| This study explores the premise that involving customers in determining customer requirements, instead of using “experts,” generates a more complete definition of customer requirements. Well-defined customer requirements can then be used for continuous improvement of a product or process.; The validation process at Diosynth Biotechnology, a contract manufacturer for the pharmaceutical industry, was selected as the process to be examined. Two methods of defining customer requirements for the validation process were employed: Quality Dimension Development was performed by “experts” on the validation process, and the Critical Incident Method involved internal customers.; The customer requirements generated by Quality Dimension Development and the Critical Incident Method were compared. The results support the hypothesis that using customer input to define customer requirements is more effective than using experts. |
