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.

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

“…The model is based on the model from Bergs et al for basic adaptations in manufacturing (cf. [2]) and was extended and adapted for the method. The adaptation options are categorized into three classes based on their scope and level of detail.…”

“…Ever faster-changing customer needs and the increasing individualization of products, as well as shorter product life-cycles result in more frequent adaptations of products and therefore, the underlying production processes [1,2].…”

Achieving parametric transparency in model-based factory planning

“…[4] This becomes particularly clear when considering an industry which needs to deliver precisely manufactured components such as the aviation industry. [5] Structural and engine components of airplanes are produced by accurate manufacturing processes along with the applicable infeed of cutting fluid-the pump of which and all feed pipes are planned by the MEP planner or by a planning department of the pump supplier. It needs to be emphasised that, in contrast to the planning of Heating, Ventilation, Air Conditioning (HVAC) or electricity, the design of cutting fluid pumps is not part of the standard planning domains of an MEP planner.…”