Editing the simple workflow CAPA while in Implementing status
If the idea is to carry out a simple CAPA workflow in which no separate Actions are specified, then, once CAPA reaches Implementing Status, the Responsible Person can edit the Performed Actions section in the Actions Tab or set the CAPA directly to Under Signing by QA.
Editing the Performed Actions section
In case it is relevant to add the information on Performed Actions, this can only be done by the Responsible Person.
In the CAPA Details Page:
- Go to the Actions Tab. It is easy to see that this is a simple workflow CAPA, because there is no number above the Actions icon, since no specific Actions have been detailed for this particular CAPA.
- Describe the Actions Performed.
- If needed, Upload a file.
- Set the Action Date. In this case it is possible to introduce a date that is prior to the date the CAPA was created. It is, on the other hand, not possible to introduce a date that is later than CAPA due date.
- Indicate if the Actions Performed were successful or not.
- Save changes.
Editing CAPA details
While the CAPA is in Implementing status it is still possible to edit some of the details such as CAPA due date, linking the CAPA to other CAPAs or Events, etc.
To edit the CAPA:
- Click on the edit button in the CAPA Details Page.
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.
Setting the CAPA to Under Signing by QA
In the case of a simple workflow CAPA the Responsible Person must manually set the CAPA to Under Signing by QA.
- In the CAPA Details Page, click on the Implementing status button.
- Set to Under Signing by QA.
Responsible Person must then:
- Sign off with electronic signature.
- Save.
The system will then give the following notification: CAPA Updated successfully.
Changing a simple workflow CAPA into a CAPA with Actions
If, after creating, approving and implementing the CAPA it is considered necessary to add specific Actions to the CAPA this can be done by editing the CAPA.
- Click on the edit button in the CAPA Details Page.
The CAPA Details Form will open, you will be able to add Custom Actions as well as Update Documents Actions to the CAPA.
While the CAPA is in Implementing status it can be edited by either of the following Users defined in the CAPA: Creator, Responsible Person, Approver and QA.
- The Performed Actions section of the Actions Tab will disappear as soon as specific Actions are added to the simple workflow CAPA.
- Once Actions have been added to the CAPA it no longer qualifies as a simple workflow CAPA, therefore the concepts described in articles for simple workflow CAPAs do not necessarily apply any longer.