At Zimmer, I was involved with a project where the Case Development team was designing and launching a new case for a product. The case was for a total knee replacement and had compartments for all the tools a surgeon would use to conduct the surgery. As an intern, I did not have a major part in the FMEA process, but I got to work on the FMEA for part of the project. I had to look at the outer components and analyze the criticality and risk should a failure occur. We had preliminary dFMEA’s available but I had to come up with additional failure locations and analyze them on the appropriate blueprint and write what was called a FIP or Feature Inspection Plan. After I wrote the FIP, I got approved by the senior QE’s and higher up on the corporate ladder. To answer your question, once an area of risk was measured, we looked at the appropriate dFMEA and assigned it a number based on severity. If the component was a critical component and the severity was high, it would have to be re-designed (for the part I did, it was not a major component of the project). The risk was determined by whether or not it would affect the user in any way. Would it cause harm, irritation, etc.