1. Purpose and scope
Every earlier stage produced safety work products; this stage asks whether they add up to a convincing argument that the chip achieves the safety goals at the ASIL claimed. ISO 26262 separates three confirmation measures. Confirmation reviews check individual work products, such as the hazard analysis, the safety plan, the safety concepts and the safety analyses, for compliance and correctness. The functional safety audit checks that the safety plan was actually carried out as tailored. The functional safety assessment judges whether the item or element achieves functional safety, using the results of the other two.
Most automotive chips are developed as a safety element out of context, so the argument rests on assumptions of use: what the integrator must do, such as running a startup self test, reacting to an error signal within the fault tolerant time interval or providing an external watchdog. The safety manual makes those assumptions visible and usable. If it is incomplete, the integrator cannot carry the chip's metrics into their own system safety case.
In scope: closing confirmation reviews, the functional safety audit, the functional safety assessment, the safety case, the safety manual, the cybersecurity case under ISO/SAE 21434, and final low-level drivers and the safety software library. Out of scope: production approval, which follows in Production Part Approval & Launch.
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