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International Journal Advanced Quality, Vol. 44, No. 3, 2016. year, Belgrade, Serbia.

PROLAB SOFTWARE FOR DATA EVALUATION OF


INTERLABORATORY STUDIES
UDC:004.388
Jelena M. Bebi 1, Luka S. Gaevi 1 , C. Blul 2
1 Laboratorija za referente materijale, Grupa za metrologiju u hemiji, Direkcija za
mere i dragocene metale, Mike Alasa 14, Beograd, Srbija; jelenabebic@dmdm.rs,
lukagazevic@dmdm.rs;
2 QuoData GmbH, Prellerstrae 14, Dresden, Saxony 01309, Germany;
blaeul@quodata.de
Paper received: 05.07.2016.; Paper accepted: 11.08.2016.

Abstract: Interlaboratory studies represent a form of external quality control for laboratories. International
standards that are used for interlaboratory comparisons, ISO 17043, ISO 13528, ISO 5725, define ways of
organisation of comparisons and data treatment of participating laboratories results. Intercomparison results can
be exploited, apart from the main goal for laboratory performance evaluation, also for method validation and
production of Certified Reference Materials. PROLab is a comprehensive, globaly accepted and standardized
software package for evaluating interlaboratory studies. It provides large data set structures, graphical and
computational methods for optimal use of the data. Directorate of Measures and Precious Metals has purchased and
installed software package PROLab Plus, licenced as the only one in the Republic of Serbia. As such, it will be
available to all interested organisers of interlaboratory comparisons, in our country.
Key Words: PROLab software, interlaboratory comparisons

1. INTRODUCTION The software helps run ISO 17043-based


proficiency testing schemes. Additionally, it allows
Measurement errors are a part of every you to evaluate your interlaboratory method validation
measurement. But errors must be predicted, described studies.
and controlled. One way of doing this is participating The software is designed to handle large numbers
in interlaboratory studies. There are several types of of participating laboratories as outline in the above
interlaboratory studies, such as: for testing the standards. Therefore, Directorate of Measures and
competence of individual laboratories (Proficiency Precious Metals has the capacity to analyze data sets
Testing), determination of the method precision from up to 300 laboratories. PROLab has the added
(Interlaboratory study for method validation, or benefit of producing customized reports from the
certification of Reference Materials. The purpose of interlaboratory comparisons.
interlaboratory comparisons is usually just one of the
above, but data can be used for many purposes [1]. 2. PROLAB SOFTWARE
International standards that are used for
organizing, for conducting of comparisons, and for PROLab is a software package specially conceived
data treatment are: ISO 17043, ISO 13528, ISO to achieve efficient performance of the various tasks
20612, ISO 5725:1-6, ISO Guide 35 for Reference arising in connection with interlaboratory studies,
materials [2-10]. from statistical analysis to professional data treatment.
Standard ISO 17043:2010 specifies general PROLab can be used for the certification of reference
requirements for the competence of the providers of materials, the validation of analytical methods and for
PT schemes as well as for the development and the assessment of laboratories. The generic term ring
implementation. test will be used to denote all three types of
PROLab is a software family for planning, interlaboratory studies.
organizing, performing and analyzing interlaboratory PROLab proves useful at every step of a ring test.
tests - that is, for both proficiency tests assessing the It provides tools which assist an operator with the
performance of laboratories (typically according to planning stage all the way to the performance of
ISO 13528) and collaborative studies for the homogeneity tests, automatic data input from
validation of analytical methods. It was created by the laboratories, statistical analysis and finally report
company QuoData GmbH, Germany, and it generation.
encompasses a family of software programs Several statistical methods are available in
(PROLab Smart for ISO 13528, PROLab Smart PROLab: DIN ISO 5725-2, DIN 38402 A42 (German
for ISO 5725-2, PROLab Standard, PROLab standard for method validation studies for water
Plus). Directorate of Measures and Precious Metals analysis), Swiss Food Manual, Q-Method/Median
has PROLab Plus, the most comprehensive of all (robust statistical method), Q-Method/Huber (robust
packages, and that program will be presented in this method for proficiency tests used e.g. by the German
paper. co-operation for water analysis LAWA), DIN 38402
A45 (robust Q-method and Hampel estimator), DIN
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International Journal Advanced Quality, Vol. 44, No. 3, 2016. year, Belgrade, Serbia.

