Vault QMS contains periodic risk review capabilities to allow your organization to store historical data about a Risk Assessment and its Assessment Risks (including risk scores and mitigation actions) in a structured format. Depending on your configuration, Vault may also automatically start an approved Risk Assessment’s periodic review workflow based on its Next Review Date field.
Configuration Overview
You must perform the following steps to enable full use of periodic risk review in your Vault:
- Configure fields on the Risk Assessment History and Assessment Risk History objects that will store copies of the data in the corresponding custom fields on the Risk Assessment and Assessment Risk objects.
- Update layouts for Risk Assessment and Assessment Risk objects.
- Enable the Assessment Risk Mitigation object (
assessment_risk_mitigation__v) - Update the Risk Assessment object lifecycle to create history records.
- Optional: Configure a workflow to enable a process that obtains approval to conduct a periodic review of a Risk Assessment record.
- Optional: Configure Vault jobs to automatically initiate a workflow to periodically request a review of an approved Risk Assessment.
Configuring Risk Assessment History & Assessment Risk History Objects
When Vault creates a Risk Assessment History or Assessment Risk History record, the system automatically copies data from certain standard fields into the history record. You can also configure Vault to copy data from custom fields in Risk Assessment and Assessment Risk records.
In order for Vault to transfer custom field data from a source Risk Assessment or Assessment Risk record to the corresponding Risk Assessment History or Assessment Risk History records, you must add the custom fields to history objects using an identical field Name and Data Type.
Configuring Layouts for Assessment & Assessment Risk Objects
Add the History related object sections to the Risk Assessment and Assessment Risk object page layouts. For both, select the Prevent record creation option.
Enable the Assessment Risk Mitigation Object
The Assessment Risk Mitigation object allows users to create and associate mitigation records for Assessment Risks. Supported mitigation record types include:
- Mitigation Actions
- Quality Events
- CAPA Actions
- Change Controls
- Continuous Improvements
- MedTech CAPAs
You must make the Assessment Risk Mitigation object active, and the Assessment Risk Mitigation related object section should be added to the Assessment Risk object layout.
Configuring the Risk Assessment Lifecycle
To ensure that Vault automatically sets field data as necessary and creates Risk Assessment History records when a Risk Assessment enters the Approved state, configure the Capture Assessment History entry action on the Risk Assessment Lifecycle’s appropriate states. You can configure the action on one or both life cycle states corresponding to the Closed and Complete state types. Typically you would do this on Approved and Approved * Pending Mitigation states.
Configuring Risk Assessment Periodic Review Workflows
Configure a workflow which allows users to obtain approval to conduct a review of an approved Risk Assessment record. If the workflow starts automatically, ensure the workflow configuration uses the Allow auto-start from entry action and event action option.
Configuring Automated Periodic Risk Review Jobs
Organizations can optionally configure Vault to automatically initiate a workflow to periodically request a review of an approved Risk Assessment. To do so, you can configure an automated Vault job that checks for approved Risk Assessment records that are due for review based on a date. When the job finds a Risk Assessment record, it changes its state to automatically start the configured periodic review workflow.