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trends in analytical chemistry, vol. 73, no.

7, 7994 17

Acknowledgement 11 Z. Liu and J.B. Phillips, J. ChromatogI: Sci., 29


(1991)227. -
Support of the National Science Foundation 12 D.W. Wright, K.O. Mahler and J. Davis, J. Chroma-
togl: Sci., 30 (1992) 291.
under grant CHE-92-01277 is gratefully acknow-
13 N. Kannan, G. Petrick, D. Schulz, J. Duinker, J.
ledged.
Boon, E. van Arnhem and S. Jansen, Chemosphere,
23 (1991) 1055.
14 C. Askari, U. Hener, H G. Schmarr, A. Rapp and A.
References Mosandl, Fresenius J. Anal. Chem., 340 (1991) 368.
15 C.L. Wilkins, Anal. Chem., 59 (1987) 571A.
1 J.C. Giddings, Anal. Chem., 39 (1967) 1027. 16 J.R. Cooper and C.L. Wilkins, Anal. Chem., 61
2 J.M. Davis and J.C. Giddings, Anal. Chem., 55 (1989) 1571.
(1983) 418. 17 F. David, P. Sandra, A. Hoffmann and J. Gerstel,
3 J.C. Giddings, Anal. Chem., 56 (1984) 1258A. Chromatographia, 34 (1992) 259
4 H. Himberg, E. Sippola and M.L. Riekkola, J. Mi- 18 K.A. Krock and C.L. Wilkins, Anal. Chim. Actu, 277
crocol. Sep., I (1989) 271. (1993) 381.
5 W. Bertsch, in H.J. Cortes (Editor), Multidimen- 19 N. Ragunathan, K.A. Krock and CL. Wilkins, Anal.
sional Chromatography, Techniques and Applica- Chem., 65 (1993) 1012.
tions (Chromatographic Science Series, Vol. 50) 20 K.A. Krock, N. Ragunathan and C.L. Wilkins, J.
Marcel Dekker, New York and Basel, 1990, pp. Chromatogr., 645 (1993) 153.
74-144.
6 H.J. Cortes, J. Chromatogr., 626 (1992) 3.
7 G. &homburg, LC.GC, 5 (1987) 304.
8 D.R. Deans, Chromatogruphiu, I (1968) 18. Charles L. Wilkins is Professor of Chemistry at the
9 G. Schomburg, H. Husmann and F. Weeke, 1. Chro- Deparfment of Chemistry, University of California,
matogr., 99 (1974) 63. Riverside, CA 92521, USA. Kevin Krock is a
10 G. Schomburg, H. Husmann and F. Weeke, J. Chro- graduate student at the University of California,
matogr., 112 (1975) 205. Riverside.

Analytical chemistry and quality

M. ValcSrcel and A. Rios Introduction


Chdoba, Spain
Quality has become a crucial demand in the
Quality has been a continuous objective in social, economic, technical and scientific field.
analytical chemistry for years, but today it is Despite the fact that the concept is as old as human
a fashionable term because of the implemen- activites, it has become a buzzword in the last few
tation of qualifyassurance principles in ana- years. Humans have always striven for excellence,
lytical laboratories. This article deals with even though this can be contradictory depending
the involvement of quality in today’s analyti- on when, how and by whom it is defined. What is
cal chemistry, establishing the definition of actually new about quality? Put simply, the imple-
the basic concepts as well as the relation- mentation of new planning, control and assess-
ships between quality and analytical chem- ment systems which are integrated in a hierarchical
istry. Moreover, analytical quality must be sequence that is applicable to any body, whether
considered as a component of overall qual- public or private: quality policy -+ quality man-
ity, playing an important role as a service agement 4 quality system + quality assurance.
involved in checking the quality of manufac- Analytical chemistry, as a chemical information
tured products, systems and other services. science [l], cannot evade this trend. The purpose

