In addition to being able to apply the SoftComply Risk Manager to any Jira projects – the new feature of the Risk Manager on Jira Cloud we released in December 2020, there are another two new features we released just now.
NEW RISK PROJECT CREATION WIZARD
When you are creating a new risk project with the SoftComply Risk Manager on Jira Cloud, you can choose between 3 out-of-the box templates: Hazard Analysis, FMEA or a generic template.
The generic template has minimum amount of fixed columns in the risk table view. In case you want to manage project risks, choosing this template provides you with most flexibility – you can build the risk table based on your risk management process needs.
Hazard analysis template is based on ISO 14971 standard and is the best fit for medical device risk management. Since our templates are all fully customisable, it fits perfectly any top down product risk management process.
FMEA template is for bottom-up risk analysis and is used most often in safety-critical product development. This template is also fully customisable.
If you would like to add automation to your risk management, please see our knowledge-base for articles of tips and tricks for SoftComply Risk Manager.
HOW TO DISABLE THE HARM-SEVERITY LOCK?
In medical device risk management, risks that have the same Harm should also have the same Severity value.
SoftComply Risk Manager helps keep your risk data consistent by locking the Harm and Severity values for you when you have chosen Hazard Analysis or FMEA templates.
If you change a Severity value of a risk, the SoftComply Risk Manager will now inform you about the other risks in which this change will occur due to the risks sharing a Harm.
In case you would like to manage other risks with the SoftComply Risk Manager, you can now disable the lock in the “Project Settings”.