The Risk Management modules, allows you to determine the risks for a product and how you plan on mitigating those risks.
Note: This video was created using V1.24.2. Enzyme is updated weekly so some elements may change.
Overview of Risk Management
Access Risk Management under Product in the navigation menu.
In the product selector, choose the product for which you want to see the risk items.
Then in the module you will see all the risks items associated with the product.
Risk is broken down into three components:
- Hazards: Aspects of the product that can introduce risk to your users (ex. Presence of an implanted battery)
- Hazardous Situations: How the hazard can become harmful (ex. Battery shorting)
- Harms: The nature of the harm to the user (ex. Tissue damage)
Those result in the risk score:
- Risk (Initial): Score based on the severity and probability of the harm
- Controls: Product requirements that mitigate the risk
- Risk (Mitigated): Score is taking into account any Controls
For ease of readability, multiple harms within a hazard will collapse into the highest severity hazard by default. To expand, click the arrows to view all the harms associated with a hazard and situation.
Risks can be set by the Admin under the Risk Matrix tab in their User Settings menu.
The CCOHS website provides additional guidance on what classifies as a risk, harm and situation.
If you have any questions, you can reach us through the chat or email us at firstname.lastname@example.org.