1. Medical Devices QMS
  2. Process
  3. Audit follow-up
Process · Audit follow-up

Audit follow-up

An audit carries the scope, schedule, auditor and status of the review. Findings give each requirement issue its own description, severity, due date and owner. The relationship keeps follow-up work in the audit that discovered it.

Step by step

  1. Plan audit Auditor

    Auditor records the number, scope, planned date and assigned auditor.

  2. Perform review Quality Reviewer

    The audit moves into in progress as the auditor works through its scope.

  3. Record findings Auditor

    Auditor adds requirement findings, severities, owners and due dates beneath the audit.

    • Connects each requirement issue to the audit
    • Updates Audit findings, Audits
  4. Report audit Auditor

    Auditor moves the audit to Reporting and shares the findings with their owners.

  5. Follow up Auditor

    Each owner addresses their finding; the closed date records its resolution.

    • Makes owner and due date visible
    • Updates Audit findings, People
  6. Record closure Auditor

    Auditor records the completed audit state after checking the findings.

    • Keeps the completed audit and findings together
    • Updates Audits, Audit findings
Auditor
Plans and reports the audit.
Quality Reviewer
Examines follow-up and closure.
Admin
Manages access to people records.

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