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Need for quality management in research and development

Article  in  Accreditation and Quality Assurance · October 1998

DOI: 10.1007/s007690050273

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Accred Qual Assur (1998) 3 : 403–405
Q Springer-Verlag 1998 PRACTITIONER’S REPORT

Reports and notes on experiences with quality assurance, validation

and accreditation

Karl Cammann Need for quality management in research

Wolfgang Kleiböhmer
and development

Abstract There is growing interest Key words Quality management 7

Received: 28 June 1998
Accepted: 13 July 1998
Presented at: Analytica Conference ’98,
Symposium 1: “Trends of accreditation
and licensing of laboratories,” Munich,
21–24 April 1998
K. Cammann 7 W. Kleiböhmer (Y)
Institut für Chemo- und Biosensorik
Münster,
Mendelstrasse 7,
D-48149 Münster, Germany
e-mail: kleiboe6uni-muenster.de
Tel.: c49-251-9802870
Fax: c49-251-9802802
in setting up a general concept for Research 7 Development 7
quality management and quality Scientific fraud
control in research and develop-
ment, which in this case means, for
example, research in the fields of
medicine and social sciences. This
article is a strong plea for a quality
management system in all fields of
research and development and will
probably initiate broad discussion
on this delicate topic.

tific community, especially the chemical industry with

Introduction
The importance of quality management (QM) systems
to improve the quality of (laboratory) services has been
long recognised due to the growing interest in the glo-
balisation of industrial activities and the market econo-
my and also due to great concern for risk and safety
factors (e.g. CASTOR transport of nuclear waste). To-
day, QM systems are established in nearly all kinds of
industrial activities, in measurement and testing labora-
tories and also in areas such as “operating theatres” or
sales departments.
During the last few years there has been ever in-
creasing interest in the development of a more general
strategy for applying QM systems in research and de-
velopment activities in research laboratories or institu-
tions. The driving force behind these activities has been
the need for conformity with international quality
standards given by ISO and others and also by the ac-
creditation and certification bodies. Parts of the scien-
its research and development (R&D) laboratories,
were also forced to adopt these mandatory standards
for international trading. However, in most academic
and public research centres for basic or applied re-
search there seems to be deep concern as well as scep-
ticism regarding the introduction of too rigid a QM sys-
tem. Furthermore, the question of quality control and
quality evaluation has expanded from R&D in analyti-
cal chemistry to R&D in general and to associated ser-
vices. This means, for example, research in the fields of
medicine, the social sciences etc. and also the quality of
university education, which is regarded as a high-quali-
ty service to society.
The status quo
Research at public research centres and at universities
is generally dependent on state, public or industrial
404
subsidies. In the eyes of the taxpayer the distribution of
financial resources should be partially dependent on
the quality of the individual institution (best value for
money). Nowadays, for example, evaluation rankings
of universities are undertaken by consumer or news
magazines, but not yet by the scientific community. In
addition, evaluation is not performed in all countries.
The aim must be to set up QM principles which will
enable us to establish QM in all fields of R&D. At the
same time criteria for quality standards through which
the quality of institutions, working groups and univer-
sity departments can be evaluated by the scientific com-
munity have to be drawn up. The time remaining for
this is short, since in some European countries govern-
ments enact laws to control the quality of public re-
search institutions periodically and possibly with stand-
ards that not everyone has agreed upon. The extent to
which the evaluated institutions are then subsidised de-
pends on these “evaluation reports”. If QM were to be
introduced in this way, it is feared that the quality eval-
uation criteria would also be drawn up by governments.
In this case, the goal of having all parties benefit from a
QM system in R&D would not be reached.
It seems that the introduction of QM in R&D by law
or, more generally, by external pressure, will strengthen
the reservations against QM in academic groups. It is
argued that the rigidity of existing, often too formal,
QM systems and an excessively normative approach re-
stricts scientific freedom and would be a serious set-
back to scientific progress, discouraging creativity in re-
search and increasing bureaucracy, sometimes without
reaching its goal (real better method or true analytical
result).
Apart from legal preconditions, there are other rea-
sons for a QM system in R&D:
1. R&D, even basic research, done in one location
should be comparable to that done elsewhere.
2. R&D is a product, the quality of which is decided by
competition for industrial subsidies.
3. More and more scientific officials of national and in-
ternational institutions, require a QM system in the
institution.
4. Furthermore basic research has to be comprehensi-
ble to third parties. The scientific community bears
the responsibility for R&D being carried out compe-
tently and honestly.
Need for a QM system in R&D
Due to some academic misinterpretations (e.g. cold fu-
sion) or even fraud in highly respected institutions in
recent years, society has become more and more doubt-
ful of the so-called “exact and objective” natural
science disciplines. One result of intensive competition
for external funding is the manipulation of experimen-
tal data to achieve the desired results in order to appear
successful. In 1997, in Germany, a very serious case of
fraud in human cancer research became public knowl-
edge. Over a period of several years the recorded data
for a series of tests were found to be completely ficti-
tious. Based on “this” promising data the researchers
received more and more financial support from public
foundations. It is now a matter of great urgency to
check whether these fictitious results have had any seri-
ous consequences on human cancer therapy, since this
might endanger the health of patients. This is a very
grave example of dubious, almost criminal, basic R&D,
but it highlights the need for control. More often less
serious thoughtlessness in analytical chemistry occurs,
for example, the ignoring of matrix effects and the
withholding of information on known or obvious disad-
vantages. An effective QM system cannot totally pre-
vent data being manipulated, or even being invented,
but the demand for the traceability of data will make it
more difficult to cheat.
The above-mentioned points should not be the main
reasons for establishing a QM system in R&D. QM in
R&D can only work if the people involved are con-
vinced of, and fully believe in, the advantages of a QM
system. Quality must be a way of thinking: quality starts
in the mind. So the most important and hardest step is
to convince the scientific community of the advantages
of a QM system in order to achieve a high degree of
motivation for the establishment of QM.
QM in R&D
A general instrument for quality assurance in research
is provided by EN ISO 9001, especially for the manage-
ment of research projects. Project management in re-
search is a possible way of making research comprehen-
sive, but it is only one tool for guaranteeing the quality
of research. Furthermore, it is doubtful whether a
guide, initially set up for quality assurance in industry,
can be adapted to quality assurance in R&D. This was
one reason why in the past 2 years a common EURA-
CHEM and CITAC working group has drawn up a spe-
cific guide for QM in analytical chemical non-routine
analysis and R&D [1]. This guide combines elements of
EN 45001 [2] and ISO 9001 [3] with principles of GLP
[4] and total quality management (TQM) as well as the
new ISO 25 [5]. The initial aim of this guide is to gua-
rantee valid analytical measurements in all fields of
analytical research as well as in non-routine analysis.
This guide may be a good starting point for determin-
ing essential quality tools in general R&D and for ad-
ding more technical quality standard elements.
Physical and chemical tests are only performed in
part of R&D. However, much theoretical or basic ex-
perimental research is original investigation and experi-
mentation with the main objective of acquiring funda-
mental knowledge and understanding without any ana-
 405

