1、Designation: E 1323 09An 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 the year oforigina
2、l adoption 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 guide covers key elements of an evaluation of alaboratorys me
3、asurement 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 the documentation needed to verifythe opera
4、tion of the practices, and what parts of the data, to testand interpret to verify the quality of data being generated bythe laboratory.1.3 This guide does not specify or provide guidance for theestablishment or assessment of a quality program.2. Referenced Documents2.1 ASTM Standards:2E 178 Practice
5、 for Dealing With Outlying ObservationsE 456 Terminology Relating to Quality and StatisticsE 691 Practice for Conducting an Interlaboratory Study toDetermine the Precision of a Test MethodE 1169 Practice for Conducting Ruggedness TestsE 2554 Practice for Estimating and Monitoring the Uncer-tainty of
6、 Test Results of a Test Method in a SingleLaboratory Using a Control Sample ProgramE 2587 Practice for Use of Control Charts in StatisticalProcess Control2.2 ISO Standard:ISO 90009001 Quality Management and Quality Assur-ance Standards3ISO/IEC 17025 General Requirements for the Competenceof Testing
7、and Calibration Laboratories32.3 Other Standard:ILAC/ISO Laboratory Accreditation Principles andPracticeCollected Reports 1979198343. Terminology3.1 Terms are defined in Terminology E 456.4. Significance and Use4.1 This guide is intended to provide guidance for anassessor to evaluate measurement pra
8、ctices of laboratories, theprotocol for statistically analyzing the resulting data from thesepractices, and the statistical results from these practices.4.2 This guide is generic in the sense that it covers the entirerange of in-house quality measurement practices found in atesting laboratory, but t
9、he results of the described evaluationmay be used by accrediting agencies if their requirements canbe satisfied through the laboratorys existing quality data.4.3 It is not the intent of this guide to serve as sole criterionfor evaluating and accrediting laboratories. It is not intended tocover the i
10、mportant generic guidelines for evaluating thelaboratorys quality program, which are contained in ISO/IEC17025 and other equivalent standards.5. Purpose of Evaluating Measurement Practices and theStatistical Analysis of the Resulting Data5.1 Data generated from the measurement practices of alaborato
11、ry are evaluated to determine its capability to obtainaccurate and precise data, and to determine if the laboratorycorrectly and efficiently analyzes and reacts to its own data.6. Documentation of Measurement Practices and theStatistical Protocol for Analyzing the Resulting Data6.1 Documentation Rel
12、ative to Calibration:6.1.1 The material to be measured should be documentedtogether with its source, expiration or shelf-life date, theaccuracy and its source, and any preparations or conditionsrequired which are specific to this material before it can beutilized as a calibration material. Any addit
13、ional components,reagents, or physical sources used along with this material,1This guide is under the jurisdiction of ASTM Committee E11 on Quality andStatistics and is the direct responsibility of Subcommittee E11.20 on Test MethodEvaluation and Quality Control.Current edition approved June 15, 200
14、9. Published August 2009. Originallyapproved in 1989. Last previous edition approved in 2002 as E132398(2002).2For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Customer Service at serviceastm.org. For Annual Book of ASTMStandards volume information, refer to the st
15、andards Document Summary page onthe ASTM website.3Available from American National Standards Institute (ANSI), 25 W. 43rd St.,4th Floor, New York, NY 10036, http:/www.ansi.org.4ILAC/ISO Laboratory Accreditation-Principles and Practice-Collected Reports19791983. American Association for Laboratory Ac
16、creditation, 656 Quince Or-chard Rd. #704 Gaithersburg, MD 20878.1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.which could potentially alter the reliability of the material,should also be documented.6.1.2 The identification of the
17、equipment used, togetherwith the date and operator responsible for the run, and anypreparations involved with the calibration run should bedocumented.6.1.3 The type of data representation to be used, includingthe exact number of data points to be used in the computationof an average, standard deviat
18、ion, or range, as well as how andwhen these data points are to be generated should 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.6.1.4 The
19、 mathematical formula for obtaining control limits,the frequency of computing new limits together with rules ofacceptability of the new limits, should be documented when-ever control limits are applied to a chart.6.1.5 The corrective action taken whenever data pointsindicate that an out of control c
20、ondition exists, or whenevertrend analysis indicates a change or shift in the instrumentresponse should be recorded.6.1.6 A table of actual measured values for each calibrationor calibration check, the corresponding reference value, and thecorresponding date should be documented.6.2 Documentation Re
21、lative to Method Precision:6.2.1 The precision of each test method used in the labora-tory should be determined using Practice E 691 or otherequivalent standards.6.2.2 The reference of the specific method being followedfor each set of data, as well as any changes to the methodshould be documented. I
22、f a method has not been published,then the laboratory should prepare a detailed procedure.6.2.3 The type of run (duplicate, replicate, single) used togenerate the data points, including specific directions on howto prepare and test a duplicate or replicate specimen, should bedocumented.6.2.4 The tim
23、e interval for testing, or a date for each datapoint if a time interval is not practical, should be documented.6.2.5 Directions on how to statistically compare the labora-tory results of precision with a known statement of precisionfor that method should be documented. These directions shouldinclude
24、 the specific statistical test, the number of data pointsused for the test and the acceptable level of precision, be itknown either from other studies on this specific method or asa limit determined by the laboratory itself.6.2.6 The method for determining if outliers exist should beaccording to Pra
25、ctice E 178 or other equivalent standards.6.2.6.1 The method should be documented, stating when itis acceptable to ignore such data points when computingcontrol limits.6.2.6.2 Outliers, which were not used in the computation ofcontrol limits, should be documented.6.2.7 The precision of each test met
