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ASTM E1169-20

(Practice)

Standard Practice for Conducting Ruggedness Tests

Standard Practice for Conducting Ruggedness Tests

SIGNIFICANCE AND USE
4.1 A ruggedness test is a special application of a statistically designed experiment that makes changes in the test method variables, called factors, and then calculates the subsequent effect of those changes upon the test results. Factors are features of the test method or of the laboratory environment that are known to vary across laboratories and are subject to control by the test method.  
4.1.1 Statistical design enables more efficient and cost-effective determination of the factor effects than would be achieved if separate experiments were carried out for each factor. The proposed designs are easy to use in developing the information needed for evaluating quantitative test methods.  
4.2 In ruggedness testing, the two levels (settings) for each factor are chosen to use moderate separations between the high and low settings. In general, if there is an underlying difference between the levels, then the size of effects will increase with increased separation between the high and low settings of the factors. A run is an execution of the test method under prescribed settings of each of the factors under study. A ruggedness test consists of a set of runs.  
4.3 A ruggedness test is usually conducted within a single laboratory on uniform material, so that the effects of changing only the factors are measured. The results may then be used to assist in determining the degree of control required of factors described in the test method.  
4.4 Ruggedness testing should precede an interlaboratory (round robin) study to correct any deficiencies in the test method and may also be part of the validation phase of developing a standard test method as described in Guide E1488.  
4.5 This standard discusses design and analysis of ruggedness testing in Section 5 and contains an example of a basic eight run design. Some caution must be used in interpretation of results, since interaction effects may be present. These effects are present when a factor effect changes with the ...
SCOPE
1.1 This practice covers conducting ruggedness tests. The purpose of a ruggedness test is to identify those factors that strongly influence the measurements provided by a specific test method and to estimate how closely those factors need to be controlled.  
1.2 This practice restricts itself to experimental designs with two levels per factor. The designs require the simultaneous change of the levels of all of the factors, thus permitting the determination of the effects of each of the factors on the measured results.  
1.3 The system of units for this practice is not specified. Dimensional quantities in the practice are presented only as illustrations of calculation methods. The examples are not binding on products or test methods treated.  
1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.5 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
Historical
Publication Date
31-Mar-2020
ICS
19.020 - Test conditions and procedures in general
Technical Committee
E11 - Quality and Statistics
Drafting Committee
E11.20 - Test Method Evaluation and Quality Control
Current Stage
Ref Project

