Improving maintenance efficiency at AstraZeneca

through increased use of TPM

Jonas Bergsman

Anders Hll

Production economics

Masters thesis

Department of Management and Engineering

LIU-IEI-TEK-A--10/00781SE

Improving maintenance efficiency at AstraZeneca

through increased use of TPM

Jonas Bergsman

Anders Hll

Supervisors:

Linkping University: Johan Johansson

AstraZeneca: Andreas Jaensson

Masters thesis

Department of Management and Engineering

LIU-IEI-TEK-A--10/00781SE

Foreword

This masters thesis has been conducted at AstraZenecas production site in Snckviken. It

covers 30 credit points and is performed at the division of production economics at Linkping

University. The project is the last phase of our masters degree in Science of Mechanical

Engineering and it has given us the opportunity to practise the expertise gained during the

education.

At Linkping University we have had an excellent support from our supervisor Johan

Johansson. And have had the honour to participate in a bigger academia-business project

called the PIC-LI. This masters thesis would not have been possible to perform without the

help and support from the employees at API and especially the maintenance engineers

which have given us important input to the project. We want to express special thanks to our

two supervisors at AstraZeneca, Andreas Jaensson and Johan Gester; who has showed

great commitment and helped us during this period.

AstraZeneca. May 2010

__________________

Anders Hll

__________________

Jonas Bergsman

Abstract

This is the report from the masters thesis, performed at AstraZeneca, Sweden Operations at

the Snckviken Active Pharmaceutical Ingredient (API) plant. AstraZeneca is a multinational

pharmaceutical enterprise with operations all over the world and our scope is the API plant in

Sdertlje, Sweden. The site is a chemical agent mixing plant, with large size batches

containing expensive agents and solutions. This means that the value in each batch is high

thus putting pressure on the maintenance department keeping the uptime high.

The areas of interest in this masters thesis are the maintenance strategy, the use of

performance indicators, the use of computerized maintenance systems, integrated

production and maintenance and motivational aspects. These topics were chosen in

collaboration with the maintenance manager at API. The report examines and provides

improvement proposals on the maintenance function at the Active Pharmaceutical Ingredient

production plant at AstraZeneca, Sweden Operations.

The purpose of this masters thesis is to examine how AstraZeneca can improve

maintenance management and work with motivational aspects in order to ameliorate the

completion of the TPM pyramid and thus increase the maintenance efficiency. The purpose

is fulfilled by providing solution proposals that improves the overall maintenance results

which in turn improves the maintenance efficiency.

It was found that the TPM work had stalled and that the TPM was not fully understood by the

employees. A perception of a stalled TPM work put the focus on the TPM and its

components and the awareness arose that the commitment from the maintenance

technicians as well as the productions operators could be better.

The features of the current maintenance systems were not fully utilized. This affected the

use of the performance indicators. It was difficult to determine how efficient the maintenance

work and planning was, regarding the performance indicators. The maintenance engineers

at API are highly experienced and the API planning department works with the current

competence but it was perceived that the planning procedure was shifting between individual

planners, and that the process was based, not on a common policy, but on the experience

and expertise the engineers possessed. When investigating how the motivational work at

API was managed it was found there was a too long-sighted goal setting with respect to the

employees and that the incitements for reaching a particular goal could be revised on a

shorter termed basis.

What we propose is that API should look at aspects such as performance indicators but also

put an equal focus on less obvious points such as motivating the staff through competitions

etc. We urge them to look at goal setting, have TPM and goal setting be intertwined and

effectively communicated throughout the organization and managing cultural change in an

active way thus making each maintenance staff member take a self interest in the TPM

program. In increasing the TPM pyramid completion we propose that API focus on extending

the use of the current maintenance system and to introduce performance indicators that can

be used for mapping performance. This will also help motivating the staff and the

performance indicators can be used in the goal setting program. As a guide on how to work

with these issues, a number of improvement proposals have been generated addressed to

API; that covers this masters thesis areas of interests.

