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
- • Hazard identification for each individual SKU, including:
- ◦ Biological hazards
- ◦ Chemical hazards (including allergens)
- ◦ Physical hazards
- • Evaluation of formulation, processing methods, packaging, and storage conditions
- • Risk-based assessment aligned with FSMA requirements
2. Product-Based Food Safety Plan (Per SKU)
- Development of a complete Food Safety Plan per product, including:
- • Product description and intended consumer profile
- • Ingredient review and process flow analysis
- • Hazard analysis with preventive control determinations
- • Allergen control and sanitation considerations
- • Documentation aligned with regulatory requirements
3. SOP & Recordkeeping System (Per SKU)
- • Development of SOPs aligned with SKU-specific processes
- • Monitoring, corrective action, and verification templates
- • Documentation covering:
- ◦ Traceability and lot tracking
- ◦ Label control and compliance
- ◦ Sanitation and allergen cross-contact prevention
- • Structured records designed for audit readiness
4. Ongoing PCQI Oversight
- • Continuous review and oversight by a Preventive Controls Qualified Individual (PCQI)
- • Verification of preventive controls and monitoring activities
- • Ongoing updates to hazard analysis and documentation as needed
- • Regular communication and compliance support
5. Team Training & Implementation Support
- • Product-specific onboarding training for QA and production teams
- • Refresher training aligned with SKU-level compliance requirements
- • Guidance on implementation of SOPs and recordkeeping practices
Deliverables
- • FDA-compliant Hazard Analysis Report for each SKU
- • Product-specific Food Safety Plan
- • SOPs and controlled records for implementation
- • PCQI oversight reports and compliance summaries
- • SKU-level compliance tracking logs
- • Optional digital compliance dashboard integration
Ideal For
- • Food and beverage brands managing multiple SKUs or product lines
- • Co-packers, private labelers, and contract manufacturers
- • Companies preparing for FDA inspections, distributor onboarding, or GFSI certification
- • Businesses requiring scalable, product-level food safety compliance systems
Program Value
- • Ensures consistent compliance across all product SKUs
- • Reduces regulatory risk through product-specific hazard control
- • Supports scalable growth as new products are introduced
- • Provides continuous expert oversight without expanding internal QA resources
- • Maintains audit-ready documentation for FDA and third-party inspections
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
