M
mschaller
Hello,
I've always worked at medical device companies where an SOP (Standard Operating Procedure) defines the reliability and confidence levels for me based on a given risk index. For example, based on the output of an FMEA I will have the estimated severity, occurrence, and detection which combine to form some risk index (sometimes an RPN is used). And based on that, I look at a table in the SOP which says I need .9900 reliability at 95% confidence, or perhaps it's a different level.
How are these levels defined? Is there a standard which defines what typical reliability/confidence levels should be used?
Typically, I have used .99 reliability as tightest control, .975 reliability as medium control, and .95 as loosest control (all with 95% confidence).
What do other companies use?
Thanks for the help!
I've always worked at medical device companies where an SOP (Standard Operating Procedure) defines the reliability and confidence levels for me based on a given risk index. For example, based on the output of an FMEA I will have the estimated severity, occurrence, and detection which combine to form some risk index (sometimes an RPN is used). And based on that, I look at a table in the SOP which says I need .9900 reliability at 95% confidence, or perhaps it's a different level.
How are these levels defined? Is there a standard which defines what typical reliability/confidence levels should be used?
Typically, I have used .99 reliability as tightest control, .975 reliability as medium control, and .95 as loosest control (all with 95% confidence).
What do other companies use?
Thanks for the help!