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

近几年来，更换产品或成分的频率显著增加。作为原因，提到了客户要求的变化、产品优化或缩短的生命周期。然而，产品变化的增加不仅发生在开发阶段，也发生在进入市场后。如果一个产品已经在市场上，然后经历了变化，为了实施所需的产品变化，必须调整该产品的现有制造工艺链。现有产品和制造工艺序列的变化对医疗技术和航空航天的安全关键部件的制造构成了特别的挑战。这样做的原因是产品和制造的法律要求、耗时和成本密集型认证，在对产品或制造进行更改后必须再次进行认证。这些新的认证要求高度的规划可靠性，以确保在制造过程中进行更改后产品的功能得到保证。为了增加规划的可靠性并减少认证工作，需要一种系统的程序，技术规划者可以借助该程序系统地计划安全关键部件的制造变化。然而，目前还不存在计划安全关键部件制造中的变更的方法。因此，节约成本的潜力仍然没有显现。拟议研究项目的目标是开发一种方法，以规划安全关键部件制造中的变化。这个目标被分为四个子目标。首先，将开发一种方法，使其能够确定制造中修改现有制造流程链的替代变化，以便能够继续按照要求制造改变后的产品。第二个子目标是开发一种方法来分析制造过程中识别的变更，以确定对所考虑的产品的不利影响。次级目标三是制定评价已查明和分析的变化的方法，以便为选择备选方案提供决策依据。最后，第四个次级目标包括将确定、分析和评价制造变化的三种方法综合成一种整体方法，通过这种方法，可以以成本优化的方式规划安全关键部件的制造变化。

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.