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Implementing status: CAPA with Actions

  • Updated

While a CAPA is in Implementing status you can:

  • Edit the Details of the CAPA.
  • Modify CAPA Due Date. 
  • Add more Actions.
  • Close Actions.

This article describes a CAPA where Actions have been created. For information on Simple workflow CAPAs, where no specific Actions have been created, please consult: Implementing status: Simple workflow CAPA

Editing CAPA Details while in Implementing status 

While the CAPA is in Implementing status it is possible to edit some of the details of a CAPA.

You can edit the CAPA from the CAPA Listings Page or from the CAPA Details Page.

Users defined in the CAPA as Creator, Responsible Person, Approver, and QA will be able to edit the CAPA Details Form.

 

Editing a CAPA from the CAPA Listings Page

  1. Go to CAPAs > CAPAs.
  2. Use the Filters and/or Search field to find the CAPA you wish to edit.
  3. Once you have found the CAPA, click on the Actions button.
  4. Click on Edit.

Implementing_status_CAPA_with_Actions_SC1.png

The CAPA Details Form will open.

Users defined in the CAPA as Creator, Responsible Person, Approver, and QA will be able to edit the CAPA Details Form.

While the CAPA is in Implementing status the following details can be edited:

  • Groups: You can assign the CAPA to more Groups but you cannot remove the Group to which the CAPA was originally assigned.
  • Events: You can link additional Events to the CAPA and/or remove Events that were linked to the CAPA in Created status.
  • CAPAs: You can link additional CAPAs to the CAPA and/or remove CAPAs that were linked to the CAPA in Created status.
  • CAPA Due Date can be modified but not from within the form, it must be done from the CAPA Details Page, more on this here: Changing the due date of a CAPA.
  • Client/Vendor/Contact field can also be modified.
  • Tags can be removed and new ones added.
  • You can add additional QAs, but not remove the QA person who already Approved Implementation.
  • Lastly, it is also possible to add Actions to the CAPA, more on this here: How to add a Custom Action to a CAPA and How to add an Update Documents Action to a CAPA.

The remaining fields cannot be edited.

 

Editing a CAPA from the CAPA Details Page

  1. Go to CAPAs > CAPAs.
  2. Use the Filters and/or Search field to find the CAPA you wish to edit.
  3. Click on the Title of the CAPA in question.

Implementing_status_CAPA_with_Actions_SC2.png

In the CAPA Details Page:

  1. Click on the Edit Icon to access the CAPA Form. There, as described above, you will be able to edit the following fields:
    • Groups: You can assign the CAPA to more Groups but you cannot remove the Group to which the CAPA was originally assigned.
    • Events: You can link additional Events to the CAPA and/or remove Events that were linked to the CAPA in Created status.
    • CAPAs: You can link additional CAPAs to the CAPA and/or remove CAPAs that were linked to the CAPA in Created status.
    • CAPA Due Date can be modified but not from within the form, it must be done from the CAPA Details Page, more on this here: Changing the due date of a CAPA.
    • Client/Vendor/Contact field can also be modified.
    • Tags can be removed and new ones added.
    • You can add additional QAs, but not remove the QA person who already Approved Implementation.
    • Lastly, it is also possible to add Actions to the CAPA, more on this here: How to add a Custom Action to a CAPA and How to add an Update Documents Action to a CAPA.
    • The remaining fields cannot be edited.
  2. At this point, you will only be able to add additional Users in the role of QA, but you cannot modify the Users who have already signed off.
  3. Edit the Due Date of the CAPA. More on this here: Changing the due date of a CAPA
  4. Go to the Actions Tab.
  5. Add additional CAPA Actions. 

Implementing_status_CAPA_with_Actions_SC3.png

 

Adding Actions to a CAPA

Both Custom Actions and Update Documents Actions can be added when the CAPA is in Implementing Status.

These can be added either by:

  1. Clicking on the +Add Action button in the Actions Tab on the CAPA Details Page.
  2. Clicking on the edit button on the CAPA Details Page.

Implementing_status_CAPA_with_Actions_SC4.png

By clicking on the + Add Action button the Add New Action window will open and all the Action details can be included.

By clicking on the edit button the CAPA Details Form will open and the Actions can be added on the right-hand side of the Form.

Closing Actions 

Before the CAPA can proceed to Under Signing by QA all CAPA Actions must be closed:

  • Custom Actions must be marked as closed by the Responsible User(s) of the CAPA Action. 
  • If system settings require QA to sign off on all Actions, then QA will need to sign off on the Custom Actions.
  • Documents included in an Update Documents Action will have to go through a full approval cycle. 

Closing Custom Actions

The Responsible Users will see the CAPA Actions pending closure on their Dashboard, in the CAPA Actions section. Actions can be closed directly from the Dashboard.

If it is not required for QA to sign off,  the Actions will disappear from the Responsible Users Dashboard as soon they are Closed.

If system settings require QA to sign off on all Actions, the Action will appear as Pending Approval until QA signs off.

QA will see the CAPA Actions Pending Approval on their Dashboard, in the CAPA Actions section. Actions can be approved by QA directly from the Dashboard.

Update Documents Actions

In this case, the Actions will be completed as soon as the Documents included in the Action have gone through a full approval cycle. The Action will be marked automatically as closed by the system once this happens.

It is not necessary for QA to sign off on this Action even if the Action Sign off for QA switch is turned ON.

Setting the CAPA to Under Signing by QA

Once all CAPA Actions have been closed, the Responsible Person must sign off and set the CAPA to Under Signing by QA.

  Relevant for: Administrators / Managers / Regular Users.

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