ASTM E1323-15

Standard Guide for Evaluating Laboratory Measurement Practices and the Statistical Analysis of the Resulting Data

ABSTRACT
This guide covers key elements of an evaluation of a laboratory’s measurement practices and the statistical analysis of the resulting data, as well as addresses an evaluation that covers a broad range of in-house quality measurements, some of which may be directly related to accreditation requirements. It provides an overview of the documentation needed for verification and monitoring of the practices used in the laboratory for measurement. In addition, it guides the user in verifying that the extent of documentation and the quality of statistical evaluations performed on the data being generated is sufficient. This guide is also intended to provide guidance for laboratory quality managers, accrediting bodies and assessors in evaluating the measurement practices of a laboratory and statistically analyzing the resulting data from these practices.
This guide provides the purpose of evaluating measurement practices and the statistical analysis of the resulting data. Data generated from the measurement practices of a laboratory are evaluated to determine its bias and precision performance, and to determine if the laboratory correctly and efficiently analyzes and reacts to its own data.
SIGNIFICANCE AND USE
4.1 This guide is intended to provide guidance for laboratory quality managers, accrediting bodies and assessors in evaluating the measurement practices of a laboratory, the protocol for statistically analyzing the resulting data from these practices, and the statistical results from these practices.  
4.2 This guide is generic in the sense that it covers the entire range of in-house quality measurement practices found in a testing laboratory, and the results of the described evaluation may be used by accrediting agencies for assessment purposes to determine whether their requirements can be satisfied through the laboratory's existing quality data program.  
4.3 It is not the intent of this guide to serve as sole criterion for evaluating and accrediting laboratories. Evaluation of measurement practices is only one aspect in a comprehensive quality program.
SCOPE
1.1 This guide covers key elements of an evaluation of a laboratory's measurement practices and the statistical analysis of the resulting data. This guide addresses an evaluation that covers a broad range of in-house quality measurements, some of which may be directly related to accreditation requirements.  
1.2 This guide provides an overview of the documentation needed for verification and monitoring of the practices used in the laboratory for measurement. In addition, it guides the user in verifying that the extent of documentation and the quality of statistical evaluations performed on the data being generated is sufficient. The user is advised to fully document all work covered by the scope of this guide as a general principle of laboratory practice and for audit purposes, whether internal or external.  
1.3 This guide is not designed to 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 standards and industry documents when appropriate.

General Information

• Status: Historical
• Publication Date: 31-Mar-2015
• ICS: 03.120.10 - Quality management and quality assurance
• Technical Committee: E11 - Quality and Statistics
• Drafting Committee: E11.20 - Test Method Evaluation and Quality Control

Standards Content (Sample)

NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
Designation: E1323 − 15 An American National Standard
Standard Guide for
Evaluating Laboratory Measurement Practices and the
1
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 E2587 Practice for Use of Control Charts in Statistical
Process Control
1.1 This guide covers key elements of an evaluation of a
E2655 Guide for Reporting Uncertainty of Test Results and
laboratory’s measurement practices and the statistical analysis
Use of the Term Measurement Uncertainty in ASTM Test
of the resulting data. This guide addresses an evaluation that
Methods
covers a broad range of in-house quality measurements, some
of which may be directly related to accreditation requirements.
3. Terminology
1.2 This guide provides an overview of the documentation
3.1 Terms are defined in Terminology E456.
needed for verification and monitoring of the practices used in
the laboratory for measurement. In addition, it guides the user
4. Significance and Use
in verifying that the extent of documentation and the quality of
4.1 This guide is intended to provide guidance for labora-
statistical evaluations performed on the data being generated is
sufficient. The user is advised to fully document all work tory quality managers, accrediting bodies and assessors in
evaluating the measurement practices of a laboratory, the
covered by the scope of this guide as a general principle of
laboratory practice and for audit purposes, whether internal or protocol for statistically analyzing the resulting data from these
practices, and the statistical results from these practices.
external.
1.3 This guide is not designed to be exhaustive for all 4.2 This guide is generic in the sense that it covers the entire
range of in-house quality measurement practices found in a
aspects of work realized under its scope. The user is encour-
aged to thoroughly realize (achieve in practice) the principles testing laboratory, and the results of the described evaluation
may be used by accrediting agencies for assessment purposes
set forth in this guide, consulting other relevant standards and
industry documents when appropriate. to determine whether their requirements can be satisfied
through the laboratory’s existing quality data program.
2. Referenced Documents
4.3 It is not the intent of this guide to serve as sole criterion
2
2.1 ASTM Standards:
for evaluating and accrediting laboratories. Evaluation of
E177 Practice for Use of the Terms Precision and Bias in
measurement practices is only one aspect in a comprehensive
ASTM Test Methods
quality program.
E178 Practice for Dealing With Outlying Observations
E456 Terminology Relating to Quality and Statistics
5. Purpose of Evaluating Measurement Practices and the
E691 Practice for Conducting an Interlaboratory Study to
Statistical Analysis of the Resulting Data
Determine the Precision of a Test Method
5.1 Data generated from the measurement practices of a
E1169 Practice for Conducting Ruggedness Tests
laboratory are evaluated to determine its bias and precision
E2554 Practice for Estimating and Monitoring the Uncer-
performance, and to determine if the laboratory correctly and
tainty of Test Results of a Test Method Using Control
efficiently analyzes and reacts to its own data.
Chart Techniques
6. Documentation of Measurement Practices and the
1
This guide is under the jurisdiction of ASTM Committee E11 on Quality and
Statistical Protocol for Analyzing the Resulting Data
Statistics and is the direct responsibility of Subcommittee E11.20 on Test Method
Evaluation and Quality Control.
6.1 Documentation Relative to Calibration:
Current edition approved April 1, 2015. Published May 2015. Originally
6.1.1 The material to be measured should be documented
approved in 1989. Last previous edition approved in 2009 as E1323 – 09. DOI:
10.1520/E1323-15.
together with its source, expiration or shelf-life date, the
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
accuracy, and any preparations or conditions required which
contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM
are specific to this material before it can be utilized as a
Standards volume information, refer to the standard’s Document Summary page on
the ASTM website. calibration material. Any additional components, reagents, or
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
E1323 − 15
phy
...

