Introduction to a Holistic Approach to Quality Risk Management of Product and Process Development

The value of a highly efficient and effective product development organization is an aspiration of companies that depend heavily on innovation to drive their business growth. The value a strong risk and science based approach to product & process development not only improve quality (process robustness) but also the efficiency of the entire product development workflow. A QRM approach to product design and process development will be presented along with case study examples. The examples will illustrate the 3 major elements of QRM, risk assessment, risk review and risk control. The approach will begin with defining a Quality Target Product Profile, defining critical quality attributes (CQAs), use of prior knowledge to risk assess material attributes, process parameters that may impact CQAs. Product & process understanding is achieved through well designed experiments, modeling or others scientific capabilities. The importance of knowledge capture and leveraging the understanding will be discussed. The knowledge gained from process understanding studies will be used to create a control strategy that results in a well controlled and capable manufacturing process. This knowledge will also serve as the foundation for future innovations to further improve the quality of product and the efficiency of the manufacturing process over its lifecycle.