Professional Documents
Culture Documents
3 (2) - (2014)
ISSN: 2223-814X Copyright: © 2014 AJHTL - Open Access- Online @ http//: www.ajhtl.com
1 2
Ratseou E & Professor RR Ramphal
1
Graduate – Department of Quality and Operations Management, University of Johannesburg,
Johannesburg, South Africa
2
UNISA Graduate School of Business Leadership, Midrand, South Africa
Abstract
It has become a trend for companies to implement and be certified to various quality management
systems so as to improve consistency, reliability, and quality of product delivery to customers. The most
common quality management systems adopted are the ISO 9000 series of standards for manufacturing
and services related organisations, with ISO 17025 and Good Laboratory Practices (GLP) standards
adopted specifically by laboratories as quality assurance initiatives. There are various reports on the
impact of the ISO 9000 series on organisational performance but no studies or reports have been done
on the performance of laboratory standards. Therefore this article reports on a study conducted to
investigate the impact of ISO 17025 and GLP on the operational performance of both commercial and
non-commercial laboratories. A qualitative research study was conducted to examine the impact
standards on the aspects of health and safety, supplier selection and performance, human resources,
customer satisfaction and profitability of the laboratory. The data collected suggest that there is no
difference in laboratory operational performance with or without the standards. In other words it appears
that the basic fundamental requirements inherent with laboratories are sufficient to perform both
operationally and optimally. This leads to the view that standards are implemented as a customer
requirement and not as an operational requirement.
Key phrases: laboratory, laboratory quality, laboratory standards, laboratory performance, ISO 17025,
GLP, laboratory quality assurance
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The standards studied on which this article as a room or building fitted out for scientific
is based are ISO 17025 and GLP (also experiments, research, teaching or the
referred to as OECD GLP). The customers manufacture of drugs and chemicals. In the
who receive services from the laboratories context of this article, a laboratory is
request the implementation and considered as a centre offering chemical
accreditation to laboratory standards as a analytical services for the examination of
means of quality assurance (Srivastav, the quality of products. Further, commercial
2009:438). Accreditation means that the laboratories are those that have external
laboratory has been assessed by an customers demanding analytical services
external body which has declared it to be and non-commercial laboratories are those
competent enough to carry out the work that that offer services to internal customers
it does (Robinson, 2005:1). Robinson only. Baiulescu, Pompilia and Zugrăvescu
(2005:1) eludes that test or calibration (1991:141) report that the main purpose of
reports issued by non-accredited any laboratory involved in analytical
laboratories may lack credibility and they do analysis is to obtain results as reliable as
not carry much legal weight if the results are possible, in the shortest possible time. This
presented to resolve any disputes that may means that irrespective of the type of
arise. laboratory, high quality and reliable
analytical results are essential. There is a
As South Africa is part of the global need to effectively manage resources such
economy, there is demand to issue or as personnel, test equipment and
produce laboratory results that are apparatus, chemicals and reagents, the
comparable to those issued by laboratories laboratory environment and any other
from other countries (Apps, 2006:1). Most contributor to the production of results and
organisations that offer laboratory services data. When selecting a laboratory to provide
are subjected to stringent supplier selection services of testing or calibration, the
criteria before being listed as preferred potential customer needs to be sure that the
suppliers, or considered for supplier supplier can issue valid results. There are
contracts. Demanding accreditation from many factors such as competence of
potential suppliers is very evident in this laboratory personnel, the reliability of
industry (Apps, 2006:1). equipment, documented and validated test
methods, proper sampling procedures and
Although laboratories are implementing traceability of measurement to national and
quality assurance systems to satisfy their international standards that contribute to a
customer requirements, it is not clear what laboratory‟s technical competence
the benefits and impact of these systems (Robertson, 2010:1).
