Labeling and Packaging Process Improvement Using DMAIC Methodology

Abstract

Medical Device Companies must ensure that each unit of product has unique identification and that it is labeled correctly. Labeling requirements include having the appropriate data on the label, not having misleading information on any of the labels, labeling content and configuration should be appropriate, and the label should remain legible through the expected usage of the device. Manual labeling and inspection processes are time-consuming, fully dependent on humans, sometimes inconsistent, and the potential of rework or scrap is higher, whereas automated processes bring consistency, help reduce cycle time, bring reproducibility, improve inspection process, and reduce human dependency. As part of this design project, the labeling and packaging process of the Neuromodulation Division of the Medical Device Company was assessed using the DMAIC methodology. This structured methodology facilitates the identification of robust solutions, integrating automation to the label print and inspection processes, reducing defects, and achieving process improvement. Key Terms⎯ automation, DMAIC, labeling, visual inspection