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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: E1169 − 20 An American National Standard
Standard Practice for
1
Conducting Ruggedness Tests
This standard is issued under the fixed designation E1169; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision.Anumber in parentheses indicates the year of last reapproval.A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope E2282Guide for Defining the Test Result of a Test Method
F2082Test Method for Determination of Transformation
1.1 This practice covers conducting ruggedness tests. The
Temperature of Nickel-Titanium Shape Memory Alloys
purpose of a ruggedness test is to identify those factors that
by Bend and Free Recovery
stronglyinfluencethemeasurementsprovidedbyaspecifictest
method and to estimate how closely those factors need to be
3. Terminology
controlled.
3.1 Definitions—The terminology defined in Terminology
1.2 Thispracticerestrictsitselftoexperimentaldesignswith
E456 applies to this practice unless modified herein.
two levels per factor. The designs require the simultaneous
3.1.1 fractional factorial design, n—a factorial experiment
change of the levels of all of the factors, thus permitting the
in which only an adequately chosen fraction of the treatments
determination of the effects of each of the factors on the
required for the complete factorial experiment is selected to be
measured results.
run. E1325
1.3 The system of units for this practice is not specified.
3.1.2 level (of a factor), n—a given value, a specification of
Dimensional quantities in the practice are presented only as
procedure or a specific setting of a factor. E1325
illustrations of calculation methods. The examples are not
3.1.3 Plackett-Burman designs, n—a set of screening de-
binding on products or test methods treated.
signs using orthogonal arrays that permit evaluation of the
1.4 This standard does not purport to address all of the
linear effects of up to n = t – 1 factors in a study of t treatment
safety concerns, if any, associated with its use. It is the
combinations. E1325
responsibility of the user of this standard to establish appro-
3.1.4 ruggedness, n—insensitivity of a test method to de-
priate safety, health, and environmental practices and deter-
partures from specified test or environmental conditions.
mine the applicability of regulatory limitations prior to use.
3.1.4.1 Discussion—An evaluation of the “ruggedness” of a
1.5 This international standard was developed in accor-
test method or an empirical model derived from an experiment
dance with internationally recognized principles on standard-
isusefulindeterminingwhethertheresultsordecisionswillbe
ization established in the Decision on Principles for the
relativelyinvariantoversomerangeofenvironmentalvariabil-
Development of International Standards, Guides and Recom-
ity under which the test method or the model is likely to be
mendations issued by the World Trade Organization Technical
applied.
Barriers to Trade (TBT) Committee.
3.1.5 ruggedness test, n—a planned experiment in which
2. Referenced Documents
environmental factors or test conditions are deliberately varied
2
in order to evaluate the effects of such variation.
2.1 ASTM Standards:
3.1.5.1 Discussion—Since there usually are many environ-
E456Terminology Relating to Quality and Statistics
mental factors that might be considered in a ruggedness test, it
E1325Terminology Relating to Design of Experiments
is customary to use a “screening” type of experiment design
E1488GuideforStatisticalProcedurestoUseinDeveloping
which concentrates on examining many first order effects. The
and Applying Test Methods
validityoftheestimatesdependsontheassumptionthatsecond
order effects such as interactions and curvature are relatively
1
ThispracticeisunderthejurisdictionofASTMCommitteeE11onQualityand
negligible.Ofteninevaluatingtheruggednessofatestmethod,
Statistics and is the direct responsibility of Subcommittee E11.20 on Test Method
if there is an indication that the results of a test method are
Evaluation and Quality Control.
highly dependent on the levels of the environmental factors,
Current edition approved April 1, 2020. Published May 2020. Originally
there is a sufficient indication that certain levels of environ-
approved in 1987. Last previous edition approved in 2018 as E1169–18. DOI:
10.1520/E1169-20.
mentalfactorsmustbeincludedinthespecificationsforthetest
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
method, or even that the test method itself will need further
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
revision. This evaluation may include extra runs in a second
Standards volume information, refer to the standard’s Document Summary page on
the
...

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: E1169 − 18 E1169 − 20 An American National Standard
Standard Practice for
1
Conducting Ruggedness Tests
This standard is issued under the fixed designation E1169; 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 practice covers conducting ruggedness tests. The purpose of a ruggedness test is to identify those factors that strongly
influence the measurements provided by a specific test method and to estimate how closely those factors need to be controlled.
1.2 This practice restricts itself to experimental designs with two levels per factor. The designs require the simultaneous change
of the levels of all of the factors, thus permitting the determination of the effects of each of the factors on the measured results.
1.3 The system of units for this practice is not specified. Dimensional quantities in the practice are presented only as illustrations
of calculation methods. The examples are not binding on products or test methods treated.
1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility
of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of
regulatory limitations prior to use.
1.5 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.
2. Referenced Documents
2
2.1 ASTM Standards:
E456 Terminology Relating to Quality and Statistics
E1325 Terminology Relating to Design of Experiments
E1488 Guide for Statistical Procedures to Use in Developing and Applying Test Methods
E2282 Guide for Defining the Test Result of a Test Method
F2082 Test Method for Determination of Transformation Temperature of Nickel-Titanium Shape Memory Alloys by Bend and
Free Recovery
3. Terminology
3.1 Definitions—The terminology defined in Terminology E456 applies to this practice unless modified herein.
3.1.1 fractional factorial design, n—a factorial experiment in which only an adequately chosen fraction of the treatments
required for the complete factorial experiment is selected to be run. E1325
3.1.2 level (of a factor), n—a given value, a specification of procedure or a specific setting of a factor. E1325
3.1.3 Plackett-Burman designs, n—a set of screening designs using orthogonal arrays that permit evaluation of the linear effects
of up to n = t – 1 factors in a study of t treatment combinations. E1325
3.1.4 ruggedness, n—insensitivity of a test method to departures from specified test or environmental conditions.
3.1.4.1 Discussion—
An evaluation of the “ruggedness” of a test method or an empirical model derived from an experiment is useful in determining
whether the results or decisions will be relatively invariant over some range of environmental variability under which the test
method or the model is likely to be applied.
1
This practice 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 Sept. 1, 2018April 1, 2020. Published September 2018May 2020. Originally approved in 1987. Last previous edition approved in 20172018 as
ɛ1
E1169 – 17E1169 – 18. . DOI: 10.1520/E1169-18.10.1520/E1169-20.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or contact ASTM Customer Service at service@astm.org. 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 ----------------------
E1169 − 20
3.1.5 ruggedness test, n—a planned experiment in which environmental factors or test conditions are deliberately varied in order
to evaluate the effects of such variation.
3.1.5.1 Discussion—
Since there usually are many environmental factors that might be considered in a ruggedness test, it is customary to use a
“screening” type of experiment design which
...

