A CAPA in Implement Actions is worked through its actions. Each action has its own Coordinators and QAs, named on the action, and its own statuses.

Before you start

  • The CAPA is in Implement Actions and the action is In Progress.
  • You are named on the action: as its Coordinator to sign it on, or as its QA to close it.
  • You know your Complere password.

Steps

  1. Open the CAPA from CAPAs, then open its Actions tab. Each action row has an Escalate button.

  2. As the action's Coordinator, select Escalate. The form Escalate status to Awaiting QA sign-off opens. Type your password and a Reason, for example what was done, then select Sign. The action is now Awaiting QA sign-off.

    Step 2. The Escalate status to Awaiting QA sign-off form for an action, with the signature warning, Email, Password and Reason

  3. As the action's QA, select Escalate on the same row. The panel offers Escalate status to Closed and Escalate status back to In Progress. Select the arrow beside Escalate status to Closed, type your password and a Reason, then select Sign.

    Step 3. The action's Escalate panel with Escalate status to Closed and Escalate status back to In Progress

Result

The action is Closed. When the last open action is closed, the CAPA moves on by itself from Implement Actions to Awaiting QA sign-off.

Next: the QAs sign the CAPA on to the effectiveness review, see Sign a CAPA as Approver or QA.

What gets recorded

Each entry appears on the CAPA's Audit Trail tab.

What the audit trail records

  1. The action's Coordinator or QA signed.

    Action Type
    Change Status
    Username
    Your username
    Date Created
    Date and time of the action
    Activity
    Names the action and the move, for example "CAPA-6-AXN-1 · The action has been signed by the Coordinators and its status has been updated from In Progress to Awaiting QA sign-off", followed by the reason.

  2. The last open action was closed.

    Action Type
    Status auto-advanced
    Username
    Your username
    Date Created
    Date and time of the action
    Activity
    "The CAPA status was updated automatically from Implement Actions to Awaiting QA sign-off because all of its actions were closed"

If something is different

The form reads Escalate status to Awaiting Dependency.

The action has Closure Dependencies that are still open. Sign it: the action waits in Awaiting Dependency, and its QA has no Escalate button on it there. It stays in Awaiting Dependency after the actions it depends on are Closed, until one of its Coordinators selects Escalate again and signs Escalate status to Awaiting QA sign-off.

The CAPA's status button is greyed out.

Its tooltip reads "All associated actions must be closed before proceeding to the next step". The CAPA moves on by itself when its last action is Closed.