Practical estimation of the uncertainty of analytical measurement standards. Procedure for estimation and reporting of uncertainty due. This procedure describes the process for the estimation of measurement uncertainty mu. However, a consensus was not apparent on the method to be used. The combining calculation yields the estimated combined standard measurement uncertainty for the whole procedure u c. Additional uncertainty information regarding higher order elements of the calibration hierarchy for a given measurement procedure should be available from the manufacturer, and should be accounted for in the medical laboratory. Quantifying uncertainty in analytical measurement eurachem. Every measured result reported by a laboratory should be accompanied by an explicit uncertainty estimate. Practical estimation of the uncertainty of analytical measurement standards ruud j. The gum describes a bottomup approach to estimating mu, by which an uncertainty budget for a given measurement procedure is assembled by identifying all potential sources of uncertainty e. The basics of calibration procedure and estimation of. Guidance document on measurement uncertainty for gmo. Applicable for use in testing and calibration laboratories.
Expression of the measurement uncertainty 3 was first produced in july 1995 with an aim to harmonize the procedure for expressing measurement uncertainty. The document has been well written and widely accepted. In metrology, measurement uncertainty is the expression of the statistical dispersion of the values attributed to a measured quantity. The approach was applied to the estimation of measurement uncertainty for the quantitative determination of ketamine k and norketamine nk at a 100 ngml threshold concentration in urine. The gum method employs two types of uncertainty estimates. Where necessary for the interpretation of the test results, the. This calibration procedure has been tested on a measurement system with the gom sensor, which served as a tool of measurement after calibration. Guide to the expression of uncertainty in measurement gum to estimate the uncertainties in the measurement of absorbed dose in radiation processing. So just what is the estimation of uncertainty of measurement. The main steps of a measurement analysis procedure are presented on the example of pesticide measurement are presented. Since more than one type of pdf likely contributed to the combined uncertainty, the type of pdf used cannot be stated. The hierarchy of total study uncertainty is presented in appendix b. These procedures apply to regulatory testing carried out by.
Estimation of the measurement uncertainty in the anisotropy. However, it only covers guided examples in the field of calibration and physical measurements. The relevant uncertainty components are those associated with the actual measurement process, commencing with the presentation of the sample to the measurement procedure and ending with the output of the measured value. Fortunately, clinical biochemistry measurement methods employ quality control qc materials to estimate and monitor whole procedure imprecision, so qc data. Type a uncertainty uses a statistical method of valuation, such as standard deviation. Simple guide for evaluating and expressing the uncertainty of.
In this paper, a novel kriging modelsbased calibration and uncertainty estimation method is developed to improve the measurement accuracy of noncontact 3d cmss. Definitions and abbreviations measurement uncertainty. Estimation of uncertainty of measurement effective date. Making the right decision on whether or not some measurement procedure is adequate for a stated use validation, as well as a realistic estimation of measurement uncertainty, is only possible when a measurement process is well known. G104 a2la guide for estimation of measurement uncertainty in testing g106 guidance on scopes of accreditation for telecommunication certification bodies g108 guidelines for estimating uncertainty for microbiological counting methods. According to isoiec 17025, a laboratory shall have and shall apply procedures for estimating uncertainty of measurement. A focus on traceability and stringent evaluation of uncertainty of measurement results may increase the pressure on manufacturers of measurement procedures to standardize their calibrators. Measurement uncertainty is a quantitative indication of the quality of. Methods for evaluation of measurement uncertainty intechopen. These steps are adopted from 1, which includes a summarized version of the bipm gum. The parameter may be, for example, a standard deviation or a given.
The bipm then convened a meeting for the purpose of arriving at a. Calibration and measurement uncertainty estimation of. In the process of a measurement, it is necessary to consider variations of measured data. The quality of the measurement result, its accuracy, is characterized by measurement uncertainty or simply uncertainty, which defines an interval around the measured value c measured, where the true value c true lies with some probability. The contribution of the uncertainty derived from the calibrated thermometer ranged between 0. The expanded uncertainty of the measurement u k 2 varied with the temperature and humidity condition and ranged between 0. In certain cases the nature of the test method may preclude rigorous. Zel this guidance document has been elaborated on request of the european network of gmo laboratories engl to further harmonise the estimation of measurement uncertainty of realtime pcr. Method validation and measurement uncertainty biochemia. Learn how to calculate measurement uncertainty using my exclusive 7 easy. By international agreement, this uncertainty has a probabilistic basis and.
A simple example is the estimation of the concentration of glucose c by weighing it w into a known volume of water v. Method validation is a set of procedures which confirms if an analytical procedure is in conformity for its intended use. The estimation and use of measurement uncertainty for a. Among several parameters, the estimate of uncertainty plays an important role in method validation.
This calibration procedure has been tested on a measurement system with the gom sensor, which served as. Procedure for estimation and reporting of uncertainty due to. To estimate uncertainty, you will want to break down the equation and. A less metrologically rigorous process than that which can be followed for calibration can also often be used. Practical estimation of the uncertainty of analytical. Equations 1,2 are to be used when integral quantities, e. Simple guide for evaluating and expressing the uncertainty. Measurement uncertainties may be calculated using quantity values obtained by the measurement of quality control. A practical way to isogum measurement uncertainty for.
