QualityOne Vaults allow organizations to manage the risk associated with enterprise, operational, product, project, and customer processes using the Risk Management feature within the QualityOne QMS and HSE applications. Risk Management includes the ability to define risk levels using risk matrices, then assess related risks using risk registers. Risk Management supports creating and performing HAZOP (Hazard and Operability Studies) and P-FMEA (Process Failure Modes and Effects Analysis) types of risk studies. These tools help your organization remain compliant with the most up-to-date requirements for risk-based decision making, allowing you to control risks before they become a reality.
Note: To enable 2D and 3D risk matrices in the same Vault, contact your Veeva Representative.
Risk Matrix Visualization
Vault can display the traditional risk matrix chart as a section in a Risk Matrix record. The visualization is a chart with colored cells corresponding to the values defined in your risk matrix for each combination of severity and likelihood.
Note: Visualization is available for two-dimensional matrices only.
To insert a risk matrix visualization section into a Risk Matrix object layout:
- Navigate to Configuration > Objects > Risk Matrix > Layouts.
- Select the layout you want to update.
- Click Insert Section, and choose Risk Matrix Preview.
- Enter a Label for the section.
- Click Done.
- Optional: Click and drag your Risk Matrix section to reorder.
- Click Save.
Example: Qualitative Risk Matrix Visualization
Example: Quantitative Risk Matrix Visualization
About Risk Matrix Dimensions
If you enabled Risk Management in your Vault prior to 23R3 and need to use both 2D and 3D matrices in the same Vault, you must contact your Veeva Representative to enable and configure.
Detectability in 3D Matrices
Vault calculates risk based on severity and likelihood of occurrence and displays it in a two-dimensional matrix. If enabled for your organization, you can also include detectability as the third factor in Vault’s risk calculations to convert your matrix into a three-dimensional matrix. Matrix visualization is not available for three-dimensional matrices. Once you enable detectability and build 3D risk matrices, we do not recommend turning off 3D matrices in your Vault.
Configuring Risk Management Object Actions
The Risk Study object lifecycle contains the Copy Risk Study action. This action triggers Vault to clone the related Risk Study, HAZOP Node, FMEA Process Step, and Risk Analysis records into a new set of records.
When users run the Copy Risk Study action, Vault does not copy the following:
- System-managed fields.
- Fields if the Do not copy this field in Copy Record configuration is selected.
- HAZOP Node and FMEA Process Step records if the Allow Hierarchy Copy configuration is unselected.
- A Risk Study record when more than 1,000 records are available to copy from the Risk Study record.
You can add this action as a record action on the Risk Study object or as a user action on the appropriate Risk Study Lifecycle states, depending on your business needs.