Additional Windchill Capabilities > Windchill Quality Solutions > The Windchill CAPA Process > Windchill CAPA Reviews
  
Windchill CAPA Reviews
After a request has been entered and completed, the CAPA moves to the Review step. As a CAPA reviewer, you must screen CAPA requests for accuracy and adequacy before they can move on in the workflow. Once the CAPA is accepted, it is referenced throughout the system according to the CAPA number, not the request number.
As a CAPA reviewer, you are responsible for performing the following tasks:
• Accepting a request: The CAPA request becomes a CAPA and moves through the workflow.
• Canceling a request: The CAPA request is removed from the workflow.
• Rejecting a request: The CAPA request is returned to the requester.
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A rejected request can be submitted for review again.
To begin a CAPA review, use the following procedure:
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At any time, you can click Save and continue working on the CAPA later.
1. Right-click the CAPA to be reviewed and select Enter Review Details.
2. Complete the following fields in the Enter Review Details window:
Name
Value
Requested By
Displays the name of the requester or requester group.
Date File Opened
Displays the date the CAPA request was created.
Evaluation Outcome
Required. Select an outcome from the list:
• Accepted
• Canceled
• Rejected
Rejection Reason
Required if canceling or rejecting the request. Select a reason for the rejection from the list:
• CAPA already exists
• Does not meet CAPA criteria
• Duplicate Request
• Inadequate/Incomplete Information
Further CAPA Investigation Required
Required. This field defaults to Yes. Select Yes or No if further investigation is needed.
• If you select Yes, the Investigation step is added to the workflow.
• If you select No, the Action Plan step is added to the workflow.
Comments
Enter text as necessary.
3. Optionally, use the Actions table to add new actions or edit existing actions required by the CAPA. For more information, see Conducting an Action Plan Task.
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You cannot edit an action in the Actions table if the action is in an Implementation or Closure state.
You can edit the action plan on the CAPA Management tab in the Actions table or on the Structure tab by right-clicking the action. You can edit the action plan if the CAPA is not in a Closure or Effectiveness state.
To cancel an action, right-click the action and select Cancel Action to move the action to the Canceled state. If you are canceling an action, you must cancel it before the action reaches the Implementation state.
a. Click the edit action plan icon .
▪ To update the Action Type and Summary fields for an existing action, edit the fields in the Actions table in the Edit Details window.
▪ To update additional fields for an existing action, click the edit action icon . Complete the information in the Edit Action Details window and click OK.
▪ To add a new action, click the add row icon . Complete the information in the Edit Action Details window and click OK.
▪ To remove an action, select the action and click the remove row icon .
b. In the Edit Details window, click Finish.
4. Click Complete Task. The CAPA is saved and moves to the next workflow state. If the CAPA is accepted, it is assigned a CAPA number. If the CAPA is canceled, it is removed from the workflow.