Manufacturing Specification Issues Ecoshelf was engaged to assist in diagnosing the causes of problems encountered during scale-up of a new material being developed for use in optical applications. The optical end use for which the material was being developed mandated extremely stringent product specifications, which the developer could not reliably meet. The problem was confounded by the fact that it occurred at random and in an unpredictable manner despite attempts to control raw material supply, solvent purity and even human factors.

We reviewed and analyzed over three years of information comprising 23 separate variables, including product data and test results, manufacturing log books and observations, and specifically including several parameters previously rejected by the development team. We resolved the problem by demonstrating the importance of two of the parameters and procedures, previously considered unimportant, in reliably achieving product specifications.

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Data Analysis and Evaluation:: Case Briefs 1 2