This article provides an overview of how the determination of absence of
unreasonable risk can be operationalized. It complements previous theoretical
work published by existing developers of automated driving systems (ADS) on the
overall engineering practices and methodologies for readiness determination.
Readiness determination is, at its core, a risk assessment process. It is aimed
at evaluating the residual risk associated with a new ADS deployment. The
article proposes methodological criteria to ground the readiness review process
for an ADS release. Specifically, it lists 12 readiness criteria connected with
system safety, cybersecurity, verification and validation, collision avoidance
testing, predicted collision risks, impeded progress, rules of the road
compliance, vulnerable road users interactions, high-severity assessment,
conservative estimate of severity, risk management, and field safety. The
criteria presented are agnostic of any specific ADS technological solution
and/or architectural choice, to support broad implementation by others in the
industry. While intended to support the readiness evaluation for the deployment
of an SAE Level 4 ADS, their use can also be generalized for lower levels of
automation and combined with the unique human interaction challenges applicable
to those levels. Following the presentation of the proposed criteria, the
article continues with a discussion on governance and decision-making toward
approval of a new release candidate for the ADS, inclusive of a discussion on
factors that affect residual risk and risk management practices. The
implementation of the presented criteria requires the existence of appropriate
safety management practices in addition to many other cultural, procedural, and
operational considerations. As such, the article is concluded by a statement of
limitations for those wishing to replicate part or all of its content. The
content presented here serves to inform important ongoing conversations on the
topic of ADS certification and the standardization of approval guidelines in
international regulatory contexts.