N
Hi there-
I am working on a IVD disposable for which there is a categorical (pass / fail) test. I have looked at the standard sampling plans for relatively tight acceptable quality limits, and I find the output results to be slightly odd: the sample size doesn't go over a large range of lot sizes. For example, for a 0.1% AQL, for a 100 piece lot, I need to 100% test. For 1000, I test 125, for 10000, I test 125. I am not a stats expert, but this doesn't seem right to me. Surely the percentage sampled should decline as lot sizes grow, but I would imagine a 10,000 part lot should require more parts tested than 1000.
Is there a different methodology y'all could recommend that is defensible from a regulatory perspective but also contains more logically sound sampling frequency?
Thanks for your help,
Nick
I am working on a IVD disposable for which there is a categorical (pass / fail) test. I have looked at the standard sampling plans for relatively tight acceptable quality limits, and I find the output results to be slightly odd: the sample size doesn't go over a large range of lot sizes. For example, for a 0.1% AQL, for a 100 piece lot, I need to 100% test. For 1000, I test 125, for 10000, I test 125. I am not a stats expert, but this doesn't seem right to me. Surely the percentage sampled should decline as lot sizes grow, but I would imagine a 10,000 part lot should require more parts tested than 1000.
Is there a different methodology y'all could recommend that is defensible from a regulatory perspective but also contains more logically sound sampling frequency?
Thanks for your help,
Nick