Reducing Particle Matter in Medical Devices Product

Abstract

In the medical device industry, particle matter in products is a problem. Recently, a medical device company noticed that, for the last three months, rejection of product due to particle matter was in an increasing trend. The problem was analyzed by evaluation of manufacturing process, storage area, personnel training and inspections performed on product. Additionally, to boost employee engagement and moral, a rewards system was implemented. Evaluation identified areas of improvement in manufacturing process, storage area cleaning, implementation of new inspections for product as well as new inspection equipment. Data collection after improvements demonstrated a better control for particulate matter. Rejection quantity was reduced from 25% to 14%, there was a profit increase of $165,000 and the rewards system implemented improved employee engagement to target the particulate matter problem. Key Terms ⎯ Generation of particle matter, increase employee engagement, medical device problems, manufacturing evaluation, surgery complications.