Last March a lot of 40,000 9 mm screw-top vials shipped against an outgoing record that read “AQL 1.0, pass.” The receiving lab found 11 vials in the first 500 with thread flash that would not seal on a HPLC vial position at 1,200 psi. Nobody had defined what “pass” meant, nobody had classified the flash as a defect, and the sampling plan had been copied from a carton supplier’s certificate. That is the failure mode this article is about: an analytical testing ...