9.2. Review the Issue

Once the New Quality Event form has been submitted, the assigned reviewer will receive a notification in their Pending Tasks prompting them to examine the issue.

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 Review the Issue form. In this form, users can review all previously entered information pertaining to the quality event and, where applicable, make necessary modifications. Users can also offer feedback or comments and determine the next course of action.

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

1. Review Notes: This is a rich text field that allows users to provide notes and observations related to the quality event.
2. Comment: This field allows users to add comments related to the quality event.
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. Correct Issue Immediately: This button allows users to promptly contain or correct the identified issue.
   • If selected, the creator of the quality event will be tasked with implementing the necessary containment or correction measures.
     

     **Users can decide to contain the issue immediately if, upon initial review, the quality event is determined not to require action items or escalation to CAPA.

5. No Issue: This button allows users to close the quality event, if upon review they find there is no underlying issue.
   • This brings the Quality Event workflow to an end.
6. Send for Modification: This button allows users to send the quality event back for modification.
   • If selected, the creator of the quality event will be tasked with modifying it.