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ASTM E1169-17e1

(Practice)

Standard Practice for Conducting Ruggedness Tests

Standard Practice for Conducting Ruggedness Tests

SIGNIFICANCE AND USE
5.1 A ruggedness test is a special application of a statistically designed experiment. It is generally carried out when it is desirable to examine a large number of possible factors to determine which of these factors might have the greatest effect on the outcome of a test method. 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.  
5.2 In ruggedness testing, the two levels for each factor are chosen to use moderate separations between the high and low settings. In general, the size of effects, and the likelihood of interactions between the factors, will increase with increased separation between the high and low settings of the factors.  
5.3 Ruggedness testing is usually done within a single laboratory on uniform material, so 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.  
5.4 Ruggedness testing is part of the validation phase of developing a standard test method as described in Guide E1488. It is preferred that a ruggedness test precedes an interlaboratory (round robin) study.
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 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
30-Sep-2017
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

Relations

Replaces
ASTM E1169-17 - Standard Practice for Conducting Ruggedness Tests
Effective Date
01-Oct-2017
Replaced By
ASTM E1169-18 - Standard Practice for Conducting Ruggedness Tests
Effective Date
01-Sep-2018
Referred By
ASTM D3670-91(2022) - Standard Guide for Determination of Precision and Bias of Methods of Committee D22
Effective Date
01-Oct-2017
Referred By
ASTM E1601-19 - Standard Practice for Conducting an Interlaboratory Study to Evaluate the Performance of an Analytical Method
Effective Date
01-Oct-2017
Referred By
ASTM G156-17 - Standard Practice for Selecting and Characterizing Weathering Reference Materials
Effective Date
01-Oct-2017
Referred By
ASTM C1067-20 - Standard Practice for Conducting a Ruggedness Evaluation or Screening Program for Test Methods for Construction Materials
Effective Date
01-Oct-2017
Referred By
ASTM D2777-21 - Standard Practice for Determination of Precision and Bias of Applicable Test Methods of Committee D19 on Water
Effective Date
01-Oct-2017
Referred By
ASTM D7778-15(2022)e1 - Standard Guide for Conducting an Interlaboratory Study to Determine the Precision of a Test Method
Effective Date
01-Oct-2017
Referred By
ASTM E3097-23 - Standard Test Method for Uniaxial Constant Force Thermal Cycling of Shape Memory Alloys
Effective Date
01-Oct-2017
Referred By
ASTM F2394-07(2022) - Standard Guide for Measuring Securement of Balloon-Expandable Vascular Stent Mounted on Delivery System
Effective Date
01-Oct-2017
Referred By
ASTM D8272-19 - Standard Guide for Development and Optimization of D19 Chemical Analysis Methods Intended for EPA Compliance Reporting
Effective Date
01-Oct-2017
Referred By
ASTM E3098-17 - Standard Test Method for Mechanical Uniaxial Pre-strain and Thermal Free Recovery of Shape Memory Alloys
Effective Date
01-Oct-2017
Referred By
ASTM E1323-15(2020) - Standard Guide for Evaluating Laboratory Measurement Practices and the Statistical Analysis of the Resulting Data
Effective Date
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Referred By
ASTM D8064-16 - Standard Test Method for Elemental Analysis of Soil and Solid Waste by Monochromatic Energy Dispersive X-ray Fluorescence Spectrometry Using Multiple Monochromatic Excitation Beams
Effective Date
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Referred By
ASTM E2653-23 - Standard Practice for Conducting an Interlaboratory Study to Determine Precision Estimates for a Test Method with Fewer Than Six Participating Laboratories
Effective Date
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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
´1
Designation: E1169 − 17 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
ε NOTE—Editorial corrections were made throughout in April 2018.
1. Scope and Applying Test Methods
E2282Guide for Defining the Test Result of a Test Method
1.1 This practice covers conducting ruggedness tests. The
F2082Test Method for Determination of Transformation
purpose of a ruggedness test is to identify those factors that
Temperature of Nickel-Titanium Shape Memory Alloys
stronglyinfluencethemeasurementsprovidedbyaspecifictest
by Bend and Free Recovery
method and to estimate how closely those factors need to be
controlled.
3. Terminology
1.2 This practice restricts itself to designs with two levels
3.1 Definitions—The terminology defined in Terminology
per factor. The designs require the simultaneous change of the
E456 applies to this practice unless modified herein.
levelsofallofthefactors,thuspermittingthedeterminationof
3.1.1 fractional factorial design, n—a factorial experiment
the effects of each of the factors on the measured results.
in which only an adequately chosen fraction of the treatments
required for the complete factorial experiment is selected to be
1.3 The system of units for this practice is not specified.
run. E1325
Dimensional quantities in the practice are presented only as
illustrations of calculation methods. The examples are not 3.1.2 level (of a factor), n—a given value, a specification of
binding on products or test methods treated.
procedure or a specific setting of a factor. E1325
3.1.3 Plackett-Burman designs, n—a set of screening de-
1.4 This standard does not purport to address all of the
safety concerns, if any, associated with its use. It is the signs using orthogonal arrays that permit evaluation of the
linear effects of up to n = t – 1 factors in a study of t treatment
responsibility of the user of this standard to establish appro-
priate safety, health, and environmental practices and deter- combinations. E1325
mine the applicability of regulatory limitations prior to use.
3.1.4 ruggedness, n—insensitivity of a test method to de-
1.5 This international standard was developed in accor-
partures from specified test or environmental conditions.
dance with internationally recognized principles on standard-
3.1.4.1 Discussion—An evaluation of the “ruggedness” of a
ization established in the Decision on Principles for the
test method or an empirical model derived from an experiment
Development of International Standards, Guides and Recom-
isusefulindeterminingwhethertheresultsordecisionswillbe
mendations issued by the World Trade Organization Technical
relativelyinvariantoversomerangeofenvironmentalvariabil-
Barriers to Trade (TBT) Committee.
ity under which the test method or the model is likely to be
applied.
2. Referenced Documents
3.1.5 ruggedness test, n—a planned experiment in which
2
2.1 ASTM Standards:
environmental factors or test conditions are deliberately varied
E456Terminology Relating to Quality and Statistics
in order to evaluate the effects of such variation.
E1325Terminology Relating to Design of Experiments
3.1.5.1 Discussion—Since there usually are many environ-
E1488GuideforStatisticalProcedurestoUseinDeveloping
mental factors that might be considered in a ruggedness test, it
is customary to use a “screening” type of experiment design
which concentrates on examining many first order effects and
1
ThispracticeisunderthejurisdictionofASTMCommitteeE11onQualityand
generallyassumesthatsecondordereffectssuchasinteractions
Statistics and is the direct responsibility of Subcommittee E11.20 on Test Method
and curvature are relatively negligible. Often in evaluating the
Evaluation and Quality Control.
ruggedness of a test method, if there is an indication that the
Current edition approved Oct. 1, 2017. Published January 2018. Originally
results of a test method are highly dependent on the levels of
approved in 1987. Last previous edition approved in 2014 as E1169–14. DOI:
10.1520/E1169-17E01.
the environmental factors, there is a sufficient indication that
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
certain levels of environmental factors must be included in the
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
specifications for the test method, or even that the test method
Standards volume information, refer to the standard’s Document Summary page on
the ASTM website. itself will need further revi
...

