fda-qsr-audit-prep

原文涵盖的主题

• /compliance-os:fda-qsr-audit-prep — FDA QSR Forcing Questions
• When to Run
• The Six QSR Questions
• 1. Show me the complaint files from the last quarter — and the corresponding MDR reports.
• 2. When was process validation (IQ/OQ/PQ) last revalidated per 21 CFR 820.75?
• 3. Show me the DHRs for products commercially distributed in last 2 years.
• 4. Show me CAPAs from the last 6 months with effectiveness verification.
• 5. Show me labeling (21 CFR 801) review for the most recent product launch.

Command: /compliance-os:fda-qsr-audit-prep 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. 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) 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 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 Cro

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