01659936494/$07.00 0 1994 Elsevier Science B.V. All rights reserved


18 trends in analytical chemistry, vol. 13, no. 1, 1994

of this article is to establish relationships between lence”, “special or distinguishing attribute”, “de-
quality and analytical chemistry. There are fre- gree of superiority”, etc. The other major group of
quent misconceptions as the literature on analyti- definitions of quality involve social, economic and
cal quality is atypical, confusing, contradictory technological utility/ability concepts. Thus, IS0
and full of acronyms, which makes it especially defines quality as “the whole of attributes and
difficult for analytical chemists who wish to know characteristics of a product, system or service that
more about quality, whether to adhere to current influence its ability to meet regulated or implicit
trends or in the belief that the analytical laboratory needs” [4].
cannot meet present demands otherwise. As can be Overall quality integrates both approaches, viz.
seen from Fig. 1, the analytical chemist is sur- the comparative and the untility/ability approach,
rounded by quality-related concepts that condition which are obviously complementary. The quality
his way of working. Systematizing quality through of a “thing” is reflected in the quality of a product
a series of comprehensible, clear definitions is thus (e.g. milk), a system (e.g. a dairy product factory)
in order with a view to facilitating effective com- or a service (e.g. an analytical control laboratory).
munication in this context. Overall quality is the result of integrating these
three types of quality and encompasses their obvi-
ous mutual relationships.
Quality In order to have a full view of quality one must
take two obligatory cornpartible components into
The difficulty involved in establishing a precise account. On the one hand, quality should reflect
definition of quality can readily be understood by observable facts that can in turn be reflected by
considering the accepted usages of this term as it numbers (data), usually grouped as the so-called
refers to persons and things [2,3]. Basically, the “quality parameters”. On the other, quality has a
quality of something is an attribute, a property, a subjective component related to the features or
special feature or a group of them. The many qualitative use of the product, system or service
available definitions of quality can be summarized concerned. The quality of a wine is determined not
in two general approaches which are illustrated in only by its compositional analytical figures, but
Fig. 2, quality can be appreciated by comparison also by its flavour, odour and other sensory prop-
(“the attribute or set of attributes inherent in one erties, which are as important, or even more so than
thing that allows one to perceive it as the same,
better or worse than the others of its kind”). This
involves such concepts as the “degree of excel-
COMPARATIVE

, 7- , 1 TESTING 1 ~

QUALITY PARAMETEF

Fig. 1. Analytical chemists surrounded by a cloud of Fig. 2. Integration of the definitions and most salient
quality-related concepts and systems. aspects of the term “quality”.
trends in analytical chemistry vol. 13, no. 1, 1994 19

the cold figures of an analytical report. In this


respect, there have been some recent attempts at EXTERNAL
,
QUALITY OF THE
PRODUCTS OR
OIJALITY SYSTEMS
developing methods for “quantifying” sensory
i
properties (e.g. by chromatographic and pattern
recognition techniques) [5].

Quality in analytical chemistry

Obtaining increasingly greater amounts of


chemical information of a higher quality by using
increasingly less material, time, human and eco-
nomic resources has been a major goal of analyti-
cal chemistry since the earliest chemical measure-
ments were made, as shown in Fig. 3. Classical and
contemporary analytical chemistry share the same Fig. 4. Aspects of the analytical chemistry/quality
generic objective: enhancing analytical features. binomial.
The real current novelty in this respect is the
development of a series of design, planning, con- components:
trol, assessment and correction activities that are l quality of the work performed inside and out-
performed simultaneously with ordinary analyti- side the laboratory; and
cal laboratory work in order to assure quality in l quality of the materials (reagents, reference sub-
analytical chemistry. stances), apparatus (extractors, centrifuges,
In dealing with quality in analytical chemistry, heaters), instruments (e.g. spectrometers) and
one should distinguish several concepts that are software used.
frequently confused. Fig. 4 shows a scheme of the Both components, which are mutually related,
different sides of the analytical chemistry/quality determine the quality of analytical results, which
binomial. Here, external quality refers to the fea- is undoubtedly the decisive element of analytical
tures of the products and/or systems of the public quality.
or private body to which the laboratory is answer- However, in order to better understand the rela-
able. On the other hand, internal quality, analytical tionship between analytical chemistry and quality,
quality proper, consists of two components: the one must relate quality unequivocally to analytical
quality of the analytical process and the quality of properties as is schematically presented in Fig. 6.
the results delivered. Analytical properties can be classified into three
Fig. 5 shows the analytical (internal) quality hierarchical blocks, namely:
concepts and their mutual relationships. The qual- l capital (accuracy and representativeness),
ity of the analytical process is made up of two

