Standard Guide for Committee D01 for Conducting an Interlaboratory Study for the Purpose of Determining the Precision of a Test Method

SIGNIFICANCE AND USE
3.1 The purpose of an interlaboratory evaluation, as defined in this guide, is to determine the variability of results obtained in different laboratories on equivalent equipment using a prescribed test method.  
3.2 The definitions of statistical terms used in this guide are contained in Terminology E456.
SCOPE
1.1 This guide covers a simplified statistical procedure for planning and conducting interlaboratory evaluations of test methods.  
1.2 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.

General Information

Status
Published
Publication Date
30-Nov-2023

Relations

Effective Date
01-Dec-2023
Effective Date
01-Apr-2022
Effective Date
01-Apr-2022
Effective Date
01-Dec-2023
Effective Date
01-Dec-2023
Effective Date
01-Dec-2023

Overview

ASTM D6631-05(2023), "Standard Guide for Committee D01 for Conducting an Interlaboratory Study for the Purpose of Determining the Precision of a Test Method," provides a simplified statistical framework for planning and executing interlaboratory evaluations of test methods. Developed by ASTM International, this standard ensures that test methods can be reliably assessed for precision across multiple laboratories using equivalent equipment. Critical for quality assurance and reliability, ASTM D6631 assists organizations in measuring and validating the consistency of test results, forming the basis for credible data in research, manufacturing, and regulatory submissions.

Key Topics

  • Interlaboratory Study Planning: The guide outlines comprehensive steps for organizing interlaboratory studies, including selection of materials, participant qualification, and pilot evaluations.
  • Precision Determination: Procedures focus on determining the variability of test results produced by different laboratories to establish the precision of a test method.
  • Continuous Data Evaluation: The standard is most effective for test methods generating continuous (measured) data, such as pH or brightness, as opposed to discrete or ranked data.
  • Statistical Protocols: Incorporates definitions from ASTM E456 and recommends statistical techniques consistent with best practices for precision evaluation.
  • Test Method Optimization: Encourages iterative procedures, such as initial pilot evaluations, to refine test instructions and ensure clarity prior to broader study implementation.
  • Reporting and Documentation: Emphasizes standardized reporting forms and detailed instructions for uniform data collection and result analysis.

Applications

Organizations across various industries can benefit from implementing ASTM D6631-05(2023) for:

  • Assessing Test Method Reliability: Laboratories can use this guide to verify whether a new or existing test method delivers consistent results when executed by different operators or facilities.
  • Quality Control and Assurance: Companies can benchmark the precision of their analytical techniques, improving process control and product compliance.
  • Development of Industry Standards: Regulatory bodies and standards committees rely on interlaboratory studies to validate the reliability of procedures adopted in technical specifications.
  • Research and Development: Researchers developing new analytical methods can apply this guide to substantiate claims of precision, critical for peer-reviewed publication and patent applications.
  • Supplier and Manufacturing Audits: Multinational organizations can ensure suppliers' laboratory capabilities match internal standards by referencing interlaboratory testing outcomes.

Related Standards

  • ASTM E177: Practice for Use of the Terms Precision and Bias in ASTM Test Methods. Offers foundational definitions for key concepts in precision studies.
  • ASTM E456: Terminology Relating to Quality and Statistics. Contains definitions of the statistical terms used within ASTM D6631.
  • ASTM E691: Practice for Conducting an Interlaboratory Study to Determine the Precision of a Test Method. Provides complementary procedures and advanced techniques.
  • ASTM E1345: Practice for Reducing the Effect of Variability of Color Measurement by Use of Multiple Measurements.

These related ASTM standards provide essential guidance and support for laboratories involved in quality and statistical precision studies.


By aligning with ASTM D6631-05(2023), organizations demonstrate adherence to internationally recognized principles on standardization, enhance the credibility of their testing, and support consistent, reliable results across laboratory networks. This enables stakeholders in manufacturing, regulatory affairs, and research to make informed decisions based on robust precision data. For best practices in interlaboratory studies and precision measurement, ASTM D6631 is a valuable reference for laboratories seeking compliance and quality assurance.

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Frequently Asked Questions

ASTM D6631-05(2023) is a guide published by ASTM International. Its full title is "Standard Guide for Committee D01 for Conducting an Interlaboratory Study for the Purpose of Determining the Precision of a Test Method". This standard covers: SIGNIFICANCE AND USE 3.1 The purpose of an interlaboratory evaluation, as defined in this guide, is to determine the variability of results obtained in different laboratories on equivalent equipment using a prescribed test method. 3.2 The definitions of statistical terms used in this guide are contained in Terminology E456. SCOPE 1.1 This guide covers a simplified statistical procedure for planning and conducting interlaboratory evaluations of test methods. 1.2 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.

SIGNIFICANCE AND USE 3.1 The purpose of an interlaboratory evaluation, as defined in this guide, is to determine the variability of results obtained in different laboratories on equivalent equipment using a prescribed test method. 3.2 The definitions of statistical terms used in this guide are contained in Terminology E456. SCOPE 1.1 This guide covers a simplified statistical procedure for planning and conducting interlaboratory evaluations of test methods. 1.2 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.

ASTM D6631-05(2023) is classified under the following ICS (International Classification for Standards) categories: 03.120.20 - Product and company certification. Conformity assessment. The ICS classification helps identify the subject area and facilitates finding related standards.

