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
25、atory and quality control management should involve labora-tory measurement systems in external exchange programs,such as: interlaboratory exchange programs, sample exchangeprograms, sample or standard round robins, and referee analy-ses programs. The programs provide some degree of externalverifica
26、tion or validation of the measurement system qualitycontrol program that is desirable.6. Quality Control Samples6.1 Quality control samples (knowns, unknowns, blinds,blanks, etc.) are used to verify and monitor measurementsystem performance. Quality control samples should be pre-pared or purchased o
27、ver the measurement range of interest andhave an impurity content and matrix composition that approxi-mates the process samples, unless the measurement method hasbeen shown to be free from sample matrix effects. Qualitycontrol sample preparation procedures, specific requirements(purity of source mat
28、erials and solvents; storage requirement;shelf life; etc.), and the preparation should be documented.Quality control samples may be prepared from the following:Certified Reference Materials (CRMs), Working ReferenceMaterials (WRMs), other reference materials, pure elements orcompounds with vendor su
29、pplied assay, reagent grade (orbetter) chemicals with assay, and process materials. Guidanceon the preparation of WRMs for use in the analysis of nuclearfuel cycle materials is provided in Guide C1128.6.2 When quality control samples are prepared, the prepa-ration procedure and data (mass, volume, e
30、tc.) should bedocumented. Further, appropriate measurements should beperformed to verify the prepared value.6.3 The quality control samples should be characterized toestablish their reference values when prepared from materialswith uncertain assays, or from process material, or whensmaller uncertain
31、ties are required on the samples than can beobtained from the source materials. A record of the preparationprocedure and data should be maintained. The characterizationmethod or procedure, complete with calibration data and thecharacterization analysis results, should be referenced or in-cluded in t
32、he preparation data.6.4 All quality control samples should be labeled with (1)the concentration, activity, abundance, etc. of the species ofinterest, (2) solvent if other than water, (3) matrix, (4) dateprepared, (5) identification of preparer, and (6) storage require-ments or limitations. Alternate
33、ly, QC samples should be codedin such a manner as to uniquely identify this same information.FIG. 1 Quality Assurance of Analytical Laboratory DataC1210 1226.5 All incoming chemicals and RMs should be labeled witha shelf life, acceptance date, or expiration date, if applicable.7. Analysis of Quality
34、 Control Samples7.1 The analysis of data from quality control samplesprovides a demonstration of measurement system performanceand provides the information necessary to quantify that perfor-mance over the portion of the system covered by the qualitycontrol samples. The reference value of the quality
35、 controlsamples may be either known or unknown to the analyst.7.1.1 The analysis of known quality control samples canprovide a satisfactory bench demonstration of whether asystem is in- or out-of-control without the need for a computerbased quality control program. In general, the data resultingfrom
36、 the analysis of known quality control samples is notrecommended for quantifying measurement system perfor-mance.7.1.2 In general, the analysis of unknown quality controlsamples provides the data necessary to quantify measurementsystem performance. The data resulting from the analysis ofunknown qual
37、ity control samples may also be used to providethe with use assurance of method performance, but some formof computer based system would be required in order toprovide the real-time, at-bench determination of system per-formance. The use of unknown quality control samples forboth functions can signi
38、ficantly increase the amount of dataavailable to model measurement systems.7.2 The frequency of analysis of quality control samplesshould be determined and described in laboratory procedures.The frequency should be a function of the stability of themeasurement system.7.3 Quality control samples shou
39、ld be subjected to the sameanalysis conditions as the actual samples. The condition shouldbe the same over the entire analysis sequence from samplealiquoting and preparation to data reduction.7.3.1 When quality control samples are not subjected to aportion of the sample analysis sequence, sufficient
40、 documen-tation should exist to demonstrate that the portion of the systemthat is not covered does not contribute significantly to themeasurement system bias and precision. The liability thatexists for not covering the entire sequence should be under-stood and documented.7.3.2 Even though sample ali
41、quoting by mass or by volumemay be included in the analysis of quality control samples, thisfunction is so fundamental and common to nearly all measure-ment systems that laboratories should maintain calibration andquality control programs on balances and, if applicable, onvolume aliquoting and measu
42、ring devices. Balance and volumealiquoting devices should be treated as measurement systemsor methods and should have calibration and quality controlprograms that satisfy the information contained in this guide.7.4 The analysis of quality control samples should bedocumented. The documentation should
43、 include, but not nec-essarily be limited to, date and time of analysis, measurementsystem identification, analyst identification, quality controlsample reference value or code, analysis results, analysis rawdata, and whether the analysis passed or failed system perfor-mance criteria.7.5 The data re
44、sulting from the analyses of quality controlsamples should be evaluated against established measurementmethod control limits immediately (real-time, at-the-bench, byplotting on some form of control chart or by computerassessment) and a determination made as to whether themeasurement system is in- or
45、 out-of-control.7.6 Corrective actions for an out-of-control measurementsystem should be defined and documented. The quality controlprogram should define responsibilities for taking correctiveactions and should establish reporting requirements to techni-cal and operation management.7.6.1 If the meas
46、urement system is out-of-control, correc-tive actions should be initiated and measurement systemcontrol should be reestablished before using the measurementsystem to produce results.7.6.2 Corrective actions vary with circumstances and sys-tems and may include but not be limited to (1) running anumbe
47、r of quality control samples; (2) a simple assignment ofcause and correction of conditions coupled with the successfulanalyses of quality control samples; (3) assignment of causethat is not readily correctable, that therefore necessitates thegeneration of a new quality control data base; and (4)acom
48、plete and detailed evaluation of measurement systemperformance and suitability to its intended purpose. In allcases, the conditions for reestablishing control need to bedefined and control should be reestablished prior to using themeasurement system. In general, a single re-measurement of aquality c
49、ontrol sample is not adequate to reestablish control.7.6.3 When a measurement system is out-of-control, anevaluation should be made as to the validity of the resultsgenerated since the measurement system was last verified to bein control and the samples should be reanalyzed if possible.8. Quality Control Data Analysis8.1 Data from the measurements of quality control samplesshould be statistically evaluated to assign control limits tomeasurement systems and to quantify system performancethrough bias and precision statements. ASTM MNL 74andvarious references provide guidance on presen
