Project Briefs


Increasing Awareness around Human Behavior - Increasing quality-oriented behaviors while decreasing deviation recurrence and costs


Our client, a large, global biologic drug manufacturer, determined that human error was a major contributing factor to a considerable number of manufacturing deviations. In mid-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.



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

  •       A change management and communication strategy
  •       Development of training materials specifically for internal specialists to learn how to properly perform deep root-cause analyses
  •       Creation of a root-cause analysis tool to guide the newly trained specialists through the new assessment process
  •       A system for monitoring the implemented solution with appropriate metrics
  •       Documentation of the pilot program results and subsequent enhancements for the full-scale implementation
  •       Transition plan for the new human-error prevention program to process owners



Rather than the hoped-for 5% improvement, 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 2014 over 50% of these were addressed by a systemic change instead of, or in addition to, counseling and retraining.  The success of the program also led to increased awareness around human behavior.  Through change management, the workplace culture transformed into a more open environment that encouraged collaboration between groups and a more proactive approach to reducing risks around human error.


Return on Investment

Our client realized a cost avoidance of approximately $100,000 within drug substance manufacturing in 2014 based on the number of human-related deviations that were closed as something other than personnel issues. (NOTE: there were no write-offs due to product loss included in that number.)  Our client is expected to achieve a cost avoidance of approximately $450,000 in 2015, and to continue to see the same or greater benefit each year thereafter.


In addition to digging deeper to uncover the root cause of each discrepancy, communication between work groups has improved dramatically, and system-related personnel errors are being properly addressed to prevent recurrences. Our client has observed a marked increase in quality-oriented behaviors, indicating a companywide shift toward a culture of continuous improvement.


1 Reducing Human Error, Simon Chalk, Jun 01, 2012, BioPharm International,