are on laboratory operations (Fisicaro,
Durbiano & Giuffredi, 2006:336). Hence the In order to ensure that laboratories produce
focus of this study on which this article is accurate and reliable results, quality
based was centred on investigating the assurance and control programmes are
impact of laboratory quality assurance essential and need to be implemented
standards, ISO 17025 and GLP on (Klinkner, 2008:487), for example Suksai,
operational performance. Suksripanich & Pobkeeree (2010:23) report
that hospital mortality rates can be lowered
Laboratories if testing laboratories produce the correct
Crosland (2005:234) defines laboratories as results the first time to assist doctors with
“places dedicated to the practical rather their diagnosis. Quality can be maintained
than the theoretical investigation of the by the employment of appropriate quality
natural world”. The Concise Oxford standards such as ISO 17025 and other
Dictionary (1995:757) defines a laboratory
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good laboratory practices such as the The standard is made up of five major
general laboratory requirements (GLP). elements; scope, normative references,
terms and definitions, management
ISO 17025 requirements and technical requirements
(Walker, 2002:1). The scope refers to the
The ISO Guide 17025 was developed by collection of methods which include those it
merging other quality standards such as performs routinely and those where either
ISO 9001 and ISO guide 25 and was commercial or legal issues make
adopted by many countries as a national accreditation to 17025 advantageous.
standard for establishing quality systems in Normative references refer to documents
laboratories and for the recognition of that give the most recent information about
laboratory competence by the national every area of the process and equipment
accreditation bodies (Kumar & Varadan, standards. Terms and definitions define for
2001:195). This standard was first published example the labeling of all equipment,
in 1999 and revised in 2005 and is known instruments, workstations, employee
as the “General requirements for the instructions, protocols, procedures and
competence of testing and calibration safety measures. Management
laboratories”. These guidelines facilitate the requirements focus on the organisation,
operationalisation of a quality system quality system, document control, review of
ensuring that the laboratory is technically requests, tenders and contracts,
competent and able to generate valid subcontracting of tests and calibrations,
results (Kumar & Varadan, 2001:195). It is purchasing of relative services and supplies,
applicable to all organisations performing service to clients, compliant management,
tests and/or calibrations. These include, for control of nonconforming testing and/or
example, first-, second- and third-party calibration work, corrective and preventative
laboratories, and laboratories where testing action, the control of records, internal audits
and/or calibration forms part of inspection and management reviews. Technical
and product certification. Laboratory requirements refer, for example, to safe
customers, regulatory authorities and working conditions, functional equipment,
accreditation bodies may also use it to proper calibration of devices, handling of
either confirm or recognise the competence tests and substances, result reporting,
of laboratories. ISO/IEC 17025:2005 is not training, audits, and so forth.
intended to be used as the basis for (http://www.ttelaboratories.com/tte-
certification of laboratories. university/iso-17025). A formal certification
Implementation of the standard increases of compliance often portrays prestige and
the confidence in the personnel performing excellence and that a laboratory has
work and makes test results even better. It demonstrated an ability to produce accurate
facilitates better control of laboratory tests and/or calibration data and has
operations and its quality assurance, and it displayed excellence in technical and
further create potential for more business management competence. It is seen as a
owing to enhanced customer satisfaction seal of approval, and therefore increases
and confidence, which lead to accreditation public confidence. It facilitates trade and
and international recognition, improved economic growth, gives laboratories a
national and global reputation and image marketing advantage, international
and ensures there is a culture of continual recognition and can be used as a
improvement of laboratory quality and benchmark for performance (Robertson,
effectiveness 2010:4).
(http://www.standards.org/standards/listing/i
so_17025).
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search for common solutions or strategies also the results originating from the
to address the challenges that they are investigations (Leballo, 2006:2).
facing (Leballo, 2006:3). Leballo (2006:4)
further announces that South Africa There are benefits of being certified to
participates in the Working Group on GLP OECD GLP. The OECD GLP system saves
via the national accreditation body, and is huge amounts of money for governments
invited to participate in the Working Group and chemical producers around the world.
of National Co-ordinators of the Test The system permits the results of different
Guidelines Programme (WNT). safety tests done on chemical products to
be shared across Organisation for
South Africa is the first non-member country Economic Cooperation and Development
to join OECD Mutual Acceptance of Data as (OECD ) countries (Leballo, 2006:1).
a full member. This means that South Africa Compliance with the principles of GLP
will accept data from OECD countries allows the validity of the test results to be
generated under Mutual Acceptance of Data accepted between organisations and
(MAD) conditions and OECD countries will countries. This minimises the need to repeat
accept data from South Africa generated the testing in different countries. This leads
under MAD conditions. A team of experts not only to monetary savings, but also
from three OECD country governments has saves the lives of countless laboratory
evaluated the South African GLP animals (Prichard, 1995:222).
authority/national accreditation body on site.
