CAPA Planning

Who is this for?

Author - drafting and authoring the CAPA, adding actions, and sending it forward
Owner - managing access and the Planning phase

How to do it

In the Planning phase the CAPA is drafted, authored and its corrective and preventive actions are defined.

Draft the CAPA

Open the CAPA and select the pencil (edit) icon to open Edit Document Information. Complete the fields and select Save.

Edit Document Information.

Edit Document Information

Field name	Description	Note
Title	The title of the CAPA.
Effective Date	The date the CAPA becomes effective.	Required before the CAPA can be sent for approval in Execution.
Due Date*	The date the CAPA is due. This is to set when the CAPA should be closed, meaning that the final approval of the execution step is captured.	Required. Send for review is unavailable until a Due Date is set.
Quality Process	The process the CAPA belongs to.	Shown as CAPA.
Tags	Keywords used to categorize the CAPA.	Optional.
Created from Template	The template the CAPA was created from, if any.	Optional.

In Document Access, assign the users, groups or sites to the required roles and select Save.

Document Access roles

Role	Activity in this work instruction
Owner	Manages the CAPA; can close a review, send it back to Planning, and complete the effectiveness assessment. Assigned by default to the creator.
Author	Maintains the CAPA content and actions and sends it for review and approval.
Reviewer	Marks the review as completed.
Approver	Approves the CAPA in the Planning and Execution approval steps.
Viewer	Can view the CAPA.

📝Note: Details also show the Source Quality Events back-link.

Author the CAPA (Author)

The CAPA content is authored in the working copy.

Select Check Out, then open the working file in Microsoft Word.
You can use the SimplerQMS Add-in to import values into the document from the property card.
Edit the document, then check in when completed.

Add CAPA actions

Corrective and preventive actions can only be created during the Planning phase. New actions start in the Planned status.

Open the Actions tab and select Add Action.
Complete the Create CAPA Action dialog and select Create. The action appears in the Corrective Actions or Preventive Actions table with the status Planned.

Creating a CAPA action.

Create CAPA Action

Field name	Description	Note
Action Type	Corrective or Preventive.
Title*	A short title for the action.	Required.
Description	What needs to be done.
Link a document	A related document, if any.	Optional.
Due date	The date the action is due.	Optional. Use Include time to add a time.
Assignees*	The user(s) responsible for completing the action.	Required.
Requires signature	Whether completing the action requires an electronic signature.	Optional toggle. When enabled, the assignee signs to complete the action.

📝Note: Actions can be edited while the CAPA is in Planning. Use the Edit Action button on the side of the action.

❗Corrective and preventive actions, their assignees and their completion are part of the final CAPA record. SimplerQMS supports controls via electronic signature, configuring them for your intended use is part of the action creation.

Send the CAPA for review or approval

When the plan is ready, select Send for review (when a review is required for the CAPA type). The reviewer is assigned and the state changes to Review.
When the review is complete, enter a Change Summary and select Send for approval. The state changes to Approval and the assigned Approver(s) are notified. In Approval, the document, actions and details are read-only.

Sending the CAPA for review or approval.

📝Note: If there is no configured review and approval for the planning stage, click on Done to progress into the execution stage.

💡Tip: Define corrective actions (addressing the root cause of what happened) and preventive actions (addressing potential causes that have not occurred yet) separately and ensure the correct type is selected when creating the actions in the system.

💡Tip: Set the Due Date early in the process. The Due Date is reflective on when the document is expected to be closed, meaning that the final approval of the execution stage is captured. Send for review stays unavailable until one is set.