Results and discussionThe step-by-s

Results and discussion
The step-by-step protocol used is illustrated in Fig.1.It
combines conventional tasks usually performed by testing
laboratories with approaches (highlighted boxes in the
figure) aimed at improving and harmonizing the internal
quality process. In box 1a in Fig.1, external requisites (if
available) are preferable in order to fix acceptability limits(i.e., ELIMand RSDiLIM; see Appendix 1). In box 2, the
accuracy (trueness and precision) respect to selected refer-ence value (i.e.,μCRM±uCRM; see Appendix 1) is always
considered a fit-for-purpose feature. In box 3, intermediate
accuracy estimates (i.e., those obtained under intermediate
precision conditions: Eand RSDi; see Appendix 1) are
estimated. The run concept (i.e., various factors such as
days/analysts/instruments that vary between validation
sessions; at least equivalent to those expected during the
working sessions at the routine analysis stage) must be
defined. Relatively short (prevalidation) or large (valida-tion) XNr×Ns experimental designs (see Appendix 1) are
possible. In the second case, outlier detection/elimination
schemes, preferably those using widely accepted criteria
(e.g.,z-score approach; see Appendix1) are recommended.
In box 4, massive (say 10
4
) simulated validations (i.e.,
Monte Carlo simulations that generate newXNr×Nsdata)
that are consistent with the experimental E, RSDrand
RSDrunestimates (see Appendix 1) enable uncertainty
intervals to be calculated and they verify that these intervals
are within the limits allowed (i.e., |E±U(E)|

Kết quả (Việt) 1:

Results and discussionThe step-by-step protocol used is illustrated in Fig.1.Itcombines conventional tasks usually performed by testinglaboratories with approaches (highlighted boxes in thefigure) aimed at improving and harmonizing the internalquality process. In box 1a in Fig.1, external requisites (ifavailable) are preferable in order to fix acceptability limits(i.e., ELIMand RSDiLIM; see Appendix 1). In box 2, theaccuracy (trueness and precision) respect to selected refer-ence value (i.e.,μCRM±uCRM; see Appendix 1) is alwaysconsidered a fit-for-purpose feature. In box 3, intermediateaccuracy estimates (i.e., those obtained under intermediateprecision conditions: Eand RSDi; see Appendix 1) areestimated. The run concept (i.e., various factors such asdays/analysts/instruments that vary between validationsessions; at least equivalent to those expected during theworking sessions at the routine analysis stage) must bedefined. Relatively short (prevalidation) or large (valida-tion) XNr×Ns experimental designs (see Appendix 1) arepossible. In the second case, outlier detection/eliminationschemes, preferably those using widely accepted criteria(e.g.,z-score approach; see Appendix1) are recommended.In box 4, massive (say 104) simulated validations (i.e.,Monte Carlo simulations that generate newXNr×Nsdata)that are consistent with the experimental E, RSDrandRSDrunestimates (see Appendix 1) enable uncertaintyintervals to be calculated and they verify that these intervalsare within the limits allowed (i.e., |E±U(E)|<|ELIM| and[RSDi + U(RSDi)] IQC (e.g., Su, AL, WL) and uncertainty (e.g., U) statistics(see Appendix 1) can be harmonized with accuracyvalidation statistics (u-approach [14]). In box 6, it isrecommended that routine work that combines sampleanalysis (and uncertainty estimations, U) and IQC tasks(e.g., method verification and control charts) is performedin order to provide a virtually “ready-to-use/validate”method (at the very least, work should be performed overa short period in order to pre-examine the reliability of thecriteria used).To illustrate its practical application, validation andsample data obtained from a differential-pulse ASV methodthat is able to perform the simultaneous direct determina-tion of cadmium and lead (the “candidate method”)inmarine water samples were used. Since the method wasadapted from an application bulletin, it should be consid-ered an internalstandard operating procedure(SOP) whichrequires validation according to the ISO 17025 standard[12].