Windchill CAPA Action Effectiveness
If the Effectiveness Required field is set to Yes for an action, the CAPA action verifier is responsible for providing details for the action effectiveness task.
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If any effectiveness measure indicates reoccurrence of the listed root cause inside the timeline for effectiveness monitoring, the CAPA record is marked ineffective and closed. An email is sent to the CAPA owner.
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As a CAPA action verifier, you are responsible for performing the following tasks to complete the Effectiveness state:
• Monitor effectiveness to ensure that the actions are getting the expected results
• Review the CAPA
• Close the CAPA
To begin a CAPA action effectiveness task, use the following procedure:
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At any time, you can click Save and continue working on the CAPA later.
Use the step navigator at the top of the screen to quickly move to a different step in the procedure.
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1. Right-click an action in an Effectiveness state and select Enter Effectiveness Details.
2. In the Enter Effectiveness Details window, most fields are automatically generated from previous workflow steps. Complete the remaining fields as necessary:
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Name
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Value
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Action ID
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The action ID specified in a previous workflow step.
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Action Type
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The action type specified in a previous workflow step.
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Primary Site
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The primary site specified in a previous workflow step.
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Effectiveness Approval Required
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The type of effectiveness approval specified in a previous workflow step.
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Effectiveness Start Date
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The effectiveness start date specified in a previous workflow step.
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Effectiveness End Date
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The effectiveness end date specified in a previous workflow step.
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Effectiveness Measure
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The effectiveness measure specified in a previous workflow step.
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Outcome
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Required. Use the list to select an Outcome:
• Effective: The proposed measure prevented the reoccurrence of the issue.
• Not Effective: The proposed measure did not prevent the reoccurrence of the issue.
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Effectiveness Comment
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Enter text to describe the effectiveness of the outcome, if necessary.
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3. Click Complete Task. The action is complete and moves to a Closure state. The action is visible in the Actions table but cannot be edited or canceled.
After all actions are completed, the CAPA moves to the Effectiveness state.