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This paper considers how a biologics manufacturer took the lagging data expressed in nonconformance data to build a system of analysis with the aim of prioritizing improvements in terms of risk management.  Nonconformance or deviation data were grouped into a hierarchy of categories, culminating in FDA compliance system categories.  Statistical process control (SPC) charts (u-charts) were generated to understand the performance of critical control processes within the manufacturing process of the biologic. Risk indicator operational definitions were developed to classify the control point process performance in terms of the risk that control point posed to both the donor and recipient of the biologic.  A 5 x 5 risk matrix was developed to merge the performance of the process to the risk indicators.  A color schematic was applied to the risk matrix to facilitate the actions warranted to assigned risk priorities within the matrix in terms of process performance and risk indicator.  The management of this process required both a computer application as well as continued human intervention for its success.  To date, the risk matrix has assisted the organization under study in allocating resources for specific higher risk areas to minimize the possibility of regulatory censure.

 

data analytics; business practices; biologics; biologic organization management; risk evaluation; risk matrix; compliance; nonconformance management; deviation management.