Methodology for the integrative adaption of manufacturing process and inspection sequences to component changes of safety–critical medical products

Abstract

Ever-shorter product lifecycles and more frequently changing customer demands challenge manufacturing companies to change their products and the components these products are composed of in ever-shorter periods. As a result, the existing manufacturing process and inspection sequences (MPISs) of the corresponding components must be adapted. Particularly in the production of safety–critical components, such as in the medical industries, component changes represent a major challenge, as very high quality requirements are placed on the components and a costly re-certification of the adapted processes is necessary. Due to the high quality requirements, not only the manufacturing process but also the inspection processes must be adapted for the realization of a component change. Furthermore, a high degree of planning reliability is necessary when deriving adaptations of MPISs for component changes to keep the re-certification effort and adaptation costs for safety–critical components as low as possible. Therefore, a methodology is introduced for the integrative derivation of adaptation options of MPISs due to component changes that supports users in identifying suitable adaptations in a systematic and time-efficient way. The methodology is successfully applied to a use case from the medical industry and supports users in identifying adaptations in established MPISs to implement a component change.