Aggressive development timelines and organizational complexity provide challenges to the development scientist beyond the typical scientific difficulties. These challenges can be overcome, in part, by the application of formal business processes that streamline, platformize, and harmonize the approach to development across both projects and sites. Manufacturability assessment constitutes one of the most important aspects of process development. In this work, principles of manufacturability and aspects of existing gap/risk analysis tools, such as FMEA, were combined to develop a manufacturability assessment tool. The tool, which is centered on a decision-making rubric, is supported by semi-quantitative formulae used to assign gap risk ratings and development difficulty scores. The tool enables the development scientist to prioritize manufacturability gaps, determine the process development plan, and effectively communicate the associated risks to stakeholders. Case study examples illustrating the tool will be presented. The decision-making rubric and overall approach may also find applicability elsewhere within our constrained environment, such as during developability, deviceability, and facility fit assessments.

Manufacturability assessment tool for effective decision-making and efficient process development: Development and applications

251st National Meeting (2016)

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