Individual (PCQI).
- • Support for FDA-directed reanalysis and compliance response.
- • Integration with corrective action, training, and supply-chain programs.
Ideal For
- • Food facilities subject to FSMA Preventive Controls requirements.
- • Manufacturers undergoing operational changes or product expansion.
- • Facilities responding to audit findings, deviations, or food safety incidents.
- • Companies preparing for FDA inspections or maintaining audit readiness.
- • Multi-product or multi-site operations requiring centralized Food Safety Plan management.
