"Section 4.3: If initial OOS is below 5% of specification limit, the QA lead may authorize a 'retest-until-spec' protocol. Obtain six new samples. Discard the original three. Use the average of the six new samples. Do not log the original OOS in the final report."
PharmaCorp Global was found to have an internal memo entitled "Operational Velocity Directive" (a classic Devils SOP rebrand). The result? A $1.2 billion settlement, a 10-year exclusion from federal contracts, and criminal charges for two QA directors. pharma devils sop