Using Periodic Risk Review (QMS)

As an organization’s business environment changes, so do the risks posed to its enterprise and operational processes. Your organization may need to periodically review its Risk Assessments to ensure they are addressing risk appropriately based on the current state. This allows your organization to understand how risk changed over a period of time, providing insight into how you might continue to address risk.

When performing periodic reviews, organizations want to capture a snapshot of a Risk Assessment and its Assessment Risks. If configured by an Admin, QMS contains 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 the configuration of your Vault, the system may also automatically start an approved Risk Assessment’s periodic review workflow based on its Next Review Date field.

About Historical Risk & Risk Assessment Data

As a result, you can easily view previously approved Risk Assessments and their Assessment Risks at points in time, including the following data:

  • Risk Assessments:
    • Summaries
    • Approvals and eSignatures
  • Assessment Risks:
    • Risk scores
    • Risk mitigation actions
    • Assessment risk documents
    • Assessment Risk Mitigations (if using the assessment_risk_mitigation__v object)
      • Mitigation Actions records (including CAPA Action, Change Control, Continuous Improvement, MedTech CAPA, and Quality Event)

Viewing Historical Risk & Risk Assessment Data

You can view historical Risk Assessment data in the folloiwng ways:

  • Navigate to the current Risk Assessment record detail page. Vault displays data from previous iterations of a Risk Assessment in the Assessment History section.
  • While viewing a Risk Assessment in the Risk Builder, click the history icon .  Vault displays the list of Assessment History records. When you select an Assessment History record, the Risk Builder grid will refresh to show the associated Assessment Risk History records records for the selected Assessment History record.
  • Compare Assessment Risk versions.

The columns displayed in the Risk Builder are based on the configuration chosen by your Admin.

Comparing Assessment Risk Versions

You can compare different versions of Assessment Risks in an Assessment by selecting Compare Versions from the Risk Builder’s Actions menu while in view mode. When you select this action, Vault displays a dialog from which you can select a previous version of the Assessment to compare against the current version and specify up to 20 Assessment Risk fields to compare. The list of selected fields defaults to the first 20 columns of the Risk Builder view the first time you run the action, and to your previous selections on subsequent runs.

After clicking Confirm in the dialog, the resulting page lets you filter Assessment Risks to see all risks that were added, modified, or unchanged since generating the selected historical version of the Assessment. Rows containing added Assessment Risks are highlighted in green, and cells containing modified field values are highlighted in blue. You can hover over cells to see the historical and current field values. Hovercards display up to 100 characters. If a field value exceeds 100 characters, you can click View More to see the full value. Vault can compare up to 2,000 risks at once.

To view historical risk and risk assessments data, you must have a security profile or role with the following permissions:

  • Read permissions on the Assessment Risk Mitigation History, Assessment Risk Documents History, Assessment History, and Assessment Risk History objects.