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Procedure documentationPerforming Tasks Related to Remediation Locate this document in the navigation structure

Prerequisites

Complete the Customizing activities under  Governance, Risk, and Compliance   Process Control   Evaluation Setup  .

Procedure

  1. From the My Home work center, navigate to Work Inbox.

  2. View the task. The system sends the Start Issue Remediation task to the issue owner.

  3. Select the task.

    A screen displays the issue details. The system presents the following options:

    • Assign Remediation Plan / Assign CAPA (if CAPA is enabled for the regulation of the issue)

      If the issue requires a remediation plan, you must assign a remediation plan owner, start date, due date, and description. To do so, select OK and Submit.

    • Close Without Plan

      If permitted, you can close the issue without a remediation plan. For example, you can use this option for a minor change. To do so, enter remediation comments and select OK to save and close the issue. Then select Submit.

    • Reassign the Issue

      You can reassign the issue to another user. To do so, select a user and choose OK. Then select Submit. The issue is rerouted to the selected user.

    • Void

      If the issue must be canceled, select Void and enter comments. The system changes the status to Canceled. Select Submit.

  4. The system sends the Enter Details for Remediation Plan task to the remediation plan owner. Depending on whether you set Review Required during the configuration or maintenance of local objects, one of two process flows occurs: With Plan Review or Without Plan Review.

    With Plan Review has the following options:

    • Reassign the Plan

      If you want to direct the remediation plan to another user, you can reassign the plan. Select a user and choose OK. Then select Submit.

    • Review

      This option allows you to document your remediation plan and submit it for review. Enter the details in the description text box and attach or link any documents. Select Submit.

      The system sends the Review Remediation Plan Details task to the reviewer who then has the following options:

      • Reject

        Selecting this option returns the plan to the plan owner for rework. Select Reject and enter review comments. Select OK and Submit.

      • Approve

        Selecting this option initiates the next remediation activity. Select Approve and enter review comments, if desired. Select OK and Submit.

    Without Plan Review has the following options:

    • Reassign the Plan

      If you want to direct the plan to another user, you can reassign it. Choose a user, select OK, and Submit.

  5. To initiate the next remediation activity, select Next. The system sends the Update Remediation Plan Progress task to the remediation plan owner who performs the following activities:

    • Selects the task

    • Enters the plan progress in the Description Text box (optional)

    • Updates the percentage of completion and chooses one of the following:

      • Submit to record the current status of the plan. The owner continues to update the task until it is complete.

      • Complete and Submit.

  6. The system sends the Review and Close Remediation Plan task to the issue owner who has the following options:

    • Reopen – This restarts the remediation process and sends the workflow to the remediation plan owner.

    • Close – This closes the issue. The status of the Remediation Plan and the Issue changes to Closed. No further activity can be performed on this task.

    Note Note

    If the issue owner and the remediation owner are the same user, the workflow is streamlined.

    End of the note.