Harms can be created by Quality Owners, Approvers and Editors.

Note: This video was created using V1.25. Enzyme is updated weekly so some elements may change.

Manage Harms

Access Risk Management under Product in the Navbar . 

In the product selector, choose the product for which you want to see the risk items. 

Create a Harm
To create a new Harm, click on the + next to it to open up a new window. 

Select the Hazardous Situation associated with the harm, add its description and its severity. 

Set the initial probability of the harm and the mitigated probability. Severity/Probability levels are set by the Admin under the Severity/Probability Levels tab in their User Settings menu. Controls reduce the probability of a harm occurring. 

You generally want to reduce risk as much as possible, and you need to have a very good explanation to regulators if you ship a product with any High risk. 

Click Save Changes when you are done and the harm will be saved as draft. You will have to submit a Change Request to get it approved. 

Edit a Harm
To edit the Harm, hover over it until you see the Edit menu. 

You can edit, delete and see the history of the Harm. When you edit a Harm (that has been approved), it will once again be in a draft state.

You will have to submit it for approval and in the Change Request provide justification for the change. 

If you have any questions, you can reach us through the in-app chat or email us at support@enzyme.com. 


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