Developing a Quality Control System for Biotechnological Device Inspection Improvement

Abstract

Incoming quality control (IQC) is integral to quality management system of manufacturing industries. IQC plays a significant role in ensuring delivery of high standard products to the target customers and, in turn, affects the company’s reputation and their competitiveness in the industry. Presenting a case from a biotechnology company, the purpose of this research is to develop a quality control system for inspection improvement of a biotechnological device. During the COVID-19 pandemic, the IQC Department encountered inconsistencies with output rate when providing inspected parts to the Manufacturing Department: an issue that could be mitigated with a documented process that addresses the prevalent issues that plague the current unestablished IQC system. This study utilized the Lean Six Sigma Methodology to achieve improvement for the IQC Department practice for enhanced performance by identifying root causes of inconsistencies, and creating a systematic documented process for IQC department. Upon successful analysis and implementation of the new IQC inspecting system, the non-value-added time decreased by over fifty percent. While this project is the first stepping stone in improving the IQC Department, its significant results emphasizes the integral contribution of quality control and Six Sigma practices in creating a continuous improvement system which ensures consistent high-quality instruments are being produced for the customers.

Keywords: Incoming Quality Control, Lean Six Sigma, Quality Control System, Quality Inspection

DOI: 10.54941/ahfe1003048