Validation Guidelines for Laboratories Performing Forensic Analysis of Chemical Terrorism

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Preface

The Scientific Working Group on Forensic Analysis of Chemical Terrorism has developed the following guidelines for laboratories engaged in the forensic analysis of chemical evidence associated with terrorism. This document provides a baseline framework and guidance for a validation program for forensic analytical procedures. Consideration may be given to alternative approaches of achieving the intent of these guidelines.

Introduction

The Scientific Working Group on Forensic Analysis of Chemical Terrorism's mission is "to develop guidelines for the forensic identification, characterization, and attribution of evidence in planned, threatened, or actual acts of chemical terrorism." The Validation Guidelines for Laboratories Performing Forensic Analysis of Chemical Terrorism may be used by laboratories to structure or enhance their validation of procedures used in the forensic analysis of chemical terrorism.

Analytical procedure validation is often a complex, iterative process that requires scientific judgment. The goal of these guidelines is to provide the laboratory with information on steps that are commonly used when validating an analytical procedure. This guidance is meant to complement the experience and professional judgment of the laboratory personnel.

Chemicals associated with terrorism may present acute hazards not normally encountered during routine operations by laboratory personnel. Appropriate caution and safety should be exercised when dealing with these types of hazardous materials.

Reference

Scientific Working Group on Forensic Analysis of Chemical Terrorism, Quality assurance guidelines for laboratories performing forensic analysis of chemical terrorism, Forensic Science Communications [Online] (2004). Available: http://www.fbi.gov/hq/lab/fsc/backissu/ april2004/standards/2004_02_standards01.htm.

Suggested Reading

EURACHEM. Fitness for Purpose of Analytical Methods: A Laboratory Guide to Method Validation and Related Topics, EURACHEM, 1998. Available: http://www.eurachem.ul.pt/guides/valid.pdf.

Wernimont, G. Use of Statistics to Develop and Evaluate Analytical Methods, AOAC International, 1985.

Peters, F. T. and Maurer, H. H. Bioanalytical method validation and its implications for forensic and clinical toxicology: A review, Accredited Quality Assurance (2002) 7:441-449.

Thompson, M., Ellison, S. L. R., and Wood, R. Harmonized guidelines for single-laboratory validation of methods of analysis, Pure and Applied Chemistry (2002) 74(5):835-855. Available: http://www.iupac.org/publications/pac/2002/pdf/7405x0835.pdf.

1. Scope

These guidelines describe validation practices that a laboratory should follow to ensure that its analytical procedures produce data that are fit for the intended purpose. It is the responsibility of each laboratory to select the appropriate analytical procedure that will meet the intended data quality objectives. A laboratory, in the context of these guidelines, is defined as a facility in which analysis associated with chemical terrorism is performed. It is assumed that the laboratory is operating under the quality assurance system described in the Quality Assurance Guidelines for Laboratories Performing Forensic Analysis of Chemical Terrorism (http://www.fbi.gov/hq/lab/fsc/backissu/april2004/standards/ 2004_02_standards01.htm).

This guidance may be useful in the following situations:

* When a standardized analytical procedure is applied in the laboratory for the first time.

* When a standardized analytical procedure is modified.

* When a published but nonstandardized analytical procedure is used in the laboratory.

* When an analytical procedure is developed in-house for subsequent routine use.

* When an analytical procedure is developed in-house as a solution to a unique analytical problem.

2. Definitions

As used in these guidelines, the following terms shall have the meanings specified. (See also Appendix A and Appendix B.)

Accuracy is the …