Reduce Human Error in Drug and Device Manufacturing: Framework and Tools to Assure Effective CAPAs
What causes drug and device manufacturing failures and recalls? Human error. Time after time, CAPA investigations single it out as the root cause of violations.
If there were a magic formula for ending human error, we’d share it. But here’s the next best thing — systematic best practices and strategies that have been proven to cut human error and boost success on the factory floor. In many cases, firms have seen error reductions of 50% in less than one year.
Learn them yourself — in half an afternoon.
Your course leader Ginette Collazzo, Ph.D., is an authority on industrial/organizational psychology boasting more than 15 years’ experience with major drug and device makers, including Bristol-Myers Squibb, J&J, Schering-Plough and Wyeth, Parexel, Perrigo and Cephalon Pharma.
She has recently developed new tools to measure, explain and predict human error from both process and cognitive load perspectives. And she’ll demonstrate her newly created tools for improving systems and processes, staff training and reducing human error:
Process-related prediction tool: This tool allows organizations to identify cracks and concerns that are based on their organizational processes. 80% of mistakes are caused by problems within these systemic areas:
Human factors engineering
Cognitive load assessment tool: Only 20% of mistakes occur due to human frailties. This tool examines best practices for restructuring training and processes to improve workers’ ability to perform as expected. The tool focuses on workers’:
And decision making
Even more, she’ll map 4 best practices for determining the scope of problems:
Diagnose — How to re-analyze failure investigations for the preceding
Categorize and Code — How to sort investigations into 4 levels
Quantify — How to determine which level to tackle first and which can wait
Plan Based on Priorities — Taking the GUT check (Gravity, Urgency and Tendency) to set training priorities
You’ll learn these specifics:
How to start an error-reduction program, then measure its effectiveness
Identifying the relationship between CAPA and human reliability and performance expectations
5 key elements of an effective human error CAPA system — essential system safeguards
Unlocking the mystery of root cause analysis and human error
Revealing destructive human behavior factors and creating effective recommendations to modify them
Why existing practices fail — “correctives” that don’t correct, “preventives” that don’t prevent
Trending and tracking — assuring that improvement is by design, not chance
Forget the band-aid approach. Learn methods and models that are proven to cut human error by half — and even more.
Training managers and coordinators
Process excellence/improvement professionals
Regulatory/legislative affairs professionals
Ginette Collazo, Ph.D. has spent more than 15 years in technical training, organizational development and human reliability for Bristol-Myers Squibb, Johnson & Johnson, Schering-Plough and Wyeth. An active researcher in specialized studies related to human reliability, she is the author of numerous publications on these topics.