lytical measurement. Obviously the same is valid for
applied research. The quality and success of R&D de-
pends mainly on the scientific and technical compe-
tence of the staff involved. Scientific competence
means the scientific knowledge and intellectual ingenu-
ity to invent new concepts, plan and design challenging
experiments, and to interpret and evaluate the results
afterwards. For ingenious research and development in
the natural sciences and engineering not only is scien-
tific competence important, but extensive technical
competence is also often indispensable.
In addition to scientific and technical competence,
efficient project management is necessary for co-ordi-
nating all scientific and technical activities. Thus, scien-
tific and technical competence are, together with effi-
cient project management, key points in the quality and
success of most kinds of R&D.
The following criteria are important for quality in
R&D activities [6]:
– Sound and fundamental concepts of high originali-
ty.
– Ideal combination of scientific expertise, intellectual
competence together with technical skills.
– Outstanding spirit of creativity, innovation and ini-
tiative.
– Well constructed and well-documented course of
the project.
– Feedback-controlled variations on the course of the
project.
– Employment of adequate and reliable technology
and methodology.
– Complete mastery of related scientific principles
combined with some elements of self-criticism.
– Project results applicable and, optimally, results ap-
plicable in different domains.
The applicability of results from research is becoming
more and more important. Society demands true answ-
ers, proof and accountability from the scientific com-
munity for the financial subsidies spent on research. At
present society generally invests money in research
without expecting direct use of the results. The period
of confidence for the return on investment is becoming
shorter and the evaluation of a provable benefit more
important, especially in times of dwindling resources.
In general, the most important criteria for the quali-
ty of R&D organisations are:
– Straight and successful way of working (suitable for
purpose; cost and time efficient)
– Scientific reputation
– Number of publications and length of citation index
of the researcher
– Number of graduates and/or doctors produced
– Customer satisfaction (experience with contract re-
search)
– Number of renewed contracts
– Direct income from contract research
– Number of patents
– Indirect income from licences.
Conclusion
New concepts and ideas are necessary for the external
verification of quality in R&D [7]. A too formal assess-
ment against published quality assurance standards, as
is usually performed in accreditation, without bench-
marking, is inconceivable and unacceptable for the
scientific community. Just imagine if a scientific genius
failed a formal assessment because he did not keep his
laboratory diary in a prescribed way or forgot to
change the oil in the oil pump of his mass spectrometer,
but nevertheless achieved true results. This may be an
exaggerated example, but it shows that verification or
assessment only makes sense when the result is accept-
ed by the persons or organisations affected. Conse-
quently criteria for verifying the quality of research can
only be set by the scientific community and quality of
research should only be verified by experts.
Visiting groups and peer review are useful tools
(benchmarking). These types of review involve the use
of accepted senior-level, and not self-proclaimed, ex-
perts, probably from a wide range of sources, to evalu-
ate an organisation or research group. The evaluation
can be made either at the laboratory itself or by the
laboratory’s scientific output. This method of evalua-
tion requires highly respectable experts to avoid the im-
pression of nepotism between experts.
In the near future the scientific community will be
confronted more and more with the question of quality
control and quality management. The scientific commu-
nity should intensify its efforts to take a more active
role in this process.

References
1. EURACHEM/CITAC (1998) Quality
assurance for research and develop-
ment and non-routine analysis, 1st edn
2. EN 45001 (1989) General criteria for
the operation of testing laboratories
3. ISO9001 (1994) Quality systems –
model for quality assurance in design/
development, production, installation
and servicing, 2nd edn
4. The OECD principles of good labora-
tory practice. Environment monograph
No 45, OECD/GD(92)32, Organisation
for Economic Co-Operation and De-
velopment, 1992
5. ISO/IEC Guide 25 (1997) General re-
quirements for the competence of cali-
bration and testing laboratories, 5th
edn
6. Mathur-De-Vré R (1997) Accred Qual
Assur 2 : 63–68
7. Cammann K, Kleiböhmer W (1997)
Accred Qual Assur 2 : 262–263

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