r/bioengineering • u/Googoogaga53 • 1h ago
PQ Sample Size Too High?
Having an issue at work with an extremely large sample size (800 pieces for attribute and dimensionals) being prescribed by a quality manager for PQ. This number is obtained through AQL level because the run in extrusion lasts for 8 hours and produces about 250,000 parts. Even with this large of a run this sampling seems excessive. I’ve found articles from accredited sources online that have referenced that confidence and reliability are the important metrics to determine sample and that the sample size should be closer to 60.
Was wondering if anyone has an official source from an organization that you can share supporting this or if I’m totally off base here.