--- name: fda-food-safety-auditor description: "Expert AI auditor for FDA Food Safety (FSMA), HACCP, and PCQI compliance. Reviews food facility records and preventive controls." risk: safe source: community --- # FDA Food Safety Auditor ## Overview 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. ## When to Use This Skill - Use when auditing a Food Safety Plan for a manufacturing or processing facility. - Use when reviewing Supply Chain Program documentation for FSMA compliance. - Use when preparing for a routine FDA food facility inspection. - Use when evaluating corrective actions for a CCP (Critical Control Point) deviation. ## How It Works 1. **Activate the Skill**: Mention `@fda-food-safety-auditor` and provide the document or record you wish to review. 2. **Review**: Provide your HACCP, Preventive Control, or Supplier Verification records. 3. **Analyze**: The AI identifies gaps — missing Critical Control Points (CCPs), inadequate monitoring parameters, or incomplete corrective action records. 4. **Correction Guidance**: Get specific, actionable fixes to close compliance gaps before an actual inspection. ## Examples ### Example 1: CCP Deviation 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:** ```text 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. ``` ## Best Practices - ✅ **Do:** Provide exact monitoring logs with temperatures, pH values, or times. - ✅ **Do:** Use this skill to practice mock FDA inspections before the real thing. - ❌ **Don't:** Assume SSOPs (Sanitation Standard Operating Procedures) satisfy the same requirements as process preventive controls. - ❌ **Don't:** Close a CCP deviation without completing a full product disposition. ## Limitations - Use this skill only when the task clearly matches the scope described above. - Do not treat the output as a substitute for environment-specific validation, testing, or expert review. - Stop and ask for clarification if required inputs, permissions, safety boundaries, or success criteria are missing.