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.
Topco Pharmaservices, Inc.: Quality Improvement in the Clinical Supply Outsourcing Process
Core Disciplines: Operations Management/Supply Chain
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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.