Windchill CAPA Investigations

Additional Windchill Capabilities > Windchill Quality Management Solutions > The Windchill CAPA Process > 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

• 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.

Set Attributes

1. Under Attributes, enter information in the following fields.

Field	Description
Name	Required. Enter a name for the investigation.
Action Required	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.

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.

◦ Click the edit affected object icon

to open the Edit Affected Objects window where you can add, remove, and edit affected objects.

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.

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 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.

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.