Cost-optimized planning of changes in manufacturing of safety-critical components through systematic manufacturing change management

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The frequency with which products or components are changed has been increasing considerably in recent years. As reasons for this, changed customer requirements, product optimizations or shortened life cycles are mentioned. However, the increase of product changes does not only take place during the development phase, but also after market entry. If a product is already on the market and then undergoes a change, the existing manufacturing process chain of the product must be adapted in order to implement the required product change.Changes of existing products and manufacturing process sequences pose a particular challenge for the manufacture of safety-critical components from medical technology and aerospace. The reasons for this are legally required, time-consuming and cost-intensive certifications of products and manufacturing, which must be carried out again after changes have been made to products or in manufacturing. These new certifications require a high degree of planning reliability to ensure that the product functionality is guaranteed after changes have been made in manufacturing. In order to increase planning reliability and to reduce certification efforts, a methodical procedure is required by the help of which technology planners can systematically plan changes in manufacturing of safety-critical components. However, a methodology for planning changes in manufacturing of safety-critical components does not currently exist. Thus, cost saving potential remains untapped.The goal of the proposed research project is to develop a methodology for planning changes in the manufacturing of safety-critical components. The goal was divided into four subgoals. First, a methodology will be developed that makes it possible to identify alternative changes in manufacturing that modify the existing manufacturing process chain so that the changed product can continue to be manufactured in line with requirements. The second subgoal is to develop a methodology to analyze the identified changes in manufacturing for unwanted impacts on the considered product. Subgoal three is the development of a methodology for the evaluation of the identified and analyzed changes, in order to generate a decision basis for the selection of an alternative. Finally, the fourth subgoal comprises the synthesis of the three methodologies for the identification, analysis and evaluation of changes in manufacturing into a holistic methodology, by means of which changes in manufacturing of safety-critical components can be planned in a cost-optimized manner.