QUALITY

ANALYTICAL ANALYTICAL
CHEMISTRY FEATURES

ANALYTICAL
DES,GN,PLANNlNG
CONTROL CHEMISTRY
ASSESSMENT
CORRECTION
TODAY

ANALYTICAL

Fig. 3. Quality in classical and contemporary analyti-


cal chemistry. Fig. 5. Basic components of analytical quality.
20 trends in analytical chemistry, vol. 13, no. 1, 1994

the standard kg, atomic masses) established via an


unbroken chain of comparisons where both stand-
ardization and calibration play a prominent role.
This entails the whole production “history”, i.e.
description and monitoring of all the elements
(material, instrumental, methodological, temporal
and human) involved in the result generation proc-
ess.
However, an accurate result may not necessarily
be a quality result, i.e. it may not meet the specific
demands. Results must be also representative, i.e.
consistent with (a) the samples that are subjected
to the analytical process, (b) the object (bulk sam-
Fig. 6. Relationships between analytical properties ple), (c) the analytical problem and (d) the eco-
and analytical quality. For details, see text. nomic/social problem for which the analytical
problem arose. The ease with which quality can be
l basic (sensitivity, selectivity, precision and achieved decreases as one advances in this se-
proper sampling), and quence. Thus, while (a) and (b) can be addressed
l accessory (expeditiousness, economy and per- by using statistical-chemometric methods, (c) and
sonnel safety and comfort) [6]. (d) require the concourse of other social, technical
Capital properties are closely related to the qual- and scientific factors for a correct approach to be
ity of results, whereas basic and accessory proper- selected.
ties arise from quality in the implementation of the If the results are to be delivered expeditiously in
analytical process. In any case, all of these proper- order to allow monitoring of strongly time-de-
ties are mutually dependent. Quality in the results pendent processes, whether productive or not, then
relies on a high sensitivity, selectivity and preci- they will be inconsistent with the problem ad-
sion, in addition to properly executed (repre- dressed unless they are delivered timely. Also, if
sentative) sampling. A high analytical profitability the sampling is not representative of the problem
(i.e. expeditiousness and low cost) can usually addressed, the results will be of no quality. Occa-
only be achieved at the expense of capital and basic sionally, the primary goal is not accuracy but con-
properties. Before the analytical problem con- sistency between the results and those provided by
cerned is addressed, one must balance the required other, widely used routine methods, whether offi-
features of the results with the expected productiv- cial or not, which are usually scarcely rigorous
ity and adjust the latter to the demands imposed on (e.g. those for the determination of bitter com-
the analytical laboratory. One should bear in mind pounds in beer and edible oils); the results will thus
that, how accurate and representative a result may be useless in order to assess product quality.
be, it will hardly be a quality result if it is not
delivered timely.
Quality of the analytical process

Quality of analytical results As shown in Fig. 5, the quality of the analytical


process consists of two components: quality in the
As noted earlier, quality in the analytical results laboratory work and quality of the material sys-
relies chiefly on two primary features: accuracy tems used. Both, which are obviously mutually
andrepresentativeness. It is essential to realize that related, are indispensable in order to accomplish
neither is sufficient by itself. quality in the analytical process and hence in the
No doubt, the accuracy of a result (i.e. its con- delivered results. Neither is thus sufficient to en-
sistency with the actual value within a given un- sure analytical quality.
certainty margin arising from both bias and ran- Analytical laboratory work includes several ele-
dom errors) is a key to defining its quality. ments, the most immediate of which is work car-
Accuracy is related to traceability, i.e. to an un- ried out at the bench; however, in a broader con-
equivocal relationship to reference standards (e.g. text, one should also consider both laboratory
trends in analytical chemistry vol. 13, no. 1, 1994 21

