/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.
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/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.
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fda-qsr-audit-prep.SKILL.md
---name: "fda-qsr-audit-prep"
description: "/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."
---# /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) last revalidated per 21 CFR 820.75?
**Cross-walks ISO 13485 Clause 7.5.6 (substantially harmonized post-Feb 2026).**
- Initial validation at process introduction
- Revalidation triggers: process / equipment / material change OR periodic schedule
- Statistical techniques per 21 CFR 820.250 where applicable
- Cross-check with cs-cqm-iso13485 for ISO 13485 alignment
### 3. Show me the DHRs for products commercially distributed in last 2 years.
**21 CFR 820.180 — 2-year retention from commercial distribution; check sampling for completeness.**
- Device History Record (DHR) for each unit/lot/batch
- Must include: dates of manufacture, quantity manufactured, quantity released, acceptance records, primary identification label, device identification, control number
- Sample stratified by product class
- Verify DHR closeness to DHF (design history file)
### 4. Show me CAPAs from the last 6 months with effectiveness verification.
**21 CFR 820.100 = ISO 13485 8.5.2 substantially harmonized.**
- Root cause analysis depth (5 Why minimum)
- Effectiveness verification = measurable evidence, not "we updated the procedure"
