My current role is that of process engineer at my company, within the manufacturing and science technology division. During this phase of the products life cycle we have to assess risks that arise from global investigations usually related to user complaint rates. So far I have been a part of 2 global investigations that are launched and initially we always assess the risk using a simple risk matrix as outlined in Dr. Simon’s lecture to categorize the risk. During this time we have all key stakeholders involved in the process to align on the categorization. Once this is completed we utilize FMECA from the information we have gathered in order to evaluate the risk and see if it is high enough to result in implementation of changes in the manufacturing process.