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TM_D_4621_
_99_2004
Designation:D 4621 99(Reapproved 2004)Standard Guide forQuality Management in an Organization That Samples orTests Coal and Coke1This standard is issued under the fixed designation D 4621;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(e)indicates an editorial change since the last revision or reapproval.1.Scope1.1 This guide describes the essential activities that arerequired to establish and operate a quality management systemin a laboratory or organization that provides services in samplecollection,sample preparation,or testing of coal,coke,orcombustion residues from coal and coke.NOTE1The word“laboratory”is used throughout this guide whenreferring to an organization that provides services in coal sampling ortesting,or both.It is recognized,however,that the word may not beappropriate to an organization that does not perform actual laboratorysample testing.1.2 The principles of this guide are suggested as being theminimum acceptable requirements for the management ofquality in a coal or coke sampling or testing organization,although some elements may not be necessary or appropriatefor organizations that provide limited services.1.3 Laboratories meeting the requirements of this guide mayor may not meet the requirements of the ISO 9000 series ofstandards.NOTE2An accrediting body may also impose other nontechnicalrequirements such as payment of fees or submittal of quality documenta-tion for review.1.4 This guide is based upon many of the issues presented inGuide E 548.The user may also consult Guide E 882 for otheritems that may be pertinent.ISO Guide 25 has also beenextensively consulted.1.5 This standard does not purport to address all of thesafety concerns,if any,associated with its use.It is theresponsibility of the user of this standard to establish appro-priate safety and health practices and determine the applica-bility of regulatory limitations prior to use.2.Referenced Documents2.1 ASTM Standards:2D 346 Practice for Collection and Preparation of CokeSamples for Laboratory AnalysisD 2013 Practice for Preparing Coal Samples for AnalysisD 2234/D 2234M Practice for Collection of a GrossSample of CoalD 3180 Practice for Calculating Coal and Coke Analysesfrom As-determined to Different BasesD 3302 Test Method for Total Moisture in CoalD 4182 Practice for Evaluation of Laboratories UsingASTM Procedures in the Sampling and Analysis of Coaland CokeE 177 Practice for Use of the Terms Precision and Bias inASTM MethodsE 456 Terminology Relating to Quality and StatisticsE 548 Guide for General Criteria Used for EvaluatingLaboratory Competence3E 882 Guide for Accountability and Quality Control in theChemical Analysis LaboratoryE 1187 Terminology Relating to Conformity AssessmentE 1323 Guide for Evaluating Laboratory MeasurementPractices and Statistical Analysis of the Resulting DataE 1579 Guide for Ensuring Data Integrity in Highly Com-puterized Laboratory Operations32.2Other ASTM Document:Manual on Presentation of Data and Control Chart Analy-ses,ASTM Manual 7,199642.3ISO Document:Guide 25 General Requirements for the Competence ofCalibration and Testing Laboratories53.Terminology3.1 control limits,nlimits on a control chart which areused as criteria for signaling the need for action,or for judgingwhether a set of data does or does not indicate a state ofstatistical control1This guide is under the jurisdiction of ASTM Committee D05 on Coal andCoke and is the direct responsibility of Subcommittee D05.30 on QualityAssurance.Current edition approved Oct,1,2004.Published October 2004.Originallyapproved in 1986.Last previous edition approved in 1999 as D 4621 99.2For 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.3Withdrawn.4The procedure described herein was adapted from Basic StatisticsTools forContinuous Improvement,M.J.Kiemele and S.R.Schmidt,Air Academy Press,Colorado Springs,CO,1991.5Manual on Presentation of Data and Control Chart Analyses,ASTM Manual 7,American Society for Testing and Materials,1996.1Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959,United States.3.1.1 DiscussionAction may be in the form of investiga-tion of the source(s)of an“assignable cause,”making aprocess adjustment,or terminating the use of a process.(E 456)3.2 calibration,nthe set of operations which establishes,under specified conditions,the relationship between valuesindicated by a measuring instrument or measuring system,orvalues represented by a material measure,and the correspond-ing known values of a measurand.(E 548)3.2.1 DiscussionThe act of calibration is also sometimesreferred to as standardization.The result of a calibration iss