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.
