Submitting CAPA Implementation Changes

Purpose

As a CAPA Owner or CAPA Coordinator, you submit Implementation Changes to document the actions completed during the Implement Stage. You can also submit changes when you add new Actions or when you mark an Action as Skipped.

Prerequisites

Installation Package: CQ Core

Product: QualityQuest

Function: CAPA

User Profile: Standard User

Permissions: CQ Base User PSG, CQ CAPA Owner PSG, CQ CAPA Coordinator PSG,

Record Stage: Implement

Steps

1. Open the CAPA record.

2. Open the Implementation tab.

3. Click New to add new Actions, if applicable.

4. Select Skip from the Action Menu to skip any actions, if applicable.

5. Click Submit in the Next Best Actions section to submit implementation changes.

Expected Outcome

• New Actions added are in a Draft Status.

• Skipped Actions are in a Skipped Status.

• An Email Notification is sent to Approvers, if all Actions are Complete or Skipped.

• The Submit Implementation Changes activity appears in the CAPA Record Activities section on the History tab.

Additional Resources

ComplianceQuest

• Adding Action Plans

• Completing CAPA Actions

• Completing Approval for CAPA Implementations