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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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