PCQI-Managed Compliance Per Product SKU
Regulatory Reference: 21 CFR Part 117 – Hazard Analysis and Risk-Based Preventive Controls for Human Food
This SKU-based PCQI Compliance Bundle delivers tailored food safety documentation and PCQI oversight per finished product SKU. Ideal for brands managing multiple products, our service ensures each SKU is backed by a compliant food safety plan, risk-based hazard analysis, and preventive controls that meet FDA requirements under FSMA.
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