R
I've been in med device for awhile now and worked a few different places. I keep running into inspection plans that call for 20% of the lot to be inspected. Typically, the company follows the 20% rule without process validation being done at all - as if 20% inspection of the lot somehow negates the need to validate the process. But, when I ask why 20% is considered sufficient since the process isn't validated, I never get an answer that makes sense to me (if I get one at all, blank stares seem to be the most common answer which is amazing to me that people can do things so blindly, what ever happened to curiosity!?!? but that's a post for a different day).
So... Has anyone else heard of this? Is this related to a standard that I haven't been able to locate? Is this a "rule of thumb" in the industry that's just accepted and not necessarily based on anything? Some people say its based on AQL and/or probability theory, but can't seem to follow the creative math used to justify these answers.
If anyone has insights - please let me know.
Thanks!
So... Has anyone else heard of this? Is this related to a standard that I haven't been able to locate? Is this a "rule of thumb" in the industry that's just accepted and not necessarily based on anything? Some people say its based on AQL and/or probability theory, but can't seem to follow the creative math used to justify these answers.
If anyone has insights - please let me know.
Thanks!
