the impact of quality assurance systems on the operational

i

THE IMPACT OF QUALITY ASSURANCE SYSTEMS ON THE OPERATIONAL PERFORMANCE OF

LABORATORIES

By

ELLEN RATSOEU

A dissertation

submitted in the fulfilment of the degree

MASTER TECHNOLOGIAE

In

OPERATIONS MANAGEMENT

At the

UNIVERSITY OF JOHANNESBURG

Supervisor:

Prof R.R. Ramphal

November 2012

ii

DECLARATION

I Ellen Ratsoeu, the undersigned, herewith declare that this dissertation submitted in

the fulfillment of the qualification M Tech Operations Management is my own,

independent work. Furthermore, I declare that this dissertation has not been submitted

for any degree at any other university.

______________________

Ellen Ratsoeu

November 2012

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ACKNOWLEDGEMENTS

I would like to take this opportunity to thank the following people who have

contributed to the completion of this dissertation and have supported me throughout

the study:

My parents;

My supervisor Prof RR Ramphal for his guidance, encouragement, and

valuable criticism; and

All the respondents for agreeing to participate in the study, which would not

have been possible without their valuable contribution.

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ABSTRACT

It has become a trend for organisations to implement and certify quality systems. The

most common quality system that organisations currently implement is ISO 9001.

Certification to ISO 9001 has in recent times been used as a marketing tool to enter

new markets. Nowadays, customers expect their suppliers and potential suppliers to

be certified to ISO 9001. It has become a primary requirement for doing business, and

customers now demand it. There have been various studies conducted to establish the

advantages of ISO 9001 and its impact on organisational performance.

Laboratories are no exception to this developing trend. They are implementing

laboratory quality standards like ISO 17025 and the Organisation for Economic

Cooperation and Development Good Laboratory Practice (OECD GLP). Some

laboratories are now applying for certification of compliance to laboratory standards.

Implementing and certifying laboratory systems is an exercise that comes at a cost.

The exercise is demanding in terms of human resources, time and capital. There has

not been a study conducted to evaluate the impact of these systems on the operational

performance of laboratories. This is the reason that resulted in identification of the

need to conduct the study.

A qualitative research approach was pursued in conducting the study, where the

researcher investigated the impact of laboratory quality standards on the operational

performance of commercial and non-commercial laboratories. Operational

performance in this study is defined as health and safety; supplier selection and

performance; human resources; customer satisfaction and profitability. Data was

collected through interviews, and was then summarised, and analysed in order to

address the research problem.

Based on the data collected, it was concluded there is no notable difference in the

performance of laboratories with or without quality assurance systems such as ISO

17025 and OECD GLP.

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TABLE OF CONTENTS DECLARATION i

ACKNOWLEDGEMENTS ii

ABSTRACT iii

CONTENTS iv

LIST OF FIGURES viii

LIST OF TABLES ix

GLOSARRY OF TERMS x

CHAPTER 1: INTRODUCTION AND ORIENTATION TO THE STUDY

1.1 INTRODUCTION 1

1.2 PROBLEM STATEMENT 2

1.3 RESEARCH QUESTION 3

1.4 AIM OF THE STUDY 3

1.5 SCOPE 4

1.6 OBJECTIVES 4

1.7 RESEARCH METHODOLOGY 4

1.7.1 Research approach 4

1.7.2 Research design 5

1.7.3 Sampling and Sample Size 6

1.7.4 Method of data collection 8

1.7.5 Data analysis 8

1.8 VALIDITY AND RELIABILITY 9

1.8.1 Validity 9

1.8.2 Reliability 9

1.9 OUTLINE OF THE CHAPTERS 10

1.10 CONCLUSION 11

CHAPTER 2: LABORATORY OPERATIONS

2.1 INTRODUCTION 12

2.2 DEFINITION OF QUALITY 12

2.2.1 Definition of Quality Assurance 14

2.2.2 The importance of Quality Assurance 15

2.2.3 The advantages and disadvantages of adopting Quality Assurance 16

2.3 OPERATIONS MANAGEMENT 17

2.4 LABORATORY OPERATIONS 18

2.4.1 Quality assurance within the laboratory 19

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2.4.2 Challenges facing laboratories 21

2.4.3 Managing information in the laboratory 23

2.4.4 Laboratory personnel competency and performance measurement 24

2.5 ISO 17025 25

2.5.1 History of ISO 17025 25

2.5.2 Description of ISO 17025 27

2.5.3 Description of the main clauses of ISO 17025 37

2.5.4 Benefits of ISO 17025 certification 29

2.6 OECD GLP 39

2.6.1 History of OECD GLP 39

2.6.2 Description of OECD GLP 41

2.6.3 Description of the main clauses of OECD GLP 42

2.6.4 Benefits of OECD GLP certification 48

2.7 CONCLUSION 49

CHAPTER 3: LABORATORY PERFORMANCE CRITERIA

3.1 INTRODUCTION 50

3.2 PERFORMANCE MEASUREMENT 50

3.2.1 The importance of performance measurement 51

3.2.2 The advantages and disadvantages of different types of performance measures 52

3.3 PERFORMANCE MEASUREMENT CRITERIA WITHIN OPERATIONS 54

3.3.1 CUSTOMER SATISFACTION 54

3.3.1.1 Recognising the importance of customer satisfaction 55

3.3.1.2 Recognising the importance of customer satisfaction 55

3.3.1.3 Addressing customer issues 56

3.3.1.3 Methods used by organisations to measure customer satisfaction 57

3.3.2 PROFITABILITY 58

3.3.2.1 Profitability within the laboratory 59

3.3.3 SUPPLIER SELECTION AND PERFORMANCE MEASUREMENT 60

3.3.3.1 The role of the purchasing function 62

3.3.3.2 Supplier selection criteria 63

3.3.3.2 Factors to be considered in enhancing supplier performance 64

3.3.3.3 Quality standards and customer-supplier relations 64

3.3.4 HUMAN RESOURCES 65

3.3.4.1 Performance measurement of laboratory personnel 66

3.3.4.2 Disadvantages of using incompetent laboratory personnel 68

3.3.5 HEALTH AND SAFETY 68

3.3.5.1 Causes of incidents and accidents in the workplace 69

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3.3.5.2 Housekeeping in the laboratory 69

3.4 CONCLUSION 71

CHAPTER 4: RESEARCH METHODOLOGY

4.1 INTRODUCTION 72

4.2 RESEARCH PARADIGMS 72

4.3 RESEARCH APPROACH 73

4.4 RESEARCH DESIGNS 77

4.5 POPULATION AND SAMPLING TYPES 70

4.5.1 Population 79

4.5.2 Sampling 80

4.5.3 Data collection methods 81

4.6 DATA ANALYSIS 85

4.7 CONCLUSION 88

CHAPTER 5: FINDINGS AND DISCUSSIONS

5.0 INTRODUCTION 89

5.1 HEALTH AND SAFETY 91

5.1.1 Non commercial laboratories that have a certified QA system 91

5.1.2 Non commercial laboratories without a certified QA system 96

5.1.3 Commercial laboratories that have a certified QA system 100

5.1.4 Commercial laboratories without a certified QA system 105

5.2 SUPPLIER SELECTION 107





5.3 HUMAN RESOURCES 114





5.4 CUSTOMER SATISFACTION 143





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5.5 PROFITABILITY 157





5.6 DISCUSSION OF RESULTS 170

5.7 CONCLUSION 174

CHAPTER SIX: CONCLUSIONS AND RECOMMENDATIONS

6.1 INTRODUCTION 175

6.2 OBJECTIVES AND CONCLUSIONS 176

6.2.1 To conduct a literature review to explore relevant literature about laboratory operations and

performance criteria in order to develop, understand, investigate and/or evaluate a research

idea on quality assurance standards and laboratory operations 176

6.2.2 To explore the views of laboratory managers about the impact of quality assurance standards

on the operational performance of commercial and non-commercial laboratories 177

6.2.3 To compare the operational performance in commercial and non-commercial laboratories177

6.2.4 To propose recommendations for laboratory managers in order to improve decision-making

and implementation of quality assurance standards 177

6.3 RESEARCH METHODOLOGY 178

6.4 LIMITATIONS 179

6.5 RECOMMENDATIONS FOR FUTURE RESEARCH 179

BIBLIOGRAPHY 180

APPENDIX A: INTERVIEW GUIDELINE 191

APPENDIX C 1 PROFILE OF LABORATORIES 194 APPENDIX C 2 PROFILE OF LABORATORIES 196 APPENDIX C 3 HSE AND SUPPLIER SELECTION 201 APPENDIX C 4 HUMAN RESOURCES 206 APPENDIX C 5 CUSTOMER SATISFACTION 211 APPENDIX C 6 PROFITABILITY 214

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LIST OF FIGURES

Figure 2.1: Advantages and disadvantages of adoption of QA Systems for organisations 17

Figure 2.2: The Quality Benchmark Deployment Model – Clarification of the relationship between

customer satisfaction and work systems and practices 21

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LIST OF TABLES Table 1.1 Planned sample matrix 7

Table 1.2 Actual sample matrix 7

Table 4.1 Difference between phenomenological paradigm and positivistic paradigm 73

Table 4.2 Qualitative versus quantitative research approach 73

Table 4.3 Characteristics of quantitative and qualitative research approaches 75

Table 5.1 The results of the content analysis 170

Table 5.3 The impact of quality assurance standards on the operational performance of

laboratories 172

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GLOSARRY OF TERMS

The following are terms defined in the context of this study. Certified laboratories:

Certified laboratories are laboratories that have implemented ISO 17025 or OECD

GLP and have been accredited by a national accreditation body.

Commercial Laboratories:

Commercial laboratories in the context of the study, refer to laboratories that function

as an independent business entity and are not attached to a bigger organisation. The

laboratories accept samples from any customer who identifies them as their service

provider.

ISO 17025:

The ISO 17025 is a standard adopted by many countries as a national standard for

establishing quality systems in laboratories and for the recognition of laboratory

competence by the national accreditation bodies (Kumar & Varadan, 2001:195).

Laboratories:

Places dedicated to the practical rather than the theoretical investigation of the natural

world (Crosland, 2005:234).

Non certified laboratories:

Non certified laboratories are laboratories that have not implemented either ISO

17025 or OECD GLP and have not been assessed by the national accreditation body

to be declared certified.

Non commercial laboratories:

Non-commercial laboratories are those laboratories that are service providers to

internal customers only. Non-commercial laboratories are linked to or form part of a

bigger organisation. They normally provide a service of quality control to the

production department.

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OECD:

The Organisation for Economic Cooperation and Development (OECD) is an

intergovernmental organisation from thirty industrialised countries. Its purpose is to

monitor economic trends in those countries. It is a centre for discussion where

governments express their view points, share experiences and search for a universal

position (Leballo, 2006:3).

OECD GLP:

OECD GLP is a managerial concept that covers the organizational process and the

conditions under which laboratory studies are planned, performed, monitored and

reported. These principles need to be followed by laboratories conducting studies that

have to be submitted to national authorities for the purposes of assessment of

chemicals (Sigman, 1999:7).

Operations management:

A function that is concerned with the activities which produce goods and/or services

as per customers’ requirements (Radnor & Barnes, 2007: 384).

Performance measurement:

Part of the diagnosis/analysis process of identifying where improvement activity

should be prioritised (Ndlovu, 2005:6).

Quality Assurance:

Quality assurance is a declaration given by an organisation to inspire confidence that

the particular organisation has the capability to achieve its stated objectives, which

will be to satisfy the needs of its customers in a consistent manner (Tricker,

2005:160).

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Testing laboratories:

Testing laboratories in this context are laboratories that carry out tests or analysis on

materials to determine their composition against the specifications and approve them

as fit for purpose.

QMS:

Quality Management System

SOP:

Standard Operating Procedure

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CHAPTER 1

INTRODUCTION AND ORIENTATION OF THE STUDY

1.1 INTRODUCTION

Many organisations have implemented and are still implementing standards such

as (International Organization for Standardization) ISO 9001 for quality

management and ISO 14001 for environmental management. Prajogo (2010:78)

reports that for the last two decades, there has been a major increase in the number

of organisations implementing ISO 9001 in a number of countries. Prajogo

(2010:78) further reports that certification to ISO 9001 has had a positive impact

on the operational performance of organisations and improved quality

performance.

Srivastav (2009: 438) also conducted research on the implementation of ISO 9001

and reported its advantages as promoting a culture of teamwork and continuous

improvement. Laboratories, especially commercial ones, have also been adopting

standards such as ISO 17025, the Organization for Economic Cooperation and

Development Good Laboratory Practice (OECD GLP) and Good Clinical

Laboratory Practice (GCLP) due to demands from their customers (Srivastav,

2009: 438).

According to Robinson (2005:1) test or calibration reports issued by non-

accredited laboratories lack credibility. The report by a non-accredited laboratory

does not carry as much weight as that issued by an accredited laboratory if it has

to be presented in a court of law to resolve legal disputes. In general accreditation

means that the laboratory has been assessed by a national accreditation body and

has been declared competent to carry out the work that it does.

As South Africa is part of the global economy, there is a demand to issue or

produce laboratory results that are comparable to those issued by laboratories

from other countries (Apps, 2006:1). Most organisations are subjected to stringent

2

supplier selection criteria before being listed as the preferred supplier, or

considered for supplier contracts. Demanding accreditation from potential

suppliers is very evident in industry (Apps, 2006:1). Robinson (2005:1) reports

that laboratory accreditation is a primary requirement for entering markets.

Crosland (2005:234) defines laboratories as “places dedicated to the practical

rather than the theoretical investigation of the natural world”. The two laboratory

quality assurance standards considered in this study are ISO 17025 and OECD

GLP. OECD GLP assures that the results issued by a test facility are valid and

produced with integrity (Leballo, 2006:1). ISO 17025 is a standard used to assess

the competency of laboratories (Sidney, 2006:6).

This study considers commercial and non-commercial laboratories. The term

commercial laboratories in this context, refers to laboratories that function as a

business entity and have external customers. Laboratories accept samples from

any customer who identifies them as a service provider. Non-commercial

laboratories are those laboratories that are service providers to internal customers

only. Non-commercial laboratories are linked to or form part of a bigger

organisation. They normally provide a service of quality control to the production

department.

1.2 PROBLEM STATEMENT

There are many studies such as that of Robinson (2005:78) indicating positive

impact on the performance of organisations that have implemented ISO 9001. By

impact the researcher means how the laboratory quality assurance standards

influence operational performance. However, despite many laboratories

implementing and certifying their laboratory quality assurance standards such as

ISO 17025 and OECD GLP, there have been no similar studies pertaining to its

impact on laboratory performance. Therefore the focus of this study was to

explore the impact of ISO 17025 and OECD GLP on the operational performance

of commercial and non-commercial laboratories.

3

Ritzman and Krajewski (2003:25) report that it is wise to use multiple factors in

an attempt to measure and improve performance in operations. Different authors

have identified factors that need to be considered as the measurement criteria to

measure performance in operations. Radnor and Barnes (2007: 389) and Uyar

(2009:74) identify customer satisfaction as an important factor that needs to be

measured. Ritzman and Krajewski (2003: 25) identify human resources factors.

Ambrose, Marshall and Lynch (2010:1269) point out that supplier selection and

performance management are critical factors to be measured. Uyar (2009:73)

advises that it is critical to measure the performance of operations using both

financial and non-financial measures. Financial measures confirm the profitability

of an operation. Groover (2007:668) identifies health and safety as important

factors that need monitoring. Compliance with health and safety requirements has

become a primary requirement enforced by governments around the world.

Hence, as suggested by the various authors, the operational performance criteria

considered in the context of this study are Health and Safety; Supplier selection

and performance; Human resources; Customer satisfaction; and Profitability. The

exploratory study investigates if the quality assurance systems have any influence

on these factors in commercial and non commercial laboratories.

1.3 RESEARCH QUESTION

Does the implementation of quality assurance systems such as OECD GLP and

ISO 17025 have an impact on the operational performance of commercial and

non-commercial laboratories? In other words, do the laboratory quality assurance

standards influence the operational performance of laboratories?

1.4 AIM OF THE STUDY

The aim of the study is to explore the impact of the quality assurance systems of

commercial and non-commercial laboratories on their operational performance.

This will then provide information for various laboratory managers towards

decision making when considering implementation of laboratory assurance

systems.

4

1.5 SCOPE

The study focused on testing laboratories that are certified to either ISO 17025 or

OECD GLP. Testing laboratories in this study are defined as commercial and non

commercial laboratories that conduct analysis of materials or products.

1.6 OBJECTIVES

The objectives of the study are as follows:

Objective 1: To conduct a literature review to explore relevant literature

about laboratory operations and performance criteria in order to develop,

understand, investigate and/or evaluate a research idea on quality

assurance standards and laboratory operations;

Objective 2: To explore the views of laboratory managers about the

impact of quality assurance standards on the operational performance of

commercial and non-commercial laboratories;

Objective 3: To compare the operational performance in commercial and

non-commercial laboratories; and

Objective 4: To provide more information for laboratory managers when

considering the implementation quality assurance systems.

1.7 RESEARCH DESIGN, METHODS AND METHODOLOGY

1.7.1 Research approach

The research approach used for the study was qualitative. Leedy and Ormonde

(2010:95) suggest a qualitative study where the available literature is limited and

where the study is exploratory. The literature available for laboratory quality

assurance standards and laboratory performance is limited hence justifying for an

exploratory qualitative study. Qualitative research enabled the researcher to gain

an understanding about the implementation of quality assurance standards in

laboratories. This approach gave the researcher some flexibility, and an approach

that can be adapted when different situations arose. An understanding of

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laboratory quality assurance was needed in order to achieve the objectives of the

study (Welman, Kruger and Mitchell, 2005: 8). Strauss and Corbin (1998:10)

define “qualitative research as any type of research that produces findings not

arrived at by statistical procedures or other means of quantification”. It can refer

to research about a person’s life, lived experiences, behaviours, emotions and

feeling as well as about organisations, social movements, cultural phenomena, and

interactions between nations.

Qualitative research is a viable mode of investigation, and tends to be field

focused. Qualitative studies display the use of expressive language and the

presence of voice in the text (Leedy, 1993:142).

There are three major components of qualitative research. Firstly, there is the data

component, which can come from various sources like interviews, observations

and documents. Secondly, there are the procedures that researchers can use to

interpret and organise the data. These usually consist of conceptualising and

reducing data, elaborating categories in terms of properties, and relating these

through a series of prepositional statements (Strauss and Corbin, 1998:11).

1.7.2 Research design

The types of qualitative research design approaches are identified as case study

research, participant observation, unstructured in-depth interviews, semi-

structured interviews, focus groups, ethnography and grounded theory (Welman et

al, 2005: 207).

The research design used for this study was the exploratory, semi structured

interview. In this design the researcher used semi structured interviews to

“identify the important variables in a particular area, to formulate penetrating

questions about them, and to generate hypotheses for further investigation”

(Welman et al, 2005:166). Schedules for interviews were compiled when the

research participants had agreed to do the interviews.

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1.7.3 Sampling and Sampling Size

Welman et al, (2005: 53) explain that a population is ‘a set of cases from which a

sample is taken’. The population in this study consisted of laboratory managers

and senior laboratory personnel from the 200 laboratories listed on the website of

the national accreditation body and the national laboratory association. A sample

represents a small subgroup of individual units drawn from the population

(Welman et al, 2005: 66). There are two categories of sampling, these being

probability sampling and non-probability sampling (Leedy and Ormond,

2010:46).

The sampling strategy utilised for this research is non-probability, convenience

sampling. Convenience sampling makes no pretense of identifying a

representative subset of a population. It takes people that are readily available

(Leedy and Ormond, 2010:212).

Convenience sampling was based on the availability and enthusiasm of the

potential respondents to participate. When a few of the laboratory managers were

contacted, they indicated that they will be unavailable and were unwilling to

participate.

The criterion used to select the participants for the research is based on their

position within the structure of their laboratory. The laboratory managers or senior

laboratory personnel who are the custodians of quality standards in their

laboratories were identified as research participants. Being involved in laboratory

management has allowed the researcher to have a good grasp of the study

objectives.

Table 1.1 is a planned sample matrix of commercial and non-commercial

laboratories that are ISO 17025 and OECD GLP certified. It was planned for each

group of laboratory to have at least two respondents.

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Table 1.1: Planned Sample Matrix

No. of commercial laboratories No. of non-commercial laboratories ISO 17025 certified

OECD GLP certified

ISO 17025 & OECD GLP non-certified

ISO 17025 certified

OECD GLP

certified


2 2 2 2 2 2

Table 1.2: Actual Sample Matrix

No. of commercial laboratories No. of non-commercial laboratories ISO 17025 certified

OECD GLP certified


ISO 17025 certified

OECD GLP

certified


4 2 2 5 2 4

Table 1.2 is a sample matrix of commercial and non-commercial laboratories that

are ISO 17025 and OECD GLP and were part of the research. Some groups of

laboratories ended up with more than the minimum of two respondents as per

table 1.2.

The sample matrix is illustrated as per the table above, and is comprised of

nineteen laboratories. The composition of the sample included non-commercial

and commercial laboratories, those ISO 17025 and OECD GLP certified, and

those without certified quality assurance systems.

A non-commercial laboratory in this context is a laboratory that is a service

provider to internal customers only. Non-commercial laboratories are normally

part of a bigger organisation, and the function of the laboratory is normally to

provide testing support to the production department. A commercial laboratory is

a laboratory that operates as an independent business unit, and accepts work or

samples from anyone who identifies them as a suitable or preferred supplier of

services. An accredited laboratory is one that is certified to a quality standard by a

recognised certification body. This certification provides confidence to the

laboratories’ customers of their competence.

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1.7.4 Method of data collection

Watkins, (2006:50) reports that there are different methods used to collect

research data in the qualitative research method. Qualitative data can be collected

through focus groups, diaries, interviews, observation, questionnaires and protocol

analysis.

For the study, data has been collected by means of semi-structured interviews.

Leedy and Ormond (2010:188) report that in semi-structured interview, the

researcher may follow the standard questions with one or more individually

tailored questions to get clarification or probe a person’s reasoning.

The interview focus area guideline was developed based on the literature review.

The purpose of developing the interview focus area guideline was to enable the

researcher to collect uniform data that can be compared consistently. During data

collection, the participants were asked to provide evidence like policies and

procedures that were talked about during the interviews and notes were made

when information was provided. Observations on issues like housekeeping in the

laboratory were made and that was also recorded.

1.7.5 Data analysis

During the interview data was recorded and brief notes were taken. After the

interview, data was transcribed using Microsoft Word format. Content analysis

was then used to analyse the data.

Content analysis is a detailed and systematic examination of the contents of a

particular body of material for the purpose of identifying patterns, themes, or

biases. Content analyses are typically performed on forms of human

communication (Leedy and Ormond, 2010:144).

The coding process of the data collected was conducted after reading the

documents several times to get a general understanding. Creswell (2003:192)

defines coding as a “process of organising the material into chunks before

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bringing meaning to these chunks”. The data was grouped in five factors which

were determined as the criterion for measuring operational performance in

laboratories. The interpretation of the data and formulation of factors used to

measure performance criteria are based on the understanding that the researcher

got from the collected data. The interpretation is also based on the literature

review conducted in chapters two and three.

1.8 VALIDITY AND RELIABILITY

1.8.1 Validity

According to Welman et al, (2005:142) validity is “the extent to which the

research findings accurately represent what is really happening in the situation”.

Data was collected in a current setting. Respondents availed and shared operation

reports and documents. Some of the documents that were shared include reports

of proficiency testing schemes, procedures for the declaration of competency for

laboratory personnel, housekeeping procedures and observations by the

researcher.

1.8.2 Reliability

Welman et al, (2005:145) reports that reliability is “concerned with the findings of

the research and relates to the credibility of the findings”.

The right people, who were able to give useful feedback, were approached to be

participants. The qualifications of the respondents ranged from a National

Diploma to a Doctorate and they were all in key positions in laboratory structures.

The data collected through interviews was tape recorded. The focus area interview

guideline ensured that there was consistency in the questions asked.

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1.9 OUTLINE OF THE CHAPTERS

The section provides a brief overview of the respective chapters in the research.

The structure of the research is as follows:

Chapter 1: Orientation to the study

The chapter gives an overview of the study, introduces the quality systems that are

implemented in the laboratory environment and the justification for conducting

the research.

Chapter 2: Laboratory operations

The chapter deals with the concept of operations management and laboratory

standards. Literature on ISO 17025 and OECD GLP will also be explored.

Chapter 3: Laboratory performance criteria

The chapter gives a detailed description on operations performance criteria and

measurement of performance.

Chapter 4: Research methodology

The chapter introduces the research design and methodology, and presents the

data used in the research. The research methods, instruments and data analysis

techniques are outlined in the chapter.

Chapter 5: Findings and discussions

The findings and discussions of the research conducted are presented in the

chapter. Data collected from accredited and non-accredited laboratories will

provide evidence of the positive or negative impact of ISO 17025 and OECD GLP

on the operational performance of laboratories.

Chapter 6: Conclusions and recommendations

The chapter provides the conclusions and recommendations made from the

research based on the results obtained. If recommendations for further research on

the subject are identified, they will be listed in this chapter.

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1.10 CONCLUSION

This chapter started by giving a brief background of laboratory quality standards.

The problem statement of the study was also discussed. The main problem being

investigated is the impact of laboratory quality systems on the operational

performance of laboratories.

The research methodology to be used was also discussed.

The next chapter will discuss laboratory operations. Literature on the two

laboratory standards, ISO 17025 and OECD GLP, will be conducted.

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CHAPTER 2

LABORATORY OPERATIONS

2.1 INTRODUCTION

Organisations around the globe invest a lot of resources in the implementation and

certification or accreditation of standards, mostly ISO standards. There are

technical and management requirements that laboratories must satisfy in order to

meet the required standards (Theodorou & Anastasakis, 2008:107). The objective

of the ISO is to develop standards that have economic and technical impact on

countries around the world (Boyer and Verma, 2010:43). Laboratories are no

exception to the trend as they are also implementing laboratory standards.

Laboratories are implementing standards with the hope of gaining a competitive

advantage in the market place, but it is not clear what the benefits of these

standards are and what their impact is on laboratory operations (Fisicaro,

Durbiano & Giuffredi, 2006:336). To understand the impact that laboratory

standards have on the operational performance of laboratories, the literature of

different laboratory standards and laboratory operations has to be reviewed.

This chapter gives a brief overview of the definition of quality and quality

standards, that is, it reviews ISO 17025 and OECD GLP. It is important to

understand the requirements of the standards, before figuring out their impact on

operational performance.

2.2 DEFINITION OF QUALITY

Quality means a certain degree of excellence (Nichols, 2006:273). Quality goes

beyond quality control testing. Quality is based on an understanding of how

different processes come together to produce valid and reliable results. When

designing quality systems, non-conformance need to be prevented and captured

before it slips through the cracks (Nichols, 2006:276). Quality can be defined as

13

the ability of goods and/or services to meet or exceed customer expectations in a

consistent manner (Boyer and Verma, 2010:28).

Suppliers of goods and/or services are constantly promoting quality in order to

gain a competitive advantage (Rowbotham, Galloway & Azhashemi, 2007:332).

Quality is an important global issue that has to be addressed in various operations

(Rowbotham et al, 2007:334).

Asif, de Bruijn, Douglas and Fisscher (2009:779) report that quality has taken the

forefront in the highly competitive environment within the business community.

Quality is considered as the ability to deliver excellence to stakeholders.

Organisations used to focus on customer satisfaction as an independent factor. But

what they should be doing nowadays, is to focus on customer satisfaction while

concurrently considering the financial and operational performance. This would

help organisations to view their performance holistically. Current quality

improvement programmes and models are based on the broader definition of

quality, which involves a system approach. Rowland-Jones, Wines and Davies

(2005:27) agree that the importance of quality in organisations needs to be

acknowledged. Quality needs to be embedded in daily working practices in the

form of standards and excellence models.

The quality of products and/or services produced by an organisation has a major

impact on its viability and competitive advantage. Organisations around the world

are acknowledging the improvements in operational and financial performance

that can be brought about by quality. Currently, continuous quality improvement

is taken as a strategic objective and is high on senior management agendas

(Fotopoulos, Psomas & Vouzas, 2010:129).

Determining the fundamental parts of quality is not easy, because customers think

of the characteristics of goods and/or services. The quality of a good is determined

by its dimensions such as performance, special features, reliability, conformance,

durability, serviceability, aesthetics, and brand equity or reputation. The quality of

a service is determined by dimensions such as reliability, responsiveness,

competence, access, courtesy and communication (Boyer and Verma, 2010:34).

14

Everyone has a clear idea of what they mean by quality. But the definition of

quality differs depending on the individual. Quality can be a complex term to

define, but a universal definition is needed so that it can be measured and

controlled (Rowbotham et al, 2007:331). To be able to direct employees’ efforts

towards an objective of customer satisfaction, there must be a common

understanding of the term quality. Nowadays, quality is regarded as a very

important strategic issue rather than an operational one. A quality management

system emphasises the ability of an organisation to satisfy customer needs

precisely and profitably with the participation of all personnel (Lai & Cheng,

2005:446).

Organisations embark on quality and improvement programs to achieve objectives

such as operations cost reduction, improved customer satisfaction, increased

customer loyalty, and improvement of financial and market performance (Boyer

and Verma, 2010:30). Quality management can contribute to the effectiveness of

marketing an organisation’s goods and/or services (Lai & Cheng, 2005:447).

2.2.1 Definition of Quality Assurance

Quality assurance is a declaration given by an organisation to inspire confidence

that the particular organisation has the capability to achieve its stated objectives,

which will be to satisfy the needs of its customers in a consistent manner (Tricker,

2005:160). The purpose of quality assurance to a customer is providing assurance

to a customer that the standard of workmanship is of the highest level, that there

must be an agreed level of quality and that there must be commitment by the

organisation for all products to meet the minimum level of the set specifications

consistently (Tricker, 2005:161).

Quality assurance needs to be a fundamental part of the processes within an

organisation. It needs to be built into the organisation’s entire processes from the

conception of an idea through to the life-cycle of the product or service. The

processes covered should include determining customer needs and requirements,

planning and designing, production/service delivery and after-sales service. The

main objective of quality assurance is to ensure that quality is built into the

15

product and/or service (Dale, Van der Wiele and Van Iwaarden, 2007:280). A lot

of emphasis is placed on factors like quality planning, training, critical problem-

solving tasks, improving the design of the product, process and services,

improving control over the process, involving and motivating people rather than

inspection and control (Dale et al, 2007:27).

When selecting a laboratory to provide the service of testing or calibration, the

potential customer needs to be sure that the supplier can issue valid results. There

are a lot of factors that contribute to a laboratory’s technical competence. These

factors include the competence of laboratory personnel, the reliability of

equipment, documented and validated test methods, proper sampling procedures

and traceability of measurement to national and international standards

(Robertson, 2010:1).

2.2.2 The importance of Quality Assurance

Quality assurance is needed as it assists in setting the standards and the

documentation of processes within different functions in an organisation. It also

assists with the documentation of the methods used to check against the specified

standards. Generally, quality assurance includes third-party approvals from

recognised national certification bodies, such as applying for ISO 9001

certification (Basu and Wright, 2004:18).

Programmes like quality inspection and quality control rely on supervision to

ensure that no mistakes carrying out tasks. The most basic approach to quality

assurance is to conduct an inspection. If non conformances are captured, the next

step would be to investigate, find the causes of problems and take actions to

prevent errors from occurring again. The method is very dependent on supervision

and inspection (Basu and Wright, 2004:18). With quality assurance, inspection

and control are still the basic approach. In addition to that, a comprehensive

quality manual that would include recording of quality costs, sampling techniques,

reporting of quality costs, and auditing the entire quality systems would be

expected to be in place (Basu and Wright, 2004:18).

16

2.2.3 The advantages and disadvantages of adopting Quality Assurance

One of the advantages of adopting quality assurance is that it results in directing

the organisational efforts towards preventing problems from occurring at source.

Finding non-conformances at a later stage is a reactive measure and is not an

effective way towards eliminating the root cause of a problem. The proactive

nature of quality assurance improves product and service quality, increases

productivity by placing the emphasis on product, service and process design. Even

when defects occur, they are identified at the early stages of the process. This is a

proactive approach compared with detection at a later stage, which is reactive.

(Dale et al, 2007:28).

Quality assurance further promotes the existence of comprehensive quality

management system that increases uniformity and conformity throughout the

entire organisation (Dale et al, 2007:26).

Tricker (2005:161) reports that the main benefit of quality assurance is that it

promotes involvement and motivation within an organisation’s workforce. It also

promotes improved customer relationship through fewer complaints, and that in

turn, can result in increased sales potential. Tricker (2005:161) further reports that

adopting quality assurance can result in a reduction of manufacturing and

production costs due to less wastage and fewer rejects. Tricker (2005:161) is also

of the opinion that there is an increased capability of an organisation supplying a

product which consistently conforms to agreed specifications.

17

Figure 2.1: Advantages and disadvantages of adoption of Quality Assurance Systems for organisations (Source: Adapted from Aramyan, Meuwissen, Alfons, Lansink, Van der Vorst, Van Kooten and Van der Lans (2009:634).

Advantages Disadvantages

Competitive advantages

Increase in sales and market share

Increased customer satisfaction

Better management control

Clearly-defined organisational tasks,

structure and responsibilities

More effective recalls

Price premium

Costs of achieving certification

Costs for capital purchases

Costs for maintenance and audits

Training costs

Reduced flexibility

Increase in administration workload

Extra storage, production materials,

personnel and documentation

Figure 2.1 is a summary of the advantages and disadvantages of adopting quality

assurance.

2.3 OPERATIONS MANAGEMENT

Radnor and Barnes (2007: 384) define operations management as a function that

is concerned with the activities which produce goods and/or services as per

customers’ requirements. Boyer and Verma (2010:24) point out that within

operations, there are different processes where resources/inputs are transformed to

deliver outputs which are services and/or products. Rowbotham et al (2007:2)

reports that the management of the resources that are directly involved in the

production of goods and/or services is very critical. The resources that are usually

needed in operations are people, materials, information and technology. All the

resources are brought together by a number of processes in order to produce

goods and/or services required by the customers.

Operations can be found in various organisations like manufacturing, commercial,

public service, and even in non-profit organisations. “Operations” is very broad

and can be found in different sectors of the economy (Rowbotham et al, 2007:2).

18

Slack, Chambers, Johnston and Betts (2005:254) are of the opinion that the

“transformation process” is a basic model that clearly defines operations

management. Inputs, which are fed into the process, produce a set of outputs,

which are goods and/or services. The transformation process can occur at various

levels in the organization. It can occur at a departmental level, across departments

and also at strategic level (Slack, Chambers, Johnston & Betts, 2005:254).

According to Radnor and Barnes (2007: 384) management issues are very similar

at all levels in an organisation. They include managing demand and planning,

capacity and process design. Davis and Heineke (2005:10) report that operations

management has over the years gained increased recognition for various reasons.

Some of the reasons include the application of operations management concepts

in service organisations. It has helped to expand the definition of quality, and

operations management concepts are now applied in functions like marketing and

not confined to production environments.

2.4 LABORATORY OPERATIONS

The importance of analytical chemistry has been indicated and highlighted over

the years. It is estimated that about 3% of the gross domestic product of advanced

nations is spent on analytical testing. The importance of analytical chemistry has

been shown in various industries. That includes industries such as food safety,

drinking water quality, fertilizers and pesticides, air and coastal water quality

monitoring, workplace health and safety monitoring, and application to the

environment. The principles of analytical chemistry are applied in the field of

health, in the quality control of pharmaceutical products, clinical analyses for both

diagnosis and to monitor the effects of therapy, and forensic science. Analytical

chemistry has a long history of application in quality control of processes like

steelmaking, microprocessors and optical fibers manufacturing. It is estimated that

analysts produce about a billion items of analytical data annually in the United

Kingdom alone (Newman, 2005:647).

Analytical data provide the basis for a lot of critical decisions that are made daily

throughout the year. The importance of chemical analysis has increased drastically

19

over the years due to changing legislations. Legislators are forcefully requiring

scientific data as evidence to compliance, and that scientific evidence comes from

analytical chemistry. Analytical data assists in framing and enforcing regulatory

requirements in different countries (Newman, 2005:647).

