Standard Practice for Estimating and Monitoring the Uncertainty of Test Results of a Test Method in a Single Laboratory Using a Control Sample Program

SIGNIFICANCE AND USE
Laboratories accredited under ISO 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.
Generally, these test results will be from a single sample of stable and homogeneous material known as a control or check sample.
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.
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.
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.
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 and health practices and determine the applicability of regulatory limitations prior to use.

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Publication Date
30-Apr-2007
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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
Designation: E2554 − 07 AnAmerican National Standard
Standard Practice for
Estimating and Monitoring the Uncertainty of Test Results
of a Test Method in a Single Laboratory Using a Control
1
Sample Program
This standard is issued under the fixed designation E2554; 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 priate safety and health practices and determine the applica-
bility of regulatory limitations prior to use.
1.1 This practice describes techniques for a laboratory to
estimate the uncertainty of a test result using data from test
2. Referenced Documents
results on a control sample.
2
2.1 ASTM Standards:
1.2 Uncertainty as defined by this practice applies to the
D5184 Test Methods for Determination of Aluminum and
capabilities of a single laboratory.Any estimate of uncertainty
Silicon in Fuel Oils by Ashing, Fusion, Inductively
determined through the use of this practice applies only to the
Coupled Plasma Atomic Emission Spectrometry, and
individual laboratory for which the data are presented.
Atomic Absorption Spectrometry
1.3 The laboratory uses a well defined and established test E177 Practice for Use of the Terms Precision and Bias in
method in determining a series of test results. The uncertainty
ASTM Test Methods
estimated using this practice only applies when the same test E456 Terminology Relating to Quality and Statistics
method is followed. The uncertainty only applies for the
51707 Guide for Estimating Uncertainties in Dosimetry for
materialtypesrepresentedbythecontrolsamples,andmultiple Radiation Processing
control samples may be needed, especially if the method has
E2282 Guide for Defining the Test Result of a Test Method
differentprecisionfordifferentsampletypesorresponselevels. 2.2 ASTM Publication:
Manual on Presentation of Data and Control Chart Analy-
1.4 The uncertainty estimate determined by this practice
2
sis, 7th Edition
represents the intermediate precision of test results. This
2.3 ISO Standard:
estimate seeks to quantify the total variation expected within a
ISO 17025 General Requirements for the Competence of
single laboratory using a single established test method while
3
Testing and Calibration Laboratories
incorporating as many known sources of variation as possible.
1.5 This practice does not establish error estimates (error
3. Terminology
budget) attributed to individual factors that could influence
3.1 Definitions:
uncertainty.
3.1.1 The terminology of Terminology E456 applies to this
1.6 This practice describes the use of control charts to
practice except as modified herein.
evaluatethedataobtainedandpresentsaspecialtypeofcontrol
3.1.2 control sample, n—sample taken from a stable, homo-
chart to monitor the estimate of uncertainty.
geneous material for the purposes of monitoring the perfor-
mance of a test method in a laboratory.
1.7 The system of units for this Standard is not specified.
3.1.2.1 Discussion—The control sample material is repre-
Dimensional quantities in the Standard are presented only as
sentativeoftheproducttypicallytestedinthelaboratorybythe
illustrations of calculation methods. The examples are not
given test method. A control sample is run periodically using
binding on products or test methods treated.
thecompletetestmethodprotocoltodevelopatestresult.Such
1.8 This standard does not purport to address all of the
test results may be statistically evaluated to monitor test
safety concerns, if any, associated with its use. It is the
method performance over time. It is not necessary to have an
responsibility of the user of this standard to establish appro-
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
1
This practice is under the jurisdiction ofASTM Committee E11 on Quality and contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
Statistics and is the direct responsibility of Subcommittee E11.20 on Test Method Standards volume information, refer to the standard’s Document Summary page on
Evaluation and Quality Control. the ASTM website.
3
Current edition approved May 1, 2007. Published June 2007. DOI: 10.1520/ Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
E2554-07. 4th Floor, New York, NY 10036, http://www.ansi.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

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E2554 − 07
accepted reference value assigned to the control sample mate- reference material, in which case the test method bias may also
rial. When the current material is nea
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