We are happy to inform you that our Risk Management solution for Jira has gotten an upgrade for Jira Server users – the SoftComply Risk Manager Plus focusing specifically on safety-critical product/device/system risks.
SoftComply Risk Manager Plus supports both Hazard Analysis as well as FME(C)A, including FME(C)A with Detectability and RPN (Risk Prioritization Number).
Although ISO 14971 requires only to identify and analyze hazards, thus suggesting a Top-Down approach, it is a best practice among safety-critical system developers to complement it with a Bottom-Up analysis, i.e. a FME(C)A.
The purpose of this combined approach is to ensure all risks and faults are captured during the analysis. The two approaches will have many scenarios in common, but this redundancy will also provide additional failures that may have been missed using only one method.