2.4.1 Quality assurance within the laboratory

Globally, everyone is concerned with the quality of services offered by the

laboratories (Kiline, 2008:301). For a laboratory to be able to produce accurate

and precise results, testing personnel must be well-trained, motivated, and have

documented standard operating procedures. Standard operating procedures must

be formulated in a way that they can identify and correct erroneous results before

they reach the customers (Kiline, 2008:301). Suksai, Suksripanich and Pobkeeree

(2010: 23) report that hospital mortality rates can be lowered if testing

laboratories produce the correct first time results that assist physicians with their

diagnosis.

Kiline (2008:301) describes a quality management framework as one that will

include the “5Q’s”. The “5Q’s” stands for quality assurance, quality control;

quality improvement; quality indicators and quality systems. A quality framework

must be designed in a way that there is continuous feedback to ensure that root

causes to arising issues are identified and corrective and/or preventive actions

implemented.

Nowadays, quality management goes beyond compliance. It is not only about

compliance with regard to documented procedures but also about continuous

improvement of the system. Quality should be assessed with regard to the

specifications for desired quality. As part of continuous improvement, quality

systems should assist employees in foreseeing future quality needs at an early

stage (Kiline, 2008:302).

Critical factors for a successful implementation of a quality standard include

acceptance and commitment by each member of the team involved to generate

“quality culture”. The documentation of the system should be simple and flexible,

20

so that employees can identify with it. The system as a whole should be self-

sustainable and add value to the organization (Grochau, Ferreira, Ferreira & Ten

Caten 2010:682).

The main purpose of laboratories is to produce and deliver accurate and reliable

measurement results at all times. In order to ensure that laboratories produce

accurate and reliable results, there are control programs and quality assurance that

can be implemented (Klinkner, 2008:487). Laboratories produce and issue a

test/calibration certificate as their end product. The product produced by the

laboratory is delivered to the customer in the form of a document, which is a

test/calibration certificate. The test/calibration certificate is the only document

which goes out of laboratory shelves in the form of ‘product’ (Gupta, 2010:591).

When selecting a laboratory to provide service of testing or calibration, the

potential customer needs to be sure that the supplier can issue valid results. There

are a lot of factors that contribute to a laboratory’s technical competence. That

includes the competence of laboratory personnel, the reliability of equipment,

documented and validated test methods, proper sampling procedures and

traceability of measurement to national and international standards (Robertson,

2010:1).

There is strong reliance on expert, highly specialised skills and knowledge of

laboratory personnel for laboratories to be able to provide the complex services

that they provide. Laboratories need to be customer focused and understand

quality from the customer’s perspective. The Quality Benchmark Deployment

Model (Figure 2.2) provides insight into the relationship between work systems,

practices and customer satisfaction. The model focuses on understanding how the

actual work systems and practices impact on the customer. It also provides a way

for agreeing to performance measures that are based on satisfying the customers

(Swanson, 1993:91).

21

According to Swanson (1993:91), it is critical to understand customer complaints

in context. The model below offers a template for achieving an understanding of

customer complaints. It also provides a systematic process for clarifying and

analysing the needs and expectations of the customers.

Figure 2.2: The Quality Benchmark Deployment Model - Clarification of the Relationship between customer satisfaction and works systems and practices (Source: Adapted from Swanson (1993: 91).

2.4.2 Challenges facing laboratories

Baiulescu, Pompilia and Zugrăvescu (1991:141) report that the main purpose of

any laboratory involved in analysis is to obtain results as reliable as possible, in

the shortest possible time. According to the three stages of the general analytical

process, input-transformation-output, the testing personnel must be ‘artistic’ in

ensuring that there is no gap between input, transformation and output.

The main challenge facing any laboratory is to analyse samples and produce

accurate and reliable results consistently. Organisations make business decisions

based on the laboratory results. Laboratories need efficient and effective quality

control and quality assurance systems in place, in order to be able to produce

consistent and reliable data. Laboratory resources like personnel, test equipment

and apparatus, chemicals and reagents, the laboratory environment and any other

Develop an implementation plan

Improved customer service delivery systems

Clearly established competitive performance benchmark

Review service delivery systems

Review work performance

Identify improvement opportunities

Survey customers Isolate expectations, priorities, and satisfaction

Establish performance measures to achieve satisfaction

Prioritise practices Clarify relationship between performance and customer expectations

Isolate practices critical to customer satisfaction

Determine customer satisfaction targets

22

contributor to the production of results and data must be properly managed. Every

sample that is brought to the laboratory for testing must be received and handled

correctly, according to documented procedures. Validated test methods must be

employed in laboratories to ensure that there is consistency in the performance of

test methods. Test results and data should be handled and reported according to

documented procedures and there needs to be traceability from receiving the

sample to issuing test result (Bailey, 2003:1).

Most laboratory personnel will agree with the fact that the samples that are not

representative prohibit the laboratory from providing accurate results. The main

cause of errors is not test method deficiencies or lack of analytical skill, but

erroneous results are mostly caused by non representative, contaminated or

unstable samples. In most cases, the laboratory often has limited control over the

sampling procedures (Milner, 1992:81). Regardless of all the sampling problems

experienced, Milner (1992:81) reports that the laboratories are still expected to

work with what they receive from its customers and make a decision. Laboratories

issues test results based on the sample received. There are occasions when the

customer questions the results issued by the laboratory. A sample that is not

representative of the bulk from which it is taken, may lead the laboratory

customer to wrong business decisions as any test results can only be as good as

the samples analysed.

Baiulescu et al (1991:171) agree that if a sample is not taken properly and does

not represent the entire lot, there is no point in conducting the analysis. The

manner, in which a sample is taken, is an extension of the definition of quality.

Sampling is the biggest concern for laboratory personnel. According to Dux

(1990: 47) ‘no analysis is better than the sample itself’. Lischer (2010:603) is of

the opinion that samples submitted by customers (primary sample) to a laboratory

for analysis, must be representative of the material/lot from which it is taken.

Lischer (2010:603) further reports that it is also very important for the sample

analysed in the laboratory (secondary sample) to be representative of the sample

submitted to the laboratory for analysis by the customer.

23

Mwakangale (2005:9) identifies challenges faced by laboratories in Tanzania.

Financial constraints are a major challenge as organisations cannot afford to

maintain the laboratories. Most laboratories do not have proper quality controls

such as certified reference materials in place to be able to verify equipment

performance and monitor the competence of personnel. This is due to the fact that

certified reference materials are too expensive to procure. Laboratories do not

have enough test equipment to meet their scope of work. If the laboratory

manages to acquire new test equipment, it cannot manage to maintain and service

equipment due to budget constraints. Even though laboratories would prefer to

certify their systems, the high costs prevent them from doing so. Most laboratories

lack adequate training on specific technical skills like measurement uncertainties,

method validation and evaluation of test results.

Laboratory certification demands a lot of resources in human, financial, and

infrastructural terms. It is a costly exercise. This places a huge disadvantage on

the developing world, specifically the (LDC’s) Least Developed Countries

(Mwakangale, 2005:1). Mwakangale (2005:1) reports that LDC’s are African

countries that have very limited resources to support quality implementation

compared to western countries. Furthermore, due to globalisation all countries

around the globe are expected to deliver quality goods and/or services, but not all

have the resources needed to accomplish that.

2.4.3 Managing information in the laboratory

Dlamini (2005:1) reports that the Laboratory Information Management System

(LIMS) impacts operations of the laboratory positively. Nowadays managing

information in the organisations has become an integral part of business. Test

results issued by the laboratories are very important in the production processes.

They have a direct impact on the process of meeting the requirements of the

customers. Management must show leadership and implement corrective action

and/or preventive actions. This can only be achieved using an effective laboratory

management system (Dlamini, 2005:1). According to Van Eeden (2005:6) the

implementation of LIMS results in major improvements within the laboratory.

The major improvement in the laboratory is identified as the turnaround time from

24

receiving the sample until the approved results are issued. The systems eliminate

non-value-adding debates about who is responsible for delaying tests results

because every activity is traceable.

Employing qualified and competent employees in laboratories gives them

confidence when issuing results. Sometimes, the importance of hiring skilled

laboratory personnel is taken lightly and not recognised. Highly automated

measurement systems and test equipments cannot replace the importance of

competent laboratory personnel. It is precisely when highly automated systems

are used that competent personnel are needed. Staffs that are competent would be

able to utilise equipment to its full potential. Equipment reproducibility would be

even more consistent (Apps, 2006:1).

2.4.4 Laboratory personnel competency and performance measurement

Laboratories face the challenge of running short of skilled personnel. This

shortage and the availability of automated equipment tempt laboratories to go

down the path of utilising sophisticated instruments that are operated by low-

skilled personnel. While this might appears to be a cost saving exercise and is

attractive, it has costly consequences. There is higher throughput per person due

to automated systems which means that one mistake affects output. Personnel

depend largely on the supplier even for minor equipment service and

troubleshooting. When laboratories use low skilled personnel, skilled personnel

spend time verifying the results produced by those low skilled personnel. That

practice is counter-productive (Apps, 2006:1).

It is a global trend these days that laboratory customers expect the quality of

results to be higher. Customers also expect the sample turn around times to be

shorter. Even though sometimes laboratories go the route of using low skilled

personnel, there is no thorough research conducted with regard to human error in

the measurement laboratories. Most of the research has been conducted in the

fields of computer programming and nuclear power industry. At times,

laboratories spend a lot of resources to establish and monitor the performance of

their equipments and test methods. However, performance specification for

25

laboratory personnel is not monitored with the exact quantitative precision as for

equipment and methods (Apps, 2006:1).

One of the methods used by laboratories to measure the performance of laboratory

personnel includes witnessing while the person conducts a test or analysis. This

method is time consuming and counter productive. It can even be seen by

personnel as discriminatory and unfair labour practice. Most laboratories have a

procedure in place of handling an out of specification instrument. But most do not

have an equivalent procedure for laboratory personnel, even though the testing of

personnel plays a critical role in laboratory testing (Apps, 2006:3).

The work of laboratory personnel is enormously important on every step of the

production process. However, chemical analysis of materials in organisations is

not given the attention it deserves by management. Due to the continuous

advancement of technology, greater accuracy, more precision, better ability to

detect lower concentrations at low cost is a primary requirement and demanded

from every laboratory. Laboratory data or information is mostly used for quality

monitoring purposes. Analytical result/data is used to measure the degree of

conformance to the quality standard set by an organisation. Quality control

processes do not identify the reasons for producing non-conforming products or

address what actions should be taken to prevent non-conformities (Dlamini,

2005:1).

2.5 ISO 17025

The history of ISO 17025, its description of clauses and benefits are given below.

2.5.1 History of ISO 17025

The ISO Guide 17025 was revised in 1990 and was adopted by many countries as

a national standard for establishing quality systems in laboratories and for the

recognition of laboratory competence by the national accreditation bodies (Kumar

& Varadan, 2001:195). For reasons of quality assurance and quality control,

laboratories which form part of larger organisations are required to operate quality

systems that meet the requirements of ISO 9001 and also with ISO Guide 25

26

(Kumar & Varadan, 2001:195). The use of two quality systems necessitated the

revision of ISO 25 to encompass the requirement of ISO 9001 (Kumar &

Varadan, 2001:195). The ISO 17025 standard is a result of this revision, which

considered the requirements of the two quality systems (Kumar & Varadan,

2001:195).

ISO 17025:1999 “General requirements for the competence of testing and

calibration laboratories” was first published in 1999 (Van de Leemput, 2000:394).

This first edition of ISO 17025 cancelled and replaced ISO Guide 25: 1990 which

was the existing laboratory quality guide (Van de Leemput, 2000:394).

ISO 17025 contains all the requirements that the testing and calibration

laboratories have to meet to demonstrate that the quality system is operational and

also to confirm that the laboratory is technically competent and able to generate

valid results (Kumar & Varadan, 2001:195).

The publication of ISO 17025 has been heralded as an indication of a new era in

the operation and evaluation of laboratories (Robinson, 2005:1). ISO 17025

standard of criteria establishes an internationally recognised standard for

laboratories and offers criteria for the evaluation of competence in testing and

calibration laboratories (Robinson, 2005:1). These criteria cover both

management systems requirements and technical requirements relevant to all

testing and calibration laboratories (Robinson, 2005:1). ISO 17025 can be applied

in different fields, from mechanical and chemical laboratories to those engaged in

electrical, optical and biological testing (Robinson, 2005:1).

Accreditation in the 20th Century was seen as a voluntary act. But nowadays,

many economies view it as a mandatory requirement. Governments around the

world are embracing it (Robertson, 2010:2). In the Asia-Pacific region, APEC (the

Asia Pacific Economic Cooperation) endorses accreditation (Robertson, 2010:2).

The Asia Pacific Laboratory Accreditation Cooperation (APLAC) is recognised as

an APEC Specialized Regional Body (Robertson, 2010:2). Accreditation is now

used to strengthen the conformity assessment component of the APEC agreements


27

Mwakangale (2005:1) adds that to ensure that testing and calibration tasks are

performed by competent service providers, governments are increasingly creating

National Accreditation Bodies. The National Accreditation Bodies are recognised

by the International Conformity assessment bodies (ILAC) International

Laboratory Accreditation Cooperation and (IAF) International Accreditation

Forum (Mwakangale, 2005:1). The ISO 17025 standard is used to provide

assessment bodies from different countries with a standard to evaluate laboratories

for competency (Sidney, 2006:6).

2.5.2 Description of ISO 17025

ISO 17025 provides key requirements framework for organisations offering

services in the field of testing and calibration (Walker, 2002:1). The standard is

made up of two major sections. One section addresses generic quality

management concerns and the other section addresses the technical requirements

regarding the testing and calibration activities (Walker, 2002:1).

The quality management requirements refer to documentation and records that are

related to policies and procedures to set up an operational laboratory (Bailey,

2003:1). The content of the technical requirements also need to be documented

(Bailey, 2003:1). The combination of both sections make up the laboratory quality

manual (Bailey, 2003:1).

Many countries rely on laboratory accreditation as a means of identifying

technical competence of potential service providers (Robertson, 2010:2). The

criteria for determining technical competence are based on the international

standards ISO 17025, or ISO 15189 for medical laboratories which are used for

evaluating laboratories globally (Robertson, 2010:2). Laboratory accreditation

bodies around the world, use the standards to assess factors relevant to a

laboratory’s ability to produce accurate and reliable data. Some of the factors that

are looked at include the personnel competency, validity of test methods,

traceability of measurements, testing environment, and suitability of test

equipments (Robertson, 2010:2).

28

Accreditation is a tool used to assist laboratories with continuous improvement in

a sustainable manner. It is an internationally accepted confirmation by an

accreditation body that a laboratory is capable of producing accurate, valid and

reliable data consistently. Having an ISO 17025 certified system assists

laboratories in that their test or calibration results can be accepted globally. Many

countries around the globe have adopted ISO 17025 as a standard used to certify

their country’s testing and calibration laboratories (McGrowder, Crawford, Irving,

Brown & Anderson-Jackson, 2010:569).

Certification to ISO 17025 confirms that tests in a laboratory are consistently

carried out by personnel who have been declared competent. For a laboratory to

be certified, work processes within the laboratory operations must be tracked and

validated. The traceability of all data produced by the laboratory also becomes

critical (Van Eeden, 2005:2).

McGrowder et al (2010:569) report that laboratory accreditation is now used

globally as a criterion to identify technically competent laboratories. Some

countries around the globe have challenges when embarking on projects to

accredit their services. McGrowder et al (2010:569) reports that in Jamaica,

barriers to certifying laboratories include cost, lack of personnel motivation,

unclear requirements and challenges related to interpreting and implementing ISO

17025 standard, and lack of involvement and support from senior management.

The accreditation is awarded by the national accreditation body using ISO 17025

standard as an acceptance criteria (Fisicaro et al, 2006:336). Most laboratories

have demonstrated interest in accreditation for their own status and marketplace

differentiation. But on the other hand, the benefits of accreditation are not clear to

other laboratories (Fisicaro et al, 2006:336).

Laboratory accreditation covers the quality systems elements that are addressed in

the ISO 9001 standard. Once laboratories are certified to ISO 17025, they are

subjected to surveillance and recertification audits to ensure their technical

compliance. ISO 17025 certified laboratories normally participate in proficiency

testing programmes to demonstrate their ongoing competence. Certification to

29

ISO 17025 is not for commercial laboratories only; manufacturing organisations

can certify their laboratories to ensure competence of their internal laboratories.

ISO 17025 certification provides formal recognition to competent laboratories


2.5.3 Description of the main clauses of ISO 17025

Requirements that laboratories have to satisfy according to ISO 17025 include

validation protocols, measurement traceability, competence of personnel, and

environmental conditions of the laboratory (Bednarova & Waddington,

2010:539). The clauses of ISO 17025 are discussed below.

2.5.3.1 Organisation

The laboratory or organisation should be an entity that can be held legally

responsible. If the laboratory is part of an organisation it should not be directly

under functions like production, finance or marketing. An arrangement like that

will ensure that laboratory management is free from undue pressures where the

quality of results may be sacrificed for profit, production volumes or speedy

sample turnaround time. In cases of commercial laboratories, it should not act as a

consultant for its customers. This could result in the laboratory’s integrity of

results and independent judgment being at stake (Gabi, 2006:1)

Clause 4.1.5(b) on organization of the ISO 17025 standard covers a requirement

which ensures that both management and personnel are free from undue pressures

that may adversely affect the quality of their work (Gabi, 2006:1). Factors like

basic compensation, fringe benefits, leave, grievance procedures and economic

protection against hazards are included in the employment contract of laboratory

personnel and these factors help to reduce undue pressures, but they do not

necessarily provide total protection unwarranted pressure and influences (Gabi,

2006:1).

The importance of deputies for key positions in the laboratory is very critical. This

can relieve management from some of the pressures resulting from the heavy

30

work loads (Gabi, 2006:1). There must be adequate staffing in the entire

laboratory to avoid pressures associated with work overload (Gabi, 2006:1).

2.5.3.2 Management system

The laboratory should establish, implement, and maintain a management system

that is relevant to the scope of its activities (Gabi, 2006:1). The policies, systems,

programmes, procedures to ensure the quality of results need to be documented

and presented in the form of a quality manual (Gabi, 2006:1). Quality objectives

should also form part of the quality manual and should be reviewed during the

management reviews. The quality policy statement should be issued under the

authority of top management (Gabi, 2006:1).

2.5.3.3 Document control

The laboratory should establish and maintain procedures to control all the

documents that form part of the management system (Gabi, 2006:1). Documents

could be of either internal or external origin and can include regulations, software,

standards, drawings and specifications in any media (Gabi, 2006:1). The

document control procedure should cover the process of approving documents,

issuing documents and also the changes to documents (Gabi, 2006:1).

2.5.3.4 Review of requests, tenders and contracts

The laboratory should have clearly defined procedures to review requests, tenders

and contracts (Gabi, 2006:1). The lead times agreed upon should be within the

laboratory’s capability. Lead times should incorporate allowances for

contingencies (Gabi, 2006:1). All the records of reviews should be maintained in

accordance with the document control procedures (Gabi, 2006:1).

2.5.3.5 Subcontracting of tests and calibrations

When a need for a laboratory to subcontract has been identified due to unforeseen

reasons, competent suppliers should be used. A competent supplier could be one

31

who is certified to ISO 17025 (Gabi, 2006:1). The customer whose work is tested

by a subcontractor needs to be informed in writing and the laboratory will still be

responsible to the customer for the subcontractor’s work, except in the case where

the customer or a regulatory authority specifies which subcontractor is to be used

(Gabi, 2006:1).

2.5.3.6 Purchasing services and supplies

The laboratory should have a documented policy and procedure for the selection

and purchasing of services and supplies it uses that affect the quality of the results

(Gabi, 2006:2). The laboratory needs to be given a reasonable budget to avoid

undue financial pressures (Gabi, 2006:2). The laboratory should be at liberty to

select quality brands and grades of analytical materials to be used in the testing

processes (Gabi, 2006:2).

2.5.3.7 Service to the customer

The laboratory should be willing to cooperate with customers on clarifying the

customer’s requests and in monitoring the laboratory’s performance in relation to

the work performed. But the laboratory should always ensure confidentiality to

other customers (Gabi, 2006:2).

2.5.3.8 Complaints

A systems approach to the analysis of root causes and corrective actions should be

defined in the form of a policy and procedure (Gabi, 2006:2). Complaints from

customers should not be regarded as an indication of poor performance of

laboratory management and testing personnel (Gabi, 2006:2). They should be seen

as an opportunity for continuously improving the quality management system. If

complaints are not viewed from a systems perspective that may result to

laboratory personnel issuing results that will please their customers in order to

protect their jobs (Gabi, 2006:2).

32

2.5.3.9 Control of non-conforming testing and/or calibration work

The laboratory should have policies and procedures that are implemented when

any aspect of its testing or calibration work do not conform to its own procedures

or the agreed requirements of the customer (Gabi, 2006:2).

2.5.4.0 Improvement

The only way to ensure continuous improvement in the laboratory system is

through management reviews (Theodorou & Anastasakis, 2008:108). The

management review agenda should include discussion points like suitability of

policies and procedures, reports from managerial and supervisory personnel,

outcome of recent internal audits, non conformances, corrective/preventive

actions, results of external quality assessments, inter-laboratory comparisons or

proficiency testing schemes, changes in the volume and type of work, customer

feedback, complaints and improvement suggestions (Theodorou & Anastasakis,

2008:108). Issues such as QC activities, resources and staff training can also be

included on the agenda (Theodorou & Anastasakis, 2008:108).

2.5.4.1 Corrective action

The laboratory should establish a policy and a procedure that will assist them in

implementing corrective action if any non conformances occur in the form of non

conforming testing or deviations from procedures (Gabi, 2006:2). Once the

corrective action to be implemented has been chosen, it should be implemented

and monitored to ensure its effectiveness (Gabi, 2006:2). Additional audits can be

conducted to verify the effectiveness of the implemented corrective action (Gabi,

2006:2).

2.5.4.2 Preventive action

When improvements and potential sources of non-conformities have been

identified, a preventive action should be developed, implemented and monitored

to reduce the likelihood of the occurrence of non-conformance and to take

33

advantage of the opportunities for improvement (Gabi, 2006:3). The preventive

action procedure should include the initiation of the action and the application of

controls to ensure that they are effective (Gabi, 2006:3).

2.5.4.3 Control of records

The laboratory should establish and maintain procedures for identification,

collection, indexing, access, filing, storage, maintenance and disposal of quality

and technical records (Gabi, 2006:3). That should include records from internal

audits, management reviews, as well as corrective and preventive action. Records

should be stored in a secure space and in confidence (Gabi, 2006:3).

2.5.4.4 Internal audits

The laboratory should develop a predetermined audit schedule and procedure to

conduct internal audits. The internal audit programme should address the elements

of the management system including the testing or calibration activities (Gabi,

2006:3). If resources permit, audits should be conducted by qualified personnel

who are independent of the activity being audited (Gabi, 2006:3).

2.5.4.5 Management reviews

Certified laboratories or laboratories aiming at certification put a lot of effort into

meeting the technical requirements of the accreditation standards (training,

calibration, method validation, etc.) but some managerial requirements, for

example management review are considered of lesser importance but they are

very critical (Theodorou & Anastasakis, 2008:107). Management reviews are key

processes in many quality management systems. These include laboratory

management systems like ISO 17025 and ISO 15189. These reviews are an

opportunity to understand and manage all the inputs and outputs of a quality

management system. In many quality management systems, management review

is a critical requirement of the system. Laboratory standards like ISO 17025 are

no exception (Theodorou & Anastasakis, 2008:107).

34

Management reviews discussions should cover customer feedback and

complaints, improvement suggestions, assessment by external bodies, corrective

and preventive measures, changes in the volume and type of work, outcome of

internal audits conducted, reports from supervisory personnel and the suitability

of policies and procedures (Gabi, 2006:3).

2.5.4.6 Technical requirements

There are factors that determine the validity and reliability of the tests performed

by the laboratory (Sithole, 2006:3). Those include human factors, accommodation

and environmental conditions, test and calibration methods and method

validation, equipment, measurement traceability, sampling and the handling of

test and calibration items (Sithole, 2006:3).

2.5.4.7 Personnel

The laboratory management should ensure the competence of all who operate

specific equipment, perform tests, evaluate results and sign test reports (Sithole,

2006:4). If personnel are undergoing training, they need to work under the

supervision of a person who has already been declared competent. Personnel’s

competence should be assessed on a continuous basis, to keep up with changes in

technology (Sithole, 2006:4).

2.5.4.8 Accommodation and environmental conditions

The clause on accommodation and environmental conditions, stipulates that the

environment in the laboratory should allow laboratory personnel to produce valid

and reliable results (Gabi, 2006:2). Incompatible materials and activities should be

segregated to avoid cross contamination (Gabi, 2006:2). The environmental

conditions may be stated in the method but also requires the competency of

personnel to be able to establish if the validity of result will be affected if there is

no control (Sithole, 2006:4)

35

2.5.4.9 Test and calibration methods and method validation

The laboratory should use appropriate methods and procedures for all tests and

calibrations within its scope (Sithole, 2006:4). Those include sampling, handling,

transport, storage and preparation of items to be tested or calibrated, and where

appropriate, an estimation of the measurement uncertainty as well as statistical

techniques for analysis (Sithole, 2006:4). The laboratory can use laboratory-

developed methods, non-standard methods, but that needs to be done in

consultation with the customer (Sithole, 2006:4). The test methods used by the

laboratory should be validated, that is confirmed by objective evidence that the

particular requirements for a specific intended use are fulfilled (Sithole, 2006:4).

2.5.5.0 Equipment

The laboratory should be properly furnished with items of sampling, measurement

and test equipment required for the correct performance of the tests or calibrations

(Sithole, 2006:4). All the equipment and software used for testing, calibration and

sampling should be capable of achieving the accuracy required (Sithole, 2006:4).

2.5.5.1 Measurement traceability

Laboratories need capable equipment that is maintained and calibrated at set

intervals to ensure traceability to national and international standards (Sithole,

2006:4). Records of equipment maintenance and calibration should be maintained.

Reference standards, reference material, and intermediate checks should be used

to ensure traceability of testing or calibration (Sithole, 2006:4).

2.5.5.2 Sampling

The critical requirement that in the achievement of valid results in specific

technologies and therefore need to be taken into account and addressed is the

process of sampling (Sithole, 2006:4). Where the laboratory is involved in

sampling, the laboratory should have established and unbiased sampling

procedures and adhere to that (Gabi, 2006:2).

36

Gabi (2006:1) points out that laboratories involved in the regulatory testing field,

should receive samples that are identified by codes and true identities withheld. It

should be a practice for laboratory personnel not to be in direct contact with the

sample owners. The arrangement guards laboratory personnel from being offered

bribes and victimization by sample owners.

2.5.5.3 Handling of test and calibration items

The laboratory should have procedures for the transportation, receipt, handling,

protection, storage, retention and disposal of test or calibration items including all

provisions necessary to protect the integrity of the test or calibration item, and to

protect the interests of the laboratory and the customer (Sithole, 2006:4).

2.5.5.4 Assuring the quality of test and calibration results

The laboratory should have quality control procedures for monitoring the validity

of tests and calibrations undertaken (Sithole, 2006:4). The monitoring of tests or

calibration could include participation in interlaboratory or proficiency testing

programmes, retesting or recalibration of retained items, replicate tests or

calibration using the same or different methods, regular use of certified material or

internal quality control using secondary reference materials (Sithole, 2006:4).

2.5.5.5 Reporting the results

The results of each test or calibration carried out by the laboratory should be

reported accurately, clearly, objectively and in accordance with any specific

instructions in the test or calibration methods (Sithole, 2006:6). An approved

template needs to be used for generate all the test reports or calibration certificates

(Sithole, 2006:6). When opinions and interpretation are included in the reports,

the laboratory should document them on the basis upon which they have been

made. Opinions and interpretation should be clearly marked as such in the report

(Sithole, 2006:6).

37

2.5.4 Benefits of ISO 17025 certification

Governments and regulators can benefit a lot by using ISO 17025 certified

laboratories. Certification to ISO 17025 increases confidence in data issued by

laboratories. It reduces uncertainties associated with decisions that affect the

protection of human health and the environment. It is seen as a seal of approval,

and therefore increases public confidence. It facilitates trade and economic

growth, gives laboratories a marketing advantage, international recognition and

can be used as a benchmark for performance (Robertson, 2010:4).

Sithole (2006:6) reports that implementing a laboratory quality standard and

certifying it can benefit laboratories. It serves as a standard to transmit

information; encourages transparency as activities are documented and accessible

to all personnel, assist personnel in the understanding and application of policies,

it is a good marketing tool to give customers confidence about the reliability and

consistency of their service providers. It is a training tool for new employees,

ensures uniformity of the organisation’s practices and tasks, and assists personnel

to make decisions (Sithole, 2006:6).

Bailey (2003:2) warns that ISO 17025 has been criticised for the emphasis it

places on documentation, records and record keeping. Experience has shown that

this criticism is to some extent true, but careful drafting of laboratory policies and

procedures can significantly reduce the record keeping workload (Bailey, 2003:2).

Care must be taken to select the correct data and information for inclusion in

laboratory records and to ensure policies and procedures support that (Bailey,

2003:2). Records are essential and the effective use and interpretation of recorded

information and data is essential to maintaining a consistently high laboratory

performance (Bailey, 2003:2).

Sithole (2006:6) reports that there are different reasons why organisations that

have attempted to implement and certify quality systems do not succeed. The

reasons are adopted from Sithole (2006:6) and are listed below.

38

The tendency to separate the “business system” from “the Quality

management system” This leads to the organisation to give attention to

their quality management system (QMS) when there is an assessment

taking place only. Both systems need to be run as a single system to

achieve the overall organisational goals.

Implementing the system just because the client demands that the

laboratory should be certified. The system becomes the client’s system but

not the organisation’s. Efforts made are simply to satisfy that particular

client but not to the benefit of the laboratory.

Implementing the system to satisfy the assessors. This means that all

efforts are made to ensure that when assessors come to assess the system,

they should be impressed to find certain practices and records in place

although they do not improve the organisation.

Implementing the system merely to meet the minimum requirements of the

standard. Other tools, good practices and improvement are found not to be

necessary for the laboratory/organisation. This leads to a situation whereby

a laboratory is only satisfied because certification has been achieved. Due

to lack of further improvement the systems falls flat.

Lack of involving personnel in running the system. The management

becomes one person’s responsibility (QA Manager/ Nominated

representative) In the event of that person deciding to leave the

organisation, the system falls apart.

39

2.6 ORGANIZATION FOR ECONOMIC COOPERATION AND

DEVELOPMENT GOOD LABORATORY PRACTICE (OECD

GLP)

2.6.1 History of OECD GLP

In the past, there have been unfortunate instances of a small but disturbing history

of falsifying or ‘massaging’ of data from studies. Companies invest a lot in

developing expensive products and some would do anything to ensure that their

products reach the market place (Prichard, 1995:221).

Major events took place in 1975 when Senator Edward Kennedy and members of

(FDA) Food and Drug Administration made allegations against research

laboratories (Searle and Hazelton laboratories) in the USA related to preclinical

research studies. Both sides were investigated, and this revealed serious problems

with the conduct of safety studies submitted to the agency. Violations included

poor record keeping and data storage, inadequate personnel training, poor test

facility management, and even fraud (Robinson, 2003:38).

As a result, in 1976 the United States Food and Drug Administration (FDA)

developed a set of principles for such studies which had to be adhered to before a

regulatory authority could accept data from the studies (Prichard, 1995:221). The

Organisation for Economic Cooperation and Development (OECD) established

and published an international standard in 1982 to enable study data to be

accepted between countries (Prichard, 1995:221).

By January 1986, scientists at Searle had developed a document, Good Laboratory

Practice. The document was developed to be used as a guide to evaluate research

activities, and submitted it to both the FDA and the Pharmaceutical Research and

Manufactures Association of America (PhRMA). In August of the same year,

FDA released a draft GLP document based on the Searle paper and published

GLP regulations in the Federal Register (Robinson, 2003:38).

Further changes to the GLP rules were proposed in 1984, and in September 1987,

FDA published its “Final Rule” – Compliance Program Bioresearch Monitoring:

40

Good Laboratory Practices, which was expanded to incorporate the requirement

for a Quality Assurance department, the requirement for protocol preparation

(study plan), the characterisation of test and control materials, the requirement to

retain specimens and samples (Robinson, 2003:39).

Since then, the requirement for laboratories to apply and comply with GLP

principles has extended from pharmaceutical companies to many other types of

research and testing establishments throughout the world. In Europe, adherence to

the principles of GLP is governed by European Union (EU) law (Robinson,

2003:39). Non-clinical health and environmental safety studies covered by the

Principles of GLP include work conducted in the laboratory, in greenhouses, and

in the field (Leballo, 2006:1).

Modern life without chemicals would be inconceivable; nowadays chemicals are

part of our daily life. For example, chemicals are used in the manufacturing of

paints, sun cream and other products. The chemical industry is one of the largest

in the world. The Organisation for Economic Cooperation and Development

(OECD) member governments and their chemical industry have a major

responsibility to ensure that chemicals are produced in a safe manner and used as

safely as possible (Sigman, 1999:5)

The OECD is an intergovernmental organisation from thirty industrialised

countries. Its purpose is to monitor economic trends in those countries. It is a

centre for discussion where governments express their view points, share

experiences and search for a universal position (Leballo, 2006:3).

The OECD clarifies the economic and social problems facing its member

countries quantitatively. There is also an exchange of information on how the

problems are approached in different countries and promotes learning between

member countries. Member countries also analyse the effectiveness of economic

and social policies; make countries aware of the impact of their actions on the

others; and search for common solutions or strategies to address the challenges

that they are facing (Leballo, 2006:3). Leballo (2006:4) further announces that

South Africa participates in the Working Group on GLP via the national

41

accreditation body, and is invited to participate in (WNT) Working Group of

National Co-ordinators of the Test Guidelines Programme.

South Africa is the first non-member country to join OECD Mutual Acceptance of

Data as a full member. This means that South Africa will accept data from OECD

Countries generated under Mutual Acceptance of Data (MAD) conditions and

OECD countries will accept data from South Africa generated under MAD

conditions. A team of experts from three OECD country governments has

evaluated the South African GLP authority/national accreditation body on site.

The OECD council has invited South Africa to become a full member of the

system with the same rights and obligations as OECD countries. The decision was

based on the positive outcome of the evaluation (Leballo, 2006:4).

2.6.2 Description of OECD GLP

The Principles of Good Laboratory Practice (GLP) have been developed to

promote the quality and validity of test data used for determining the safety of

chemicals and chemical products (Leballo, 2006:1). It defined as a managerial

concept that covers the organizational process and the conditions under which

laboratory studies are planned, performed, monitored and reported. These

principles need to be followed by laboratories conducting studies that have to be

submitted to national authorities for the purposes of assessment of chemicals.

Other uses relate to the protection of humans and the environment (Sigman,

1999:7).

Most of the principles are contained in ISO 17025 standard. But there is a

different focus for OECD GLP compliance due to the type of work that they are

engaged in and also the results originating from the investigations (Leballo,

2006:2).

According to Leballo (2006:2), there are defined processes that need to be

followed when conducting a non-clinical study in accordance with the OECD

Principles of Good Laboratory Practice. Requirements with regard to the sponsor,

42

facility management, study director, principal investigator and quality assurance

programme needs to be satisfied.

2.6.3 Description of the main clauses of OECD GLP

The OECD principles have requirements that laboratories need to compliant with,

in order to satisfy GLP. Those includes test facility management‘s requirements,

study director’s responsibilities, principal investigator’s responsibilities, study

personnel’s responsibilities, quality assurance programme, facilities, apparatus,

materials and reagents, test systems, test and reference items, standard operating

procedures, performance of the study, reporting of the study results, storage and

retention of records and materials (Leballo, 2006:1). The requirements are

discussed below.

Different personnel have different responsibilities with regard to the system. The

responsibility of the management of the test facility is to ensure that the quality

assurance is performed according to the principles of Good Laboratory Practice.

The facility management needs to ensure that “the Study Director has made the

approved study plan and is available to the Quality Assurance personnel”. The

responsibility of the Study Director to ensure that if there are any changes to the

study plan, they are communicated to the Quality Assurance personnel on time

during the conduct of the study (Sigman, 1999:5).

2.6.3.1 Test facility management’s requirements

The Facility Management has the responsibility to ensure that principles of Good

Laboratory Practice are complied with. Part of the facility management

responsibility is to designate a competent person who is trained, qualified and has

experience as the study director before the initiation of the study (Leballo,

2006:2). An essential management responsibility is the appointment and effective

organisation of an adequate number of qualified and experienced personnel in the

laboratory. The manager or person ultimately responsible for GLP should be

clearly identified. The responsibility of the manager responsible for GLP includes

the appointment of qualified and competent personnel for the experimental

43

programme and for conducting an independent quality assurance function

(Sigman, 1999:7).

