ASTM E1323-15(2020)

This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the
Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
Designation: E1323 − 15 (Reapproved 2020) An American National Standard
Standard Guide for
Evaluating Laboratory Measurement Practices and the
Statistical Analysis of the Resulting Data
This standard is issued under the fixed designation E1323; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope E456 Terminology Relating to Quality and Statistics
E691 Practice for Conducting an Interlaboratory Study to
1.1 This guide covers key elements of an evaluation of a
Determine the Precision of a Test Method
laboratory’s measurement practices and the statistical analysis
E1169 Practice for Conducting Ruggedness Tests
of the resulting data. This guide addresses an evaluation that
E2554 Practice for Estimating and Monitoring the Uncer-
covers a broad range of in-house quality measurements, some
tainty of Test Results of a Test Method Using Control
of which may be directly related to accreditation requirements.
Chart Techniques
1.2 This guide provides an overview of the documentation
E2587 Practice for Use of Control Charts in Statistical
needed for verification and monitoring of the practices used in
Process Control
the laboratory for measurement. In addition, it guides the user
E2655 Guide for Reporting Uncertainty of Test Results and
in verifying that the extent of documentation and the quality of
Use of the Term Measurement Uncertainty in ASTM Test
statistical evaluations performed on the data being generated is
Methods
sufficient. The user is advised to fully document all work
covered by the scope of this guide as a general principle of
3. Terminology
laboratory practice and for audit purposes, whether internal or
3.1 Definitions—For definitions of terms used in this guide,
external.
refer to Terminology E456.
1.3 This guide is not designed to be exhaustive for all
aspects of work realized under its scope. The user is encour-
4. Significance and Use
aged to thoroughly realize (achieve in practice) the principles
set forth in this guide, consulting other relevant standards and
4.1 This guide is intended to provide guidance for labora-
industry documents when appropriate.
tory quality managers, accrediting bodies and assessors in
1.4 This international standard was developed in accor- evaluating the measurement practices of a laboratory, the
dance with internationally recognized principles on standard- protocol for statistically analyzing the resulting data from these
ization established in the Decision on Principles for the practices, and the statistical results from these practices.
Development of International Standards, Guides and Recom-
4.2 This guide is generic in the sense that it covers the entire
mendations issued by the World Trade Organization Technical
range of in-house quality measurement practices found in a
Barriers to Trade (TBT) Committee.
testing laboratory, and the results of the described evaluation
may be used by accrediting agencies for assessment purposes
2. Referenced Documents
to determine whether their requirements can be satisfied
2.1 ASTM Standards:
through the laboratory’s existing quality data program.
E177 Practice for Use of the Terms Precision and Bias in
4.3 It is not the intent of this guide to serve as sole criterion
ASTM Test Methods
E178 Practice for Dealing With Outlying Observations for evaluating and accrediting laboratories. Evaluation of
measurement practices is only one aspect in a comprehensive
quality program.
This guide is under the jurisdiction of ASTM Committee E11 on Quality and
Statistics and is the direct responsibility of Subcommittee E11.20 on Test Method
Evaluation and Quality Control. 5. Purpose of Evaluating Measurement Practices and the
Current edition approved Sept. 1, 2020. Published September 2020. Originally
Statistical Analysis of the Resulting Data
approved in 1989. Last previous edition approved in 2015 as E1323 – 15. DOI:
10.1520/E1323-15R20.
5.1 Data generated from the measurement practices of a
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
laboratory are evaluated to determine its bias and precision
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
performance, and to determine if the laboratory correctly and
Standards volume information, refer to the standard’s Document Summary page on
the ASTM website. efficiently analyzes and reacts to its own data.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
E1323 − 15 (2020)
6. Documentation of Measurement Practices and the 6.2.6.1 The method should be documented, stating when it
Statistical Protocol for Analyzing the Resulting Data is acceptable to ignore such data points when computing
control limits.
6.1 Documentation Relative to Calibration:
6.2.6.2 Outliers, which were not used in the computation of
6.1.1 The material to be measured should be documented
control limits, should be documented.
together with its source, expiration or shelf-life date, the
6.2.7 The precision of each test method used in the labora-
accuracy, and any preparations or conditions required which
tory should be documented.
are specific to this material before it can be utilized as a
6.2.8 The precision of a test method should be documented
calibration material. Any additional components, reagents, or
in the test report for that method.
physical sources used along with this material, which could
6.3 Documentation Relative to Instrument or Method Bias:
potentially alter the reliability of the material, should also be
6.3.1 The method for determining if bias exists and the
documented.
frequency for continued checks on the instrument or method
6.1.2 The identification of the equipment used, together
having a bias should be documented, including any adjust-
with the date and operator responsible for the run, and any
ments made to the test data as a result of the bias determined
preparations involved with the calibration run should be
from these measurements (see Practice E177).
documented.
6.3.2 A table of actual values and the corresponding dates
6.1.3 The type of data representation to be used, including
should be documented for each instrument and method used in
the exact number of data points to be used in the computation
the laboratory.
of an average, standard deviation, or range, as well as how and
6.3.3 The bias of an instrument or method should be
when these data points are to be generated should be docu-
documented in the test report for that instrument or method.
mented. This requires information regarding testing of
replicates, duplicates, or single runs tested on one day, a series
6.4 Documentation Relative to Operator Precision and
of days, or a specific time interval to be clearly stated for each
Bias:
set of data.
6.4.1 The material, methods, and equipment used to deter-
6.1.4 Themathematicalformulaforobtainingcontrollimits,
mine levels of operator precision and bias should be docu-
the frequency of computing new limits together with rules of
mented.
acceptability of the new limits, should be documented when-
6.4.2 The source of stated bias of the material, the current
ever control limits are applied to a chart.
precision and bias of the equipment, and the current precision
6.1.5 The corrective action taken whenever data points and bias of the method should be documented, together with
indicate that an out of control condition exists, or whenever
the exact computations used to determine the single or group
trend analysis indicates a change or shift in the instrument
operator precision, bias, or both.
response should be recorded.
6.4.3 The number of d
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