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ASTM D6299-10e1

(Practice)

Standard Practice for Applying Statistical Quality Assurance and Control Charting Techniques to Evaluate Analytical Measurement System Performance

Standard Practice for Applying Statistical Quality Assurance and Control Charting Techniques to Evaluate Analytical Measurement System Performance

SIGNIFICANCE AND USE
This practice can be used to continuously demonstrate the proficiency of analytical measurement systems that are used for establishing and ensuring the quality of petroleum and petroleum products.
Data accrued, using the techniques included in this practice, provide the ability to monitor analytical measurement system precision and bias.
These data are useful for updating test methods as well as for indicating areas of potential measurement system improvement.
SCOPE
1.1 This practice covers information for the design and operation of a program to monitor and control ongoing stability and precision and bias performance of selected analytical measurement systems using a collection of generally accepted statistical quality control (SQC) procedures and tools.  
Note 1—A complete list of criteria for selecting measurement systems to which this practice should be applied and for determining the frequency at which it should be applied is beyond the scope of this practice. However, some factors to be considered include (1) frequency of use of the analytical measurement system, (2) criticality of the parameter being measured, (3) system stability and precision performance based on historical data, (4) business economics, and (5) regulatory, contractual, or test method requirements.
1.2 This practice is applicable to stable analytical measurement systems that produce results on a continuous numerical scale.  
1.3 This practice is applicable to laboratory test methods.
1.4 This practice is applicable to validated process stream analyzers.
1.5 This practice is applicable to monitoring the differences between two analytical measurement systems that purport to measure the same property provided that both systems have been assessed in accordance with the statistical methodology in Practice D6708 and the appropriate bias applied.
Note 2—For validation of univariate process stream analyzers, see also Practice D3764.
Note 3—One or both of the analytical systems in 1.5 can be laboratory test methods or validated process stream analyzers.
1.6 This practice assumes that the normal (Gaussian) model is adequate for the description and prediction of measurement system behavior when it is in a state of statistical control.
Note 4—For non-Gaussian processes, transformations of test results may permit proper application of these tools. Consult a statistician for further guidance and information.

General Information

Status
Historical
Publication Date
28-Feb-2010
ICS
03.120.30 - Application of statistical methods
Technical Committee
D02 - Petroleum Products, Liquid Fuels, and Lubricants
Drafting Committee
D02.94 - Coordinating Subcommittee on Quality Assurance and Statistics
Current Stage
Ref Project

Relations

Replaced By
ASTM D6299-10e2 - Standard Practice for Applying Statistical Quality Assurance and Control Charting Techniques to Evaluate Analytical Measurement System Performance
Effective Date
01-Mar-2010

