1. Pharmaceuticals QMS
  2. Process
  3. Corrective action
Process · Corrective action

Corrective action

Link a remedy to the source issue, record owner completion and review effectiveness independently.

Step by step

  1. Record nonconformance Quality Reviewer

    Quality Reviewer links the issue to its source Inspection and records detection date, severity and description.

    • Preserves the source issue and severity
    • Updates Nonconformances, Inspections
  2. Plan correction Corrective Action Owner

    Corrective Action Owner documents root cause, action and due date in a record linked to that issue.

    • Records cause, remedy, owner and due date
    • Updates Corrective actions, Nonconformances
  3. Approve the action Quality Reviewer

    Quality Reviewer approves the remedy before implementation.

    • Moves reviewed plan toward implementation
    • Updates Corrective actions
    ApprovalA person approves before the work moves on.
  4. Complete corrective action Corrective Action Owner

    The Owner performs the remedy and submits the completion date against their People identity.

    • Attributes completion to the assigned owner
    • Updates Corrective actions, People
  5. Verify effectiveness Quality Reviewer

    A Quality Reviewer who is independent of the Owner tests the result against the original inspection. Failed verification returns the action to implementation.

    • Accepts or returns the action
    • Updates Corrective actions, Inspections
    ApprovalA person approves before the work moves on.
  6. Close parent issue Quality Reviewer

    Quality Reviewer closes the nonconformance after every linked corrective action has been accepted.

    • Closes only after linked actions pass
    • Updates Nonconformances, Corrective actions
Corrective Action Owner
Performs the remedy; Quality Reviewer approves and verifies; Inspector supplies the source inspection evidence.

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Start free, then use Proto to change fields, steps and approvals before your team goes live.

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