Contents

Table of figures ...................................................................................................................... I

List of abbreviations .............................................................................................................. II

1 Introduction .................................................................................................................... 1

1.1 Background............................................................................................................. 1

1.2 Problem definition ................................................................................................... 2

1.3 Purpose .................................................................................................................. 3

1.4 Delimitations ........................................................................................................... 3

2 Methodology .................................................................................................................. 4

2.1 The work process.................................................................................................... 4

2.2 Ensuring validity and reliability ................................................................................ 5

3 Company description ..................................................................................................... 7

3.1 AstraZeneca ........................................................................................................... 7

3.2 History .................................................................................................................... 7

3.3 Active pharmaceutical ingredient production at Snckviken .................................... 7

4 Theory ........................................................................................................................... 8

4.1 Total productive maintenance ................................................................................. 8

4.2 Maintenance planning ........................................................................................... 10

4.2.1 The scheduling problem ................................................................................. 13

4.3 Integrated production and maintenance planning .................................................. 13

4.4 Maintenance performance indicators .................................................................... 14

4.5 Computerized maintenance management system................................................. 15

4.6 Motivational Theory ............................................................................................... 16

4.6.1 The theory of X and Y .................................................................................... 17

4.6.2 Maslows theory of motivation ......................................................................... 18

4.6.3 McClellands motivational theory .................................................................... 19

4.6.4 Expectancy Theory ........................................................................................ 20

5 Present situation .......................................................................................................... 21

5.1 Active pharmaceutical ingredient production site .................................................. 21

5.2 Maintenance strategy ............................................................................................ 22

5.3 Standard operation procedures ............................................................................. 23

5.4 Planning coordination ........................................................................................... 25

5.5 Production planning .............................................................................................. 25

5.6 Maintenance planning ........................................................................................... 26

5.6.1 Preventive maintenance ................................................................................ 27

5.6.2 Corrective maintenance ................................................................................. 28

5.7 Calibration planning .............................................................................................. 29

5.8 Key measurements ............................................................................................... 31

5.9 Computerized maintenance management system................................................. 33

5.10 Mechanical workshop and operative maintenance ................................................ 34

5.11 Motivation ............................................................................................................. 35

5.12 Strengths and improvement potentials .................................................................. 36

6 Analysis ....................................................................................................................... 38

6.1 Total productive maintenance ............................................................................... 38

6.2 Maintenance management .................................................................................... 40

6.3 Integration between maintenance and production planning ................................... 41

6.4 Performance indicators ......................................................................................... 42

6.5 Motivation ............................................................................................................. 45

6.5.1 Extrinsic motivation ........................................................................................ 46

6.5.2 Intrinsic motivation ......................................................................................... 47

6.5.3 Leadership and cultural change at API .......................................................... 48

6.6 Performance indicators related to motivational theory ........................................... 48

7 Improvement proposals ................................................................................................ 50

7.1 Total productive maintenance ............................................................................... 50

7.1.1 TPM-pyramid related to responsibility and mandate....................................... 50

7.1.2 TPM-pyramid, goal setting and measurement ................................................ 50

7.1.3 TPM-zoomed in charts and step by step guide to World Class Maintenance . 51

7.1.4 TPM-pyramid and personal commitment and competition .............................. 51

7.2 Planning Process .................................................................................................. 53

7.2.1 Improve the planning process ........................................................................ 53

7.2.2 Define safety time that maintenance and production needs. .......................... 54

7.3 System use ........................................................................................................... 55

7.3.1 Introduce more comprehensive classification of work orders ......................... 55

7.3.2 Review of the maintenance policies for equipment ........................................ 56

7.3.3 Increase the length of visualized plans........................................................... 56

7.3.4 Document time needed for preventive maintenance ...................................... 57

7.3.5 Introduce time data in SAK ............................................................................ 58

7.4 Performance indicators ......................................................................................... 58

7.4.1 Introduce more useful performance indicators ............................................... 58

7.5 Motivation ............................................................................................................. 59

