ABSTRACT
OVERVIEW: QUALITY BY DESIGN AND PRODUCT DEVELOPMENT Quality by design (QbD) is not a new term. In 1985, R. Kacker stated that “consideration of
quality in manufacturing should begin before manufacturing starts, even before any capital
commitments are made and this is quality by design” (1). The experimentation at the
manufacturing stage is orders of magnitude more costly than experimentation at the R&D
stage (2), and it is the designs of both the product and the manufacturing process that play
crucial roles in determining the degree of performance variation and the overall manufacturing
cost (1). Then in 1986, M. Walton (3), said that the manufacturing group (the consumer) should
receive from R&D (the producer) a process that has inherent good quality characteristics, and in particular, R&D should develop-in collaboration with manufacturing-a process that is
rugged with respect to anticipated manufacturing variables.
