Analytical & Quality
Integrating Human Performance Principles into BioPharma Operations
Errors are a part of life. With human errors accounting for approximately 50% of quality deviations and related problems within the BioPharma industry, the vital importance and real-world value of integrating human performance principles is obvious. The Lonza Error Prevention System (EPS) is a cultural change program build on proven approaches around coaching by leaders at the shop floor and error proofing of Work Instructions, Batch Records, Standard Operating Procedures as well as practices for structuring, conducting, and documenting training to assure operator competence. These practices shift the “training for compliance” paradigm to “training for competence” in GMP environment. Results have been significant - so far Human Error-related quality deviations and non-conformities have reduced by more than 50% across 12 sites globally and will continue to fall.