ASTM C1210-2006 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制.pdf
《ASTM C1210-2006 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制.pdf》由会员分享,可在线阅读,更多相关《ASTM C1210-2006 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制.pdf(5页珍藏版)》请在麦多课文档分享上搜索。
1、Designation: C 1210 06Standard Guide forEstablishing a Measurement System Quality ControlProgram for Analytical Chemistry Laboratories Within theNuclear Industry1This standard is issued under the fixed designation C 1210; the number immediately following the designation indicates the year oforiginal
2、 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 standard provides guidance for establishing andmaintaining a
3、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, analyst qualifi-cation, measurement system calibration, measurement methodqualification, and m
4、easurement system maintenance.1.2 This guidance is provided in the following sections:SectionGeneral Quality Control Program Considerations 4Quality Control Samples 5Analysis of Quality Control Samples 6Quality Control Data Analysis 7Analyst Qualification 8Measurement System Calibration 9Measurement
5、 Method Qualification 10Measurement System Maintenance 112. Referenced Documents2.1 ASTM Standards:2C 1009 Guide for Establishing a Quality Assurance Pro-gram for Analytical Chemistry Laboratories Within theNuclear IndustryC 1068 Guide for Qualification of Measurement Methodsby a Laboratory Within t
6、he Nuclear IndustryC 1128 Guide for Preparation of Working Reference Mate-rials for Use in the Analysis of Nuclear Fuel CycleMaterialsC 1156 Guide for Establishing Calibration for a Measure-ment Method Used to Analyze Nuclear Fuel Cycle Mate-rialsC 1297 Guide for Laboratory Analysts for the Analysis
7、 ofNuclear 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. Significance and Use3.1 A laboratory quality assurance program is an essential
8、program for laboratories within the nuclear industry. GuideC 1009 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, training
9、and 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 pr
10、o-gram. Fig. 1 shows the relationship of measurement controlwith other essential aspects of a laboratory quality assuranceprogram.3.2 The fundamental purposes of a measurement controlprogram are to provide the with use assurance (real-timecontrol) that a measurement system is performing satisfactori
11、lyand 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
12、 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, thelaboratory quality control program should address (1) thepreparation and verification of standards and reagents, (2) da
13、taanalysis 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 also1This guide is under the jurisdiction of ASTM Committe
14、e C26 on Nuclear FuelCycle and is the direct responsibility of Subcommittee C26.08 on QualityAssuranceApplications.Current edition approved Jan. 1, 2006. Published February 2006. Originallyapproved in 1991. Last previous edition approved in 1996 as C 1210 96e1.2For referenced ASTM standards, visit t
15、he 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
16、 10036.1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.impact the laboratory quality control program. These elementsor requirements include (1) chemical analysis procedures andprocedure control, (2) records storage and retrieval requ
17、ire-ments, (3) internal audit requirements, (4) organizational con-siderations, and (5) training/qualification requirements. To theextent possible, this standard will deal primarily with qualitycontrol requirements rather than overall quality assurancerequirements.3.3 Although the Standard Guide use
18、s suggestive ratherthan prescriptive language (for example, “should” as opposedto “shall”), the elements being addressed should not beinterpreted as optional. An effective and comprehensive labo-ratory quality control program should, at minimum, completelyand adequately consider and include all elem
19、ents listed inSection 1 and in the corresponding referenced sections of thisguide.4. General Quality Control Program Considerations4.1 The quality control activities described in this guide areintended for a quality control function which is internal to ananalytical chemistry laboratory. The quality
20、 control programshould have an administrator or manager working in concertwith laboratory managers to produce 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,
21、 or torequest or require additional quality control sample analyses. Itis desirable for the quality control program to have periodicinternal assessments. These assessments should involve labo-ratory managers, the quality control manager, and laboratorycustomers. The quality control program should be
22、 audited forprocedure compliance at periodic intervals by the qualityassurance organization.4.2 The analytical 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 doc
23、umentation should be describedin laboratory procedures and consistent with other laboratorystorage requirements and any applicable contractual or regula-tory requirements.4.3 External quality control program assessment should beconducted by an outside organization or agency at a frequencydictated by
24、 company or facility policy, contract, or otherapplicable regulations or requirements. When possible, labo-ratory and quality control management should involve labora-tory measurement systems in external exchange programs,such as: interlaboratory exchange programs, sample exchangeprograms, sample or
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