GLOSSARY OF TERMS -
LABORATORY QUALITY ASSURANCE (QA) AND
QUALITY CONTROL (QC) SYSTEM
1. |
Accreditation |
Formal
recognition of the competence of a body or an organization for a well-defined
purpose. It is the procedure by which a laboratory is assessed to perform a
specific range of test or measurements
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2.
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Accuracy
|
The closeness of agreement
between the "true" value and the measured value. The smaller the
systematic error of the analysis is, the more accurate is the analytical
procedure. It is assessed by means of reference samples and percent
recoveries
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3.
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Audit
Sample
|
Prepared reference
sample inserted into the sample processing procedure as close to the
beginning as possible.
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4.
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Background
Sample
|
A sample taken
from a location on or proximate to the site of interest and used to document
baseline or historical information
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5.
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Bias
|
Systematic error,
consistent deviation of measured values from the true value.
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6.
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Calibration
|
In chemical
measurement, Calibration refers to the process by which the response of a
measurement system is related to the concentration or the amount analyte of
interest
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7.
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Calibration
Laboratory
|
Laboratory that
performs calibration.
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8.
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Calibration
Method
|
Defined technical
procedure for performing a calibration.
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9.
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Calibration
Standards
|
A series of known standard solutions used by
the analyst for calibration of instrument (i.e. preparation of the analytical
curve).
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10.
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Certified
Reference Material (CRM)
|
A certified
reference material is a material or substance whose property or properties
can be defined so exactly that it may be used for the calibration of
measuring instruments, the check of results obtained from measuring, testing
and analytical processes, and for the characterization of substance
properties.
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11.
|
Chain
of Custody (COC)
|
Documentation of
the history of the sample. The components of chain of custody are sample seals;
log book, record and sample analysis request sheet and the procedures used
for estimation.
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12.
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Confidence
Interval
|
Set of possible
values within which the true value will lie with a specified level of
probability.
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13.
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Confidence
Limit
|
One of the
boundary values defining the confidence interval
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14.
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Contamination
|
Something
inadvertently added to the sample during the sampling or analytical process.
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15.
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Control
|
Type of sample
against which the results of a procedure are judged.
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16.
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Conventional
true value
|
Value attributed
to a particular quantity and accepted, sometimes by convention, as having an
uncertainty appropriate for a given purpose
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17.
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Data
Quality Objectives (DQOs)
|
Statements on the
level of uncertainty that a decision-maker is willing to accept in the results
derived from environmental data.
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18.
|
Environmental
sample
|
An environmental
sample or field sample is a representative sample of any material (aqueous,
no aqueous or multimedia) collected from any source for which determination
of composition of contamination is requested or required.
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19.
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Error
|
Difference
between a measured value and the true value.
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20.
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Good
Laboratory Practice(GLP)
|
Good laboratory
Practice(GLP) is concerned with the organizational process and the conditions
under which laboratory studies are planned, monitored, recorded and reported
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21.
|
Gross
error
|
Which makes it necessary to begin a new
analysis (Ex. using a wrong reagent, taking a wrong pipette, measuring at a
wrong wavelength. instrument breakdown, heavily contaminated glassware etc.).
These errors should easily be recognized.
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22.
|
Instrumentation
Detection Limit
|
The concentration
equivalent to a signal due to the analyte which is equal to three times the
standard deviation of a series of 7 replicate measurements of a reagent
blank’s signal at the same wave length
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23.
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Inter
Laboratory Precision
|
(Reproducibility)
Variation associated with two or more laboratories or organizations using the
same measurement method.
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24.
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Inter
Laboratory Test
|
A series of
measurements of one or more quantities performed independently by a number of
laboratories on samples of a given material (other terms: Round robin test,
Collaborative trial, Collaborative reference program, Collaborative
analytical study, ring test).
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25.
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Interferences
|
Compounds whose
presence obscures the measurement of the analyte of interest by the
introduction of an unrelated analytical signal where the analyte is measured.
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26.
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Internal
Quality Control
|
Internal quality
control encompasses all measures, which are planned, ordered and executed by
a laboratory itself.
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27.
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Intra-laboratory
Precision
|
(Repeatability)
Variation associated with a single laboratory or organization.
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28.
