The Observations page is where an authorized user can review any observation that is part of a non-draft audit that either i) your company issued on an external supplier or internal site; ii) your company issued to an internal site; iii) a client issued to you directly through ZenQMS; or iv) a client or regulatory audit of your site that you logged in ZenQMS.
Quick Links to a Reports Observations
- Take advantage of the quick links in any of the reports tables to find related observations right away! In any audit reports tables (myReports or Audit>Reports or Show All Reports), you will see each listed report has a column called "# Obs." which stands for "Number of Observations" where any non-zero values are listed as hyperlinks. You can also add another column using the Customize button called "Unresolved Observations".
- Click the hyperlinks from either column to go immediately to the Audit>Observations page prefiltered to show the selected observations.
- Navigate to the Home > Audit > Observations tab. The default view of the table is all observations that your audit staff issued in audits of external or internal Auditees.
- Click on a column heading to sort the table by that column. You can change column order by dragging/dropping the column. Or click the "Customize" button to add/remove columns.
- Select a few observations using the check boxes in left column and click the "Export to PDF" button to download a PDF of the selected observations organized by Audit.
- Keyword search all observations for a keyword you know to be in the observations.
- Enter search terms in any column heading to instantly filter that column's data
Group Assign or Edit Observations
- Select two observations and click the "Assign" button to assign both observations to any user in your company. Since these are your 'outbound' audits, these assignments would be "Auditor Assignees". Assignees will receive a notification of their new assignment and appear in that user's myObservations page and on the dashboard. All assignments will be logged in the audit trail and comments section and assignees will be notified of items that are past their due date.
- Select two observations and click the "Edit" button to easily reset the Status or Action Due Date for all selected observations. Any actions will be logged in the audit trail and comments section.
- For the same observation, click on the "Review" link to open the Observation Review window for that observation (See picture below). Again, you can see the Action Due Date that was just assigned and can toggle it.
- You can also change the audit due date and review any Auditee or Auditor Assignee Names.
- If you don't want a particular observation to count against the audit score, click the "ZenQMS Scoring Algorithm” dropdown field to change the option.
- If the auditee has already supplied a response, you can review the response in this window under Observation Response. Auditors are able to edit the Audit Response section to enter an audit response on behalf of the auditee so long as the auditee has not yet completed the Send to Auditee workflow. Once the response is complete, you can click submit final response. If need be, there is a hyperlink to unlike the final response.
- Click the "Upload Attachments" link to upload any relevant documents. Both Auditors and Auditees can do this for an observation.
- If the observation has resulted in a CAPA, you can create and issue and add the CAPA directly from this screen by clicking the “Create an Issue/CAPA” button.
- You can choose to resolve the observation straight from this screen by clicking the “Resolve Observation” button at the top. You can reset the status to unresolved by clicking the blue hyperlink if need be.
- Note that all actions are logged in the audit trail and comments section.