feat: add fda-food-safety-auditor and fda-medtech-compliance-auditor skills

skills/fda-food-safety-auditor/SKILL.md

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+---
+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.

skills/fda-medtech-compliance-auditor/SKILL.md

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+---
+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.