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HARPC Food Safety Plan Reanalysis Checklist
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Guide the periodic reanalysis of a HARPC food safety plan, verifying triggers, hazard re-evaluation, and required updates under the Preventive Controls for Human Food rule.
21 CFR 117FSMA Preventive Controls
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Reanalysis Triggers
- Has the food safety plan been reanalyzed at least once every three years? *
- Was a reanalysis performed whenever a significant change in activities created a reasonable potential for a new hazard or increased a previously identified hazard? *
- Was the plan reanalyzed after new information about potential hazards associated with the food became available? *
- Was reanalysis triggered when a preventive control or the food safety plan was found to be ineffective? *
- Date reanalysis initiated
Hazard Re-Evaluation
- Was the hazard analysis reviewed for new biological, chemical, and physical hazards, including radiological and economically motivated hazards? *
- Were changes in raw materials, suppliers, and ingredients evaluated for new hazards? *
- Were process, equipment, and facility changes assessed for their impact on identified hazards? *
- Were consumer complaints, recalls, or illness data considered as inputs to the reanalysis?
Preventive Control Adequacy
- Were existing preventive controls confirmed to remain adequate for controlling identified hazards? *
- Were critical limits, monitoring, corrective actions, and verification procedures reviewed for continued suitability? *
- Were any new or revised preventive controls implemented as a result of the reanalysis?
Completion and Documentation
- Was the reanalysis completed within 90 days of production of the applicable food, or was a written justification for a longer timeframe prepared? *
- Was the reanalysis conducted or overseen by a preventive controls qualified individual (PCQI)? *
- Were plan revisions and the reanalysis outcome documented as records? *
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