In many cases, context is paramount. By putting issues in context, it helps focus on addressing relevant issues with meaning. It is this clarity of thought that drives innovation. The context used in creating functional safety systems is defined by the system integrator who is ultimately responsible for compliance with the safety standard. This in-context approach to functional safety is key for its success and why an FMEA at the system level makes sense for the system integrator. The issue is how the system integrator judges the quality of the components. The standards currently suggest the component manufacturer is to assume an application, putting the component in-context, and providing performance artifacts based on the analysis of the component within the assumed application. This presents an issue for components that can support several contexts, such as the extreme example of an FPGA.
This notion of context becomes key to understanding how to judge a component that is designed without context of the specific application and how quality is defined. If quality is defined as conformance to requirements, then unintended operation is not quality. This can be extended to say that unintended operation is dangerous in the context of functional safety.