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

近年来，产品或部件更换的频率大大增加。其原因包括客户需求的变化、产品优化或生命周期的缩短。然而，产品变化的增加不仅发生在开发阶段，也发生在进入市场之后。如果一个产品已经在市场上，然后经历了一个变化，该产品的现有制造工艺链必须进行调整，以实现所需的产品变化。现有产品和制造过程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提出了特别的挑战。其原因是法律要求对产品和生产进行耗时且成本高的认证，在产品或生产发生变化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功能得到保证。为了提高计划的可靠性和减少认证工作，需要一个有条理的程序，技术计划人员可以借助它系统地计划安全关键部件制造中的变化。然而，目前还没有一种方法来规划安全关键部件的制造变化。因此，节约成本的潜力仍未得到开发。拟议的研究项目的目标是开发一种方法，用于规划安全关键部件制造中的变化。目标被分为四个子目标。首先，将开发一种方法，使识别制造中修改现有制造过程链的替代变更成为可能，以便更改后的产品可以继续按照要求生产。第二个子目标是开发一种方法来分析制造中确定的变化对所考虑的产品的不良影响。子目标三是开发一种方法，用于评价已识别和分析的变更，以便为选择备选方案提供决策基础。最后，第四个子目标包括将识别、分析和评估制造变化的三种方法综合为一种整体方法，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.