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FSMA Preventive Controls Readiness Checklist
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Verify your food safety plan meets the FDA FSMA Preventive Controls for Human Food rule before an inspection or audit.
FSMAHACCP21 CFR 117
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Hazard Analysis
- Has a hazard analysis been conducted for each product/process? *
- Are biological, chemical, and physical hazards identified and evaluated? *
- Is the hazard analysis reviewed at least every 3 years or on change? *
Preventive Controls
- Are preventive controls identified for each significant hazard? *
- Are process, allergen, sanitation, and supply-chain controls documented? *
- Are critical limits defined and validated? *
Monitoring & Records
- Is monitoring performed and documented at the required frequency? *
- Are corrective actions procedures established and recorded? *
- Are verification and validation activities documented? *
Recall Plan
- Is a written recall plan in place for products with a hazard requiring a preventive control? *
- Are recall roles, notifications, and effectiveness checks defined? *
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