ISO 13528/5725-5 (algorithm A+S), Nested Design All terms can be changed via the menu File
2x2 (ISO 5725-3/5), Nested Design (DIN ISO 5725- Settings in the tab Caption to fit your individual needs
3), (empirical) Horwitz function. better.
Different protocols for the assessment of The main menu is the starting point of every
laboratories are also included, such as the international evaluation using PROLab, and it opens as soon as
Harmonized Protocol of IUPAC, ISO and AOAC1, PROLab successfully starts. The main menu contains
DIN ISO 13528, DIN 38402, A45, CD ISO 20612 and eight modules, which can be selected using the
the LAWA2 protocol. common Windows techniques (mouse, arrow keys or
More specifically, the laboratories can be assessed input of the corresponding character):
by Z scores, Zu scores, Zeta scores, Z scores, En File
scores, Youden plots, RSZ (Rescaled Sum of Z Data
Scores), RLP (Relative Laboratory Performance), Homogeneity/stability
Percentage of successful measurements. Selection
PROLab allows flexible data input, whether Statistics
manually or through the import of digital files. The Charts and tables
easy-to-use data entry program RingDat is provided Window
and may be forwarded to the participating laboratories
Help
without extra charge. Additional information on the
laboratories and the methods can be entered into the One starts in the module File with the definition of
system, such as addresses, quantification and detection settings for PROLab itself and reports. That is
limits, sample preparation method and analytical followed by the description of the ring test, of the
method. samples and measurands that are to be examined and
A powerful data selection program assists the user evaluated, and of the encoding of laboratories and
in the evaluation and the presentation of results, samples. Once the results start coming in, they will
enabling application of data filters as convenient, to thus be able to be imported or entered manually. All
generate individual reports. Up to 19 selection patterns necessary functions for the latter procedure are located
per interlaboratory study can be saved. in the module Data.
All results are saved in the database. Comments If required, a test of the homogeneity of the
relating to participants, measurements and charts can samples in preparation for the ring test can be
be saved. conducted in the module Homogeneity/stability,
Numerous specialised chart-generating functions which also provides the necessary functions for any
are provided to assist in the presentation of results, stability tests to be conducted later on.
while a powerful report designer enables the The Selection module provides all relevant tools
generation of editable reports. Reports can be exported for the selection of samples, measurands and
into the formats PDF, RTF (Word), XLS (Excel), laboratories to be included in assessment and analysis
HTML, Text and CSV. Charts can be converted into procedures or in the presentation of results.
Bitmaps (BMP), Scalable Vector Graphics (SVG) and The evaluation, analysis and assessment
the Windows Meta File format (WMF). procedures are then carried out in the module
Statistics, while reports and charts in various layouts
can be generated and displayed in the module Charts
3. OVERVIEW OF PROLAB
and tables.
FUNCTIONALITIES Each step within this sequence affects subsequent
steps. All statistical results obtained at any stage will
PROLab uses throughout the program some
be directly stored in the database. Earlier results of the
specific or generic terms:
same ring test will be overwritten automatically. If
Ring test: this term refers to a method validation there are some modifications to implement (e.g. in the
study, a proficiency test or a certification of calculation of Z scores) it is not necessary to create a
reference material at the same time new test: changing the data at the earliest relevant step
Measurand: this term denotes what should be is sufficient.
evaluated (measured) by the laboratories
Laboratory: this term denotes a participant in the
4. WORKING AND EVALUATING IN
ring test
PROLAB
S.d.: is the abbreviation for standard deviation
Target s.d.: refers to the standard uncertainty for
In the FILE - SETTINGS - CAPTIONS, there is a
proficiency assessment (see ISO 13528)
table with the fundamental terms and their
abbreviations.

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International Journal Advanced Quality, Vol. 44, No. 3, 2016. year, Belgrade, Serbia.

Figure 1. Settings panel


It should be noted in particular the abbreviation s.d. is for standard deviation, and the use of the term target
standard deviation is to refer to the standard deviation for proficiency assessment.
The user can replace the first four terms (ring test, sample, measurand, and laboratory) with other terms. For
example, if user likes to use the term analyte instead of measurand, he should carry out the following
changes:

Figure 2. Changing captions


To define a new ring test under DATABASE - BASIC TABLES, the RING TESTS tab should be opened,
and a name for the ring test should be entered in the first row. (It is empty and marked with a star on the left.)

