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- Manufacturing QMS
- Process
- Nonconformance and Correction
Nonconformance and Correction
Contain rejected inspection scope, approve corrective work and test effectiveness.
Step by step
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Reject failed scope Reviewer
Reviewer examines the inspection checks, rejects the affected scope and creates a linked containment Nonconformance.
- Rejected inspection and linked issue
- Updates Inspections, Inspection checks, Nonconformances
ApprovalA person approves before the work moves on. -
Contain failure Quality Manager
Quality Manager records the issue description and severity, then moves it through containment toward investigation.
- Affected issue tracked through containment
- Updates Nonconformances
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Investigate cause Corrective Action Owner
Corrective Action Owner reads the inspection and issue, records root cause and proposes an action linked to the Nonconformance.
- Root cause and proposed remedy recorded
- Updates Corrective actions, Nonconformances
-
Approve action Quality Manager
Quality Manager reviews the proposed remedy before the owner implements it.
- Action plan accepted for implementation
- Updates Corrective actions
ApprovalA person approves before the work moves on. -
Submit implementation Corrective Action Owner
Corrective Action Owner retains the approved action and submits implementation details for effectiveness review.
- Implemented work enters effectiveness review
- Updates Corrective actions
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Verify effectiveness Quality Manager
Quality Manager tests whether the action addressed the issue and accepts closure only after every linked action is accepted.
- Accepted actions close; issue closes when all are accepted
- Updates Corrective actions, Nonconformances
ApprovalA person approves before the work moves on.
Who does what
Roles and permissions- Reviewer
- Makes the inspection decision.
- Quality Manager
- Directs issue disposition and approves action and effectiveness.
- Corrective Action Owner
- Investigates and submits implementation details.
- Inspector
- Supplies source observations.
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