Why Mock Inspections Work
Even the most compliant companies get nervous before FDA visits. A mock inspection under QMSR conditions transforms anxiety into readiness. It exposes weak documentation, unclear ownership, and inconsistent communication—while there’s still time to fix them.
Think of it as a rehearsal with the lights on.
Designing a Realistic Simulation
- Scope Definition – Choose representative product lines, sites, and departments.
- Inspection Flow – Start with an opening meeting, facility tour, document requests, and interviews.
- Document Sampling – Pull CAPA, training, and supplier records at random.
- Behavioral Assessment – Observe how employees respond: confident or defensive?
- Exit Debrief – Deliver objective findings with clear grading (major/minor/observation).
Records the FDA Will Scrutinize
- Quality Manual and Medical Device Files
- Risk management reports and FMEAs
- Supplier evaluations and quality agreements
- Internal audit reports
- CAPA logs and trend analyses
- Management review minutes
These documents must not only exist but also tell a consistent story.
How to Strengthen Record Readiness
- Use consistent numbering and revision history.
- Keep sign-offs legible, dated, and justified.
- Link related documents through hyperlinks or indexes.
- Archive obsolete versions but ensure accessibility of the current one.
After the Mock Audit
Treat findings as CAPAs. Root-cause analysis may reveal systemic issues like unclear responsibilities or missing risk documentation. Verify corrections before the next inspection cycle.
The Payoff
Companies that rehearse reduce audit findings by up to 40%. Confidence replaces fear, and consistency replaces chaos.
Schedule a QMSR mock inspection with Compliance Insight—our experts replicate FDA expectations and leave you with a practical improvement plan. Contact us today!