There are many risk management plans for different backgrounds. In the medical device industry we base our risk management plans on ISO 14971. Every time we mention risk management I think of ISO 14971, because the medical devices companies have to be comply with ISO 14971. In this industry of design, manufacturing, research and development, the ISO 14971 process must be followed, it is the bread and butter to the risk management plan. This plan covers everything from potential hazard to the severity to an adverse event that can take place. It really important especially in the medical device industry. Any device has a potential liability, the plan is to find and state the potential issues.