Additional Windchill Capabilities > Windchill Quality Management Solutions > The Windchill CAPA Process > Action Plans > Conducting an Action Plan Task
Conducting an Action Plan Task
When a CAPA is investigated, the investigator determines if an action plan is necessary. Action plan tasks appear on the My Tasks table of your Home page if you are assigned to the appropriate role. Use the following procedure to conduct the action plan task:
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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.
1. From your My Tasks table, right-click a CAPA in a Plan state and select Enter Plan Details.
2. Under Attributes, enter information in the following fields:
Field
Description
Number
The number is automatically generated from a previous step.
Name
Enter the name for the action plan.
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When creating the plan, the name defaults to the CAPA name and a suffix. You can change the default value during plan creation if needed.
When editing the plan, the name is read-only. To rename the plan, go to the plan information page and use the Rename action.
Description
Enter text as necessary.
Approval Required
Required. Confirm whether an approval is needed for the plan.
• If you select Yes, an approval is required for the action plan by the CAPA plan approver.
• If you select No, an approval is not required for the action plan.
3. Under Actions, add actions to your action plan. Click the add row icon and complete the following fields:
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Use the edit details icon to edit the following fields after an action type has been added to the table.
Field
Description
Type
Required. Select the CAPA Activity type. If there are subtypes available for the CAPA Activity type, additional rows for the subtypes are displayed. Select the applicable subtype objects.
Action Type
Required. Select the action needed to correct the CAPA:
• Correction
• Corrective Action (Completed)
• Corrective Action (Planned)
• Preventive Action (Completed)
• Preventive Action (Planned)
• Supplier Corrective Action (Completed)
• Supplier Corrective Action (Planned)
For more information, see Internal and External Action Plan Owners.
Change Notice Required?
This field defaults to No. Select an option.
• If a change notice is not required, select No.
• If a change notice is required, select Yes. Select the objects needing a change notice from the Affected Objects table and complete the following fields:
◦ Change Notice Context—Select a context.
◦ Change Notice Type—Select a type.
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If you accessed the Edit Action Details window from the Structure tab, a change notice is not created even if you select Yes in the Change Notice Required field.
For more information, see Change Notices.
Summary
Enter text as necessary to provide a summary of the action needed.
Description
Enter details to describe the action required for the task.
Hold Until Plan Completed?
To release the action item before the plan is completed, select No. The system creates an action in the Implementation state. The action begins after you click Finish on the current state of the CAPA.
To hold the action item until the plan is completed, select Yes. The system creates an action in the Proposal state.
Confirmation Required
This field defaults to No. Select an option.
• If a confirmation is not needed, select No.
• If a confirmation is needed, select Yes. Complete the following fields:
◦ Confirmation Type—Select a confirmation type (Other, Repeat Action, or Visual).
◦ Confirmation Measure—Enter text as necessary to describe the evaluation method for this task.
For more information, see Windchill CAPA Action Confirmations.
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If you are the task owner, you can add additional confirmation measures until the task is marked complete. You can also add other types of confirmations.
Effectiveness Required?
This field defaults to No. Select an option.
• If effectiveness is not needed, select No.
• If effectiveness is needed, select Yes. Enter information in the following fields:
◦ Effectiveness Approval Required
▪ If you select Yes, the approval package is created for the plan. You must create the package and specify a CAPA action effectiveness approver for the plan.
▪ If you select No, the system does not create an approval package. Once the action plan is complete, the CAPA is closed.
◦ Effectiveness Start Date—Select a start date for the CAPA. Click the calendar icon to select the date the request must be completed. You can also enter the date manually using the YYYY-MM-DD format.
◦ Effectiveness End Date—Select an end date for the CAPA. Click the calendar icon to select the date the request must be completed. You can also enter the date manually using the YYYY-MM-DD format.
◦ Effectiveness Measure—Enter text as necessary to describe the evaluation method for this task.
For more information, see Windchill CAPA Action Effectiveness .
4. Click OK.
5. Click Next.
6. Use the Attachments table to associate any additional documents with the CAPA. The following table describes the available icons:
Icon
Description
Remove the selected attachment.
Add a local file attachment. Local file attachments are files that you upload from your local machine to Windchill.
Click Browse to select a file on your local machine. You can also drag and drop one or more files onto the action window to upload them as attachments.
For more information, see About Drag-and-Drop.
Add a URL attachment. URL attachments are hyperlinks to content stored on a website outside of Windchill. For example, this can be a wiki page or product help site.
Add an external storage attachment. External content attachments are items that cannot be attached as local files or URL links because they are physical objects or places. For example, this can be a three-dimensional item such as a product model or prototype, or highly sensitive data stored in a secure location. An externally stored content attachment describes the content and refers the user to its location.
7. Click Complete Task. The CAPA is saved and moves to the next workflow state.
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