- Quality Basics: QMS User; QMS Owner: Deviation
When a Deviation is first created, Vault assigns a Complete Assessment task to the Deviation Owner.
For Minor Deviations, the Deviation record is managed in three (3) main stages: assessment, approval, and closure.
To assess a Minor Deviation:
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Access the Deviation from the assigned task.
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Click Edit, then review and update any deviation info as needed.
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Select Minor for the rating.
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Click the Impact & Risk Analysis section and enter details regarding the impact of the deviation and the risk analysis performed.
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Click the Investigation Summary & Conclusion section and enter the results of the investigation.
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Expand the Plan Details section.
- In the CAPA Required field, select whether a CAPA Action is required:
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Select Yes if a CAPA Action must be completed as a result of the deviation. The CAPA Actions section is displayed and at least one CAPA Action must be created before the Deviation can be approved and closed.
Note: At least one CAPA Action must be created before the Deviation can be approved and closed, and CAPA Actions can be added after the Deviation is saved.
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Select No if a CAPA Action is not required. In the Rationale for No CAPA field, enter the justification for why a CAPA Action is not required.
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- In the Effectiveness Check Required field, select whether an Effectiveness Check is required:
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Select Yes if an Effectiveness Check must be completed as a result of the deviation. The Effectiveness Checks section is displayed.
Note: At least one Effectiveness Check must be created before the Deviation can be approved and closed, and Effectiveness Checks can be added after the Deviation is saved.
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Select No if an Effectiveness Check is not required. In the Rationale for No Effectiveness Check field, enter the justification for why an Effectiveness Check is not required.
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Click Save to save the Deviation information
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To send the Deviation for approval, select the Complete verdict and click Complete. Vault updates the Deviation status to In Approval and assigns a Quality Approval task to the Deviation QA Approver.
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To request cancellation of the Deviation, select the Request Cancellation verdict, enter the Cancellation Reason, and click Complete. Vault changes the Deviation status to Pending Cancellation and assigns an Approve Deviation Cancellation task to the QA Approver.
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To request cancellation of the Deviation, select the Request Cancellation verdict, enter the Cancellation Reason, and click Complete. Vault changes the Deviation status to Pending Cancellation and assigns an Approve Deviation Cancellation task to the QA Approver.
