1、Designation: E 1323 89 (Reapproved 2002)An American National StandardStandard Guide forEvaluating Laboratory Measurement Practices and theStatistical Analysis of the Resulting Data1This standard is issued under the fixed designation E 1323; the number immediately following the designation indicates
2、the year oforiginal 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 guide covers key elements of an evaluation
3、 of alaboratorys measurement practices and the statistical analysisof the resulting data. This guide addresses an evaluation thatcovers a broad range of in-house quality measurements, someof which may be directly related to accreditation requirements.1.2 This guide describes what to look for as docu
4、mentationin order to verify the operation of the practices, and what partsof the data to test and interpret in order to verify the quality ofdata being generated by the laboratory.1.3 This guide does not specify or provide guidance for theestablishment or assessment of a quality program.NOTE 1Generi
5、c guidelines dealing with elements of a quality pro-gram may be found in ANSI, A1, A3, Q1, Q2, Z34.1; ISO90009004; andILAC/ISO Collected Reports 19791983.22. Referenced Documents2.1 ASTM Standards:E 548 Practice for Preparation of Criteria for Use in theEvaluation of Testing Laboratories and Inspect
6、ion Bodies3E 994 Guide for Laboratory Accreditation Systems3E 1187 Terminology Relating to Laboratory Accreditation32.2 ANSI Standards:ANSI/ASQC A1 Definitions, Symbols, Formulas andTables for Control Charts4ANSI/ASQC A3 Quality Systems Terminology4ANSI/ASQC Q1 Generic Guidelines for Auditing of Qua
7、l-ity Systems4ANSI/ASQC Q2 Quality Management and Quality SystemElements for LaboratoriesGuidelines4ANSI Z34.1 American National Standard forCertificationThird Party Certification Program42.3 ISO Standard:ISO 90009004 Quality Management and Quality Assur-ance Standards32.4 Other Standard:ILAC/ISO La
8、boratory AccreditationPrinciples andPracticeCollected Reports 1979198343. Terminology3.1 Terms are defined in Terminology E 1187.3.2 Definitions of Terms Specific to This Standard:3.2.1 duplicatea separate specimen, taken from the samesource as the first specimen, tested at the same time and in thes
9、ame manner as the first specimen. Duplicates can providepooled precision data for a homogeneous specimen, the testmethod, and the test equipment.3.2.2 out of controlthe condition that exists when a datapoint falls outside the control limits and when retesting andfurther evaluation indicates that a p
10、roblem exists in analystperformance, the method, equipment, standardization, or cali-bration.3.2.3 replicate analysisthe same specimen tested again,usually at a different time. Replicate data can be used toprovide pooled precision of the test method, equipment, andoperator, providing the specimen is
11、 homogeneous in nature.4. Significance and Use4.1 This guide is intended to provide guidance for anassessor to evaluate measurement practices of laboratories,their protocol for statistically analyzing the resulting data fromthese practices, and their statistical results from these practices.4.2 This
12、 guide is generic in the sense that it covers the entirerange of in-house quality measurement practices found in atesting laboratory, but the results of the described evaluationmay be used by accrediting agencies if their requirements canbe satisfied through the laboratorys existing quality data.4.3
13、 It is not the intent of this guide to serve as sole criterionfor evaluating and accrediting laboratories. It is not intended tocover the important generic guidelines for evaluating the1This guide is under the jurisdiction of ASTM Committee E11 on Quality andStatistics and is the direct responsibili
14、ty of Subcommittee E11.20 on Test MethodEvaluation adn Quality Control.Current edition approved Dec. 29, 1989. Published February 1990.2ILAC/ISO Laboratory Accreditation-Principles and Practice-Collected Reports19791983. American Association for Laboratory Accreditation, 656 Quince Or-chard Rd. #704
15、 Gaithersburg, MD 208783Annual Book of ASTM Standards, Vol 14.02.4Available from American National Standards Institute, 1430 Broadway, NewYork, NY 10018.1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.laboratorys quality program whic
16、h can be found in PracticeE 548 and Guide E 994.5. Purpose of Evaluating Measurement Practices and theStatistical Analysis of the Resulting Data5.1 Data generated from the measurement practices of alaboratory is evaluated to determine its capability to obtainaccurate and precise data and to determin
17、e if the laboratorycorrectly and efficiently analyzes and reacts to their own data.6. Documentation of Measurement Practices and theStatistical Protocol for Analyzing the Resulting Data6.1 The following documentation shall contain the informa-tion necessary for someone to carry out the same stepsinv
