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The Windchill CAPA Process
Windchill CAPA provides a workflow to manage corrective and preventive actions (CAPAs). Windchill CAPA allows you to initiate, evaluate, assign, monitor, review, and approve actions in a formal manner.
Each CAPA starts as a request. If a qualified CAPA team reviewer approves the request, the request becomes a CAPA. The CAPA then moves through the workflow process as defined by the configured workflow and the data in the request.
• As the CAPA moves through the workflow, different roles are preassigned to the team member to fulfill the workflow steps.
• The CAPA process is managed in the Quality Tasks table. You can see the current state of the CAPA and enter additional information from this table. You can also access CAPA tasks in the My Tasks table.
• Once you complete a workflow state, all attributes are persisted and available for review in the next workflow state.
• As you complete the CAPA process flow, a record of previous steps is provided below each table.
Roles
CAPA records often require authorizations, reviews, and signatures. However, the number and types of approvers, the order in which they review the record, and other aspects of the routing are configurable. The default configuration provided by Windchill CAPA contains optional approvals for the following tasks:
• CAPA Investigation (if an action plan is not created)
• CAPA Plan
• CAPA Effectiveness
For more information, see Windchill CAPA Roles.
Configuration
All workflow steps are configured for your organization during implementation. In addition, you can configure optional workflow steps, such as investigation, implementation, and effectiveness.
Process Flow
The default process flow provided by Windchill CAPA includes the following steps:
1. Request (Intake)
2. Review (Evaluation)
3. Investigation
4. Plan
5. Implementation
6. Confirmation
7. Effectiveness
8. Closure
Task Names and Workflow States
After a request is created, the available tasks that appear are defined by your configured workflow and the data in the request.
At any time, you can see the details for all previous states (including attached objects) by clicking the information icon . Clicking this icon takes you directly to the information page for the object. Additionally, the details are listed below each process flow table.
Task Name
Description
CAPA Request
In the CAPA Intake state, a CAPA requester initiates the CAPA process. Actions can also be created in this state. Once the request is marked complete, the system moves the request to the Evaluation state. For more information, see CAPA Requests.
CAPA Review
After a request is entered and completed, the CAPA moves to the Evaluation state. As a CAPA reviewer using the information collected in the previous state, you are responsible for determining if the CAPA meets the criteria to become a full CAPA. Actions can also be created in this state. If the CAPA request meets the criteria, it can then continue through the workflow. For more information, see CAPA Reviews.
CAPA Investigation
If an investigation is requested during the Evaluation state, the system moves the CAPA to the Investigation state. The Investigation state serves as a summary of all investigation activities associated with the CAPA and is optional. Actions can also be created in this state. As a CAPA investigator, you must determine whether further action is required. For more information, see CAPA Investigations .
CAPA Action Plan
If an investigation was not indicated in the CAPA Evaluation state, the CAPA automatically moves to the Plan state. If the CAPA passed through the Investigation state, the CAPA investigator decides if action plans are needed and sends the CAPA to the Plan state.
In the Plan state, the CAPA planner is responsible for creating actions 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, confirmation, and effectiveness tasks. For more information, see Action Plans.
CAPA Effectiveness
This is an optional task. For more information, see CAPA Effectiveness.
Action Implementation
After the action plan is defined, the system advances the CAPA record to the Implementation state. In the Implementation state, the CAPA implementer executes the actions and records the outcome. A CAPA implementer can also create a workflow task based on the approved plan and can assign individual implementation tasks. For more information, see CAPA Implementations.
Action Confirmation
After the action plan passes through the Implementation state, the system advances the CAPA record to the Confirmation state. The Confirmation state is optional and appears if the CAPA planner requested a confirmation task in the Plan state. The Confirmation state allows you to approve the corrective action plan. As a CAPA confirmer, you are responsible for confirming the corrective action measures. For more information, see CAPA Confirmations.
Action Effectiveness
After the action plan passes through the Implementation and/or Confirmation state, the system advances the CAPA record to the Effectiveness state. The Effectiveness state is optional and appears if the CAPA planner requested an effectiveness task in the Plan state. The CAPA effectiveness approver provides information for each effectiveness measure and creates a workflow task based on the approved plan. The CAPA effectiveness approver then assigns the task to a CAPA verifier. Following the completion of all effectiveness periods the CAPA is closed and marked as effective. For more information, see CAPA Effectiveness.