<p>Team Name: Reviewer Name: [OhioU ME SrD – Project Mentor Checklist]</p><p>Tollgate 4 Checklist: Prototype Safety (including Design for Safety)</p><p>Checklist Item N Y E Notes:</p><p>Is there evidence that a Design For Safety (DFS) approach was used to eliminate significant hazards and to provide protection (and warnings as applicable) for those that cannot be eliminated? Is there evidence that a Failure Modes and Effects Analysis (FMEA) was completed, and all high severity items have acceptably low probability of occurrence? Does the design follow safety standards, ‘fail safe’ principles and include safety features and redundancy for significant hazards? Has the safety of the delivered prototype been assessed: For all design features.</p><p>For all modes of operation.</p><p>In all reasonable conditions, not just expected or favorable conditions. For all types of users, not just the most capable and conscientious, including (as applicable) ‘broad customer experience’ tests to mimic low-dexterity users, impaired eyesight users, etc. Using what-if scenarios and other methods to assess severity and risk, including scenarios where one or more safety features malfunction. Using checklists or similar to make use of compiled hazard analysis knowledge to increase likelihood that potential hazards are considered. Using tests in controlled situations to gain as much operating experience as possible before delivery to the customer.</p>