ROOT CAUSE ANALYSIS AND IMPLEMENTATION

Product complaints were being received by a medical device manufacturer and resolution of a design issue was needed to address product quality and safety issues. Dellshire engineers recommended that a root cause analysis be completed using a structured problem solving approach. After a clear and accurate problem statement was created and agreed upon, root cause analysis tools were deployed including Is-Is Not, Fault Tree Analysis, Fishbone Diagram and Contradiction Matrix to quickly identify probable root cause. A test machine was designed and built and was used to evaluate design options. The business was able to evaluate the implementation plans for the viable options and determine the appropriate course of action based on the work that Dellshire completed.