An approach to manage the concept phase of ISO 26262

We face two difficulties when applying ISO 26262[1] in the concept phase. ISO 26262 is the functional safety standard in the automobile field and requires strict safety requirements. Usually, it is not easy to divide requirements into safety parts and non-safety parts because they are closely connected with each other. That is, we have to perform two activities, functional development and functional safety activity, simultaneously. Other difficulty is a term item. From the definition, the item is a 'system 1.129 or array of systems to implement a function at the vehicle level'. In concept phase, we apply hazard analysis to an item, not system. The system definition comes after item definition and hazard analysis and risk assessment. So, it is hard to use the conventional methods e.g. Failure Mode and Effect Analysis FMEA and Fault Tree Analysis FTA.