1. Pharmaceuticals QMS
  2. Process
  3. Audit and finding review
Process · Audit and finding review

Audit and finding review

Plan an audit, document each finding and follow its owner and due date after reporting.

Step by step

  1. Plan audit Auditor

    Auditor records scope, planned date and their People assignment under an audit number.

    • Sets scope, date and auditor
    • Updates Audits, People
  2. Conduct audit Auditor

    Auditor moves the audit into progress and examines the defined scope.

    • Tracks audit progress
    • Updates Audits
  3. Record findings Auditor

    Auditor links each requirement and finding to the audit and assigns severity, Owner and due date.

    • Attributes requirement, severity and owner
    • Updates Audit findings, Audits, People
  4. Prepare report Auditor

    Auditor compares the finding list with the examined scope while the audit is in reporting.

    • Brings findings into reporting review
    • Updates Audits, Audit findings
  5. Follow closure Quality Reviewer

    Quality Reviewer checks finding owners, due dates and closure dates even after the audit itself is closed.

    • Shows due dates and closure dates together
    • Updates Audit findings, Audits
Auditor
Conducts the audit; Quality Reviewer follows findings; Document Controller supplies relevant controlled versions and acknowledgment history.

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