FMEA stands for Failure Modes and Effects Analysis, it is a step-by-step approach for identifying all possible failures in a design, a manufacturing or assembly process, or a product or service. From ISO 14971: “FMEA is a technique by which the consequences of an individual fault mode are systematically identified and evaluated. It is an […]
Hazard Analysis & FME(C)A on Jira – SoftComply Risk Manager PLUS is out now!
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 […]