Initiating a CAPA

  1. From the SmartSolve Portal Page, click the Home tab at the top of the window.
  2. In the CAPA Management section of the list, select Create CAPA.
    Result: The Initiate CAPA window is displayed.
  3. Enter the information in the following fields:
Field Description

CAPA Type*

Select a CAPA type. Default CAPA Types include Internal, Supplier, and Customer. A CAPA Team must be configured by an administrator in order for users to be able to create CAPAs.

NOTE: If the CAPA type selected is Supplier or Customer, a required Client field will display in the Initiate CAPA form. For information on configuration, see CAPA Types.

CAPA Against*

Select a CAPA Against option. Default CAPA Against options include the following:

  • Product - This option makes the Product field required.
  • Process - This option makes the Process field required.

CAPA Source*

Select a CAPA Source. Default CAPA Sources include General, NC, Audit, Complaint, and External. For information on configuration, see CAPA Source.

Source Number

The Source Number field is a free text field where the initiator can enter the number for the CAPA Source selected, such as the complaint number.

NOTE: If the CAPA record is automatically created from an NC record used in the NC Management application, then this number is assigned by the system.

Site*

Enter or zoom to select the site associated with the CAPA. A site must be configured by an administrator in order for users to be able to create CAPAs. For information on configuration, see Organization Units.

Department

Enter or zoom to select the department associated with the CAPA. For information on configuration, see Organization Units.

Client

Enter or zoom to select or type to enter the client associated with the CAPA. For information on configuration, see Clients.

NOTE: This field is only displayed if Supplier or Customer is selected as the CAPA Type.

Supplier Site

Enter the supplier location, such as Acme - San Jose.

NOTE: This field is only displayed if Supplier is selected as the CAPA Type.

Product*

Enter or zoom to select or type to enter a product associated with the CAPA.

NOTE: If Product is selected as the CAPA Against, then the Product field is required. For information on configuration, see Product Setup.

Product Revision

Enter the product revision.

UDI-DI

Enter the device identifier.

Process

Enter or zoom to select or type to enter a process (operation) associated with the CAPA.

NOTE: If Process is selected as the CAPA Against, then the Process field is required. For information on configuration, see Process Setup.

Discovery/Plant Area

Enter or zoom to select or type to enter a discovery/plant area associated with the CAPA.

NOTE: For information on configuration, see Organization Units.

Priority

Select the priority of the CAPA. For information on configuration, see Priorities.

Title*

Enter the title of the CAPA.

Description*

Enter a description of the CAPA.

  1. Click the Submit button.
    Result: The user who created the CAPA record now advances to the Verify CAPA Initiation step. If the user who created the CAPA is a different user than the user who will verify the CAPA Initiation, you may want to disable the Skip Confirmation option in the Workflow Designer in order for the initiator to see the Result window before continuing. The Result window is a pop-up window that displays after the task sign-off and asks the user where they would like to go next, such as the CAPA Detail or the Portal Page. If the user is assigned the role for the next step in the workflow, such as Verify CAPA Initiation, then the user will see the option to enter the next step.
     

 

 
Wednesday, December 4, 2019
11:57 AM