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4.1 A ruggedness test is a special application of a statistically designed experiment that makes changes in the test method variables, called factors, and then calculates the subsequent effect of those changes upon the test results. Factors are features of the test method or of the laboratory environment that are known to vary across laboratories and are subject to control by the test method.  
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5.4 Each of the Techniques 1, 2, and 3 provides a procedure for testing and evaluating sample homogeneity when replicate testing of the samples is possible. Technique 4 provides a plan to evaluate sample homogeneity when replicate testing is not possible. Technique 5 recommends practices for producing homogeneous samples for circumstances when homogeneity testing is not possible.  
5.5 When the conditions of adequate within-sample homogeneity and between-sample homogeneity are satisfied, any differences in test results on multiple samples can reasonably be attributed to testing variation and not due to sample variation.  
5.6 When differences within or between samples are discovered and the samples are deemed insufficiently homogeneous, the sample preparation process can be improved or corrected and a new set of samples can be prepared. Or, in cases where the sample homogeneity cannot be improved or for other reasons when the samples must be used, the method of eval...
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1.1 This guide presents techniques and guidance for evaluating and assuring homogeneity of individual samples and bulk materials used for interlaboratory and intra-laboratory studies.  
1.2 This guide is applicable to samples and reference materials used for proficiency testing programs and for interlaboratory studies to determine precision estimates for test methods. It may also be useful for activities related to quality control of testing within a single laboratory.  
1.3 Five techniques are presented for assessing sample homogeneity. The five techniques are not an exhaustive list of available techniques for assessing homogeneity of samples, but the techniques were chosen to cover a range of circumstances (and various degrees of rigor required) for laboratory studies of various types and purposes.  
1.4 Each of the first four techniques provides a scheme for testing for homogeneity and a statistical procedure for evaluating the results of the homogeneity testing. The circumstances are described for which each of the techniques is suited.  
1.5 For circumstances when homogeneity testing is not possible, the fifth technique provides guidance for producing homogeneous samples.  
1.6 The appendixes of this guide provide example spreadsheets for Techniques 1, 2, 3, and 4.  
1.7 This guide is not intended for evaluation of certified reference materials (CRMs) or materials used for calibration.  
1.8 Units—The system of units for this standard is not specified. Dimensional quantities in the standard are presented only as illustrations of calculation methods. The examples are not binding on products or test methods treated.  
1.9 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to ...

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ASTM
ASTM E177-20(Practice)
Standard Practice for Use of the Terms Precision and Bias in ASTM Test Methods

