Determine product classification and system scope
Confirm which products and activities are included in the FSSC 22000 scope and whether products are conventional foods or dietary supplements under FDA law.
Use supplier management to support ingredient control
Maintain supplier approval, ingredient specifications, risk assessments, change notifications, and traceability records. Ensure supplier controls address actual safety and regulatory risks.
Evaluate dietary ingredient eligibility
For supplements, assess whether ingredients meet applicable statutory requirements and whether NDI notification provisions may apply. Certification status does not establish ingredient eligibility.
Maintain product and process documentation
Ensure specifications, manufacturing records, traceability, change control, and nonconformity records reflect the product category and applicable regulatory requirements.
Integrate corrective action and management review
Investigate ingredient or supplier deficiencies, identify root causes, assign actions, and verify effectiveness. Escalate regulatory concerns through appropriate quality and regulatory personnel.
Keep certification and regulatory audits distinct
Prepare evidence for the applicable certification scheme while maintaining separate records demonstrating compliance with FDA dietary supplement requirements.
How Consultare Inc. Group Can Help
Consultare can assist with FSSC 22000 readiness, FSMS development, supplier assurance, traceability, internal audits, corrective action, and continual improvement for eligible operations. Dietary supplement Part 111 and ingredient-regulatory needs should be assessed separately.
Free Consultation
Need Help Managing Your FSSC 22000 Responsibilities?
Whether you are reviewing ingredient eligibility, supplier documentation, quality systems, or regulatory responsibilities, request a free consultation through FoodSafetySystems.co. Discuss your products, suppliers, documentation, and compliance priorities with the Consultare team.
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.