There are two different options in QualityKick for defining your CAPA workflow
- The first one offers the possibility of creating a more simple CAPA in which the CAPA plan is described and can be implemented by one responsible person.
- The second option allows you to create a more complex CAPA in which various persons are implicated, giving you the possibility to set up as many Actions as you need and assigning each Action to different Users in the system.
This article describes the first option Creating a CAPA with a simple workflow.
Creating a simple workflow CAPA
- Go to CAPAs > CAPAs.
- Click on the + New button.
In the CAPA Details Form:
You will see the page is divided into two parts, on your left hand side you can include all the necessary relevant CAPA details for a simple workflow CAPA.
On the right hand side you will see the possibility of creating Actions, this is described in the article on complex CAPAs including various responsible Actions and Users.
CAPA Mandatory fields
There are very few mandatory fields in a CAPA:
- Groups: Remember that only the people that are in the Group(s) to which you assign the CAPA will be able to see it.
- CAPA Title.
- Due date: Set a due date that is as realistic as possible, at a later stage, depending on CAPA status, you will not be able to edit the due date.
- Responsible Person: Select the User from the drop-down list who will be responsible for the CAPA.
- Select Approver(s): You can define more than one Approver. Depending on Module Settings, if you define several Approvers they will all have to sign off on the CAPA.
- Select QA: You can define more than one QA. Depending on Module Settings, if you define several QAs they will all have to sign off on the CAPA.
CAPA optional fields
Events: the CAPA you are creating may be a result of one or more Events that have taken place and that you have registered in the system. When creating the CAPA you will be able to link the CAPA to the Event(s).
CAPAs: you can link the new CAPA to other related CAPAs that are already in place in the system.
Product/Service/Project: these must be preconfigured in the Events Module before you can add information in this field. When clicking on the Product/Service/Project field in the CAPA Details Form, the available options will appear and you can select as many as you need. If the Events Module is not activated you will not be able to add any information in this field.
Client/Vendor/Contact: these have been preconfigured in Manage > Contacts but you can also add them on the fly when creating the CAPA in case you need to.
Impacted Batch/Version/Aspect: there is a large text field in which you can describe these in detail.
Define CAPA Plan: In the case of a simple workflow CAPA, this field is particularly important seeing that this is where you can describe in detail the Actions that will be performed. In more complex CAPAs, where you add the Actions one by one, the description does not need to be as detailed because all the Actions are described separately.
Select Tags: by clicking on the field all available tags will appear, you can select more than one. If needed you can also create Tags on the fly by clicking on the Add New Tag button.
- Turn the User Selection Criteria switch ON, if you wish to add Users that do not belong to the Group(s) to which you have assigned the CAPA, as Responsible User, Approver(s) and/or QA(s) to the CAPA.
- Regular Users will only be able to add Tags on the fly if Allow Regular User to create tags switch is turned ON in Manage > Permission Settings > General > Tags.