CAP · Inspection Prep
CAP Inspection Readiness: A 90-Day Checklist
CAP inspections are unannounced within a window. Labs that treat inspection readiness as a continuous discipline — not a scramble — consistently outperform those that don't. This checklist gives you a 90-day framework.
TL;DR — CAP Readiness Snapshot
- CAP inspections are unannounced within a defined window — readiness must be continuous, not a pre-inspection scramble.
- Start remediation 90 days out: most documentation fixes (SOP updates, CAPA closure, competency records) take 4–8 weeks done properly.
- The most underestimated task is CAPA closure — open corrective actions without a documented effectiveness check take longer to close than labs expect.
- The 10-point checklist covers SOPs, competency assessments, QC logs, CAPAs, proficiency testing, test menu alignment, critical values, reference lab agreements, calibration records, and a mock inspection.
90-Day CAP Inspection Readiness Checklist
- Review and update all SOPs — verify currency, signatures, and version history
- Confirm all personnel competency assessments are current and on file
- Audit QC logs for completeness and corrective action documentation
- Close all open CAPAs or document an accepted risk rationale
- Review proficiency testing enrollment and documentation
- Verify test menu matches documented procedures and personnel qualifications
- Confirm critical value notification logs are complete
- Review reference laboratory agreements and documentation
- Audit instrument maintenance and calibration records
- Conduct a mock inspection with a sample of records
Why 90 days?
Most documentation remediation — updating SOPs, closing open CAPAs, completing competency records — takes 4–8 weeks when done properly. Starting at 90 days gives you time to identify gaps, remediate them, and verify closure before the inspection window opens.
Where most labs underestimate the work
The most common underestimation is in CAPA closure. Labs often have open corrective actions with no documented effectiveness check — and closing them properly takes more time than expected. Start there first.