12.1.9. Review and Approve Audit Results

Once the audit results have been submitted, the auditor manager will receive a notification in their Pending Tasks informing them that they need to review and approve the audit results.

They will also receive an email informing them that they have a new task to do.

Clicking on either the subject in Pending Tasks or the link in the email should direct the auditor manager to the Review & Approve Audit Results form. This form can be divided into three main sections: (1) Requirements, (2) Entered Observations, and (3) Trigger Quality Event(s).

1. Requirements

Users cannot make any modifications in this section of the form. They can, however, individually view the requirement reports (submitted by the auditors).

1. View: This button allows users to view the audit requirement report.
   • To view, select the desired requirement from the grid and click on the View button. In viewing mode, users cannot make any modifications. They can, however, view details inside supplemental forms and download any attached files.
2. Export to Excel: This button allows users to export the Requirements grid to Excel.

2. Entered Observations

Users cannot make any modifications in this section of the form. They can, however, view any previously defined observations.

1. View: This button allows users to view an audit observation.
   • In viewing mode, users cannot make any modifications.
2. Export to Excel: This button allows users to export the Entered Observations grid to Excel.
3. : This button allows users to view the full contents of the note.
   • If selected, it will open a pop-up window with the information.
     

3. Trigger Quality Event/CAPA

In this section of the form, users can trigger quality events/CAPAs for the audit observations (shown in the previous section).

!Once a quality event/CAPA has been triggered, it will apply to all observations selected in the dropdown. If users wish to create a separate quality event/CAPA instance for different observations, they will need to select those observations one by one and click on either the Create Quality Event or Create CAPA button after each selection. An observation can only be selected and triggered for a quality event/CAPA once.

*For more details on the single-select and multi-select dropdown fields populating this form, click here.

1. Observation(s) for Quality Event: This is a multi-select dropdown field that retrieves the list of observations for the audit. The observation(s) selected in this dropdown will be, upon request, sent to the Quality Event application.
2. Observation(s) for CAPA: This is a multi-select dropdown field that retrieves the list of observations for the audit. The observation(s) selected in this dropdown will be, upon request, sent to the CAPA application.
3. Reviewer: This is a single-select dropdown field that retrieves the list of users. It is a mandatory field. The user selected will be assigned as the reviewer of the quality event/CAPA.
4. Create Quality Event: This button allows users to create a quality event.
   • If selected, a message will appear informing the user of the Quality Event ID.
     
   • The assigned user will automatically be tasked with reviewing the issue. Details about the audit plan and the selected observations associated with the audit plan will be included in this task.
     • For more details on the Quality Event workflow, see the User Manual for the Quality Event Application.
5. Create CAPA: This button allows users to create a CAPA.
   • If selected, a message will appear informing the user of the CAPA ID.
     
   • The assigned user will automatically be tasked with reviewing the CAPA. Details about the audit plan will be included in this task.
     • For more details on the CAPA workflow, see the User Manual for the CAPA Application.
   • Note: Only major observations can be sent to CAPA.
6. Clarification Required: This button allows users to send the audit results back for further clarification.
   • If selected, the assigned auditor(s) will be tasked with re-executing the audit.
     • They will again receive the Execute Audit form, except this version will include all previously populated information. Users can still make modifications where applicable.
     • Once the audit has been re-executed, its results will be sent back for review.
       • If upon review, the results are approved, the Plan & Execute Audits workflow will end.
       • If upon review, the results are sent back for further clarification, this process will repeat.
7. Sign-Off: This button allows users to sign-off on the audit results, bringing the Plan & Execute Audits workflow to an end.