ASTM C1210-2018 Standard Guide for Establishing a Measurement System Quality Control Program for Analytical Chemistry Laboratories Within the Nuclear Industry.pdf

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1、Designation: C1210 18Standard 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, analystqualification, measurement system calibration, measurementmethod qualification, and measur

4、ement 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 Met

5、hod Qualification 11Measurement System Maintenance 121.3 This international standard was developed in accor-dance with internationally recognized principles on standard-ization established in the Decision on Principles for theDevelopment of International Standards, Guides and Recom-mendations issued

6、 by the World Trade Organization TechnicalBarriers to Trade (TBT) Committee.2. Referenced Documents2.1 ASTM Standards:2C859 Terminology Relating to Nuclear MaterialsC1009 Guide for Establishing and Maintaining a QualityAssurance Program forAnalytical Laboratories Within theNuclear IndustryC1068 Guid

7、e 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 Ma

8、te-rialsC1297 Guide for Qualification of Laboratory Analysts forthe Analysis of Nuclear Fuel Cycle MaterialsE2554 Practice for Estimating and Monitoring the Uncer-tainty of Test Results of a Test Method Using ControlChart Techniques2.2 ANSI Standards:3ANSI/ASQ B1 Guide for Quality Control ChartsANSI

9、/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 but notdefined herein, see Terminology C859.3.2 Definitions:3.2.1 measurement system, nset of all components used toprod

10、uce an analytical result.3.2.1.1 DiscussionComponents may include, for example,equipment or instrumentation used to prepare samples, performthe analytical measurement, perform any needed datamanipulations, and record results in printed or electronic form,or both.3.2.2 quality control program, ndocum

11、ented system ofactivities utilizing quality control samples and appropriateacceptance criteria to ensure that measurement systems areproducing results that are suitable for their intended purpose.3.2.3 quality control sample, na sample used to verify andmonitor measurement system performance and rel

12、iability.3.2.3.1 DiscussionQuality control samples may includeknowns, unknowns, blinds, blanks, duplicates, matrix spikes,and so forth.1This guide is under the jurisdiction of ASTM Committee C26 on Nuclear FuelCycle and is the direct responsibility of Subcommittee C26.08 on QualityAssurance, Statist

13、ical Applications, and Reference Materials.Current edition approved Nov. 1, 2018. Published December 2018. Originallyapproved in 1991. Last previous edition approved in 2012 as C1210 12. DOI:10.1520/C1210-18.2For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Custome

14、r 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

15、Drive, PO Box C700, West Conshohocken, PA 19428-2959. United StatesThis international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for theDevelopment of International Standards, Guides and Recommendations

16、 issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.13.2.3.2 DiscussionQuality control samples may be used toestimate bias in the measurement system or analytical method.4. Significance and Use4.1 A laboratory quality assurance program is an essentialprogram for labor

17、atories 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,

18、 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 sho

19、ws 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 t

20、he 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 provid

21、ed 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) dataanalysis procedu

22、res 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 requirem

23、ents include (1) chemical analysis procedures andprocedure control, (2) records storage and retrievalrequirements, (3) internal audit requirements, (4) organiza-tional considerations, and (5) training/qualification require-ments. To the extent possible, this standard will deal primarilywith quality

24、control requirements rather than overall qualityassurance requirements.4.3 Although this guide uses suggestive rather than pre-scriptive language (for example, “should” as opposed to“shall”), the elements being addressed should not be inter-preted as optional. An effective and comprehensive laborato

25、ryquality control program should, at minimum, completely andadequately consider and include all elements listed in Section1 and in the corresponding referenced sections of this guide.5. General Quality Control Program Considerations5.1 The quality control activities described in this guide areintend

26、ed 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 produce cost effective measure-ments of demonstrated and acceptable quality. The programmanager s

27、hould have the authority based on quality controlsample performance to disqualify analysts or measurementsystems, or to request or require additional quality controlsample analyses. It is desirable for the quality control programto have periodic internal assessments on a pre-determinedschedule. Thes

28、e assessments should involve laboratorymanagers, the quality control manager, and laboratory custom-ers. The quality control program should be audited for proce-dure compliance at periodic intervals by the quality assuranceorganization.5.2 The analytical laboratorys quality control programshould be

29、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 requirements and any applicable contractual or regula-tory

30、 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-ratory and quality control management should invol

31、ve 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 externalverification or validation of the measurement system qual

32、itycontrol program that is desirable.6. Quality Control Samples6.1 Preparation:6.1.1 Quality control samples should be prepared or pur-chased over the measurement range of interest and have animpurity content and matrix composition that approximates theFIG. 1 Quality Assurance of Analytical Laborato

33、ry DataC1210 182process samples, unless the measurement method has beenshown to be free from sample matrix effects.6.1.2 Quality control sample preparation procedures, spe-cific requirements (purity of source materials and solvents;storage requirement; shelf life; and so forth), and the prepara-tion

34、 should be documented.6.1.3 Quality control samples may be prepared from thefollowing:6.1.3.1 Certified Reference Materials (CRMs);6.1.3.2 Working Reference Materials (WRMs), prepared asdescribed in Guide C1128;6.1.3.3 Pure elements or compounds with vendor suppliedassay;6.1.3.4 Reagent grade (or be

35、tter) chemicals with assay; and6.1.3.5 Well-characterized process materials.6.2 When quality control samples are prepared, the prepa-ration procedure and data (mass, volume, etc.) should bedocumented. Further, appropriate measurements should beperformed to verify the prepared value.6.3 The quality c

36、ontrol samples should be characterized toestablish their reference values when prepared from materialswith uncertain assays, or from process material, or whensmaller uncertainties are required on the samples than can beobtained from the source materials. A record of the preparationprocedure and data

37、 should be maintained. The characterizationmethod or procedure, complete with calibration data and thecharacterization analysis results, should be referenced or in-cluded in the preparation data.6.4 Quality control samples should be prepared from adifferent supplier lot from the standards used for c

38、alibration(see Guide C1156).6.5 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. A

39、lternately, QC samples should be codedin such a manner as to uniquely identify this same information.6.6 All incoming chemicals and RMs should be labeled witha shelf life, acceptance date, or expiration date, if applicable.7. Analysis of Quality Control Samples7.1 The analysis of data from quality c

40、ontrol 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 controlsamples may be either known or unknown to the a

41、nalyst.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 the analysis of known quality control samples is notre

42、commended 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 quality control samples may also be used to providethe with

43、 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 significantly increase the amount of dataavailable to model

44、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 should be subjected to the sameanalysis conditions as the a

45、ctual 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 documen-tation should exist to demonstrate that the po

46、rtion 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 aliquoting by mass or by volumemay be included in the anal

47、ysis 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 measuring devices. Balance and volumealiquoting devices shou

48、ld be treated as measurement systemsor methods and should have calibration and quality controlprograms that satisfy the information contained in this guideand in Guide C1009.7.4 The analysis of quality control samples should bedocumented. The documentation should include, but not nec-essarily be lim

49、ited 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 resulting 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 out-of-control.7.6