7.5.1 Intrinsic motivation results .............................................................................. 59

7.5.2 Extrinsic motivation Results ........................................................................... 61

7.5.3 Intrinsic versus extrinsic motivation ................................................................ 61

8 Conclusions ................................................................................................................. 63

9 Recommendations ....................................................................................................... 65

9.1 Improvement actions ............................................................................................. 65

9.2 Prioritizing the improvement proposals ................................................................. 66

9.3 Future research .................................................................................................... 68

References ......................................................................................................................... 69

Performance indicators schematics ........................................................................ Appendix 1

Policy decision model............................................................................................. Appendix 2

TPM pyramid (Current state) .................................................................................. Appendix 3

TPM pyramid (After improvements) ........................................................................ Appendix 4

Table of figures | I

Table of figures

Figure 1:1 The areas of interest in this masters thesis .......................................................... 3

Figure 2:1 Work process, (Lekvall & Wahlbin, 2007 modified) ............................................... 4

Figure 4:1 Pillars of TPM ....................................................................................................... 8

Figure 4:2 The maintenance total cost picture, (Pintelon & Gelders, 1992, modified) .......... 10

Figure 4:3 Categories of maintenance ................................................................................ 11

Figure 4:4 Maintenance policy decision model (Waeyenberg & Pintelon, 2002) .................. 12

Figure 4:5 The Motivation Quadrant (Pagan, 2006) Hybrid with (Robbins, 1991) ................ 16

Figure 4:6 The Behaviour Model (Abrahamsson & Andersen, 2005) ................................... 17

Figure 4:7 Maslow's pyramid (Abrahamsson & Andersen, 2005) ........................................ 18

Figure 4:8 Motivation Loop .................................................................................................. 18

Figure 4:9 Victor Vrooms Expectancy Theory (Abrahamsson & Andersen, 2005) .............. 20

Figure 5:2 TPM Pyramid (AstraZeneca, TPM pyrmid, 2009d) ............................................. 22

Figure 5:1 Schematic view of the active ingredient substance production process .............. 22

Figure 5:3 Hierarchical structure of the SOPs associated with maintenance ...................... 24

Figure 5:4 The SOP staircase ............................................................................................. 24

Figure 5:5 The coordinators organizational function ............................................................ 25

Figure 5:6 The production planning process ....................................................................... 26

Figure 5:7 The maintenance organization structure. (Jaensson, A. 2010) ........................... 27

Figure 5:8 The preventive maintenance process ................................................................. 28

Figure 5:9 The corrective maintenance process (AstraZeneca, 2009b) ............................... 28

Figure 5:10 Calibration work process (AstraZeneca, 2009b) ............................................... 30

Figure 5:11 History of TA at API 2009 ................................................................................. 31

Figure 5:12 History of unfinished work orders 2009 ............................................................ 32

Figure 5:13 The history of urgent work orders ..................................................................... 32

Figure 5:14 Schematic view of the maintenance information system (Based on AstraZeneca,

(2009e) ............................................................................................................................... 33

Figure 5:15 Principle view of the hierarchical system structure. .......................................... 34

Figure 6:1 TPM Implementation and cultural change pyramid anchorage schematics ........ 38

Figure 6:2 The relation between critical and non-critical work orders .................................. 40

Figure 6:3 Total cost curve of maintenance (Johansson, 1993) .......................................... 43

Figure 6:4 Victor Vrooms Expectancy Theory ..................................................................... 45

Figure 6:5 Intrinsic and extrinsic vs. Maslov's pyrmid .......................................................... 46

Figure 6:6 The bonus (incentive) made out of percentage of base salary............................ 46

Figure 6:7 The Maslow Pyramid intrinsic higher order need compared to lower order need of

hygiene factors.................................................................................................................... 48

Figure 7:1 TPM Zoomed chart with the what, why and hows shows the whole chain. ........ 52

Figure 7:2 The Planning Process visualization .................................................................... 53

Figure 7:3 Safety time ......................................................................................................... 54

Figure 7:4 Capacity/ utilization diagram............................................................................... 57

