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Human Error Reduction

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

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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.
Client:
Global Biologic Drug Manufacturer
Category:
Manufacturing

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DESIGN & IMPLEMENTATION

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

RESULTS ACHIEVED

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.

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