Topco Pharmaservices, Inc.: Quality Improvement in the Clinical Supply Outsourcing Process

by: Damian R. Beil, Wallace Hopp

Publication Date: February 19, 2020
Length: 12 pages
Product ID#: 1-528-696

Core Disciplines: Operations Management/Supply Chain

Partner Collection:

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Teaching Note

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This case asks students to consider questions about where and how to implement Statistical Process Control (SPC) within the fictional Topco Pharmaservices company. Topco’s documentation process for outsourcing clinical drug manufacture was experiencing high rates of errors. By constructing and interpreting a p-chart for SPC, students can begin to address Topco’s challenges.

Teaching Objectives

After reading and discussing the material, students should:

  • Identify at least four strategies for convincing quality assurance and manufacturing managers to adopt SPC.
  • Describe the characteristics of a process that would be appropriate for SPC.
  • Explain why vendor relationships should not be measured by SPC.
  • Construct a p-chart with 3-sigma control limits for Topco's FPA metric and then interpret the results in terms of process performance.