ASTM D3764-13
(Practice)Standard Practice for Validation of the Performance of Process Stream Analyzer Systems
Standard Practice for Validation of the Performance of Process Stream Analyzer Systems
SIGNIFICANCE AND USE
5.1 This practice can be used to quantify the performance of a process stream analyzer system or its subsystem in terms of precision and bias relative to those of a primary test method for the property of interest.
5.2 This practice provides developers or manufacturers of process stream analyzer systems with useful procedures for evaluating the capability of newly designed systems for industrial applications that require reliable prediction of measurements of a specific property by a primary test method of a flowing component or product.
5.3 This practice provides purchasers of process stream analyzer systems with some reliable options for specifying acceptance test requirements for process stream analyzer systems at the time of commissioning to ensure the system is capable of making the desired property measurement with the appropriate precision or bias specifications, or both.
5.4 PPTMR from Analyzer Systems validated in accordance with this practice can be used to predict, with a specified confidence, what the PTMR would be, to within a specified tolerance, if the actual primary test method was conducted on the materials that are within the validated property range and type.
5.5 This practice provides the user of a process stream analyzer system with useful information from on-going quality control charts to monitor the variation in Δ over time, and trigger update of correlation relationship between the analyzer system and primary test method in a timely manner.
5.6 Validation information obtained in the application of this practice is applicable only to the material type and property range of the materials used to perform the validation. Selection of the property levels and the compositional characteristics of the samples must be suitable for the application of the analyzer system. This practice allows the user to write a comprehensive validation statement for the analyzer system including specific limits for the validated range of application. ...
SCOPE
1.1 This practice describes procedures and methodologies based on the statistical principles of Practice D6708 to validate whether the degree of agreement between the results produced by a total analyzer system (or its subsystem), versus the results produced by an independent test method that purports to measure the same property, meets user-specified requirements. This is a performance-based validation, to be conducted using a set of materials that are not used a priori in the development of any correlation between the two measurement systems under investigation. A result from the independent test method is herein referred to as a Primary Test Method Result (PTMR).
1.2 This practice assumes any correlation necessary to mitigate systemic biases between the analyzer system and PTM have been applied to the analyzer results. See Guide D7235 for procedures for establishing such correlations.
1.3 This practice requires that both the primary method against which the analyzer is compared to, and the analyzer system under investigation, are in statistical control. Practices described in Practice D6299 should be used to ensure this condition is met.
1.4 This practice applies if the process stream analyzer system and the primary test method are based on the same measurement principle(s), or, if the process stream analyzer system uses a direct and well-understood measurement principle that is similar to the measurement principle of the primary test method. This practice also applies if the process stream analyzer system uses a different measurement technology from the primary test method, provided that the calibration protocol for the direct output of the analyzer does not require use of the PTMRs (see Case 1 in Note 1).
1.5 This practice does not apply if the process stream analyzer system utilizes an indirect or mathematically modeled measurement principle such as chemometric or multivariate analysis techniques where...
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Designation: D3764 − 13
StandardPractice for
Validation of the Performance of Process Stream Analyzer
1
Systems
This standard is issued under the fixed designation D3764; 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.
INTRODUCTION
Operation of a process stream analyzer system typically involves four sequential activities.
(1) Analyzer Calibration —When an analyzer is initially installed, or after major maintenance has
been performed, diagnostic testing is performed to demonstrate that the analyzer meets the
manufacturer’sspecificationsandhistoricalperformancestandards.Thesediagnostictestsmayrequire
that the analyzer be adjusted so as to provide predetermined output levels for certain reference
materials. (2) Correlation—Once the diagnostic testing is completed, process stream samples are
analyzed using the analyzer system. For application where the process analyzer system results are
required to agree with results produced from an independent (primary) test method (PTM), a
mathematical function is derived that relates the analyzer results to the primary test method results
(PTMR). The application of this mathematical function to an analyzer result produces a predicted
primary test method result (PPTMR). (3) Probationary Validation—After the correlation relation-
shipbetweentheanalyzerresultsandprimarytestmethodresultshasbeenestablished,aprobationary
validation is performed using an independent but limited set of materials that were not part of the
correlation activity. This probationary validation is intended to demonstrate that the PPTMRs agree
with the PTMRs to within user-specified requirements for the analyzer system application. (4)
General and Continual Validation—After an adequate amount of PPTMRs and PTMRs have been
accrued on materials that were not part of the correlation activity, a comprehensive statistical
assessment is performed to demonstrate that the PPTMRs agree with the PTMRs to within the
tolerances established from the correlation activities. Subsequent to a successful general validation,
qualityassurancecontrolchartmonitoringofthedifferencesbetweenPPTMRandPTMRisconducted
duringnormaloperationoftheprocessanalyzersystemtodemonstratethattheagreementbetweenthe
PPTMRsandPTMRsestablishedintheGeneralValidationismaintained.Thispracticedealswiththe
third and fourth of these activities.