2.6.3.2 Study director’s responsibilities

The study director is the main person responsible for conducting the study. The

responsibilities of the study director include approving the study plan; ensuring

that the Quality Assurance personnel have a copy of the study plan, assures that

the study plan, amendments and (Standard Operating Procedures) SOPs are

available to study personnel; ensuring that the study plan and SOPs are followed;

communicating effectively with QA; ensuring that computerised systems have

been validated; ensuring that raw data is documented; signing of the final report

and extent of GLP compliance; archiving raw data, study plan, final report and

supporting materials; identifying and defining the role of Principal Investigators

(Leballo, 2006:3).

2.6.3.3 Principal investigator’s responsibilities

There should also be a competent principal investigator with relevant experience

in case there is a multi site study. All personnel need to be trained with regard to

the documented standard operating procedures. A quality assurance programme

needs to be in place in accordance with the principles of Good Laboratory

Practice. The facility management needs to ensure that the study plan is approved

by the study director and quality personnel should be made aware of it. Test and

reference items should be appropriately characterized. There should be a person

appointed as an archivist. The organisation structure needs to be clearly developed

and the reporting lines need to be clearly identifiable (Leballo, 2006:2). The

principal investigator is the second in charge; he/she acts on the Study Director’s

behalf if not available. The principal investigator ensures that deviations from the

study plan and Standard Operating Procedures (SOPs) are documented, reported

and approved by the Study Director and contributes to the final report transfers

specimens and all data to the Study Director (Leballo, 2006:3).

44

2.6.3.4 Quality assurance programme

The test facility should have a documented Quality Assurance Programme to

assure that studies are conducted according to the Principles of GLP. The Quality

Assurance Programme should be carried out by an individual designated and

directly responsible to management and who are familiar with the test procedures.

To ensure that there is no bias, the individual should not be involved in the

conduct of the study being assured (Leballo, 2006:4).

Quality assurance should be conducted by a personnel reporting directly to the

Facility Management and should be familiar with the test methods. The quality

assurance personnel should be independent of the study being assured. The

responsibility of the quality assurance personnel is to maintain copies of approved

study plans and SOPs used in the test facility. The quality assurance personnel

should have access to the current copies of the master schedule. They should also

confirm that information contained in the study plan is what is required for

compliance with Principles of Good laboratory Practice. Quality assurance

personnel are responsible for conducting inspections to ensure that studies are

conducted according to principles of Good Laboratory Practice; inspect final

reports to confirm that the methods and observations are accurately described, and

that the reported results are accurately and completely a reflection of the raw data

of the studies conducted (Leballo, 2006:3).

Sigman (1999:6) describes the responsibilities of the Quality Assurance personnel

as set out below. The responsibilities of the Quality Assurance personnel include,

but are not limited to, the following functions. They should:

Maintain copies of all approved study plans and Standard Operating

Procedures in use in the first facility and have access to an up to date copy

of the master schedule.

Verify that the study plan contains the information required for

compliance with these Principles of Good Laboratory Practice. This

verification should be documented.

Conduct inspections to determine if all studies are conducted in

compliance with these Principles of Good laboratory Practice. Inspections

45

should also determine that study plans and Standard Operating Procedures

have been made available to study personnel and are being followed.

Inspections can be of three types as specified by Quality Assurance

Programme Standard Operating Procedures:

- Study based inspections

- Facility based inspections

- Process based inspections

Inspect the final reports to confirm that the methods, procedures, and

observations are accurately and completely described, and that the

reported results accurately and completely reflect the raw data of the

studies.

Promptly report any inspection results in writing to management and to the

Study Director, and to the Principal Investigators and the respective

management, when applicable.

Prepare and sign a statement, to be included with the final report, which

specifies types of inspections and their dates, including the phases of the

study inspected, and the dates inspection results were reported to

management and the Study Director and Principal Investigators, if

applicable. The statement would also serve to confirm that the final report

reflects the raw data.

It is the OECD GLP requirement that QA personnel should have the training,

expertise and experience necessary to fulfil their responsibilities. A training

programme needs to be defined and implemented. The training programme should

include where possible, on-the-job training and experience under the supervision

of personnel who is already declared competent. The training records of both

internal and external training attended should be recorded. Training should not be

a once off exercise, it needs to be a continuous exercise and be constantly

reviewed to ensure relevance (Sigman, 1999:7).

46

2.6.3.5 Test facilities

The test facility should be of suitable size. Its construction and location should

meet the requirements of the study and interferences with the validity of the study

should be minimal. There should be proper separation of incompatible activities to

assure proper conduct of each study (Leballo, 2006:5).

2.6.3.6 Apparatus, materials and reagents

All the apparatus including validated computerised systems that is used to

generate, store and retrieve data relevant to a certain study, should be located and

of appropriate design and adequate capacity. Apparatus used in the study need to

be inspected and calibrated on a regular basis. Where appropriate, calibration

should be traceable to national or international standards (Sigman, 1999:22).

2.6.3.7 Test systems

With regard to the physical or chemical apparatus used for the generation of

physical or chemical data, apparatus need to be suitably located and should be of

proper design and adequate capacity. Proper conditions should be established and

maintained for the storage and handling of biological test systems in order to

ensure the quality of the data (Sigman, 1999:22).

2.6.3.8 Test and reference items

Procedures and records for the sample receipts, handling of the sample, the

sampling process and storage of the sample need to be documented and

maintained. Each test item should be properly identified. For each study,

information such as the test item batch number, purity, composition,

concentrations should be known. The stability of the test item and reference item

should be known so as to determine the suitable storage conditions for them

(Sigman, 1999:24).

47

2.6.3.9 Standard operating procedures

Test facilities should have documented Standard Operating Procedures that have

been approved by the test facility management in order to ensure the quality and

integrity of the data generated. All the revisions to Standard Operating Procedures

should be approved by the test facility management to ensure adherence to

document control procedures. Each separate test facility unit should have current

Standard Operating Procedures relevant to the activities being performed. Any

deviations form the Standard Operating Procedures related to the study should be

documented and acknowledged by the Study Director and the Principal

Investigator (Sigman, 1999:24).

2.6.4.0 Performance of the study

There needs to be a documented plan prior to the initiation of each study. The

study plan should be approved by the Study Director and verified for GLP

compliance by the Quality Assurance personnel. The study plan should be

approved by the test facility management and the sponsor, if required by the

national regulation or legislation in the country where the study is performed

(Sigman, 1999:25).

2.6.4.1 Reporting of the study results

There should be a final report for each study conducted. Reports of Principal

Investigators or scientists involved in the study should be signed and dated by

them. The final report should be signed and dated by the Study Director to

indicate acceptance of responsibility for the validity of the data. The extent of

compliance with the Principles of Good Laboratory Practice should be indicated.

All the corrections and additions to a final report should be in the form of

amendments. Amendments should clearly specify the reason for the corrections or

additions and should be approved by the Study Director.

48

2.6.4.2 Storage and retention of records and materials

In order to prevent contamination of materials, there should be separate rooms for

receipt and storage of the test and reference items. Storage rooms for the test

items should be separate from rooms containing test systems and should be

preserved. Archive facilities should be provided for the secure storage and

retrieval of study plans, and all activities relating to the study (Sigman, 1999:22).

There must be archive facilities to ensure secure storage and retrieval of

documents like the study plans, raw data, final reports, and also samples of test

items. Archive design and archive conditions should protect contents from

untimely deterioration (Sigman, 1999:22). Apparatus used in a study should be

periodically inspected, cleaned, maintained, and calibrated according to

documented standard operating procedures. It is a requirement to records the

activities in the laboratory. To ensure that the laboratory is a safe working

environment for all employees, chemicals, reagents, and solutions used in the

studies should be labelled to indicate their identity and concentration. Where

applicable, the expiry date and specific storage instructions should also be

indicated on the containers (Sigman, 1999:22).

2.6.4 Benefits of OECD GLP certification

There are benefits of being certified to OECD GLP. The OECD GLP system

saves huge amounts of capital for governments and chemical producers around

the world. The system permits the results of different safety tests done on

chemical products to be shared across OECD (Organisation for Economic

Cooperation and Development) countries (Leballo, 2006:1).

Compliance with the principles of GLP allows the validity of the test results to be

accepted between organisations and countries. This minimises the need to repeat

the testing in different countries. This leads not only to monetary savings, but also

saves the lives of countless laboratory animals (Prichard, 1995:222).

49

2.7 CONCLUSION

This literature review highlights that organisations and countries around the world

implement international standards to monitor the quality of their products and/or

services. Some organisations implement standards due to pressure from their

customers, while others identify the need to implement quality standards from

within. Whatever the reason is for implementing and certifying or accrediting

quality assurance standards, Prajogo (2010:78) the number of organisations

implementing them is has increased.

Implementing laboratory standards is not an easy task for many laboratories.

There are challenges facing laboratories from different parts of the world with a

desire to implement quality assurance standards like ISO 17025 and OECD GLP.

Such challenges include the cost of certification, a challenge that is especially felt

by laboratories from the developing countries. There is also a challenge of lack of

resources in terms of valid equipment and competent personnel to interpret the

standard.

To assist in understanding the activities in a laboratory, there is a focus on

defining the processes within the laboratory that make up operations in the

laboratory. The literature also focused on giving the background of laboratory

standards, especially internationally accepted standards. There are technical and

management requirements that laboratories need to satisfy as per laboratory

standards like ISO 17025 and OECD GLP, in order to be declared competent. The

requirements of the laboratory standards, both the technical and management

requirements, address the handling of processes within the laboratory operations.

The next chapter is a literature review on the performance criteria within

operations. It will also elaborate on the factors that are used as the criterion for

measuring performance within operations.

50

CHAPTER 3

LABORATORY PERFORMANCE CRITERIA

3.1 INTRODUCTION

There are different factors that can be used as criteria for measuring performance

in the operations environment. The chapter starts by exploring performance

criteria within operations management.

The chapter also defines the subject of performance measurement. Performance

measurement forms part of the root cause analysis process when identifying

challenges in processes, and identifying areas that need attention with regard to

performance improvement. Performance measurement is the only way challenges

can be identified and the progress of improvement programs monitored to verify if

they bring about the desired change (Ndlovu, 2005:6).

The factors that have been identified from the literature as criteria for measuring

laboratory performance are customer satisfaction, profitability, supplier selection

and performance, human resources and health and safety. The identified factors

are discussed in more detail in the chapter.

3.2 PERFORMANCE MEASUREMENT

Radnor and Barnes (2007: 394) confirms that (Taylor, 1911) has proven that

improving operational performance starts with measurement. The challenge faced

in this regard is ensuring that the right factors are measured and that these

measures are used as the foundation for managing performance improvement. The

process of merely reporting performance without performance management can

be counter-productive.

Performance measurement is ‘part of the diagnosis/analysis process of identifying

where improvement activity should be prioritised’ (Ndlovu, 2005:6). Measures

51

are the starting point for analysis. Measurement is critical for monitoring change

and progress when an improvement program has been implemented. Before

embarking on measuring performance, SMART objectives have to be established.

SMART is an acronym for “Specific, Measurable, Achievable, Relevant/Realistic,

Time-Bound” (Ndlovu, 2005:6). An effective performance management system

should inform management and give an indication of the extent to which set

objectives are met. Such information can be obtained and reported once key

performance indicators (KPIs) have been set and agreed upon (Ndlovu, 2005:6).

3.2.1 The importance of performance measurement

There are four generic critical areas identified that establish a balanced view of the

organisation (Norton and Kaplan, 1992:71). The identified critical areas can be

used by any organisation from the production or service sectors to create

meaningful measures that can be used to track performance. Financial measures

give an indication of the financial health of an organisation at any point in time

(balance sheet) or a reflection of past performance (income statement). Both the

balance sheet and income statement are used by organisations to measure

performance, but they merely give indications of past or current performance.

They do not inform organisations of future performance (Sidney, 2004:1).

According to Chow and Van der Stede (2006:27) performance measurement plays

an important role in running an organisation. The strategy has to be translated into

the desired behaviours and results. Expectations with regard to the strategy should

be communicated, progress monitored and feedback provided. Employees should

be motivated through performance-based rewards and sanctions (Chow & Van der

Stede, 2006:27).

Nowadays, organisations implement quality initiatives in order to increase the

quality of their processes and products. If performance is not evaluated,

management will not know if their initiatives are moving them towards set goals.

Management needs to know if their initiatives are not bringing them fruitful

results at an early stage so that they can implement corrective and/or preventative

52

measures. Quality performance can be measured by using both financial and non-

financial measures. But all have to be used in a balanced way (Uyar, 2009:85).

3.2.2 The advantages and disadvantages of different types of performance

measures

Sidney (2004:1) reports that financial measures give information such as the time

it takes to collect outstanding debtors, debtors’ days and cash flow statement. The

only concern is that these measures do not give information about non-tangible

issues like efficiency, process quality or effectiveness of training programmes

(Sidney, 2004:1).

Chow and Van der Stede (2006:27) agree that managers have been using financial

measures to evaluate performance of their organisations but that this practice has

its own limitations. No measure is better than the other; organisations should use

both financial and non-financial measures as they complement each other.

Horngren, Datar & Foster, (2006:668) are also of the opinion that there should be

an integrated use of financial and non-financial measures as they supplement each

other.

According to Horngen et al, (2006:669) there are advantages to using financial

and non-financial measures. Some of the advantages include the fact that financial

measures focus management’s attention on the costs of poor quality. They provide

a measure of quality performance for evaluating trade-offs among prevention cost,

appraisal costs and internal failure costs of poor quality. They also help when

comparing costs and benefits of different quality improvement programs and

setting priorities for cost reduction. Horngen et al, (2006:669) identify the

advantage of non-financial measures as being easy to understand and quantify.

They direct attention to the physical processes, and therefore assist management

in identifying problem areas that need improvement. Non-financial measures,

such as the number of non-conformances, provide immediate feedback on

whether quality improvement efforts are succeeding or not. Measures on customer

and employee satisfaction are useful indicators of long-run, future performance

(Horngen et al, 2006:669).

53

Uyar (2009:73) advises that it is very critical to measure the performance of

operations in terms of both financial and non-financial measures. According to

Uyar (2009:73) as much as organisations would want to know the number of

reworks and rejects in their operations, they would also want to know if they are

running a profitable operation, hence financial measures should be factored into

measuring operations performance. Bourne et al (2005: 381) also support the idea

that financial measures should be one of the factors used to measure performance

in operations. That should give an indication as to whether the operation is

running at a loss or at a profit. Price (2005: 451) advises that regular budget

reviews in laboratory operations should be seen as part of good financial

management practice. Price (2005: 452) further reports that measuring income

and expenditure in laboratory operations, will confirm whether the laboratory

operations are running at a loss or at a profit. Ritzman and Krajewski (2003:15)

report that operations should strive to lower the costs of operations. If this is

achieved, lowered prices can increase the demand for products or services, which

in turn leads to profitable operations (Ritzman & Krajewski, 2003:15).

Sidney (2004:3) is of the opinion that if you cannot measure something, it means

you know very little about it and therefore cannot control it. For a measurement

system to assist in controlling performance, it should not be operated in isolation.

It should be part of a complete control mechanism. If a measurement system

operates in isolation, it might not be possible to use the data collected to make

important decisions. A performance measure system should be designed in a way

that participants are trained and empowered to make changes based on the

feedback that they get from the system (Ndlovu, 2005:4).

Price (2005:454) has defined criteria for appropriate performance indicators. For

evaluations to be meaningful, they need to be appropriate, dependable,

discriminatory, free of risk, valid and “fit for purpose”. Price (2005:452) further

reports that there has been a focus on quality control and quality assurance when it

comes to performance. But lately there has also been focus on internal measures

like turnaround times and customer satisfaction measurement through

questionnaires (Price, 2005:452).

54

3.3 PERFORMANCE MEASUREMENT CRITERIA WITHIN

OPERATIONS

Operations management is the management of activities within an organisation

that produces goods or services required by customers. It is critical for personnel

managing operations to be able to measure the performance of their activities in

order to improve efficiency and effectiveness (Radnor & Barnes, 2007:384).

“Efficiency is based around the notion of output divided by input, which focuses

measures around the productivity of a process and the utilization of resources.

Effectiveness is based around the notion of the appropriateness of the outputs of

the process” (Radnor & Barnes, 2007:385). According to Radnor and Barnes

(2007:385) there are factors that are used within operations as criteria to measure

performance.

Ritzman & Krajewski (2003:25) advise that it is wise to use multiple factors in an

attempt to measure and improve performance in operations. Hence, five factors

have been identified and used to measure performance for the purpose of the

study. The five factors are discussed below.

3.3.1 CUSTOMER SATISFACTION

Radnor and Barnes (2007: 389) identify customer satisfaction as one of the

important factors that needs to be measured. Uyar (2009:74) and Bourne et al

(2005: 381) agree that customer satisfaction measurement gives an indication of

the performance of operations. Price (2005:452) supports the measure of customer

satisfaction by using questionnaires as a good means of measuring laboratory

operations. Questions like sample turnaround times can be included in

questionnaires sent out to customers. Johnston and Clark (2005:105) explain that

if operations meet customer expectations, or even exceed them, then the end result

is satisfied customers. When customers are satisfied or delighted, there is a chance

that they will recommend the product or service to other potential customer

(Johnston & Clark, 2005:105).

55

Bakar, Hakim, Chong and Lin (2010: 76) describes customer satisfaction as a

‘psychological attitude which indicates a customer’s positive or negative feeling

about the value he or she receives as a result of using a particular organisation’s

products or services’. Most organisations have made customer satisfaction the

heart of their slogans in working towards achieving 100 percent customer

satisfaction. Customer satisfaction is adopted as a strategic objective for most

organisations. It is not only acknowledged in the private sector, but also in the

public sector (Bakar et al, 2010: 76).

3.3.1.1 Recognising the importance of customer satisfaction

Boyer and Verma (2010:32) report that it is a challenge to increase market share.

But keeping existing customers can keep the organisation in business and it is a

less costly exercise. Organisations that invest in producing high-quality products

and services tend to have high customer retention and loyalty. A satisfied

customer is more likely to be loyal and spread positive reports by word of mouth.

A satisfied customer markets the products of the organisation on its behalf. But, it

has to be noted that low quality products and/or services lead to negative word of

mouth and lower customer satisfaction (Boyer and Verma, 2010:32).

Wirtz (2003:96) reports that organisations are recognising customer satisfaction as

the main ingredient and primary requirement for success in the market place and

thus for staying in business. Customer satisfaction leads to repeat purchases,

loyalty, positive word-of-mouth and increased long-term profitability.

Organisations have started seriously monitoring their performance regarding

customer satisfaction. Organisations have defined the attributes by which they

measure themselves, which assists them in implementing measures to address

their weaknesses and capitalise on their strengths (Wirtz, 2003:96).

Customer satisfaction is an indication of the long-term profitability of an

organisation. The quality of products and/or services produced by an organisation

has a big impact on customer satisfaction (Boyer & Verma, 2010:31). When

developing an improvement plan, and before implementing it, it is critical to get

customer feedback. Customer feedback can be monitored in different ways.

56

Customer satisfaction measures provide organisations with useful information.

They can measure if the products and/or services that an organisation produces

meet or exceed customer expectations. They can also monitor how the

implementation of quality initiatives and efforts impact on customers’ perceptions

over time (Boyer and Verma, 2010:408).

According to Boyer and Verma (2010:408), keeping track of and monitoring

customer complaints can provide organisations with valuable customer feedback

that identifies issues that need to be acted upon. Rowbotham, Galloway &

Azhashemi (2007:347) report that if organisations are serious about quality, they

should encourage keeping track of customer feedback, both compliments and

complaints. Rowbotham et al (2007:347) warn that customers are likely to give

the supplier feedback when it is positive. On the other hand, they are more likely

to tell ten other people when they are disappointed and not tell the supplier or

service provider.

Service quality depends on the customer’s perception, and not necessarily the

product/service provided. Customer satisfaction depends largely on the mood of

the customer (Rowbotham et al, 2007:346). Rowbotham et al, (2007:346) report

that distributing satisfaction questionnaires in an attempt to measure customer

satisfaction is not effective at all times. The percentage of customers who

complete the questionnaires is normally low. The questionnaires themselves are

sometimes poorly designed. They further report that questionnaires that are

properly designed and distributed to a well representative sample, to identify

customer issues will give reliable data, but the exercise is very expensive.

3.3.1.2 Addressing customer issues

Boyer and Verma (2010:408) point out that sometimes organisations appoint

customer panels or teams, to assess the quality of products and services that they

offer. There is normally a selection criterion of individuals who become part of a

panel. Rowbotham et al (2007:347) clarify that organisations form focus groups to

resolve any issues that arise from completed questionnaires. The focus groups

57

meet at regular intervals with a facilitator to discuss how issues will be resolved


Lai and Cheng (2005:452) report that when issues have been identified, quality

improvement initiatives should be focused on the customer and not internally

focused. When improvements are internally focused, they do not seem to have a

positive impact on performance. A market-oriented culture must be encouraged as

a focus on market needs can drive organisational performance and have a positive

impact on it (Lai & Cheng, 2005:452).

Implementing a quality standard like ISO 9001, without the voice of the customer

might not yield the desired results like customer satisfaction and competitive

advantage (Lai & Cheng, 2005:453). Customer satisfaction can only be achieved

by an effort from the entire organisation. All organisational members should be

made aware that quality management and marketing performance for customer

satisfaction are the responsibly of all personnel. Quality and marketing

management should not be the responsibility of certain departments only (Lai &

Cheng, 2005:455).

3.3.1.3 Methods used by organisations to measure customer satisfaction

Different sectors in industry consider perception as a critical factor in satisfying

customers. Organisations use different methods to measure customer satisfaction.

Methods used include surveys and questionnaires, focused group interviews and

monitoring customer complaints. It is advisable for organisations to use different

methods to collect data on customer satisfaction. Most organisations monitor

customer complaints on a continuous basis. Organisations acknowledge that

customer complaints are not efficiently used for quality improvement purposes,

and sometimes organisations display defensive behaviour when customer alerts

are raised against them (Oja, Kouri & Pakarinen, 2010: 415).

Laboratories are following the trend of measuring customer satisfaction by using

customer satisfaction surveys. Most laboratories distribute customer satisfaction

questionnaires annually to their customers. The customer satisfaction

58

questionnaire is a valuable tool to assess performance and identify opportunities

for improvement in services offered by laboratories (Grochau, Ferreira, Ferreira &

Ten, 2010:686). Oja et al (2010:415) add that modern quality standards that are

implemented in laboratories recommend the use of customer feedback as part of

quality improvement.

ISO 17025 and ISO 15189 standards which are laboratory specific standards,

require laboratories to have a documented policy of how customer complaints are

resolved. The records of the corrective and/or preventive actions taken, need to be

maintained (Oja et al, 2010: 415). The root causes of customer complaints must

be identified in order to ensure that the actions taken will prevent the same issue

from coming up again (Oja et al, 2010: 419).

Smith (2006:88) reports that most of the time, management spend a lot of time

and effort resolving customer complaints. The process becomes a never ending

cycle, personnel find themselves facing dissatisfied customers continuously

(Smith, 2006:88).

3.3.2 PROFITABILITY

Quality is the most central criterion in many markets and is even an entry

requirement in others. Poor quality has a negative impact on cost and the

competitive advantage of an organisation. In sectors like non-profit organisations

and internal customer-suppliers relations, poor quality wastes resources that could

be dedicated to achieving other organisational objectives (Rowbotham et al,

2007:368). Organisations that produce superior quality product/services reap the

rewards of enhanced financial performance (Boyer & Verma, 2010:32).

It has become standard practice globally to assess the performance of a business

by using financial measures. The financial status of an organisation is what is

looked at when reporting whether a business is successful or not. Eventually, the

success of an organisation depends on whether or not it makes money.

Organisations are now realising that assessing the performance of an organisation

59

using only financial measures does not provide enough information to help guide

the organisation (Sidney, 2004:1).

Uyar (2009:73) agrees that though financial measures report the performance of

an organisation in monetary terms, looking at financial performance only, does

not cover a lot of critical performance activities happening behind the scenes. The

financial reports do not do justice to the activities behind the numbers presented.

3.3.2.1 Profitability within the laboratory

The era prior to the 1980s performance of organisation/laboratory was

characterised by an emphasis on financial measures like profit, return on

investment and productivity as the indicators of laboratory performance.

Performance with regard to intangible assets was ignored. Those include internal

processes that produce the product or service required by customers, meeting

objectives with regard to personnel learning and growth, customer retention and

satisfaction. Considering both the tangible and intangible assets assists in

reviewing the performance of an organisation holistically (Ndlovu, 2005:2).

Ndlovu (2005:3) further elaborates that the period of contemporary or emerging

laboratory performance management is a representation of the second part of the

‘performance management dichotomy’ which started around the 1990s due to

globalisation and changes in world markets. When global markets became

accessible to everyone, there were challenges that caused some laboratories to

lose their place in the market. For laboratories to regain their competitive

advantage, they had to change their strategy from low cost operation to that of

focusing on quality, better sample turnaround times, be flexible when customer

needs change and implemented operations management ideas and guidelines to be

able to view laboratory performance in a complete manner (Ndlovu, 2005:3).

Rodrigues (2006:6) reports that nowadays, laboratories need to assess their

processes throughout the supply chain. There is a constant increase in the number

of regulations and standards. There is also a major focus on quality control

principles globally. Sidney (2004:1) is of the opinion that ‘measurements form

60

the backbone of all testing and calibration laboratories in the day-to-day

operations’. Sidney (2004:1) also points out that laboratories should think of using

the Balanced Score Card in order to achieve their set objectives.

Sidney (2004:2) further suggests that when compiling a laboratory strategy, it is

critical to ensure that customer needs and laboratory internal processes are

considered for a Balanced Score Card. There must be a defined laboratory scope

and the turnaround time should be determined. The laboratory internal processes

should ensure that personnel competency and equipment required are addressed

(Sidney, 2004:2).

Ndlovu (2005:2) is of the view that using financial measures only has limitations.

Modern laboratories should strive to develop new performance measures that will

look at the entire system. The limitations of traditional performance measures in

the laboratory are identified as being irrelevant to practice, inflexible to the needs

of different departments, not incorporating a culture of continuous improvement

and conflicting with sustainable growth (Ndlovu, 2005:2).

Rowbotham et al (2007:333) warn that ‘quality of the operation itself can have a

direct impact upon costs and hence on profitability’. If the quality of the process is

poor, it leads to wasteful results like a high percentage of rejects and rework.

Rejects and reworks are a non-value-adding exercise and result in wasting more

material and capacity that could have been used elsewhere. Rowbotham et al

(2007:333) further report that in today’s competitive markets around the world, a

process of poor quality has an unfavourable effect on profitability.

3.3.3 SUPPLIER SELECTION AND PERFORMANCE MEASUREMENT

Most organisations depend on outside suppliers for some of the materials, services

or parts used in producing their products and services to satisfy their customers.

The quality of these inputs can affect operations of the buying organisations. Both

the buyer’s approach and specification management are keys to controlling the

selection and performance of the supplier. Once the buyer has identified and

selected suppliers, they must work with them so that they can supply defect-free

61

parts, consistently. The specifications for purchased goods and services must be

clear and realistic (Ritzman & Krajewski, 2003:119).

The operations function is not independent; it is linked to other functions like

purchasing in an organisation. The performance of suppliers can have a positive

or negative impact on the performance of operations, therefore supplier selection

and performance is identified as one of the factors affecting the performance of

operations (Radnor & Barnes, 2007: 390). Bourne et al (2005: 375) raise the

importance of supplier characteristics and performance in relation to the

performance of operations. A selection of good suppliers and the management of

selected supplier can have a positive impact on operations performance (Ambrose,

Marshall and Lynch, 2010:1269). Chin, Yeung and Pun (2006:743) advice that

operations managers need to manage the performance of their suppliers and

always strive to correct any deficiencies as and when they arise. Chin et al (2006,

744) point out that suppliers have the ability to influence customer satisfaction;

there it is the imperative that the supplier selection and performance be measured

as part of measuring operations performance.

The purchasing function has implications on the financial, operational and

strategic status of an organisation. It is one of the determining functions with

regard to the efficiency and effectiveness of the entire organisation. Purchasing

has an impact on performance of an organisation when it comes to delivery of

goods and/or services, cost and customer satisfaction. Therefore there must be

communication and integration with other functions within an organisation. The

main responsibility of the purchasing function is to source the right suppliers who

will supply products that meet the needs and requirements of the organisation. An

organisation normally has a number of suppliers for different materials and

services, and therefore it is the responsibility of the function to develop and

maintain close working relationships with suppliers (Rowbotham et al, 2007:308).

The suppliers’ actions can contribute to creating a competitive advantage for the

organisations. If the suppliers play their role positively, it will impact their

customers positively. Suppliers are ultimately responsible for parts and

subsystems needed to deliver goods and/or services. Therefore, they are selected

62

according to operational and strategic factors. The selection criteria used for

selecting suppliers, should be in alignment with the company’s competitive

strategy (Jabbour & Jabbour, 2009:481).

3.3.3.1 The role of the purchasing function

Purchasing starts with identifying the goods and/or services required. This is

followed by locating and selecting suppliers. The buyers then negotiate the

contract; agree on the terms of the service level agreement and payment terms.

The last step is for the buying organisation to track and assess the performance of

the selected suppliers (Verma & Boyer, 2010:19).

Rowbotham et al (2007:311) also elaborate on the steps that initiate the

purchasing process. The buyer receives a formal request from other departments

in an organisation and the product specifications are defined. The goods or

services that can be supplied by the same supplier are grouped together, and the

requisition is be forwarded to the supplier. Quotations from different suppliers are

then assessed and a preferred supplier chosen. A formal purchase order is then

sent to the supplier and the supplier commits to the delivery date. When the order

arrives it goes though the organisation’s quality control checks. Information on

the supplier’s price, quality, and delivery performance should be kept for future

supplier evaluation (Rowbotham et al, 2007:311).

According to Rowbotham et al (2007:314) purchasing goods and services at the

right price, has a major impact on the operation’s costs. This in turn has an impact

on the overall profitability of the organisation. If an organisation uses suppliers

that will provide it with quality goods and/or services consistently, this in turn

improves the organisation’s speed and reliability of delivering goods and/or

services. Purchasing poor quality parts and/or services can increase the

organisation’s operational costs. To prevent problems associated with poorly

performing suppliers, customers should assist their suppliers with quality

assurance programmes so that they can consistently perform at optimum levels


63

3.3.3.2 Supplier selection criteria

Rowbotham et al (2007:316) warns that organisations must spend enough time

selecting the right suppliers at an early stage to avoid problems. When selecting

suppliers, the focus should be on getting a supplier who can deliver quality goods

and/or services consistently and cost effectively. Organisations should also opt for

flexible suppliers who are able to manage the quantities that the organisation

requires. Organisations should never do business with suppliers who make late

deliveries as this has implications for efficiency, and might result in reworks due

to delivery of poor quality supplies. Rowbotham et al (2007:308) further report

that suppliers need to be included in the planning processes of an organisation. In

this way, suppliers gain an understanding of their customers’ long-term goals and

objectives.

According to Jabbour and Jabbour (2009:482) the supplier selection criteria

should include quality, cost, delivery, price and service. They (2009:477) point

out that very few organisations adopt environmental requirements as part of the

supplier selection criteria in a consistent manner. Only those organisations that

have very advanced environmental management systems will consider

environmental requirements when selecting suppliers. Wu (2009:193) is of the

opinion that supplier selection criteria should include costs, quality, delivery

performance, trust, contract flexibility, and commitment to working together.

According to Kang & Lee, (2010:37) the criteria for selecting suppliers should

include factors like net price, quality, delivery, performance history, capacity and

service. But management needs to make trade-offs on some of the attributes.

Organisations need to know the abilities of their potential suppliers before

formalising relationships. The critical factors that an organisation should verify

about potential suppliers are financial stability, ability to do the job, capacity

constraints and ease of access. The supplier should be able to finance the working

capital needed to carry out the orders as per customer requirements. Suppliers’

ability to do the job must be proven by the presence of a quality standard in their

operations. It is always wise to do ‘site walk’ at the potential supplier’s premises

to get a feel for their system and confirm their capacity to do the job. Potential

64

suppliers must understand the product or service specifications of customers. A

misunderstanding of the given specification can cause major delays and extra

costs. Suppliers should always be accessible and easy to deal with especially

when things go wrong (Rowbotham et al 2007:317).

3.3.3.3 Factors to be considered in enhancing supplier performance

As part of managing supplier quality, organisations must be willing to train their

suppliers, monitor their performance and inform them when they get off track, and

even audit and certify them. Managing supplier quality is critical, and if well

managed can lead to world class success for an organisation. The contribution of

supplier performance towards enhancing an organisation’s competitiveness should

not be underrated (Chin & Pun, 2006:744). Managing supplier quality properly is

a proactive approach to pursuing continuous quality improvement as per quality

standards requirements (Chin & Pun, 2006:762).

Communication is a key factor in ensuring that there is a working relationship

between suppliers and buyers. When buyers have completed their supplier

evaluation processes, they need to give suppliers feedback so that they can act on

any non-conformances that could have been identified. Suppliers need to be made

aware of buyers’ perceptions about their products at any given time. This assists

suppliers in continuously increasing the quality of products and/or services they

offer to customers (Theodorakioglou, Gotzamani & Tsiolvas, 2006:149).

Organisations can also develop assessment criteria for their suppliers. The

expected quality from suppliers should be listed, and each supplier’s performance

should be recorded against these criteria. Action should then be taken against a

quantified performance score to improve supplier performance (Rowbotham et al,

2007:318).

3.3.3.4 Quality standards and customer-supplier relations

To establish quality assured suppliers is a costly exercise and requires resources.

To cut costs when sourcing suppliers, organisations can source suppliers that are

certified to a quality standard like ISO 9001. That is proof for an organisation that

65

they are dealing with a supplier who is able to produce quality products and/or

service consistently (Rowbotham et al, 2007:318).

Suppliers and buyers should work together towards close, long-term relationships

for objectives to be met. If suppliers are not properly equipped to deal with the

requirements of their customers, buyers should assist with training so that

suppliers can reach the standard required to supply quality goods and/or services

to customers. Suppliers’ achievements should be recognised by the purchasing

organisation to motivate them to reach even greater heights (Theodorakioglou et

al, 2006: 150).

Suppliers need to be flexible in order to meet fluctuating requirements from their

customers. Flexible suppliers assist buyers to react when faced with uncertainties

and unexpected demands from their customers (Wu, 2009:195). Nowadays, it is

beneficial for organisations to engage in business with flexible suppliers. Flexible

suppliers are very valuable to buyers when uncertainties arise (Wu, 2009:199).

3.3.4 HUMAN RESOURCES – PERSONNEL PERFORMANCE

MEASUREMENT

Regarding the human resources factor as one of the critical factors that can be

used as a criterion for measuring operations performance attention needs to be

paid to training and improving competency levels of personnel. Team work,

communication and employee involvement need to be encouraged (Radnor &

Barnes, 2007: 392). The motivation level of employees also needs to be monitored

(Radnor & Barnes, 2007: 385).

Bourne et al (2005: 381) adds that employee satisfaction needs to be measured

and employees need to be trained so that they are fully capable of doing their jobs.

When human resources issues like competency are addressed, it will lead to high-

performance personnel, and therefore, high-performance operations. Price (2005:

451) advises that it is also important to monitor the workload in the laboratory.

Price (2005:452) has identified that when it comes to laboratory operations,

Quality Control and Quality Assurance schemes need to be used to measure

66

performance. These include participating in proficiency testing schemes and

taking preventive and corrective measures when a need arises to take performance

to the next level (Price, 2005:452).

It is a growing trend that organisations are no longer competing by offering new

products and services. Addressing human resources issues like competencies can

lead to high performance in operations (Ritzman & Krajewski, 2003: 25).

According to ISO 17025 standard, the competency of the laboratory is normally

defined in the scope of certification. The laboratory scope specifies information

on tests performed by the laboratory, methods used and material tested. To be

certified to ISO 17025, the laboratory has to satisfy requirements on the

competence of laboratory personnel. There should be a documented procedure on

the validation and traceability of measurement results. The competence level of

personnel who are directly involved in testing must be known. The records of

their training must be maintained (Bednarova & Waddington, 2010:539).

