QualityOne Vaults provide audit-specific checklist functionality to allow you to create your own audit checklists to conduct an audit. These checklists enable you to identify one (1) or more checklist items as audit findings when performing an audit. When you complete and submit a checklist, QualityOne automatically creates audit finding records along with the finding type, observations, and objective evidence (attachments) for any audit checklist question flagged as an audit finding.
Before you can utilize this functionality for your audits, your Admin must configure it for use. For help with general checklist functionality, see Working with Checklists for more details.
Depending on your Admin’s configuration, object, field, and section labels may appear differently than the labels mentioned in this article.
If enabled, you can use QualityOne Audit Checklist Mobile to download and perform an audit checklist on an iPadOS and an Android device for a checklist already configured in Vault.
About Audits
Conducting internal and supplier audits generally requires checklists as part of standard practice in quality management. An Audit record consists of an audit team responsible for auditing processes based on the scope assigned to them as part of an audit program plan. You may run an action to trigger Vault to automatically assign each team member an audit checklist to aid them in conducting audits based on the matching fields and metadata. Based on a checklist design, you may also run an action to assign a specific checklist to a specific user manually. Typically, each user prepares their checklist as part of their preparation before they conduct the audit remotely on-site. As a result, an Audit record may have one (1) or more checklists assigned to one (1) or more users in the team. When you work with your checklists, you can respond to a series of questions in a form-filling UI. Each question allows you to flag a response with one (1) or more audit findings. Entering audit findings in a checklist allows the audit team to review each response for additional follow-ups and create necessary action items.
How to Create Audits
In order for you to start checklists, you need to have all the required Audit records created. You may also include these Audit records as part of your audit program planning to scope the type of checklists required.
To create an Audit record:
- Navigate to Audits and select the audit type required.
- Click Create.
- Enter a Title.
- Enter a Description, Purpose, and Scope.
- Select an Audit Criteria.
- Enter the Audit Criteria Details.
- Select a Facility.
- Optional: Enter the Supplemental Field.
- Click Save, or to create another Audit type, click Save + Create.
Assigning Audit Checklists
There are three (3) ways to assign audit checklists to audit team members:
- Running a user action that manually assigns a specific checklist to a specific audit team member as the respondent. See About the Manual Checklist Assignment Action for more details.
- Starting a checklist through a user action, which assigns the audit checklist to the workflow owner as the respondent. See Starting an Audit Checklist for more details.
- Triggering Vault to automatically assign each team member as the respondent for the audit checklist by an entry action (lifecycle state change). See Starting an Audit Checklist for more details.
About the Manual Checklist Assignment Action
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 action lets you assign specific checklists to specific users without adding the additional metadata that automatic checklist assignment requires.
For example, an auditor is preparing for an upcoming internal audit in manufacturing. The auditor creates a Checklist Design record called “Manufacturing Audit” which includes all the questions they want to answer when performing the audit. In the Audit Preparation lifecycle state of the Audit workflow, the auditor adds an audit checklist template to the Audit record in the Audit Checklist Assignment section of the page layout. The auditor 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 conducted.
If you use matching fields in the Checklist Design record, you can only have one (1) audit checklist template with the same matching field values. So if you want to create a new version of your checklist for a future audit, you cannot save both checklists in Vault.
How to Manually Assign a Checklist
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.
Starting an Audit Checklist
Depending on your configuration, you can start an internal and supplier audit checklist through either a lifecycle state change or a user action on the Audit object type record. Your organization may modify these workflows or add custom workflows to suit your team’s needs. You can initiate a workflow from the Workflow Actions menu and start a checklist from the appropriate record’s All Actions menu.
Vault automatically assigns the workflow owner as the checklist respondent when you start the checklist through a user action. Vault relies on the entry action configuration to determine the respondents when starting through an entry action. During configuration for the entry action, Admins choose a role from the object. When the lifecycle state change occurs, any user with that role sees the checklist task as an available task.
Using Audit Findings
Depending on your permissions and checklist configurations, you can view, create, and delete audit findings related to an audit checklist question response.
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 major finding 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 the audit team’s decision, this nonconformance may require resolution by the next audit since it is lower in severity.
- Opportunity for Improvement (OFI): A suggestion from another user to help improve a product or process based on observation 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 audit team.
To create one (1) or more audit findings, click the Create button under Audit Findings, then select an Audit Finding Type and click Continue.
After completing the Finding Type and Observations fields, 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.
Completing Audit Checklists Remotely
Once assigned an audit checklist, you can complete the audit checklists in Vault on your browser or remotely on your device. Completing your checklist remotely on a portable device allows you the freedom to conduct your audit on-site in real-time. See Using QualityOne Audit Checklist Mobile for more details.