This gets sorta esoteric, but what the hey...
Not long after I signed onto this gig, a rash of out-of-specification results came up associated with about 10 of our product codes.
We were pretty sure the issue was central to a raw material (actually a film) that we use, but the end result was we had an OOS.
In my line of work, that's a problem.
But the actual specification range (at the high end) was fundamentally subjective in nature. If the spec was exceeded, the worst thing that would happen is that a customer/patient would have to employ The Hulk to activate the pouch and thereby create cold. (We manufacture thermal packs.)
In other words, the subassembly that is supposed to burst upon squeezing, wouldn't.
Assigning a value to this kind of spec is a little iffy too.
Anyway, we've been limping along for more than two years now on a system that I imported from the pharma world called "planned deviations". This one was planned a lot longer than is intended, but the upshot is, I crunched the numbers and wrote a paper justifying raising the upper spec limit. I verbally talked it over with my boss, who is in Chicago (I'm in Missouri) and he liked what I'd done.
So I get to close out a thorn that's been in my side for more than two years AND raise the spec limit, which should remove our problem.
(There's a lot of detail I didn't get into, what with how the specs came to be, etc., but let's just say it's a Happy Day.)