18、olved in generating, charting, and reporting the data.6.1.1 Documentation Relative to Calibration:6.1.1.1 The material to be measured must be documentedtogether with its source, expiration or shelf-life date, theaccuracy and its source, and any preparations or conditionsrequired which are specific t
19、o this material before it can beutilized as a calibration material. Any additional components,reagents, or physical sources used along with this materialwhich could potentially alter the reliability of the material mustalso be documented.6.1.1.2 The identification of the equipment used, togetherwith
20、 the date and operator responsible for the run, and anypreparations involved with the calibration run must be docu-mented.6.1.1.3 The type of data representation to be used, includingthe exact number of data points to be used in the computationof an average, standard deviation, or range, as well as
21、how andwhen these data points are to be generated must be docu-mented. This requires information regarding testing of repli-cates, duplicates, or single runs tested on one day, a series ofdays, or a specific time interval to be clearly stated for each setof data.6.1.1.4 The mathematical formula for
22、obtaining controllimits, the frequency of computing new limits together withrules of acceptability of the new limits, must be documentedwhenever control limits are applied to a chart.6.1.1.5 The corrective action taken whenever data pointsindicate that an out of control condition exists, or whenever
23、trend analysis indicates a change or shift in the instrumentresponse must be recorded.6.1.1.6 A table of actual values for each calibration orcalibration check and the corresponding date must be kept.6.1.2 Documentation Relative to Method Precision andBias:6.1.2.1 The reference of the specific metho
24、d being followedfor each set of data, as well as any changes to the method mustbe documented. If a method has not been published, then thelaboratory is responsible for preparing a detailed procedure.6.1.2.2 The type of run (duplicate, replicate, single) used togenerate the data points, including spe
25、cific directions on howto prepare and test a duplicate or replicate specimen, must berecorded.6.1.2.3 The time interval for testing, or a date for each datapoint if a time interval is not practical, must be noted.6.1.2.4 Directions on how to statistically compare the labo-ratory results of precision
26、 with a known statement of precisionfor that method must be clearly documented. These directionsmust include the specific statistical test, the number of datapoints used for the test and the acceptable level of precision, beit known either from other studies on this specific method or asa limit dete
27、rmined by the laboratory itself.6.1.2.5 The method for determining if outliers exist mustalso be documented, stating when it is acceptable to ignoresuch data points when computing control limits.6.1.2.6 The method for determining if bias exists and thefrequency for continued checks on the instrument
28、 or methodhaving a bias must be recorded, including any adjustmentsmade to test data as a result of the bias determined from thesemeasurements.6.1.2.7 A table of actual values and the corresponding datesmust be kept.6.1.3 Documentation Relative to Operator Precision andAccuracy:6.1.3.1 The material,
29、 methods, and equipment used to de-termine levels of precision and accuracy of operators must bedocumented.6.1.3.2 The source of stated accuracy of the material, thecurrent precision and accuracy of the equipment, and thecurrent precision and bias of the method must be documented,together with the e
30、xact computations used to determine thesingle or group operator precision, accuracy, or both.6.1.3.3 The number of data points generated per operator forthis comparison test as well as the type (duplicate, replicate orsingle) and description of the type of runs being made. It mustbe clearly stated w
31、hich runs are related to the accuracy andwhich are related to precision.6.1.3.4 The limits of acceptability for both operator accu-racy and operator precision must be noted.6.1.3.5 The records must show the frequency of obtainingoperator accuracy and precision as well as the corrective actiontaken w
32、henever an operator fails to meet the limits of accept-ability.6.1.3.6 A table of actual values and corresponding dates foreach operator must also be documented.7. Evaluation of the Laboratorys Measurement Practicesand of the Statistical Analysis from the Resulting Data7.1 A general overview of the
33、laboratorys documentationof measurement practices and the statistical analysis of the datashould be made, verifying that all practices cited are actually inuse and that the rules stated by the laboratory for the generationand use of the data are followed.7.2 A walk-through of the laboratory to verif
34、y the locationof all data representation charts must be made as well asgeneral discussions with laboratory personnel to verify theirknowledge of the measurement practices.E 1323 89 (2002)27.3 The choice of representation of the data, as well as thegeneration of control chart limits must be reviewed