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ASTM D6299-10e1 - Standard Practice for Applying Statistical Quality Assurance and Control Charting Techniques to Evaluate Analytical Measurement System PerformanceASTM D6299-10e1 - Standard Practice for Applying Statistical Quality Assurance and Control Charting Techniques to Evaluate Analytical Measurement System Performance
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ASTM D6299-10e1 - Standard Practice for Applying Statistical Quality Assurance and Control Charting Techniques to Evaluate Analytical Measurement System Performance
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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
An American National Standard
´1
Designation:D6299–10
Standard Practice for
Applying Statistical Quality Assurance and Control Charting
Techniques to Evaluate Analytical Measurement System
1
Performance
This standard is issued under the fixed designation D6299; 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
´ NOTE—Corrected definition references and figure numbering editorially in March 2011.
may permit proper application of these tools. Consult a statistician for
1. Scope
further guidance and information.
1.1 This practice covers information for the design and
operationofaprogramtomonitorandcontrolongoingstability
2. Referenced Documents
and precision and bias performance of selected analytical
2
2.1 ASTM Standards:
measurement systems using a collection of generally accepted
D3764 Practice for Validation of the Performance of Pro-
statistical quality control (SQC) procedures and tools.
cess Stream Analyzer Systems
NOTE 1—Acomplete list of criteria for selecting measurement systems D5191 Test Method for Vapor Pressure of Petroleum Prod-
towhichthispracticeshouldbeappliedandfordeterminingthefrequency
ucts (Mini Method)
at which it should be applied is beyond the scope of this practice.
D6708 PracticeforStatisticalAssessmentandImprovement
However, some factors to be considered include (1) frequency of use of
of Expected Agreement Between Two Test Methods that
the analytical measurement system, (2) criticality of the parameter being
Purport to Measure the Same Property of a Material
measured, (3) system stability and precision performance based on
D6792 Practice for Quality System in Petroleum Products
historical data, (4) business economics, and (5) regulatory, contractual, or
and Lubricants Testing Laboratories
test method requirements.
D7372 Guide forAnalysis and Interpretation of Proficiency
1.2 This practice is applicable to stable analytical measure-
Test Program Results
ment systems that produce results on a continuous numerical
E177 Practice for Use of the Terms Precision and Bias in
scale.
ASTM Test Methods
1.3 This practice is applicable to laboratory test methods.
E178 Practice for Dealing With Outlying Observations
1.4 This practice is applicable to validated process stream
E456 Terminology Relating to Quality and Statistics
analyzers.
E691 Practice for Conducting an Interlaboratory Study to
1.5 This practice is applicable to monitoring the differences
Determine the Precision of a Test Method
between two analytical measurement systems that purport to
measure the same property provided that both systems have
3. Terminology
beenassessedinaccordancewiththestatisticalmethodologyin
3.1 Definitions:
Practice D6708 and the appropriate bias applied.
3.1.1 accepted reference value, n—a value that serves as an
NOTE 2—Forvalidationofunivariateprocessstreamanalyzers,seealso
agreed-uponreferenceforcomparisonandthatisderivedas(1)
Practice D3764.
atheoreticalorestablishedvalue,basedonscientificprinciples,
NOTE 3—One or both of the analytical systems in 1.5 can be laboratory
(2) an assigned value, based on experimental work of some
test methods or validated process stream analyzers.
national or international organization, such as the U.S. Na-
1.6 This practice assumes that the normal (Gaussian) model
tional Institute of Standards and Technology (NIST), or (3)a
is adequate for the description and prediction of measurement
consensus value, based on collaborative experimental work
system behavior when it is in a state of statistical control.
under the auspices of a scientific or engineering group.
E177, E456
NOTE 4—For non-Gaussian processes, transformations of test results
3.1.2 accuracy, n—the closeness of agreement between an
observed value and an accepted reference value. E177, E456
1
This practice is under the jurisdiction ofASTM Committee D02 on Petroleum
Products and Lubricants and is the direct responsibility of Subcommittee D02.94 on
2
Coordinating Subcommittee on Quality Assurance and Statistics. For referenced ASTM standards, visit the ASTM website, www.astm.org, or
Current edition approved March 1, 2010. Published June 2010. Originally contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
approved in 1998. Last previous edition approved in 2009 as D6299–09. DOI: Standards volume information, refer to the standard’s Document Summary page on
10.1520/D6299-10. the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
1

---------------------- Page: 1 ----------------------
´1
D6299–10
3.1.3 assignable
...

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ASTM D7915-22(Practice)
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3.1 The GESD procedure can be used to simultaneously identify up to a pre-determined number of outliers (r) in a data set, without having to pre-examine the data set and make a priori decisions as to the location and number of potential outliers.  
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This practice presents rules for accepting or rejecting evidence based on a sample. Statistical evidence for this practice is in the form of an estimate of a proportion, an average, a total, or other numerical characteristic of a finite population or lot. This practice is an estimate of the result which would have been obtained by investigating the entire lot or population under the same rules and with the same care as was used for the sample. One purpose of this practice is to describe straightforward sample selection and data calculation procedures so that courts, commissions, etc. will be able to verify whether such procedures have been applied.
SIGNIFICANCE AND USE
4.1 This practice is designed to permit users of sample survey data to judge the trustworthiness of results from such surveys. Practice E105 provides a statement of principles for guidance of ASTM technical committees and others in the preparation of a sampling plan for a specific material. Guide E1402 describes the principal types of sampling designs. Practice E122 aids in deciding on the required sample size.  
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4.3 If the sample design was relatively simple, such as simple random or stratified, then fully valid estimates of sampling variance are easily available. If a more complex design was used then methods such as discussed in Ref (1)3 or in Guide E1402 may be acceptable. Use of replicate subsamples is the most straightforward way to estimate sampling variances when the survey design is complex.  
4.4 Once the survey procedures that were used satisfy Section 5, see if any increase in sample size is needed. The calculations for making it objectively are described in Section 6.  
4.5 Refer to Section 7 to guide in the interpretation of the uncertainty in the reported value of the parameter estimate, θ^, that is, the value of its standard error, se(θ^). The quantity se(θ^) should be reviewed to verify that the risks it entails are commensurate with the size of the sample.  
4.6 When the audit subsample shows that there was reasonable conformity with prescribed procedures and when the known instances of departures from the survey plan can be shown to have no appreciable effect on the est...
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ASTM E3080-23(Practice)
Standard Practice for Regression Analysis with a Single Predictor Variable

