1、Designation: E2027 09E2027 17Standard Practice forConducting Proficiency Tests in the Chemical Analysis ofMetals, Ores, and Related Materials1This standard is issued under the fixed designation E2027; the number immediately following the designation indicates the year oforiginal adoption or, in the
2、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 practice provides direction for organizing and conducting proficiency test programs
3、 in analytical chemistry for metals,ores, and related materials. It is consistent with ISO Guide 43ISO/IEC 17043 and Guide E1301. It does not address the selectionand use of proficiency testing schemes by accrediting bodies.1.2 This international standard was developed in accordance with internation
4、ally recognized principles on standardizationestablished in the Decision on Principles for the Development of International Standards, Guides and Recommendations issuedby the World Trade Organization Technical Barriers to Trade (TBT) Committee.2. Referenced Documents2.1 ASTM Standards:2E135 Terminol
5、ogy Relating to Analytical Chemistry for Metals, Ores, and Related MaterialsE826 Practice for Testing Homogeneity of a Metal Lot or Batch in Solid Form by Spark Atomic Emission SpectrometryE1187 Terminology Relating to Conformity Assessment (Withdrawn 2006)3E1301 Guide for Proficiency Testing by Int
6、erlaboratory Comparisons (Withdrawn 2012)3E1724E2972 Guide for Testing and Certification of Metal, Ore, and Metal-Related Reference Production, Testing, and ValueAssignment of In-House Reference Materials for Metals, Ores, and Other Related Materials (Withdrawn 2010)2.2 ISO Standards:4ISO 9001 Quali
7、ty ManagementISO 13528 Statistical Methods for Proficiency Testing by Interlaboratory ComparisonISO 17025ISO/IEC 17025 General Requirements for the Competence of Calibration and Testing LaboratoriesISO Guide 43ISO/IEC 17043 Proficiency Testing by Interlaboratory ComparisonsConformity Assessment Gene
8、ral Require-ments for Proficiency TestingISO Guide 9000 Quality Management and Quality System Elements3. Terminology3.1 DefinitionsFor formal definitions related to laboratory accreditation, Terminology E1187 applies.3.1 DefinitionsFor formal definitions related to laboratory accreditation, Terminol
9、ogy E135 applies.3.1.1 assigned value, nvalue that serves as a declared or agreed-upon reference for comparison, normally derived from orbased on experimental work of a national or international organization.3.1.1.1 DiscussionThe assigned value is given to a property or constituent of a reference ma
10、terial or proficiency test material through technical andstatistical evaluation of test results.1 This practice is under the jurisdiction of ASTM Committee E01 on Analytical Chemistry for Metals, Ores, and Related Materials and is the direct responsibility ofSubcommittee E01.22 on Laboratory Quality
11、.Current edition approved Nov. 1, 2009Nov. 15, 2017. Published December 2009December 2017. Originally approved in 1999. Last previous edition approved in 20052009as E2027 05.E2027 09. DOI: 10.1520/E2027-09.10.1520/E2027-17.2 For referencedASTM standards, visit theASTM website, www.astm.org, or conta
12、ctASTM Customer Service at serviceastm.org. For Annual Book of ASTM Standardsvolume information, refer to the standards Document Summary page on the ASTM website.3 The last approved version of this historical standard is referenced on www.astm.org.4 Available from American National Standards Institu
13、te (ANSI), 25 W. 43rd St., 4th Floor, New York, NY 10036, http:/www.ansi.org.International Organization forStandardization (ISO), ISO Central Secretariat, BIBC II, Chemin de Blandonnet 8, CP 401, 1214 Vernier, Geneva, Switzerland, http:/www.iso.org.This document is not an ASTM standard and is intend
14、ed only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Becauseit may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current
15、 versionof the standard as published by ASTM is to be considered the official document.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States13.2 For other definitions of terms used in thethis practice, refer to Terminology E135.4. Significa
16、nce and Use4.1 This practice sets the basic requirements for proficiency test programs in the chemical analysis of metals, ores, and relatedmaterials. It does not set specific procedural requirements, but does establish a framework for particular programs, including thosewith either small or large n
17、umbers of participants. (WarningThe data from proficiency testing programs must never be used toassign certification values to the materials used in the program.The elements of a properly conceived and implemented certificationprogram are described in detail in Guide E1724.)4.2 The data from profici
18、ency testing programs can be used for value assignments for in-house reference materials developedin accordance with Guide E2972.4.3 Most accreditation bodies require that laboratories participate regularly in proficiency testing programs that they haveaccepted for thethis purpose. Therefore, it is
