ASTM_E_2857_-_11.pdf

Designation:E285711Standard Guide forValidating Analytical Methods1This standard is issued under the fixed designation E2857;the number immediately following the designation indicates the year oforiginal adoption or,in the case of revision,the year of last revision.A number in parentheses indicates the year of last reapproval.Asuperscript epsilon()indicates an editorial change since the last revision or reapproval.1.Scope1.1 This guide describes procedures for the validation ofchemical and spectrochemical analytical methods of analysisthat are used by a metals,ores,and related materials analysislaboratory.1.2 This guide may be applied to the validation of labora-tory developed(in-house)methods,addition of analytes to anexisting standard test method,variation or scope expansion ofan existing standard method,or the use of new or differentlaboratory equipment.1.3 This guide may also be used to validate the implemen-tation of standard test methods used routinely by laboratoriesof the mining,ore processing,and metals industry.2.Referenced Documents2.1 ASTM Standards:2E135 Terminology Relating to Analytical Chemistry forMetals,Ores,and Related MaterialsE1601 Practice for Conducting an Interlaboratory Study toEvaluate the Performance of an Analytical MethodE1763 Guide for Interpretation and Use of Results fromInterlaboratory Testing of Chemical Analysis Methods2.2 ISO Standard:3ISO/IEC 17025 General requirements for the competence oftesting and calibration laboratories3.Terminology3.1 DefinitionsFor definitions of terms used in this guide,refer to Terminology E135.3.2 Definitions of Terms Specific to This Standard:3.2.1 validation(of an analytical method),nconfirmation,by the provision of objective evidence and examination,that amethod meets performance requirements and is suitable for itsintended use.4.Significance and Use4.1 Method validation is a process of demonstrating that themethod meets the required performance capabilities.Interna-tional standards such as ISO/IEC 17025,certifying bodies,andregulatory agencies require evidence that analytical methodsare capable of producing valid results.This applies to labora-tories using published standard test methods,modified standardtest methods,and in-house test methods.4.2 Although a collaborative study is part of this guide,thisguide may be used by a single laboratory for method validationwhen a formal collaboration study is not practical.This guidemay also be applied before a full collaboration study to predictthe reliability of the method.4.3 The use of multiple validation techniques described inthis guide increases confidence in the validity or application ofthe method.4.4 It is beyond the scope of this guide to describe fully thefundamental considerations in Section 5.For a more descrip-tive definition of these concepts,refer to the InternationalUnion of Pure and Applied Chemistry(IUPAC)technicalreport,“Harmonized Guidelines for Single Laboratory Valida-tion of Methods of Analysis,”4the IUPAC Compendium ofAnalytical Nomenclature(Orange Book),5and the Eurachempublication,The Fitness for Purpose of Analytical Methods,ALaboratory Guide to Method Validation and Related Topics.65.Fundamental Considerations5.1 During the process of method validation,the user of ananalytical method should apply a number of fundamental tenets1This guide is under the jurisdiction of ASTM Committee E01 on AnalyticalChemistry for Metals,Ores,and Related Materials and is the direct responsibility ofSubcommittee E01.22 on Laboratory Quality.Current edition approved Nov.1,2011.Published January 2012.DOI:10.1520/E285711.2For referenced ASTM standards,visit the ASTM website,www.astm.org,orcontact ASTM Customer Service at serviceastm.org.For Annual Book of ASTMStandards volume information,refer to the standards Document Summary page onthe ASTM website.3Available from American National Standards Institute(ANSI),25 W.43rd St.,4th Floor,New York,NY 10036,http:/www.ansi.org.4M.Thompson,S.Ellison,and R.Wood,“Harmonized Guidelines for Single-Laboratory Validation of Methods of Analysis,”Pure Appl.Chem.,Vol 71,No.2,2002,pp.835-855.http:/iupac.org/publications/pac5International Union of Pure and Applied Chemistry Compendium of AnalyticalNomenclature:Definitive Rules 1997,http:/old.iupac.org/publications/analytical_compendium/6EURACHEM Guide,The Fitness for Purpose of Analytical Methods,ALaboratory Guide to Method Validation and Related Topics,LGC,Teddington,Middlesex,United Kingdom,1998.www.eurachem.orgCopyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 of analytical chemistry as they relate to the development andimplementation of test methods.It is important to make thedistinction between the validation of a test method by astandards-developing organization and the implementation ofthat test method by a laboratory.Whether the test method wasdeveloped by a committee of experts or by one chemist in acompany laboratory,the laboratory shall impleme