When we test design changes or process changes at our medical device manufacturing company, we typically have a Cpk or %Confidence/%Reliability requirement we have to pass. However, it's possible to pass this requirement but have one or more individual values that fall outside the spec limits. Is this considered acceptable or should we have a second pass/fail criterion where every individual value must also pass? I have seen it both ways. I'm curious how FDA or ISO auditors would view this.