I proposed and was the chairholder of EP27, the CLSI standard about error grids. A while ago during the document development committee discussions, I suggested that an error limit specification contain two items – the level of error (e.g., ± 10%) and the percentage of results that would meet the limit (e.g., 95%). A committee member strongly objected and said no – the spec should be the level or error only. So I said, would it be acceptable for the 10% spec, if 20% of results met the spec. He said, of course no. So I said, what about 60%? He said again no and commented – I see where you’re going. Yes, the percentage of results is used to determine acceptability but is not part of the spec. So I said, a spec is a set of criteria and an evaluation is conducted to determine if those criteria have been met, but this line of reasoning didn’t convince him. There might have been more to this story but then I was unexpectedly and rather unceremoniously thrown off the document development committee.
The basis of a spec