Impact of FMEA on improving software reliability of an ultrasound system designed for emerging market countries

Philips has developed a new Ultrasound system, ClearVue, targeted for emerging market countries such as India and China. The product has been developed at different global locations in the world, including North America, China and India. The authors are part of the India team located at Bangalore. The authors, in their role as system architect, system reliability lead, and software architect, have led several activities focused on improving the overall product reliability from software and hardware aspects. This paper is to share their experiences on usage of a variation of FMEA (Failure Mode Effect Analysis) techniques to improve the software reliability of the system. The variation that the team followed was to include criticality analysis of the identified failure modes. This variation, called as FMECA (Failure mode effect and criticality analysis), was specifically chosen since the software under consideration is for a medical device where patient safety and correct diagnosis are of critical importance to the reliable software operation.