ASTM_C_1210_-_12.pdf

Designation:C121012Standard Guide forEstablishing a Measurement System Quality ControlProgram for Analytical Chemistry Laboratories Within theNuclear Industry1This standard is issued under the fixed designation C1210;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 standard provides guidance for establishing andmaintaining a measurement system quality control program.Guidance is provided for general program considerations,preparation of quality control samples,analysis of qualitycontrol samples,quality control data analysis,analystqualification,measurement system calibration,measurementmethod qualification,and measurement system maintenance.1.2 This guidance is provided in the following sections:SectionGeneral Quality Control Program Considerations5Quality Control Samples6Analysis of Quality Control Samples7Quality Control Data Analysis8Analyst Qualification9Measurement System Calibration10Measurement Method Qualification11Measurement System Maintenance122.Referenced Documents2.1 ASTM Standards:2C859 Terminology Relating to Nuclear MaterialsC1009 Guide for Establishing and Maintaining a QualityAssurance Program forAnalytical Laboratories Within theNuclear IndustryC1068 Guide for Qualification of Measurement Methods bya Laboratory Within the Nuclear IndustryC1128 Guide for Preparation of Working Reference Materi-als for Use in Analysis of Nuclear Fuel Cycle MaterialsC1156 Guide for Establishing Calibration for a Measure-ment Method Used to Analyze Nuclear Fuel Cycle Mate-rialsC1297 Guide for Qualification of Laboratory Analysts forthe Analysis of Nuclear Fuel Cycle Materials2.2 ANSI Standards:3ANSI/ASQ B1 Guide for Quality Control ChartsANSI/ASQ B2 Control Chart Method of Analyzing DataANSI/ASQ B3 Control Chart Method of Controlling QualityDuring Production3.Terminology3.1 For definitions of terms used in this guide,see Termi-nology C859.4.Significance and Use4.1 A laboratory quality assurance program is an essentialprogram for laboratories within the nuclear industry.GuideC1009 provides guidance for establishing a quality assuranceprogram for an analytical laboratory within the nuclear indus-try.The basic elements of a laboratory quality assuranceprogram are organization,quality assurance program,trainingand qualification,procedures,laboratory records,control ofrecords,control of procurement,control of measuring equip-ment and materials,control of measurements,and deficienciesand corrective actions.This guide deals with the control ofmeasurements aspect of the laboratory quality assurance pro-gram.Fig.1 shows the relationship of measurement controlwith other essential aspects of a laboratory quality assuranceprogram.4.2 The fundamental purposes of a measurement controlprogram are to provide the with use assurance(real-timecontrol)that a measurement system is performing satisfactorilyand to provide the data necessary to quantify measurementsystem performance.The with use assurance is usually pro-vided through the satisfactory analysis of quality controlsamples(reference value either known or unknown to theanalyst).The data necessary to quantify measurement systemperformance is usually provided through the analysis of qualitycontrol samples or the duplicate analysis of process samples,orboth.In addition to the analyses of quality control samples,the1This guide is under the jurisdiction of ASTM Committee C26 on Nuclear FuelCycle and is the direct responsibility of Subcommittee C26.08 on QualityAssurance,Statistical Applications,and Reference Materials.Current edition approved June 1,2012.Published July 2012.Originally approvedin 1991.Last previous edition approved in 2006 as C1210 06.DOI:10.1520/C1210-12.2For 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.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 laboratory quality control program should address(1)thepreparation and verification of standards and reagents,(2)dataanalysis procedures and documentation,(3)calibration andcalibration procedures,(4)measurement method qualification,(5)analyst qualification,and(6)other general program con-siderations.Other elements of laboratory quality assurance alsoimpact the laboratory quality control program.These elementsor requirements include(1)chemical analysis procedures andprocedurecontrol,(2)recordsstorageandretrievalrequirements,(3)internal audit requirements,(4)organiza-tional considerations,and(5)training/qualification re