alirezarezvani/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

# 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

# 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
• Skill: fda-consultant-specialist
• Adjacent: ../iso13485-audit-prep/, ../compliance-readiness/

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Version: 1.0.0