ASTM C1210-2012 Standard Guide for Establishing a Measurement System Quality Control Program for Analytical Chemistry Laboratories Within the Nuclear Industry 《制定核工业分析化学实验室用测量系统质量控.pdf
《ASTM C1210-2012 Standard Guide for Establishing a Measurement System Quality Control Program for Analytical Chemistry Laboratories Within the Nuclear Industry 《制定核工业分析化学实验室用测量系统质量控.pdf》由会员分享,可在线阅读,更多相关《ASTM C1210-2012 Standard Guide for Establishing a Measurement System Quality Control Program for Analytical Chemistry Laboratories Within the Nuclear Industry 《制定核工业分析化学实验室用测量系统质量控.pdf(5页珍藏版)》请在麦多课文档分享上搜索。
1、Designation: C1210 12Standard 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 a
2、doption 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 mea
3、surement system quality control program.Guidance is provided for general program considerations,preparation of quality control samples, analysis of qualitycontrol samples, quality control data analysis, analyst qualifi-cation, measurement system calibration, measurement methodqualification, and meas
4、urement system maintenance.1.2 This guidance is provided in the following sections:SectionGeneral Quality Control Program Considerations 5Quality Control Samples 6Analysis of Quality Control Samples 7Quality Control Data Analysis 8Analyst Qualification 9Measurement System Calibration 10Measurement M
5、ethod Qualification 11Measurement System Maintenance 122. Referenced Documents2.1 ASTM Standards:2C859 Terminology Relating to Nuclear MaterialsC1009 Guide for Establishing a Quality Assurance Programfor Analytical Chemistry Laboratories Within the NuclearIndustryC1068 Guide for Qualification of Mea
6、surement Methods bya Laboratory Within the Nuclear IndustryC1128 Guide for Preparation of Working Reference Mate-rials 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 Qu
7、alification 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 Qual-ity During Production3. Terminology3.1 For definiti
8、ons 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 t
9、he 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,
10、 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 m
11、easurement 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 quali
12、ty 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 cont
13、rol samples, thelaboratory quality control program should address (1) thepreparation and verification of standards and reagents, (2) dataanalysis procedures and documentation, (3) calibration and1This guide is under the jurisdiction of ASTM Committee C26 on Nuclear FuelCycle and is the direct respon
14、sibility of Subcommittee C26.08 on Quality Assur-ance, 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, v
15、isit 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 Yo
16、rk, NY 10036.1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.calibration procedures, (4) measurement method qualification,(5) analyst qualification, and (6) other general program con-siderations. Other elements of laboratory quality
17、assurance alsoimpact the laboratory quality control program. These elementsor requirements include (1) chemical analysis procedures andprocedure control, (2) records storage and retrieval require-ments, (3) internal audit requirements, (4) organizational con-siderations, and (5) training/qualificati
18、on requirements. To theextent possible, this standard will deal primarily with qualitycontrol requirements rather than overall quality assurancerequirements.4.3 Although the Standard Guide uses suggestive ratherthan prescriptive language (for example, “should” as opposedto “shall”), the elements bei
19、ng addressed should not beinterpreted as optional. An effective and comprehensive labo-ratory quality control program should, at minimum, completelyand adequately consider and include all elements listed inSection 1 and in the corresponding referenced sections of thisguide.5. General Quality Control
20、 Program Considerations5.1 The quality control activities described in this guide areintended for a quality control function which is internal to ananalytical chemistry laboratory. The quality control programshould have an administrator or manager working in concertwith laboratory managers to produc
21、e cost effective measure-ments of demonstrated quality. The program manager shouldhave the authority based on quality control sample perfor-mance to disqualify analysts or measurement systems, or torequest or require additional quality control sample analyses. Itis desirable for the quality control
22、program to have periodicinternal assessments. These assessments should involve labo-ratory managers, the quality control manager, and laboratorycustomers. The quality control program should be audited forprocedure compliance at periodic intervals by the qualityassurance organization.5.2 The analytic
23、al laboratories quality control programshould be described in laboratory procedures and all measure-ment system quality control activities should be documented.The retention period for the documentation should be describedin laboratory procedures and consistent with other laboratorystorage requireme
24、nts and any applicable contractual or regula-tory requirements.5.3 External quality control program assessment should beconducted by an outside organization or agency at a frequencydictated by company or facility policy, contract, or otherapplicable regulations or requirements. When possible, labo-r
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