1、Designation: E1323 09E1323 15 An American National StandardStandard Guide forEvaluating Laboratory Measurement Practices and theStatistical Analysis of the Resulting Data1This standard is issued under the fixed designation E1323; the number immediately following the designation indicates the year of
2、original 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 a labora
3、torys measurement practices and the statistical analysis of theresulting data. This guide addresses an evaluation that covers a broad range of in-house quality measurements, some of which maybe directly related to accreditation requirements.1.2 This guide describes provides an overview of the docume
4、ntation needed to verify the operation of the practices, and whatparts of the data, to test and interpret to verify for verification and monitoring of the practices used in the laboratory formeasurement. In addition, it guides the user in verifying that the extent of documentation and the quality of
5、 statistical evaluationsperformed on the data being generated by the laboratory.is sufficient. The user is advised to fully document all work covered bythe scope of this guide as a general principle of laboratory practice and for audit purposes, whether internal or external.1.3 This guide does not s
6、pecify or provide guidance for the establishment or assessment of a quality program. is not designedto be exhaustive for all aspects of work realized under its scope. The user is encouraged to thoroughly realize (achieve in practice)the principles set forth in this guide, consulting other relevant s
7、tandards and industry documents when appropriate.2. Referenced Documents2.1 ASTM Standards:2E177 Practice for Use of the Terms Precision and Bias in ASTM Test MethodsE178 Practice for Dealing With Outlying ObservationsE456 Terminology Relating to Quality and StatisticsE691 Practice for Conducting an
8、 Interlaboratory Study to Determine the Precision of a Test MethodE1169 Practice for Conducting Ruggedness TestsE2554 Practice for Estimating and Monitoring the Uncertainty of Test Results of a Test Method Using Control Chart TechniquesE2587 Practice for Use of Control Charts in Statistical Process
9、ControlE2655 Guide for Reporting Uncertainty of Test Results and Use of the Term Measurement Uncertainty in ASTM Test Methods2.2 ISO Standard:ISO 90009001 Quality Management and Quality Assurance Standards3ISO/IEC 17025 General Requirements for the Competence of Testing and Calibration Laboratories3
10、2.3 Other Standard:ILAC/ISO Laboratory Accreditation Principles and PracticeCollected Reports 1979198343. Terminology3.1 Terms are defined in Terminology E456.4. Significance and Use4.1 This guide is intended to provide guidance for an assessor to evaluate laboratory quality managers, accrediting bo
11、dies andassessors in evaluating the measurement practices of laboratories, a laboratory, the protocol for statistically analyzing the resultingdata from these practices, and the statistical results from these practices.1 This guide is under the jurisdiction ofASTM Committee E11 on Quality and Statis
12、tics and is the direct responsibility of Subcommittee E11.20 on Test Method Evaluationand Quality Control.Current edition approved June 15, 2009April 1, 2015. Published August 2009May 2015. Originally approved in 1989. Last previous edition approved in 20022009 asE1323 98 (2002).E1323 09. DOI: 10.15
13、20/E1323-09.10.1520/E1323-15.2 For referencedASTM standards, visit theASTM website, www.astm.org, or contactASTM Customer Service at serviceastm.org. For Annual Book of ASTM Standardsvolume information, refer to the standards Document Summary page on the ASTM website.This document is not an ASTM sta
14、ndard and is intended 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 cas
15、es only the current 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 States14.2 This guide is generic in the sense that it covers the entire range of in-hou
16、se quality measurement practices found in a testinglaboratory, butand the results of the described evaluation may be used by accrediting agencies if for assessment purposes todetermine whether their requirements can be satisfied through the laboratorys existing quality data.data program.4.3 It is no
17、t the intent of this guide to serve as sole criterion for evaluating and accrediting laboratories. It is not intended tocover the important generic guidelines for evaluating the laboratorys quality program, which are contained in ISO/IEC 17025 andother equivalent standards.Evaluation of measurement
18、practices is only one aspect in a comprehensive quality program.5. Purpose of Evaluating Measurement Practices and the Statistical Analysis of the Resulting Data5.1 Data generated from the measurement practices of a laboratory are evaluated to determine its capability to obtain accurateand precise d
