CAPA roles and responsibilities

Which are the Roles in a CAPA and what are they responsible for?

Creator

The Creator of the CAPA is, as the name indicates, the User that creates the CAPA in the system.

CAPA Creator can be an Administrator, Manager or Regular User. Read Only Users cannot create CAPAs.

The Creator as well as the Responsible Person (see below) can change the status of the CAPA from Created to Under Signing by Approver.

Responsible Person - for the entire CAPA

The Responsible Person in a CAPA is the User that is to be held responsible for the CAPA.

The Responsible Person in a CAPA can be an Administrator, Manager or Regular User. Read Only Users cannot be responsible for CAPAs.

While in Created status, the Responsible Person as well as the Creator will be able to change the status of the CAPA from Created to Under Signing by Approver.

When the CAPA reaches Implementing status, if the CAPA has a simple workflow with no specific Actions created, the Performed Actions Section will appear in the Actions Tab. The Responsible Person will be the only one person that can edit this section.

For simple workflow CAPAs, the Responsible Person will have to manually change the status of the CAPA from Implementing to Under Signing by QA.

Larger CAPAs that include specific Actions will change automatically from Implementing to Under Signing by QA once all the Actions have been completed. If it is required for QA to sign off on Actions, then QA will have to sign off on each Action before the CAPA automatically changes status.

If QA requires an Effectiveness Check for the CAPA, the Responsible Person will be in charge of introducing the  Effectiveness Check Conclusion and must sign off at Effectiveness Check Pending status. Thereafter the CAPA will change to Effectiveness Pending Approval.

Approvers 

Administrators, Managers and Regular Users can be defined as CAPA Approvers. Read Only Users cannot Approve CAPAs.

Approvers must sign off during Under Signing by Approver Status in order for the CAPA to reach Implementing Status.

Approvers can also reject the CAPA and send it back to Created status. A reason must be given for rejecting the CAPA.

Responsible Users - for the individual Actions in a complex CAPA workflow

This role only exists in CAPAs where specific Actions have been created. Each Action can have more than one Responsible User, the Responsible Users in each Action do not have to be the same, this means that if needed, a CAPA can involve a large number of Users.

Administrators, Managers and Regular Users can be defined as Responsible Users for CAPA Actions. Read Only Users cannot be defined in this role.

Simple workflow CAPAs, with no Actions assigned, will not have any Responsible Users.

Responsible Users must complete their assigned Actions and sign off on them while the CAPA is in Implementing status.

QA

Only Users that are configured globally in the system as QA can be assigned as QA in a CAPA.

If the Action Sign off for QA switch is turned ON in CAPA Module Settings, then QA must sign off on all Actions while the CAPA is in Implementing status 

Once all CAPA Actions have been completed, and if necessary also signed off by QA, then the CAPA will go from Implementing status to Under Signing by QA.

At this point QA can either:

• Close the CAPA and indicate that an Effectiveness Check is not Required.
• Close the CAPA and Indicate that an Effectiveness Check is required.
• Reject the CAPA and give a reason for rejecting the CAPA. 

If no Effectiveness Check is required then the CAPA will Close and the responsibility of the QA in the CAPA ends.

If Effectiveness Check is Required, then QA must sign off or reject the Effectiveness Check in Effectiveness Pending Approval status.

At each point where QA rejects the CAPA, Actions or the Effectiveness Check, a reason must be given and the CAPA goes back one step in the CAPA cycle.

Responsibility of QA ends once Effectiveness Check is finally approved and the CAPA closes.