CAPA Requests Page

This page lists the CAPA requests that you own or you created. This page is appears as a page tab on the CAPA and Audit Management home page.

To access this page:

  1. From the Compass, click Social and Collaborative Apps , and select My Social and Collaborative Apps > CAPA & Audit.
  2. Select the CAPA Requests tab.

This topic describes:

This page discusses:

Columns

Column Name Description
Name Name of the CAPA request. Click to view its details.
Status Status of the CAPA request.
Type Type of the CAPA request. Possible types are corrective and preventive.
StateState of the CAPA request. Possible states are Preliminary, Requested, Review, Approved, Committed, Fulfilled, and Not Approved.
Sev.Severity of the CAPA request.
TitleTitle of the CAPA request.
AgeNumber of days before which the CAPA request was created. The age is updated until the CAPA request reaches the Approved state or the Not Approved state.
Accept OwnershipClick to accept the CAPA request.
Note: This column appears only when the CAPA request is in the Requested state, you are a Quality Manager , and use the Unassigned filter.
Source TypeSources through which the problem was identified.
ScopeScope of the CAPA request.
Problem StatementDescription of the problem provided by the creator.
OriginatorName of the CAPA request creator. Click to view the details.
Transfer Notes is displayed if any message is available in the Reassignment Notes discussion thread. Point to to view the message.
Approval Route is displayed if a route is created for the review process. Click to view the details of the route.
OwnerName of the CAPA request owner. Click to view the details.
OrganizationName of the CAPA request owner's organization. Click to view the details.
CAPAName of the associated CAPA. Click to view its details.

Filters

Based on your role, you can use the following filters to filter the CAPA Requests page by states or statuses.

  • Assigned: This filter is available for all users. You can select this filter to view the CAPA requests you own that are in the Preliminary, Review, Approved, or the Committed state.
  • Unassigned: This filter is available only for Quality Manager s. You can select this filter to view the CAPA requests that are in the Requested state and are assigned to your organization.
  • Opened: This filter is available for all users. You can select this filter to view the CAPA requests you created that are currently in the Preliminary, Requested, Review, Approved, or the Committed state.
  • Closed: This filter is available for all users. You can select this filter to view the CAPA requests you created that are currently in the Not Approved state or the Fulfilled state.

CAPA requests marked as duplicate are displayed in the Assigned, Opened, and the Closed filter, based on the state of the corresponding master request.

Actions

Action DescriptionFor More Information
Submit for Review Promotes the selected CAPA requests from the Preliminary state to the Requested state. Submitting a CAPA Request for Review.
Accept Assigns you the selected CAPA requests.
Notes:
  • You must be a Quality Manager .
  • You can select only the CAPA requests that are in the Requested state. These requests are displayed when you select the Unassigned filter.
  • After they are assigned to you, the CAPA requests are moved to the Review state. In addition, a route object is created between the Review state and the Approved state.
--
Needs Information Sends the CAPA request back to the creator to obtain more information.

Type your comments and click Done.

Notes:
  • You must be a Quality Manager .
  • The selected CAPA request must be in the Review state.
--
Change OwnerTransfers the CAPA request to the selected person. Transferring a CAPA Request.
Create CAPACreates a CAPA. Creating a CAPA.
Associate CAPAAssociates an existing CAPA to the selected CAPA request. Select the required CAPA from the Search Results page and click Submit.
Notes:
  • You must be a Quality Manager or a Project Lead.
  • The CAPA request must be in the Approved state.
  • The CAPA must be in the Create, Assign, Active, or the Review state.
  • The CAPA request must not be connected to the CAPA.
--
Set DuplicateMarks a CAPA request as a duplicate of the selected master CAPA request.

Select the required CAPA request from the Search Results page and click Submit.

Notes:
  • You must be a Quality Manager and the owner of the CAPA request.
  • The CAPA request to be duplicated must be in the Review state.
  • The master CAPA request must be in the Approved, Committed, Fulfilled, or the Not Approved state.
  • The master CAPA request must be of the same CAPA type as the duplicate CAPA request.
--
DeleteDeletes the selected CAPA requests. Click OK to confirm.--
Create NewLets you create a CAPA request. Creating a CAPA Request.
Enable Edit/Disable EditActivates or deactivates edit mode in which you can modify the Severity, Title, Source Type, and the Scope columns. Click Save when done.
Notes:
  • You must be the owner of the CAPA requests that you want to modify.
  • You can modify only the CAPA requests that are in the Preliminary state and the Review state.
  • If the CAPA request is in the Preliminary state, you can also modify the CAPA type.
--