Determining Sample Size in Design V&V activities

Statistical Steven

Statistician
Staff member
Super Moderator
#41
Steven,

I hate it when standards use terms like "when used" or "where appropriate" ambiguously, as they do (IMO) in this 21 CFR 820.250. Maybe they mean what you suggest (non-statistical sampling is okay if you say it is). Maybe they mean if you don't 100% test, then you are sampling, and then you need supporting rationale.

It is much more clear if they use language like this: "Seller shall perform 100% inspection, or, if sampling inspection is used, the sampling shall conform to requirements of blah blah blah..."
The history is even more confusing...it was intended for final inspection and in-process testing, but has been expanded for ALL sampling issues. It needs to be cleaned up, I agree.
 

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