3.3.4.1 Performance measurement of laboratory personnel

Performance measurement and management is not only mechanical; it has some

human behaviour and motivational aspects to it as well. If these aspects are not

well handled, they can result in unfavourable overall performance of the

laboratory. Not all performance measurement systems are effective for controlling

laboratory performance. If measurement systems are poorly designed and

implemented, they might result in confusion in the laboratory. The impact that

measures can have on the performance management system should be considered

(Ndlovu, 2005:4).

There are laboratories that are still using measures like the number of samples

tested per day and linking this to the performance bonus of testing personnel.

Initially, a measure like that might look like it motivates personnel to give their

best performance. But it can result in poor quality work by laboratory personnel as

shifts mentality from quality to quantity. Laboratory personnel can end up

67

producing a lot of invalid results. A laboratory that issues invalid and unreliable

results will not be sustainable (Ndlovu, 2005:5).

One way to prove that it produces valid and reliable data and measure the

performance of laboratory personnel is by taking part in some form of external

assessment, like the proficiency testing scheme. Laboratory personnel test

samples which have already been tested by an independent laboratory to check if

they will get the same results under the same conditions. The objective of

proficiency testing (PT) is to provide a quality assurance tool for laboratories that

will assist them in comparing their performance to other laboratories who are

conducting similar tests. Results can be used to facilitate improvement regarding

the testing capabilities of the laboratory. Laboratories are encouraged to

participate in proficiency testing schemes as part of quality control (Mwakangale,

2005:4).

The performance of laboratory personnel has hardly been researched, yet they are

the major role players in laboratory operations. Studies have rather been

conducted on the proficiency of the entire laboratory or the performance of test

methods. Most of the research conducted is on clinical and forensic laboratories. It

has been observed that laboratory reviews put an emphasis on patents, turn around

times and budgets, but ignore the most important factor at the heart of laboratory

operations, which is laboratory personnel. Simply counting the number of

qualified people in the job market, does not necessarily equate to measuring

competence (Apps, 2006:2).

Apps (2006:3) elaborates that to explicitly test a laboratory person’s proficiency

in unit operations, requires testing and witnessing while the person conducts a

test. This is, however, time consuming and can be counter productive. Apps

(2006:3) further reports that although the importance of testing person’s skill and

competence is apparent, it does not get the recognition it deserves.

One of the methods to measure performance of laboratory personnel is by

monitoring the amount of re-work that is due to ‘human error’. The amount of

hardware or software failure can be linked to ‘human error’. It has to be pointed

68

out that equipment maintenance is routine and breakdowns due to misuse or

improper maintenance are eventually human errors. These measurements are

possible and can be tracked in laboratories that keep sufficient instrument logs. It

is also possible when laboratories have implemented them out of specification

results as part of their quality system (Apps, 2006:3).

3.3.4.2 Disadvantages of using incompetent laboratory personnel

The cost of incompetent testing personnel depends largely on what the

measurement result will be used for. It also depends on whether or not the false

results were released from the laboratory or captured before being issued to

customers. The minimum cost, if erroneous test results are captured before

release, is wasted time and the consumables used to generate the result. Rework,

which is an extra quality control, is a waste of more time and more consumables.

The consequence of discovering erroneous results when they are in customers’

hands can be massive and even difficult to quantify. It may include brand damage,

damage to reputation and even legal disputes (Apps, 2006:3).

3.3.5 HEALTH AND SAFETY

Groover (2007:668) identifies health and safety as factors that need to be used as

criteria to measure performance in operations. Compliance to health and safety

requirements has become a primary requirement enforced by governments around

the world.

Tayler (2003:2) is of the opinion that if health, safety and environmental issues

are not addressed, they can have a negative impact on operations in the laboratory.

The quality of the results issued by the laboratory and the safety and well-being of

employees might be compromised if issues like housekeeping and health and

safety policies are non-existent or not adhered to (Tayler, 2003:2).

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It is evident that there is nothing like an accident-free environment (Langford,

2007:171). Healthy working environment and safety are not just desirable

objectives. They are a primary requirement in industry. They are a major issue in

industry and for governments around the globe (Groover, 2007:668).

3.3.5.1 Causes of incidents and accidents in the workplace

Accidents generally occur in industry due to three factors. These are human error,

environmental conditions and job factors. If an accident is due to human error,

then the employee or employees who are involved in the processes could have

made a mistake that resulted in an accident. Job factors refer to the types of tasks,

methods, materials and equipment used in the operation. Some jobs are more

dangerous than others by their very nature. The environment is a combination of

factors like lighting, noise, temperature, and other conditions surrounding the

operation. The three factors listed above can act in combination. It then becomes

impossible to identify a single factor that could have caused an accident. But, in

addition to the three identified factors, there are organisational variables and

management policies or procedures that can influence the probability of an

accident occurring in an organisation (Groover, 2007:670).

In some organisations, management shows little or no regard for safety in the

work environment. If a negative culture towards safety prevails in an organisation

it filters down to every level. Personnel on the shop floor and throughout the ranks

of the organisation would not make safety their concern or priority. An

environment where hazards are disregarded will increase the possibility of

reportable incidents and accidents (Groover, 2007:670).

3.3.5.2 Housekeeping in the laboratory

Housekeeping is an important factor contained in ISO 17025 and the

environmental regulation of the OHS Act. Regulation 6.2.b states that ‘an

employer shall keep every indoor workplace clean, orderly and free of materials,

tools and similar things that are not necessary for the work to be undertaken’.

Clause 5.3.5 of ISO 17025 requires measures to be taken in order to ensure that

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good housekeeping is maintained in the laboratory. There should be documented

procedures for housekeeping where it is deemed necessary, depending on the

complexity of the activities required to ensure good housekeeping standards

(Tayler, 2003:2).

Clause 5.3.2 of ISO 17025 refers to biological sterility, sound, vibration levels and

dust in the laboratory. Housekeeping is the heart of many safety programs. But,

research has shown that the majority of incidents or accidents that occur in

industry are as a result of unsafe acts rather than unsafe working conditions. It can

be argued that the individual’s actions are a reflection of the working

environment. Therefore personnel working in a laboratory where good

housekeeping standard are maintained are more likely to show that in the way

they work. Personnel from laboratories that have clear safety guidelines would be

careful in their approach to work. From a managerial standpoint, a simple rule

should be ‘everything in its place and a place for everything’. The rule should be

applied consistently and strictly so that all laboratory equipment has allocated

storage space when not in use (Tayler, 2003:2).

Both the OHS Act and ISO 17025 have a requirement that internal audits be

conducted. Some laboratories develop checklists as an internal control, and they

check their systems against this checklist. To avoid running parallel systems,

laboratories can develop an integrated checklist that would review safety issues as

stipulated in the OHS Act and ISO 17025 (Tayler, 2003:5).

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3.4 CONCLUSION

From the literature review, five factors were selected to evaluate laboratory

performance. Those factors are customer satisfaction; profitability; supplier

selection and performance; human resources; and health and safety. These factors

will be used as a basis of the framework for the content analyses. The factors will

also guide the framework for the semi structured interviews.

The next chapter discusses the research methodology used in the study to

investigate the research objectives that were identified in chapter one. The chapter

will explore different paradigms, research instruments used to collect data for the

study, and explanations as to why these research instruments were chosen to

collect data.

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CHAPTER 4

RESEARCH METHODOLOGY

4.1 INTRODUCTION

The research methodology used to investigate the research objectives outlined in

chapter one, is discussed in this chapter. For one to gain an understanding of the

impact of laboratory quality assurance standards on the operational performance of

laboratories, a qualitative research approach has been employed. In answering the

research questions asked in the first chapter, the investigation was conducted using an

explorative methodology. The data collected to meet the objectives of the study are

descriptive, that is peoples’ spoken words through interviews.

The chapter starts by explaining the reasons why the qualitative research approach

was the appropriate method for the study. It identifies different paradigms. Different

instruments used to collect data are also discussed in the chapter. The instrument used

to collect data for the research has been identified and discussed. The chapter

concludes with discussions on how the research data collected was analysed.

4.2 RESEARCH PARADIGMS

There are different approaches, based on certain paradigms, which can be used when

conducting research. These include the phenomenological paradigm and positivistic

paradigm (Welman, Kruger & Mitchell, 2005:191). Miller & Brewer (2003:220)

define a paradigm as a “theoretical structure or framework of thought that acts as a

template or example to be followed”. The difference between the two paradigms is

outlined in table 4.1.

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Table 4.1: Difference between the phenomenological and positivistic paradigms (Source: Adapted from Welman et al (2005: 192). Phenomenological paradigm Positivistic paradigm Tends to produce qualitative data Tends to produce quantitative data Uses small samples Uses large samples Concerned with generating theory Concerned with hypothesis testing Data is rich and subjective Data is highly specific and precise High validity Low validity Natural location Artificial location

4.3 RESEARCH APPROACH

There are two research approaches, namely the qualitative and the quantitative

research approaches. Quantitative and qualitative research methodologies allow

researchers to explore different kinds of “unexplained as well as the so called

previously explained but misunderstood phenomena” (Welman & Kruger, 2001:9).

Table 4.2 gives a distinction between the two approaches. Table 4.2: Qualitative versus quantitative research approaches (Source: Adapted from Leedy & Ormond (2001:102).

Research Focus Quantitative Qualitative

Purpose of the research To explain and predict

To confirm and validate

To test theory

To describe and explain

To explore and interpret

To build theory

Nature of the research

process

Focussed

Known variables

Established guidelines

Static design

Context free

Detached view

Holistic

Unknown variables

Flexible guidelines

Emergent design

Context bound

Personal view

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Method of data collection Representative, large

sample

Standardised instruments

Informative, small sample

Observations, interviews

Analytical form of

reasoning

Deductive analysis Inductive analysis

Method of

communicating findings

Numbers

Statistics, aggregated data

Formal voice, scientific

style

Words

Narratives, individual

quotes

Personal voice, literary

style

Easterby-Smith, Thorpe & Jackson (2008:83) agree that there is a distinction between

the qualitative and quantitative research methods. Qualitative research is about

collecting data that is mainly in the form of words, while quantitative research is

about data which is in the form of or is expressed in terms of numbers. Keegan

(2009:11) points out that quantitative research is about precise numerical

measurements. Qualitative research focuses on exploring questions such as what,

why, and how, rather than how much. The primary concern of qualitative research is

finding the meaning rather than measuring.

Qualitative and quantitative research can be characterised in the ways outlined in

table 4.3.

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Table 4.3: Characteristics of quantitative and qualitative research approaches (Source: Adapted

from Keegan (2009:12).

Quantitative Qualitative

It generally involves large numbers of

people.

Usually involves small samples of people,

who may be representative of the

population as a whole or who may

represent a small sub section of the

general population.

It usually involves the administration of a

pre-prepared questionnaire, containing

questions put to respondents.

It is person-centred, in that it starts with

an attempt to understand the world of the

individuals being researched. The

emphasis is on the depth of understanding

and relationships.

Each respondent is taken through the

questionnaire, without reference to other

research participants, and their individual

responses are collated.

The interaction between researcher and

participant is fluid and open-ended

It involves statistical and numerical

measurement of the raw data captured in the

questionnaires.

The aim is to get beneath their ‘top of

mind’ responses

The results can be used as a benchmark; the

survey can be repeated in the future using

the same questions, and the results can be

compared.

The outcomes of qualitative research is

not data, they refer to behaviour, thoughts,

opinions, meaning and the like.

The questionnaire, once, designed can be

administered by interviewers who are

trained to administer quantitative

questionnaires.

It involves a high level of interpretation

and synthesis of data by the researcher

and participants in the analysis and

presentation of the research outcomes.

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The purpose of both quantitative and qualitative research is to try to understand the

subject’s point of view. Quantitative researchers try to understand the subject’s point

of view by controlling the situation and using experiential methods. Qualitative

researchers normally use methods like unstructured interviewing and detailed

observation to better understand the matter (Welman et al, 2005:9). The main purpose

of quantitative research is the evaluation of objective data produced by research

participants. Qualitative data are presented in words and not in numbers (Welman et

al, 2005:8).

Welman et al (2005:9) further report that quantitative researchers use complex

structured methods to confirm or disprove hypotheses based on the quantitative data

collected. Qualitative research is based on flexible and exploratory methods and that

enables the researchers to adapt during the research process in order to gain a better

and deeper understanding of the subject being researched. Quantitative research

involves larger samples and the analysis of data is based on statistical significance.

Qualitative research normally involves small samples, studied by means of in-depth

methods like unstructured interviews (Welman et al, 2005:9).

In this study, the qualitative research method was used. Leedy and Ormonde

(2010:95) suggest a qualitative study where the available literature is limited and

where the study is exploratory. The literature available for laboratory quality

assurance standards and laboratory performance was very limited, hence justifying

for an exploratory qualitative study. Conducting a qualitative research enabled the

researcher to gain an understanding about the implementation of quality assurance

standards in laboratories. The qualitative approach gave the researcher some

flexibility, and an approach that could be adapted when different situations arose.

The qualitative research, as opposed to quantitative research, gave the researcher an

opportunity get beneath the respondents’ ‘top of mind’ responses (Keegan, 2009:12).

The interaction between the researcher and the laboratory managers was planned to

be fluid and open-ended. The outcome of the research was information provided by

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laboratory managers regarding the impact of laboratory quality assurance on the

operational performance of laboratory. This was achieved by identifying laboratory

managers or senior laboratory personnel as participants in the study. The researcher

collected data by interviewing the research participants, and used their words and the

meaning of these words. The research was conducted in a natural setting. It was in the

participants’ work environment.

4.4 RESEARCH DESIGN

Research design can be described as a model used by the researcher to gain a certain

level of comfort that the research has reached a valid conclusion (Miller & Brewer

2003:262). Research design is defined as “the logical sequence that connects the

empirical data to a study’s initial research question and ultimately, to its conclusions”

(Yin, 1994:19). Watkins (2006:37) defines a research design as an action plan to get

from one point to the next. Initially, questions to be answered are defined and at the

end, there have to be conclusive answers to those questions.

Research design is “about organising research activity, including the collection of

data, in ways that are most likely to achieve the research aims. Research design is

about making choices about what will, and will not, be observed” (Easterby-Smith et

al, 2008: 82). A research design should be clearly defined before data is collected. It

should clearly specify and justify what data is to be collected, how it is collected and

where the data was collected from. Data analysis methods should also be clearly

spelled out to be able to provide answers to the research question (Easterby-Smith et

al, 2008: 82).

Welman et al (2005:78) identifies different types of quantitative research design as

experimental research, quasi-experimental research, and non-experimental research.

In experimental research, research participants are subjected to conditions that they

would not otherwise have been subjected to. The researcher measures the extent to

which the independent variable/intervention changes or affects the dependent variable

(Welman et al, 2005:78). Welman and Kruger (2001: 69) further report that in

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experimental research, there are two groups involved in the study conducted. One is

subjected to the experimental intervention while the ‘controlled group’ is not

subjected to the experimental intervention. “The pre-measurement and post-

measurement of the experimental group is measured before and after subjection to the

experimental intervention” (Welman and Kruger, 2001: 69). That assists in measuring

the impact of the research intervention (Welman and Kruger, 2001: 69).

Quasi-experimental research, involves measurement at a single time. Survey research

is an example of quasi-experimental research (Welman et al, 2005:102). Quasi-

experimental research is very critical because “true experimental research is

impossible in the case of several important problems in the business and

administrative sciences” (Welman & Kruger, 2001: 79). The difference between

quasi experimental research and true experimental is that the researcher cannot

randomly assign subjects to the different groups. Quasi-experimental research is

viewed as the second best alternative for eliminating nuisance (Welman & Kruger,

2001: 79).

With regard to non-experimental research, the researcher examines the relationships

occurring between two or more variables without any planned intervention (Welman

et al, 2005:93). Welman and Kruger (2001:83) explain that in this type of research,

the researcher only deals with the examination of relationships that occur between

two or more variables without any planned intervention.

The types of qualitative research design approaches are identified as case study

research, participant observation, unstructured in-depth interviews, focus groups,

ethnography and grounded theory (Welman et al, 2005:207). In this study the

research design was around the semi structured interviews relating to a qualitative

approach. The researcher used semi-structured interviews to gain an understanding

regarding the impact of laboratory quality assurance standards on the operational

performance of laboratories. Schedules for interviews were compiled when the

research participants had agreed to do the interviews.

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4.5 POPULATION AND SAMPLING TYPES

4.5.1 Population

Leedy & Ormond (2001:47) define the population as a collection of units or

individuals that can be considered for research purposes. Welman & Kruger

(2001:46) describe the population as the object under study. That object can be

individuals, a group of individuals or organisations. Welman et al, (2005: 53) explain

that a population is ‘a set of cases from which a sample is taken’. A set of cases is not

necessarily people; it can also be objects or business units.

The population ‘encompasses the total collection of all units of analysis about which

the researcher wishes to make specific conclusions’. In most cases, due to the size of

the population, it is impractical and uneconomical to collect data from each and every

unit within the population. That raises the need to collect data and draw a conclusion

from a sample, which is taken from the population (Welman et al, 2005: 55).

The population in this study consisted of laboratory managers and senior laboratory

personnel from the 200 laboratories listed on the website of the national accreditation

body and the national laboratory association.

A list of potential respondents from the above mentioned websites was compiled with

the contact persons and contact details. The original plan was to have at least two

respondents per group. Potential respondents were approached by the researcher,

giving them the scope to participate in the research. If they agreed, a date was set and

agreed upon by the respondent and the researcher. If the potential respondent declined

to participate, the next potential respondent on the list was approached. The process

continued until there were at least two participants per group.

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4.5.2 Sampling

A sample represents a small subgroup of individual units drawn from the population

(Welman et al, 2005: 66). Walliman (2006:75) defines sampling as “a process of

selecting a small group of people from a large group of people”. A representative

sample assists the researcher in making conclusions from research findings that are

representative of the entire population. It is critical that the sample be like a small

image of the population. The sample should be representative of the population so

that the findings of the research can be applicable not only to the sample or units that

were measured, but to the population as a whole (Welman et al, 2005: 55).

There are two categories of sampling, these being probability sampling and non-

probability sampling. There is a distinction between probability and non-probability

samples (Leedy & Ormond, 2001:46). With probability sampling, there is a selection

of a random sample of names from the population being sampled. With non-

probability sampling, samples are selected using non-random means (Walliman,

2006:76).

The sampling strategy utilised for this research is a non-probability, convenience

sampling. Leedy & Ormond (2001:46) reports that convenience sampling makes no

pretense of identifying a representative subset of a population and takes people that

are readily available. In this research, available laboratory managers or senior

laboratory personnel who were available and willing to participate in the research,

were approached and interviews were conducted.

In keeping with the objectives of the study, the sample has been defined as laboratory

managers from commercial and non-commercial laboratories. Commercial

laboratories in this context; refer to laboratories that function as a business entity and

are not attached to a bigger organisation. The laboratories accept samples from any

customer who identifies them as their service provider. Non-commercial laboratories

are those laboratories that are service providers to internal customers only. Non-

commercial laboratories are linked to or form part of a bigger organisation. They

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normally provide a service of quality control to the production department. The

sample represented laboratories that are certified to ISO 17025, OECD GLP, and

laboratories that operate without a certified laboratory quality standard.

The planned research sample was two laboratories per group. But some groups of

laboratories ended up with more than a minimum of two respondents. The final

sample size is comprised of nineteen laboratories. There are eleven non commercial

laboratories and eight commercial laboratories. From the group of non commercial

laboratories, there were five respondents from ISO 17025 certified laboratories, two

respondents from OECD GLP certified laboratories and four respondents from

laboratories without ISO 17025 or OECD GLP standards. From the group of

commercial laboratories, there were two respondents from OECD GLP certified

laboratories, four respondents from ISO 17025 certified laboratories and two

respondents from laboratories without ISO 17025 or OECD GLP standards.

4.5.3 Data collection methods

The data collection method is face-to-face interviews. Data for the study was

collected using face-to-face interviews and thus the method is discussed in detail

below. Watkins (2006:51) defines interviews as a data colleting method where

research participants are asked the same questions in order to establish their thought

about the subject under study. However, Easterby-Smith (et al, 2008:147) warns that

there are six critical issues involved in conducting interviews that researchers must

consider. If those critical issues are not properly addressed, they may affect the

outcome of an interview. The six issues are identified as obtaining trust, being aware

of social interaction, using the appropriate language, getting access, choosing the

location for the interviews, and recording interviews. Obtaining trust is a very

important element in ensuring that interviews render the researcher with the

information that they are looking for in order to answer the research questions and

satisfy the identified research objectives.

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Keegan (2009:107) advises that the two fundamental qualitative skills are “good

communication and thorough, insightful analysis”. Interviewing is not only about

verbal skills. All interviews involve watching people’s behaviour, how they express

themselves and how they respond in a particular situation. The most important stage

when collecting data through interviews is establishing rapport quickly during the

initial introductions. “Rapport is a pre-requisite of good qualitative research”.

Welman & Kruger (2001:160) state that there are three different types of interviews

that are commonly used and are identified as structured, semi-structured and

unstructured interviews. The differentiating factor for these types is based on the

extent of the depth of the response sought. Welman and Kruger (2001:160) further

explain that in structured interviews, there are pre-determined questions that

participants have to answer. “The interviewer is restricted to the questions, their

wording and their order as they appear on the schedule, with relatively little freedom

to deviate from it” (Welman and Kruger, 2001:160). With regard to semi-structured

interviews, pre-determined questions are used but the researcher can restructure the

order during the interview if a need arises. The face-to-face, unstructured, individual

focus type of interview using an interviewing focus area guideline was used for this

study. Welman and Kruger (2001:161) report that “unlike completely structured

interviews, unstructured and semi-structured interviews allow the interviewer to clear

up vague responses; and to ask for elaboration of incomplete answers from

participants”.

A face-to-face, individual focus interviews permits the respondents to freely express

themselves without the concern for privacy and confidentiality that would usually

arise in a group situation. In the study, all the interviews were scheduled according to

the times that coincided with the availability and preference of the research

participants. The interview duration with each research participant was scheduled to

be an hour. To minimise inconvenience and disruptions to the research participants,

the interviews were collected at the participants’ work places.

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The interview guideline was used as the data collection instrument. This interview

guideline was developed from the literature review chapters, which are chapters two

and three. The purpose of developing the interview guideline is to enable the

researcher to collect uniform data that can be compared consistently. The questions

that were asked required more than a simple yes/no answer. Research participants

were at liberty to give detailed explanations.

There are different ways of collecting data through interviews. Respondents may be

asked to rate their opinion along a defined scale, and choose the most relevant

response from a set of multiple questions asked, or even give their own opinion to

predetermined open-ended questions. The role of the interviewer is very critical in the

interview process. The researcher needs to get people relaxed, so that they can answer

questions satisfactorily. It normally helps to kick start the interview process by asking

open-ended, descriptive questions (Taylor & Bogdan, 1998:102). Respondents need

to feel comfortable with the researcher so that they can express their opinions without

fear of disclosure or negative evaluation (Taylor & Bogdan, 1998:50).

Kumar (2005:131) confirms that there are advantages associated with collecting data

through interviews. The interview is suitable for complex situations that require

gathering in-depth information. When data is collected through interviews, it can be

supplemented with observations and non-verbal reactions that the interviewer will

have access to. It is unlikely that questions can be misunderstood. The interviewer

can either repeat a question or rephrase it to help the respondent understand it.

The interview focus area guideline used to conduct interviews facts about the

laboratory profiles and the identified five factors, which are health and safety;

supplier selection; profitability, human resources; customer satisfaction. The

interview focus area guideline is made up of open questions, closed questions, and

multiple questions. It covered the five factors used as a criterion for measuring

performance in operations as they were identified in chapter three.

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The interview focus area guideline assisted the researcher in collecting data about the

laboratory profiles. Data collected included the responsibilities of the respondent, the

nature of the testing laboratory and the quality assurance standards implemented.

That assisted the researcher to paint the picture or identify the background of the

research participants and their laboratories. This assisted the researcher to categorise

different participating laboratories as certified or non certified laboratories. It also

assisted in identification of laboratories as commercial or non commercial. Other

questions included the research participants’ qualifications. Those were not sensitive

questions, but there were some questions to determine if there is a trend in industry of

persons with the same level of qualification having similar responsibility when it

comes to managing laboratories.

Further to that, the interview focus area guideline focused on the operations within

the laboratories and the management of human resources, sampling, training and

competency issues and also on health, safety and environment. There was also a focus

on the effort made by laboratories to comply with environmental and health and

safety requirements. The section of the interview focus area guideline assisted the

researcher to understand how operations in different laboratories were managed and if

the requirements of laboratory quality assurance standards contributed to managing

laboratory operations better or whether laboratory quality assurance standards do not

make a difference.

Data was also collected on the methods used by laboratories to measure competency,

supplier selection and customer satisfaction. The impact of the laboratory standards

on factors like marketing advantage, laboratory recognition, acceptance of exported

goods in overseas markets, retention and growth of customer base and the impact on

the profit margin were explored. The section of the questionnaire assisted the

researcher to identify objectively, whether the quality standards have an impact on the

operational performance of laboratories by using the factors that were identified in

chapter three as criteria for measuring laboratory performance.

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Taylor and Bogdan (1998:112) advise that interviews should be audio taped when it

is possible to do so. The data collected through interviews was recorded using a tape

recorder. Taylor and Bogdan (1998:112) further state that tape recording can

sometimes alter participants’ responses in the early stages of research. Interviewers

generally get by with taping interviews. Research participants were asked that the

interviews be tape recorded, and permission was granted. They were also requested

and made aware that the researcher would from time to time make notes while they

were speaking and permission on that was also granted. Recording the interviews

helped the researcher to pay attention in understanding the participant’s responses and

also capture body language. Every interview was transcribed after each session.

Observations were made by the researcher during the interviews. Notes were taken

for records made available by the participants.

Leedy & Ormond (2001:144) report that most ethical issues in research fall into one

of four categories, which are protection from harm, informed consent, right to

privacy, and honesty with professional colleagues. In this study, once potential

respondents were identified, they were contacted by the researcher. The researcher

explained the objectives of the study and asked the respondents if they would be

available to contribute to the study. The researcher at the stage informed the

respondents that data would be collected through a semi-structured interview and the

conversation would be recorded. Once respondents were willing and enthusiastic to

participate, arrangements were made for the meeting. If the potential respondents

were unavailable and not willing to participate, they were not forced to participate.

The researcher then called other potential respondents. The names of the laboratories

have not been disclosed as they shared their operations with the researcher.

4.6 DATA ANALYSIS

Analysis of research data is a process of analysing and making sense of the

qualitative or quantitative data collected. Qualitative data can be analysed using

computer aided qualitative data analysis software (CAQDAS). CAQDAS is a general

term for the computer software packages that can be used to analyse qualitative data.

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Data can also be analysed by six different methods that allow for an analysis of

natural language data or words. Those are content analysis, grounded analysis,

discourse analysis, narrative analysis, conversation analysis and argument analysis

(Easterby-Smith et al, 2008:172). According to Silverman (2011:288) the process for

conducting data analysis involves steps such as organising and preparing data, and

reading through all the data transcribed.

In this study, content analysis was used for data analysis. Content analysis is a

detailed and systematic examination of the contents of a particular body of material

for the purpose of identifying patterns, themes, or biases. Content analyses are

typically performed on forms of human communication (Leedy and Ormond,

2010:144).

As a general rule, a content analysis is systematic and measures are taken to make the

process as objective as possible (Leedy & Ormond, 2001:144). One of the steps is

that the researcher identifies the body of material to be studied (Leedy & Ormond,

2001:144). In this study, the researcher identified the five factors, which are the

operational performance criteria considered in the context of the study. The five

factors are Health and Safety; Supplier selection and performance; Human resources;

Customer satisfaction; and Profitability. Leedy & Ormond (2001:144) report that if

the material to be analysed involves complex or lengthy items, the researcher breaks

down each item into small, manageable segments that are analysed separately. In this

study, the transcription of the information provided by respondents during interviews

was lengthy. The information was broken down into manageable segments which are

the five factors identified as the operational performance criteria. The information

provided by various laboratory managers was reported according to the five factors

and grouped according the nature of the laboratory. Judgements were made by the

researcher based on the certain words from the interview guideline to summarise the

information provided by respondents.

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During the study, the initial step was to report the questions and responses of the

participants from the interviews conducted. The researcher transcribed all the

recorded data and saved the information in Microsoft Word format. The transcription

was done after the completion of each interview. The process assisted the researcher,

as data transcription was done when the interview was still fresh in the interviewer’s

mind to ensure the accuracy of transcriptions.

The next step was for the researcher to read through all data to obtain a general sense

of the information and to reflect on the general meaning of the data collected for the

keywords for content analyses. The content analysis featured around the five

performance factors which were Health and Safety; Supplier selection and

performance; Human resources; Customer satisfaction; and Profitability. Data from

all participating laboratories was read over and over again to get an understanding of

their operations and laboratory standards. The coding process of the data collected

was conducted after reading the documents several times to get a general

understanding. Creswell (2003:192) defines coding as a “process of organising the

material into chunks before bringing meaning to these chunks”. The data was grouped

in five factors which were determined as the criterion for measuring operational

performance in laboratories. The interpretation of the data and formulation of factors

used to measure performance criteria are based on the understanding that the

researcher got from the information provided by participating laboratory managers.

To evaluate the qualitative study conducted, the research question (Does the

implementation of quality assurance systems such as OECD GLP and ISO 17025

have an impact on the operational performance of commercial and non-commercial

laboratories?) drove the methods used to collect and analyse data. The researcher

used rigorous methods to collect, record, and analyse data. A pre-developed interview

guideline was used to collect consistent information from participants through semi-

structured interviews. The researcher was open minded, showed willingness to

modify interpretations when newly acquired data caused conflict with previously

collected data.

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4.7 CONCLUSION

This chapter covered the methods and processes used in the study to explain the

research methodology used and why it was chosen. The researcher explained why the

qualitative research method was chosen over the quantitative method. The last section

of the chapter discussed how interviews were used to collect the data and how the

collected data was analysed.

For a better understanding of the questions that the participants were asked, reference

can be made to Appendix A – Interview Focus Areas Guideline. The interview focus

area guideline was used for all interviews conducted. It was used to ensure

consistency in the collection of data, and to ensure that all the participants were asked

the same questions. It was developed from the literature review conducted in chapters

two and three. Most of the questions that were asked required more than a simple

yes/no answer. Respondents were encouraged to participate in the discussions.

The next chapter will provide a brief background of participating laboratories and

will focus on analysing and interpreting the interview data collected during the

interview sessions. The research data is used to investigate the research objectives

that were identified in the first chapter. The responses made by the participants will

shed some light into the impact of laboratory quality assurance standards on the

operational performance of laboratories.

The participants in the research participated voluntarily and no participant was forced

to take part. All the research participants were informed of the scope, aim and

objectives of the study. Research participants were assured that the findings would

not be used in any other capacity except to complete an M Tech Operations

Management. The requests of anonymity from respondents were highly respected.

Taylor and Bogdan (1998:34) stress the importance of guaranteeing the

confidentiality and privacy of the participants in research.

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CHAPTER 5

FINDINGS, ANALYSIS AND DISCUSSION

5.0 INTRODUCTION

The chapter is a report on the findings, analysis and discussion of the results to

answer the research question which was posed in the first chapter. The research

question was stated as - Does the implementation of quality assurance systems such

as OECD GLP and ISO 17025 have an impact on the operational performance of

commercial and non-commercial laboratories?

Potential respondents were identified, and once identified; an appointment was set

between the respondent and the researcher for the semi structured interview. Data was

collected through the semi structured interviews using the interview focus area

guideline, which is Appendix A. The respondents that were consulted for the research

were cooperative. They availed evidence like documented policies, procedures and

records that they referred to during the semi structured interview when asked by the

researcher.

The sample for the study was laboratory managers or personnel responsible for

managing commercial and non-commercial laboratories. Appendix C1 and C2 give

detailed information regarding the demographics of the laboratories that were part of

the study. Data collected as per Appendix C1 and C2 included the laboratory number,

nature of the laboratory, respondent position and qualification, number of employees

in the laboratory, minimum qualification required when hiring employees, services

offered by the laboratory, length of systems certification where applicable, reasons

for implementing the quality assurance standard, and challenges in maintaining the

standard.

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The participating laboratories have been identified as laboratory one to nineteen as

per the laboratory profiles/demographics tables Appendix C1 and C2. The

laboratories have been identified as one to nineteen for reporting purposes, and the

sequence used is not linked to the order of the interviews or data collection. As per

the column, “nature of the laboratory” of Appendix C1 the acronyms used to identify

the nature of the laboratories are NCL-QA; NCL-NO QA; CL-QA and CL-NO QA

and they have been described below as:

NCL-QA: Non-commercial laboratories with a certified quality assurance system

(ISO 17025 or GLP).

NCL-NO QA: Non-commercial laboratories without a certified quality assurance

system (ISO 17025 or GLP) in place.

CL-QA: Commercial laboratories with a certified quality assurance system (ISO

17025 or GLP).

CL-NO QA: Commercial laboratories without a certified quality assurance system

(ISO 17025 or GLP) in place.

Appendix B is the responses of the participants during the interviews. The summary

of the five factors has been reported as per Appendix C3 to Appendix C6. The

selected criteria, that is, health and safety; supplier selection and performance; human

resources; customer satisfaction; and profitability were accepted as the framework.

The main categories and codes depicted in the findings are as per table 5.1. The

responses of the participants have been reported in italics, and were the actual words

of the respondents. At the end of the each section, a summary is given using a single

square line, and the conclusions towards the framework were reported in double

square lines.

The analysis of the interviews follows focusing on the five factors which are health

and safety; supplier selection and performance; human resources; customer

satisfaction; and profitability.

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These were the findings after conducting the data analysis.

5.1 Health and Safety

5.1.1 Non commercial laboratories that have a certified QA system

The respondents from laboratories 1 to 7 were asked to explain the measures

implemented to ensure that the laboratory is a safe working environment for

employees. Their responses were as follows;

“Safety forms part of induction training for all permanent and contract employees.

Before employees are left to work on their own, they have to write a safety test and

pass it. Once they have shown the required safety competency level, their work

environment is assessed by their supervisor to determine which protective personal

equipment (PPE) will be required. Once decided, they are provided with the relevant

PPE that they need to work in the area. The records of training are kept in the

personnel files. We also have HS&E policies and procedures are available

electronically on the shared drive, and they can be accessed by all laboratory

personnel.” (LAB 1 - T 3)

It was observed during the visit that there were safety signs all over the laboratory

building, highlighting mandatory PPE to be worn at different sections of the

laboratory. There were clearly identified bins outside the laboratory, indicating where

to throw paper waste, glass waste and chemical waste. The HSEQ policies were

visible at the reception area and the flags of the organisation’s certification were

flying high at the company entrance. Visitors are accompanied by the host all the

time, and are not allowed to be on their own while on the premises.

“Health and safety forms part of our system. To ensure that the laboratory is a safe

working environment for everyone, the work instructions for operating laboratory

equipments incorporate health and safety requirements.” (LAB 2 - T12)

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The observation made by the researcher was that during the laboratory tour, there

were health and safety signs seen all over the laboratory building. The respondent

was wearing PPE as dictated by the health and safety signs on the walls. And also,

during the visit, a five minutes video on health and safety was watched as part of

induction. Alcohol test was also conducted before being allowed on the premises.

“All the HS&E policies and procedures are available electronically on the shared

drive, and they can be accessed by laboratory personnel.” (LAB 3 - T18)

“To ensure that the laboratory is a safe working environment for employees we are

guided by the OHS Act. We also have safety representatives and safety committees in

the laboratory. Health, safety and environment form part of induction training for all

permanent and contract employees. I, together with my supervisor take turns to do

the laboratory walk about to identify any risks in the laboratory and we take the

necessary actions. What we also do is that, health and safety is incorporated into the

test methods. Each test method stipulates which protective clothing to wear when

handling reagents for a certain test method.” (LAB 4 - T24)

“Health, safety and environment factors are put first in the operation. Health, safety

and environment form part of induction training for all employees. Employees are

trained to identify risks and using equipments and tools in the laboratory. To engage

employees in the process, employees are expected to walk around the laboratory, and

must come up with at least two non conformances and implement

corrective/preventive action. Daily meetings are held on a daily basis in the

laboratory and the first point on the agenda is safety, health and environment.” (LAB

5 - T30)

During the visit, a fifteen minutes induction training video was watched before being

given access to the premises. It was observed that there were safety signs on the

laboratory walls. Laboratory personnel were seen around the building wearing PPE

like safety boots, eye protection and laboratory coats.

