sudabg 059f91f1a4 feat: add 5 production Python tools for RA/QM skills (#238) ...

Add comprehensive CLI tools for regulatory affairs and quality management:

1. regulatory-affairs-head/scripts/regulatory_pathway_analyzer.py
   - FDA/EU MDR/UK UKCA/Health Canada/TGA pathway analysis
   - Timeline & cost estimation, optimal submission sequence

2. capa-officer/scripts/root_cause_analyzer.py
   - 5-Why, Fishbone, Fault Tree analysis methods
   - Auto-generates CAPA recommendations

3. risk-management-specialist/scripts/fmea_analyzer.py
   - ISO 14971 / IEC 60812 compliant FMEA
   - RPN calculation, risk reduction strategies

4. quality-manager-qmr/scripts/quality_effectiveness_monitor.py
   - QMS metric tracking, trend analysis
   - Predictive alerts, management review summaries

5. quality-documentation-manager/scripts/document_version_control.py
   - Semantic versioning, change control
   - Electronic signatures, document matrix

All tools: argparse CLI, JSON I/O, demo mode, dataclasses, docstrings.

Closes #238

2026-03-13 22:26:03 +08:00

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