ABSTRACT
This practice covers regression analysis of a set of data to define the statistical relationship between two numerical variables for use in predicting one variable from the other. This practice is restricted in scope to consider only a single numerical response variable and a single numerical predictor variable. The objective is to obtain a regression model for use in predicting the value of the response variable Y for given values of the predictor variable X.
SIGNIFICANCE AND USE
4.1 Regression analysis is a procedure that uses data to study the statistical relationships between two or more variables (1, 2).3 This practice is restricted in scope to consider only a single numerical response variable and a single numerical predictor variable. The objective is to obtain a regression model for use in predicting the value of the response variable Y for given values of the predictor variable X.  
4.2 A regression model consists of: (1) a regression function that relates the mean values of the response variable distribution to fixed values of the predictor variable, and (2) a statistical distribution that describes the variability in the response variable values at a fixed value of the predictor variable.  
4.2.1 The regression analysis utilizes either experimental or observational data to estimate the parameters defining a regression model and their precision. Diagnostic procedures are utilized to assess the resulting model fit and can suggest other models for improved prediction performance.  
4.3 The information in this practice is arranged as follows.  
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1.4 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.  
1.5 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.  
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ASTM E2709-23(Practice)
Standard Practice for Demonstrating Capability to Comply with an Acceptance Procedure

ABSTRACT
This practice provides a general methodology for evaluating single-stage or multiple-stage acceptance procedures which involve a quality characteristic measured on a numerical scale. This methodology computes, at a prescribed confidence level, a lower bound on the probability of passing an acceptance procedure, using estimates of the parameters of the distribution of test results from a sampled population.
SIGNIFICANCE AND USE
4.1 This practice considers inspection procedures that may involve multiple-stage sampling, where at each stage one can decide to accept or to continue sampling, and the decision to reject is deferred until the last stage.  
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SCOPE
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ASTM E2862-23(Practice)
Standard Practice for Probability of Detection Analysis for Hit/Miss Data

SIGNIFICANCE AND USE
5.1 The POD analysis method described herein is based on a well-known and well established statistical regression method. It shall be used to quantify the demonstrated POD for a specific set of examination parameters and known range of discontinuity sizes under the following conditions.  
5.1.1 The initial response from a nondestructive evaluation inspection system is ultimately binary in nature (that is, hit or miss).  
5.1.2 Discontinuity size is the predictor variable and can be accurately quantified.  
5.1.3 A relationship between discontinuity size and POD exists and is best described by a generalized linear model with the appropriate link function for binary outcomes.  
5.2 This practice does not limit the use of a generalized linear model with more than one predictor variable or other types of statistical models if justified as more appropriate for the hit/miss data.  
5.3 If the initial response from a nondestructive evaluation inspection system is measurable and can be classified as a continuous variable (for example, data collected from an Eddy Current inspection system), then Practice E3023 may be more appropriate.  
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SCOPE
1.1 This practice covers the procedure for performing a statistical analysis on nondestructive testing hit/miss data to determine the demonstrated probability of detection (POD) for a specific set of examination parameters. Topics covered include the standard hit/miss POD curve formulation, validation techniques, and correct interpretation of results.  
1.2 The values stated in inch-pound units are to be regarded as standard. The values given in parentheses are mathematical conversions to SI units that are provided for information only and are not considered standard.  
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Standard Practice for Setting an Upper Confidence Bound for a Fraction or Number of Non-Conforming items, or a Rate of Occurrence for Non-Conformities, Using Attribute Data, When There is a Zero Response in the Sample