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“To ensure that the laboratory is a safe working environment for employees, all the

newly hired employees go through orientation during the first week and are

introduced to the organisation policy. They are also introduced to the quality, health

and safety policies and standard operating procedures in their work areas. They are

then taken to different laboratories and introduced to other employees, canteens,

lockers, the starting and finishing times etc.” It was further mentioned that “health,

safety and environmental issues are also communicated to laboratory personnel

through the ‘Health & Safety’ notice board within the laboratory building. We also

have elected safety officers who are trained on health and safety issues. There is also

a clinic run by a qualified nursing sister on the premises, and that assists a lot. We

hold safety committee meetings every third month to discuss any incidents that have

been raised and come up with actions to be taken. Laboratory personnel are trained

to use the system for reporting incidents and accidents in the laboratory.” (LAB 6 -

T38)

It was observed during the laboratory tour that the spillage control procedure was

displayed on the board for accessibility.

“To ensure that the laboratory is a safe working environment, OECD GLP helps to

enable constant monitoring to ensure safe workplace and also helps to ensure clean,

well-maintained environment. OECD GLP also helps them to document and manage

chemicals in the laboratory.” (LAB 7 – T46)

Still on health and safety issues, laboratories were asked to identify any other

certified systems that are enhancing their approach to health and safety in the

laboratory. The responses were as follows;

“The entire organisation is certified to ISO 9001, ISO 14001 and OHSAS 18001.

Having a certified environmental, health and safety systems helps us to clearly

identify high risk areas and measures to manage them.” (LAB 1 – T3)

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“The entire organisation is also certified to ISO 14001 and OHSAS 18001 to help us

manage the health, safety and environmental issues.” (LAB 2 – T13)

“The entire organisation is certified to ISO 14001 and OHSAS 18001 to manage the

environmental, health and safety issues.” (LAB 3 – T19)

“The entire organisation is certified to ISO 9001 and ISO 14001. We are now

working towards getting certified in OHSAS 18001. Having a certified environmental

system helps in dealing with environmental issues. Even if we are not certified to the

health and system yet, we are complying with the requirements of the standard and

that helps to manage H&S issues that may arise.” (LAB 4 – T24)

“We are certified to ISO 14001 and OHSAS 18001. Having a certified environmental

and, health and safety systems helps us to clearly identify high risk areas and to

manage them.” (LAB 5 – T31)

“Even though our organisation’s environment, health and safety systems are not

certified, our internal system covers processes like waste removal, remember we deal

with medical samples and handling of bio hazardous chemicals and it works for us.

We only use accredited service providers to remove medical waste and are provided

with bio hazard boxes to contain waste.” (LAB 6 – T38)

“No, but the organisation is in the process of implementing ISO 9001 and will be

applying for certification as soon as the implementation process is complete.” (LAB

7 – T46)

Respondents were asked to explain how housekeeping is managed in the laboratory

and their responses were as follows;

“When we have received a lot of samples, it becomes difficult to maintain good

housekeeping standards. To monitor housekeeping standards in the laboratory, we

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conduct risk assessment before carrying out daily tasks. The continuous risk

assessment is conducted daily by laboratory personnel on their work area before

doing their job. A developed check sheet is used to identify any areas that need

attention before starting with the daily tasks. If there are any measures to be taken

before working, the laboratory personnel will act accordingly. Records of the risk

assessment are kept.” It was further reported that “task based risk assessment is done

on a yearly basis provided the test methods has not been changed before a twelve

months period has elapsed. The test method is reviewed step by step, to identify where

things can go wrong with each test method. If there are changes to be made, they are

handled in a controlled manner. There is also baseline risk assessment which is

conducted yearly, and is performed by management. And also what we do to promote

maintenance of good housekeeping standards, is that different laboratory sections

take part in housekeeping competitions. Winners are given vouchers to get company

merchandise, and that motivates staff to maintain good housekeeping standards in

their sections.” (LAB 1 – T4)

“I am responsible for maintaining housekeeping standards. What I normally do is

that I clean the laboratory on a daily basis as part of maintaining good housekeeping

standards.” (LAB 2 – T13)

“All the Analysts are responsible for housekeeping in the laboratory. They all clean

their work areas after conducting tests to ensure good housekeeping standards are

maintained.” (LAB 3 – T19)

“Housekeeping is everyone’s responsibility in the laboratory. Analysts have to clean

up after conducting analysis. Housekeeping is also supervised by myself and the

supervisor when we do our lab walks.” (LAB 4 – T25)

“General inspection is conducted regularly in the laboratory.” (LAB 5 – T31)

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“Housekeeping is everyone’s responsibility in the laboratory. The laboratory

personnel clean work benches after conducting tests or analysis. One of the main

responsibilities of the Laboratory Assistants is to ensure that they decontaminate the

work benches with a prescribed disinfectant as per the implemented roster to ensure

that it is done. We also clean our equipments thoroughly on a monthly basis and keep

records of cleaning. As far as the health and safety performance is concerned we

don’t end up with a lot of accidents or incidents in the laboratory, fortunately we

don’t use needles and sharp objects that can result in accidents.” (LAB 6 – T39)

“All employees are responsible for housekeeping.” (LAB 7 – T46)

The non commercial laboratories that participated in the study, showed some

consensus regarding having a defined approach to health and safety issues.

Laboratories have implemented induction training for employees, issue employees

with PPE to mention a few of the approaches used. As per the above, the most

common method for managing housekeeping standard is that housekeeping is

everyone’s responsibility. All laboratory personnel have a responsibility to keep their

work spaces clean and this arrangement seems to work for all laboratories.

For the non commercial laboratories that have a quality assurance system in place,

there is a positive culture of health and safety, that is, maintaining good housekeeping

standards and H&S induction training.

5.1.2 Non commercial laboratories without a certified QA system




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“To ensure that the laboratory is a safe working environment for employees, there is

a SHE representative in the laboratory, employees are provided with personal

protective equipment (PPE) and they are shown how to use them.” And further to

that, “the health and safety training for laboratory employees is initiated by the

Health and Safety Committee, which is a department outside the laboratory.

Laboratory personnel have been trained by an external training provider on health

and safety issues like handling of hazardous chemicals and first aid.” (LAB 8 - T 51)

It was observed that the laboratory was clean, closed and identified chemical

containers were seen on top of the working benches.

“Laboratory personnel are trained on health and safety procedures, risk assessment

is conducted, there are monthly safety talks held, there is a safety representative

elected, and we also do planned job observations with regard to health and safety

procedures. We also have an incident reporting system, we are generally happy with

our performance regarding health and safety.

Generally, we are doing well with regard to the health and safety compliance.” (LAB

9 – T57)

It was observed during the laboratory and plant tour that employees were wearing the

personal protective equipment (PPE) as per the health and safety signs displayed

around the laboratory and plant buildings. There was enough signage around the

laboratory building, including the plant. It was also observed during the tour that the

laboratory was clean.

“Laboratory employees are trained on health and safety procedures like handling of

hazardous chemicals, and managing dangerous situations. There are qualified first

aiders, a SHE representative, and all our test methods address the health and safety

issues.” (LAB 10 – T63)

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The health and safety signs (eye protection, masks, safety shoes and laboratory coats)

were visible in the plant and the laboratory building. It was also observed that

laboratory and plant personnel were wearing the personal protective equipment (PPE)

as per the health and displayed safety signs. It was also observed during the tour that

the laboratory was clean, with all chemical containers on the bench clearly identified.

“To ensure that the laboratory is a safe working environment for employees,

laboratory employees are trained on health and safety procedures. Safety committees

have been appointed at district and laboratory level, job observation, risk assessment

is conducted and controls are put in place based on the risk scores. Potential hazards

are identified in the laboratory and corrective/preventive actions taken, and that is

done on a monthly basis to measure their performance. Our performance is

acceptable but we do have minor incidents and we report them.” (LAB 11 – T69)

It was observed during the tour that the laboratory was clean. It was also observed

that employees were wearing the personal protective equipment (PPE) as per the

health and safety signs displayed around the laboratory building.




“The laboratory does not have documented environmental, health and safety

procedures and is not certified to the environmental, health and safety systems. There

are no plans to implement the any quality, environment, or health and safety.” (LAB

8 – T51)

“We have documented environmental, health and safety procedures. We are currently

working towards ISO 14001 due to environmental issues raised by the local

municipality. But there are no plans to implement OHSAS 18001 in the near future.”

(LAB 9 – T57)

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“There are documented environmental, health and safety procedures and we are

certified to the ISO 14001 and OHSAS 18001 systems. The two systems help us to

deal with any health, safety or environmental issues that may suffice.” (LAB 10 –

T63)

“There are documented environmental, health and safety procedures and we are not

certified to the ISO 14001 and OHSAS 18001 and have no plans to implement the two

systems in the near future. We do however comply with the regulations but will not go

the certification way. We comply with the OHS Act.” (LAB 11 – T70)



“Even though the laboratory has two Laboratory Helpers whose main responsibilities

include housekeeping, housekeeping is everyone’s responsibility in the laboratory.”

(LAB 8 – T52)

“Housekeeping is everyone’s responsibility in our laboratory. But, we have cleaners

whose main responsibility is to maintain good housekeeping standards in the

laboratory.” (LAB 9 – T57)

“Housekeeping is everyone’s responsibility in our laboratory. The laboratory

personnel clean their work benches after conducting tests or analysis. It is not always

easy to keep the benches clean when working, but it is the responsibility of every

personnel to clean their work area after completing a task.” (LAB 10 – T64)

“Housekeeping is everyone’s responsibility in our laboratory. The laboratory

personnel clean their work benches after conducting tests or analysis but there are

people who are responsible for cleaning the floors. We have an electronic inventory

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management system where we are able to handle our inventory requirements

including material for cleaning.” (LAB 11 – T70)

Based on the data gathered from all the respondents, the non commercial laboratories

without a quality assurance system have methods in place to ensure that the

laboratory is a safe working environment for its employees. Methods employed by

these laboratories included appointing a SHE representative in the laboratory, issuing

of PPE, training laboratory personnel in first aid, and conducting risk assessments and

monthly safety talks. Laboratories that do not have certified H&S and environmental

management systems, have documented procedures to assist in the management of

health, safety and environmental issues. The respondents also had clearly defined

procedures in terms of the management of housekeeping. The respondents agreed that

housekeeping in the laboratory is the responsibility of all laboratory personnel.

For the non commercial laboratories without a quality assurance system in place,

there is a positive culture of health and safety, that is, maintaining good housekeeping

standards and H&S training.

5.1.3 Commercial laboratories that have a certified QA system




“To ensure that the laboratory is a safe working environment for everyone, health,

safety and environment form part of induction training for all laboratory personnel.

Employees spend the first week being introduced to their colleagues, Human

Resources policies, HS&E policies and their work areas. New laboratory personnel

are also trained on procedures regarding handling of hazardous chemicals and

maintaining good housekeeping standards in their work areas. Once training has

101

been conducted for employees, the records of training are kept in the personnel files.”

(LAB 12 - T 76)

“To ensure that employees are provided with a safe working environment, the

laboratory personnel have been trained in first aid and fire fighting.” (LAB 13 –

T83)

All the laboratory personnel were seen wearing the appropriate personal protective

equipment. There were health and safety signs displayed all over the laboratories

identifying which protective clothing they need at different sections of the laboratory.

It was also observed during the tour that the laboratories and sample retention room

were clean.

“Housekeeping is everybody’s responsibility. There is no one person whose

responsibility is housekeeping, laboratory personnel clean after themselves.” (LAB

14 - T89)

“In order to ensure that the laboratory is a safe working environment for personnel,

there is generic health and safety manual used for induction training throughout the

group. The health and safety checks are done regularly, we work according to the

OHS Act and there are Health and Safety committees in place. A first aid checklist

has been developed and is in use, there is a storeroom for chemicals; and we have a

documented procedure for containing leaks.” (LAB 15 – T97)

“To ensure that the laboratory is a safe working environment, health, safety and

environment form part of induction training for all permanent and contract

employees. As part of induction training for new employees or contractors rendering

the services, the individuals are each given the general safety manual for a specific

site where they will be doing their job. Laboratory personnel or contractors working

in the laboratory are given the general safety manual that relates to the laboratory

activities like handling hazardous chemicals and strong acids, understanding of

materials safety data sheets of chemicals they will be working with. The environment,

102

health and safety procedures have been documented and form part of our laboratory

system. Once training has occurred, the records of the training are kept in the

personnel or contractor’s files. Personal protective equipment is provided to the

laboratory employees.” (LAB 16 – T104)

It was observed that there were safety signs all over the laboratory building,

highlighting mandatory PPE to be worn in the laboratory.

“In ensuring that the laboratory is a safe working environment for personnel,

employees are provided with the necessary PPE and in house training is conducted.

The provided PPE protects employees against hazardous chemicals.” (LAB 17 –

T112)




“The environment, health and safety procedures are documented and form part of our

laboratory system. The entire organisation is certified to ISO 14001 and OHSAS

18001, and that helps because our system is managed in an integrated manner.”

(LAB 12 – T76)

“As far as health and safety is concerned, we work according to the OHS Act. It is

enough to help us deal with any health and safety issues that may arise. Currently,

there are no plans to implement ISO 14001 and OHSAS 18001.” (LAB 13 – T83)

“Having a certified environmental, health and safety system, helps us to be in control

of the environment, health and safety issues. If we were only ISO 17025 certified and

did not have the other systems; it was not going to be enough to help us manage the

environment, health and safety issues. Being certified to ISO 14001 and OHSAS

18001 helped us to formalise our systems in an integrated manner.” (LAB 14 – T89)

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“We have identified the need to implement ISO 9001 and are not planning to

implement ISO 14001 and OHSAS 18001 in future.” (LAB 15 – T97)

“We have documented health and safety procedures, even though we are not certified

to the environmental, health and safety systems. Our non certified HS&E system is

enough to help us deal with any environmental, health and safety issues that may

arise.” (LAB 16 – T104)

“We are not certified to ISO 14001 and OHSAS 18001, and there are no plans to

implement the systems. But our current system ensures that we are covered on

environmental, health and safety issues.” (LAB 17 – T112)




personnel clean their work benches after conducting tests or analysis. It is not always

possible to keep the benches clean during sample analysis, but laboratory personnel

are aware that they have to clean up immediately after completing the analysis.”

(LAB 12 – T76)

“Housekeeping is the responsibility of everyone in the laboratory, with the

Laboratory Manager and Supervisor overseeing that function.” (LAB 13 – T84)

“Housekeeping is everybody’s responsibility. There is no one person whose

responsibility is housekeeping, laboratory personnel clean after themselves.” (LAB

14 – T90)

“To maintain good housekeeping standards, there are maintenance charts that have

been developed to manage that and the work benches are decontaminated twice a

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day. There are trained personnel who are responsible for the decontamination of the

bench.” (LAB 15 – T97)


personnel clean their work benches after conducting tests or analysis. But I must

admit that it is not always possible to keep the benches clean during sample

analysis.” (LAB 16 – T105)

“We have rules and regulations that all employees have to follow to ensure that the

laboratory housekeeping standard is maintained at all times.” (LAB 17– T112)

Based on the data gathered from all the respondents, the laboratories have methods in

place to ensure that the laboratory is a safe working environment for its employees.

Methods employed by these laboratories included induction training on health and

safety matters for both permanent and contract employees, and also training on first

aid and the use of fire extinguishers. For laboratories that do not have a certified H&S

and environmental management systems, there are documented health and safety

procedures to help them deal with any environmental, health and safety issues that

may arise. Laboratories are also working according to the OHS Act. The respondents

also had clearly defined procedures for handling housekeeping issues. There is

consensus from laboratories that housekeeping in the laboratory is the responsibility

of all laboratory personnel.

For the commercial laboratories that have a quality assurance system in place, there is

a positive culture of health and safety, that is, maintaining good housekeeping


105

5.1.4 Commercial laboratories without a certified QA system




“We are in the process of moving to different premises. I have hired a consultant or

independent OHSAS representative who conducted an audit on our laboratory and

we will in the future start working on the non-conformances raised during the audit.

At the stage, the health, safety and environmental policies and procedures are not

formalised or documented. Training on safe handling of chemicals has been

organised for all laboratory personnel and it will be conducted by an external

training organisation.” (LAB 18 - T 117)

During the laboratory tour, laboratory personnel were wearing laboratory coats and

safety shoes. There was not even a single health and safety or personal protective

equipment signage displayed within the laboratory building.

“To ensure laboratory personnel are working in a safe environment, there are Health

& Safety representatives, there is a documented Health & Safety Policy and the

laboratory works according to that. Employees undergo induction training before

they can start doing the actual work. Once they have been trained, they sign a form

as an acknowledgement that they have been trained and they understand the training.

H&S inspections are also conducted on a weekly basis and corrective action is

taken.” (LAB 19 – T125)

Laboratory personnel were seen wearing appropriate personal protective equipment

as per the health and safety signs displayed around the laboratory building. The

respondent was asked how the lab is made to be a safe working environment for

employees.

106




“Our laboratory is not certified to ISO 14001 and OHSAS 18001. Going for

certification of the environmental, health and safety systems is not something that we

are planning to do in the near future.” (LAB 18 – T118)

“We are not certified to ISO 14001 and OHSAS 18001. But we do have documented

procedures to address the environment, health and safety issues and it works for us

without being certified. ISO 14001 and OHSAS 18001 certification is not in our plans

for the near future.” (LAB 19 – T125)



“The main responsibility of the Laboratory Assistant is housekeeping and also, all the

other laboratory personnel are responsible for ensuring that their work stations are

kept clean at all times. At the stage, we are managing well and are never really under

pressure. Even though we do not conduct formal audits, as far as housekeeping is

concerned, I do weekly inspections and the results are discussed during weekly

meetings.” (LAB 18 – T118)

“To ensure that good housekeeping standards are maintained, there are people who

are dedicated cleaners of the laboratory floors. Work spaces or benches are cleaned

by the Analysts after they complete their tasks.” (LAB 19 – T125)

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Based on the data gathered from all the respondents, the laboratories have methods in

place to ensure that the laboratory is a safe working environment for its employees.

The methods used by the laboratories included hiring a consultant to conducted an

audit as against the OHS Act requirements, providing employees with the required

PPE, the appointment of the Health & Safety representatives, a documented Health &

Safety Policy that guides the laboratory and induction training. The respondents also

had clearly defined procedures for handling housekeeping issues. There are personnel

whose main responsibility is housekeeping in the laboratory and also analysts clean

their work spaces after conducting tests.

For the commercial laboratories without a quality assurance system in place, there is

a positive culture of health and safety, that is, maintaining good housekeeping


5.2 Supplier Selection


The respondents from laboratories 1 to 7 were asked to explain the criterion to select

suppliers. Their responses were as follows;

“Suppliers are selected based on the history of their previous relationship with the

laboratory. If a new supplier has to be sought, they would have to bring a sample of

the product they want to supply. The laboratory would conduct tests on the sample to

verify that the product is not contaminated with the elements of interest. They are

approved based on the quality of the product they supply. If the potential supplier has

a quality system, it will be recognised, but it is the results of the product that would

determine if the supplier is included on the approved suppliers’ list or not. The only

suppliers that are ever audited are the fire assay flasks suppliers. That happens

seldom, and only occurs if it is suspected that the preparation of the flasks caused

errors in the results produced.” (LAB 1 – T6)

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“Suppliers are selected based on their Black Economic Empowerment (BEE)

compliance status. The turn around time and quality of the reagents form part of the

selection criteria. The reagents that we get from the suppliers are tested prior to

using them. The suppliers are also audited and the frequency of conducting audits

depends on their performance. Suppliers are rated on a six monthly basis. If a new

supplier has to be sought, those who are certified or accredited get an edge over

others, provided everything is equal. The relationship that we’ve had with the

suppliers is also important and that includes their pricing. Most of our approved

suppliers are ISO 9001 and ISO 14001 certified.” (LAB 2 – T14)

“Suppliers are selected based on their accreditation or certification status. We also

audit our suppliers. To avoid disappointment in case a supplier can’t deliver, there is

more than one supplier for each reagent. We also do consider the cost of material

when selecting suppliers.” (LAB 3 – T20)

“Suppliers are selected based on the quality of the reagents they supply. The reagents

from suppliers are tested before use. If there are any non-conformances, they can be

picked up at an early stage. Suppliers are also audited as part of the criteria before

adding them on the approved suppliers’ list.” (LAB 4 – T26)

“Due to the tests that we conduct; we deal mostly with distributors locally as the

manufacturers are overseas. But when we can, before adding a supplier on our

approved supplier’ list, we audit them to see if they will be able to deliver. The

suppliers that have a quality system are preferred over those who don’t have a

system.” (LAB 5 – T32)

“The laboratory has a procurement policy which is based on the WHO standards.

The important factor on our purchasing policy is that reagents must be supplied with

a certificate of analysis and are tested for sensitivity before being used against the

supplied certificate of analysis from the supplier. The certification status of suppliers

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does not form part of a supplier selection criteria as reagents are tested before us.

We mostly deal with sole suppliers not by choice, because the supplier is the only one

locally to provide us with the products and we do not have problems with sole

suppliers, we are happy with the service.” (LAB 6 – T41)

“When it comes to selecting suppliers, we consider quality, speed, and cost of service

or products as important factors. We also consider the ISO 17025 certification and

ISO 9001 certification status of potential supplier, we prefer suppliers with a certified

quality standard.” (LAB 7 – T47)

Non-commercial laboratories with a certified quality assurance system have clear

policies and procedures regarding the selection of their suppliers and measuring their

performance. The criteria used by the non commercial laboratories to select suppliers

and manage their performance include testing materials from suppliers prior to use,

auditing suppliers, and implementation of the procurement policy. The non

commercial laboratories consulted with certified quality assurance system, select

suppliers based on objective evidence like certificate of analysis or supplier audits.

For the non commercial laboratories with a quality assurance system in place, there is

a clearly documented procedure for managing suppliers.


The respondents from laboratories 8 to 11 were asked to explain the criterion to select

suppliers. Their responses were as follows;

“When selecting a supplier, we consider the reputation of the supplier. Factors like

the status of their certification are not considered when selecting suppliers. For us,

the main objective is to get a product that is not expensive yet not compromising

quality at the same time. After receiving reagents from our suppliers, we don’t test

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them before use. We accept them based on the trust that we have on our suppliers

because of their reputation. We don’t audit our suppliers.” (LAB 8 – T53)

“We deal mostly with distributors locally as the manufacturers of the raw materials

that we use are overseas. But we audit our local suppliers on a two yearly basis. We

just accept the raw materials from suppliers based on the Certificate of Analysis and

products are not tested before use. Most of our suppliers are ISO 9001 certified. We

also consider the costs as part of the selection criteria. When we are dealing with a

potential supplier, trials are conducted before they can be added on the approved

suppliers’ list.” (LAB 9 – T59)

“When selecting suppliers, preference is given to those who are certified. When

dealing with a potential supplier, a purchasing specification would be given to the

supplier. Once the product is delivered, a trial batch would be made using the

material from the potential supplier. A decision on whether to include the supplier on

the approved suppliers’ list will depend on the quality of their product after making a

trial batch. The potential supplier must also adhere to the agreed delivery times.

Suppliers that are already on the approved suppliers’ list are assessed annually to

monitor their performance.” (LAB 10 – T65)

“When it comes to selecting suppliers we only deal with distributors and we also deal

with sole suppliers not by choice. The reagents that are used in our field are made

overseas and come from certified organisations. Therefore, we don’t get the chance

to audit our suppliers. We only buy certified products from reputable companies.”

(LAB 11 – T71)

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Some of the non commercial laboratories without a certified quality assurance system

have clear policies and procedures regarding the selection of their suppliers and

measuring their performance. The criteria used by the laboratories to select suppliers

and manage their performance include testing materials from suppliers prior to use,

cost without compromising quality, and certificate of analysis. But for one laboratory,

the respondent reported that suppliers are selected based on their reputation only,

which is a subjective measure. Factors like the certification status of the supplier and

auditing suppliers do not form part of the selection criterion. In general, we can

accept that there is supplier management.

For the non commercial laboratories without a quality assurance system in place,

generally, there is a positive culture of managing suppliers.


The respondents from laboratories 12 to 17 were asked to explain the criterion to

select suppliers. Their responses were as follows;

“We have a documented purchasing procedure indicating the criteria to be used to

select suppliers. Basically, suppliers are selected based on the quality of the products

that they supply, the Certificate of Analysis is also required to be delivered with the

product, the ability of the supplier to keep to the agreed lead times, and also the

reputation of the suppliers. Suppliers who are certified or accredited are preferred

over non certified ones and they get an edge over everyone provided everything is the

same. But, our laboratory does not audit its suppliers.” (LAB 12 – T79)

“As part of our supplier selection criteria, our suppliers are ISO 9001 certified and

we purchase from certified suppliers only. We also require all the reagents supplied

to come with a certificate of analysis and we don’t test them before use. We have only

had one product that was out of specification over a period of ten years, so we have

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suppliers who provide good products. Suppliers are also audited to ensure that they

do not drop the standard.” (LAB 13 – T85)

“In our field; the reagents that we use are mostly manufactured overseas. We only

deal with local distributors who get the products from abroad. As part of our supplier

selection criteria, the minimum that we require from their suppliers is to have a

certified or accredited quality management system. The suppliers must be able to

produce the certificate of analysis for products purchased before they can be listed as

approved suppliers. But sometimes it does happen that the only person who can

supply you with what you are looking for does not have a recognised or certified

quality system. When buying from suppliers like that, they have to at least provide a

certificate of analysis for that product. In that way, we are able to make an informed

decision before purchasing. And as we are dealing mostly with distributors, we don’t

audit our suppliers.” (LAB 14 – T91)

“Our suppliers must be ISO 9001 certified. When choosing new suppliers, products

are tested first before adding the supplier on the approved list. The cost is also

considered, and it must be reasonable.” (LAB 15 – T99)

“According to our procurement procedure when selecting suppliers, a tender has to

be opened. The quotation and technical competence has to be evaluated by a team

consisting of laboratory personnel and procurement. The motivation for selecting the

supplier has to be included. This has been developed to root out corruption that

might develop if a supplier is sourced and approved by one person, and avoids

conflict of interest. Once the supplier has been approved and contracted, the contract

validity is specified and reviewed when it has expired. Furthermore, when material or

reagents are received from the suppliers, the certificate of analysis is inspected to

verify that the percentages or concentrations of the components reported will not

have an effect on the detection limit of samples to be analysed. Also, with regard to

supplier selection, certification gives suppliers an edge over those who do not have it,

but does not mean that you qualify to be on their approved suppliers’ list based on

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that only. The quality of the product supplied is very important. We don’t audit our

suppliers to monitor their quality.” (LAB 16 – T107)

“The criterion for selecting suppliers is word of mouth and recommendations. The

ISO 17025 certification and ISO 9001 certification status is not the only factor

considered when selecting suppliers.” (LAB 17 – T114)

Commercial laboratories with a certified quality assurance system have clear policies

and procedures regarding the selection of their suppliers and measuring their

performance. The criteria used by the laboratories to select suppliers and manage

their performance include the implementation of the documented purchasing

procedure, certification status, and testing materials from suppliers. The commercial

laboratories consulted with a certified quality assurance system, select suppliers based

on objective evidence like considering the certification status of the supplier.

For the commercial laboratories with a quality assurance system in place, laboratories

have a clearly documented procedure for managing suppliers.


The respondents from laboratories 18 to 19 were asked to explain the criterion to

select suppliers. Their responses were as follows;

“Suppliers are selected based on the quality of the product supplied, the price and the

service. Our suppliers have to supply reagents with certificates of analysis, and they

are tested to verify their results before being used to produce results. If a potential

supplier has a quality system, it will be recognised, but it is the results of the physical

product that would determine if the supplier is used or not. We also don’t audit our

suppliers; the most important thing is the test results of the reagents from our

suppliers.” (LAB 18 – T120)

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“Criteria used by the laboratory to select suppliers include the quality of results and

the cost. Products have to be delivered with certificate of analysis. We sometimes test

the reagents before using them but it is not a norm. Products from suppliers are only

tested when there is a problem. Certified or accredited suppliers do not get an edge

over those without a formal quality system.” (LAB 19 – T127)

Commercial laboratories without a certified quality assurance system have defined

ways regarding the selection of their suppliers and measuring their performance. The

criteria used by the laboratories to select suppliers and manage their performance

include the costs, service, delivering the product with a certificate of analysis, and

testing reagents before use. The commercial laboratories consulted without a certified

quality assurance system, also select suppliers based on objective evidence like

certificate of analysis.

Commercial laboratories without a quality assurance system in place have a clearly

documented procedure for managing suppliers.

5.3 Human Resources


The respondents from laboratories 1 to 7 were asked to explain the laboratory’s

procedure for declaring employees competent. Their responses were as follows;

“We have implemented what is called planned task observation, and we use it during

training in order to declare employees competent. There is a form that we have

prepared and different tasks or activities that the trainee must be able to perform

before being declared competent are listed on that form. The time required for

training personnel depends on the complexity of the test method and on the capability

of the person being trained. For an example most employees can be declared

competent in weighing materials within a day, but it can take different employees

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from one to three months to be declared competent in operating analytical equipment

like an Inductively Coupled Plasma. Training is conducted by the laboratory

personnel who have already been declared competent in the test method. Training

records of planned task observation are signed by the trainee as an acknowledgement

that they have been trained.” (LAB 1 - T 5)

“Before employees can be allowed to work on their own, they are trained by

introducing them to the system. There is no time frame defined when it comes to

training. Training depends on the capability of the employee. We have implemented a

job observation as a system used during the training phase of employees. It is also

used to declare employees competent once they have been trained on test methods.”

(LAB 2 - T 13)

“Laboratory personnel are trained and declared competent before they can be left to

work independently. New employees learn by observing a competent person

conducting a test. They then get a chance to do it in practice. Once they are proficient

in a test method, they sign a training form as an acknowledgement that they have

been trained.” (LAB 3 - T 19)

“Laboratory employees are trained and declared competent before they can be left to

work independently. When an employee is new, they are introduced and taught about

the business the organisation is in. They also attend a course on water purification.

Depending on the job description of the new person, they would be assigned a

competent person who will demonstrate how to conduct tests in practice. They also

get an opportunity as trainees to do the tests. When they have proved that they are

capable of working on their own through job observation, they are declared

competent by their trainer.” (LAB 4 - T 26)

“All new employees have to undergo induction training before they can be left to

work on their own. They are introduced to the integrated system and the test methods

during the training phase.” (LAB 5 - T 31)

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“As part of a procedure for declaring employees competent, new employees are given

documents to read. Training on laboratory procedures starts during the second week

using documented standard operating procedures. Personnel are also trained on

procedures like receiving and processing specimen, testing for viruses, and all the

theories that go along with the tasks. As personnel go through the standard operating

procedures, they have a form that they have to sign to acknowledge that they have

been taken through the procedures and trained. When a new employee has been

witnessed by a competent person and reaches the required competency level

regarding a certain test method, he/she is given a competency form to complete and

sign as an acknowledgement that he/she has been trained on that test method.

Competency for all employees is reviewed annually, regardless of the number of

years a person has been working at the laboratory.” (LAB 6 - T 40)

“New employees work under close supervision of a laboratory person who has been

declared competent. The role of the competent person is to demonstrate to the new

employee how to conduct the tests. Some techniques take longer to achieve

competency on than others. For an example, it takes some time to be competent in the

microscope and it requires a lot of skill. Once a person has been trained, the onus is

upon the trainer to ensure that new employees conduct the tests properly. During the

first few months, the competent employees will do checks with reading microscope as

it takes a while. A competent person would read the slide and a trainee would be

asked to do the same. If there are any discrepancies between the reading of a

competent person and a trainee, the training need is identified at that stage to assist

the new employee reach the required level of competency.” (LAB 6 - T 40)

“Our procedure for declaring laboratory personnel competent is by ensuring that

they all participate in inter-laboratory and intra-laboratory comparisons, and

measure them against specified level of reproducibility and accuracy.” (LAB 7 - T

47)

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The respondents were asked to explain the laboratory’s procedure for measuring the

effectiveness of training once training has been conducted. Their responses were as

follows;

“Once employees have attended training, when they come back they are given a

project to complete using the knowledge gathered at the training. For example, if

employees have been to a course on method validation, when they come back they are

given a task of validating methods used in the laboratory. The records of the project

outcome are stored in the personnel files.” (LAB 1 – T6)

“The results of the PTS are used to measure the effectiveness of training conducted.”

(LAB 2 – T14)

“Once employees have been trained, they also write a test afterwards to measure the

effectiveness of training conducted. The records of training are maintained in the

personnel files.” (LAB 3 – T20)

“Once the employees have been declared competent, the quality control measures like

quality control samples and ‘blind’ or spiked samples are used to measure the

effectiveness of the training conducted.” (LAB 4 – T26)

“Once employees have been trained, they are assessed by writing an exam and also

are assessed by a panel where they are given an oral examination. Competency status

lasts for three years. After a period of three years, employees go through the same

cycle of training as if they are new hired. New material that has been incorporated

into the system over a period of three years is included when retraining employees.”

(LAB 5 – T32)

“When employees have been trained on test methods, the effectiveness of the training

conducted is measured by giving personnel ‘blind’ samples. We also use both

internal and external quality control checks during the testing of specimen as a way

to determine the effectiveness of training. That also assists to identify any mistakes

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that might have happened before reporting the final results. Analysis of Quality

Control samples and intra-laboratory samples are the best way for us to measure the

effectiveness of training. Weekly laboratory meetings are used as a platform for

discussing test methods and any other laboratory issues. If it is identified that there is

a misunderstanding on a standard operating procedure, training is organised to help

everyone be on the same page. Based on our experience so far regarding training

needed, it is normally internal training that is needed to address the areas of

concern.” (LAB 6 – T40)

“Once employees have been through training, the effectiveness of training is

measured by observing the practical application of training, i.e. observing the

personnel conduct the actual test. Furthermore, the outcome is then quantified and

assessed against predetermined levels of reproducibility and accuracy.” (LAB 7 –

T47)

Still on training issues, the respondents were asked to identify the methods used to

check personnel’s competency in the laboratory. The responses were as follows;

“The laboratory participates in proficiency testing schemes both internally and

externally, analyse certified reference materials and QC samples as a continuous way

of monitoring the competency of the laboratory personnel. If the results of the

proficiency testing scheme show that the laboratory results were out, a non

conformance report is raised, and the root cause would be identified and

corrective/preventive measures put in place. ‘Blind’ or spiked samples are only used

during the period of training. Once employees are declared competent, ‘blind’ or

spiked samples are no longer used.” (LAB 1 – T6)



of monitoring the competency of the laboratory personnel. ‘Blind’ or spiked samples

are also used. If the results of the proficiency testing scheme show that the laboratory

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results were out, a non conformance report is raised, and the root cause would be

identified and corrective/preventive measures put in place. The results of the PTS are

discussed during management reviews.” (LAB 2 – T14)



of measuring the competency of the laboratory personnel. We are satisfied with our

PTS performance but there is always room for improvement. ‘Blind’ or spiked

samples are also used as another method of measuring the competency of

employees.” (LAB 3 – T20)


externally, analyse certified reference materials and QC samples. ‘Blind’ or spiked

samples are also used to measure the competency of laboratory personnel.” (LAB 4 –

T26)


externally, analyse certified reference materials and QC samples. ‘Blind’ or spiked

samples are also analysed and so far their general performance is good.” (LAB 5 –

T32)

“The results of the intra-laboratory testing schemes are used as a continuous way of

monitoring the competency of our laboratory personnel. Our last intra-laboratory

test results were within the specified limits. We also use ‘blind’ or spiked samples to

check the competency of our staff. The laboratory also takes part in external quality

control, and those samples are tested on a six monthly basis to check competency.”

(LAB 6 – T41)

“The competency of the laboratory personnel is measured using Certified Reference

Material, in-house QC samples, blind/spiked samples and taking part in Proficiency

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Testing Schemes. And we are happy with our performance when it comes to our

results of the proficiency testing schemes.” (LAB 7 – T47)

The respondents were asked to explain the impact of their system on KPI’s and

performance appraisals. The responses were as follows;

“Our system helps with the training of employees. One of the requirements is to have

a procedure in place for declaring laboratory personnel competent. During the

process of training employees, it gives the supervisors an opportunity to identify

training needs of personnel. When it comes to performance appraisals, the system

helps to set the level or expectations that are required from the employee once they

have been declared competent. If personnel are not performing to the expected level,

I normally first counsels them and they are encouraged to communicate any problems

that they might have.” (LAB 1 – T7)

“My concern is that ISO 17025 contributes to loosing good and talented employees.