Figure 3. Basic tables


To import your data it is important that the relevant ring test is displayed in the long box under the main
menu bar (indicates ring test that is currently being worked with) and that it is in EDIT MODE.

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International Journal Advanced Quality, Vol. 44, No. 3, 2016. year, Belgrade, Serbia.

Figure 4. Selection of ring tests tables


In the DATABASE - IMPORT - STRUCTURE / RING TEST RESULTS, data can be imported by clicking
on OPEN FILE of via Copy & Paste (e.g. from Excel), and for each relevant column, choosing the correct header
from the list in the selection menu (in some cases, this assignation is carried out automatically).

Figure 5. Importing structure/ring test results


It may be simpler to import data for each sample-measurand combination separately. If this is the case,
indicate the sample and the measurand in the boxes on the right.

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International Journal Advanced Quality, Vol. 44, No. 3, 2016. year, Belgrade, Serbia.

Figure 6. Importing structure/ring test results


To define the mode of the assigned value and of the target s.d., use the menu item DATABASE -
CHARACTERISTICS OF MEASURANDS, tab called FORM.
For evaluation according to the ISO 13528 robust statistics:
Mode of assigned value: M Mean (Consensus value)
Target s.d. mode: S Reprod. s.d. (empirical)
For evaluation with a reference value and a predefined relative standard deviation:
Mode of assigned value: R Reference value
Target s.d. mode: L Limited (relative s.d.)
and type e.g. 10 in the "Rel s.d. min (%)" and "Rel s.d. max (%)" boxes to have a target s.d. of 10 % of the
assigned value

Figure 7. Evaluation according to the ISO 13528


To calculate mean and standard deviation, e.g. for evaluation according to ISO 13528, in the menu item
STATISTICS - RING TEST PARAMETERS select the desired statistical method on the right, and click on
COMPUTATION.

Figure 8. Computation of ring test parameters


Also, to calculate z scores go to STATISTICS - COMPUTATION OF SCORES AND TOLERANCE
LIMITS.

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International Journal Advanced Quality, Vol. 44, No. 3, 2016. year, Belgrade, Serbia.

Charts are generated in CHARTS AND TABLES - SUMMARY RESULTS. In the box labelled VIEW,
chart contents should be defined.

Figure 9. Summary results of measured values


In CHARTS AND TABLES - SURVEY OF Z SCORES. appropriate chart type should be selected.

Figure 10. Survey of Z scores


5. CONCLUSION
REFERENCES
Only basic features and basic steps of working
with PROLab were presented in this paper, but it [1] http://www.quodata.de
shows that comprehensive and standardized software [2] PROLab Plus Manual (2015). QuoData GmbH.
like PROLab can provide computation methods and [3] ISO IEC 17043 (2010) Conformity assessment General
structure data for use in different types of requirements for proficiency testing
interlaboratory studies thereby enabling the optimized [3] ISO 5725, Accuracy (trueness and precision) of
use of ones data. measurement methods and results
Directorate of Measures and Precious Metals has [4] ISO 5725-1:1994, Part 1: General principles and
installed software package PROLab Plus, licenced as definitions
the only one in the Republic of Serbia, and as such, it [5] ISO 5725-2:1994, Part 2: Basic method for the
will be available to all interested organisers of determination of repeatability and reproducibility of a
interlaboratory comparisons, in our country. standard measurement method
Software was a donation from the Physikalisch- [6] ISO 5725-3:1994, Part 3: Intermediate measures of the
precision of a standard measurement method
Technische Bundesanstalt (PTB) project "Support of
[7] ISO 5725-4:1994, Part 4: Basic methods for the
the Quality Infrastructure in Serbia", as a help from determination of the trueness of a standard measurement
the Republic of Germany in the field of Metrology in method
Chemistry. [8] ISO 5725-5:1998, Part 5: Alternative methods for the
determination of a standard measurement method
[9] ISO 5725-6:1994, Part 6: Use in practice of accuracy
values
[10] ISO/IEC 13528, Statistical methods for use in
proficiency testing by interlaboratory comparisons.
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