PCQI Oversight & Verification Records Maintenance
Compliant with 21 CFR §§117.180 & 117.190 — PCQI Qualification & Recordkeeping
This service provides structured PCQI oversight and verification record management to ensure compliance with 21 CFR §117.180 and 21 CFR §117.190, ensuring that all required Food Safety Plan records, verification activities, and compliance documentation are properly maintained, reviewed, and audit-ready under the Food Safety Modernization Act (FSMA).
Program Objective
To establish and maintain a fully compliant PCQI oversight and records management system that:
- • Ensures all implementation records meet FDA Subpart F requirements
- • Provides documented PCQI review, verification, and sign-off
- • Maintains traceable and organized compliance documentation
- • Supports audit readiness for FDA and third-party inspections
- • Ensures continuous monitoring of preventive control effectiveness
Scope of Work
Core PCQI Oversight & Documentation Management
- • Creation, organization, and maintenance of all required implementation records, including:
- ◦ Hazard analyses and justification for controls not established
- ◦ Monitoring logs and trend analysis
- ◦ Corrective action reports and response timelines
- ◦ Validation studies and calibration records
- ◦ Product testing and environmental monitoring documentation
- ◦ Supply-chain verification records
- ◦ PCQI and auditor training documentation
- ◦ Food Safety Plan reanalysis justifications and audit trails
Verification Records & Compliance Monitoring
- • Ongoing review of records aligned with FSMA Subparts C, F, and G
- • Verification of preventive control implementation and effectiveness
- • Identification and correction of documentation gaps or inconsistencies
- • Maintenance of audit-ready documentation systems
Ongoing Maintenance & PCQI Support
- • Real-time document review and update tracking
- • Annual PCQI audit-readiness assessment and report
- • Quarterly review of training records and refresher tracking
- • Continuous monitoring of compliance documentation and verification activities
- • Secure digital recordkeeping aligned with FDA requirements
- • On-demand PCQI support for:
- ◦ New hazard evaluations
- ◦ Supply-chain events or changes
- ◦ Corrective action and verification guidance
Deliverables
- • Fully maintained implementation records aligned with FSMA requirements
- • PCQI-reviewed and verified documentation with audit trails
- • Monitoring, corrective action, and verification record logs
- • Training documentation and qualification records
- • Annual audit-readiness report and compliance summary
- • Organized digital or physical recordkeeping system
- • Ongoing compliance tracking and documentation updates
Ideal For
- • FDA-regulated food manufacturers and processors
- • Facilities requiring ongoing PCQI oversight and documentation control
- • Companies preparing for FDA inspections or third-party audits
- • Multi-site operations requiring centralized compliance record management
- • Businesses seeking to maintain continuous FSMA compliance without expanding internal QA resources
Program Value
- • Ensures complete and compliant recordkeeping under FSMA
- • Strengthens audit readiness through verified documentation
- • Reduces compliance risk with continuous PCQI oversight
- • Improves traceability and accountability across food safety systems
- • Supports long-term regulatory compliance and operational stability
Fees and Subscriptions
Service Fee Structure
| Plan | Description | Monthly Fee |
|---|---|---|
| Compliance Essentials | PCQI oversight, implementation records, training log management | $950/month |
| Audit-Ready Premium | Includes verification prep, auditor coordination, and mock FDA inspection support | $1,750/month |
| Multi-Facility Enterprise | Covers multiple sites, centralized record control, and annual audit program | Starts at $2,950/month |
