As we all know, A major step of risk management is risk assessment and identification. Recently, usability has been a hot topic for risk management. Most Regulatory agencies around the world would ask for the company strategy to mitigate risks arising from use issues. Some manufacturers utilize and Application FMECA to address use issues. Other companies utilize the new methodology introduced by Department of health and human services. The new methodology includes developing Task Analysis and Use Error Analysis (TA-UEA). In your opinion what is the best way to address usability Risks and what is your preference?