19、ata,bias and precision performance, and to determine if the laboratory correctly and efficiently analyzes and reactsto its own data.6. Documentation of Measurement Practices and the Statistical Protocol for Analyzing the Resulting Data6.1 Documentation Relative to Calibration:6.1.1 The material to b
20、e measured should be documented together with its source, expiration or shelf-life date, the accuracy andits source, and accuracy, and any preparations or conditions required which are specific to this material before it can be utilizedas a calibration material. Any additional components, reagents,
21、or physical sources used along with this material, which couldpotentially alter the reliability of the material, should also be documented.6.1.2 The identification of the equipment used, together with the date and operator responsible for the run, and any preparationsinvolved with the calibration ru
22、n should be documented.6.1.3 The type of data representation to be used, including the exact number of data points to be used in the computation of anaverage, standard deviation, or range, as well as how and when these data points are to be generated should be documented. Thisrequires information re
23、garding testing of replicates, duplicates, or single runs tested on one day, a series of days, or a specific timeinterval to be clearly stated for each set of data.6.1.4 The mathematical formula for obtaining control limits, the frequency of computing new limits together with rules ofacceptability o
24、f the new limits, should be documented whenever control limits are applied to a chart.6.1.5 The corrective action taken whenever data points indicate that an out of control condition exists, or whenever trendanalysis indicates a change or shift in the instrument response should be recorded.6.1.6 A t
25、able of actual measured values for each calibration or calibration check, the corresponding reference value, and thecorresponding date should be documented.6.2 Documentation Relative to Method Precision:6.2.1 The precision of each test method used in the laboratory should be determined using Practic
26、e E691 or other equivalentstandards.6.2.2 The reference of the specific method being followed for each set of data, as well as any changes to the method should bedocumented. If a method has not been published, then the laboratory should prepare a detailed procedure.6.2.3 The type of run (duplicate,
27、replicate, single) used to generate the data points, including specific directions on how toprepare and test a duplicate or replicate specimen, should be documented.6.2.4 The time interval for testing, or a date for each data point if a time interval is not practical, should be documented.6.2.5 Dire
28、ctions on how to statistically compare the laboratory results of precision with a known statement of precision for thatmethod should be documented. These directions should include the specific statistical test, the number of data points used for thetest and the acceptable level of precision, be it k
29、nown either from other studies on this specific method or as a limit determinedby the laboratory itself.6.2.6 The method for determining if outliers exist should be according to Practice E178 or other equivalent standards.6.2.6.1 The method should be documented, stating when it is acceptable to igno
30、re such data points when computing controllimits.6.2.6.2 Outliers, which were not used in the computation of control limits, should be documented.6.2.7 The precision of each test method used in the laboratory should be documented.6.2.8 The precision of a test method should be documented in the test
31、report for that method.6.3 Documentation Relative to Instrument or Method Bias:6.3.1 The method for determining if bias exists and the frequency for continued checks on the instrument or method having abias should be documented, including any adjustments made to the test data as a result of the bias
32、 determined from thesemeasurements.measurements (see Practice E177).6.3.2 A table of actual values and the corresponding dates should be documented for each instrument and method used in thelaboratory.6.3.3 The bias of an instrument or method should be documented in the test report for that instrume
33、nt or method.6.4 Documentation Relative to Operator Precision and Bias:6.4.1 The material, methods, and equipment used to determine levels of operator precision and bias should be documented.E1323 1526.4.2 The source of stated bias of the material, the current precision and bias of the equipment, an
34、d the current precision andbias of the method should be documented, together with the exact computations used to determine the single or group operatorprecision, bias, or both.6.4.3 The number of data points generated per operator for this comparison test as well as the protocol design should bedocu