The system requires that employees be continuously trained, and by doing that they

reach a high level of competency and become very good performers. And since every

organisation wants the best in their teams, they become good candidates when

employment opportunities outside our company arise. To keep good employees,

promotion happens but not everyone can be promoted. I try my level best to assist

them as a manager where I can, but sometimes employees get good offers that the

laboratory cannot give and I have to let them go.” (LAB 1 – T7)

“With regard to performance appraisal, we don’t restrict that to the requirements of

the standard and we go beyond that. We look at things like succession planning, and

what we need to do to help employees reach the required level of performance to be

able to perform at the next levels. Developing key performance indicators for

personnel take into account succession planning, and our system helps us to identify

the factors to be included as people’s key performance indicators.” (LAB 1 – T8)

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“The system contributes positively to performance appraisals. Due to our

performance on factors like the proficiency testing scheme scores, employees get

grading and when performing well they are considered for promotions to the higher

levels. That promotion comes with more responsibility and getting a better salary.

And the system also helps when developing key performance indicators for

employees.” (LAB 2 – T15)

“The system helps with regard to the key performance indicators and performance

appraisal. There is a training matrix in place, where employees know what they are

working towards. Once performance at a certain level is achieved, the employee can

move to the next level. Most of the training is conducted internally, but if there is a

need external training providers are used.” (LAB 3 – T21)

“You have to appraise employees whether you are accredited or not. ISO 17025 is

there to harmonise things, ensure that supervisors and analysts are on the same page.

It does help when doing performance appraisal and developing key performance

indicators because as a supervisor you can look at objective evidence from the third

party or accreditation body, and how soon analysts close non conformances.” (LAB

4 – T27)

“ISO 17025 helps us to plan for training of employees; it helps us to be proactive.

There will be those employees who are high flyers and you will have to let them go.

But we keep our good employees motivated and retain them through development like

job rotation where they are exposed to everything that happens in the laboratory. ISO

17025 (round robin samples) results help when doing performance appraisals and

developing key performance indicators. The records of activities help because I have

evidence of personnel’s performance. Records of internal audits, customer audits and

certification and accreditation body are also helpful in providing evidence when

conducting performance appraisals.” (LAB 5 – T33)

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“With regard to performance appraisal, we will be working towards a performance

based system which is under development and we also work according to job

descriptions. Employees are rewarded by giving them more responsibilities and

opportunities for training. They are also given an opportunity to be facilitators and

provide training to registrars and other African countries.” (LAB 6 – T42)

“The system has both a positive and negative impact on staff morale. It is motivating

in the sense that you know a proper system has been followed and can release the

results with confidence. But what is de-motivating is the amount of documents that

you have to keep track of, and that can be overwhelming. The system can never be

100% perfect as quality is a continuous journey. Therefore, during external audits,

issues are always raised and that results in more work. The system helps management

to know what happens in the laboratory as I cannot be in the laboratory all the time.

The system helps especially during busy periods. Each laboratory employee has clear

and set responsibilities and they all know what to do even when the work load is

heavy.” (LAB 6 – T42)

“Being GLP compliant helps during the process of performance appraisal for our

staff and developing key performance indicators. Staff performance and competencies

are quantified, making it easy to recognize good and bad performance. It also helps

to develop measurable key performance indicators for personnel.” (LAB 7 – T48)

The respondents were asked if their system helps when working under pressure. The

responses were as follows;

“ISO 17025 gives us confidence in the results that we produce, even when working

under pressure because of the documented procedures. As a manager, I always

encourage my subordinates to never release results if in doubt, even when the

customer was expecting them. They are encouraged to inform me so that I can inform

customers in time that their results would not be ready as per the original

arrangement. There is a laboratory meeting held weekly, where I communicate all the

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customer complaints and compliments to the laboratory personnel to keep them in the

loop. Employees are also encouraged to speak out and point out any issues that they

feel if improved would improve their attitude towards their work.” (LAB 1 – T7)

“To ensure that employees behave ethically and handle their work well while under

pressure, the issue of ethics and pressure is handled formally. There is a documented

policy on ethics and pressure. If the number of samples is too high to handle and

customers cannot get results as promised, the customers always want to know what

action have been taken to correct that. But the customer is always informed if there

are delays and they appreciate being told. ISO 17025 helps to manage training of

employees. The system has a positive impact on staff morale; it is motivating to work

in a certified laboratory.” (LAB 2 – T14)

“In order to ensure that employees are free from undue pressures and they behave

ethically, there is a documented policy on ethics and employees are trained on that.

To help employees with pressure, there is a clearly defined channel of

communication. Customers are not allowed to communicate to the testing personnel

directly; they only deal with the supervisors.” (LAB 3 – T20)

“To ensure that employees behave ethically, work well under pressure and do not

produce poor quality while in a hurry to reach the target planned for the week, you

have to lead by example as a manager when it comes to ethical issues. The manager

must help employees to feel welcome in the workplace, and in that way be able to

unleash their potential. With regard to retaining good employees, if people leave

because they don’t feel technically challenged by the work, then we can try to provide

challenges. But if it is because of personal issues, there is nothing we can do and

people leave. But, if employees left on a good record, sometimes they come back and

we welcome them.” (LAB 4 – T27)

“To ensure that Analysts do not bear undue pressures, they do not have access to the

phone and they do not deal directly with the customers. If a customer wants to

contact a laboratory person, they speak to the Sample Administrator or the Section

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Manager. To help employees behave ethically, a meeting is held every morning. That

helps to find out who is struggling with the work load so that they are not tempted to

just produce figures or reports.” (LAB 5 – T33)

“OECD GLP helps to ensure that personnel are free from undue pressures and

employees are ethical because there is a system for doing everything. We instil

ethical behaviour in the attitude of all personnel by making them aware that

documentation or recording of every test conducted is very important. They

understand that if there are no records for a test, then it was not done and if records

are found missing during audits, non conformances will be raised. The system makes

you work in an orderly manner, and keeps your mind in a step by step format. The job

descriptions also ensure that personnel are free from undue pressures.” (LAB 6 –

T42)

“In order to ensure that personnel are free from undue pressures that may affect their

work, they share workload and we encourage communication amongst personnel.

Furthermore, to achieve good ethical behavior from employees, being a good mentor

myself, and setting an example helps foster good ethical behavior. Additionally, GLP

environment requires accurate and true reporting of test results. This is monitored by

the audit process. We also try as management to retain performing employees by

providing them with stimulating work environment and good remuneration package.”

(LAB 7 – T48)

The non commercial laboratories that have a certified quality assurance system have

proper procedures to handle HR issues. The laboratories have clearly defined

procedure for declaring employees competent. Methods like planned task observation

and job observation are used. There are procedures in place to measure the

effectiveness of training once training has been conducted. Employees are given a

project to complete using the knowledge gathered at the training and the testing of

reference cultures and QC samples. Methods used to check personnel’s technical

competence included PTS, QC samples and also blind samples.

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Non commercial laboratories with a quality assurance system in place have a positive

culture on performance of HR issues like training, declaration of competency and

methods to checking personnel’s competency.




“All employees are trained and are competent to do their job. The laboratory does

not have a defined procedure regarding how we declare employees competent. We

only hire qualified employees and are therefore competent. We keep copies of

certificates if training was offered by an external training provider.” (LAB 8 - T 52)

“What helps us with the competency of our laboratory personnel is that we have set a

minimum requirement with regard to qualification. The qualification level that we

have set as a minimum makes it easy for us because we are sure that the people that

we hire have been trained to do calculations, for example needed in a laboratory.

Once the right person has been employed, they would then be trained by a competent

person on things like specific equipment calibration and individual test methods used

in the laboratory.” (LAB 9 - T 58)

“Laboratory personnel have to be declared competent before they are allowed to test

and approve products without supervision. During induction period, the trainee or

new employee would be given a sample and the results are compared with those of a

person who has been declared competent.” (LAB 10 - T 64)

“Laboratory personnel have to be declared competent before they are allowed to

work on their own. Training starts with initial assessment to identify any skills that

could be lacking in order for the employee to do his/her job. A training plan is

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developed based on the outcome of the training assessment. Taking part in

proficiency testing schemes and Intra/Inter sample testing are used as part of

training. Both in-house and external training providers are used.” (LAB 11 - T 70)



follows;

“Once employees have been offered training, either internally or externally, we do

task observation to see if there is any change in behaviour. Not so long ago,

employees were trained on handling hazardous chemicals, and when they came back

from training, they had to move chemicals from one store room to the other. There

were no incidents reported, showing that attending the course has helped and this is

how we measured the effectiveness of the training attended.” (LAB 8 – T52)

“There is a competency evaluation once a year of the personnel on all the methods

that they have been trained on. Most of the training is done internally, but if a need

arises external training providers are used. To measure the competency of personnel

during training, the laboratory has implemented a planned job observation where the

manager will observe the trainee conducting tests before declaring them competent.

If there are any shortcomings, a non conformance will be raised and the trainer will

identify training needs to help the employee reach the required level of competency.”

(LAB 9 – T58)

“The employees are given a practical test where they are observed and also a theory

test and the pass mark is 90%. Safety related issues are included in the test, for

example there are questions on what the employee would do if there a fire.” (LAB 10

– T64)

“Job observation or witnessing is used to measure the effectiveness of training

provided. Training records are maintained in the personnel files.” (LAB 11 – T71)

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“We are limited to using one method only. We use internally prepared standard

solutions to check the competency of the laboratory personnel. Other methods like

Proficiency Testing Schemes, Certified Reference Materials, and ‘Blind’ or spiked

samples are not used. We have never explored the benefits that can be brought by

using methods like Proficiency Testing Schemes, Certified Reference Materials, and

‘Blind’ or spiked samples.” (LAB 8 – T53)

“The laboratory does not analyse QC samples before analysing the samples from

production, we also do not run certified reference materials, do not take part in the

proficiency testing schemes and do not use ‘blind’ or spiked samples. The laboratory

only does equipment verification when for example the solutions of the equipment

have been changed. Or, we conduct parallel tests like titration, one automatic and

one manual as a way of checking that the equipment is still on track.” (LAB 9 – T59)

“The laboratory does not analyse QC samples before analysing the samples from

production. We don’t run certified reference materials and don’t take part in the

proficiency testing schemes. We only rely on standardisation.” (LAB 10 – T65)

“The laboratory analyses QC samples before analysing the samples, ‘blind’ or spiked

samples are also used to check the consistency of personnel. The laboratory takes

part in the proficiency testing schemes. We also take part in inter and intra

laboratory testing schemes and between analysts. So far, I am happy with our

performance in proficiency testing schemes but we are not always within the set

ranges, sometimes we have outliers.” (LAB 11 – T71)



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“When doing performance appraisals and developing key performance indicators we

look for different factors. That includes professional conduct, quality of work, and the

results of service questionnaires issued to our customers. Professional conduct

includes sub factors like punctuality.” (LAB 8 – T54)

“We have a training matrix that is developed to help with training and performance

measurement of employees. The matrix refers to what employees need to have, what

they need to do like testing and reporting on the computer system and that is what is

looked at during their performance reviews. Employees decide to leave their

employment for different reasons like families, better offers and sometimes you

cannot stop them.” (LAB 9 – T59)

“Regarding the development of key performance indicators and performance

appraisals, it is handled by the Human Resources department and is conducted once

a year. I can only make an input on forms and the full report is handled by the

Human Resources department. One way that we use to retain good employees is

giving them training and development.” (LAB 10 – T65)

“ISO 17025 helps with developing key performance indicators and during

performance appraisals. For each employee, the work plan includes the ISO 17025

requirement, and the target dates are decided upon.” (LAB 11 – T72)



“It must be the manager’s role to ensure that there is compliance to internal

standards. As a manager, you must be a very observant person and be able to notice

changes in personnel’s behaviour. Any issues arising must be resolved as soon as

possible to ensure that the quality of work is not compromised. A standard of

performance and what is expected from personnel must be set. One way of retaining

good employees is through communication and communicating freely to employees,

giving them more responsibility and rewarding them in monetary terms.” (LAB 8 –

T54)

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“We can cope with what we currently have, which is ISO 9001 certified system.”

(LAB 9 – T59)

“To ensure that personnel are free from undue pressures and they remain ethical, the

QC Supervisor attends daily meetings with the production team and plan for the day

but at the same time have to be flexible as the plan may change during the day. But

due to constant communication between production and the laboratory, the plant is

happy with our sample turn around time.” (LAB 10 – T65)

“To ensure that personnel are ethical, all employees are registered with South

African Veterinary Council, and it is a regulated profession and the employees know

the code of conduct. Since it is a state facility, there are times when employees are

under a lot of pressure. For example when a laboratory person leaves, it takes much

long to replace the person compared to a private sector. Even if the laboratory

person is valuable and deserves more in terms of salary, the employee’s immediate

supervisor does not decide on the salary of the subordinates. Those are some of the

challenges that we face with regard to the pressures that exist in the laboratory. That

also makes it difficult to retain good employees, especially when they raise the issue

of salary as their reason for leaving.” (LAB 11 – T72)

“At the end of the financial year, a performance and management development

system evaluation is done. Based on how the person performed regarding the work

plan that they were given at the beginning of the year, they can be scored as poor,

average or top performer. Also when there are conferences or workshops, a good

performer will be sent to represent the laboratory. But when it comes to training, the

poor performers will be the ones given an opportunity to attend training to reach the

required level of competency.” (LAB 11 – T72)

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Non commercial laboratories without a certified quality assurance system have

procedure to handle HR issues. Some labs have a clearly defined procedure for

declaring employees competent. Methods like training of new employees by

competent persons are employed. But for one laboratory, there is no defined

procedure regarding how they declare their employees competent. Qualification was

given as a reason for being competent. There are procedures in place to measure the

effectiveness of training once training has been conducted. Planned job observation is

one of the methods used. In order to check personnel’s technical competence,

methods that are used by laboratories included internally prepared standard solutions

and equipment verifications are used.

For non commercial laboratories without a quality assurance system in place, there is

a positive culture on performance of HR issues like training, declaration of

competency and methods to checking personnel’s competency.




“Laboratory personnel are trained and declared competent before being left to work

on their own. The laboratory has both internal and external quality control checks

implemented to help identify areas of weaknesses before they become major. Here,

I’m referring to analysis of reference materials, in-house QC samples, and

participating in proficiency testing schemes. QC samples are tested before testing

actual samples. Therefore, non-conformances are identified at an early stage and

corrected before testing the samples from customers.” (LAB 12 - T 77)

“Once newly hired employees have been introduced to the HR and HS&E policies,

they then begin with the test procedures training. New employees work under the

supervision of a laboratory employee who has been declared competent in the test

methods. The role of the competent employee is to demonstrate to the new employee

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how to conduct tests and everything that has to do with a particular test procedure

like calibration and the sensitivity of the test methods. The training time depends on

the complexity of the test methods and the capability of an individual trainee. But,

once the trainer and the trainee are confident about the training conducted, the

trainee will sign a competence form as an acknowledgement that he/she has been

trained. The records of training conducted are kept in the personnel files.” (LAB 12 -

T 77)

“All employees have personnel files where documents like their job description and

training plans are stored. Internal training is conducted but when a need arises,

external training providers are used. As personnel are audited by the clients and the

accreditation body, the outcomes of the audit are used to identify training needs that

may arise as part of continuous training.” (LAB 13 - T 84)

“Laboratory employees are trained and declared competent before they can be left to

work independently. We have a clear procedure on training of laboratory personnel.

When employees have to be trained on a new method, the training time depends on

the history or previous experience of the person being trained. Training time is also

dictated by the capability of the trainee. Employees are trained by a person who has

already been declared competent. The first step is to take the employee through the

test procedure, step by step. As part of training, the trainee would then be involved in

tasks like preparing standards, analyzing material already analysed by a competent

personnel and also equipment troubleshooting. When the trainee gets to a point

where their results compare with that of a competent person, they complete a

competency form and sign it as an acknowledgment that they have received training

and are declared competent.” (LAB 14 - T 90)

“The qualification of employees forms a big part of that. We also have our own

training centre. All employees need to be declared competent before carrying out

work on their own. When it comes to the technical staff, those involved in testing,

their induction training is conducted on site for a week and they get a chance to do

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the practical. They would then go back for one more week of theoretical training and

get another chance to practice. When the trainers have done job observation and are

confident about the personnel’s performance, they are declared competent.” (LAB 15

- T 98)

“If the employee is new, they spend the first two months working under close

supervision of a Laboratory Technician who has been declared competent. The role

of the competent Laboratory Technician is to demonstrate to the new employee how

to conduct tests and everything that has to do with a test procedure. That includes

calibration of the equipment used, equipment maintenance, standards or reference

materials used to check the optimal performance of equipment and any other factor

that relates specifically to that test method. During that time, the competent personnel

will ask the trainee to be involved in tasks like sample dilutions, trouble shooting of

equipment and the trainee will be observed and given feedback regarding his/her

progress.” (LAB 16 - T 106)

“If after three months, according to the trainer’s recommendation the trainee is

competent and the trainee feels the same way, he/she will be given a competency form

to complete and sign as an acknowledgement that he/she has been trained on a

certain method. A competency form is completed and signed for each test method

which the trainee has been trained on. The records of the training conducted are kept

in the personnel files. A personal development plan (PDP) for each laboratory

employee is prepared yearly. A training plan is developed by the employee and their

immediate supervisor. A list would then be compiled regarding the courses or

training that each individual has to attend.” (LAB 16 - T 106)

“To declare laboratory personnel competent, the trainees have to witness an already

competent person doing the test. The competent person would then watch the

technician/trainee run a known sample three times. If the trainee is able to produce

results that are within three standard deviations consistently, then the trainee is

declared competent. A form is then completed by the trainee and trainer as an

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acknowledgement that training has been conducted and the records are kept in

personnel files.” (LAB 17 - T 113)



follows;

“When employees have been trained, different methods are in place to measure the

effectiveness of the training attended. For an example, when an employee has been

trained on a certain method, they would then take part in testing samples of

proficiency testing schemes and intra-laboratory test samples. In that way, there is

objective evidence of whether the employee understood all the principles of a test

method that they have been trained on. The results of proficiency testing schemes

help us to identify training needs for new employees. If there are outliers, you’ll know

what to focus on when you train employees.” (LAB 12 – T78)

“To evaluate the effectiveness of training conducted; personnel are given ‘blind’

samples. Lab personnel also take part in proficiency testing schemes. And also, the

outcomes of audits conducted are used to measure if the of training conducted is

effective.” (LAB 13 – T84)

“During the training phase on test methods, employees are given ‘blind’ or spiked

samples to test their competency. It that way, the effectiveness of the training

conducted is measured objectively, based on the results the employee produce.

Records of training are kept in personnel files.” (LAB 14 – T91)

“When employees have been trained and declared competent the effectiveness of

training is measured by job observation or witnessing. They are given proficiency

testing samples, and internal QC samples. The effectiveness of training is measured

by the results of the proficiency testing scheme (PTS) samples that employees or

trainees get. And I have to say, we are doing generally well in our PTS. The

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administration people who are involved in capturing data are also trained on the

organisation’s electronic system for two weeks.” (LAB 15 – T99)

“When employees have been to training, they have to report back to their immediate

supervisor about the training attended, and advise whether they would recommend it

to other employees. This would be discussed at the management review and will

assist to decide whether the course would benefit other employees. The training needs

are identified during performance appraisals. When developing the training plans,

the laboratory employee’s supervisor considers the cost, and the relevance of the

course to the responsibilities of the person.” (LAB 16 – T107)

“Effectiveness of the training conducted on employees is measured by task

observation when employees have been declared competent.” (LAB 17 – T113)



“The methods used as a continuous check of personnel competency include testing

certified reference materials, in-house QC samples, samples from internal and

external proficiency testing scheme providers. We take part in proficiency testing on

a monthly basis using an external proficiency scheme provider. We performed well in

our previous PTS. All the elements tested were within the limits according to the

report of our last proficiency testing provider. Spiked or ‘blind’ samples are not used

by our laboratory to check the competency of the personnel; we just never used

them.” (LAB 12 – T78)

“As I have already mentioned, we take part in proficiency testing schemes. The

results of the PTS samples are used to measure the performance of the laboratory

and competency of personnel. The results of the PTS are also given to customers if

they ask for them.” (LAB 13 – T85)

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“The laboratory participates in proficiency testing schemes offered by external

proficiency testing schemes providers. In our field of work, it is not easy to get

certified reference materials, so we depend on the proficiency testing schemes to

measure our performance and employee competency. We also use ‘blind’ or spiked

samples as another way of continuously monitoring the technical competency of

employees. Employees are generally doing well when given spiked samples.” (LAB

14 – T91)

“The laboratory measures the competency of the personnel by participating in

proficiency testing schemes offered by external proficiency testing scheme providers.

Internal QC samples are also used to monitor technical competency. Our

performance with regard to PTS varies as we have different departments or branches

around the country.” (LAB 15 – T99)

“The results of the proficiency testing schemes are used as a continuous way of

monitoring the performance and competency of the Laboratory Technicians. The

laboratory takes part in proficiency testing on a monthly basis using an external

proficiency testing scheme provider. We performed well in our last PTS; of all the

thirty methods that the laboratory took part in, our performance was within the

acceptable level. Spiked or ‘blind’ samples have never been used to check the

competency of personnel.” (LAB 16 – T107)

“Competency of laboratory personnel is measured by using in house QC samples and

by taking part in the proficiency testing schemes. But we don’t use certified reference

materials and ‘blind’/spiked samples. We got our results from the proficiency testing

scheme that we participated in, and I’m happy with the results.” (LAB 17 – T114)



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“The system helps during the process of performance appraisal and developing key

performance indicators for personnel. Some of the factors included in the

laboratory’s performance appraisal include the results of the proficiency testing

schemes and that is a quantifiable measure. The requirements of OECD GLP help us

to formalise the development of performance indicators for employees, and training

needs. It also helps management to know what happens in the laboratory through the

reports of internal audits and assessments and proficiency testing reports.” (LAB 12

– T79)

“Having a system like OECD GLP helps with developing key performance indicators

and performance appraisal. The key performance indicators for staff are reviewed

every three months and can include things like time keeping to performance in the

laboratory. The system also helps us with managing the training needs of employees.”

(LAB 13 – T85)

“Results of the proficiency testing schemes are used as key performance indicators

for laboratory personnel and are also evidence during performance appraisals.”

(LAB 14 – T93)

“ISO 17025 helps with the development of key performance indicators. And as far as

performance appraisal is concerned, it is mostly handled by the HR department.”

(LAB 15 – T100)

“Through certification, a culture is developed where people know what to do if one

person is not in. ISO 17025 helps to develop training needs for laboratory personnel.

It also helps during the process of performance appraisal and developing key

performance indicators for personnel. Some of the factors included in the

laboratory’s performance appraisal include the results of the proficiency testing

schemes and that is a quantifiable measure. Training plans are also developed based

on some of the requirements of the standard (e.g. method validation and the results of

the proficiency testing schemes).” (LAB 16 – T108)

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“The system does not necessarily help during the process of performance appraisal

for staff. But it assists in developing key performance indicators for laboratory

personnel.” (LAB 17 – T114)



“Our system helps to ensure personnel are free from undue pressures and employees

are ethical. This is due to the fact that processes like purchasing are documented in

the form of policies and audited to ensure compliance, and buyers cannot purchase

from anyone who is not on the approved suppliers’ list. The system can help detect

any unethical practices or trends that may occur. Furthermore, to ensure that

laboratory personnel are free from undue pressures, customers do not communicate

directly with the testing personnel about the results or samples but only with the

supervisors. Communication between laboratory personnel and supervisors is valued

as it can identify if personnel are under pressure or acting unethical at an early

stage.” (LAB 12 – T79)

“To ensure that personnel are free from undue pressures and are ethical, laboratory

personnel do not deal directly with customers. Meetings are held regularly to

promote communication between supervisors and personnel.” (LAB 13 – T85)

“To ensure employees are not under undue pressures, laboratory personnel are cross

trained to conduct all the tests in the laboratory, but job rotation is not practiced. I

fully agree with the principles of job rotation, but at the moment the job is not big

enough to practice it. If a need arises for that, the laboratory will be ready as

employees know all the test methods used in the laboratory. If personnel are under

pressure, I have to intervene as a manager to reallocate staff responsibilities to

complete the project. If it happens very often, then I would look at my resources and

recruit more personnel if it is justified.” (LAB 14 – T92)

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“The laboratory personnel are constantly trained on ethical issues. Employees are

trained on issues like making changes to reported results. They know they have to

sign next to the changes made to ensure traceability. I have a training plan in place

and all employees must attend training on ISO 17025 to help them understand why

they have to do things in a certain way. Personnel are constantly reminded of

producing trustworthy results and not what the customer wants to see. If there are

any non conformances, they are recorded during audits and the root cause identified,

and measures put in place to ensure it does not happen again.” (LAB 14 – T92)

“To ensure employees behave ethically and are not put under undue pressures; they

are registered with the Health Professional Council. The nursing sisters have their

own ethics board and are they are governed by DENOSA. There is a confidentiality

clause in the job descriptions stipulating expected behaviour. The employees are also

aware that their clients can report them to the council if they have not been treated in

accordance with the rules and policies that they have to work within. With regard to

undue pressures, the laboratory has policies governing that. For example, there is a

policy on accepting gifts.” (LAB 15 – T99)

“ISO 17025 helps ensure personnel are free from undue pressures and employees are

ethical because there is a system for doing everything. ISO 17025 ensures that

personnel are free from undue pressures as critical processes like procurement are

clearly defined, documented and audited against. The system can help detect any

changes or trends that occur. But supervisors must communicate with laboratory

personnel to identify any changes in the behaviour of their subordinates. Achieving

good ethical behaviours from employees depends a lot on how supervisors relate to

laboratory personnel. It is not something that you can control by procedure, but by

how you relate and communicate to employees.” (LAB 16 – T108)

“To ensure that personnel are free from undue pressures that may affect their work,

each employee has a job description. To achieve good ethical behavior from

employees, they have all signed a contract of employment. In an attempt to retain

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good employees, laboratory personnel get a free monthly lunch and annual bonuses.”

(LAB 17 – T114)

The commercial laboratories that have a certified quality assurance system have a

clearly defined procedure for declaring employees competent. Methods like training

of personnel by a competent person, taking part in proficiency testing schemes and

intra-laboratory test samples are used. There are procedures in place to measure the

effectiveness of training once training has been conducted. Those include audits by

clients, ‘blind’ samples, and participating in proficiency testing schemes. Methods

used to check personnel’s technical competence included testing samples of

proficiency testing schemes and certified reference materials.

Commercial laboratories with a quality assurance system in place have a positive

culture on performance of HR issues like training, declaration of competency and

methods to checking personnel’s competency.




“Since this is a small laboratory, training is ongoing and I am hands on and can

therefore pick up any mistakes made by the laboratory personnel before they become

major. I conduct training for personnel on all the test methods. There are no defined

or specific times for personnel to spend on a method; it depends on how fast the

individual picks up information. I declare employees competent after witnessing the

employees during training. Records to declare employees competent are then signed

by the trainee and myself, and are kept in the personnel files. We test internal

standards before testing samples and this helps us to identify errors that can occur

before reporting the final results.” (LAB 18 - T 119)

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“To declare new employees competent, they go through training on the test

procedures. The trainee would observe while the competent person is conducting a

test and they would get the chance to also do it in practice. If the trainer is confident

after observing the trainee, they are declared competent.” (LAB 19 - T 126)



follows;

“Once employees have been trained on test methods, the effectiveness of training is

measured by observing or witnessing when employees conduct the tests, and

identifying the need for further training.” (LAB 18 - T 119)

“Training effectiveness is measured by giving personnel proficiency testing scheme

samples.” (LAB 19 - T 126)



“The laboratory participates in three proficiency testing schemes provided by

certified external providers on a quarterly basis, analyse internal standards before

actual samples and laboratory personnel are also given ‘blind’ and spiked samples

as a continuous way of monitoring their competency. At the stage, the reason for not

using certified reference materials as part of our quality control procedure is because

CRM’s are too expensive.” (LAB 18 – T120)

“If the results of the proficiency testing scheme show that the laboratory results were

out, at the stage, a non-conformance report is not raised to embark on a formal

investigation. But our proficiency testing performance has been acceptable so far; it

is only the last results which showed that we had outliers.” (LAB 18 – T120)

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“The laboratory takes part in proficiency testing. We have fifty five methods and we

are happy with the performance of certain methods, and are unhappy with

performance on some methods, so there is some work to be done. We also get errors

in our results due to human error. Some of the Analyst are capable of reproducing

results in triplicate and still get them wrong! Certified reference materials, internal

QC samples and ‘blind’ samples are use to measure the performance and competency

of personnel.” (LAB 19 – T126)



“With regard to performance appraisal, the most important factors to look at are

trustworthiness and honesty in results produced, and a passion for the job. The above

is quantified by looking at the employee’s attitude towards their job like

timekeeping.” (LAB 18 – T121)

“There is a criterion to do performance appraisal in the laboratory. Managers know

all the employees as it is not a very big organisation. There is a day to day contact

between managers and employees, and the managers know the employees personally

and know their performance.” (LAB 19 – T127)



“Our work load is manageable; there is nothing that can put employees under

pressure to release unreliable results. To achieve good ethical behaviour from

employees, all laboratory personnel sign a service contract and it has a

confidentiality clause. Samples are given job numbers when received from customers,

and they are identified by numbers throughout the testing process not customer

names. This helps laboratory personnel to be impartial throughout the testing

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process; they only know the identity of the customer once they have submitted the

results to the Laboratory Manager for approval.” (LAB 18 – T120)

“To ensure that personnel are free from undue pressures and behave ethically,

training is conducted and quality control measures are used. Before testing the

sample, the person tests a quality control sample first. That helps personnel to make a

decision on whether to continue with the analysis or not. There is a fine line between

training and negligence when an employee gives wrong results. The manager will

have to use his/her discretion to determine whether the employee has to be trained or

disciplined. When employees have just been hired, during induction training they are

also trained on ethical issues.” (LAB 19 – T127)

The commercial laboratories without a certified quality assurance system have some

procedures to handle HR issues with one not satisfied about the performance in PTS.

The procedure for declaring employees competent included training by the

Laboratory Manager. There are procedures in place to measure the effectiveness of

training once training has been conducted, and the method used is witnessing of

personnel by the trainer. Methods used to check personnel’s technical competence

included in house QC samples, spiked samples, and PTS. But one laboratory had

outliers in their last PTS participation.

Generally commercial laboratories without a quality assurance system in place

address the HR issues adequately, internal methods are used to measure employee

competency.

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5.4 Customer Satisfaction


The respondents from laboratories 1 to 7 were asked to explain how customer

satisfaction is measured, how customer issues are communicated to laboratory

personnel. Their responses were as follows;

“The laboratory measures customer satisfaction by questionnaires which are sent out

to customers on a quarterly basis. Customers are asked to comment on issues like the

quality of the results, if they are happy with the sample turn around times, and the

communication or updates from the laboratory. Since some of the customers are

onsite with us, we communicate daily to discuss any issues before they become

major.” (LAB 1 – T8)

“We also have quarterly meetings with our customers where customer issues and the

results of the questionnaires are discussed in detail. Customers are made aware of

the challenges the laboratory faces if customers feel their expectations are not met. If

a sample has to be treated as urgent, it has to be signed by the head of department,

but sometimes we are faced with a challenge of all samples being submitted marked

as urgent. When we meet face to face during the quarterly meetings with the

customers, we make them aware of challenges that we face, like the current economic

times where the resources are limited.” (LAB 1 – T8)

“One factor that keeps coming out as a source of customer complaints is the issue of

sample turn around time. Being ISO 17025 certified results in a lot of work, like

checking weighing scale more frequently compared to a non-certified laboratory but

it helps us to release results with confidence as our work is traceable.” (LAB 1 – T8)

“Customer complaints are communicated to employees during laboratory meetings. If

there is a complaint, it is not used as a finger pointing exercise. The root cause is

identified and a person will be appointed to implement the corrective and preventive

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actions. The laboratory measures customer satisfaction by questionnaires which are

sent out to customers on a yearly basis. Since some of the customers are onsite with

us, we communicate daily to discuss any issues before they become major.” (LAB 2 –

T15)

“Since some of the customers are onsite with us, we communicate daily to discuss any

issues before they become major.” (LAB 2 – T15)

“As an internal laboratory, to measure customer satisfaction we communicate with

the customers as often as possible as they are on the same premises to find out if they

are satisfied. Customers are always asked to comment about the service and how it

can be improved. Customers also rate our performance by using questionnaires that

are sent to them on a quarterly basis. Customer complaints are communicated to

laboratory personnel during laboratory meetings which are held twice a week.”

(LAB 3 – T21)


to customers once a year. Customers are asked to comment on issues like the service

they receive, if they are happy with the sample turn around time, and the reports.

Weekly and monthly meetings are also held where customer issues and complaints

are discussed. Being ISO 17025 can help you grow your customer base because

potential customers know that you have been checked by the accreditation body and

you have demonstrated that you are technically competent.” (LAB 4 – T27)


to customers annually. Customers are asked to comment on issues like the quality of

the results, which is considered paramount due to the type of products that we

produce. The production meetings are also used to measure customer satisfaction as

they are attended by the production and laboratory personnel. Issues can be raised

and resolved when everyone is around the table. If a customer complaint comes out

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during the day when the daily meeting has adjourned, it does not wait for the next

day, it is tackled immediately.” (LAB 5 – T33)

“The laboratory measures customer satisfaction by using questionnaires through the

customer complaints department on an annual basis. We don’t get a lot of customer

complaints, but one factor that always comes up is the issue of sample turn around

time. This is addressed by making customers aware of the processes of conducting

tests on the submitted specimen. In our industry, the sample turn around time is

dictated by the standard operating procedure used. Some test procedures clearly

specify that specimen must be tested within 48 -72 hours after being received. Some

samples have to be centrifuged or treated before the actual analysis and customers

need to be briefed of how long it takes to test specimen. Customer issues are

discussed during weekly lab meetings.” (LAB 6 – T42)

“The laboratory measures customer satisfaction by sending questionnaires out to

customers once a year. If there are customer complaints, they are communicated to

laboratory personnel in the form of feedback meeting and the CAR/PAR system.”

(LAB 7 – T48)

The respondents were also asked if they have ever dealt with legal implications due to

the test results that they have issued. The responses were as follows;

“We haven’t been through that. Chances of issuing wrong results and discovering

that later are minimised by the fact that there are a lot of control measures put in

place. They include analysis of certified reference materials and QC samples before

analysing the actual sample. And also, measures like calibrating equipments and

weighing balances before using them on a daily basis helps. If I can be asked to

defend our results in a court of law, our accredited system would give me the

confidence to deal with the situation as everything we do is traceable to national and

international standards.” (LAB 1 – T9)

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“Even though we are an internal laboratory and deal with internal customers, our

customers are not obliged to submit samples to us. They have the freedom to look for

external service providers. Over the years and according to our history, we have

never lost a customer. What our customers do sometimes do, is that they send

samples to other laboratories to check our performance as their internal service

provider but they still use us as their preferred supplier.” (LAB 1 – T9)

“Certification reduces customer complaints. The rate of re tests can also be

decreased because the laboratory would have documented procedures. If things go

wrong, there is a system to follow that up. Working in the ISO 17025 certified

laboratory has a positive impact on staff morale as their roles and responsibilities

have been clarified through the system. We hold our management review twice a year

where the results of audits, pending and closed non conformances are discussed. That

keeps management informed about the general performance of the laboratory.” (LAB

1 – T9)

“What I can also say is that ISO 17025 certification is no longer a major marketing

advantage like it used to be. About five to ten years ago, accreditation used to be a

major factor. The reason for that was because back then, few laboratories especially

in the mining industry were certified to ISO 17025 but now most of them have the

system in place and are certified. Nowadays when people look for laboratories as

service providers, they do recognise the certification status of potential service

providers but the important thing is they are more interested in laboratories taking

part in proficiency testing schemes as they would be capable of producing good

results. Customers are now looking for service providers who can offer them more

than certification to ISO 17025, for example, everyone is looking for shorter sample

turn around time.” (LAB 1 – T9)

“No, we haven’t. If a legal action had to be taken against the laboratory, being ISO

17025 certified would help us with the internal investigation and deal with the matter.

If a need arises to defend our results in a court of law, our certified system would

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give us confidence to deal with the situation as everything we do is traceable.” (LAB

2 – T15)

“One advantage of being accredited is that you must validate your methods, so you

would know that you used proper methods and there is a system that you follow. Also

taking part in proficiency testing schemes helps to manage your competency as a

laboratory. Chances of issuing wrong results and discovering that later are

minimised by the fact that there are a lot of control measures put in place. But if

anything had to go wrong; we have a documented procedure for recalling reports.

