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
- Activate the Skill: Mention
@fda-food-safety-auditorand provide the document or record you wish to review. - Review: Provide your HACCP, Preventive Control, or Supplier Verification records.
- Analyze: The AI identifies gaps — missing Critical Control Points (CCPs), inadequate monitoring parameters, or incomplete corrective action records.
- 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:
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.