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Limit
of detection (LOD)
|
The LOD of an
individual analytical procedure is the lowest analytical amount of an analyte
in a sample, which can be detected but not necessarily quantified as an exact
value. For many purposes, the LOD is arbitrarily taken to be 3sb
or 3 x the standard deviation of the blank value or of background
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29.
|
Limit
of determination
|
The lower level
where measurements become arbitrarily meaningful and is defined arbitrarily
as LOQ-10sb (10 x the standard deviation of the blank value or of
background) At this concentration, the relative confidence in the measured
value is ±
30% at the 95% confidence level.
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30.
|
Limit
of Quantitation (LOQ)
|
The constituent
concentration that produces a signal sufficiently greater than it can be
detected within specified limits by good laboratories during routine
operating conditions. Typically it is the concentration that produces a
signal time 10s above the reagent water blank signal.
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31.
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Matrix
|
The matrix of a
material is the totality of all parts of a material and their chemical and
physical properties including mutual influences.
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32.
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Matrix
/Spike Duplicate Analysis
|
In matrix/spike
duplicate analysis, predetermined quantities of stock solutions of certain
analytes are added to a sample matrix prior to sample extraction/digestion
and analysis. Samples are split into duplicates, spiked and analyzed. Percent
recoveries are calculated for each of the analytes detected. The relative
percent difference between the samples is calculated and used to assess
analytical precision. The concentration of the spike should be at the
regulatory standard level or the estimated or actual method quantification
limit. When the concentration of the analyte in the sample is greater than
0.1% no spike of the analyte is necessary.
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33.
|
Method
Detection Limit (MDL)
|
The minimum
concentration of a substance that can be measured and reported with 99 %
confidence that the analyte concentration is greater than zero. The MDL is determined from analysis of a
sample in given matrix containing analyte which has processed through the
pre-operative procedure
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34.
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Method
Quantification Limit (MQL)
|
The Method
Quantification Limit is the minimum concentration of a substance that can be
measured and reported.
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35.
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Optimum
Concentration Range
|
A range defined
by limits expressed in concentration, below which scale must be used and
above which curve correction should be considered. This range varies with the sensitivity of
the instrument and the operating conditions employed.
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36.
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Outlier
data
|
The data, which
are suspected to be extremely low or high from the expected value or mean.
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37.
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Precision
|
The closeness of
agreement between the results obtained by applying the experimental procedure
several times under prescribed conditions. (The smaller the random part of
the experimental errors, which affect the results, the more precise is the
procedure). Within run and between day precisions have to be considered. (See
repeatability and reproducibility)
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38.
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Proficiency
Testing
|
Determination of
the laboratory calibration or testing performance by means of
inter-laboratory comparisons.
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39.
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Protocol
|
Thorough written
description of the detailed steps and procedures involved in the collection
of samples.
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40.
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Quality
Assessment
|
Procedure for
determining the quality of laboratory measurements by use of data from
internal and external quality control measures.
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41.
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Quality
assurance
|
All those planned
and systematic actions necessary to provide adequate confidence that a
product or a service will satisfy given requirements for quality
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42.
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Quality
Assurance Programme Plan (QAPP)
|
An orderly
assemblage of management policies, objectives, principles and general
procedures by which an organization involved in environmental data generation
activities outlines how to produce data of known quality.
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43.
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Quality
Assurance Project Plan (QAPP)
|
An orderly
assemblage of detailed procedures designed to produce data of sufficient
quality to meet the DQOs for a specific data collection activity.
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44.
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Quality
Characteristic
|
The
characteristics and characteristic values (or expressions) of something (e.g.
a method, a piece of equipment, a measurement result etc.) in relation to
their suitability to fulfill set requirements.
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45.
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Quality
Control
|
Set of measures
within a sample analysis methodology to assure that the process is in
control.
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46.
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Quality
Control Charts
|
A Quality control chart is a sequential
plot of some quality characteristic. It may be a day-by –day measurement of
any interest of analyte (e.g. COD or BOD or Nitrate). The Chart consists of
central line and two pairs of limit lines, the Upper and Lower Warning Limits
(UWL, LWL )and Upper and Lower Control Limits (UCL., LCL) Example : Shewart’s Quality Control Chart
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47.
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Quality
Manual
|
A document
stating the quality policy, quality system and quality practices of an
organization.
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48.
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Quality
System
|
The
organizational structure, responsibilities, procedures, processes and
resources for implementing quality management.
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49.
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Random
Errors
|
Random errors are
indicated by the scatter of the results of repeated measurements on the
aliquot of same sample about the mean value.