Guide to expression of uncertainty in measurement approach. Laboratory measurements always involve uncertainty, which must be considered when analytical results are used as part of a basis for making decisions. Guide to the expression of uncertainty in measurement. Policy and procedure for estimation of measurements. The value of the uncertainty associated with the measurement system ranged between 0. The aim of the guide to expression of uncertainty in measurement gum is to harmonize the different practices for estimating and reporting uncertainty of measurement. The complexity involved in estimation of uncertainty of measurement in the case of. Estimation of uncertainty of measurement procedure iso 17025. Sometimes, and particularly in complex measurement procedures, we do not have access to or we are not able to estimate the variation from repeated experiments, which is a prerequisite for the estimation of the sd.
Each tier of the analytical process increases the total study uncertainty. A i is the area of the i th cell, and n is the total number of cells used for the computations. Measurement uncertainty quality procedure measurement uncertainty page 1 of 14 approved by the state toxicologist effective date. Uncertainty in measurement introduction and examples from. A proper evaluation of uncertainty is good professional testing body practice and can provide laboratories and customers with valuable information about the quality and reliability of the result. Uncertainty is an unpreventable part of any measurement, and it begins to matter when results are close to a specified limit. The estimation and use of measurement uncertainty for a drug substance test procedure validated according to usp m. The nature of the test method may preclude a rigorous, metrologically and statistically valid calculation of measurement uncer. The complexity involved in estimation of uncertainty of measurement in the case of testing varies considerably from one test field to another and also within one field itself. Metrological traceability and measurement uncertainty are key factors to be considered in the evaluation of measurement data.
Its goodness is characterized in terms of random and systematic errors that affect the measurements. Method validation and measurement uncertainty biochemia medica. The results of the measurement and uncertainty analysis should be reported in terms of the uncertainty interval and the confidence level. Guidance document on measurement uncertainty for gmo testing. Uncertainty in measurement introduction and examples. It is stressed that the measurement procedure must correspond to measurand definition. Jane weitzel 1 accreditation and quality assurance volume 17, pages 9 146 2012 cite this article. In ordinary use, the word uncertainty does not inspire confidence. Clearly, if an observed global variable is used, it is then appropriate to use also an average global cell size. Guidelines for estimation and expression of uncertainty in. Apr 05, 2001 estimation of the uncertainty in measurement, type b. Oct, 2011 the estimation and use of measurement uncertainty for a drug substance test procedure validated according to usp m. The degree of rigour needed in an estimation of uncertainty may differ between testing and calibration laboratories and in some cases the nature of the test method may preclude rigorous, metrologically and. For field variables, the local cell size can be used.
It is a parameter, associated with the result of a measurement e. Where uncertainty calculations are applicable, it is required that testing and calibration laboratories calculate measurement uncertainty in accordance with the iso guidance for the use of repeatability, reproducibility and trueness estimates in measurement uncertainty estimation iso 21748. Guidance document on measurement uncertainty for gmo testing laboratories s. Original estimation and reporting of measurement uncertainty the laboratory employs policies and procedures for the estimation of. The measurement uncertainty u itself is the halfwidth of that interval and is always nonnegative. Estimation of the uncertainty in measurement, type b. In this contribution, we outline the estimation of measurement uncertainty of analytical assays in a practical way, according to the socalled reconciliation paradigm, by considering the heritance of uncertainties according to the iso guide to the expression of uncertainty in measurement isogum approach and the accuracy bias and precision study coming from the inhouse method validation.
Although there are clear advantages in having a common approach for evaluating uncertainty, application of the gum approach to chemistry measurements is not straightforward. The estimation and use of measurement uncertainty for a drug. Estimation of the measurement uncertainty in quantitative. The degree of rigour needed in an estimation of uncertainty may differ between testing and calibration laboratories and in some cases the nature of the test method may preclude rigorous, metrologically and statistically valid calculation of measurement uncertainty. Mar 29, 2019 expression of the measurement uncertainty 3 was first produced in july 1995 with an aim to harmonize the procedure for expressing measurement uncertainty.
Calibration and uncertainty estimation of noncontact. Iso 17025 accreditationquality management systems panel. All measurements are subject to uncertainty and a measurement result is complete only when it is accompanied by a statement of the associated uncertainty, such as the standard deviation. The gum is a procedure based on statistical analysis and experimental observation of the measured values. The uncertainty of measurement is a doubt about the result of any measurement, expressing its quality 1. Estimation of uncertainty of measurement laboratory quality. The measurement uncertainty is a combination of the uncertainty derived from the sampling strategy, field sample collection, and laboratory preparation and testing.
Nov 01, 2003 it is no law of nature that different measurement procedures in clinical chemistry should differ systematically by 20%, 50%, or even more. In estimation of the measurement uncertainty, all uncertainty components in a given situation shall be taken into account as foreseen by appropriate analysis. Requirements for the estimation of measurement uncertainty xi measurement uncertainty u parameter, associated with the result of a measurement, that characterises the dispersion of the values that could reasonably be attributed to the measurand. Iso 15195 2 and iso guide 34 3 have similar requirements for reference measurement laboratories and reference material producers. In this step, the measurement procedure should be modeled in order to have a. In addition to uncertainty due to calibration, sample analysis was. This sop describes detailed procedure for estimating measurement of uncertainty mou associated with any measurement activity. However, when used in a technical sense it carries a specific meaning. Evaluation of measurement uncertainty in testing laboratories.
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