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How to add an Update Documents Action to a CAPA

  • Updated

You can add Update Documents Actions to a new CAPA or to an already existing CAPA.

Actions can be added to an existing CAPA while the CAPA is either in Created or in Implementing status.

Administrators can add Actions to a CAPA regardless of having a role in the CAPA.

Managers and Regular Users can only add Actions to a CAPA if they have a role in it as Responsible User, Approver(s) or QA(s).

Adding an Update Documents Action to a new CAPA

  1. Go to CAPAs > CAPAs.
  2. Click on the + New button.

new_capa1.png

In the CAPA Details Form you will see the page is divided into two parts, on your left hand side you can include all relevant CAPA details. 

On the right hand side you will be able to add all the necessary Actions to your CAPA.

new_capa2.png

 

To add an Update Documents Action click on the + icon in the Add Action section:

add_action.png

In the Add Action section:

  1. Per default the Action drop-down is always set to Custom Action, change it to Update Documents.
  2. In the Action Documents field you can add as many Documents as you need to. Once you click on the field, all available Documents will appear: these will be all the Documents that have been assigned to the same Group(s) as the CAPA.

add_update_documents_Action.png

In order to avoid confusion add all the Documents that need updating to the same Update Documents Action. Don't create one Update Documents Action per Document.

Save the CAPA once you have added the Update Documents Actions.

 

Adding an Update Documents Action to an existing CAPA

If no Actions have been created yet for the CAPA, then you can only add Actions to an existing CAPA by following the steps mentioned in the section above.

Once Actions have been added to a CAPA then you will also be able to add Actions directly in the Actions Tab in the CAPA Details Page, this is described later in this article.

Adding Actions to an existing CAPA in the CAPA Details Form

  1. Go to CAPAs > CAPAs.
  2. Use the Filters and Search field to find the CAPA to which you want to add Actions.
  3. Click on the Edit button.

edit_capa1.png

In the CAPA Details Form, add a Custom Action by clicking on the + icon in the Add Actions section:

add_action.png

Follow the steps mentioned in section above (adding Actions to a new CAPA), in the Add Update Documents Action section:

  1. Per default the Action drop-down is always set to Custom Action, change it to Update Documents.
  2. In the Action Documents field you can add as many Documents as you need to. Once you click on the field, all available Documents will appear: these will be all the Documents that have been assigned to the same Group(s) as the CAPA.

Once you have added the Update Documents Action, save the CAPA.

 

Adding Actions to an existing CAPA directly in Actions Tab of the CAPA Details Page

If the CAPA already contains some Actions, then you will also be able to add more Actions directly in the Actions Tab in the CAPA Details Page.

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

add_action_existing_capa1b.png

In the CAPA Details Page:

  1. Go to the Actions Tab
  2. Click on the + Add Action button.

add_action_existing_capa1c.png

In the Add New Action window:

  1. Per default the Action drop-down is always set to Custom Action, change it to Update Documents.
  2. In the Action Documents field you can add as many Documents as you need to. Once you click on the field, all available Documents will appear: these will be all the Documents that have been assigned to the same Group(s) as the CAPA.
  3. Click on Save if you just want to add 1 Action. 
  4. Click on Save & New if you wish to add more than 1 Action to the CAPA. As mentioned before, it is best to group all Documents that need to be updated in one Update Documents Action. If you need to add a Custom Action as well as this point you can choose to click on Save & New.

After creating each Action the system will ask you to confirm, and then you will be notified that the new Action was added successfully.

add_action_existing_capa1e.png

  Relevant for: Administrators / Managers / Regular Users.
  Please note:
  • You do not have to assign Responsible User(s) to the Update Documents Action. The responsible Users are those who already have a role in the Document(s): (Author(s), Reviewer(s), Approver(s), QA(s).
  • If the Update Documents Action was added to the CAPA while it was in Created status then the Responsible Users will receive an email notification indicating that the Document(s) need to be updated when the CAPA reaches Implementing status.
  • If the Update Documents Action was added to the CAPA while it was in Implementing status then the Responsible Users will receive an email notification indicating that the Document(s) need to be updated as soon as the Action is saved.
  • When the Update Documents Action is implemented, the Documents will go back to Draft status. If the Action was added when the CAPA was in Created Status then this will happen once the CAPA reaches Implementing status, if the Action was added to CAPA when it was in Implementing status then the Document will go back to Draft as soon as the Action is saved.
  • If the Documents included in the Action are not in Approved not Published or Published status when the Action is created, then the Action will not be completed until the documents have finalized the Approval Cycle they are currently in and are then pushed through another full Approval Cycle. In other words the Documents need to go through a full approval cycle before the Action is completed. The Action will be marked automatically as closed by the system once this happens.
  • In order to avoid confusion, add just one Update Documents Action and include all the Documents that need updating in the same Action field.
  • You can add Update Documents Actions to a CAPA while it is in Created and in Implementing status.
  • You can only edit or delete Update Documents Actions while the CAPA is in Created status.
  • Carefully consider if it can be useful to activate that QA must to sign off on all Actions. If QA does not sign off on all Actions, it may be problematic to go back and carry out all Actions again if QA rejects the CAPA at a later stage when Under Signing by QA.
  • Actions that are added to the CAPA while it is in Created status will be not be implemented until the CAPA has been Signed off by Approver(s) and reaches Implementing status.
  • Actions that are created while the CAPA is in Implementing status do not have to be Signed off by Approver, they will be implemented right away.

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