StageControl Method
Acceptance Criteria
Frequency
Tools / Instruments
Responsibility
Material R Visual checClean, undEach Lot Visual checWarehouse Inspector
Pre-AssembSOP adheren All fasteneEach Unit Torque wren Operator + Line QC
SubassembChecklist- Components Each Unit Digital cali Line QC Inspector
Main Asse Work instruNo wire strEach Unit Torque toolAssembly Technician
In-Process Inspector cNo label miEach Unit Manuals, ch In-Process Inspector
Electrical TElectrical cPass/fail li Each Unit Multimeter, QA Electrical
PerformancSimulated lVentilator Each Unit Test lung, QA Validation Team
Labeling &Label positAll labels Each Unit Barcode rea Packaging + QA
Final QC R Full checkl Zero defectEach BatchMaster QC Final QC Inspector
Product ReQA sign-offAll QC stagEach BatchRelease forQA Manager