19、essential that each program comply with accepted principles including technicalrequirements, statistical procedures (see Annex A1), and quality management (see Annex A2).5. Types of Proficiency Testing5.1 Proficiency testing techniques vary depending on the nature of the test item, the method in use
20、 and the number oflaboratories participating. The most common approach involves randomly selected sub-samples from a source of material beingdistributed simultaneously to participating testing laboratories for concurrent testing. It is essential that all of the material fromwhich the participants te
21、st materials are taken be sufficiently homogeneous so that any results later identified as outliers shouldnot be attributed to any significant test item variability. After completion of the testing, the results are returned to the coordinatingbody, and compared with the assigned value(s) or to the m
22、ean and standard deviations obtained from a statistical analysis of thedata to give an indication of the performance of the individual laboratories and the group as a whole.5.2 In some cases, separate portions of previously certified reference materials are circulated.6. Organization and Design6.1 F
23、ramework:6.1.1 The design stage of any proficiency testing program requires the input of technical experts, statisticians and a programcoordinator to ensure its success and smooth operation.6.1.2 The coordinator, in consultation with these other personnel, develops a program appropriate to the parti
24、cular proficiencytest. A proficiency test program shall be designed to avoid any confusion about its objectives. A plan shall be established anddocumented (see Annex A2) before the start of the program and shall include the following information:6.1.2.1 The name and the address of the organization c
25、onducting the proficiency program,6.1.2.2 The name and address of the coordinator and other personnel involved in the design and operation of the proficiencyprogram,6.1.2.3 The nature and the purpose of the proficiency program,6.1.2.4 A procedure for the manner in which the participants are selected
26、, or criteria that need to be met before participationis allowed,6.1.2.5 The name and address of the laboratory or laboratories performing the various parts of the program (for example,sampling, sample processing, homogeneity testing and assigning values) and a description of the market to be served
27、,6.1.2.6 The nature of the test material(s) and test(s) selected, as well as a short description of the considerations underlying thesechoices,6.1.2.7 A description of the manner in which the test materials are obtained, processed, checked and transported,6.1.2.8 The time schedule for the various ph
28、ases of the proficiency testing,6.1.2.9 The expected initial and target dates or deadlines of the proficiency program including the date(s) for the testing to beconducted by the participants,6.1.2.10 For ongoing programs, the frequency at which test materials are distributed,6.1.2.11 Information on
29、methods or procedures which participants may need to use to perform the tests or measurements(ASTM test methods, laboratory standard procedures/methods, etc.),6.1.2.12 An outline of the statistical analysis to be used including the determination of assigned value(s) and any outlierdetection techniqu
30、es,6.1.2.13 The basis for performance evaluation techniques, and6.1.2.14 A description of the extent to which the test results, and the conclusions that will be based on the outcome of theproficiency tests, are to be made public.6.2 Staff:6.2.1 The staff shall include, or collaborate closely with, t
31、hose holding adequate qualifications and experience in the design,implementation and reporting of interlaboratory comparisons. They shall possess appropriate technical, statistical and adminis-trative skills.E2027 1726.2.2 The operation of specific interlaboratory comparisons requires the guidance o
32、f persons with detailed technical knowledgeand experience of the test methods involved. To this end the coordinator shall enlist some professionals to act as an advisory group.The functions of this advisory group may be to:6.2.2.1 Develop and review procedures for the planning execution, analysis, r
33、eporting and monitoring the effectiveness of theproficiency testing program,6.2.2.2 Identify and evaluate interlaboratory comparisons organized by other bodies,6.2.2.3 Evaluate proficiency test results of participating laboratories,6.2.2.4 Provide advice to any body anyone assessing the technical co
34、mpetence of participating laboratories, both on the resultsobtained during a proficiency test program, and how those results should be used with other aspects of laboratory evaluations,6.2.2.5 Provide advice to participants who appear to experience problems, and6.2.2.6 Resolve disputes between the c
