diff --git a/skills/fda-food-safety-auditor/SKILL.md b/skills/fda-food-safety-auditor/SKILL.md new file mode 100644 index 00000000..7ccee96b --- /dev/null +++ b/skills/fda-food-safety-auditor/SKILL.md @@ -0,0 +1,57 @@ +--- +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." +--- + +# 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. diff --git a/skills/fda-medtech-compliance-auditor/SKILL.md b/skills/fda-medtech-compliance-auditor/SKILL.md new file mode 100644 index 00000000..6c1b93a1 --- /dev/null +++ b/skills/fda-medtech-compliance-auditor/SKILL.md @@ -0,0 +1,60 @@ +--- +name: fda-medtech-compliance-auditor +description: "Expert AI auditor for Medical Device (SaMD) compliance, IEC 62304, and 21 CFR Part 820. Reviews DHFs, technical files, and software validation." +--- + +# FDA MedTech Compliance Auditor + +## Overview + +This skill transforms your AI assistant into a specialized MedTech Compliance Auditor. It focuses on Software as a Medical Device (SaMD) and traditional medical equipment regulations, including 21 CFR Part 820 (Quality System Regulation), IEC 62304 (Software Lifecycle), ISO 13485, and ISO 14971 (Risk Management). + +## When to Use This Skill + +- Use when reviewing Software Validation Protocols for Medical Devices. +- Use when auditing a Design History File (DHF) for a software-based diagnostic tool. +- Use when ensuring IT infrastructure meets 21 CFR Part 11 requirements for electronic records. +- Use when preparing a CAPA (Corrective and Preventive Action) for a software defect. + +## How It Works + +1. **Activate the Skill**: Mention `@fda-medtech-compliance-auditor` and provide the document you wish to review. +2. **Specify the Standard**: State whether the focus is on Part 820, Part 11, ISO 13485, ISO 14971, or IEC 62304. +3. **Receive Findings**: The AI outputs specific audit findings categorized by severity (Major, Minor, Opportunity for Improvement) with regulatory citations. +4. **Correction Guidance**: Get actionable steps to resolve each finding and strengthen your audit readiness. + +## Examples + +### Example 1: CAPA Root Cause Review + +**Scenario:** A CAPA was opened for a software defect in a Class II device. The documented root cause is “developer error — unclear requirements.” The corrective action is developer retraining. + +**Finding:** + +```text +FDA AUDIT FINDING +Severity: Major +Citation: 21 CFR 820.100(a)(2) / IEC 62304 Section 5.1 + +Analysis: +"Developer error" is a symptom, not a root cause. Retraining alone is +a known red flag for FDA inspectors and will not withstand scrutiny. +The true root cause lies in the software requirements engineering +process itself — not an individual. + +Required Actions: +1. Perform a 5-Whys or Fishbone analysis targeting the requirements + gathering and review process. +2. Update the SRS (Software Requirements Specification) and the + corresponding process SOP. +3. Document an effectiveness check with a measurable criterion + (e.g., zero requirements-related defects in next 3 releases). +4. Do not close the CAPA on retraining alone. +``` + +## Best Practices + +- ✅ **Do:** Provide exact wording from SOPs, risk tables, or validation plans for the most accurate review. +- ✅ **Do:** Expect strict interpretations — the goal is to find weaknesses before a real inspector does. +- ❌ **Don't:** Forget to link every software defect to a clinical risk item in your ISO 14971 risk file. +- ❌ **Don't:** Assume "we tested it and it works" satisfies IEC 62304 software verification requirements.