ASTM_E_1323_-_15.pdf

Designation:E132315An American National StandardStandard Guide forEvaluating Laboratory Measurement Practices and theStatistical Analysis of the Resulting Data1This standard is issued under the fixed designation E1323;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 covers key elements of an evaluation of alaboratorys measurement practices and the statistical analysisof the resulting data.This guide addresses an evaluation thatcovers a broad range of in-house quality measurements,someof which may be directly related to accreditation requirements.1.2 This guide provides an overview of the documentationneeded for verification and monitoring of the practices used inthe laboratory for measurement.In addition,it guides the userin verifying that the extent of documentation and the quality ofstatistical evaluations performed on the data being generated issufficient.The user is advised to fully document all workcovered by the scope of this guide as a general principle oflaboratory practice and for audit purposes,whether internal orexternal.1.3 This guide is not designed to be exhaustive for allaspects of work realized under its scope.The user is encour-aged to thoroughly realize(achieve in practice)the principlesset forth in this guide,consulting other relevant standards andindustry documents when appropriate.2.Referenced Documents2.1 ASTM Standards:2E177 Practice for Use of the Terms Precision and Bias inASTM Test MethodsE178 Practice for Dealing With Outlying ObservationsE456 Terminology Relating to Quality and StatisticsE691 Practice for Conducting an Interlaboratory Study toDetermine the Precision of a Test MethodE1169 Practice for Conducting Ruggedness TestsE2554 Practice for Estimating and Monitoring the Uncer-tainty of Test Results of a Test Method Using ControlChart TechniquesE2587 Practice for Use of Control Charts in StatisticalProcess ControlE2655 Guide for Reporting Uncertainty of Test Results andUse of the Term Measurement Uncertainty in ASTM TestMethods3.Terminology3.1 Terms are defined in Terminology E456.4.Significance and Use4.1 This guide is intended to provide guidance for labora-tory quality managers,accrediting bodies and assessors inevaluating the measurement practices of a laboratory,theprotocol for statistically analyzing the resulting data from thesepractices,and the statistical results from these practices.4.2 This guide is generic in the sense that it covers the entirerange of in-house quality measurement practices found in atesting laboratory,and the results of the described evaluationmay be used by accrediting agencies for assessment purposesto determine whether their requirements can be satisfiedthrough the laboratorys existing quality data program.4.3 It is not the intent of this guide to serve as sole criterionfor evaluating and accrediting laboratories.Evaluation ofmeasurement practices is only one aspect in a comprehensivequality program.5.Purpose of Evaluating Measurement Practices and theStatistical Analysis of the Resulting Data5.1 Data generated from the measurement practices of alaboratory are evaluated to determine its bias and precisionperformance,and to determine if the laboratory correctly andefficiently analyzes and reacts to its own data.6.Documentation of Measurement Practices and theStatistical Protocol for Analyzing the Resulting Data6.1 Documentation Relative to Calibration:6.1.1 The material to be measured should be documentedtogether with its source,expiration or shelf-life date,theaccuracy,and any preparations or conditions required whichare specific to this material before it can be utilized as acalibration material.Any additional components,reagents,or1This guide is under the jurisdiction of ASTM Committee E11 on Quality andStatistics and is the direct responsibility of Subcommittee E11.20 on Test MethodEvaluation and Quality Control.Current edition approved April 1,2015.Published May 2015.Originallyapproved in 1989.Last previous edition approved in 2009 as E1323 09.DOI:10.1520/E1323-15.2For 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.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 physical sources used along with this material,which couldpotentially alter the reliability of the material,should also bedocumented.6.1.2 The identification of the equipment used,togetherwith the date and operator responsible for the run,and anypreparations involved with the calibration run should bedocumented.6.1.3 The type of data representation to be used,includingthe exact num