The OECD council has invited South Africa The OECD GLP principles have
to become a full member of the system with requirements that laboratories need to be
the same rights and obligations as OECD compliant with, in order to satisfy GLP.
countries. The decision was based on the Those includes test facility management„s
positive outcome of the evaluation (Leballo, requirements, study director‟s
2006:4). responsibilities, principal investigator‟s
responsibilities, study personnel‟s
The principles of Good Laboratory Practice responsibilities, quality assurance
(GLP) have been developed to promote the programme, facilities, apparatus, materials
quality and validity of test data used for and reagents, test systems, test and
determining the safety of chemicals and reference items, standard operating
chemical products (Leballo, 2006:1). It procedures, performance of the study,
defined as a managerial concept that covers reporting of the study results, storage and
the organisational process and the retention of records and materials (Leballo,
conditions under which laboratory studies 2006:1).
are planned, performed, monitored and
reported. These principles need to be Performance measurement criteria
followed by laboratories conducting studies within operations
that have to be submitted to national
authorities for the purposes of assessment
of chemicals. Other uses relate to the Operations management is the
protection of humans and the environment management of activities within an
(Sigman, 1999:7). organisation that produces goods or
services required by customers. It is critical
Most of the principles are contained in ISO for personnel managing operations to be
17025 standard. But there is a different able to measure the performance of their
focus for OECD GLP compliance due to the activities in order to improve efficiency and
type of work that they are engaged in and effectiveness (Radnor & Barnes, 2007:384).
“Efficiency is based around the notion of
output divided by input, which focuses
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impact on the performance of operations, Bourne et al (2005: 381) add that employee
therefore supplier selection and satisfaction needs to be measured and
performance is identified as one of the employees need to be trained so that they
factors affecting the performance of are fully capable of doing their jobs. When
operations (Radnor & Barnes, 2007:390). human resources issues like competency
Bourne et al (2005:375) raise the are addressed, it will lead to high-
importance of supplier characteristics and performance personnel, and therefore, high-
performance in relation to the performance performance operations. Price (2005:451)
of operations. A selection of good suppliers advises that it is also important to monitor
and the management of selected suppliers the workload in the laboratory. Price
can have a positive impact on operations (2005:452) has identified that when it comes
performance (Ambrose, Marshall and to laboratory operations, quality control and
Lynch, 2010:1269). Chin, Yeung and Pun quality assurance schemes need to be used
(2006:743) advice that operations managers to measure performance. These include
need to manage the performance of their participating in proficiency testing schemes
suppliers and always strive to correct any and taking preventive and corrective
deficiencies as and when they arise. Chin et measures when a need arises to take
al (2006:744) point out that suppliers have performance to the next level (Price,
the ability to influence customer satisfaction; 2005:452). According to ISO 17025
therefore it is imperative that supplier standard, the competency of the laboratory
selection and performance be measured as is normally defined in the scope of
part of measuring operations performance. certification. The laboratory scope specifies
The main responsibility of the purchasing information on tests performed by the
function is to source the right suppliers who laboratory, methods used and material
will supply products that meet the needs tested. In order to be certified to ISO 17025,
and requirements of the organisation. An a laboratory has to satisfy requirements on
organisation normally has a number of the competence of laboratory personnel.
suppliers for different materials and There should be a documented procedure
services, and therefore it is the on the validation and traceability of
organisation‟s responsibility and function to measurement results. The competence
develop and maintain close working level of personnel who are directly involved
relationships with its suppliers (Rowbotham in testing must be known. The records of
et al, 2007:308). their training must be maintained
(Bednarova & Waddington, 2010:539).
Human Resources – Personnel
Performance Measurement Health and Safety
Regarding the human resources factor as Groover (2007:668) identifies health and
one of the critical factors that can be used safety as factors that need to be used as
as a criterion for measuring operations criteria to measure performance in
performance, attention needs to be paid to operations. Compliance to health and safety
training and improving competency levels of requirements has become a primary
personnel. Teamwork, communication and requirement enforced by governments
employee involvement need to be around the world. Tayler (2003:2) is of the
encouraged (Radnor & Barnes, 2007:392). opinion that if health, safety and
The motivation level of employees also environmental issues are not addressed,
needs to be monitored (Radnor & Barnes, there could be a negative impact on
2007: 385). operations in the laboratory. The quality of
the results issued by the laboratory and the
safety and well-being of employees might
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ISO 17025 and /or GLP No ISO 17025 and /or GLP No standards
Certified Standards
6 3 6 4
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the effort made by laboratories to comply before the commencement of the analyses.
with the environmental, health and safety This also improves the validity of the data.
requirements by identifying laboratories that The data was analysed by means of the
were certified for health and safety; and also content analysis methodology. Content
the environmental system. This section of analysis is a detailed and systematic
the interview guideline; assisted the examination of the contents of a particular
researcher in understanding operations in body of material for the purpose of
different laboratories. identifying patterns, themes, or biases.
