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The Case of Prioritizing Remediation of Acquired Plasma Centers for FDA-Licensure: A Risk Matrix Approach
Lisa Marie Walters, Susan McNamara

Last modified: 2018-01-14

Abstract


In today’s world of competing resources, it becomes necessary to find a way to prioritize many business endeavors. In this case study, students are asked to assist the Director of Plasma Quality and Regulatory Operations (D PQ/RO) and her staff members in prioritizing the remediation activities needed to prepare a slate of recently purchased plasma centers for FDA-licensure. The parent company, biologics giant Meridian International, recently purchased 30 plasma centers to grow that aspect of its supply chain, as plasma is a key component in several of its product lines. Although 15 of these centers are already licensed by the FDA, 15 are not; those that are not are unknown in terms of their FDA compliance and will need remediation to be successful in their FDA licensure quest. A risk matrix is used to determine the scheduling sequence of each of these 15 centers in terms of remediation support for FDA licensure. Students are challenged to discuss the validity of the use of such a matrix, to propose a remediation schedule for the centers, to provide other uses for the matrix other than remediation prioritization scheduling, and to explain how such a matrix might be constructed for other industries. This case is unique in that it allows the student to consider prioritization of activities in regulated industries, which may use different determinants of risk other than financial.


Keywords


Biomedical, Risk Matrix, Risk Prioritization, Resource Allocation, Operations Management, Process Performance, Operations Risk