11.10. Review and Approve Audit Results

Once the audit results have been submitted, the audit manager will receive a notification in their Pending Tasks prompting them to review and approve the audit results.

*An email notification will also be sent to alert them of the task. For more information on email notifications and their role in the application, click here.

Clicking on either the subject in Pending Tasks or the button in the email will direct users to the Review & Approve Audit Results form.

This form can be divided into five main sections: (1) Participant Selection & Audit Schedule, (2) Requirements, (3) Observations & Comments, (4) Trigger Quality Event(s)/CAPA(s), and (5) Audit Distribution & Approval.

1. Participant Selection & Audit Schedule

In this section of the form, users can review the audit schedule and its assigned participants.

2. Requirements

In this section of the form, users can individually review the requirement reports (submitted by the auditors).

1. View ( ): This button allows users to view an audit requirement report.
   • In viewing mode, users cannot make any modifications. They can, however, view details inside supplemental forms and download any attached files.
2. Expand ( ): This button allows users to access the full requirement description.

*To access additional options or perform actions related to the grid, please utilize the corresponding kebab menu ( ) located in the upper rightmost corner.

3. Observations & Comments

In this section of the form, users can review any observations and/or comments related to the audit and its requirements (submitted by the auditors).

1. View ( ): This button allows users to view an audit observation.
   • In viewing mode, users cannot make any modifications. They can, however, view details inside supplemental forms and download any attached files.
2. Expand ( ): This button allows users to access the full notes associated with an observation.

*To access additional options or perform actions related to the grid, please utilize the corresponding kebab menu ( ) located in the upper rightmost corner.

4. Trigger Quality Event/CAPA

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

!Once a quality event or CAPA has been triggered, it will apply to all observations selected in the respective dropdown. If users wish to create a separate quality event or 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 guidance on how to utilize single-select and multi-select dropdown fields, click here.

1. QE / CAPA Reviewer: This is a single-select dropdown field that retrieves the list of users, roles, and groups in the system. It is a mandatory field. It allows for the selection of the user, role, or group responsible for reviewing the quality event or CAPA.
2. 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.
3. 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 information on the Quality Event Management workflow, see the User Manual for the Quality Event Application.
4. 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.
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 information on the CAPA Management workflow, see the User Manual for the CAPA Application.
       

       !!While all types of observations can trigger a quality event, only major observations can trigger a CAPA.

5. Audit Distribution & Approval

In this section of the form, users can determine the recipients of the audit report, if distribution of the report is desired. Users can also decide whether to send the audit results back for further clarification or approve them.

1. Distribute Audit Report To: This is a multi-select dropdown field that retrieves the list of users, roles, and groups in the system. It allows for the selection of the the recipient(s) for the audit report.
   • Once the audit results are approved, the selected recipient(s) will receive an email including the audit report template as an attached PDF.
     
2. 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 entered 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.
3. Sign-Off: This button allows users to sign-off on the audit results, bringing the workflow to an end.
   • If selected, a pop-up window will appear prompting users to authenticate their signature with a unique code.
     

     **Users will receive this code via email. Once the code is entered, the event will be successfully signed off, and the task will be marked as completed. Users can then access their signature by viewing a PDF template of the form.