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.
´1
Designation: E1169 − 17 E1169 − 17 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
ε NOTE—Editorial corrections were made throughout in April 2018.
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 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 – 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—
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 Oct. 1, 2017. Published January 2018. Originally approved in 1987. Last previous edition approved in 2014 as E1169 – 14. DOI:
10.1520/E1169-17.10.1520/E1169-17E01.
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 ----------------------
´1
E1169 − 17
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.
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 ex
...

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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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1.1 This standard includes those statistical items related to the area of design of experiments for which standard definitions appear desirable.  
1.2 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
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 E3264-21(Guide)
Standard Guide for Homogeneity of Samples and Reference Materials Used for Inter- and Intra-Laboratory Studies

SIGNIFICANCE AND USE
5.1 This guide presents techniques and guidance for evaluating and assuring homogeneity of individual samples or bulk materials and can be used for either interlaboratory or intra-laboratory studies. The types of studies include, but are not limited to, studies to determine precision estimates for test methods, proficiency testing programs, and studies related to quality control of testing within a single laboratory.  
5.2 Because the test results of any laboratory study are affected by the quality of the samples tested, producing homogeneous samples and determining the degree of homogeneity is important for interpreting the results of the study.  
5.3 Five techniques are presented in this guide to evaluate sample homogeneity for a range of circumstances and degrees of rigor. The circumstances under which the studies are conducted and the degree of rigor required may differ. The user should consider the circumstances listed in each technique to determine which is appropriate for the study at hand.  
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...
SCOPE
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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