17 Is there a large number of installed items for which an operational profile and records of all failures exist? (i.e., can in be a ‘proven use’ possible assessment method?) 18 Does the developer have any experience of failure modes and effects analysis (FMEA) using quantified component failure rates? 19 What are the intended environmental conditions for the equipment (temperature, location, mechanical, service, etc) 20 Are there any components that could limit lifetime or duty, (e.g., gas sensors, mechanical cycling, etc) 21 Are there any internal diagnostics? (If so, how are any faults indicated so that the system can take a safe action?) 22 Does the equipment have any limitations or restrictions in terms of conducting proof tests, repair or replacement after it is installed? Application for company certification (functional safety management system)
17 Is there a large number of installed items for which an operational profile and records of all failures exist? (i.e., can ‘proven in use’ be a possible assessment method?) 18 Does the developer have any experience of failure modes and effects analysis (FMEA) using quantified component failure rates? 19 What are the intended environmental conditions for the equipment (temperature, location, mechanical, service, etc) 20 Are there any components that could limit lifetime or duty, (e.g., gas sensors, mechanical cycling, etc) 21 Are there any internal diagnostics? (If so, how are any faults indicated so that the system can take a safe action?) 22 Does the equipment have any limitations or restrictions in terms of conducting proof tests, repair or replacement after it is installed? Application for company certification (functional safety management system)
FS7RFQ.docx