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Quality by Design (QbD) is a concept first outlined by quality expert Joseph M. Juran in publications, most notably ''Juran on Quality by Design''. Designing for quality and innovation is one of the three universal processes of the Juran Trilogy, in which Juran describes what is required to achieve breakthroughs in new products, services, and processes. Juran believed that quality could be planned, and that most quality crises and problems relate to the way in which quality was planned. While Quality by Design principles have been used to advance product and process quality in industry, and particularly the automotive industry, they have also been adopted by the U.S. Food and Drug Administration (FDA) for the discovery, development, and manufacture of drugs.〔(Pharmaceutical Quality by Design: Product and Process Development, Understanding, and Control )〕〔(Roadmap for implementation of quality by design (QbD) for biotechnology products )〕〔(Development of a new predictive modelling technique to find with confidence equivalence zone and design space of chromatographic analytical methods )〕 == Juran on Quality by Design == The Juran Trilogy〔 defines the word "quality" as having two meanings: first, the presence of features that create customer satisfaction; second, the reliability of those features. Failures in features create dissatisfactions, so removing failures is the purpose of quality improvement, while creating features is the purpose of quality by design. Juran's process seeks to create features in response to understanding customer needs. These are customer-driven features. The sum of all features is the new product, service, or process. The Quality by Design model consists of the following steps: # Establish the project design targets and goals. # Define the market and customers that will be targeted. # Discover the market, customers, and societal needs. # Develop the features of the new design that will meet the needs. # Develop or redevelop the processes to produce the features. # Develop process controls to be able to transfer the new designs to operations.〔 It is not a statistical design method like Design for Six Sigma. 抄文引用元・出典: フリー百科事典『 ウィキペディア（Wikipedia）』 ■ウィキペディアで「Quality by Design」の詳細全文を読む スポンサード リンク
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