<img height="1" width="1" style="display:none;" alt="" src="https://px.ads.linkedin.com/collect/?pid=56875&amp;fmt=gif">

Human Error Reduction

Global biologic enterprise drug manufacturer needed to reduce human error leading to manufacturing challenges

Set up a free consultation


Human Error Reduction MANUFACTURING

project info

A large, global biologic drug manufacturer determined that human error was a major contributing factor to a considerable number of manufacturing deviations. In min-2014, the client set a goal to reduce the deviation rate for personnel error by 5% in order to avert regulatory agency scrutiny and potential penalties.
Global Biologic Drug Manufacturer



As part of the execution, our team developed a detailed implementation plan that included:

  • A change management and communication strategy
  • Development of training materials to properly perform deep root-cause analysis'
  • Creation of a root-cause analysis tool to guide the newly trained specialists
  • System for monitoring the implemented solution with appropriate metrics
  • Documentation of the pilot program results and subsequent enhancements
  • Transition plan for the new human-error prevention program to process owners


Our client doubled their goal by achieving a >10% improvement on the personnel discrepancy rate. In addition, prior to the project rollout, 100% of personnel discrepancies resulted in counseling or retraining as the only corrective action.

As a result of more impactful corrective actions, by the end of the year, over 50% of these were addressed by a systemic change instead of counseling and retraining. Our client realized a cost avoidance of approximately $100,000 within drug substance manufacturing that year based on the number of human-related deviations that were closed as something other than personnel issues.

Contact Us!

Speak to a Life Sciences Compliance & Efficiency expert today!

get in touch
Free Process Improvement Plan for Life Science Companies