CLSI EP18 A2 : 2ED 2009

Abstract
Committee Membership
Foreword
Laboratory Failure Sources and CLSI Evaluation Protocols
Documents
1 Scope
2 Introduction
3 Standard Precautions
4 Terminology
5 User-Manufacture Quality Partnership
6 FMEA/FTA, and FRACAS
References
Explanation of the Appendixes
Appendix A - Example of a "System-Specific Sources of Failure"
             Matrix - an FMEA
Appendix B - An Example of a Manufacture's FMEA
Appendix C - Laboratory FMEA: Manufacturer-Completed Part and
             Clinical Laboratory-Completed Part
Appendix D - Example of a FRACAS
Appendix E - A Note on Unit-Use Devices
Summary of Comments an Subcommittee Responses
The Quality Management System Approach
Related CLSI Reference Materials

Specifies risk management techniques that will aid in identifying, understanding, and managing sources of failure (potential failure modes) and help to ensure correct results.