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Risk Analysis GuidelinesThe Poor Lab's Guide

Six Sigma Risk Analysis

Six Sigma Risk Analysis

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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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