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The Forgotten Origins of Quality by Design | IVT

Quality by design can be traced to the original work of Dr. Joseph M. Juran. Juran believed that nearly all problems (e.g., deviations, quality defects, etc.) are built into the system, and that they can be traced to inadequate design of the process.  Therefore, if addressed during the design phase, they can be largely designed out. QbD starts with the quality target product profile.  Juran calls this defining the customer needs. QbD then proceeds with identification of critical quality attributes (CQAs).  Juran calls this development of product features. These should be reviewed...

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