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- Pharmaceuticals QMS
- Process
- Corrective action
Corrective action
Link a remedy to the source issue, record owner completion and review effectiveness independently.
Step by step
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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
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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
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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. -
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
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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. -
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
Who does what
Roles and permissions- Corrective Action Owner
- Performs the remedy; Quality Reviewer approves and verifies; Inspector supplies the source inspection evidence.
Set up Pharmaceuticals QMS your way.
Start free, then use Proto to change fields, steps and approvals before your team goes live.