The system also helps management to know what happens in the laboratory, because

performance reports are submitted to company management.” (LAB 2 – T15)

“We haven’t been through that, if a need could arise to defend our results in a court

of law, the certified system would give us confidence to deal with the situation as

everything we do is traceable. The test results are signed for by technical signatories

who have been declared competent.” (LAB 3 – T21)

“We haven’t been through that but the system would assist with traceability.” (LAB 4

– T28)

“The laboratory hasn’t been through that. But, if a need can arise to defend our

results in a court of law, our certified system would help us to go through the exercise

because there is evidence of the QC done and traceability is there in terms of

competency and validation of methods. The system helps us to release the test results

with confidence, and we can hold results if not happy. But we don’t look at ISO

17025 as something that can improve sample turn around time; it is something that

gives us confidence when releasing results.” (LAB 5 – T34)

“The laboratory has never dealt with legal implications due to the test results that we

have issued. But if we had to deal with issues like that; our certified quality system

would help us deal with the situation. We would have proof of competency, controls

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in place and the fact that we have been assessed by the national accreditation body.”

(LAB 6 – T43)

“No, we have never dealt with any legal implications due to the test results issued. If

it can happen, our quality standard and status will be very handy, all our data will be

fully traceable, equipment is properly calibrated and maintained, test methods are

validated and personnel are competent. And also, GLP informs us, management,

about the general performance of the laboratory.” (LAB 7 – T48)

The non commercial laboratories with quality assurance have procedures for handling

customer related issues. The labs measure satisfaction by means of questionnaires

that are sent out to customers. The laboratories communicate customer issues during

laboratory meetings. And also, the laboratories have never been through legal

disputes because of the test results they have issued. But, respondents mentioned that

if a need had to arise for them to defend their results, they would be comfortable in

doing that, because they have a traceable system.

Non commercial laboratories with a quality assurance system in place, have a positive

culture of managing customer issues.





“The laboratory measures customer satisfaction by using service questionnaires.

Questionnaires are handed out to customers at the end of each practical session.

Customers are also asked to comment on how the service can be improved. Once the

questionnaires have been completed, I would then analyse. If there are any issues

that are raised showing dissatisfaction, they are addressed with the laboratory staff.

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Customers also get feedback on how the issues raised will be addressed to ensure

there is no recurrence. After a period of six months, all laboratory personnel are

briefed about the performance over the period.” (LAB 8 – T54)

“The laboratory measures customer satisfaction by using customer evaluation forms

annually. The feedback that we get shows that customers are generally happy.

Customers are asked to comment on issues like suggestions for service; quality,

invoicing and customer support. Customer complaints are also logged on the system

when raised and are investigated and discussed during lab meetings.” (LAB 9 – T60)

“The laboratory measures customer satisfaction by using questionnaires.

Questionnaires are handed out to customers once a year. Customers are asked to

comment on whether they are happy with communication or updates from the

laboratory and also improvement suggestions. From what I’ve seen, there is a poor

response rate to questionnaires from the customers. So what we do, we always make

sure that we get response from our top twelve customers. If there are issues that

arise, all the customer complaints are communicated during monthly meetings where

the management and supervisors are there.” (LAB 10 – T66)

“Customer satisfaction is measured by using questionnaires. At the stage we have not

started to send them out to outside customers but so far have sent to internal

customers. But we will start sending the questionnaires to external customers. Our

test methods include the time it must take to report the results, and we are generally

happy with our performance. Issues raised are discussed during lab meetings.” (LAB

11 – T72)



“No, we haven’t been though that. Our results are used in the academic environment

and are not used to make business decisions.” (LAB 8 – T54)

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“The laboratory has not dealt with legal implication due to the quality of the product

that we have approved. What we have experienced with our customers who were not

happy is that they took their business somewhere else, but did not go the legal route.

There is no chance of dispatching sub standard products because every batch has to

be dispatched with a certificate of analysis and material safety data sheets and those

documents are issued by the laboratory.” (LAB 9 – T60)

“Our certification to ISO 9001 would help us if they have to deal with legal disputes

but we’ve never been through that.” (LAB 10 – T66)

“The laboratory has not been through any legal disputes, but I feel ISO 17025

certification can help when issues like that come up because there will be

traceability. Let me give you an example, one of my colleagues has been asked to give

evidence in a court of law. According to the test results that my colleague issued,

there were farmers who couldn’t export their cattle, and those were commercial

farmers. Now, certification can help with situations like that because the system is

traceable.” (LAB 11 – T73)

The non commercial laboratories without quality assurance measure satisfaction by

means of questionnaires that are sent out to customers. The laboratories communicate

customer issues during laboratory meetings. And also, the laboratories have never

been through legal disputes because of the test results they have issued.

Non commercial laboratories without a quality assurance system in place have a

positive culture of managing customer issues.

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“The laboratory measures customer satisfaction by using questionnaires which are

handed out to customers on a six monthly basis. Some of the factors listed on the

questionnaire include how customers feel about the laboratory’s turn around time,

and suggestions to improve the service. The sample turn around time is one factor

that needs improvement according to the customer survey results and being OECD

GLP certified does not help deal with it. If there are any issues, a non conformance

report will be raised on the electronic system and investigated by involving all

laboratory personnel. To measure the laboratory’s performance, the laboratory also

looks at the results of the proficiency schemes and intra-laboratory results. If the

results of a method were unacceptable or off limit according to the proficiency testing

scheme provider, the laboratory raises a non conformance, identify the root causes

and implement corrective and/or preventive measures. The customer complaints are

communicated to laboratory personnel in various ways. This includes monthly quality

meetings and monthly departmental meetings.” (LAB 12 – T80)

“The laboratory measures customer satisfaction by sending questionnaires out to

customers once a year. The question that is considered important that we ask

customers is if they were happy with the way the issues they raise are dealt with. If

the customers are not happy, then the internal investigation would identify why the

customer complaint or issue was not addressed. Being a certified laboratory does not

have an impact on the sample turn around time, but our sample turn around time is

three-five days and we are happy with our performance. Issues are discussed during

lab meetings.” (LAB 13 – T86)

“We measure customer satisfaction by using questionnaires which are sent out to

customers at least twice a year. Customers are asked to comment on issues like the

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quality of the results, if they are happy with the sample turn around times, and the

service they get from the laboratory. But after sending questionnaires out, sometimes

we only get two back and they are mostly positive comments. Based on my

observation over the years, when customers are happy they keep quiet, and only raise

their voices when they are unhappy. We actually don’t have any set objectives

regarding customer satisfaction that is measured over time. When it comes to

customer related issues, I prefer complaints or issues to be raised and they can help

us improve our system. We don’t even have any factor that stands out as a major

issue from the customer responses but we discuss issues during lab meetings.” (LAB

14 – T93)

“The laboratory measures customer satisfaction by questionnaires which are issued

at depots and I don’t think that it fulfils the objective. If there is a customer

complaint, it is managed through the electronic system. Issues are also discussed

during laboratory meetings. Customers, especially at our depots do not give enough

feedback. Most of the time when there is a customer complaint, it is linked to

accounts and not the actual testing. The barcode system helps with the samples turn

around times because any sample can be traced if there are any delays.” (LAB 15 –

T100)

“Laboratory measures customer satisfaction by using questionnaires. Once we

receive them back from the customers, they are analysed by the business unit

department. The results would then be communicated to the laboratory personnel

during lab meetings to inform them about their performance. Some of the factors

listed on the questionnaire include how customers feel about the laboratory’s turn

around time, and suggestions to improve the services. If there are any non-

conformances raised, a non-conformance report will be raised and investigated by

involving all laboratory personnel. To measure the laboratory’s performance, the

laboratory also looks at the results of the proficiency schemes. If the results of a

method were unacceptable or off limit according to the proficiency testing scheme

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provider, the laboratory raises a non conformance, identify the root causes and

implement corrective and/or preventive measures.” (LAB 16 – T109)

“The major factor that causes customer complaints in our laboratory is our sample

turn around time. Our LIM system is set up in a way that when a sample is logged

onto the system, the person logging it must include the urgency status. If it is TP, it

means the report must be compiled within three days, if P1 it must take between three

to five days and if P10 it can take up to 10 days. But the challenge that we face is that

all customers identify all their samples as urgent and at the end of the day we cannot

satisfy them all. We are not doing very well regarding sample turn around time, and

we are in the process of developing an objective to help us manage the situation.

When all samples are urgent; it is when time management becomes crucial. The trick

is to ensure that if there are any delays, the customer is informed on time and not

wait for them to ask for their results. Customers are normally irritated when told

about delays but they appreciate being told the truth than being surprised on the last

minute that their results are not available.” (LAB 16 – T109)

“Customer satisfaction with regard to our services is measured by sending out

questionnaire to customers, at least annually. If customer complaints are raised, they

are communicated to laboratory personnel during laboratory staff meetings.” (LAB

17 – T115)



“The laboratory has not been in a legal dispute due to the test results that they issued.

But I feel that, if it had to happen, our quality system will help us to deal with the

situation. Due to the traceable nature of our system, we will be able to work

backwards and identify where things could have gone wrong. According to our

history, we seldom get requests to re-analyse because of queries raised based on the

results issued. If that happens, it is normally because the results were not what the

customer expected and not because there is something wrong with the results. We

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have a documented procedure that if we identify that something is not right with a

test method used, we will have to recall all the reports issued while we investigate the

method used.” (LAB 12 – T80)

“The laboratory has never been taken through legal proceedings due to test results

issued. But things like that do happen because of human error. But I feel that if it can

happen to us, our traceable system would help us to deal with the situation.” (LAB

13 – T86)

“We haven’t been through that. Chances of us issuing wrong results and discovering

that later are minimised by the fact that there are a lot of control measures put in

place like analysis of internal standards. If I need to defend my results in a court of

law, our certified system would give me confidence to deal with the situation as

everything we do is traceable to the international standards. Certification improves

efficiency and improves customer satisfaction and the laboratory customer base.

What I have experienced is that, by having the system in place there is a change of

mind set. The number of samples received for analyses can increase due to your

certification status and when that happens, you find yourselves being able to plan

better and get a lot done with the same resources. The number of re tests can also be

decreased because the laboratory will have documented procedures.” (LAB 14 –

T93)

“We haven’t been through that. Our system should be able to help us find the root

cause of the problem.” (LAB 15 – T100)

“The laboratory has never been taken through legal proceedings because of the

results issued, but if that had to happen, our traceable system would help us to deal

with the situation.” (LAB 16 – T110)

“The laboratory has dealt with legal implications due to the test results issued. It has

happened about four times in the past twenty years. Our certified system has helped

155

us to deal with those situations as we had records of things like calibrations, and

method validations.” (LAB 17 – T115)

The commercial laboratories with a quality assurance system measure satisfaction by

means of questionnaires that are sent out to customers. The laboratories communicate

customer issues during laboratory meetings and customer complaints are raised

through the system. And also, one laboratory has been through legal disputes because

of the test results they have issued and their certified system came in handy. But,

other respondents have never been through that and mentioned that if a need had to

arise for them to defend their results; they would be comfortable in doing that,

because they have a traceable system.

Commercial laboratories with a quality assurance system in place have a positive






“The laboratory does not measure customer satisfaction at the stage. But if we start

with that process, we will be interested in measuring our performance regarding turn

around time, correct invoicing and whether customers find their reports user friendly.

At the stage; we do not have any factor that stands out as a source of customer

dissatisfaction. Our average turn around time is five days, and our customers accept

it. We discuss issues during lab meetings. Chances of issuing wrong results and

discovering that later are minimised by the fact that we analyse internal standards

before analysing the samples. Once the laboratory personnel have tested and

reported the results, they are checked and approved by myself, and I will send the

report to the customer.” (LAB 18 – T121)

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“Customer satisfaction is currently not measured. We will measure customer

satisfaction in future by using questionnaires. At the stage, the laboratory does not

have a formal system of measuring customer satisfaction. We take it as a sign of

customer retention or good results when customers continuously come back to us for

service. At the stage, if there is a customer complaint; it is communicated to

laboratory personnel by holding meetings. If complaints are not communicated to

employees, they will not be aware that there are problems. Every laboratory will

have problems whether certified or non-certified. It is like deciding whether to hire a

qualified or non qualified person. The non-qualified person can end up performing

better than a qualified person. The laboratory has an open book policy. Customers

are welcome to check the raw data of their samples anytime.” (LAB 19 – T128)



“We have never been in legal disputes because of the results issued. But if the

laboratory had to deal with legal issues, being certified or non-certified does not

have an impact on the issue.” (LAB 18 – T122)

“The laboratory has not been through any legal disputes due to the test results that

they issued. But being ISO 17025 certified does not mean if a customer goes the legal

route, you will be covered. There are internal problems anyway, whether ISO 17025

certified or not. What matters is the traceability of your system. Customers are

becoming more aware of certification, and certification can make a difference. But

the winning combination for any laboratory is cost; quality and good sample turn

around time. With regard to the impact of ISO 17025 on staff morale, the system is

only as good as the way it was implemented. If personnel are well trained, then it is

good, if they are not well trained, there won’t be benefits of being certified.” (LAB 19

– T128)

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Commercial laboratories without a quality assurance system do not have procedures

to manage customer issues. All the labs consulted do not have a procedure for

measuring customer satisfaction. Any issues that arise are discussed during laboratory

meeting. And also, the laboratories have never been through legal disputes because of

the test results they have issued. The respondents were of the opinion that being

certified does not mean if a customer goes the legal route, you will be covered.

Commercial laboratories without a quality assurance system in place have a positive


5.5 Profitability


The respondents from laboratories 1 to 7 were asked to identify which of the benefits

(marketing advantage; international recognition for the lab; facilitation of trade and

economic growth; acceptance of exported goods in overseas markets; retention and

growth of customer base; an increase in profit growth) they have realized due to their

certification status. Their responses were as follows;

“ISO 17025 gives a laboratory international recognition. It facilitates trade and

economic growth especially in the production organisations and also in research.

For example, in our environment, once research on a project has been completed and

is successful, it brings economic growth in a big way when the research outcome

results in large scale production. The system does lead to acceptance of exported

goods in overseas markets. When buying products from certified laboratories, it gives

the feeling that the product is safe. In a research environment, ISO 17025 gives

consistency, and helps to manage research in a controlled manner. ISO 17025 also

increases the profit margin as the product is of good quality, and more customers

would be interested in it.” (LAB 1 - T 10)

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“Certification improves marketing advantage, international recognition and can

facilitate economic growth. The system also has a positive impact on the profit

margin of the company.” (LAB 2 - T16)

“ISO 17025 gives a laboratory a marketing advantage, international recognition;

facilitates trade and the results are accepted in overseas market. People have

confidence in the laboratories that are certified, and in turn the certified laboratories

feel confident when releasing the results. But as an internal laboratory; it is not easy

to measure profit.” (LAB 3 – T22)

“Certification improves marketing advantage, gives the laboratory international

recognition and can facilitate trade and the test results are accepted everywhere.

The system has a positive impact on the profit margin of the company.” (LAB 4 -

T28)

“ISO 17025 certification gives a laboratory marketing advantage; facilitates growth

and gives laboratory international recognition. Sometimes we are contacted by

potential customers who got our details from the accreditation body website, and that

alone tells you that certification puts you on the map. ISO 17025 certification has a

positive impact on the profit margin.” (LAB 5 – T35)

“As I’ve mentioned, we are only doing surveillance work. We are not in business to

make money and to look for customers. Our main focus is to determine the level or

extent of flue each year and we charge the minimum for our services. And, if we were

not certified, people would still come to us for services, but there wouldn’t be same

level of confidence that we have now as a certified laboratory.” (LAB 6 – T43)

“The benefits that we have realised as a certified laboratory include marketing

advantage, international recognition for our laboratory, acceptance of our services

in overseas markets, retention and growth of the customer base. But our certification

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status has not given us the benefits like facilitation of trade and economic growth,

and an increase in the profit margin.” (LAB 7 – T49)

The respondents were further asked to explain how they measure profit, whether it’s

measured in terms of revenue or new customers. The responses were as follows;

“We measure our success or profit margin by considering if we still have our old

internal customers. In that way we know we are contributing to the increase in profit

margin as we are also adding value by keeping customers happy and not pushing

them to external service providers. And I can say we are profitable, and are doing

well in retaining our customers.” (LAB 1 – T10)

“We have a fixed contract with our customer in terms of the services that we will

provide to the customer. In our case, during the process of contract review, the

amount that the customer will be charged for services is decided upon before even

rendering services. And, we were given the current contract because of our

certification status.” (LAB 2 – T16)

“ISO 17025 is worth all the efforts because it helps with daily operations and

efficiencies in the laboratories. We also have two audits per year, one internal and

one external. The reports of both the internal and external audits are sent to the

customers so that they can also see the performance of their service provider.” (LAB

2 – T16)

“Our profitability is based mainly on the performance of our water treatment plants

as we are their service providers. ISO 17025 is worth the effort and it is not a lot of

work. There is a lot of work only during the implementation of the system or starting

the project, after that it becomes second nature. A lot of work would be when you

have an audit coming and you don’t know where things are. But with ISO 17025 you

can locate everything. You just get nervous because the audit is coming; but to us it is

like second nature.” (LAB 3 – T22)

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“We measure profit in terms of the new customers that we get. That would mean there

is something better that you are offering, that people are so happy with and they want

to share it with the rest. Proper management is still needed to be in control besides

being ISO 17025 certified. Certification is just a cherry on top. ISO 17025 is not a lot

of work, you just need to formalise and document your procedures.” (LAB 4 – T28)

“ISO 17025 certification draws more customers and therefore more revenue and that

is what the shareholders want. We measure profit in terms of revenue, and we are

profitable.” (LAB 5 – T35)

“The objective of our laboratory is not to make profit but to contribute and make a

difference in people’s lives regarding the control and monitoring of influenza that

comes when no one is prepared for it. For laboratories which are involved in the

same tests that we do, and their main objective is to make profit or are commercial,

certification will be the primary requirement and certification can help them get more

revenue. For us, one of the advantages of being OECD GLP certified is the smooth

running of the laboratory, confidence in the staff competence and the results that the

laboratory issue. For us, a certified system is important because we learn during

internal and external audits. If the accreditation body raises a non-conformance, we

take it as an opportunity to learn.” (LAB 6 – T44)

“We measure profitability in terms of revenue received from laboratory services.”

(LAB 7 – T49)

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The impact of quality assurance on the profit margin gave mixed responses for non

commercial laboratories with a quality assurance system. Some laboratories

mentioned that certification has a positive impact on profitability, and one mentioned

that certification has not given them any advantage of profitability. It could not be

concluded on what the impact of quality assurance is on the profit margin.

For non commercial laboratories with a quality assurance system in place, it could not

be concluded what the impact of profitability is on performance.


The respondents from laboratories 8 to 11 were asked to identify which of the

benefits (marketing advantage; international recognition for the lab; facilitation of

trade and economic growth; acceptance of exported goods in overseas markets;

retention and growth of customer base; an increase in profit growth) they have

realized due to their certification status. Their responses were as follows;

“I’m not able to comment on that because I’m in an environment where the focus is

different. But, being certified by an independent body should be a goal that any

laboratory must work towards. It would make our test results to be reliable and

improve the quality of our results, would give us recognition, help with

documentation, and also help with staff issues like laboratory personnel training.”

(LAB 8 - T 55)

“ISO 9001 certified system can help to grow our business; and our customers would

not have chosen us as their preferred supplier if we did not have a certified system.

But customers don’t require us to certify the laboratory to ISO 17025. Our current

defines clearly what employees need to do in completing their tasks. There are

documented procedures regarding how they should conduct tests, what to do when

the equipment is not performing so that they do not have to assume things. ISO 9001

certification means that there are procedures to be followed, the organisation is

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audited by a certification, and the system helps employees to plan their work and has

helped us to do things better.” (LAB 9 - T60)

“Being ISO 9001 certified has helped us especially during management reviews. Our

agenda is based on the system requirements like customer complaints, corrective and

preventive action and if we did not have a quality system, our discussion points would

not be as good as for a certified organisation. ISO 9001 certification gives us a

marketing advantage, international recognition, and facilitates economic growth. We

have major organisations or potential customers who audit us before they even

discuss price or buying.” (LAB 9 - T60)

“The entire organisation is able to retain and grow its customer base because of our

ISO 9001 certification. Our ISO 9001 certification gives us the marketing advantage,

international recognition, facilitates economic growth, and leads to acceptance of

products in overseas markets. It has a positive impact on the profit margin and is

worth the hard work.” (LAB 10 – T67)

“Being ISO 17025 can serve as a marketing advantage, gives the laboratory

international recognition, and facilitates trade and economic growth. Even if our

objective as a state laboratory is not to make profit, for us it can have a positive

impact on the economic growth. By being ISO 17025, we will be able to venture into

other markets outside the scope of the national department of agriculture. The

services that we will provide, will contribute to economic growth and collect revenue

for the state. Certification can help retain and even grow the customer base. Our

laboratory is acknowledged not just in the country but in the SADEC region before

even achieving certification.” (LAB 11 – T73)

“The employees, who were hired when the implementation process had started, do

not see it as extra work because that is all they know. But, there can be challenges

when dealing with employees who have been with the company for a while and

sometimes they do not see the need for change. Old employees see it as extra work

163

for a while, but get used to it after a while. The system helps the manager to know

what happens in the laboratory since I cannot be in the laboratory all the time.”

(LAB 11 – T73)



“Our facility is an academic laboratory and we are our customers’ sole service

providers, so we don’t have competition. We are not in an environment where we are

pushing for profit, but give support in an academic environment.” (LAB 8 – T55)

“In our case, certification to ISO 9001 has a positive impact on the profit margin of

our organisation. We measure profit in terms of revenue but I’m not able to give you

the numbers. To give you an example, a major manufacturing organisation that has

just selected us to be their supplier and they will be taking seven tankers of our

product per day.” (LAB 9 – T61)

“Profit is measured in terms of revenue. The system is a preventive measure, and it

helps to keep our customer satisfied.” (LAB 10 – T67)

“As a government department we recognise the principle of ‘Batho Pele’ – which

means ‘People First’; profit is not measured in terms of money. But, it is measured by

the number of people that have been assisted by using our services. Our services can

result in job creation and reduction of mortality rate in the farms. If we help a farmer

to reduce the mortality rate by two percent, then that farmer can employ one more

person and reduce unemployment. It is definitely necessary to implement ISO 17025

in laboratories.” (LAB 11 – T74)

164

The impact of quality assurance on the profit margin gave mixed responses for non

commercial labs without a quality assurance system. The respondent from lab 8

pointed out that though their lab is not certified, being certified by an independent

body should be a goal that any laboratory should strive for. The other two

laboratories, labs 9 and 10 were of the opinion that since they are part of

organisations certified to ISO 9001, they get the same benefits from that certification.

For non commercial laboratories without a quality assurance system in place, it could

not be established what the impact of profitability is on performance.












“OECD GLP certification gives our laboratory a marketing advantage and

international recognition. It facilitates trade and economic growth because people

around the globe can identify with it. Certification leads to acceptance of exported

goods in overseas markets, and it is very important as our customers are involved in

exporting goods to overseas markets. OECD GLP increases the profit margin, as it

becomes easier to sell your services to potential customers.” (LAB 12 - T 81)

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“I would be less secure if there was no system in place. The system gives management

an extra pair of eyes, even when I cannot be in the laboratory all the time; it gives me

an idea about the general performance of the laboratory. The system gives us a

marketing advantage, international recognition, facilitates economic growth, and

makes it easier for your product to be accepted in overseas market. We have been

able to sell our services outside the country because of our certification status. Being

certified puts you in the market and gives you visibility, and therefore helps you with

the marketing of your services and has a positive impact on the profitability. The

OECD GLP certification has helped us to retain and even grow our customer base,

due to our certification status.” (LAB 13 – T86)

“ISO 17025 gives any laboratory a marketing advantage and international

recognition. We actually have few customers from abroad, and our certification

status could have contributed to us being chosen as the service provider. ISO 17025

facilitates trade and economic growth especially when you have countries with high

ethical standards; and they choose you as their supplier based on your certification

status even if they have never dealt with you. Regarding whether being ISO 17025

increases the profit margin, I can’t comment on that.” (LAB 14 – T95)

“ISO 17025 gives any laboratory a marketing advantage, international recognition

and facilitates growth. It also facilitates trade and economic growth. If doctors run

clinical trials, they only use certified laboratories. ISO 17025 certification status

keeps them in the market and it can also increase the profit margin. The system helps

me as a National Manager to know what is happening in all the laboratories. I

cannot be in all laboratories at the same time.” (LAB 15 – T101)

“ISO 17025 can give laboratories a marketing advantage and international

recognition. It gives customers confidence on you as a supplier that your goods are

safe and reliable. It facilitates trade and economic growth because people around the

globe can identify with it. Certification also leads to acceptance of exported goods in

166

overseas markets. ISO 17025 increases the profit margin, as it becomes easier to sell

your services to potential customers.” (LAB 16 – T110)

“ISO 17025 gives any laboratory a marketing advantage and international

recognition, facilitates trade and economic growth, leads to acceptance of exported

goods/test results in overseas markets and helps with the retention and growth of

their customer base. However, being ISO 17025 certified does not necessarily lead to

an increase on the profit margin.” (LAB 17 – T115)



“Profit in our laboratory is measured in terms of the number of new customers

acquired. We have been able to maintain our old customers and got new ones over

the years due to our OECD GLP certification status. Customers have contacted us

after getting our details from the website of the national accreditation body. For the

potential overseas customers, OECD GLP certification is a prerequisite before

discussing the costs of doing business with them.” (LAB 12 – T81)

“We measure profit by the number of customers and the variation of the test methods

or analysis the laboratory offers. What we want to do to grow the organisation; is to

offer more tests than we are currently doing.” (LAB 13 – T87)

“We look at profitability in terms of the number of new customers we get and I

believe certification can increase that.” (LAB 14 – T95)

“Our services are regulated and therefore we don’t decide on what to charge clients.

For us, profit is measured in terms of new customers.” (LAB 15 – T101)

“In our laboratory, profit is measured in terms of the number of new customers that

we acquire. Clients trust you if you have the system in place. We have been contacted

167

by customers who got our details from the website of the accreditation body, and that

is proof that we are profitable and certification has a positive impact on the profit

margin of our laboratory.” (LAB 16 – T110)

“We measure profit margin in terms of revenue from the laboratory services, and

can’t say we are profitable because of certification, but it can be a contributing

factor.” (LAB 17 – T115)

The impact of quality assurance on the profit margin gave mixed responses for

commercial labs with a quality assurance system. Laboratories 12 and 13 reported

that certification can have a positive impact on profitability. Laboratory 14 could not

comment on what the impact of certification is on profitability. The non profit

organisation could not comment on profitability as they are not in business to make

profit and the respondent of lab 17 mentioned that certification does not necessarily

have a positive impact on the profit margin. It could not be concluded on what the

impact of quality assurance is on the profit margin.

For commercial laboratories with a quality assurance system in place, it could not be

established what the impact of profitability is on performance.







“A system like ISO 17025 slows down production in the laboratory. There are some

requirements of ISO 17025 that we have implemented. For an example, we have

started to monitor and record the temperature of the laboratory, and also checking

168

weighing scales more frequently, and that is a time consuming activity. I can’t

comment on whether ISO 17025 can have an impact on customer satisfaction and

sample turn around time as we have not experienced the system. I have already

briefed the employees that there is pressure to implement the system, but the

paperwork is making them to be despondent. Some of the requirements that I see as

benefits at the stage include management review, which keeps management informed

about the general performance of the laboratory.” (LAB 18 - T 122)

“We do not even go out to market our services; we rely on word of mouth. Nowadays

when people look for laboratories as service providers; they look for service

providers who can give them shorter turn around time and certification does not

guarantee that. I don’t think having a certified ISO 17025 system can guarantee

benefits like giving a laboratory international recognition; facilitation of trade and

economic growth, acceptance of exported goods in overseas markets. Certification is

no guarantee that there will be a positive impact on the profit margin.” (LAB 18 - T

122)

“The system gives a laboratory a marketing advantage, international recognition for

the laboratory, acceptance overseas, and economic growth. ISO 17025 can help a

manager know about the general performance of the laboratory. With regard to the

impact of the system on the profit margin, the system can have a positive impact on

the profit margin but there are start up costs of implementing the system. We do cost

and profit analysis and know the financial performance of our laboratory. But, it is

difficult to measure cost and profitability in a commercial laboratory. Before reaping

the benefits of certification, you must invest in resources for implementation first.”

(LAB 19 – T129)



169

“We measure profit margin by revenue and after implementing the system one day, I

would like to see if achieving certification can contribute positively to the revenue. At

the stage I can’t see the link between certification and an increase in profit margin.”

(LAB 18 – T123)

“The laboratory measures profit in monetary terms.” (LAB 19 – T129)

The respondent from one of the respondents, laboratory 18 reported that though they

are not certified, certification does not guarantee a positive impact on profitability.

The respondent from laboratory 19, which is also not certified, reported that system

can have a positive impact on the profit margin but there are start up costs of

implementing the system.

For commercial laboratories without a quality assurance system in place, it could not

be established what the impact of profitability is on performance.

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5.6 DISCUSSION OF RESULTS

Table 5.1: The results of the content analysis

Non-commercial laboratories that have a

certified QA system

Non-commercial laboratories without a

certified QA system

Health and safety: positive culture of health and safety -Defined approach to health and safety -Induction programmes -Issuing of PPE’s -Shared housekeeping responsibility -High demand on clean laboratory area Supplier selection: clearly documented procedure for managing suppliers -Policies and procedures for suppliers selection -Supplier selection on objective evidence like COA’s -Supplier performance measurement Human resources: positive culture on HR issues -Procedures to handle HR issues -Procedures to declare employees competent -Procedures to measure the effectiveness of training conducted -Methods to check personnel’s technical competence Customer satisfaction: positive culture of managing customer issues -Procedures for handling customer issues -Customer satisfaction measurement -Communication of customer issues Profitability: inconclusive -mixed responses on what the effect of quality assurance system is on profitability

Health and safety: positive culture of health and safety -Defined approach to health and safety -Induction programmes -Issuing of PPE’s -Shared housekeeping responsibility -High demand on clean laboratory area Supplier selection: positive culture of managing suppliers -Criteria for suppliers selection -Supplier selection on objective evidence like sampling and testing material before use -Supplier performance measurement Human resources: positive culture on HR issues -Procedures to handle HR issues -Procedures to declare employees competent -Procedures to measure the effectiveness of training conducted -Methods to check personnel’s technical competence Customer satisfaction: positive culture of managing customer issues -Customer satisfaction measurement -Communication of customer issues Profitability: inconclusive -mixed responses on what the effect of quality assurance system is on profitability

171

Commercial laboratories that have a certified QA system

Commercial laboratories without a certified QA system

Health and safety: positive culture of health and safety -Defined approach to health and safety -Induction programmes -Issuing of PPE’s -Shared housekeeping responsibility -High demand on clean laboratory area Supplier selection: documented procedures for managing suppliers -Policies and procedures for suppliers selection -Supplier selection on objective evidence certification status -Supplier performance measurement ,Human resources: positive culture on HR issues -Procedures to handle HR issues -Procedures to declare employees competent -Procedures to measure the effectiveness of training conducted -Methods to check personnel’s technical competence Customer satisfaction: positive culture of managing customer issues -Customer satisfaction measurement -Communication of customer issues Profitability: inconclusive -mixed responses on what the effect of quality assurance system is on profitability

Health and safety: positive culture of health and safety -Defined approach to health and safety -Induction programmes -Issuing of PPE’s -Shared housekeeping responsibility -High demand on clean laboratory area Supplier selection: documented procedures for managing suppliers -Policies and procedures for suppliers selection -Supplier selection on objective evidence like COA’s -Supplier performance measurement Human resources: positive culture on HR issues -Procedures to handle HR issues -Procedures to declare employees competent -Procedures to measure the effectiveness of training conducted -Methods to check personnel’s technical competence Customer satisfaction: positive culture of managing customer issues -Communication of customer issues Profitability: inconclusive -mixed responses on what the effect of quality assurance system is on profitability

The impact of the above (positive, negative, or no impact) is deducted below from the

above table and shown as per table 5.2.

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Table 5.2: The impact of quality assurance standards on the operational performance of

laboratories

NCL with QA NCL without QA

CL with QA CL without QA

Health and Safety (5.1)

5.1.1 Positive

5.1.2 Positive

5.1.3 Positive

5.1.3 Positive

Supplier Selection (5.2)

5.2.1 Positive

5.2.2 Positive

5.2.3 Positive

5.2.4 Positive

HR (5.3) 5.3.1 Positive

5.3.2 Positive

5.3.3 Positive

5.3.4 Positive

Customer Satisfaction (5.4)

5.4.1 Positive

5.4.2 Positive

5.4.3 Positive

5.4.4 Positive

Profitability (5.5)

5.5.1 Non conclusive




This study has considered the operational performance in terms of health and safety;

supplier selection; human resources; customer satisfaction; and profitability as

reported in chapter 1. Radnor and Barnes (2007: 389) and Uyar (2009:74) identify

customer satisfaction as an important factor. Ritzman and Krajewski (2003: 25)

identify human resources factors. Ambrose et al, (2010:1269) reports supplier

selection and performance management to be critical factors that needs to be

measured. Uyar (2009:73) advises that financial measures confirm the profitability of

an operation. Groover (2007:668) identifies health and safety as important factors that

need monitoring.

It appears that health and safety is equally important for all laboratories irrespective

of the nature of the laboratory or whether it’s got a quality assurance system or not.

This is probably due to the fact that health and safety can be deemed as an obvious

requirement based on the South African government stand of health and safety in the

work place as per the Occupational Health and Safety Act (OHS Act). This shows

173

that health and safety obligation is not dependent on the implementation of a quality

assurance standard. Tayler (2003:5) reports that both the OHS Act and ISO 17025

have a requirement that internal audits be conducted and that can be used to identify

any non-conformances to the health and safety rules. Tayler (2003:5) further

mentions that some laboratories develop checklists as an internal control, and they

check their systems against this checklist. To avoid running parallel systems,

laboratories can develop an integrated checklist that would review safety issues as

stipulated in the OHS Act.

Parkany (1995:9) reports that the primary requirements and principles for any

laboratory include the education and training of the analysts, good testing methods,

test equipment that are in known state of calibration, participating in proficiency

testing schemes (PTS), and documented procedures of all laboratory processes.

In terms of the supplier selection, there appears to be no difference whether the

laboratory has a quality assurance standard or not. This may be due to the general

practice in laboratories to seek high quality goods and services from reputable

suppliers. It once again seems obvious that laboratories engage themselves with

suppliers of high quality goods and services.

Similar to the discussion on suppliers, we can have the same discussion on human

resources. It appears that having a quality standard or not, does not impact on the

employment and development of laboratory employees.

In terms of customer satisfaction, the methods of determining customer satisfaction

comprises of customer surveys and monthly or quarterly meetings. These

methodologies seemed not to rely on whether there was a quality assurance standard

or not. It appeared as part of the laboratory function.

In terms of profitability, there were mixed contributions from the various laboratory

managers or senior personnel from laboratories. Some managers indicated that

174

certification made it attractive to gain more customers and hence improve

profitability. Wu and Liu (2010: 44) are of the opinion that ISO certification

improves profitability and the productivity of facilities. Some managers did not

support the notion of growing profitability with certification of a quality assurance

standard but, felt that profitability depended on good relationship with their

customers.

5.7 CONCLUSION

Globally, everyone is concerned with the quality of services offered by the

laboratories (Kiline, 2008:301). For a laboratory to be able to produce accurate and

precise results, testing personnel must be well-trained, and there must be documented

standard operating procedures (Kiline, 2008:301).

In conclusion, this exploratory study shows that having a quality assurance standard

does not really impact on the performance of the laboratory. In addition there are no

basic differences between the operational performance of commercial and non-

commercial laboratories. It appears that laboratories are managed by a system of

laboratory principles.

175

CHAPTER 6

CONCLUSIONS AND RECOMMENDATIONS

6.1 INTRODUCTION

This chapter focuses on the conclusions and recommendations based on the study

conducted. Chapters two and three focused on conducting the literature review. The

literature review in chapter two covered laboratory operations and the literature

review in chapter three covered laboratory performance criteria.

The study was conducted to answer the research question as reported in chapter one.

The research question for the study was raised as: Does the implementation of quality

assurance systems such as OECD GLP and ISO 17025 have an impact on the

operational performance of commercial and non-commercial laboratories?