35、to deter-mine if appropriate models have been used for each type ofpopulation. For further information, see ASTM STP 15D.57.4 The raw data from the calibration records must becompared to status indicated for that piece of equipment. Everyout of control or out of specification data point in the raw d
36、atamust have a corresponding corrective action which resulted inrestoring the equipment to normal operation (status of incalibration) or resulted in a recommendation for further work(status of out of calibration). Dates and results from the rawdata must agree with the status shown on that piece ofeq
37、uipment.7.5 All charts must be viewed for trend analysis. Checks oftrends or shifts must include the interpretation of such bylaboratory personnel as well as the corrective action taken. Thisinformation does not have to be on the chart itself, but it mustbe documented somewhere by the laboratory and
38、 available forreview upon request by the assessor.7.6 All data calculations for any kind of limits, be it foraccuracy or precision of equipment, precision or bias ofmethods, or accuracy or precision of an operator, must bereviewed to determine if the appropriate type of chart has beenused and the op
39、timum number of data points have been used.7.7 Spot checks of the raw data must also be made to verifythat no data point is being disregarded unless an outlier test hasindicated that the data point can be omitted from the calcula-tion of control limits. The outlier is still documented as a checkand
40、listed in the table of data with corresponding dates.7.8 Raw data checks must also be made to verify thefrequency of testing for calibration. For example, a measure-ment practice that requires that a replicate be tested on 1 ofevery 10 specimens received, must show, through raw data,that the appropr
41、iate number of replicate tests were performed,reported, and transferred to the corresponding chart.7.9 Statistical tests, such as t, f, chi square, ANOVA, orother related tests as found in statistical analysis text books,that have been performed by the laboratory, must be verifiedfor accuracy. If no
42、ne of these tests were performed then theassessor could perform the tests for the laboratory, interpret theresults, and offer references to help prepare the laboratory toperform these computations in the future.8. Use of the Evaluation by Accrediting Bodies8.1 An accrediting body could use this eval
43、uation to deter-mine the extent of a laboratorys participation in proficiencytesting programs, based on the credibility of the laboratorysstatistical results of their measurement practices.8.2 An accrediting body may want to use the evaluation todetermine the extent and frequency of future on-site v
44、isits tothe laboratory. On site visits could possibly be replaced withcorrespondence by mail of the data from the measurementpractices in order to verify the laboratorys continued state ofstatistical control.8.3 The accrediting body may want to use the evaluation todetermine the needs of the laborat
45、ory as far as education isconcerned. They could refer the laboratory to adequate sourcesof reading material and short courses so that the laboratorycould make improvements in their overall quality program.9. Keywords9.1 accreditation; laboratory accreditation; laboratory mea-surement practices; stat
46、istical analysisASTM International takes no position respecting the validity of any patent rights asserted in connection with any item mentionedin this standard. Users of this standard are expressly advised that determination of the validity of any such patent rights, and the riskof infringement of
47、such rights, are entirely their own responsibility.This standard is subject to revision at any time by the responsible technical committee and must be reviewed every five years andif not revised, either reapproved or withdrawn. Your comments are invited either for revision of this standard or for ad
48、ditional standardsand should be addressed to ASTM International Headquarters. Your comments will receive careful consideration at a meeting of theresponsible technical committee, which you may attend. If you feel that your comments have not received a fair hearing you shouldmake your views known to
49、the ASTM Committee on Standards, at the address shown below.This standard is copyrighted by ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959,United States. Individual reprints (single or multiple copies) of this standard may be obtained by contacting ASTM at the aboveaddress or at 610-832-9585 (phone), 610-832-9555 (fax), or serviceastm.org (e-mail); or through the ASTM website(www.astm.org).5Manual on Presentation of Data and Control Chart Analysis, ASTM STP15 D,ASTM, 1982.E 1323 89 (2002)3
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