Although severity and number of occurrence are the main large categories that must be looked at for risk management, there should be more evaluation and discussion of other categories such as user’s age, quality of life after product failure, cost of replacement, cost of losing or damaging brand name, number of users, shares affected, patterning companies affected, etc.

To elaborate on one of the above mentioned category: User’s age, is a very important category that is actually analyzed a lot when evaluating orthopedic implants. About 40-50 years ago, hip and knee replacements were meant for people over 50 years, so failure after 10-20 years was not taken too seriously. Now a days, people as young as 20 or 30 get such replacements, so risk analysis patterns have changed, and failure after 10-20 years is a high risk.