How to add a Custom Action to a CAPA

  • Updated

You can add Custom Actions to a new CAPA as well as 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 or QA.

Adding a Custom Action to a new CAPA

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

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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.

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In the Add Action section:

  1. Click on the + icon.
  2. Per default, the Action Type drop-down is always set to Custom Action.
  3. Give the Action a Title.
  4. It is not mandatory to set a Due Date. If you do wish to define one, you will see that you can only select a Due Date that lies between the date when you created the CAPA and the due date of the CAPA. You cannot include previously performed actions here.
  5. It is also not mandatory to give an Action Description. If the Action Title is self-explanatory it may not be necessary although, depending on the Action, it may be useful to clarify to the Responsible User exactly what needs to be done.
  6. It is required to define at least one Responsible User.
  7. If relevant you can also upload an Action File to the Action.

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You can add as many Actions as you needSave the CAPA once you finish adding all the necessary Actions.

Adding a Custom Action to an existing CAPA

Custom Actions can be added to an existing CAPA in two ways:

  • In the CAPA Form.
  • In the Actions Tab on the CAPA Details Page.

Adding Actions to an existing CAPA in the CAPA Form

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

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

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Follow steps 1 - 7 mentioned in the section above (adding Custom Actions to a new CAPA).

Once you have added the Custom Actions you need, save the CAPA.

 

Adding Actions to an existing CAPA from the Actions Tab of the CAPA Details Page

  1. Go to CAPAs > CAPAs.
  2. Use the Filters and/or Search field to find the CAPA to which you want to add Actions.
  3. Click on the Title or ID of the CAPA.

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In the CAPA Details Page:

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

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  Please note:
  • If no Actions have been added to the CAPA, the Actions Tab will look like the screenshot above and include a text area for Performed Actions.
  • If Actions have already been added to the CAPA, the Actions Tab will be similar to the screenshot below.

How_to_add_a_Custom_Action_to_a_CAPA_SC8.png

In the Add New Action window:

  1. Per default, the Action Type drop-down is always set to Custom Action.
  2. Give the Action a Title.
  3. It is not mandatory to set a Due Date. If you do wish to define one, you will see that you can only select a Due Date that lies between the date when you created the CAPA and the due date of the CAPA. You cannot include previously performed actions here.
  4. It is also not mandatory to give an Action Description. If the Action Title is self-explanatory it may not be necessary although, depending on the Action, it may be useful to clarify to the Responsible User exactly what needs to be done.
  5. It is required to define at least one Responsible User.
  6. If relevant you can also upload an Action File to the Action.
  7. Click on Save if you just want to add one Action.
  8. Click on Save & New if you wish to add more than one Action to the CAPA. 

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

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  Relevant for: Administrators / Managers / Regular Users.
  Please note:
  • You can add as many Custom Actions as you need.
  • You can add Custom Actions to a CAPA while it is in Created and in Implementing status.
  • You can only edit or delete Custom Actions while the CAPA is in Created Status.
  • Carefully consider if it can be useful to activate that QA must 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 not be implemented until the CAPA has been Signed off by Approver(s) and reaches Implementing status. Responsible Users of the Actions will be notified of the Action when the CAPA 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. At this status, Responsible Users of the Actions will be notified as soon as the Action is added to the CAPA.

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