QC Sampling Plan

Quality Control qc at inovadx.com
Wed Nov 6 12:40:30 EST 1996


We're an IVD manufacuting company.  We'd like to establish a QC
sampling plan for components and finished kits in compliance with
FDA's statement of "acceptable statistical rational".  We follow GMP's
listed in Code of Federal Regulations title 21, part 820 for medical
device manufacturers.

We would like something based on MIL STD 105E.  We are not sure which
table would be best to follow and do not know how to determine an
appropriate AQL.

We do destructive testing.  Products are expensive and time consuming
to test.  Therefore sample sizes should be as low as resonably
possible.

We are not statisticians, Please help.

Thanks in advance for your time.

INOVA Diagnostics, INC.




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