• 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. |
Field | Description | ||
Number | The number is automatically generated from a previous step. | ||
Name | Enter the name for the action plan.
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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. |
Use the edit details icon to edit the following fields after an action type has been added to the table. |
Field | Description | ||
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.
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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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 . |
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. |