/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