ABSTRACT
This practice presents methodology for the setting of an upper confidence bound regarding an unknown fraction or quantity non-conforming, or a rate of occurrence for nonconformities, in cases where the method of attributes is used and there is a zero response in a sample. Three cases are considered. In Case 1, the sample is selected from a process or a very large population of interest. In Case 2, a sample of n items is selected at random from a finite lot of N items. In Case 3, there is a process, but the output is a continuum, such as area (for example, a roll of paper or other material, a field of crop), volume (for example, a volume of liquid or gas), or time (for example, hours, days, quarterly, etc.) The sample size is defined as that portion of the �continuum� sampled, and the defined attribute may occur any number of times over the sampled portion.
SIGNIFICANCE AND USE
4.1 In Case 1, the sample is selected from a process or a very large population of interest. The population is essentially unlimited, and each item either has or has not the defined attribute. The population (process) has an unknown fraction of items p (long run average process non-conforming) having the attribute. The sample is a group of n discrete items selected at random from the process or population under consideration, and the attribute is not exhibited in the sample. The objective is to determine an upper confidence bound, pu, for the unknown fraction p whereby one can claim that p ≤ pu with some confidence coefficient (probability) C. The binomial distribution is the sampling distribution in this case.  
4.2 In Case 2, a sample of n items is selected at random from a finite lot of N items. Like Case 1, each item either has or has not the defined attribute, and the population has an unknown number, D, of items having the attribute. The sample does not exhibit the attribute. The objective is to determine an upper confidence bound, Du, for the unknown number D, whereby one can claim that D ≤ Du with some confidence coefficient (probability) C. The hypergeometric distribution is the sampling distribution in this case.  
4.3 In Case 3, there is a process, but the output is a continuum, such as area (for example, a roll of paper or other material, a field of crop), volume (for example, a volume of liquid or gas), or time (for example, hours, days, quarterly, etc.) The sample size is defined as that portion of the “continuum” sampled, and the defined attribute may occur any number of times over the sampled portion. There is an unknown average rate of occurrence, λ, for the defined attribute over the sampled interval of the continuum that is of interest. The sample does not exhibit the attribute. For a roll of paper, this might be blemishes per 100 ft2; for a volume of liquid, microbes per cubic litre; for a field of crop, spores per acre; for a time interval, ca...
SCOPE
1.1 This practice presents methodology for the setting of an upper confidence bound regarding a unknown fraction or quantity non-conforming, or a rate of occurrence for nonconformities, in cases where the method of attributes is used and there is a zero response in a sample. Three cases are considered.  
1.1.1 The sample is selected from a process or a very large population of discrete items, and the number of non-conforming items in the sample is zero.  
1.1.2 A sample of items is selected at random from a finite lot of discrete items, and the number of non-conforming items in the sample is zero.  
1.1.3 The sample is a portion of a continuum (time, space, volume, area, etc.) and the number of non-conformities in the sample is zero.  
1.2 Allowance is made for misclassification error in this practice, but only when misclassification rates are well understood or known and can be approximated numerically.  
1.3 The values stated in inch-pound units are to be regarded as standard. No other units of measurement are included in this standard.  
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Standard Practice for Statistical Treatment of Thermoanalytical Data

SIGNIFICANCE AND USE
5.1 The standard deviation, or one of its derivatives, such as relative standard deviation or pooled standard deviation, derived from this practice, provides an estimate of precision in a measured value. Such results are ordinarily expressed as the mean value ± the standard deviation, that is, X ± s.  
5.2 If the measured values are, in the statistical sense, “normally” distributed about their mean, then the meaning of the standard deviation is that there is a 67 % chance, that is 2 in 3, that a given value will lie within the range of ± one standard deviation of the mean value. Similarly, there is a 95 % chance, that is 19 in 20, that a given value will lie within the range of ± two standard deviations of the mean. The two standard deviation range is sometimes used as a test for outlying measurements.  
5.3 The calculation of precision in the slope and intercept of a line, derived from experimental data, commonly is required in the determination of kinetic parameters, vapor pressure or enthalpy of vaporization. This practice describes how to obtain these and other statistically derived values associated with measurements by thermal analysis.
SCOPE
1.1 This practice details the statistical data treatment used in some thermal analysis methods.  
1.2 The method describes the commonly encountered statistical tools of the mean, standard derivation, relative standard deviation, pooled standard deviation, pooled relative standard deviation, the best fit to a (linear regression of a) straight line (or plane), and propagation of uncertainties for all calculations encountered in thermal analysis methods (see Practice E2586).  
1.3 Some thermal analysis methods derive the analytical value from the slope or intercept of a linear regression straight line (or plane) assigned to three or more sets of data pairs. Such methods may require an estimation of the precision in the determined slope or intercept. The determination of this precision is not a common statistical tool. This practice details the process for obtaining such information about precision.  
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.

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Standard Practice for Use of Process Oriented AOQL and LTPD Sampling Plans

