Audit Food Safety Plans Against FSMA Standards

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.

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.

Do not treat the output as a substitute for environment-specific validation, testing, or expert review. Use this skill only when the task clearly matches the scope described above.

Inputs:

• Food Safety Plan, HARPC documentation, HACCP plans, Supply Chain Program documentation, or specific records such as monitoring logs with temperatures, pH values, or times.

Outputs:

• Identification of gaps such as missing Critical Control Points (CCPs), inadequate monitoring parameters, or incomplete corrective action records.
• Specific, actionable fixes to close compliance gaps.
• Audit findings including severity, citation, analysis, and required actions.

This skill is designed to extend an AI assistant.

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.