QualityOne Vaults provide audit-specific checklist functionality to allow Auditors to create their own audit checklists. These checklists allow Auditors to identify one or more checklist items as audit findings when performing an audit. When an Auditor completes and submits a checklist, QualityOne automatically creates audit finding records along with the finding type, observations, and objective evidence (attachments) for any audit checklist question that is flagged as an audit finding.
Before you can utilize this functionality, Admins must configure it for use in audit checklists.
Note that QualityOne Mobile for iPadOS™ allows users to download and perform an audit checklist on an iPad® for a checklist already configured in Vault.
Manual Checklist Assignment for Audits
The Manual Checklist Assignment user action assigns an audit checklist template, also called a Checklist Design record, to a specific Vault user, without the use of matching fields. This lets users assign specific checklists to specific Auditors without adding the additional metadata that automatic checklist assignment requires. Note that this user action may have a different label, as configured by an Admin.
For example, Adam Auditor is preparing for an upcoming internal audit in manufacturing. Adam creates a Checklist Design record called “Adam Manufacturing Audit” which includes all of the questions they want to answer when performing the audit. In the Audit Preparation lifecycle state of the Audit workflow, Adam adds an audit checklist template to the Audit record in the Audit Checklist Assignment section of the page layout. Adam then selects the user action Manual Checklist Assignment which creates a new instance of the checklist design and makes it available for completion in the Audit Performance lifecycle state of the workflow where the audit is being conducted.
Using matching fields, you can only have one audit checklist template with the same matching field values. This means that if an Auditor wants to create a new version of their checklist for a future audit, they will not be able to save both checklists in the system.
Using Manual Checklist Assignment
On an Audit record, selecting a checklist template in the Audit Checklist Template section without matching fields leaves an empty User Responsible field.
To assign a User Responsible manually:
- Create an Audit Checklist Assignment record.
- Select a checklist template from the available checklists.
- Select the user responsible for completing the checklist.
- Click Save.
- Select the Manual Checklist Assignment user action.
Vault then creates a checklist and assigns it to the selected user.
Audit Findings
This option allows a response to an audit checklist question by having the ability to create one or more Audit Findings when you click the Create button under Audit Findings.
Using Audit Findings
Depending on your permissions and checklist configurations, you may be allowed to view, create, and/or delete audit findings related to an audit checklist question response.
To create one or more audit findings, click the Create button under Audit Findings, then select an Audit Finding Type and click Continue.
Typically, finding types match these descriptions:
- Major Finding: A major nonconformance, observed during the audit, that requires corrective action within a specified time frame. This most likely includes a detailed investigation, root cause analysis, and action plan.
- Minor Finding: A minor nonconformance, observed during the audit, that requires corrective action. Depending on what is discussed in the audit team, this nonconformance may require resolution by the next audit, since it is lower in severity.
- Opportunity for Improvement (OFI): A suggestion from the Auditor to help improve a product or process based on what was observed during the audit. No action is required for these types of findings. Decisions on whether and how to address OFIs are at the discretion of the Auditee(s).
After the Finding Type and Observations fields are completed, click Save. The saved Audit Finding will appear as a token. To view the audit finding, hover over the token to display the hovercard details.
To delete audit findings, click the X beside the token to remove it from the question. Note that the hovercard detail display and ability to view, create, and delete the Audit Findings may differ depending on your Admin’s configuration.