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HACCP Plan Verification & Validation Checklist

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Verify that a Hazard Analysis and Critical Control Point (HACCP) plan is complete, validated, and being executed against its seven principles.

HACCPCodex Alimentarius21 CFR 120

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Prerequisite Programs & Team

  • Is a multidisciplinary HACCP team assembled with documented product-specific knowledge and expertise? *
  • Is a full product description documented, including composition, packaging, and intended shelf life? *
  • Is the intended use and target consumer (including vulnerable populations) identified? *
  • Has the process flow diagram been constructed and verified on-site against actual operations? *
  • Are prerequisite programs (GMPs, sanitation, pest control) documented and functioning? *

Hazard Analysis (Principle 1)

  • Is a hazard analysis conducted for each process step covering biological, chemical, and physical hazards? *
  • Are allergens evaluated as a hazard within the analysis? *
  • Is the likelihood and severity of each hazard documented to justify whether it is significant? *
  • Are control measures identified for each significant hazard? *

Critical Control Points & Limits (Principles 2-3)

  • Are Critical Control Points (CCPs) determined using a decision tree or equivalent justified method? *
  • Are validated critical limits established for each CCP? *
  • Is scientific or regulatory support (validation study, process authority letter) on file for each critical limit? *
  • Number of CCPs identified in the plan

Monitoring & Corrective Action (Principles 4-5)

  • Does each CCP have a defined monitoring procedure specifying what, how, frequency, and who? *
  • Are monitoring records reviewed and signed by a qualified individual? *
  • Are predetermined corrective actions documented for each CCP deviation? *
  • Do corrective action records address product disposition and root cause of the deviation? *
  • Date of most recent CCP deviation reviewed

Verification & Recordkeeping (Principles 6-7)

  • Are verification activities (record review, calibration, sampling) scheduled and performed? *
  • Is the HACCP plan reassessed at least annually or when a process change occurs? *
  • Are monitoring instruments calibrated on a defined schedule with records retained? *
  • Are all HACCP records maintained and readily retrievable? *

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