Quality by design (QbD) is a widely discussed approach that is often neither well understood nor effectively executed. Joseph Juran also called QbD “quality planning.” QbD is not primarily focused on typical quality issues such as corrective action, testing, measurement, or monitoring. QbD is a holistic approach to planning to ensure quality is inherent in products and processes.

QbD starts with quality goals, and identifying customers and their true needs. This sets up the target and meaningful goals for the quality program. Meaningful goals are those that customers care about and will thus pay for in your products.

Product and process design drive quality performance. These are clearly shown on the inner ring in the U.S. Food and Drug Administration’s (FDA) QbD graphic in figure 1.

Figure 1: Quality by design (QbD) concept as presented by U.S. Food and Drug Administration (FDA)

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