35、oordinator and participants.6.3 Data Processing EquipmentEquipment shall be adequate to conduct all necessary data entry and statistical analyses andprovide timely and valid results. Procedures for checking data entry shall be implemented and all software shall be verified,supported and backed up. T
36、he storage and security of data files shall be controlled.6.4 Statistical Design:6.4.1 The statistical model and data analysis techniques to be used shall be documented together with a short description of thebackground to their selection. Further details of common statistical procedures and treatme
37、nt of proficiency testing data arediscussed in Annex A1.6.4.2 Careful consideration shall be given to the following matters and their interactions: the repeatability and reproducibilityof the test(s) involved; the smallest differences to be detected between participating laboratories at a desired co
38、nfidence level; thenumber of participating laboratories; the number of samples to be tested and the number of repeat tests or measurements to becarried out on each sample; the procedures to be used to estimate the assigned value; procedures to be used to identify outliers;and,outliers and potential
39、bias in the test methods employed.6.5 Test Materials Preparation:6.5.1 Preparation of test materials may either be outsourced or undertakenperformed by the coordinator. The organizationpreparing the test material shall have demonstrable competence to do so.6.5.2 Any conditions relating to the test m
40、aterials that may affect the integrity of the interlaboratory comparison, such ashomogeneity, stability, possible damage in transit and effects of ambient conditions shall be considered.6.5.3 The test materials or materials to be distributed in the program shall be similar in nature to those routine
41、ly tested byparticipating laboratories.laboratories using the methods prescribed.6.5.4 The number of test materials to be distributed may depend on whether there is a requirement to cover a range ofcompositions.6.5.5 The assigned value(s) shall not be disclosed to the participants until after all th
42、e results have been collated. collated, oruntil such time that no new results will be considered. However, in some cases it may be appropriate to advise target ranges priorto testing.6.5.6 Consideration may be given to preparation of additional test materials other than those needed for the proficie
43、ncy testprogram. Surplus test materials may be useful as quality control materials, test samples for interlaboratory tests of new testmethods, or training aids for laboratories after results from participants have been evaluated.6.6 Test Materials Management:6.6.1 Procedures for sampling, randomizin
44、g, transporting, receiving, identifying, labelling,labeling, storing and handling of testmaterials shall be documented.6.6.2 Where bulk material is prepared for a proficiency test, it shall be sufficiently homogeneous (based on evaluation byPractice E826) for each test parameter so that all laborato
45、ries will receive test materials that do not differ significantly in theparameters to be measured. An estimate of permissible variation between results on different test portions (homogeneity test)obtained by the same operator applying the same test method with the same apparatus under identical ope
46、rating conditions withinshort intervals of time can be obtained from the reproducibility limits. The coordinator shall clearly state the procedure used toestablish the homogeneity of the test item (see A1.4). Homogeneity testing shall be conducted prior to the dispatch of the testmaterials to the pa
47、rticipating laboratories.6.6.3 Where applicable, the coordinating laboratory coordinator shall also provide evidence that the test materials aresufficiently stable to ensure that they will not undergo any significant change throughout the conductperformance of the proficiencytest. When unstable anal
48、ytes need to be assessed, it may be necessary for the coordinating organization to prescribe a date by whichthe testing shall be completed, including required special pretesting procedures.6.6.4 Coordinators shall consider any hazards that the test materials might pose and take appropriate action to
49、 advise any partythat might be at risk (for example, test material distributors, testing laboratories, etc.).6.7 Choice of Test Method:E2027 1736.7.1 The coordinator may instruct participants to use a specified test method. Such test methods are usually nationally orinternationally-accepted standard test methods, and will have been validated by an appropriate procedure (for example,collaborative trial).6.7.2 Participants may be able to use the test method of their choice, which is consistent with routine procedures used in theirlaboratories. Where participants are f
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