Proactive reliability: using the right improvement tools to grow reliability in product development

摘要

This case study paper will provide practical tools, used in a systematic process, to improve reliability of new products enabling Six Sigma levels of customer satisfaction. The case study will show the progressive reliability growth of a Mammotome ST Breast Biopsy System from early development, through manufacturing, to worldwide field release of the product. The case study will also show how the proactive reliability process defined ongoing reliability assessments and warranty management activities. A robustly designed product is the foundation for achieving Six Sigma levels of quality. Using the concept of "Proactive Reliability" the product development team actively pursued creating a highly reliable device by consistently applying many reliability tools to seek out product design weaknesses, correct the design flaws early, then confirm their results. This led to three cycles of improvement resulting in an over 2 times improvement in reliability from the early prototypes to the production units.