CLSI EP18 P2 : 2ED 2007

Abstract
Committee Membership
Foreword
Laboratory Error Sources and CLSI Evaluation Protocols
Documents
1 Scope
2 Introduction
3 Standard Precautions
4 Terminology
  4.1 Definitions
  4.2 Acronyms/Abbreviations
5 User-Manufacturer Quality Partnership
  5.1 Manufacturer's Responsibility
  5.2 User's Responsibility
6 FMEA and FRACAS
  6.1 Description of FMEA and FRACAS
  6.2 Definition and Purpose
  6.3 Some General Guidelines for FMEA and FRACAS
  6.4 Description of FMEA Table Entries
  6.5 Description of FRACAS Table Entries
  6.6 Control Measures (FMEA) or Corrective Action
       (FRACAS)
  6.7 Validation (FMEA)
  6.8 Rate Measure (FRACAS)
  6.9 Other Considerations
  6.10 Pareto Analysis
  6.11 More on FRACAS for Clinical Laboratories
  6.12 Aids to Facilitate FMEA and FRACAS
7 Components of a Quality Management System
  7.1 Standard Operating Procedures
  7.2 Training and Competency
  7.3 Ongoing Process Control
  7.4 Preventive Maintenance
  7.5 Failure, Hazard, and Harm Reporting
  7.6 Auditing
References
Appendix A. Example of a "System-Specific Sources of Error"
            Matrix - an FMEA
Appendix B. An Example of a Manufacturer'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 Consensus Comments and Committee Responses
The Quality Management System Approach
Related CLSI/NCCLS Publications

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