PCQI-Managed Compliance Per Product SKU
SKU-Based Food Safety Plan & Preventive Controls | 21 CFR Part 117
This SKU-based PCQI Compliance Program delivers tailored food safety documentation and ongoing oversight for each finished product, ensuring every SKU is supported by a compliant Food Safety Plan, hazard analysis, and preventive controls system aligned with 21 CFR Part 117, with each product evaluated independently to address specific risks, formulations, and processes under the Food Safety Modernization Act (FSMA).
Program Objective
To develop and maintain SKU-level food safety compliance systems that:
- • Address product-specific hazards and risk factors
- • Establish preventive controls tailored to each SKU
- • Ensure FDA-compliant documentation and recordkeeping
- • Provide continuous PCQI oversight and verification
- • Support audit readiness across multiple products and product lines
Scope of Work
1. SKU-Specific Hazard Analysis
- • Conduct hazard identification for each SKU
- • Address biological, chemical (including allergens), and physical risks
- • Assess formulation, processing, packaging, and storage conditions
2. Product-Based Food Safety Plan
- Develop FDA-compliant food safety plans (per SKU) including:
- • Product and consumer profile
- • Ingredient and process flow
- • Hazard analysis with preventive control determinations
- • Allergen and sanitation considerations
3. SOP & Recordkeeping Bundle per SKU
- • Develop SOPs linked to SKU-specific processes
- • Include monitoring, corrective action, and verification templates
- • Address traceability, label controls, sanitation, and allergen cross-contact
4. Monthly PCQI Oversight
- • Continuous monthly PCQI review for covered SKUs
- • Verification of controls, updated risk assessments, and documentation
- • Email support and quarterly strategy sessions
5. Team Training & Onboarding
- • Onboarding training for QA or production teams (product-specific)
- • Staff refresher materials aligned with SKU compliance needs
Deliverables
- • FDA-Compliant Hazard Analysis Report (per SKU) • Product-Specific Food Safety Plan • SOPs and Controlled Records for Implementation • PCQI Oversight Summary Reports (Monthly) • SKU Compliance Log (updated monthly) • Optional Access to InterlinkIQ Compliance Dashboard
Fees and Subscriptions
Base Package – First SKU
- • One-Time Setup: $895
- • Monthly Maintenance: $195/month
Additional SKUs
- • Setup Fee (Per Additional SKU): $695
- • Add-On Monthly Maintenance (Per Additional SKU):
- 1–3 SKUs: $145/month each
- 4–10 SKUs: $125/month each
- 11+ SKUs: Custom pricing available
Optional Add-Ons
- • HACCP/Food Safety Plan Development/Validation: $2500
Ideal For:
- • Food and beverage brands with expanding product lines
- • Co-packers, private labelers, and contract manufacturers
- • Businesses preparing for distributor onboarding, FDA audits, or GFSI certification
