Files
claude-skills-reference/ra-qm-team/.codex/instructions.md
Reza Rezvani ac845cf476 fix: add root-level SKILL.md and .codex/instructions.md to all domains (#301)
Root cause: CLI tools (ai-agent-skills, agent-skills-cli) look for SKILL.md
at the specified install path. 7 of 9 domain directories were missing this
file, causing "Skill not found" errors for bundle installs like:
  npx ai-agent-skills install alirezarezvani/claude-skills/engineering-team

Fix:
- Add root-level SKILL.md with YAML frontmatter to 7 domains
- Add .codex/instructions.md to 8 domains (for Codex CLI discovery)
- Update INSTALLATION.md with accurate skill counts (53→170)
- Add troubleshooting entry for "Skill not found" error

All 9 domains now have: SKILL.md + .codex/instructions.md + plugin.json

Closes #301

Co-Authored-By: Claude Opus 4.6 <noreply@anthropic.com>
2026-03-09 14:31:08 +01:00

1.3 KiB

RA/QM Skills — Codex CLI Instructions

When working on regulatory or quality management tasks, use the RA/QM skill system:

Routing

  1. Identify the domain: Regulatory (FDA/MDR), quality (ISO 13485), security (ISO 27001), or privacy (GDPR)
  2. Read the specialist SKILL.md for detailed instructions

Python Tools

All scripts in ra-qm-team/*/scripts/ are stdlib-only and CLI-first:

python3 ra-qm-team/risk-management-specialist/scripts/risk_matrix_calculator.py --help
python3 ra-qm-team/gdpr-dsgvo-expert/scripts/gdpr_compliance_checker.py --help

Key Skills by Task

Task Skill
FDA submissions regulatory-affairs-head
EU MDR compliance mdr-745-specialist
FDA 510(k)/PMA fda-consultant-specialist
ISO 13485 QMS quality-manager-qms-iso13485
QMS governance quality-manager-qmr
Risk management risk-management-specialist
CAPA management capa-officer
Document control quality-documentation-manager
ISO 13485 audits qms-audit-expert
ISO 27001 ISMS information-security-manager-iso27001
ISO 27001 audits isms-audit-expert
GDPR compliance gdpr-dsgvo-expert

Rules

  • Load only 1-2 skills per request — don't bulk-load
  • Always verify outputs against current regulations