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In various branches of industry, the need for flexible production options is becoming increasingly apparent. This trend is met with higher automation, digitalization, and modularization strategies of production systems to reduce time to market and create easily adaptable systems. However, acceleration and flexibility must not be at the expense of plant safety.

Flexible systems are accompanied by new requirements for (1) risk analysis and evaluation, (2) implementation of safety systems, and (3) regulatory approval of plant safety. The approaches from conventional plants are reaching their limits when transitioning towards lot size one and approving them individually becomes impossible for every single plant setup. The possible compositions of systems are hardly foreseeable, and the combinations of system configurations and parameter settings explode. Systems such as autonomous mobile robots (AMRs), collaborative robots (cobots), robotic manipulators, or drones can implement various tasks and dynamically form a system of systems for achieving a common mission. Moreover, the trend to Software-Defined Manufacturing (SDM), where a software update can drastically change the entire production process, requires a completely new approach to risk analysis that should be performed in automated way before each software update. Assuring the safety of such system of systems is challenging due to their dynamic nature and their unstable system boundaries.