Figure 9:1 Effect/ Effort diagram of the 10 important improvement proposals ..................... 67

Figure 9:2 Execution order when using priority option no. 1 ................................................ 67

Figure 9:3 Execution order when using priority option no. 2 ................................................ 68

Figure 9:4 Execution order when using priority option no. 3 ................................................ 68

List of abbreviations | II

List of abbreviations

ANL ........... Plant registry

AOH .......... Work order manager

API ............ Active pharmaceutical ingredient

CBM .......... Condition based maintenance

CM ............ Corrective maintenance

CMX .......... Calibration management software

CP ............. Calibration point

DOM ......... Design-out maintenance

EFA ........... Replacement factory/ Ersttningsfabrik

ERP .......... Enterprise resource planning

FBM .......... Failure based maintenance

FDA .......... Food and Drug administration

FUH .......... Preventive maintenance manager

GMP ......... Good manufacturing practice

KPI ............ Key performance indicator

MRP .......... Material resource planning

MTBF ........ Mean time between failure

MTTR ........ Mean time to repair

MWT ......... Mean wait time

OMA ......... Operations maintenance API/R&D

PI .............. Performance indicator

PM ............ Preventive maintenance

RAM .......... Random access memory

SAK .......... Systemet fr anlggningskontroll

SHE ......... Safety, Health, Environment

SOP .......... Standard operation procedure

SYFA ........ Synthesis factory/ Syntet fabrik

TA ............. Technical availability

TGS .......... Technical governance and support

TPM .......... Total productive maintenance

UBM .......... Use based maintenance

VMI ........... Vendor managed inventory

Introduction | 1

1 Introduction

This chapter will present an introduction to this masters thesis. It includes a background of

the problem that initiated the project. It also presents the purpose for this masters thesis

which is broken down to a set of research fields. At last the delimitations of the work are

presented.

1.1 Background

AstraZeneca is a global player on the pharmaceutical market. Their yearly sales exceeds $

32 Billion and the company has nearly 63 000 employees all over the world. AstraZeneca is

active in over 100 countries with a growing presence in emerging markets. The research and

development headquarter is sited in Sweden and there is a total of five production sites,

located in Sdertlje, Lund, Mlndal and Ume. (AstraZeneca, Annual Report, 2009a)

A large part of the production is located in Sweden and some of the most important factories

are located in Sdertlje. The production is always aiming at maximizing the efficiency in the

supply chain (through continuous improvements). The Lean philosophy has been adapted in

order to reduce waste and to use the capacity in an efficient way.

In pharmaceutical production there are strict regulations and policies that need to be

considered in order to ensure that the product quality is high. In the first manufacturing steps

of a product the production is managed as a chemical plant were different ingredients get

mixed in several chemical processes. This production has a high level of automation which

places high demands on the equipments functionality. The processes need to be properly

operated, equipment needs to be calibrated and the machines need to be well maintained.

Since the value of a batch is very high, the production needs to be processed without

interruptions. The maintenance work is therefore an important issue to handle in the active

pharmaceutical ingredient (API) production.

The API unit in Sdertlje is now facing a future shutdown and some products have already

been outsourced to other manufactures. Although there will still be work for some years, due

to a forecasted increase in orders. AstraZeneca is also undergoing a rationalization process,

reducing cost and number of employees. This has affected the maintenance department

which has reduced its work force which had resulted in a need for more effective work.

Due to the situation, the maintenance work is now needed to be handled with less capacity.

In order to get a more efficient maintenance, AstraZeneca works with the Total productive

maintenance (TPM) concept but due to high utilization of the employees, the improvement

work within TPM has been constrained. The fact that API is also facing a shutdown makes it

important to work with motivating the personnel, since the motivation can suffer during these

kinds of circumstances. The maintenance engineers and the manager are highly utilized and

have therefore no time to identify improvement opportunities to make the maintenance work

more efficient or finding ways in how to motivate the employees. Due to the high utilization of

the maintenance engineers and manager this masters thesis has been initiated to

investigate these issues.

