Audit and Inspection Preparation Template

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Proper preparation for audits and inspections is crucial in the medical device industry to maintain regulatory compliance and avoid costly penalties. This template helps you organize and prioritize tasks related to audits and inspections, ensuring all necessary actions are taken on time.

From reviewing previous audit reports to conducting internal audits and preparing for external ones, this template provides a comprehensive guide to managing all critical tasks efficiently. Stay on top of deadlines and regulatory requirements with ease.

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Audit and Inspection Preparation for Priority Matrix

Audit and Inspection Preparation in Priority Matrix

Ensure timely and organized preparation for audits and inspections in the medical device industry.

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Proposed Tasks

High Impact, Urgent

  • Task 1: Review Previous Audit Reports (due in 1 day)
    ☐ Identify common findings ☐ Prepare corrective actions
  • Task 2: Update Compliance Manuals (due in 1 week)
    ☐ Review recent regulatory changes ☐ Update procedures
  • Task 8: Review and Update Risk Management Plan (due in 1 week)
    ☐ Review current plan ☐ Update plan with recent changes
  • Task 5: Prepare for External Audit (due in 1 month)
    ☐ Review audit schedule ☐ Prepare necessary documents

High Impact, Not Urgent

  • Task 3: Train Staff on Regulatory Changes (due in 2 weeks)
    ☐ Prepare training materials ☐ Conduct training sessions
  • Task 7: Conduct Mock Inspection (due in 2 weeks)
    ☐ Prepare inspection plan ☐ Conduct mock inspection ☐ Prepare inspection report
  • Task 10: Review and Update Device Master Records (due in 2 weeks)
    ☐ Review current records ☐ Update with recent changes
  • Task 4: Conduct Internal Audit (due in 3 weeks)
    ☐ Prepare audit plan ☐ Conduct audit ☐ Prepare audit report

Low Impact, Urgent

  • Task 6: Review Inspection Checklist (due in 2 days)
    ☐ Review and update checklist ☐ Distribute updated checklist to relevant departments
  • Task 9: Update Quality System Documentation (due in 3 days)
    ☐ Review current documentation ☐ Update with recent changes