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  • Mattie718 replied to the topic Design Transfer in the forum Project Management Process and Medical Device Development 6 years, 6 months ago

    There are many obstacles to consider when attempting to ramp up something from prototype to mass production. Usually a Performance or Process Qualification protocol will need to be completed to prove there is long-term stability and quality built in to the process. Each part needs to have acceptance criteria with upper and lower control limits which determine whether it is considered a failure or not. This is most likely done through various statistical process control methods such as control charts. Different types of products will require a certain tolerance and acceptance criteria based off of its risk profile. Utilization of statistical process control is crucial in preventing defective parts from slipping through the cracks and determining if the process is robust enough to satisfy the customer’s demands.