| 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. |
| compatibility | opencode |
/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"
- Containment / correction / corrective action distinction documented
- Closure approval by appropriate authority
- Aging CAPAs > 90 days flagged
5. Show me labeling (21 CFR 801) review for the most recent product launch.
FDA-specific overlay not in ISO 13485.
- Labeling per 21 CFR 801 requirements
- For specific device types: also 21 CFR 800 series sectoral overlays
- UDI (Unique Device Identification) per 21 CFR 830
- Promotional materials reviewed for accuracy + non-misleading
6. If a Form 483 was issued in the last 3 years, show me the closure status.
Form 483 = FDA observation; not equivalent to ISO nonconformity.
- Response within 15 working days
- Each observation has documented corrective + preventive action with timeline
- Effectiveness verification evidence
- For Warning Letters: separate response track + potentially FDA meeting
Workflow
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
Output Format
# FDA QSR Audit Prep: <scope>
**Date:** YYYY-MM-DD
## The Decision Being Made
[programme-plan | inspection-readiness | 483-response | MDR-decision | recall]
## Complaint + MDR Posture
- Complaints last quarter: N
- MDR-reportable events: M
- MDR reports filed within timeline: % (target 100%)
- Complaint trending review at management level: yes/no
## Process Validation Status (21 CFR 820.75)
- Validations on schedule: %
- Stale validations: <list>
- Statistical techniques applied: yes/no per process
## DHR Completeness (21 CFR 820.180)
- DHRs sampled: N
- Completeness rate: %
- 2-year retention compliant: yes/no
- Stratified by product class: yes/no
## CAPA Health (21 CFR 820.100)
- CAPAs sampled: N
- Root cause analysis depth: adequate/inadequate
- Effectiveness verification: complete/incomplete
- Aging CAPAs > 90 days: N
## Labeling (21 CFR 801)
- Recent products reviewed: <list>
- Labeling accurate + non-misleading: yes/no
- UDI compliance per 21 CFR 830: yes/no
## Form 483 / Warning Letter History
- Form 483s last 3 years: N (each: closed/in-progress)
- Warning Letters last 5 years: N (each: closed/in-progress)
- Pattern across observations: <thematic>
## ISO 13485 Cross-Walk (post-Feb 2026 harmonization)
ISO 13485 audit findings:
FDA-specific overlays remaining: labeling + complaint handling + MDR reporting + recall procedures
Cross-framework reuse: % of evidence shared
🟢 INSPECTION-READY | 🟡 GAPS-IDENTIFIED | 🔴 NOT-READY
[3 concrete next steps with owner + FDA-cited timeline (15 days / 30 days / etc.)]
[For Warning Letter response, recall decisions, or 510(k) / PMA strategy disputes]
Routing
/cs:compliance-readiness — for multi-framework view/cs:iso13485-audit-prep — for ISO 13485 cross-walk pair (substantially harmonized)/cs:gdpr-audit-prep — if connected device handles personal data/cs:gc-review — for Warning Letter response coordination
Related
Version: 1.0.0
