PDF Edition - Reduce Human Error in Drug and Device Manufacturing

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Minimizing human error continues to be a challenge for both device and drug makers, even those that have successful quality programs.

More frequent training doesn't seem to be the answer. In fact, studies show that lack of training is responsible for only about 10 percent of the human errors that occur.

So what other options do you have to reduce human error in your organization?

Take a step in the right direction by ordering a new management report from FDAnews, Reduce Human Error in Drug and Device Manufacturing.

You'll start with a basic premise: Investigations of “equipment failure” never end without learning why the equipment failed … so why do investigations of human error often end without learning what led to the error and how to prevent it from happening again?

Then you'll begin to learn to think about human error in a significantly different way:

  • The human behavior that led to an error has to be analyzed to get to the problem's root cause.
  • 80 percent of human error can be controlled by managing the aspects of a job that make it more likely for a worker to make mistakes.
  • The other 20 percent of human errors can be controlled by managing some employee habits.

Then you'll be introduced to root cause analysis techniques and how to apply them to your workers as well as your systems. The report includes the following tools that are essential to root cause analysis:

  • Cognitive Load Tool
  • Root Cause Determination Tool
  • Predictive Load Tool
  • Human Error Prediction Tool Assessment Form
  • Task Criticality Assessment Tool
  • Human Error – Floor Assessment Checklist
  • Human Error Assessment Tool
  • Process vs. Procedure Analysis Tool
  • SOP Template to Prevent Human Error
  • On the Job Training Test Template

Why not take a step that could make you a leader in your organization … by taking on the difficult subject of human error?

Order Your Copy Today!

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Table of Contents

  • Understanding Human Error
  • Conducting a Root Cause Analysis
  • Using Predictive Load and Other Tools
  • Developing Strategies to Reduce and Prevent Error

View the entire TOC

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Not satisfied with your publication? For the PDF version, you must notify FDAnews within 24 hours of receipt of purchase and we will refund 100 percent of your purchase price. Return the hard copy within 30 days (in resalable condition) to receive your refund (less shipping/handling).

  • Drug and device company executives
  • Quality assurance managers
  • Manufacturing plant managers
  • GMP compliance managers
  • Regulatory affairs professionals
  • Human error investigators/experts

Get Multi-user Access With The Electronic Books Library.
Save money with a license agreement allowing significant numbers of users access to an electronic version of this book. For multi-user access to multiple titles, FDAnews offers the Electronic Books Library – a personalized collection of FDAnews publications that is fully searchable. Contact customer service for a quote or more information.

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