Monthly PCQI Oversight & Preventive Controls Compliance
Professionally Managed by Consultare Inc. Group Powered by PCQIServices.com
This fully managed, end-to-end monthly service provides food facilities with designated Preventive Controls Qualified Individual (PCQI) oversight and full regulatory compliance with 21 CFR Part 117.
Whether you’re a domestic manufacturer, co-packer, or private labeler, we ensure that your food safety program is active, audit-ready, and continuously aligned with FDA requirements.
Scope of Work
What’s Included – Standard Monthly Plan ($1,900/month)
✅ PCQI Designation & Oversight
- • Official PCQI designation for your facility
- • PCQI sign-off on food safety documentation
- • Representation during FDA audits (virtual support)
✅ Food Safety Plan Development & Management
- • Full development or review of a 21 CFR 117-compliant Food Safety Plan
- • Includes hazard analysis, preventive controls, recall plans, and verification procedures
- • Continuous updates as processes, products, or suppliers change
✅ SOPs & Recordkeeping System
- • Implementation and monthly review of Good Manufacturing Practices (cGMP) and process SOPs
- • Editable templates and documentation tools for monitoring, verification, and corrective actions
✅ Internal Audits & CAPA Support
- • Quarterly Internal Audit or Mock FDA Inspection (remote)
- • Identification of non-conformities and issue of CAPA reports
- • Ongoing support with implementation and tracking of corrective actions
✅ Monthly Compliance Review
- • Monthly call or virtual session with a PCQI specialist
- • Documentation check-in and compliance coaching
✅ Training & Refresher Support
- • Staff compliance coaching and onboarding orientation
- • Access to refresher training materials (cGMP, food safety, SOP practices)
- • PCQI-led coaching for QA and operations team
✅ Regulatory Monitoring & Alerts
- • Real-time updates on relevant FDA regulation changes
- • Risk alerts for recalls, outbreaks, or ingredient-specific concerns
- • Guidance for responding to FDA communications and inspection preparation
✅ Audit Readiness Support
- • Pre-audit document review and digital compliance dashboard prep
- • Virtual PCQI presence during audits (as requested)
- • Audit history analysis and CAPA response guidance
Deliverables
• PCQI Designation Letter
• Editable and validated Food Safety Plan
• SOP and Record Template Set
• Quarterly Audit Reports with CAPA logs
• Monthly Compliance Summary Report
• Access to Refresher Training Materials
• Regulatory Bulletins and Alerts
Fees and Subscriptions
Standard Monthly Plan – $1,900/month
- • Covers 1 facility and up to 10 product SKUs
Custom Quote Available For:
- • 11+ SKUs or multiple facilities
- • International supplier PCQI oversight
- • Integration with FSVP, U.S. Agent, and labeling services
Optional Add-On Services
| Service | Fee (USD) |
|---|---|
| Onsite PCQI Audit (U.S.) | $1,200/day + travel |
| New Label Compliance Review (per SKU) | $450 |
| FDA Mock Inspection (Full Remote Audit) | $2,000 one-time |
| Additional Food Safety Plan (per product line) | $950 |
Ideal For:
- • U.S. food processors, manufacturers, and co-packers
- • Private labelers and brand owners
- • Facilities lacking in-house PCQI expertise
- • Companies preparing for FDA, GFSI, or 3rd-party audits
- • Foreign facilities aiming for U.S. market compliance
Why Choose PCQIServices.com?
- ✔ Managed by Consultare Inc. Group, a trusted compliance firm
- ✔ Experienced PCQI specialists with audit and regulatory expertise
- ✔ Proactive compliance support and hands-on documentation management
- ✔ All-in-one solution with clear deliverables and monthly accountability