The four objectives of the study were reported in chapter one as follows:

Objective 1: To conduct a literature review to explore relevant literature

about laboratory operations and performance criteria in order to develop,

understand, investigate and/or evaluate a research idea on quality assurance

system and laboratory operations;

Objective 2: To explore the views of laboratory managers about the impact of

quality assurance systems on the operational performance of commercial and

non-commercial laboratories;

Objective 3: To compare the operational performance in commercial and

non-commercial laboratories; and

Objective 4: To propose recommendations for laboratory managers in order

to improve decision-making and implementation of quality assurance systems.

176

The research was conducted to explore the impact of laboratory standards on the

operational performance of laboratories. That was achieved by identifying the

‘suitable respondents’ or key personnel in laboratories who are the custodians of

laboratory standards as participants in the study. The researcher collected data by

interviewing the identified research participants. The interpretation of data which was

collected by semi-structured interviews in chapter five assisted the researcher in

making conclusions about the study conducted.

The results obtained by conducting semi-structured interviews show that there is no

notable difference in the performance of laboratories that are with or without quality

assurance standards such as ISO 17025 and OECD GLP.

6.2 OBJECTIVES AND CONCLUSIONS

Below is a recap of the objectives of the study as listed in chapter one. The impact of

quality assurance standards on the operational performance of testing laboratories

was explored by undertaking the following objectives.

6.2.1 To conduct a literature review to explore relevant literature about

laboratory operations and performance criteria in order to develop,

understand, investigate and/or evaluate a research idea on quality

assurance standards and laboratory operations;

The objective has been achieved by the literature review conducted in chapters two

and three. The literature review conducted assisted to understand, investigate and

evaluate quality assurance standards and laboratory operations. These suggest that

laboratory managers should be cautious when selecting quality assurance systems for

any internal motivation.

177

6.2.2 To explore the views of laboratory managers about the impact of quality

assurance standards on the operational performance of commercial and

non-commercial laboratories;

The views of laboratory managers about the impact of quality assurance standards on

the operational performance of commercial and non-commercial laboratories were

collected through semi-structured interviews and discussed in chapter five.

6.2.3 To compare the operational performance in commercial and non-

commercial laboratories;

The semi-structured interviews gave information to compare the operational

performance in commercial and non-commercial laboratories. As per discussion

tables 5.1 and 5.2, there is no notable difference in the operational performance

between commercial and non-commercial laboratories.

6.2.4 To propose recommendations for laboratory managers in order to

improve decision-making and implementation of quality assurance

standards.

Based on the discussion of results in chapter five, there is no notable difference in the

performance of laboratories with or without quality assurance standards such as ISO

17025 and OECD GLP.

The impact of the quality assurance standards does not necessarily improve

performance as laboratories without standards are performing equally well on four

factors which are health and safety, supplier selection, human resources and customer

satisfaction. There may be differences in terms of the profitability but this could not

be adequately substantiated by the respondents.

178

6.3 RESEARCH METHODOLOGY

The qualitative, exploratory research approach was used for this study. Leedy and

Ormonde (2010:95) suggest a qualitative study where the available literature is

limited and where the study is exploratory. The literature available for laboratory

quality assurance standards and laboratory performance was limited and justified the

use of an exploratory qualitative study. The research design used for this study was

the exploratory, semi structured interview. Schedules for interviews were compiled

when the research participants had agreed and were willing to do the interviews.

The population in this study consisted of laboratory managers and senior laboratory

personnel from the 200 laboratories listed on the website of the national accreditation

body and the national laboratory association. The sampling strategy utilised for this

research was non-probability, convenience sampling. According to Leedy and

Ormond (2010:212) convenience sampling takes people that are readily available.

Convenience sampling was based on the availability and enthusiasm of the potential

respondents to participate in the study.

For the study, data has been collected by means of semi-structured interviews. Leedy

and Ormond (2010:188) report that in semi-structured interview, the researcher may

follow the standard questions with one or more individually tailored questions to get

clarification or probe a person’s reasoning.

During the interview data was recorded and brief notes were taken, with the

permission from the respondents. After the interview, data was transcribed using

Microsoft Word format. Content analysis was used to analyse the data. The coding

process of the data collected was conducted after reading the documents several times

to get a general understanding. The data was grouped in five factors (Health and

Safety; Supplier selection and performance; Human resources; Customer satisfaction;

and Profitability) which were determined as the criterion for measuring operational

performance in laboratories. Data collected from the respondents was presented in the

179

form of the respondent’s words or responses and were discussed in chapter five. The

data gathered from respondents was used to deduce findings, conclusions and

recommendations for future research.

6.4 LIMITATIONS

Literature on laboratory performance was very limited. Some of the literature used

that contained issues relevant to the topic was older than ten years. Therefore some of

the literature reviewed was collected via the internet.

Some potential respondents did not want to participate in the research. But when that

happened, other suitable respondents were approached to participate until the set

sample size was achieved.

There was no funding for the study to reach laboratories all over the country;

therefore the respondents were from Gauteng and the North West provinces.

The study was focused on testing laboratories and not on other types of laboratories

like calibration laboratories.

6.5 RECOMMENDATIONS FOR FUTURE RESEARCH

Future research on this topic should be done with a bigger sample. Further, the

profitability performance of the laboratories should be considered as a future financial

research project. It appears that the laboratories can be managed with a set of general

laboratory principles, hence, the justification of the quality assurance standards on

external performance needs to be investigated.

180

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Yin, R.K. 1994: Case Study Research: Design and Methods. Thousand Oakes: Sage.

192

APPENDIX A – INTERVIEW FOCUS AREAS GUIDELINE

SECTION A

1. What is the title of your position?

Quality Manager Quality Assurance Manager Quality Control Manager Quality Coordinator Quality Supervisor Quality Systems Manager Quality Auditor- Internal/Lead

SHEQ Manager Quality Technician Laboratory Manager Other (Please specify)

1.1 What is your qualification?

2. What is the nature of your testing facility?

Non-commercial Laboratory

Commercial Laboratory

3. What type of services/tests does your laboratory offer?

4. Please indicate whether your laboratory is ….

ISO 9001 Certified GLP Compliant ISO 17025 Certified ISO 14001 Certified OHSAS 18001 Certified None of the above

5. How long have you been certified to ISO 17025 or GLP?

5.1 If there is no ISO 17025 or GLP in place, are you planning to implement any of

the two systems?

6. a. What were the reasons for implementing ISO 17025 or GLP? (Certified)

b. Don’t you see the need or feel pressure to implement a system? (Non certified)

193

7. What is the main challenge in maintaining and improving the system?

8. How many employees are employed in the laboratory? Permanent/contract?

9. What is your criterion (minimum qualification) when hiring laboratory personnel?

10. Do you have an electronic/manual QA system or LIM system?

YES NO Electronic Manual

SECTION B

1. How do you ensure that the laboratory is a safe working environment for

employees?

2. If you are ISO 14000 and OHSAS 18000 certified, are you planning to implement

any of the two systems?

3. How do you handle or manage housekeeping in the laboratory?

4. Are you involved in sampling or do you test samples as received?

5. Can you identify sampling errors or problems that encounter if there are any?

6. What are the factors that contribute to errors in the laboratory results?

7. What is your procedure for declaring laboratory employees competent?

8. Once employees have been trained, how do you measure the effectiveness of

training attended?

____________________________________________________________________

SECTION C

1. Which of the following is used to measure the competency of your laboratory

personnel?

YES NO Certified Reference Material

In-house QC Samples Blind/Spiked Samples Proficiency Testing Scheme

194

2. If you do not use any of the above, how do you check personnel’s technical

competence?

3. What is your criterion for selecting suppliers? Is the accreditation/certification

status one of the minimum requirements when selecting suppliers?

4. Does your system help with developing key performance indicators for personnel

and the performance appraisal process?

5. How do you measure customer satisfaction and complaints with regard to your

laboratory services?

6. How are customer issues communicated to laboratory personnel?

8. Have you ever dealt with legal implications due to the test results that you issued?

Can certification help with an issue like that?

9. Does your system, (certified and non certified) helps when working under

pressure?

10. Which of the following have you realized due to your accreditation status?

POSITIVE NEGATIVE Marketing advantage International recognition for your laboratory Facilitation of trade and economic growth. Leads to acceptance of exported goods in overseas markets

Retention and growth of customer base Increase in your profit margin

11. How do you measure profit? Do you measure it in terms of revenue or new

customers?

THANK YOU

APPENDIX C1 PROFILE OF LABORATORIES LAB NUMBER

NATURE OF LAB RESPONDENT POSITION

QUALIFICATION LAB SERVICES LENGTH OF SYSTEMS CERTIFICATION

195

Lab 1 NCL-QA (ISO 17025) Section Manager MSc Chemistry Wet chemistry and analytical

techniques 6 yrs ISO 17025, OHSAS 18001 & ISO 14001

Lab 2 NCL-QA (ISO 17025) Lab Analyst ND Biotechnology Microbiology tests and spectrophotometer

1 yr ISO 17025, OHSAS 18001 & ISO 14001

Lab 3 NCL-QA (ISO 17025) Chemical Technician ND Analytical Chemistry

Wet chemistry and analytical techniques

3 yrs ISO 17025, OHSAS 18001 & ISO 14001

Lab 4 NCL-QA (ISO 17025) Chemistry Manager BSc Honours Physical test 14 yrs ISO 17025, ISO 14001, ISO 9001

Lab 5 NCL-QA (ISO 17025) Quality Manager B Tech Anal Chemistry

Analytical techniques 4 yrs ISO 17025, OHSAS 18001 & ISO 14001

Lab 6 NCL-QA (GLP) Medical Technologist ND Medical Technology

Drug and vaccine physic-chemical testing and formulation development

2 yrs GLP

Lab 7 NCL-QA (GLP) Research & Development Manager

PhD, MEng and BEng Chemical Engineering

Surveillance work 6 months GLP

Lab 8 NCL-NO QA (0) Senior Technical Officer

BSc Honours Gravimetric tests, wet chemistry and analytical techniques

0

Lab 9 NCL-NO QA (0) Technical Manager ND Anal Chemistry Wet chemistry 6 yrs ISO 9001 Lab 10 NCL-NO QA (0) SHEQ Manager B Tech Anal

Chemistry Wet chemistry and analytical techniques

11 yrs ISO 9001, OHSAS 18001 & ISO 14001

Lab 11 NCL-NO QA (0) Provincial Head of Laboratory Services

M Med Vet in Microbiology

Specialised tests in controlled diseases

0

Lab 12 CL-QA (GLP) Test Officer ND Anal Chemistry Wet chemistry and analytical techniques

13 yrs GLP, OHSAS 18001 & ISO 14001

Lab 13 CL-QA (GLP) Managing Director ND Microbiology Microbiological and chemistry tests

10 yrs GLP

Lab 14 CL-QA (ISO 17025) Laboratory Manager MSc Chemistry Analytical techniques 14 yrs ISO 17025, OHSAS 18001 & ISO 14001

Lab 15 CL-QA (ISO 17025) National Quality Manager

BSc Chemistry Wet chemistry and analytical techniques

10 yrs ISO 17025

Lab 16 CL-QA (ISO 17025)

Laboratory Technician ND Anal Chemistry Clinical trials and diagnostic work

12 yrs ISO 17025


NATURE OF LAB RESPONDENT POSITION

QUALIFICATION LAB SERVICES LENGTH OF SYSTEMS CERTIFICATION

196

Lab 17 CL-QA (ISO 17025) Quality Manager ND Biotechnology Chemical and microbiology tests

7 yrs ISO 17025

Lab 18 CL-NO QA (0) Laboratory Manager BSc Honours Chemistry, BSc Honours Water Treatment

Microbiology tests and analytical techniques

0

Lab 19 CL-NO QA (0) Laboratory Services Manager & Quality Manager

BSc Chemistry Wet chemistry and chromatographic analysis

0


NATURE OF LAB

NUMBER OF EMPLOYEES IN THE LAB

REASONS FOR IMPLEMENTING THE STANDARD

CHALLENGES IN MAINTAINING THE STANDARD

MINIMUM QUALIFICATION WHEN HIRING LAB PERSONNEL

MANUAL/ ELECTRONIC QA & LIMS

197

Lab 1 NCL-QA (ISO

17025) There are 33 employees. 12 are permanently employed, and 18 are on contract as in service trainees.

It was something that was initiated from within. Seeking accreditation was a result of joint ventures with other companies in the same industry.

Sometimes different assessors from the accreditation body have different expectations and do not interpret the standard consistently.

Prior experience is also considered, not just formal education. For operating analytical equipment, ND in Anal Chem is the minimum requirement

Have a LIMS.

Lab 2 NCL-QA (ISO 17025)

1 employee. Permanently employed.

Customers required it. It requires and takes time to maintain the system.

ND in Anal Chemistry, Biotechnology or Microbiology

On-site and off-site backup electronic system.


There are 11 permanent technicians employed in the laboratory.

Came from within the organisation. There were no external pressures.

Keeping or maintaining the standard you have achieved is challenging.

Matric with Mathematics and Science for basic tests. Advanced testing requires ND in Analytical Chemistry.

Test results are reported and stored on the electronic system.


There are 30 analysts. 26 are permanent. 4 are on a contract doing in service training.

Initiated from within and they wanted to be a trend setter in their field.

Staff turnover is the challenge in maintaining the system.

ND Analytical Chemistry and one year industry exposure.

Have a LIMS.


24 analysts. 22 are permanent and two are doing in service training and are on contract.

Initiated from within. To align with the certified competitors, and wanted confidence in the services of the laboratory

The human factor, not being consistent all the time.

Matric with Mathematics and Science. Prior experience is also considered, not just formal education.

The system is both electronic and manual.

Lab 6 NCL-QA (GLP) 2 laboratory assistants and 4

The reason came from within and not pressure

Keeping track of changes in

Three year qualification in

Have a LIMS.


NATURE OF LAB






198

medical technologists. All are permanent.

from outside documentation especially SOPs.

Medical Technology

Lab 7 NCL-QA (GLP) 4 permanently employed laboratory personnel.

Regulatory submissions are done at both FDA (US) and EMEA. The material will have to be tested under GLP for the results to be accepted by these regulatory agencies.

Getting the corrective and preventative action process working properly.

Minimum requirement is MSc, but skills shortage forced the lab to settle for less qualified personnel.

The system is both electronic and manual.

Lab 8 NCL-NO QA (0)

6 employees. 5 employees are permanent. The laboratory assistant is on contract doing in-service training.

There is no pressure to implement a quality system and going for certification.

No comment Instrument Scientist or Laboratory Assistant is a B Tech Degree in Analytical Chemistry or BSc. Laboratory Helper is Matric, preferably with Mathematics and Science. For in service positions, all the theoretical courses must be completed.

There is no electronic or LIM System.

Lab 9 NCL-NO QA (0)

There are 3permanently employed personnel.

As an internal laboratory, there’s no need to get ISO 17025 certification.

No comment ND in Analytical Chemistry. For in-service positions, all the theoretical courses must be completed.

Have both an electronic and manual QA system. There is no LIM System.

Lab 10 NCL-NO QA (0)

There are 4 employees. 2 are permanently employed and 2 are students doing in-service training.

The lab test samples from the plant. Samples from external customers are never tested, so there is no need to implement ISO 17025.

No comment Permanent employees need ND in Analytical Chemistry. Trainees must have completed theoretical work towards their ND.

Have both an electronic and manual QA system. There is no LIM System.


NATURE OF LAB






199


There are 17 permanent employees.

The reason for implementing ISO 17025 comes from within. Indirect pressure from other sectors within the department which the lab is in, presents a commercial opportunity for the lab and contributed to the decision for wanting to implement the system.

The challenge of running a non-accredited laboratory is that as a laboratory person there is a feeling of constant pressure to implement the system due to personal belief in a quality management system.

The minimum requirement for Vets is to be a qualified Vet and be registered with SAVC. For Vet Technologist, the minimum qualification is ND or B Tech in Veterinary Technology and must be registered with the SAVC. For Laboratory Assistants, the minimum is Matric.

There is LIMS for reporting the results but it is not fully utilised.

Lab 12 CL-QA (GLP) 15 permanent employees.

Customers from the food industry only use OECD GLP compliant laboratories. The European Union countries, only accept results from accredited laboratories.

The ever changing customer and regulatory requirements in the industry, a continuous development of new test methods.

ND Chemistry or Microbiology

There is an electronic system and LIM System.

Lab 13 CL-QA (GLP) 13 permanent laboratory personnel.

The reason for implementing the quality system was initiated from within. It was influenced by personal experiences after working for organisations that had implemented quality

Paper work. The minimum requirement depends on the positions available. Matriculants are hired for basic tests and ND is required for advanced tests.

Has both a manual and electronic system. There is LIM System.


NATURE OF LAB






200

systems, and these led to personal belief in quality systems.


7 permanent laboratory analysts.

Pressure from external customers; they wanted assurance that the results produced by the laboratory could be trusted.

Discipline by laboratory personnel to follow documented procedures.

ND Analytical Chemistry but preferably B Tech in Analytical Chemistry or BSc. Junior positions are filled by Matriculants.

Have a LIMS.


About 3000 employees nationally, and most of them are permanently employed.

The competitive nature of the business. The system became the primary requirement for people to do business with the lab.

People’s attitudes, getting them to conform to procedures

ND in Medical Technology and registration with the HPCSA.

The system is both electronic and manual. There is a LIM System.


There are 3 permanently employed laboratory technicians and 2 laboratory assistants doing in-service training and are on contract.

The laboratory wanted to give itself and customers the assurance about the quality of the results that it issues

There are no major challenges in maintaining the system.

Permanent employees require ND Analytical Chemistry or Microbiology. Completion of theoretical work for in-service training.

Have an electronic QA system. There is a LIM System.


7 permanent employees.

Pressure from some customers

It is too costly to maintain.

ND Anal Chemistry, ND Biotech and ND Food Tech.

The QA system is manual and there is no LIM System.

Lab 18 CL-NO QA (0) 4 permanent employees.

As a non certified laboratory, there is a lot of pressure from the current and potential

No comment Individual’s work experience is considered, not just formal education.

Documents are stored on a drive shared by all laboratory


NATURE OF LAB






201

customers to implement and be accredited to ISO 17025

personnel. There is no LIM System.

Lab 19 CL-NO QA (0) 30 permanent employees.

It is a long term plan to implement the system and get certified. At this stage, customers are not asking for it, so the pressure is not there yet.

No comment

There is no minimum criterion in terms of qualification when hiring employees. The people hired have been exposed to the same tests and have had on–the-job training.

Their QA system is manual. There is no LIM System.

LAB NUMBER NATURE OF LAB APPENDIX C3 HEALTH AND SAFETY SUPPLIER SELECTION

Making the laboratory a safe working environment

OHSAS 18001 and ISO 14001 systems implementation status

Managing housekeeping in the laboratory

Supplier Selection Criteria

202

Lab 1 NCL-QA (ISO 17025) Safety forms part of

induction training. PPE is provided. Safety signs are displayed in the lab. Written safety test. HS&E policies and procedures are available electronically on the shared drive.

OHSAS 18001 and ISO 14001 Certified.

Housekeeping issues when the sample number is high. Risk assessment is conducted before carrying out daily tasks.

Previous relationship with the laboratory. Quality of the product to be supplied. Suppliers are not audited.

Lab 2 NCL-QA (ISO 17025) Five minutes video on health and safety. Alcohol test is conducted. Work instructions for operating laboratory equipment incorporates H&S requirements. Visible H&S signs. PPE provided.

ISO 14001 and OHSAS 18001.

Cleaning on a daily basis by lab person.

BEE compliance status. The turn around time and quality of the reagents. Supplier auditing. Supplier rating.

Lab 3 NCL-QA (ISO 17025) A safety video. Employees go through induction training. PPE for employees. H&S signs displayed. Accessible HS&E policies and procedures.


All analysts are responsible for housekeeping in the laboratory.

Certification status. Supplier audits.

Lab 4 NCL-QA (ISO 17025) Guided by the OHS Act. Safety representatives and safety committees in the laboratory. Induction training. Laboratory walk about by supervisors.

Certified to ISO 9001 and ISO 14001. Working towards OHSAS 18001 certification.

Housekeeping is everyone’s responsibility in the laboratory.

Suppliers are selected based on the quality of the reagents they supply.






203

Test method stipulates PPE. Safety signs all over the laboratory building.

Lab 5 NCL-QA (ISO 17025) Fifteen minutes induction training video. HS&E form part of induction training. Regular general inspection is conducted. Daily meetings. PPE is provided.


Housekeeping is everyone’s responsibility in the laboratory.

Supplier audits.

Lab 6 NCL-QA (GLP) Newly hired employees go through orientation. ‘Health & Safety’ notice board. Elected safety officers. Clinic on premises. System for reporting incidents and accidents.

Not certified H&S and EMS. The internal system covers processes like waste removal and handling of bio hazardous chemicals.

Housekeeping is everyone’s responsibility.

Certificate of analysis. Products are tested before use.

Lab 7 NCL-QA (GLP) OECD GLP helps to enable constant monitoring to ensure safe workplace.

No ISO 14001 and OHSAS 18001 certification.


Considers quality, speed, and cost of service or products. Also consider the ISO 17025 accreditation and ISO 9001 certification status of potential supplier.

Lab 8 NCL-NO QA (0) SHE representative. PPE provided. H&S training for laboratory employees. Training on hazardous chemicals and first aid.

No plans to implement the OHSAS 18001 and ISO 14001.


The reputation of the supplier.






204

Lab 9 NCL-NO QA (0) Laboratory personnel are trained in health and safety procedures. Risk assessment is conducted. Monthly safety talks held. Elected safety representative. Planned job observations with regard to health and safety procedures. Incident reporting system. PPE provided. H&S signage.

Working towards ISO 14001 due to environmental issues raised by the local municipality. There are no plans to implement OHSAS 18001 in the near future.


Supplier Audits. COAs. Cost. ISO 9001 certification.

Lab 10 NCL-NO QA (0) Trained on H&S procedures. Qualified first aiders. SHE representative. Test methods address the H&S issues.

ISO 14001 and OHSAS 18001 certified systems.


Preference is given to those who are certified. Adhere to the agreed delivery times.

Lab 11 NCL-NO QA (0) Training on health and safety procedures, safety committees, job observation and risk assessment. PPE provided. H&S signs comply with the OHS Act.

No plans to implement ISO 14001 and OHSAS 18001.


They only deal with distributors and they deal with sole suppliers not by choice.

Lab 12 CL-QA (GLP) Induction training. Human Resources policies, HS&E policies. PPE. Health and safety signs.

Certified to ISO 14001 and OHSAS 18001.

Everyone is responsible for housekeeping.

Based on the quality of the products that they supply, the Certificate of Analysis is also required to be delivered with the product, the ability of the supplier to keep to the agreed lead times, and also the reputation of the suppliers.






205

Lab 13 CL-QA (GLP) HS&E training. OHS Act. PPE.

Not certified to ISO 14001 and OHSAS 18001.

Everyone is responsible for housekeeping.

Use ISO 9001 certified suppliers.

Lab 14 CL-QA (ISO 17025) Policies that govern the environment, health and safety. Training employees. PPE.

Certification to ISO 14001 and OHSAS 18001.

Housekeeping is everybody’s responsibility.

Certified or accredited quality management system and certificate of analysis for products purchased.

Lab 15 CL-QA (ISO 17025) Induction training. Work according to OHS Act. Health and Safety committees in place.

No plans to implement ISO 14001 and OHSAS 18001.

There are maintenance charts that have been developed to manage housekeeping and the work benches are decontaminated twice a day.

Suppliers must be ISO 9001certified. Reasonable cost.

Lab 16 CL-QA (ISO 17025) HS&E form part of induction. General safety manual. Materials safety data sheets of chemicals. PPE. H&S Signs.



A tender has to be opened and evaluated. Certificate of analysis. Accreditation gives suppliers an edge over those who do not have it.

Lab 17 CL-QA (ISO 17025) PPE.


There are rules and regulations that all employees have to follow.

Word of mouth and recommendations.

Lab 18 CL-NO QA (0) PPE. No H&S signs.


All employees are responsible for housekeeping.

Suppliers are selected based on the quality of the product that they supply, the price and the service. Certificates of analysis. Reagents are tested before use.






206

Lab 19 CL-NO QA (0) PPE.

H&S signs. Not certified to ISO 14001 and OHSAS 18001.

All employees are responsible for housekeeping.

The quality of results and cost. Products are delivered with certificates of analysis. Certified or accredited suppliers do not get an edge over those without a formal quality system.

LAB NUMBER

NATURE OF LAB

APPENDIX C4 HUMAN RESOURCES

Procedure for declaration of competency

Measuring the effectiveness of training conducted

Methods used to check personnel’s technical competence

The impact of the standard on KPIs and Performance Appraisal

Coping with work pressure

207

Lab 1 NCL-QA (ISO

17025) Planned task observation.

Employees are given a project to complete using the knowledge gathered at the training.

PTS results. CRM results. QC samples results. ‘Blind’ or spiked samples are only used during training.

The system helps to set the level or expectations required from the employees. Succession planning considered when doing performance appraisals

ISO 17025 gives the lab confidence in the results produced, even when working under pressure because of the documented procedures


Job observation Reference cultures or QC samples.

PTS results. CRM results. QC samples results. ‘Blind’ or spiked samples are used.

ISO 17025 contributes positively to performance appraisal and developing KPIs

There is a documented policy on ethics and pressure


Observing a competent person.

Get a chance to do after observing a competent person. Written test.

PTS results. CRM results. QC samples results. ‘Blind’ or spiked samples are used.

The system helps. There is a training matrix in place, where employees know what they are working towards.

There is a documented policy on ethics and employees are trained on that.


Employees attend a course/training.

Job observation is conducted once employees have been trained.

CRM results. QC samples results. ‘Blind’ or spiked samples are used.

ISO 17025 is there to harmonise things

The manager must lead by example w hen it comes to ethical issues.


Induction training. Written exam. Assessment by a panel where they are given an oral examination.

PTS samples. QC samples. Blind samples.

Helps with performance appraisals and developing key performance indicators.

Analysts do not have access to the phone and they do not deal directly with the customers

LAB NUMBER

NATURE OF LAB







208

Lab 6 NCL-QA (GLP) Training by

competent person. Involving employees in inter and intra-laboratory comparisons, and measurement against specified level of reproducibility and accuracy.

The results of the intra-laboratory testing schemes. Blind samples.

New Performance Appraisal System is under review.

The system helps to ensure that personnel are free from undue pressures and employees are ethical because there is a system for doing everything

Lab 7 NCL-QA (GLP) Witnessing by a competent person. ‘Blind’ samples. Intra-laboratory samples.

Observing the practical application of training.

CRM, in-house QC samples, blind/spiked samples and taking part in Proficiency Testing Schemes.

Helps with performance appraisal and helps develop key performance indicators for personnel.

Employees share workload and we encourage communication amongst personnel.

Lab 8 NCL-NO QA (0)

No defined procedure regarding how they declare their employees competent. Qualification was given as a reason for being competent.

Observation but no records kept.

Internally prepared standard solutions are used.

Factors like punctuality are considered when developing KPI’s and performance appraisal.

It must be the manager’s role to ensure that there is compliance to internal standards

Lab 9 NCL-NO QA (0)

Training by a competent person.

Planned job observation.

The laboratory only does equipment verification.

training matrix that is developed to help with training and performance measurement of employees

Can cope with what we currently have, which is ISO 9001 certified system.

LAB NUMBER

NATURE OF LAB







209

Lab 10 NCL-NO QA

(0) Employees trained by competent personnel.

Practical and theoretical test.

Rely on standardisation. handled by the Human Resources department

QC Supervisor attends daily meetings with the production team and plan for the day


Training plan is developed. Taking part in PTS and intra/inter sample testing are used as part of training.

Job observation. QC samples, blind samples. Inter and intra- PTS samples. Comparison of results between analysts.

Helps with developing key performance indicators and performance appraisal.

All employees are registered with South African Veterinary Council

Lab 12 CL-QA (GLP) Laboratory personnel are trained and declared competent.

Proficiency testing schemes samples. Intra laboratory samples.

Certified reference materials, in-house QC samples, samples from internal and external proficiency testing scheme providers.

Helps during the process of performance appraisal and developing key performance indicators for personnel.

Our system helps to ensure personnel are free from undue pressures and employees are ethical.

Lab 13 CL-QA (GLP) Proficiency testing schemes and intra-laboratory test samples.

Audits by clients. ‘Blind’ samples. PTS samples.

‘Blind’ samples. PTS samples

helps with developing key performance indicators and performance appraisal

Laboratory personnel do not deal directly with customers.


Employees are trained and work under the supervision of a competent person.

‘Blind’ or spiked samples are used to test competency.

PTS samples. ‘Blind’ or spiked samples.

Results of the PTS are used as key performance indicators for laboratory personnel and are also evidence during performance appraisals

Laboratory personnel are cross trained to conduct all the tests in the laboratory.

LAB NUMBER

NATURE OF LAB







210

Lab 15 CL-QA (ISO

17025) The organisation has its own training centre.

Job observation or witnessing. Training effectiveness is also measured by the results of the (PTS) samples.

PTS samples. Internal QC samples.

Helps with the development of key performance indicators

Personnel are constantly trained on ethical issues, and are registered with the Health Professional Council


Employees are trained and declared competent before being left to work independently.

Observation by the trainer.

PTS samples. Helps during the process of performance appraisal and developing key performance indicators for personnel

The system helps ensure personnel are free from undue pressures and employees are ethical because there is a system for doing everything


Employees are trained and declared competent before being left to work independently.

Witnessing by the trainer.

In house QC samples. PTS samples.

Assists in developing key performance indicators

Each employee has a job description.

Lab 18 CL-NO QA (0) Employees are trained by the Laboratory Manager.

Witnessing of personnel by the trainer.

In house QC samples, spiked samples, PTS.

With regard to performance appraisal, the most important factors to look at are trustworthiness and honesty in results produced, and a passion for the job.

All laboratory personnel sign a service contract

LAB NUMBER

NATURE OF LAB







211

Lab 19 CL-NO QA (0) Employees are

trained and work under the supervision of a competent person.

Personnel proficiency testing scheme samples. Certified reference materials, internal QC samples and ‘blind’ samples are used.

CRMs, in-house QC samples, spiked samples, PTS.

There is day-to-day contact between managers and employees, and managers know employees personally and are aware of their performance.

Before testing the sample, the person tests a quality control sample first. That helps personnel to make a decision on whether to continue with the analysis or not.

LAB NUMBER

NATURE OF LAB

APPENDIX C5 CUSTOMER SATISFACTION

Customer satisfaction measurement

How are customer issues communicated to employees

Have you ever dealt with legal implications due to test results issued

212

Lab 1 NCL-QA (ISO

17025) Questionnaires are sent out to customers on a quarterly basis. Customers comment on issues like the quality of the results, if they are happy with the sample turn around times, and the communication or updates from the laboratory. Complaints are mostly about sample turn around time.

Quarterly meetings with customers.

No. Chances of issuing wrong results and discovering that later are minimised by the fact that there are a lot of control measures put in place.


Questionnaires are sent out to customers on a yearly basis.

Meetings No. If a legal action had to be taken against the laboratory, being ISO 17025 certified would help us with the internal investigation and deal with the matter.


To measure customer satisfaction there is constant communication with the customers. Customers also rate their performance by using questionnaires on a quarterly basis.

Lab meetings held twice a week.

No. If a need could arise to defend our results in a court of law, the certified system would give us confidence to deal with the situation as everything we do is traceable.


Questionnaires are sent out to customers once a year. Customers are asked to comment on issues like the service they receive, if they are happy with the sample turn around time, and the reports.

Weekly and monthly meetings.

No, the system would assist with traceability.

LAB NUMBER

NATURE OF LAB





213


Questionnaires which are sent out to customers annually.

Daily Meetings No, if a need can arise to defend our results in a court of law, our certified system would help us to go through the exercise because there is evidence of the QC done and traceability is there in terms of competency and validation of methods

Lab 6 NCL-QA (GLP)

Questionnaires are sent out to customers annually. Sample turn around time results in complaints.

Lab meetings No, if we had to deal with issues like that; our certified quality system would help us deal with the situation.

Lab 7 NCL-QA (GLP)

Customer satisfaction is measured by sending questionnaires out to customers once a year.

Feedback meetings and CAR/PAR system.

No. If it can happen, our quality standard and status will be very handy, all our data will be fully traceable

Lab 8 NCL-NO QA (0)

Service questionnaires are issued to customers after rendering service.

Lab meetings No. Our results are used in the academic environment and are not used to make business decisions

Lab 9 NCL-NO QA (0)

Customer satisfaction is measured by using customer evaluation forms annually. Customers comment on issues like suggestions for service; quality, invoicing and customer support.

Lab meetings No. When our customers are not happy, they take their business somewhere else, but don’t go the legal route


Questionnaires are handed out to customers once a year.

Monthly meetings No, the ISO 9001 certification would help.


Customer satisfaction is currently not measured but will be measured by questionnaires in the future.

Lab meetings No. Certification can help when issues like that come up because there will be traceability

Lab 12 CL-QA (GLP) Customer satisfaction is measured by using questionnaires which are

Non conformances are raised electronically.

No. If it had to happen, our quality system will help us

LAB NUMBER

NATURE OF LAB





214

handed out to customers on a six monthly basis.

Lab 13 CL-QA (GLP) Customer satisfaction is measured by using questionnaires which are handed out to customers yearly.

Meetings No. If it can happen, our traceable system would help


Customer questionnaires are sent out to customers twice a year.

Lab meetings No. Chances of issuing wrong results and discovering that later are minimised by the fact that there are a lot of control measures put in place like analysis of internal standards


Customer questionnaires are sent out to customers.

Lab meetings No. Our system should be able to help us find the root cause of the problem


Questionnaires are sent out twice a year. Major factor that causes customer complaints in laboratory is sample turn around time.

Lab meetings No, system would help


Questionnaires are sent out at least once a year.

Lab meetings Yes. The certified system has helped to deal with legal implications in the past.

Lab 18 CL-NO QA (0) The laboratory does not measure customer satisfaction.

Lab meetings No, being certified or non-certified does not have an impact on the issue

Lab 19 CL-NO QA (0) Customer satisfaction is currently not measured.

Lab meetings No. But being certified does not mean if a customer goes the legal route, you will be covered

LAB NUMBER

NATURE OF LAB

APPENDIX C6 PROFITABILITY

Marketing Advantages International recognition for the lab

Facilitates economic growth

Acceptance of goods/services in overseas markets

Profit margin Profit measurement

215

Lab 1 NCL-QA (ISO

17025) ISO 17025 accreditation is no longer a major marketing advantage

Positive Positive Positive Positive New customers


Taking part in PTS helps to manage your competency as a laboratory

Positive Positive Positive Positive Revenue


Positive Positive Positive Positive Positive Revenue


Positive Positive Positive Positive Positive New customers


Positive Positive Positive Positive Positive Revenue

Lab 6 NCL-QA (GLP) Non-profit organisation and charge minimum fee. Certification gives a certain level of confidence. New customers Lab 7 NCL-QA (GLP) Positive Positive Negative Positive Negative Revenue Lab 8 NCL-NO QA (0) An academic institution But, being certified by an independent body should be a goal that any laboratory must work

towards.

Lab 9 NCL-NO QA (0) Get the benefits from ISO 9001 certification Revenue Lab 10 NCL-NO QA (0) Get the benefits from ISO 9001 certification Revenue Lab 11 NCL-NO QA (0) Being ISO 17025 can serve as a marketing advantage, gives the laboratory international recognition,

and facilitates trade and economic growth. New customers

Lab 12 CL-QA (GLP) Positive Positive Positive Positive Positive New customers Lab 13 CL-QA (GLP) Positive Positive Positive Positive Positive New customers,

variation of test methods


Positive Positive Positive Positive Could not comment

New customers


Positive Positive Positive Positive Non-profit organisation.

New customers


Positive

Positive Positive Positive Positive New customers

LAB NUMBER

NATURE OF LAB

APPENDIX C6 PROFITABILITY

Marketing Advantages International recognition for the lab

Facilitates economic growth

Acceptance of goods/services in overseas markets

Profit margin Profit measurement

216


Positive Positive Positive Positive Does not necessarily impact positively on profit margin.

Revenue

Lab 18 CL-NO QA (0) Certification does not guarantee.

Certification does not guarantee.




Revenue

Lab 19 CL-NO QA (0) Can have a positive impact.

Can have a positive impact.



The system can have a positive impact on the profit margin but there are start up costs of implementing the system

Revenue