9.4. Contain/Correct Issue

If the reviewer submits the quality event for immediate containment or correction, the creator will receive a notification in their Pending Tasks prompting them to address and rectify the issue.

*An issue is submitted for immediate containment if, upon initial review, the quality event is determined not to require action items or escalation to CAPA.

They will also receive an email notification informing them of the assigned task.

Clicking on either the subject in Pending Tasks or the link in the email will direct the user to the Contain/Correct Issue form. In this form, users can review the details of the quality event, report immediate containment measures, and then decide whether to conclusively close the quality event or proceed with submitting it for further exploration.

*For guidance on common form functions, please refer to the dedicated section in the manual.

1. Attach Any Relevant Documents: This is an attachment field that allows users to upload any documents related to the issue containment.
2. Provide the Details of the Containment Measures: This is a rich text field that allows users to provide detailed information about the implemented containment measures.
3. Need More Details: This button allows users to submit the issue for further exploration.
   • If selected, the creator of the quality event will be tasked with gathering additional details.
4. Close QE: This button allows users to to close the quality event, bringing the workflow to an end.
5. Save Form: This button allows users to save the form. It will remain in the Pending Tasks folder.