The sign and magnitude of the error of any particular result varies at
random and cannot be known exactly. Random errors arise from uncontrolled
variations in the conditions of the analytical system (factors like analyst,
equipment, instrument, method, quality of glassware and chemicals, reagents
etc.,) during different analysis.
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50.
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Range
|
Spread of values
calculated by subtracting the lowest value from the highest value
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51.
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Reagent
Blank
|
A reagent blank
is an aliquot of analyte –free water or solvent analysed with the analytical
batch.
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52.
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Reference
material
|
A material or
substance one or more of whose property value are sufficiently homogeneous
and well established to be used for the calibration of an apparatus, the
assessment of a measurement method, or for assigning value to materials
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53.
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Reference
Standard
|
A standard,
generally of the highest meteorological quality available at a given
location, from which measurements made at that location, is derived.
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54.
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Relative
Standard Deviation (RSD)
|
Estimate of the
average error in the measurement due to unassignable causes and usually
expressed as a percentage of the average sample concentration.
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55.
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Repeatability
|
The closeness of
agreement between successive results obtained with the same method on
identical test material under the same condition. (Same operator, same
apparatus, same laboratory and short intervals of time) can also be
interpretable as within – run precision.
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56.
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Replicate
Sample
|
A replicate
sample is a sample prepared by dividing a sample into two or more separate
aliquots. Duplicate sample is considered to be two replicates.
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57.
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Reproducibility
|
The closeness of
agreement between individual results obtained with the same method and on
identical material but under different test conditions (different operator,
different time’s etc.) Can also be interpreted as "Between-run
precision".
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58.
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Sample
Holding Time
|
The storage time allowed between sample
collection and sample analysis when the designated preservation and storage
techniques are employed.
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59.
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Sampling
|
Attempt to choose
and extract a representative portion of a physical system from it’s surroundings.
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60.
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Sensitivity
|
Sensitivity
describes the ability of an experimental method to differentiate between
related values (e.g. concentrations).
It indicates to which degree value changes depending upon the signal
of the measuring system and can be quantified using the slope of the
calibration curve.
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61.
|
Standard
Curve
|
A standard curve
is a curve, which plots concentrations of known analyte standard versus the
instrument response to the analyte.
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62.
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Standard
Deviation
|
Square root of
the variance (statistical analysis).
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63.
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Standard
Methods
|
A standard method
is an acknowledged analytical method according to an international or
national standard or guidelines or to a given legal statue.
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64.
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Standard
Operating procedure (SOP)
|
Standard
Operating procedure (SOP) means written procedure, which describes how those
routine laboratory operations, are to be performed.
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65.
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Stratified
Random Sampling
|
Sampling
technique in which estimates of strata means are combined to yield estimates
of the population mean.
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66.
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System
Blank
|
(Instrument
Blank): Measure of the instrument background or baseline response in the
absence of a sample.
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67.
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Systematic
Error
|
Systematic errors
are indicated by a unidirectional tendency of results, which could be greater
or smaller than the true value. When systematic error is present, the result
are said to be biased (bias = systematic error) Systematic errors in
analytical results may occur when: method
used is not specific for the analyte; due to presence of some interfering
substances; improper performing of the analysis, instability of samples
between sample collection and analysis.
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68.
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Test
|
A technical
operation that consists of the determination of one or more characteristics
or performance of a given product, material equipment organism, physical
phenomenon, process or service according to a specified procedure.
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69.
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Test
Method
|
Defined technical
procedure for performing a test
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70.
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Traceability
|
The property of a
result of a measurement whereby it can be related to appropriate standards,
generally international or national standards, through an unbroken chain of
comparisons.
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71.
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True
value
|
Real amount or
concentration of an analyte in a certain sample. It is an ideal value, which
could be arrived at only if all causes of measurement error were eliminated.
The amount or concentration given for an analyte in a certified reference
material is a good substitute for the true value.
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72.
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Trueness
|
The closeness of
agreement between the average value obtained from a large series of test
results and an accepted reference value
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73.
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Uncertainty
of measurement
|
Parameter,
associated with the result of a measurement, that characterizes the
dispersion of the values that could reasonably be attributed to the measurand
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74.
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Validation
|
Validation is the
total testing procedure if an analytical method is free of random and
systematic error, not only within calibration but also and especially frees
of interference when analyzing real samples.
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75.
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Variance
|
Measure of the
variability in a population / set of analytical data. It is the square root of the standard
deviation
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