Investigation Process Improvement in a Pharmaceutical Company

Abstract

Manufacturing companies are subject to product incidents. These are managed by investigators to identify root causes, solutions and avoid reoccurrence. Investigation completion within time ensures that product will reach the customer. Pfizer Pharmaceuticals had an increment in investigations that exceeded the established due date. Using the Define, Measure, Analyze, Improve and Control (DMAIC) methodology, causal factors were identified and addressed by standardizing investigation planification and execution. Furthermore, controls were placed to ensure process monitoring by placing strategic meetings to discuss investigation using the improved standardize process and monthly monitoring. Key Terms ⎯ continuous improvement, manufacturing and packaging investigations, product disposition, standardization.