Lab
OOS
Out Of Specification
Lab result that fails its acceptance spec — triggers a regulated investigation.
An Out Of Specification (OOS) result is a lab test result that falls outside its acceptance specification. Under FDA's 2006 OOS guidance, OOS investigations follow a defined phase-1 (lab error?) → phase-2 (manufacturing error?) workflow before any retest. V5 LIMS auto-flags OOS, opens the investigation, and locks the lot to quarantine until disposition.