Abstract Every time a component’s design is changed, the corresponding manufacturing has to be changed as well. Due to several recent developments such as increasing market dynamics or ever-shorter product life cycles, the amount of component changes is rising sharply. Therefore, the number of manufacturing changes is increasing at a fast pace. Particularly for safety-critical components, the implementation of component changes within manufacturing poses a significant challenge. The reason for this is the high planning reliability required to implement a component change via a manufacturing change. This implementation has to be performed without endangering the component’s functionality, by causing any other change than the intended one. An approach for the systematic generation of manufacturing changes was developed as a contribution to increasing planning reliability and efficiency. The approach systematically enables technology planners to identify alternative manufacturing changes, to analyze the propagation of these changes, and to evaluate the alternatives to form a basis for decision-making. Its practical applicability is validated using a case study from medical technology.

中文翻译：

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系统地生成安全关键组件的制造变更

摘要 每改变一个部件的设计，相应的制造也随之改变。由于最近的一些发展，例如市场动态增加或产品生命周期越来越短，组件更改的数量急剧增加。因此，制造变化的数量正在快速增加。特别是对于安全关键组件，在制造过程中实施组件更改构成了重大挑战。这样做的原因是通过制造变更实施组件变更所需的高规划可靠性。必须在不危及组件功能的情况下执行此实现，因为会导致任何其他更改而不是预期更改。开发了一种系统生成制造变更的方法，以帮助提高规划的可靠性和效率。该方法系统地使技术规划人员能够识别替代制造变化，分析这些变化的传播，并评估替代方案以形成决策基础。其实际适用性已通过医疗技术案例研究得到验证。