ASTM_C_1297_-_03_2011.pdf

Designation:C129703(Reapproved 2011)Standard Guide forQualification of Laboratory Analysts for the Analysis ofNuclear Fuel Cycle Materials1This standard is issued under the fixed designation C1297;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 the qualification of analysts to per-form chemical analysis or physical measurements of nuclearfuel cycle materials.The guidance is general in that it isapplicable to all analytical methods,but must be appliedmethod by method.Also,the guidance is general in that it maybe applied to initial qualification or requalification.1.2 The guidance is provided in the following sections:SectionQualification Considerations4Demonstration Process5Statistical Tests61.3 This standard does not apply to maintaining qualifica-tion during routine use of a method.Maintaining qualificationis included in Guide C1210.1.4 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:2C1009 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-rialsC1210 Guide for Establishing a Measurement System Qual-ity Control Program for Analytical Chemistry Laborato-ries Within the Nuclear IndustryC1215 Guide for Preparing and Interpreting Precision andBias Statements in Test Method Standards Used in theNuclear Industry2.2 ISO Standard:ISO Guide 30 Terms and Definitions Used in Connectionwith Reference Materials33.Significance and Use3.1 This is one of a series of guides designed to provideguidance for implementing activities that meet the require-ments of a sound laboratory quality assurance program.Thefirst of these,Guide C1009,is an umbrella guide that providesgeneral criteria for ensuring the quality of analytical laboratorydata.Other guides provide expanded criteria in various areasaffecting quality,producing a comprehensive set of criteria forcontrolling data quality.The approach to ensuring the qualityof analytical measurements described in these guides is de-picted in Fig.1.3.2 The training and qualification of analysts is one of theelements of laboratory quality assurance presented in GuideC1009,which provides some general criteria regarding quali-fication.This guide expands on those criteria to provide morecomprehensive guidance for qualifying analysts.As indicatedin Guide C1009,the qualification process can vary in ap-proach;this guide provides one such approach.3.3 This guide describes an approach to analyst qualificationthat is designed to be used in conjunction with a rigorousprogram for the qualification and control of the analyticalmeasurement system.This requires an existing data base whichdefines the characteristics(precision and bias)of the system inroutine use.The initial development of this data base isdescribed in Guide C1068.The process described here isintended only to qualify analysts when such a data base existsand the method is in control.3.4 The qualification activities described in this guide as-sume that the analyst is already proficient in general laboratory1This guide is under the jurisdiction of ASTM Committee C26 on Nuclear FuelCycleand is the direct responsibility of Subcommittee C26.08 on QualityAssurance,Statistical Applications,and Reference Materials.Current edition approved June 1,2011.Published June 2011.Originallyapproved in 1995.Last previous edition approved in 2003 as C1297-03.DOI:10.1520/C1297-03R11.2For 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.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 operations.The training or other activities that developed thisproficiency are not covered in this guide.3.5 This guide describes a basic approach and principles forthe qualification of laboratory analysts.Users are cautioned toensure that the qualification program implemented meets theneeds and requirements of thei