ASTM D3764-06
(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
SCOPE
1.1 This practice describes procedures and methodologies based on the statistical principles of Practice D 6708 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.
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 D 6299 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 PTMRs are required for the chemometric or multivariate model development. Users should refer to Practice D 6122 for detailed validation procedures for these types of analyzer systems (see Case 2 in ).Note 0
For example, for the measurement of benzene in spark ignition fuels, comparison of a Mid-Infrared process analyzer system based on Test Method D 6277 to a Test Method D 3606 gas chromatography primary test method would be considered Case 1, and this practice would apply. For each sample, the Mid-Infrared spectrum is converted into a single analyzer result using methodology (Test Method D 6277) that is independent of the primary test method (Test Method D 3606). However, when the same analyzer uses a multivariate model to correlate the measured Mid-Infrared spectrum to Test Method D 3606 reference values using the methodology of Practice E 1655, it is considered Case 2 and Practice D 6122 applies. In this case 2 example, the direct output of the analyzer is the spectrum, and the conversion of this multivariate output to an analyzer result require use of Practice D 6122, hence it is not independent of the primary test method.
1.6 Performance Validation is conducted by calculating the precision and bias of the differences between results from the analyzer system (or subsystem) after the application of any necessary correlation, (such results are herein referred to as Predicted Primary Test Method Results (PPTMRs)), versus the PTMRs for the same sample set. Results used in the calculation are for samples that are not used in the development of the correlation. The calculated precision and bias are statistically compared to user-specified requirements for the analyzer system application.
1.6.1 For analyzers used in product release or product quality certification applications, the precision and bias requirement for the degree of agreement are typically based on the site or published precision of the Primary Test Method.Note 2
In most applications of this type, the PTM is the specification-cited test method.
1.6.2 This practice does not describe procedures for e...
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An American National Standard
Designation:D3764–06
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.Anumber in parentheses indicates the year of last reapproval.A
superscript epsilon (e) 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) Gen-
eral 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 investigation. A result from the independent test method is
herein referred to as a Primary Test Method Result (PTMR).
1.1 This practice describes procedures and methodologies
1.2 This practice assumes any correlation necessary to
basedonthestatisticalprinciplesofPracticeD6708tovalidate
mitigatesystemicbiasesbetweentheanalyzersystemandPTM
whether the degree of agreement between the results produced
have been applied to the analyzer results.
byatotalanalyzersystem(oritssubsystem),versustheresults
1.3 This practice requires that both the primary method
produced by an independent test method that purports to
against which the analyzer is compared to, and the analyzer
measure the same property, meets user-specified requirements.
system under investigation, are in statistical control. Practices
This is a performance-based validation, to be conducted using
described in Practice D6299 should be used to ensure this
a set of materials that are not used a priori in the development
condition is met.
ofanycorrelationbetweenthetwomeasurementsystemsunder
1.4 This practice applies if the process stream analyzer
system and the primary test method are based on the same
1
This practice is under the jurisdiction ofASTM Committee D02 on Petroleum measurement principle(s), or, if the process stream analyzer
ProductsandLubricantsandisthedirectresponsibilityofSubcommitteeD02.25on
system uses a direct and well-understood measurement prin-
Validation of Process Analyzers.
ciplethatissimilartothemeasurementprincipleoftheprimary
Current edition approved July 1, 2006. Published August 2006. Originally
test method. This practice also applies if the process stream
approved in 1980. Last previous edition approved in 2001 as D3764–01.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
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D3764–06
analyzersystemusesadifferentmeasurementtechnologyfrom 1.10 Validation information obtained in the application of
the primary test method, provided that the calibration protocol this practice is applicable only to the type and property range
for the direct output of the analyzer does not requ
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