Methodology for the identification of alternative manufacturing changes for safety–critical components

Abstract

A variety of factors are forcing companies to change their products and the components these products are composed of. Examples of current factors are changing customer requirements, product optimizations or ever-shorter product lifecycles. These component changes, particularly in safety–critical components in the medical and aerospace industry, pose great challenges and are limited in scope. The challenges and limitations arise from the high costs and the amount of time involved in component recertification as required by law, as well as revalidations of the manufacturing after a change has been implemented. Some component changes are even mandatory. In this case there are no options for reducing recertification efforts by choosing between different design changes. In contrast, there are alternative manufacturing options with which to implement the prescribed component changes that can reduce the amount of revalidation required on the manufacturing side. Due to the fact that changes to the manufacture of safety–critical components require validation, the existence of alternative manufacturing changes offers the potential to save time and money by selecting the best-suited alternative. In order to be able to select the best-suited alternative, all alternative manufacturing changes must be known, which poses a challenge for technology planners dealing with the complex manufacture of safety–critical components. Therefore, a methodology is introduced to support technology planners in identify alternative manufacturing changes with which to implement scope-restricted changes to safety–critical components. The methodology is validated by applying it to a case study from the medical industry.