Impact of Smart Incoming Inspection System on the Production, in a Medical Device Manufacturing MSME

Quality of medical devices is an important criterion when it comes to addressing health of a human being. Medical devices are manufactured with great effort to reduce risk. However, Micro, Small, Medium Enterprises (MSME)s in manufacturing are unable to afford high-end technology and complex quality control methods. A Smart Incoming Inspection system was developed to address the quality challenges faced by a local micro-enterprise for medical device manufacturing. The system was deployed in the manufacturing location, and inspection of incoming raw materials was carried out. Comparison of the final inspection data with and without the use of the smart incoming inspection system exhibited significant improvement in quality control when the system was used. Using the Define-Measure-Analyse-Improve-Control (DMAIC) method of six sigma, the impact of introducing the system to the production line was analysed, indicating improved First Pass Yield (FPY) of 1.88% and over threefold reduction in rejection rate.