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Prioritization of Process Improvement Using Risk Evaluation in the Manufacturing of Biologics

Summary: [This abstract is based on the authors' abstract.] 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 to facilitate meeting the challenges of a consent decree. Nonconformance or deviation data were grouped into a hierarchy of categories, culminating in FDA compliance system categories. Statistical process control 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 × 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 and continued human intervention for its success. To date, the risk matrix has assisted the organization under study in allocating resources to specific higher-risk areas to minimize the possibility of regulatory censure.

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  • Topics: Continuous Improvement
  • Keywords: Biomedical, Manufacturing, Risk management, Process improvement, Nonconformance, Data, Deviation
  • Author: Walters, Lisa; Barneva, Reneta;
  • Journal: Quality Management Journal