Determine which FDA framework applies

Identify whether the facility processes fish or fishery products subject to Part 123 and whether other products or activities trigger additional Part 117 obligations. Do not assume every seafood facility needs a PCQI food safety plan for its seafood operations.

Conduct hazard analysis for each kind of seafood product

Evaluate species, process, intended use, and hazards reasonably likely to occur. Consider histamine, parasites, pathogen growth and toxin formation, and Clostridium botulinum in relevant reduced-oxygen packaged products.

Develop and implement seafood HACCP plans

Establish appropriate critical control points, critical limits, monitoring procedures, corrective actions, verification, and records in accordance with Part 123.

Implement monitoring and verification as written

Ensure trained personnel perform monitoring at the required frequency and that records accurately document the activity. A written plan without implementation is insufficient.

Establish appropriate corrective actions

Control affected product, evaluate safety, correct the cause of the deviation, and document actions. Generic instructions to make a note or discard product may not adequately address the cause.

Monitor sanitation under seafood HACCP requirements

Implement and document monitoring of applicable sanitation conditions and practices under 21 CFR 123.11, including relevant CGMP practices.

Assess PCQI requirements for other covered activities

Where a facility manufactures other foods subject to Part 117 preventive controls, assess whether a PCQI and written food safety plan are required for those activities.

Maintain records and reassess when needed

Keep hazard analyses, HACCP plans, monitoring, sanitation, corrective action, calibration, and verification records. Review changes in species, process, packaging, and intended use.

How Consultare Inc. Group Can Help

Your leading partner for seafood HACCP, preventive controls, and food safety planning.

Consultare Inc. Group is positioning itself as the world’s No. 1 choice for food safety, regulatory compliance, certification consulting, and quality management solutions. Our ambition is to set the global standard through practical expertise, integrated services, and technology-driven compliance support.

Consultare can support seafood HACCP plan development and review, species-specific hazard analysis, CCP monitoring procedures, corrective action development, sanitation monitoring, and regulatory framework assessments. For facilities with mixed seafood and non-seafood operations, Consultare can help distinguish Part 123 obligations from applicable Part 117 and PCQI requirements.

Free Consultation

Need Help Managing Your PCQI Responsibilities?

Whether you operate a seafood processing facility, handle multiple fish species, or need to determine whether PCQI requirements apply to your other food activities, request a free consultation through PCQIServices.com. Discuss your products, seafood HACCP plans, and FDA regulatory responsibilities. You can also create a free SystemsBuilder account to organize your compliance documentation and processes.

Start Building Your Compliance System

If you prefer to organize and manage your compliance activities yourself, you can also create a free SystemsBuilder account and begin building a structured system for your compliance documentation and processes