Working with Effectiveness Checks

Effectiveness Checks allow you to monitor the effectiveness of a change after it is implemented. Effectiveness Checks are created during change planning, deviation, or Standalone CAPA assessment and are completed after the associated Change Control or Deviation is closed.

Creating Effectiveness Checks

The Change Control, Deviation, or Standalone CAPA Owner is responsible for creating Effectiveness Checks during change planning, deviation, or Standalone CAPA assessment.

Complete the following steps to create an Effectiveness Check:

  1. In the Change Control or Deviation record, expand the Effectiveness Checks section.
  2. Click Create to open the Create Effectiveness Check page. 
  3. Enter the Effectiveness Check Title and a Description of the activities required to check for effectiveness of the executed plan.
  4. Enter the Start Date on which Vault will automatically initiate the Complete Effectiveness Check task. We recommend entering a Start Date later than the Change Control or Deviation Current Due Date, because Effectiveness Checks are completed after the associated Change Control or Deviation is closed. 
  5. Enter the Current Due Date, which is the date the Effectiveness Check must be completed and approved. 
  6. Click Save to save the record and open the Effectiveness Check page.
  7. In the Team section, click Manage Team. 
  8. Select the Owner responsible for completing the effectiveness check and one or more QA Approvers responsible for approving the effectiveness check completion. A QA Approver cannot be the same user as the Owner.
  9. Click Save to save the selected team members. Vault updates the Effectiveness Check status to Initiated.
  10. Optional: Add Library References or Attachments as needed.

Completing Effectiveness Checks

The Effectiveness Check Owner is assigned a Complete Effectiveness Check task after the source Change Control or Deviation is closed and the Effectiveness Check Start Date has passed. To complete the task, document if the change was effective or ineffective, or if the results of the change are inconclusive.

If you need additional time to complete an Effectiveness Check, create an Extension Request to request a later due date.

Complete the following steps to complete an Effectiveness Check:

  1. Access the Effectiveness Check from the assigned task. Vault opens the Effectiveness Check and displays a task banner with the task due date and instructions.
  2. Expand the Results section and click Edit () on the action bar.
  3. In the Results section, select the Outcome and enter any additional information:
    • If the change was implemented successfully, select Effective and enter the Results information about the successful results.
    • If the change implementation was ineffective, select Ineffective, enter Next Steps required as a result of the change being found ineffective, and enter the Results information about the ineffective results.
    • If the change implementation is inconclusive, select Inconclusive, enter Next Steps required as a result of the change results being found inconclusive, and enter the Results information about the inconclusive results.
  4. Click Save to save the result details.
  5. Optional: Add Library References or Attachments as needed. 
  6. Click Complete on the Complete Effectiveness Check task banner to open the QA Final Approval dialog and select the appropriate verdict:
    • To complete the Effectiveness Check, select the Complete verdict and click Complete. Vault changes the Effectiveness Check status to In Approval and assigns an Approve Effectiveness Check task to the QA Approver.
    • To request cancelation of the Effectiveness Check, select the Request Cancelation verdict, enter the Cancelation Reason, and click Complete. Vault changes the Effectiveness Check status to Pending Cancelation and assigns an Approve Effectiveness Check Cancelation task to the QA Approver.

Approving Effectiveness Checks

When an Effectiveness Check is completed, Vault assigns an Approve Effectiveness Check task to the QA Approver of the Effectiveness Check. The QA Approver can approve and close the Effectiveness Check, or reject and return it to the Effectiveness Check Owner for revision.

Complete the following steps to approve an Effectiveness Check:

  1. Access the Effectiveness Check from the assigned task. Vault opens the Effectiveness Check and displays a task banner with the task due date and instructions.
  2. Review the Effectiveness Check results to determine whether to approve or reject it.
  3. Click Complete on the Approve Effectiveness Check task banner to open the Approve Effectiveness Check dialog and select the appropriate verdict:
    • To approve and close the Effectiveness Check, select the Approve verdict, select Quality Effectiveness Check Approval for the Electronic Signature Approval Meaning, enter your User Name and Password, and click Complete. Vault changes the Effectiveness Check status to Closed.
    • If the Effectiveness Check requires further work, select the Reject verdict, enter a Rejection Reason for what further work is required, and click Complete. Vault changes the Effectiveness Check status back to Effectiveness Check In Progress and assigns a Complete Effectiveness Check task to the Effectiveness Check Owner.

Approving Effectiveness Check Cancelation

When a user requests cancelation of an Effectiveness Check, the QA Approver is assigned an Approve Effectiveness Check Cancelation task. The QA Approver can approve the cancelation or reject it and return it to the Effectiveness Check Owner.

Complete the following steps to approve a request to cancel an Effectiveness Check:

  1. Access the Effectiveness Check from the assigned task. Vault opens the Effectiveness Check and displays a task banner with the task due date and instructions.
  2. Review the Effectiveness Check details to determine whether to approve or reject the cancelation.
  3. Click Complete in the Approve Effectiveness Check Cancelation task banner to open the Approve Effectiveness Check Cancelation dialog and select the appropriate verdict:
    • To approve the cancelation, select the Approve Cancelation verdict, select Cancelation Approval for the Electronic Signature Approval Meaning, enter your User Name and Password, and click Complete. Vault changes the Effectiveness Check status to Canceled. 
    • To reject the cancelation, select the Reject Cancelation verdict, enter the Rejection Reason, and click Complete. Vault changes the Effectiveness Check status to Effectiveness Check in Progress and assigns a Complete Effectiveness Check task to the Effectiveness Check Owner.