ASTM D6631-05(2023) has the following relationships with other standards: It is inter standard links to ASTM D6631-05(2019), ASTM E456-13a(2022)e1, ASTM E456-13a(2022), ASTM G141-09(2021), ASTM G154-23, ASTM D4587-23. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.

ASTM D6631-05(2023) is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.

Standards Content (Sample)


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: D6631 − 05 (Reapproved 2023)
Standard Guide for
Committee D01 for Conducting an Interlaboratory Study for
the Purpose of Determining the Precision of a Test Method
This standard is issued under the fixed designation D6631; 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 current limits of both the software, and the statistical protocols
currently available, this effectively restricts the use of this
1.1 This guide covers a simplified statistical procedure for
guide to test methods which yield results that are continuous.
planning and conducting interlaboratory evaluations of test
This generally means a measured quantity, such as pH or
methods.
brightness. Results that are discrete (such as counts or pass-
1.2 This international standard was developed in accor-
fail), or ordered (ranked), present three special problems in the
dance with internationally recognized principles on standard-
creation of a meaningful precision statement:
ization established in the Decision on Principles for the
4.1.1 The amount of information contained in discrete and
Development of International Standards, Guides and Recom-
ordered data is much less than in continuous data, necessitating
mendations issued by the World Trade Organization Technical
the collection of much more data.
Barriers to Trade (TBT) Committee.
4.1.2 The sensitivity (the ability to discriminate between
similar samples) is much less in discrete and ordered data than
2. Referenced Documents
continuous data.
2.1 ASTM Standards:
4.1.3 Since the precision statement relies on the normal
E177 Practice for Use of the Terms Precision and Bias in
distribution, and the distributions of discrete and ordered data
ASTM Test Methods
are usually decidedly non-normal, the normal precision state-
E456 Terminology Relating to Quality and Statistics
ment is invalid.
E691 Practice for Conducting an Interlaboratory Study to
4.2 Given these concerns with discrete and ordered data, a
Determine the Precision of a Test Method
simple statement of the results obtained in these types of
E1345 Practice for Reducing the Effect of Variability of
studies might be the most useful information for a prospective
Color Measurement by Use of Multiple Measurements
user of a test method.
3. Significance and Use
5. Preliminary
3.1 The purpose of an interlaboratory evaluation, as defined
5.1 Flow chart the test method.
in this guide, is to determine the variability of results obtained
in different laboratories on equivalent equipment using a
5.2 Survey known sources of information related to the test
prescribed test method.
method to establish how results are affected by variations in
operating conditions, atmospheric conditions, differences be-
3.2 The definitions of statistical terms used in this guide are
tween operators, etc. Select what appears to be the optimum
contained in Terminology E456.
procedure.
4. Problem Formulation
5.3 Provide instructions for the test method and, without
4.1 The objective of the evaluation should be to clearly comment, observe a laboratory technician perform a test
define the expected precision of the test method. Within the according to these instructions. Revise any parts of the draft
causing difficulty.
1 5.4 If desirable, make a comparative study with other test
This guide is under the jurisdiction of ASTM Committee D01 on Paint and
Related Coatings, Materials, and Applications and is the direct responsibility of methods for measuring the property by using specimens with a
Subcommittee D01.20 on Quality Assurance and Statistics.
wide range of values of the property under test (and possibly
Current edition approved Dec. 1, 2023. Published December 2024. Originally
with wide ranges in other properties).
approved in 2001. Last previous edition approved in 2019 as D6631 – 05 (2019).
DOI: 10.1520/D6631-05R23.
For referenced ASTM standards, visit the ASTM website, www.astm.org, or 6. Preparation for Interlaboratory Study
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
6.1 Prepare a clear statement of the type of information
Standards volume information, refer to the standard’s Document Summary page on
the ASTM website. required from the interlaboratory evaluation.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
D6631 − 05 (2023)
6.2 Based on the study made in one laboratory (Section 5), reproducibility. (It must be emphasized that the word “differ-
prepare a proposed master plan for the interlaboratory evalu- ent” in this section, could apply to multiple manufacturers, or
ation. Discuss the plan, in an open meeting, if possible, with models of equipment.) However, different equipment, using
other participants in the study. different techniques or protocols for measurement, for
example, rotational and efflux cup viscometers, must NOT be
6.3 Select the materials to be used in the interlaboratory
used in the same study.
evaluations so as to:
10.1.4 Replicates—Each evaluation must at least be run in
6.3.1 Cover the applicable range of the property or compo-
duplicate.
nent to be measured, and
6.3.2 Represent as many classes of materials as feasible, to
10.2 Intralaboratory Precision is usually ascertained by
which the test method will be applied. having repeats made over the shortest possible time, preferably
the same day. If considered desirable, a completely unbiased
7. Pilot Evaluation
estimate of intralaboratory error can be obtained by use of
“blind” repetition. In this procedure two samples of at least
7.1 If the test method is new or the procedure for an old test
method is greatly altered, a pilot study by one laboratory one, and preferably more, of the test materials are distributed as
separate materials. If all the materials are duplicated, the total
involving a few materials (two or three) may reveal seriously
misleading directions in the written procedure. A Box and amount of work can be kept the same by not repeating the test
at another time. However, elimination of the time variable
Whisker Plot (as outlined in Practice E1345), or a Violin Plot
may help to clarify this evaluation. might alert cooperators to the use of blind repetition which, in
any event, is not readily applicable when all the test materials
8. Participating Laboratory Qualification
differ markedly in properties.
8.1 It is important that the managers of proposed partici-
10.3 For analytical test methods, the precision of which is
pants in an interlaboratory stu
...

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