There are two different options in Scilife for defining your CAPA workflow:
- The first one offers the possibility of creating a more simple CAPA workflow in which the CAPA plan is described and carried out by one Responsible Person.
- The second option allows you to create a more complex CAPA in which various Users 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 Actions and Users.
Creating a CAPA workflow with Actions
- Go to CAPAs > CAPAs.
- Click on the New + icon.
In the CAPA 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: from the drop-down list you can select the user 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
The number of optional fields you see will depend on the modules that have been activated in your environment. In other words, there are a series of standard optional fields that all users will see and then there are also a few optional fields that will only be shown if the corresponding modules are active for you in your environment.
Standard optional fields
- CAPAs: you can link the new CAPA to other related CAPAs that are already in place in the system. This will only be possible if the option of Linking CAPA to CAPA has been enabled in Module Settings.
- Products & Services: these have been preconfigured in Manage > Products & Services. When clicking on the Product/Service/Project field in the CAPA Form, the available options will appear and you can select as many as you need.
- Contacts: 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.
- 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.
Module related optional fields
These fields will only be visible if the corresponding modules are active for you in your environment.
- 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) while these are Under Investigation.
- Audits: the CAPA you are creating may be a result of one or more Audits that have registered in the system. When creating the CAPA you will be able to link the CAPA to these Audits.
- Findings: the CAPA you are creating may be a result of one or more Audits Findings that have been registered in the system. When creating the CAPA you will be able to link the CAPA to these Audit Findings.
Please note:
- 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 in the roles of Responsible User, Approver(s), and/or QA(s).
- 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
There are two different types of CAPA Actions:
- Custom Actions.
- Update Documents Action.
Adding a Custom Action
- Click on the Add Action + icon in the Add Action section.
- Per default, the Action Type drop-down is always set to 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.
Please note:
- You can add as many Custom Actions as you need. To add more, repeat steps 1-7 described above.
- 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 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
- Click on the Add Action + icon in the Add Action section.
- Per default the Action Type 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.
- Set a Due Date. It will be used to send email notifications to remind Users that the action is due.
- It can be helpful to add an Action Description, detailing what needs to be modified in the selected Documents.
Please note:
- You can add as many Update Document Actions as you need. To add more, repeat steps 1-4 described above. Although it is possible to add many Documents in one same Action, it can be useful to separate the Update Document Actions into various Actions if the updates to be made in the Documents are not the same and the Action Description needs to be different.
- 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 the Users with a role in the Document(s) will receive an email notification indicating that the Document(s) need to be updated.
- As soon as the CAPA reaches Implementing status, the system will Force Review on the Documents if these are in Published status, and they will go back to Draft status.
- If the Documents included in the Action are not in Draft or in Published status when the CAPA reaches Implementing Status, 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.
- 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.
- Even if it has been activated in module settings that QA must sign off on all Actions this does not mean that QA will have to sign off on Update Document Actions. These are closed the moment the Document finalizes a full new Approval Cycle.
Relevant for: Administrators / Managers / Regular Users.