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Six Sigma Risk Analysis

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A new reference on how to introduce Risk Analysis to the medical laboratory, using quantitative, data-driven Six Sigma techniques
Six Sigma Risk A 4defb4345de53
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Description

 

First Edition
2011, 296 pages, 6" x 9" perfect bound
ISBN 1-886958-27-0
ISBN-13  978-1-886958-27-2

Risk Analysis is coming to medical laboratories. But for too many labs, Risk Analysis is a buzzword without meaning, an approach without defined technique. At worst, it threatens to appear like science while being implemented like guesswork.

In this book, Dr. Westgard surveys the ISO standards, as well as published CLSI guidelines, and the long-established Joint Commission methodology for Proactive Risk Reduction.

After providing an overview of the general Risk Analysis approach, Dr. Westgard explains how to adapt the principles for the medical laboratory, with performance-based tools and practical implementation tips:

  • Process maps, flowcharts and fishbone diagrams
  • Risk Acceptability matrices
  • Assessment of hazards through Failure Mode Effects Analysis (FMEA)
  • Fault Tree Analysis (FTA) and Failure Reporting, Analysis and Corrective Actions System (FRACAS)
  • Six Sigma metric integration into Risk Analysis

Using Six Sigma metrics, Dr. Westgard shows how Risk Analysis can be converted from qualitative and ephemeral to something more quantitative and concrete. When performance data informs Risk Analysis, the decisions become more relevant to medical laboratories and the patients they serve.

Don't settle for arbitrary guesswork in your Risk Analysis. Combine the power of Six Sigma and Risk Analysis tools.

Table of Contents
Download the Table of Contents, Preface, and Chapter Excerpts (web membership required)

CHAPTER PAGE
1. Controlling Quality
 1
2. Managing Analytical Quality
 13
3. Analyzing and Assessing Risk
 25
4. A Safety Net to Catch Analytical Errors
 51
5. ISO 14971 Risk Managment for Medical Devices
 67
6. ISO 15198 and CLSI C24 Guidance for Safe Use and QC
 95
7. EP18 and EP23 Guidance for Risk Analysis and QC Plans
 113
8. ISO 22367 Guidance for Risk Management
 137
9. Adopting the JC Risk Analysis Methodolgoy
 147
10. Diagramming a Laboratory Process
 163
11. Identifying Failure Modes
 177
12. Prioritizing Failure Modes
 189
13. Determining Root Causes
 203
14. Mitigating Risks with an Analytical QC Plan
 213
15. Estimating Detection and Evaluating Residual Risks
 233
16. Monitoring Failures and Measuring Perofrmance
 259
17. Implementing Analytical QC Plans
 275
18. Integrating Six Sigma into Risk Analysis
 283
Index 291

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