ABSTRACT

Forward-looking companies strive to build high quality and reliability into products during design and validation. Despite this, it is still, however, possible that reliability of the manufactured product may fail to meet requirements due to an inherent problem that somehow was missed during design and validation. Moreover, product reliability might worsen over time due to such factors as changes in raw materials or parts, wear-out of equipment or tools, deterioration of raw materials during storage, inadequate training of operators, and various cost-cutting ventures by suppliers or by the manufacturer. Traditionally, manufacturing used a reactive stance whereby much effort is spent on addressing problems after they have already occurred. In the reactive approach, there was a heavy reliance on end-of-line product testing to assure that only good products are shipped to the customers. In recent years, many companies have taken a more proactive stance whereby the goal is to assure final product reliability by effective control and monitoring of the manufacturing process itself. In this chapter, we describe how statistical methods are used in transitioning newly designed products to manufacturing and to assure that high-reliability products can be manufactured consistently over time, subject to the variability encountered in normal production.