This document is not an ASTM standard and is intended only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Because
it 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 version
of the standard as published by ASTM is to be considered the official document.
Designation: E1323 − 09 E1323 − 15 An American National Standard
Standard Guide for
Evaluating Laboratory Measurement Practices and the
1
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
1.1 This guide covers key elements of an evaluation of a laboratory’s measurement practices and the statistical analysis of the
resulting data. This guide addresses an evaluation that covers a broad range of in-house quality measurements, some of which may
be directly related to accreditation requirements.
1.2 This guide describes provides an overview of the documentation needed to verify the operation of the practices, and what
parts of the data, to test and interpret to verify for verification and monitoring of the practices used in the laboratory for
measurement. In addition, it guides the user in verifying that the extent of documentation and the quality of statistical evaluations
performed on the data being generated by the laboratory.is sufficient. The user is advised to fully document all work covered by
the 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 specify or provide guidance for the establishment or assessment of a quality program. is not designed
to 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 standards and industry documents when appropriate.
2. Referenced Documents
2
2.1 ASTM Standards:
E177 Practice for Use of the Terms Precision and Bias in ASTM Test Methods
E178 Practice for Dealing With Outlying Observations
E456 Terminology Relating to Quality and Statistics
E691 Practice for Conducting an Interlaboratory Study to Determine the Precision of a Test Method
E1169 Practice for Conducting Ruggedness Tests
E2554 Practice for Estimating and Monitoring the Uncertainty of Test Results of a Test Method Using Control Chart Techniques
E2587 Practice for Use of Control Charts in Statistical Process Control
E2655 Guide for Reporting Uncertainty of Test Results and Use of the Term Measurement Uncertainty in ASTM Test Methods
2.2 ISO Standard:
3
ISO 9000–9001 Quality Management and Quality Assurance Standards
3
ISO/IEC 17025 General Requirements for the Competence of Testing and Calibration Laboratories
2.3 Other Standard:
4
ILAC/ISO Laboratory Accreditation Principles and Practice—Collected Reports 1979–1983
3. Terminology
3.1 Terms are defined in Terminology E456.
4. Significance and Use
4.1 This guide is intended to provide guidance for an assessor to evaluate laboratory quality managers, accrediting bodies and
assessors in evaluating the measurement practices of laboratories, a laboratory, the protocol for statistically analyzing the resulting
data from these practices, and the statistical results from these practices.
1
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.
Current edition approved June 15, 2009April 1, 2015. Published August 2009May 2015. Originally approved in 1989. Last previous edition approved in 20022009 as
E1323 – 98 (2002).E1323 – 09. DOI: 10.1520/E1323-09.10.1520/E1323-15.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM Standards
volume information, refer to the standard’s Document Summary page on the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
E1323 − 15
4.2 This guide is generic in the sense that it covers the entire range of in-house quality measurement practices found in a testing
laboratory, butand the results of the described evaluation may be used by accrediting agencies if for assessment purposes to
determine whether their requirements can be satisfied through the laboratory’s existing quality data.data program.
4.3 It is not the intent of this guide to serve as sole criterion
...