65 lines
3.0 KiB
Markdown
65 lines
3.0 KiB
Markdown
---
|
|
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.
|