management and the need to establish interfaces suite of specific operations performed by both the
with other social and technical areas in order to laboratory staff and hired workers (quality audits)
ensure representativeness of the results. Analytical with a view to ensuring that quality control is done
chemistry does not begin at the laboratory door and correctly and efficiently. It thus entails systematic,
end at the printer that delivers the results. continuous contrast (in space and time) of the
One other essential component of the analytical features of the analytical process within the labo-
process is the suite of systems used in the labora- ratory and the analytical information produced.
tory. Their quality can be defined in terms of puri ty Quality control and quality asessment share indis-
(of reagents and standards), accuracy and trace- tinguishable aspects (e.g. the use of control charts
ability (to reference materials, whether certified or or blind samples), but differ in proper quality
not), proper functioning (of both all-purpose and control systems implemented by the laboratory
specific apparatus and instruments) and consis- and in which the activity is preferentially per-
tency of the whole suite with the analytical prob- formed: laboratory staff (Quality Control) or out-
lem addressed. laboroty personnel (Quality Assessment).
(c) Correcting activities, which are obvious
consequences of quality assessment and affect
Analytical quality assurance both QC activities and laboratory work, both of
which must be adjusted in order to ensure that the
Quality assurance (QA) for the analytical labo- results meet the requirements in terms of the
ratory can be defined as the overall set of activities planned quality parameters.
planned in accordance with the policy, manage- In conclusion, quality assurance uses quality
ment and quality systems of a public or private asessment systems at the required intervals in or-
body to which the laboratory is answerable in order der to check that the quality control systems used
to ensure that the analytical information produced are efficient and consistent with the problem so as
meets the demanded quality requirements in terms to assure quality (accuracy and representativeness)
of accuracy and representativeness-chiefly. in the analytical results. Quality assurance pro-
As can be seen in Fig. 7, quality assurance (QA) vides the analytical laboratory with a guarantee
is made up of three components, namely: that relies on the credibility and reliability of the
(a) Quality control (QC), which can be defined information it produces provided control, assess-
as the suite of specific activities intended to facili- ment and correction activities are preformed and
tate operation of the analytical laboratory under documented systematically, and are never imple-
conditions ensuring analytical quality (organiza- mented indifferently and mechanically, but in the
tion, management, work, materials, instuments); deep conviction that this is the best route to excel-
not only the analytical laboratory, but also the lence.
results produced must be controlled. Finally, it should be noted that the term “Quality
(b) Quality assessment, which encompasses a Assessment” can have both the above-described
generic meaning or a more specific one when used
as part of Good Laboratory Practices, which are
QUALITY ASSURANCE discussed in the following section.

:\\\*.
Analytical quality systems

,
,__._._\
LABORATORY QUALITY
l
CONTROL ASSESSMENT From a more practical and operative point of
view, the activities involved in assuring analytical

\’ v
quality have led to the development of specific
systems [7-91, for some of which the laboratory
+.’
staff (executives, technicians, specialists and
I

____________..__. *’ CORRECTION
‘\
workers) are the sole actors and those responsible,
\\ ACTIVITIES ,?
\
s_______’ whereas others require establishing external rela-
tionships with other sections (e.g. the quality de-
Fig. 7. Quality assurance in analytical chemistry. partment) of the public or private body to which
22 trends in analytical chemistry, vol. 13, no. 1, 1994