Content analyses are typically performed on
Section C of the interview guideline assisted forms of human communication (Leedy and
the researcher in identifying the different Ormond, 2010:144).
methods used by laboratories to measure
competency, supplier selection and The coding process of the data collected
customer satisfaction. The impact of was conducted after reading the documents
laboratory quality assurance standards on several times to get a general
factors like marketing advantage, laboratory understanding. Creswell (2003:192) defines
recognition, acceptance of exported goods coding as a “process of organising the
in overseas markets, retention and growth material into chunks before bringing
of customer base and the impact on profit meaning to these chunks”. The data was
margins were explored. The section also grouped into five factors which were
used the factors that have been identified as determined as the criteria for measuring
performance measurement criteria to operational performance in laboratories.
determine whether laboratory quality The interpretation of the data and
assurance standards have an impact on the formulation of factors used to measure
operational performance of laboratories. performance criteria are based on the
understanding that the researcher got from
Prior to the actual data collection, the collected data. The interpretation is also
appointments were scheduled when there based on the literature review conducted.
was voluntary telephonic acceptance with
the researcher to participate, followed by Results
the formal acceptance in writing before the
actual start of the data collection. The All respondents had appropriate academic
respondents were made aware of the analytical qualifications and had more than
recording of the interview from which three of laboratory management
transcriptions were processed. Evidence experience.
that was presented during the interview
such as policies, procedures, and so forth The results of the content analyses are
was noted to maintain the validity of the presented in the categories of certified
data collected. Other observations such as laboratories (laboratories with quality
housekeeping, safety awareness, laboratory assurance systems) against those that do
layouts and many others were also noted. not have quality assurance systems. All the
The duration of each interview was between results have been combined into one table
60-90 minutes. A copy of the transcription which shows that there is no difference in
was e-mailed to each respondent to ensure the operational performance of the
the accuracy of contents of the interview laboratories irrespective of if it is
commercial or non-commercial or if there
was a quality assurance system or not.
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Operational Commercial and non-commercial laboratories certified to ISO Commercial and Non-commercial
performance measure 17025, or to GLP or both. laboratories without a certified QA
systems
Customer satisfaction Positive culture and procedures for managing customer Positive culture and procedures for
issues managing customer issues
Supplier selection Clearly documented procedures for supplier selection and Clearly documented procedures for
supplier performance management supplier selection and supplier
performance management
Human resources Documented procedures to address human resource issues Documented procedures to address
human resource issues
Clear procedures to train and ensure that employees
(analysts) are competent Clear procedures to train and ensure
that employees (analysts) are
Procedures to measure the effectiveness of training competent
programmes
Procedures to measure the
Various methods to check analyst‟s technical competence effectiveness of training programmes
Profitability Mixed responses on what the effect of quality assurance Mixed responses on what the effect of
system is on profitability quality assurance system is on
(inconclusive) profitability
Health and safety Positive culture and approach to implementation and Positive culture and approach to
maintenance of health and safety procedures. implementation and maintenance of
health and safety procedures.
Induction programmes in place
Induction programmes in place
Personal protective equipment available
Personal protective equipment
Shared housekeeping responsibilities and high demand on available
keeping clean laboratory area clean, neat and tidy.
Shared housekeeping responsibilities
and high demand on keeping clean
laboratory area clean, neat and tidy
It appears that health and safety is equally of 1993 (the OHS Act). This shows that
important for all laboratories irrespective of health and safety obligation is not
the nature of the laboratory or whether it dependent on the implementation of a
has got a quality assurance system or not. quality assurance standard. Tayler (2003:5)
This is probably due to the fact that health reports that both the OHS Act and ISO
and safety can be deemed as an obvious 17025 have a requirement that internal
requirement based on the South African audits be conducted and that can be used
government‟s stand on health and safety to identify any non-conformances to the
issues at the workplace as per the health and safety rules. Tayler (2003:5)
Occupational Health and Safety Act No.85 further mentions that some laboratories
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African Journal of Hospitality, Tourism and Leisure Vol. 3 (2) - (2014)
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