Windchill CAPA Investigations
When a CAPA is accepted and needs investigation, the CAPA moves to the Investigation state. The Investigation state serves as a summary of all investigation-related activities associated with the CAPA. As an investigator, you must determine whether further action is required. These actions can be added to the CAPA.
As a CAPA investigator, you are responsible for performing the following tasks:
• Add or update affected objects
• Enter risk assessment information
• Enter root cause information
• Enter conclusion information
To complete a CAPA investigation, navigate to your My Tasks table, right-click a CAPA in an Investigation state, and select Enter Investigation Details. Then complete the following steps:
1. Set Attributes
2. Risk Assessment
3. Conclusion
4. Set Attachments
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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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Set Attributes
1. Under Attributes, enter information in the following fields.
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Field
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Description
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|---|---|
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Name
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Required. Enter a name for the investigation.
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Action Required
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Required. Select Yes or No.
• If you select Yes, the system advances the CAPA to the Plan state.
• If you select No, the CAPA is completed and removed from the CAPA workflow.
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2. Under Affected Objects, review any information entered by the user who initiated the CAPA.
◦ Click the view details icon 
to learn more about the affected object.
to learn more about the affected object.◦ Click the edit affected object icon 
to open the Edit Affected Objects window where you can add, remove, and edit affected objects.
to open the Edit Affected Objects window where you can add, remove, and edit affected objects.3. Click Next.
Risk Assessment
Enter information in the following fields and click Next.
Field | Description |
|---|---|
Risk Assessment Required | Required. Select Yes or No. • If you select Yes, you must enter a risk assessment code. • If you select No, enter a description in the Risk Assessment Text field. |
Risk Assessment | Click the find icon  to select from a list of codes. |
Risk Assessment Text | Enter text as necessary to describe the risk assessment. |
Date Completed | Select the date the risk assessment was completed. Click the calendar icon  to select the date or enter the date manually using the MM/DD/YYYY format. |
Conclusion
1. Under Root Cause, enter information to track the root cause of the problem. Click the add icon 
to open a window from which you can select an external or internal issue.
to open a window from which you can select an external or internal issue.2. Under Conclusion enter information in the following fields:
Field | Description |
|---|---|
Root Cause Text | Enter text as necessary to describe each root cause for the entire investigation. |
Date Completed | Select the date the conclusion was completed. Click the calendar icon to select the date or enter the date manually using the MM/DD/YYYY format. |
Investigation Conclusion Text | Enter text as necessary to describe the conclusion of the investigation. |
3. Click Next.
Add Attachments
1. Use the Attachments table to add attachments to the investigation. 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. |
2. Click Complete Task. The CAPA is saved and moves to the next workflow state.