Abstract:This paper describes the comprehensive safety framework that underpinned the development, release process, and regulatory approval of BMW's first SAE Level 3 Automated Driving System. The framework combines established qualitative and quantitative methods from the fields of Systems Engineering, Engineering Risk Analysis, Bayesian Data Analysis, Design of Experiments, and Statistical Learning in a novel manner. The approach systematically minimizes the risks associated with hardware and software faults, performance limitations, and insufficient specifications to an acceptable level that achieves a Positive Risk Balance. At the core of the framework is the systematic identification and quantification of uncertainties associated with hazard scenarios and the redundantly designed system based on designed experiments, field data, and expert knowledge. The residual risk of the system is then estimated through Stochastic Simulation and evaluated by Sensitivity Analysis. By integrating these advanced analytical techniques into the V-Model, the framework fulfills, unifies, and complements existing automotive safety standards. It therefore provides a comprehensive, rigorous, and transparent safety assurance process for the development and deployment of Automated Driving Systems.