fda-qsr-audit-prep

name: "fda-qsr-audit-prep" description: "/cs:fda-qsr-audit-prep — 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"
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

Agent: cs-fda-qsr-auditor
Skill: fda-consultant-specialist
Adjacent: ../iso13485-audit-prep/, ../compliance-readiness/

Version: 1.0.0