Two faculty members in the School of Business, Drs. Lisa M. Walters and Reneta Barneva, co-authored the paper, “Prioritization of Process Improvement Using Risk Evaluation in the Manufacturing of Biologics,” that appeared in Quality Management Journal, a Cabell's white-listed journal published quarterly by the American Society for Quality.
Their paper considered 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.
A 5-by-5 risk matrix was developed to merge the performance of the process to 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. 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.
Dr. Barneva, a professor and chair of the Department of Applied Professional Studies, has served over 30 years in academia. Dr. Walters, an assistant professor of Operations Management in the Department of Business Administration, has spent a majority of her career in the biomedical arena with particular emphasis on data analysis for biomedical regulatory compliance.