1. Scope* ofanycorrelationbetweenthetwomeasurementsystemsunder
investigation. A result from the independent test method is
1.1 This practice describes procedures and methodologies
herein referred to as a Primary Test Method Result (PTMR).
basedonthestatisticalprinciplesofPracticeD6708tovalidate
whether the degree of agreement between the results produced
1.2 This practice assumes any correlation necessary to
byatotalanalyzersystem(oritssubsystem),versustheresults
mitigatesystemicbiasesbetweentheanalyzersystemandPTM
produced by an independent test method that purports to
havebeenappliedtotheanalyzerresults.SeeGuideD7235for
measure the same property, meets user-specified requirements.
procedures for establishing such correlations.
This is a performance-based validation, to be conducted using
a set of materials that are not used a priori in the development 1.3 This practice requires that both the primary method
against which the analyzer is compared to, and the analyzer
system under investigation, are in statistical control. Practices
1
This practice is under the jurisdiction ofASTM Committee D02 on Petroleum
described in Practice D6299 should be used to ensure this
Products, Liquid Fuels, and Lubricants and is the direct responsibility of Subcom-
condition is met.
mittee D02.25 on Performance Assessment and Validation of Process Stream
Analyzer Systems.
1.4 This practice applies if the process stream analyzer
Current edition approved May 1, 2013. Published June 2013. Originally
system and the primary test method are based on the same
approved in 1980. Last previous edition approved in 2009 as D3764–09. DOI:
10.1520/D3764-13. measurement principle(s), or, if the process stream analyzer
*A Summary of Changes section appears at the end of this standard
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
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D3764 − 13
system uses a direct and well-understood measurement prin- 1.9 The line sample procedure is limited to applications
ciplethatissimilartothemeasurementprincipleoftheprimary where material can be safely withdrawn from the sampling
point of the analyzer unit without significantly alterin
...
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: D3764 − 09 D3764 − 13
Standard Practice for
Validation of the Performance of Process Stream Analyzer
1
Systems
This standard is issued under the fixed designation D3764; 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.
INTRODUCTION
Operation of a process stream analyzer system typically involves four sequential activities.
(1) Analyzer Calibration —When an analyzer is initially installed, or after major maintenance has
been performed, diagnostic testing is performed to demonstrate that the analyzer meets the
manufacturer’s specifications and historical performance standards. These diagnostic tests may require
that the analyzer be adjusted so as to provide predetermined output levels for certain reference
materials. (2) Correlation—Once the diagnostic testing is completed, process stream samples are
analyzed using the analyzer system. For application where the process analyzer system results are
required to agree with results produced from an independent (primary) test method (PTM), a
mathematical function is derived that relates the analyzer results to the primary test method results
(PTMR). The application of this mathematical function to an analyzer result produces a predicted
primary test method result (PPTMR). (3) Probationary Validation—After the correlation relation-
ship between the analyzer results and primary test method results has been established, a probationary
validation is performed using an independent but limited set of materials that were not part of the
correlation activity. This probationary validation is intended to demonstrate that the PPTMRs agree
with the PTMRs to within user-specified requirements for the analyzer system application. (4)
General and Continual Validation—After an adequate amount of PPTMRs and PTMRs have been
accrued on materials that were not part of the correlation activity, a comprehensive statistical
assessment is performed to demonstrate that the PPTMRs agree with the PTMRs to within the
tolerances established from the correlation activities. Subsequent to a successful general validation,
quality assurance control chart monitoring of the differences between PPTMR and PTMR is conducted
during normal operation of the process analyzer system to demonstrate that the agreement between the
PPTMRs and PTMRs established in the General Validation is maintained. This practice deals with the
third and fourth of these activities.
1. Scope Scope*
1.1 This practice describes procedures and methodologies based on the statistical principles of Practice D6708 to validate
whether the degree of agreement between the results produced by a total analyzer system (or its subsystem), versus the results
produced by an independent test method that purports to measure the same property, meets user-specified requirements. This is a
performance-based validation, to be conducted using a set of materials that are not used a priori in the development of any
correlation between the two measurement systems under investigation. A result from the independent test method is herein referred
to as a Primary Test Method Result (PTMR).
1.2 This practice assumes any correlation necessary to mitigate systemic biases between the analyzer system and PTM have
been applied to the analyzer results. See Guide D7235 for procedures for establishing such correlations.
1.3 This practice requires that both the primary method against which the analyzer is compared to, and the analyzer system
under investigation, are in statistical control. Practices described in Practice D6299 should be used to ensure this condition is met.
1
This practice is under the jurisdiction of ASTM Committee D02 on Petroleum Products and Lubricants and is the direct responsibility of Subcommittee D02.25 on
Performance Assessment and Validation of Process Stream Analyzer Systems.
Current edition approved June 1, 2009May 1, 2013. Published July 2009June 2013. Originally approved in 1980. Last previous edition approved in 20062009 as
ε1
D3764D3764 – 09.–06 . DOI: 10.1520/D3764-09.10.1520/D3764-13.
*A Summary of Changes section appears at the end of this standard
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
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D3764 − 13
1.4 This
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