fda-qsr-audit-prep
/cs:fda-qsr-audit-prep <scope> — FDA 21 CFR 820 (QSR / QMSR) audit 6-question forcing interrogation. Post-Feb 2026 substantially harmonized with ISO 13485. Use before annual internal QSR audit, pre-FDA-inspection readiness, or Form 483 response.
Profile →npx skills add alirezarezvani/claude-skills --skill fda-qsr-audit-prep --agent claude-code
Same command for any agent — swap --agent for codex, cursor, copilot.
Weekly change comes from our own snapshots, not the repository page — it measures attention, not adoption.
# /cs:fda-qsr-audit-prep — FDA QSR Forcing Questions **Command:** `/cs:fda-qsr-audit-prep <scope>` The FDA QSR auditor pressure-tests any US medical-device QSR work. Six questions before any internal audit, FDA inspection, Form 483 response, or recall decision. ## When to Run - Before annual internal QSR audit - Before pre-FDA-inspection readiness review (any device commercially distributed in US) - After receiving Form 483 observations - After Warning Letter receipt - After MDR-reportable event - Before recall decision (voluntary vs FDA-initiated) - Before submitting 510(k) / PMA (where QSR posture affects approval timeline) ## The Six QSR Questions ### 1. Show me the complaint files from the last quarter — and the corresponding MDR reports. **21 CFR 820.198 + 21 CFR 803 — most-cited FDA inspection area.** - Complaint log complete: who / what / when / device / batch - Investigation closure within reasonable timeline - MDR-reporting decision tree applied: death OR serious injury OR malfunction-that-could-cause = MDR - 30-day timeline for most MDR reports; 5 days for certain serious events - Complaint trending input to management review ### 2. When was process validation (IQ/OQ/PQ)
- When to Run
- The Six QSR Questions
- 2. When was process validation (IQ/OQ/PQ) last revalidated per 21 CFR 820.75?
- 3. Show me the DHRs for products commercially distributed in last 2 years.
- 4. Show me CAPAs from the last 6 months with effectiveness verification.
- 5. Show me labeling (21 CFR 801) review for the most recent product launch.
- 6. If a Form 483 was issued in the last 3 years, show me the closure status.
- Workflow
- Output Format
- Routing
- Related
python ra-qm-team/skills/fda-consultant-specialist/scripts/qsr_compliance_checker.py compliance_state.json python ra-qm-team/skills/fda-consultant-specialist/scripts/fda_submission_tracker.py submissions.json python ra-qm-team/skills/fda-consultant-specialist/scripts/hipaa_risk_assessment.py phi_inventory.json python ../../skills/compliance-os/scripts/audit_simulator.py fda_qsr_scope.json
What does the fda-qsr-audit-prep skill do?
/cs:fda-qsr-audit-prep <scope> — FDA 21 CFR 820 (QSR / QMSR) audit 6-question forcing interrogation. Post-Feb 2026 substantially harmonized with ISO 13485. Use before annual internal QSR audit, pre-FDA-inspection readiness, or Form 483 response.
How do I install it?
Run `npx skills add alirezarezvani/claude-skills --skill fda-qsr-audit-prep --agent claude-code` — it drops the skill into your project so the agent can pick it up. Swap the --agent value for codex, cursor or copilot if you use one of those.
Where does this skill come from?
From alirezarezvani/claude-skills, a repository with 23,791 stars. We read it straight from the repository tree rather than a submitted listing, so what you see here is what is actually published.
Is a popular skill a good skill?
Not necessarily. Stars measure attention, not adoption — a repository can trend for a week and be abandoned. That is why we show the weekly change from our own snapshots next to the total, instead of a single flattering number.