26、hod used in the labora-tory should be documented.6.2.8 The precision of a test method should be documentedin the test report for that method.6.3 Documentation Relative to Instrument or Method Bias:6.3.1 The method for determining if bias exists and thefrequency for continued checks on the instrument
27、 or methodhaving a bias should be documented, including any adjust-ments made to the test data as a result of the bias determinedfrom these measurements.6.3.2 A table of actual values and the corresponding datesshould be documented for each instrument and method used inthe laboratory.6.3.3 The bias
28、of an instrument or method should bedocumented in the test report for that instrument or method.6.4 Documentation Relative to Operator Precision andBias:6.4.1 The material, methods, and equipment used to deter-mine levels of operator precision and bias should be docu-mented.6.4.2 The source of state
29、d bias of the material, the currentprecision and bias of the equipment, and the current precisionand bias of the method should be documented, together withthe exact computations used to determine the single or groupoperator precision, bias, or both.6.4.3 The number of data points generated per opera
30、tor forthis comparison test as well as the protocol design should bedocumented.6.4.4 The limits of acceptability for both operator bias andoperator precision should be documented.6.4.5 The records should show the frequency of obtainingoperator accuracy and operator precision as well as thecorrective
31、 action taken whenever an operator fails to meet thelimits of acceptability.6.4.6 A table of actual measured values, the correspondingreference values, and corresponding dates for each operatorshould be documented.6.5 Documentation Relative to Uncertainty:6.5.1 The uncertainty of results for each te
32、st method used inthe laboratory should be determined according to PracticeE 2554 or other equivalent standards.6.5.2 The actual measured values and the correspondingdate used in the calculation of uncertainty should be docu-mented.6.5.3 The uncertainty of each test method used in thelaboratory shoul
33、d be documented.6.5.4 The uncertainty of a test method should be docu-mented in the test report for that method.6.6 Documentation Relative to Ruggedness:6.6.1 The ruggedness of each test method used in thelaboratory should be determined according to Guide E 1169 orother equivalent standards.6.6.2 Th
34、e factors used in the ruggedness study, their mag-nitude, statistical significance and date of the study should bedocumented.6.6.3 The experimental design, factor settings and actualmeasured values for each experimental run should be docu-mented.6.6.4 The statistically significant ruggedness factors
35、 shouldbe documented for each test method used in the laboratory.6.6.5 The factor settings for each statistically significantfactor in a method should be documented in the test report forthat method.E13230927. Evaluation of the Laboratorys Measurement Practicesand of the Statistical Analysis from th
36、e Resulting Data7.1 1 A general overview of the laboratorys documentationof measurement practices and the statistical analysis of the datashould be made, verifying that all practices cited are actually inuse and the rules stated by the laboratory for the generation anduse of the data are followed.7.
37、2 A walk-through of the laboratory to verify the locationof all data representation charts should be made. Discussionswith laboratory personnel to verify their knowledge of themeasurement practices also should be made7.3 The choice of representation of the data, as well as thegeneration of control c
38、hart limits, should be reviewed todetermine if appropriate models have been used for each typeof population. For further information, see Practice E 2587.7.4 Each piece of equipment used in the laboratory togenerate a test result should be calibrated on a periodic basis.The raw data from the calibra
39、tion records should be comparedto the status indicated for that piece of equipment. Every rawdata point outside of control limits or outside of specificationlimits should have a corresponding documented correctiveaction which resulted in restoring the equipment to normaloperation (status of in calib
40、ration) or resulted in a recommen-dation for further work (status of out of calibration). Dates andresults from the raw data should agree with the status shown onthat piece of equipment.7.5 All charts should be viewed for trend analysis. Checksof trends or shifts should include the interpretation of
41、 such bylaboratory personnel as well as the corrective action taken. Thisinformation does not have to be on the chart itself, but it shouldbe documented somewhere by the laboratory and available forreview upon request by the assessor.7.6 All data calculations for any kind of limits, be it foraccurac
42、y or precision of equipment, precision or bias ofmethods, or bias or precision of an operator, should bereviewed to determine if the appropriate type of chart has beenused and the optimum number of data points have been used.7.7 Spot checks of the raw data should also be made toverify that no data p
43、oint is being disregarded unless an outliertest has indicated that the data point can be omitted from thecalculation of control limits. The outlier is still documented asa check and listed in the table of data with corresponding dates.7.8 Raw data checks should also be made to verify thefrequency of
44、 testing for calibration. For example, a measure-ment practice that requires a replicate be tested on 1 of every10 specimens received, should show, through raw data, that theappropriate number of replicate tests were performed, reported,and transferred to the corresponding chart.8. Use of the Evalua
45、tion by Accrediting Bodies8.1 An accrediting body may use the evaluation to deter-mine the methods of monitoring the quality control of thelaboratory, such as the extent and frequency of future on-sitevisits to the laboratory,review of the data from the measure-ment practices, and review of the data
46、 from proficiency testingprograms to verify the laboratorys continued state of statisticalcontrol.9. Keywords9.1 accreditation; laboratory accreditation; laboratory mea-surement practices; statistical analysisASTM International takes no position respecting the validity of any patent rights asserted
47、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 such rights, are entirely their own responsibility.This standard is subject to revision at any time by the
48、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 additional standardsand should be addressed to ASTM International Headquarters. Your comments will receive ca
49、reful 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 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-