35、mented.6.4.4 The limits of acceptability for both operator bias and operator precision should be documented.6.4.5 The records should show the frequency of obtaining operator accuracybias and operator precision as well as the correctiveaction taken whenever an operator fails to meet the limits of acc
36、eptability.6.4.6 A table of actual measured values, the corresponding reference values, and corresponding dates for each operator shouldbe documented.6.5 Documentation Relative to Uncertainty:6.5.1 The uncertainty of results for each test method used in the laboratory should be determined according
37、to PracticePracticesE2554 or E2655 or other equivalent standards.6.5.2 The actual measured values and the corresponding date used in the calculation of uncertainty should be documented.6.5.3 The uncertainty of each test method used in the laboratory should be documented.6.5.4 The uncertainty of a te
38、st method should be documented in the test report for that method.6.6 Documentation Relative to Ruggedness:6.6.1 The ruggedness of each test method used in the laboratory should be determined according to Guide E1169 or otherequivalent standards.6.6.2 The factors used in the ruggedness study, their
39、magnitude, statistical significance and date of the study should bedocumented.6.6.3 The experimental design, factor settings and actual measured values for each experimental run should be documented.6.6.4 The statistically significant ruggedness factors should be documented for each test method used
40、 in the laboratory.6.6.5 The factor settings for each statistically significant factor in a method should be documented in the test report for thatmethod.7. Evaluation of the Laboratorys Measurement Practices and of the Statistical Analysis from the Resulting Data7.1 1 A general overview of the labo
41、ratorys documentation of measurement practices and the statistical analysis of the datashould be made, verifying that all practices cited are actually in use and the rules stated by the laboratory for the generation anduse of the data are followed.7.2 A walk-through of the laboratory to verify the l
42、ocation of all data representation charts should be made. Discussions withlaboratory personnel to verify their knowledge of the measurement practices also should be made.7.3 The choice of representation of the data, as well as the generation of control chart limits, should be reviewed to determineif
43、 appropriate models have been used for each type of population. For further information, see Practice E2587.7.4 Each piece of equipment used in the laboratory to generate a test result should be calibrated on a periodic basis. The rawdata from the calibration records should be compared to the status
44、 indicated for that piece of equipment. Every raw data pointoutside of control limits or outside of specification limits should have a corresponding documented corrective action which resultedin restoring the equipment to normal operation (status of in calibration) or resulted in a recommendation fo
45、r further work (statusof out of calibration). Dates and results from the raw data should agree with the status shown on that piece of equipment.7.5 All charts should be viewed for trend analysis. Checks of trends or shifts should include be documented, including theinterpretation of such those found
46、 to be beyond acceptance limits by laboratory personnel as well as the corrective action taken.This information does not have to be on the chart itself, but it should be documented somewhere by the laboratory and availablefor review upon request by the assessor.7.6 All data calculations for any kind
47、 of limits, be it for accuracy or precision of equipment, precision or bias of methods, orbias or precision of an operator, should be reviewed to determine if the appropriate type of chart has been used and the optimumnumber of data points have been used.7.7 Spot checks of the raw data should also b
48、e made to verify that no data point is being disregarded unless an outlier test hasindicated that the data point can be omitted from the calculation of control limits. The outlier is still documented as a check andlisted in the table of data with corresponding dates.7.8 Raw data checks should also b
49、e made to verify the frequency of testing for calibration. For example, a measurement practicethat requires a replicate be tested on 1 of every 10 specimens received, should show, through raw data, that the appropriate numberof replicate tests were performed, reported, and transferred to the corresponding chart.E1323 1538. Use of the Evaluation by Accrediting Bodies8.1 An accrediting body may use the evaluation to determine the methods of monitoring the quality control of the laboratory,such as the extent and frequency of future on-site visits to the laboratory,review
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