ABSTRACT
This practice is primarily a statement of principals for the guidance of ASTM technical committees and others in the use of average outgoing quality limit, AOQL, and lot tolerance percent defective, LTPD, sampling plans for determining acceptable of lots of product. Two general types of tables are given, one based on the concept of lot tolerance, LTPD, and the other on AOQL. For each of the types, tables are provided both for single sampling and for double sampling. Each of the individual tables constitutes a collection of solutions to the problem of minimizing the over-all amount of inspection.
SIGNIFICANCE AND USE
4.1 Two general types of tables (Note 1) are given, one based on the concept of lot tolerance, LTPD, and the other on AOQL. The broad conditions under which the different types have been found best adapted are indicated below.  
4.1.1 For each of the types, tables are provided both for single sampling and for double sampling. Each of the individual tables constitutes a collection of solutions to the problem of minimizing the over-all amount of inspection. Because each line in the tables covers a range of lot sizes, the AOQL values in the LTPD tables and the LTPD values in the AOQL tables are often conservative.
Note 1: Tables in Annex A1 – Annex A4 and parts of the text are reproduced by permission of John R. Wiley and Sons. More extensive tables and discussion of the methods will be found in that text.  
4.2 The sampling tables based on lot quality protection (LTPD) (the tables in Annex A1 and Annex A2) are perhaps best adapted to conditions where interest centers on each lot separately, for example, where the individual lot tends to retain its identity either from a shipment or a service standpoint. These tables have been found particularly useful in inspections made by the ultimate consumer or a purchasing agent for lots or shipments purchased more or less intermittently.  
4.3 The sampling tables based on average quality protection (AOQL) (the tables in Annex A3 and Annex A4) are especially adapted for use where interest centers on the average quality of product after inspection rather than on the quality of each individual lot and where inspection is, therefore, intended to serve, if necessary, as a partial screen for defective pieces. The latter point of view has been found particularly helpful, for example, in consumer inspections of continuing purchases of large quantities of a product and in manufacturing process inspections of parts where the inspection lots tend to lose their identity by merger in a common storeroom from which quantities are withdraw...
SCOPE
1.1 This practice is primarily a statement of principals for the guidance of ASTM technical committees and others in the use of average outgoing quality limit, AOQL, and lot tolerance percent defective, LTPD, sampling plans for determining acceptable of lots of product.  
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.

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ASTM
ASTM D7915-22(Practice)
Standard Practice for Application of Generalized Extreme Studentized Deviate (GESD) Technique to Simultaneously Identify Multiple Outliers in a Data Set

SIGNIFICANCE AND USE
3.1 The GESD procedure can be used to simultaneously identify up to a pre-determined number of outliers (r) in a data set, without having to pre-examine the data set and make a priori decisions as to the location and number of potential outliers.  
3.2 The GESD procedure is robust to masking. Masking describes the phenomenon where the existence of multiple outliers can prevent an outlier identification procedure from declaring any of the observations in a data set to be outliers.  
3.3 The GESD procedure is automation-friendly, and hence can easily be programmed as automated computer algorithms.
SCOPE
1.1 This practice provides a step by step procedure for the application of the Generalized Extreme Studentized Deviate (GESD) Many-Outlier Procedure to simultaneously identify multiple outliers in a data set. (See Bibliography.)  
1.2 This practice is applicable to a data set comprising observations that is represented on a continuous numerical scale.  
1.3 This practice is applicable to a data set comprising a minimum of six observations.  
1.4 This practice is applicable to a data set where the normal (Gaussian) model is reasonably adequate for the distributional representation of the observations in the data set.  
1.5 The probability of false identification of outliers associated with the decision criteria set by this practice is 0.01.  
1.6 It is recommended that the execution of this practice be conducted under the guidance of personnel familiar with the statistical principles and assumptions associated with the GESD technique.  
1.7 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.  
1.8 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 E122-17(2022)(Practice)
Standard Practice for Calculating Sample Size to Estimate, With Specified Precision, the Average for a Characteristic of a Lot or Process

ABSTRACT
This practice covers simple methods for calculating how many units to include in a random sample in order to estimate with a specified precision, a measure of quality for all the units of a lot of material or produced by a process. It also treats the common situation where the sampling units can be considered to exhibit a single source of variability; it does not treat multi-level sources of variability.
SIGNIFICANCE AND USE
4.1 This practice is intended for use in determining the sample size required to estimate, with specified precision, a measure of quality of a lot or process. The practice applies when quality is expressed as either the lot average for a given property, or as the lot fraction not conforming to prescribed standards. The level of a characteristic may often be taken as an indication of the quality of a material. If so, an estimate of the average value of that characteristic or of the fraction of the observed values that do not conform to a specification for that characteristic becomes a measure of quality with respect to that characteristic. This practice is intended for use in determining the sample size required to estimate, with specified precision, such a measure of the quality of a lot or process either as an average value or as a fraction not conforming to a specified value.
SCOPE
1.1 This practice covers simple methods for calculating how many units to include in a random sample in order to estimate with a specified precision, a measure of quality for all the units of a lot of material, or produced by a process. This practice will clearly indicate the sample size required to estimate the average value of some property or the fraction of nonconforming items produced by a production process during the time interval covered by the random sample. If the process is not in a state of statistical control, the result will not have predictive value for immediate (future) production. The practice treats the common situation where the sampling units can be considered to exhibit a single (overall) source of variability; it does not treat multi-level sources of variability.  
1.2 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.  
1.3 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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