Creating a New CAPA Request
To create a new CAPA request, click the new CAPA request icon 
from one of the following locations:
from one of the following locations:• Home 
page
pageThe New CAPA Request window appears. Complete the following steps:
1. Set Attributes
2. Set Attachments
3. Select Associations
 | • At any time, you can click Save and continue working on the request later. The request moves to an Intake state. To edit the item, right-click the Update CAPA Request task, select Enter Request Details, and complete the rest of the information. Click Complete Task to move the request to the evaluation workflow state. • If you cannot save the record, verify that your administrator has removed the required attributes from the Reference Record Type and Reference Record ID fields. • Use the step navigator at the top of the screen to quickly move to a different step in the procedure. |
Set Attributes
In the Set Attributes step, use the following procedure:
1. Under Attributes, enter values for all relevant attributes, including:
Attribute | Description |
|---|---|
Requested By | The initiator of the request. This name is automatically generated. |
Date File Opened | The date and time the CAPA request was opened. This information is automatically generated. |
Name | Required. The name of the CAPA request. |
Number | The number of the CAPA request. This number is automatically generated. |
Subject Type | Required. Use the Subject Type list to classify the CAPA request by type. • Product • Process • Personnel • Documentation • Supplier • Other |
Source Type | Required. Use the Source Type list to classify the CAPA request by source. • Audit Finding • CAPA • Complaint • Management Review • Nonconformance • Sales/Marketing • Trend • Other |
Control Authority | Required. The authority who owns the CAPA. Use the list to select the control authority who owns the CAPA. • Corporate • Manufacturing • Quality Assurance • Research and Development |
Description | Enter text as necessary. |
Request Additional Information | Enter additional information about the CAPA. This field has unlimited text. The name of this field changes depending on the state of the CAPA. For example, the field appears as Review Additional Information in the review state, Investigation Additional Information in the investigation state, and so on. |
2. Under Investigation, select Yes or No for Investigation Completed. If you select Yes, you must complete the Reference Record Type and Reference Record ID fields.
Attribute | Description |
|---|---|
Reference Record Type | Use the Reference Record Type list to select the reference used to refer to this record type. This reference was provided in the completed investigation. • Audit Finding • CAPA • Complaint • Nonconformance • Other |
Reference Record ID | Enter a Reference Record ID number to associate with the CAPA request. |
3. Use the Site Information table to add the Primary/Origination Site for the CAPA request. This table is required. These sites represent the location where the CAPA was involved.
For more information, see Selected People and Places Table.
To add a site, do one of the following:
◦ Click the add sites icon 
to search for and add the site.
to search for and add the site.◦ Enter information in the Add by Alternate Identifier or Add by Name fields to add the site. Begin typing in the field. Sites matching the information entered appear in a list from which you can select a site.
4. Optionally, use the Related Personnel and Locations table to enter the names of people and places relevant to the subject of the CAPA request.
◦ If you enter information in this table, the Type, Name, and Primary fields are required for each row.
◦ Under the Primary column, select one person or place as primary by changing the value to Yes.
Icon | Description | ||
|---|---|---|---|
 | Add people and places that exist in your system. These are already loaded in the People and Places Administration utility in the current quality context. In the People and Place Picker window, search for and select one or more people and places.
| ||
 | Remove rows by selecting them and clicking the icon. | ||
 | Enter a free-form person or place that does not exist in the system. | ||
 | To save time entering similar new contacts, select one or more rows and click the icon to duplicate the selected rows into the table. For example, use this icon when the contact is the initial reporter but is also a patient. You can copy the contact and set the Type field to an additional value. | ||
 | Remove a row and replace a contact. For example, use this icon when a contact was originally entered as a free-form contact but was later added to the People and Places Administration utility, allowing the contact to be found in a search. You can replace the free-form contact with the new contact from the system. | ||
 | After you have added a row, enter additional information about the person or place. For example, if a contact has a Type of Patient, you can add more information, such as the age of a patient, to the Patient Details section of the Edit Details window. |
5. Optionally, use the Affected Objects table to add objects affected by this CAPA:
a. Do one of the following:
▪ Click the add affected objects icon 
to search for and add objects as needed.
to search for and add objects as needed.▪ Enter information in the Add by Number or Add by Name fields to add an object. Begin typing in the field and objects matching the information entered appear in a list from which you can select an object.
b. Complete the Type, Quantity and Unit fields in the table row. To enter additional information, click the edit details icon and complete the fields in the Edit Details window.
and complete the fields in the Edit Details window.Attribute | Description |
|---|---|
Type | Required. Select the CAPA Request Affected Objects type. If there are subtypes available for the CAPA Request Affected Objects type, additional rows for the subtypes are displayed. Select the applicable subtype objects. |
Number | The system automatically completes this field with the number of the object. |
Name | The system automatically completes this field with the name of the object. |
Unique Identifier (UDI) | Enter the unique identification number (if applicable). |
Other Lot/Batch Number | Enter the lot or batch number (if applicable). |
Purchase Order Number | Enter the purchase order number (if applicable). |
Supplier Number | Enter the supplier number (if applicable). |
Quantity | Required. Enter the quantity affected. |
Unit | Required. Select the unit type: • Box • Dozen • Each • Gross • Kit |
Manufactured Quantity | Enter the total quantity manufactured. |
Manufactured Unit of Measure | Select the unit type: • Box • Dozen • Each • Gross • Kit |
Manufactured From | Select the date that manufacturing started. |
Manufactured To | Select the date that manufacturing ended. |
Lot Controlled | Select Yes if the item is lot controlled. |
Enter Lot/Serial Range | Select Yes to enter a range. If you select Yes, complete the Lot/Serial From and Lot/Serial To fields, which replace the Lot/Serial Number field. |
Lot/Serial Number | Enter the lot or serial number. |
6. Optionally, use the Actions table to add actions required by the CAPA. For more information, see Conducting an Action Plan Task.
a. Click the add row icon .
.b. In the Edit Action Details window, select an Action Type. Optionally, complete the rest of the fields in the window.
| | Use the edit details icon to edit these fields after an action type has been added to the table. |
c. Click Finish.
7. Click Next.
Attachments
Use the Set Attachments page to add attachments to your request and click Next. The following table describes the icons available in the table:
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. |
Select Associations
1. In the Select Associations step, complete the Associated Process Objects table and the Associated Reference Objects table to link the CAPA to other objects. Available objects depend on the business rules defined in your system.
Do one of the following:
◦ Click the add icon to search for and add objects as needed.
to search for and add objects as needed.◦ Enter information in the Add by Number or Add by Name fields to add an object. As you type in the field, objects matching the information appear in a list from which you can select an object. You must enter a minimum of three characters for the list to appear.
◦ Click the paste icon 
or paste selection icon 
to paste objects from the clipboard.
or paste selection icon to paste objects from the clipboard. | For customers using a standalone Windchill Quality Management Solutions server, the functionality for flexible links is not available. The Select Association step does not appear on the windows for creating and editing CAPAs. These windows include the Associated Reference Objects and Associated Process Objects tables. |
2. Click Finish. The CAPA request is saved and moves to the next workflow state. Once the request is marked complete, users can only edit or cancel the request. To edit a new CAPA request, click Edit CAPA Request. For more information, see Editing a CAPA Request.