Description:
This log captures and tracks external audit findings from identification through closure so we can maintain an auditable trail of decisions, actions, and objective evidence.

• Assign a unique Finding ID and record Audit date and auditor/source for traceability

• Document the finding Description and map it to the applicable Requirement/Clause

• Classify severity using Grading (major/minor) and record Risk/impact notes where relevant

• Define Correction and the linked CAPA reference (or document why CAPA is not required)

• Set Owner and Due date to control accountability and timely follow-up

• Track Status (open/in progress/closed) with key milestones and completion dates

• Capture Closure evidence and an Effectiveness check outcome before final closure

This external audit finding log is used immediately after an external audit to centralize findings, drive consistent responses, and maintain revision-safe traceability from nonconformity to closure.

At Lexqara, we help you operationalize audit response workflows, strengthen CAPA traceability, and embed the log into QMS routines (audits support, training, and inspection readiness). Use our Resource Center [https://lexqara.com/resource-center] and Audits & Training [https://lexqara.com/services/audits-training], and align expectations with the European Commission medical devices sector overview [https://health.ec.europa.eu/medical-devices-sector_en]. Download the template and request a short gap assessment.