CAPA remediation is available for issues coming from manual test of controls, automated test of controls, and self-assessment. It is also available for ad hoc issues.
If CAPA is configured for your compliance initiative through the Customizing activities, the following CAPA functions are available:
Assign CAPA Plan pushbutton
CAPA tab
CAPA Worklog/Audit Trail tab
You have configured the CAPA business process. See Configuring CAPA.
You have configured e-signature and approval. This is only required if you use e-signature and approval in the CAPA remediation process. See Configuring CAPA Plan Values.
An issue has been triggered by manual or automated tests, or by self-assessment. Or, an issue has been created through the ad hoc process.
This figure illustrates the CAPA remediation process:
The issue owner creates a plan and submits it for approval.
For more information, see Creating a CAPA Plan.
The plan approver approves the plan.
You receive the Approve CAPA Plan task in your Work Inbox. You have the following options:
Approve the CAPA plan
Cancel the CAPA plan
Send the plan back to the issue owner for rework
The remediators complete the corrective and preventative actions and submit the plan for approval.
A user may be assigned:
only corrective actions or
both corrective and preventive actions.
Note
All corrective actions must be completed before the preventive actions. If you are assigned both actions, you must complete and submit all corrective actions before the preventive action tasks are available in your Work Inbox.
The CAPA plan execution approver reviews and approves the execution.
You receive the Approve CAPA Execution task in your Work Inbox. You have the following options:
Approve the CAPA plan.
You must answer all the Verification of Appropriateness and Effectiveness of the CAPA Plan questions.
Send the CAPA plan back to the issue owner for re-execution.