While a CAPA is in Implementing status you can:
- Describe the Actions Performed.
- Set the CAPA to Under Signing by QA once the Actions Performed section has been completed.
- Edit the Details of the CAPA.
- Modify CAPA Due Date.
- Add Actions if you wish to change from a simple CAPA workflow to a CAPA with Actions. This article describes a simple CAPA workflow where no Actions have been created. For information on a CAPA with Actions created, please consult: Implementing status: CAPA with Actions.
Describing the Actions Performed
If the idea is to carry out a simple CAPA workflow in which no separate Actions are specified, then, once the CAPA reaches Implementing Status, the Responsible Person must edit the Performed Actions section in the Actions Tab before setting the CAPA to Under Signing by QA.
The Performed Actions section can only be edited 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 defined for this particular CAPA.
- Describe the Actions Performed.
- If needed, upload one or more files.
- Set the Action Date. 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.
Setting the CAPA to Under Signing by QA
Once the Performed Actions field has been completed, the Responsible Person can 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.
The Responsible Person must then:
- Sign off.
The system will then give the following notification: CAPA Updated successfully.
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.
The CAPA will show on the Dashboards of the Users who have a role in the CAPA such as Responsible Person, Approver, and QA.
The CAPA can be edited from the CAPA Listings Page and from the CAPA Details Page.
Editing a CAPA from the CAPA Listings Page
- Go to CAPAs > CAPAs.
- Use the Filters and/or Search field to find the CAPA you wish to edit.
- Once you have found the CAPA, click on the Actions button.
- Click on Edit.
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
CAPAs can also be edited from the CAPA Details Page by clicking on the Edit button in the middle column.
After clicking on the Edit icon, 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 (for details see the section above on Editing a CAPA from the Listings Page).
Changing a simple workflow CAPA into a CAPA with Actions
While a CAPA is in Implementing status it is still possible to add specific Actions if needed.
Actions can be added by editing the CAPA (as described above) or by clicking on the + Add Action button from the Actions Tab on the CAPA Details Page:
More on adding actions here:
- 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.