FDA QSR Audit Prep

# /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 ```bash # 1. QSR compliance posture python ra-qm-team/skills/fda-consultant-specialist/scripts/qsr_compliance_checker.py compliance_state.json # 2. FDA submission tracking (510(k) / PMA / IDE) python ra-qm-team/skills/fda-consultant-specialist/scripts/fda_submission_tracker.py submissions.json # 3. HIPAA overlap (if connected device handles PHI) python ra-qm-team/skills/fda-consultant-specialist/scripts/hipaa_risk_assessment.py phi_inventory.json # 4. Mock FDA inspection python ../../skills/compliance-os/scripts/audit_simulator.py fda_qsr_scope.json ``` ## Output Format ```markdown # 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: <link to cs-cqm-iso13485 output> - FDA-specific overlays remaining: labeling + complaint handling + MDR reporting + recall procedures - Cross-framework reuse: % of evidence shared ## Verdict 🟢 INSPECTION-READY | 🟡 GAPS-IDENTIFIED | 🔴 NOT-READY ## Top 3 Actions [3 concrete next steps with owner + FDA-cited timeline (15 days / 30 days / etc.)] ## Outside Counsel Required [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 - Agent: [`cs-fda-qsr-auditor`](../../agents/cs-fda-qsr-auditor.md) - Skill: [`fda-consultant-specialist`](../../../ra-qm-team/skills/fda-consultant-specialist/SKILL.md) - Adjacent: `../iso13485-audit-prep/`, `../compliance-readiness/` --- **Version:** 1.0.0