ABSTRACT
The purpose of this practice is to present concepts necessary to the understanding of the terms “precision” and “bias” as used in quantitative test methods. This practice also describes methods of expressing precision and bias and, in a final section, gives examples of how statements on precision and bias may be written for ASTM test methods. A statement of precision allows potential users of a test method to assess in general terms the test method’s usefulness with respect to variability in proposed applications.
SIGNIFICANCE AND USE
4.1 Part A of the “Blue Book,” Form and Style for ASTM Standards, requires that all test methods include statements of precision and bias. This practice discusses these two concepts and provides guidance for their use in statements about test methods.  
4.2 Precision—A statement of precision allows potential users of a test method to assess in general terms the test method’s usefulness with respect to variability in proposed applications. A statement of precision is not intended to exhibit values that can be exactly duplicated in every user’s laboratory. Instead, the statement provides guidelines as to the magnitude of variability that can be expected between test results when the method is used in one, or in two or more, reasonably competent laboratories. For a discussion of precision, see 8.1.  
4.3 Bias—A statement of bias furnishes guidelines on the relationship between a set of typical test results produced by the test method under specific test conditions and a related set of accepted reference values (see 9.1).  
4.3.1 An alternative term for bias is trueness, which has a positive connotation, in that greater bias is associated with less favorable trueness. Trueness is the systematic component of accuracy.  
4.4 Accuracy—The term “accuracy,” used in earlier editions of Practice E177, embraces both precision and bias (see 9.3).
SCOPE
1.1 The purpose of this practice is to present concepts necessary to the understanding of the terms “precision” and “bias” as used in quantitative test methods. This practice also describes methods of expressing precision and bias and, in a final section, gives examples of how statements on precision and bias may be written for ASTM test methods.  
1.2 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.3 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.

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ASTM
ASTM E2554-18e1(Practice)
Standard Practice for Estimating and Monitoring the Uncertainty of Test Results of a Test Method Using Control Chart Techniques

ABSTRACT
This practice describes techniques for a laboratory to estimate the uncertainty of a test result using data from test results on a control sample. This practice provides one method for a laboratory to estimate Measurement Uncertainty in accordance with Section A22.3 in Form and Style for ASTM Standards. This practice describes the use of control charts to evaluate the data obtained and presents a special type of control chart to monitor the estimate of uncertainty.
This practice provides one way for a laboratory to develop data-based Type A estimates of uncertainty as referred to in Section A22 in Form and Style for ASTM Standards.
SIGNIFICANCE AND USE
4.1 This practice provides one way for a laboratory to develop data-based Type A estimates of uncertainty as referred to in Section A22 in Form and Style for ASTM Standards.  
4.2 Laboratories accredited under ISO/IEC 17025 are required to present uncertainty estimates for their test results. This practice provides procedures that use test results to develop uncertainty estimates for an individual laboratory.  
4.3 Generally, these test results will be from a single sample of stable and homogeneous material known as a control or check sample.  
4.4 The true value of the characteristic(s) of the control sample being measured will ordinarily be unknown. However, this methodology may also be used if the control sample is a reference material, in which case the test method bias may also be estimated and incorporated into the uncertainty estimate. Many test methods do not have true reference materials available to provide traceable chains of uncertainty estimation.  
4.5 This practice also allows for ongoing monitoring of the laboratory uncertainty. As estimates of the level of uncertainty change, possibly as contributions to uncertainty are identified and minimized, revision to the laboratory uncertainty will be possible.
SCOPE
1.1 This practice describes techniques for a laboratory to estimate the uncertainty of a test result using data from test results on a control sample. This practice provides one method for a laboratory to estimate Measurement Uncertainty in accordance with Section A22.3 in Form and Style for ASTM Standards.  
1.2 Uncertainty as defined by this practice applies to the capabilities of a single laboratory. Any estimate of uncertainty determined through the use of this practice applies only to the individual laboratory for which the data are presented.  
1.3 The laboratory uses a well defined and established test method in determining a series of test results. The uncertainty estimated using this practice only applies when the same test method is followed. The uncertainty only applies for the material types represented by the control samples, and multiple control samples may be needed, especially if the method has different precision for different sample types or response levels.  
1.4 The uncertainty estimate determined by this practice represents the intermediate precision of test results. This estimate seeks to quantify the total variation expected within a single laboratory using a single established test method while incorporating as many known sources of variation as possible.  
1.5 This practice does not establish error estimates (error budget) attributed to individual factors that could influence uncertainty.  
1.6 This practice describes the use of control charts to evaluate the data obtained and presents a special type of control chart to monitor the estimate of uncertainty.  
1.7 The system of units for this standard is not specified. Dimensional quantities in the standard are presented only as illustrations of calculation methods. The examples are not binding on products or test methods treated.  
1.8 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmenta...

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