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Risk Triage Tool

NOTE

Describe the issue as much as possible!

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No name, reference or document required.

Our Values

Describe the issue as much as possible!

For best results: (examples provided)!


  1. Issue description (foreign particle)
  2. Potential impact (non-compliance)
  3. Evidence status (Verifiable with QC records/Not verifiable)
  4. Current control in place (what you did? quarantine)
  5. History (repeat occurrence yes/no)
  6. Responsible Unit (QC)
  7. Required Deadline (your plan)
  8. Supporting Evidence (records)
  9. Applicable Standard/Region (ISO 9001, ICH Q9)

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