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- Medical Devices QMS
- Process
- Corrective action
Corrective action
A nonconformance connects the failed inspection to the quality response. Its severity and description frame the issue. The corrective action retains the root cause, approved action, owner, due date and completion date so the reviewer can assess the result.
Step by step
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Open issue Quality Reviewer
Quality Reviewer records the failed scope against the inspection and identifies its severity.
- Keeps the failed scope linked
- Updates Nonconformances, Inspections
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Contain and investigate Corrective Action Owner
The issue moves through containment and investigation while the owner identifies the cause.
- Grounds cause in the observed failure
- Updates Nonconformances, Inspection checks
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Plan action Corrective Action Owner
Corrective Action Owner records the planned action and due date against the issue.
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Approve action Quality Reviewer
Quality Reviewer decides whether that action should proceed.
ApprovalA person approves before the work moves on. -
Implement Quality Reviewer
Corrective Action Owner carries out the action and submits completion evidence for effectiveness review.
- Moves through effectiveness review to closure
- Updates Corrective actions
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Verify effectiveness Quality Reviewer
Quality Reviewer accepts effectiveness before closing the action.
ApprovalA person approves before the work moves on.
Who does what
Roles and permissions- Quality Reviewer
- Decides the action and effectiveness.
- Corrective Action Owner
- Investigates and implements.
- Inspector
- Supplies the inspection evidence.
Set up Medical Devices QMS your way.
Start free, then use Proto to change fields, steps and approvals before your team goes live.