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 second option: Creating a CAPA with a more complex workflow that includes various Users.
Creating a CAPA workflow with Actions
- 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 relevant CAPA details.
On the right hand side you will be able to add all the necessary Actions to your CAPA
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: It may not be necessary to give a very detailed description of your CAPA Plan in this field, since you will be adding Actions and describing them separately in the Action fields.
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.
Adding Actions to the CAPA
To add an Action click on the + icon in the Add Actions section:
There are two different types of CAPA Actions:
- Custom Actions
- Update Documents Action
Adding a Custom Action
- Give the Action a Title.
- 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 where you created the CAPA and the due date of the CAPA. You cannot include previously performed actions here.
- 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.
- It is required to define at least one Responsible User.
- If relevant you can also upload an Action File to the Action.
- You can add as many Custom Actions as you need.
- You will be able to add Custom Actions to a CAPA later, while it is in Implementing status.
- Once the CAPA changes from Created to next status you will no longer be able to edit or delete Custom Actions.
- 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.
Adding an Update Documents Action
- Per default the Action drop-down is always set to Custom Action, change it to Update Documents.
- 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.
- 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).
- When the CAPA reaches Implementing status they will receive an email notification indicating that the Document(s) need to be updated.
- As soon as the CAPA reaches Implementing status, the Documents will go back to Draft status.
- If the Documents included in the Action are not in Approved not Published or Published status when the 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 will be able to add Update Documents Actions to a CAPA later, while it is in Implementing status.
- You can only edit or delete Actions while a CAPA is in Created status.