Application and validation of machine vision inspection for efficient in-process monitoring of complex biomechanical device manufacturing

Abstract

A technique is presented for shifting the manufacturing quality control of complex biomechanical catheters away from destructive testing of finished parts. This technique uses a more efficient real-time in-process monitoring through the application of machine vision inspection of patient critical quality parameters. The approach acknowledges the challenge of this industry operating in a strict regulated environment. The higher standards of built-in quality are achieved by developing automated inspection solutions that are more accurate and repeatable. Machine vision system and associated inspection job tools are developed and used to detect defects at crucial stages of manufacturing. The vision system is then tested for its robustness using a statistical approach to ensure its measurement capability is within the allowable process range and tolerances. The integrated solution developed is proven to be robust and highly precise in maintaining the manufacturing process stable. It enabled the manufacturing process to move away from a destructive double sampling plan with a standard LTPD of 5% to an otherwise real-time 100% non-destructive verification of units. This technique provides an alternative to otherwise cost-inefficient quality control inspections utilized in regulated manufacturing environment. It gives confidence to these conservative industries to move towards adopting digital manufacturing and Industry 4.0 practices.