Action Plans
A CAPA automatically moves to the Plan state if an investigation was not specified in the CAPA review state. If the CAPA passed through the Investigation state, the CAPA investigator decides if an action plan is needed and sends it to the Plan state.
In the Plan state, the CAPA planner is responsible for creating an action plan to address the root cause of the CAPA. As a CAPA planner, you can define the tasks that are required to complete a CAPA including implementation, change notice, confirmation, and effectiveness tasks. Multiple tasks can be assigned for each task that is defined, and an internal or external CAPA planner is assigned to the task. You are either the assigned owner, or you accept ownership. As the owner, you are responsible for completing the task.
For more information, see Roles.
As a CAPA planner, you can request an approval package for each task. This package must be reviewed by an approver. If the CAPA needs immediate action or if the action already took place, the approval package can be omitted.
As a CAPA planner, you are responsible for performing the following tasks to complete the action plan:
• Investigate and define the action plan
• Identify implementation, change notice, confirmation, and effectiveness approval activities
To create an action plan, use the following procedure:
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At any time, you can click Save and continue working on the CAPA later.
Use the step navigator at the top of the screen to quickly move to a different step in the procedure.
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1. Right-click a CAPA in a Plan state and select Enter Plan Details.
2. Complete all steps as described in Conducting an Action Plan Task.
3. Click Complete Task. The CAPA is saved and moves to the next workflow state.