CLSI EP18 P2 : 2ED 2007
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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RISK MANAGEMENT TECHNIQUES TO IDENTIFY AND CONTROL LABORATORY ERROR SOURCES
10-03-2009
12-01-2013
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
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