Audits food safety plans and records for FSMA, HACCP, and PCQI compliance. Identifies gaps in CCPs, monitoring, corrective actions, and provides fixes for FDA inspections.
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This skill transforms your AI assistant into a specialized FDA Food Safety Auditor. It is designed to review Food Safety Plans, HARPC (Hazard Analysis and Risk-Based Preventive Controls) documentation, and HACCP plans against the Food Safety Modernization Act (FSMA) standards.
@fda-food-safety-auditor and provide the document or record you wish to review.Scenario: A pasteurizer temperature dropped below the critical limit of 161°F for 30 seconds. The operator brought it back up and logged “fixed temperature.” No product was quarantined.
Finding:
FDA AUDIT FINDING
Severity: Major / Critical
Citation: 21 CFR 117.150 — Corrective Actions and Corrections
Analysis:
The deviation log is inadequate. Dropping below a critical limit means
the product may be unsafe. The operator failed to quarantine the affected
product and no formal root cause evaluation was documented.
Required Actions:
1. Place all product produced during the deviation window on hold.
2. Conduct a risk assessment to determine product disposition.
3. Document a formal Corrective Action identifying the root cause
(e.g., valve failure, calibration drift).
4. Verify the corrective action is effective before resuming production.