the laboratory is answerable (quality assurance to which it is answerable (personnel of the Quality
unit in Good Laboratory Practices, GLPs), with Assurance Unit) in GLPs, whereas accreditation is
other quality-related agents (e.g. national accredi- done by an indepenent body.
tation bodies) and other laboratories, whether Interlaboratory exercises involve analyses of
compulsorily (e.g. by business deals) or voluntar- the same sample for determining the same analytes
ily (e.g. participation in inter-laboratory exercises in order to critically compare the results produced.
and creditation). They should be desgined, planned, implemented
One essential element of quality systems in an and supervised by a qualified independent body.
analytical laboratory is the so-called Quality Man- The objectives of interlaboratory exercises can be
ual, a detailed description of all the laboratory quite varied, e.g. (a) training, (b) validation of
features and activities, with special emphasis on analytical methods, (c) monitoring the quality of
the systems used for quality control and assess- laboratory results (proficiency testing) and (d) cer-
ment, and derived from the adopted quality policy. tification of reference materials. As a rule, a dis-
The quality manual is slow, costly and tedious to tinction is made between collaborative and coop-
compile and keep, but it is absolutely indispensa- erative studies according to whether a single or
ble for quality systems of analytical laboratories. several methods are used.
Good Laboratory Practices (GLPs) are sets of
rules, operational procedures and practices of Analytical and total quality
compulsory fulfillment (enforced by national gov-
ernments, for example) that are established by It is interesting to note that quality should never
some bodies (e.g. OECD, EC, FDA) in order to be viewed in isolation, but rather in a global form,
assure quality in the information produced by considering the different aspects of things that are
laboratories. These practices introduce external assigned attributes or features.
assessment via the so-called Quality Assurance As can be seen in Fig. 8, analytical quality is a
Unit (QAU) and consist, among other elements, of component of overall quality. As a service, the
Standard Operational Procedures (SOPS), which analytical laboratory can help to check and im-
are detailed descriptions of the specific operations prove the quality of products (via 3), that of sys-
performed at the laboratory from reception of the tems -whether productive or not- (via 2), and
samples to filing of the reports. that of other services (via 4).
Laboratory Accreditation is a formal acknow-
ledgement of the competence of an analytical labo- Final remarks
ratory to carry out specific analyses (specific ana-
lytes in definite samples). It is an external audit This article was written with the aim of provid-
requested by the laboratory and performed by a ing an overview of the many sides of the qual-
specialized national body in coordination with ity/analytical chemistry binomial. Notwithstand-
those of other countries via supranational institu-
tions (ILAC, WELAC). Subjection to the scheme ___,---_--_---.---
is voluntary, temporary (it must be repeated after I 1 OVERALL QUALITY : I
, L__________________~
I
a given period) and partial (only some specific
activities are accredited, but not the whole labora-
tory).
For those not well versed in quality, reading the
contents and structuring of GLPs and accreditation
schemes can be rather confusing as they are quite
similar. The objectives, subjects and systems in-
volved are common to both, and both entail third
party approval/control and provide a solid guaran-
tee for laboratories. The most conspicuous differ-
ences between GLPs and accreditation processes
lie in the fact that, while GLPs are compulsory,
accreditation is voluntary, and the laboratory ex-
ternal assessment is performed by staff of the body Fig. 8. Overall quality and analytical quality.
trends in analytical chemistry vol. 13. no. 1, 1994 23

ing the fact that the tasks involved in enforcing and borne in mind that these topics give rise to new,
maintaining quality systems in analytical labora- interesting jobs that will no doubt appeal to under-
tories pose some problems that are more closely graduates.
related to the so-called “human factor” (viz., men-
tality and attitudinal changes, task extension and
diversification, constancy) than they are to the References
economic factor, the benefits obtained (credibility,
rationalized work, avoidance of unnecessary repe- M. Valcarcel, Fresenius J. Anal. Chem., 343 (1992)
titions, etc.) largely offset the disadvantages. It 814.
should be made quite clear that the activities re- Webster S Third New International Dictionary, Mer-
quired to enforce QA should never prevent the riam-Webster Inc., Chicago, IL, 1981.
Oxford English Dictionary, Oxford University
analytical laboratory from fulfilling its ordinary
Press, Oxford, 1989.
commitments, which should be harmonized and International Standards Organization, Guide 25,
made compatible with quality control, assessment American National Standards Institute, New York,
(and correction), whether out of necessity (e.g. 1982.
mutual acknowledgement of results in interna- K.C. Persaud, Trends Anal. Chem., 11 (1992) 61.
tional trade relationships) or conviction. M. Valcarcel and A. Rfos, Anal. Chem., 65 (1993)
Quality should be a key to analytical laboratory 78.
work in the same way as it is in other social and J.K. Taylor, Quality Assurance of Chemical Mea-
technical areas. Therefore, it should be included in surements, Lewis Publishers, Chelsea, MI, 1987.
the chemistry graduate curriculum if it is to be EM. Garfield, Quality Assurance Principles for
Analytical Laboratories, AOAC, Arlington, VA,
regarded as a substantial part of analytical chem-
1991.
istry from the beginning. This entails training uni-
M. Valcarcel and A. Rfos, LA Calidad en 10s Labo-
versity teachers in analytical laboratory QA-re- ratorios Analiticos, Revert& Barcelona, 1992.
lated topics that are quite disparate from the basic
research they usually conduct. Proper coordina- Professor M. Valca’rcel and Dr. A. Rios are at the
tion with experts and laboratory officials under the Department of Analytical Chemistry, Faculty of
umbrella of quality are two possible starting points Sciences, University of Cdrdoba, E-14004 Cdr-
for overcoming the initial hurdle. It should be doba, Spain.

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