1. Manufacturing QMS
  2. Process
  3. Nonconformance and Correction
Process · Nonconformance and Correction

Nonconformance and Correction

Contain rejected inspection scope, approve corrective work and test effectiveness.

Step by step

  1. 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.
  2. 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
  3. 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
  4. 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.
  5. 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
  6. 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.
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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