Introduction | 2

1.2 Problem definition

The high utilization of the staff has increased the importance for the maintenance workers to

perform their maintenance and calibration work more efficiently so that the time needed for

maintenance is reduced. This also places high demands on the maintenance engineers, to

plan the maintenance and calibration work in an efficient manner, so that there will be less

need for maintenance resources.

All maintenance performed at API is based on the underlying maintenance strategy of

AstraZeneca which is the Total productive maintenance. This intends to achieve a sense of

joint responsibility between the management, the operators and the maintenance workers to

run the machines as efficiently as possible and also to optimize their overall performance.

Since TPM is an important issue in the maintenance management at API, this concept will

be explored in depth in this masters thesis.

In meetings with the maintenance manager the current situation was briefed to us and he

pinpointed the fields of interest that he thought could be important to examine. A known

problem was the use of the maintenance system. For several years API have worked to get

an extended system use, but there is still some work to be done before one can consider it

as excellent. This has resulted in an insufficient amount of historical data that could be used

for analyzing and improving the maintenance performance. Related to this, there have been

several attempts to introduce new maintenance performance indicators to better measure

the maintenance work and efficiency. Due to the unavailability of adequate data this has

been hindered,

An important issue in the use of performance indicators is their interconnection to the

motivational aspect. The current set of performance indicators, are supposed to be used in

an efficient way with respect to key targets and motivation. This is not the case today. An

overview of the set of performance indicators may help solve this problem. We will dive

deeper into performance indicators and how they relate to motivation in later chapters.

In cooperation with the maintenance manager the following areas have been deemed

important to examine in this masters thesis.

The maintenance strategy, Total productive maintenance

The maintenance management and planning issues

The use of the current maintenance systems

The use of maintenance performance indicators

Motivating the employees

Within each of the topics there will be thorough research and a breakdown of the problems

posed. We will have a look at the current performance, highlighting weaknesses and put

down a proposal on how these could be improved. To give the big picture and to verify that

the proposals lead to improvements, the results from the different topics will be connected to

the TPM pyramid (a framework for measuring TPM completion). The areas of interest in this

masters thesis are showed in Figure 1:1 and this will be used to visualize the report.

Introduction | 3

Figure 1:1 The areas of interest in this masters thesis

1.3 Purpose

The purpose of this masters thesis is to examine how AstraZeneca can improve

maintenance management and work with motivational aspects in order to ameliorate the

completion of the TPM pyramid and thus increase the maintenance efficiency.

1.4 Delimitations

This masters thesis corresponds to approximately 20 weeks of work. It is focused on the

active pharmaceutical ingredient department at AstraZeneca in Snckviken, Sdertlje. Due

to the limited timeframe and the aim of the research, some parts in the study will be

delimited from this masters thesis.

AstraZenecas global organisation has launched an implementation of an ERP (Enterprise

resource planning) system. This implementation is planned to begin in Q3 (for the Swedish

part of AstraZeneca). Due to insufficient information this will not be examined further.

During the masters thesis other departments at Sdertlje will be visited. The information

from these visits will only be used as inspirational source to collect ideas and inputs on the

problems API is facing. Thus they are not going to be analysed in depth in this masters

thesis. Since the managerial aspects are in focus, details in the operational (hands on)

maintenance work will not be revised. An important issue to consider in maintenance work is

the handling and coordination of spare parts. Due to an ongoing project, aiming to

centralizing the spare part inventory, this management issue will not be covered in this

masters thesis.

Increase maintenance efficiency

Maintenance management

TPMPerformance

indicators

Use of the current maintenance

system

Integration of maintenance,

calibration and production planning

Motivation

Methodology | 4

2 Methodology

This chapter will present the methodology addressed in this masters thesis. The phases will

be described and the chapter will end with an evaluation of the sources of errors that can

occur in this masters thesis and how these have been managed.

2.1 The work process

The work in this masters thesis is performed with the following methodology, Figure 2:1. The

methodology is based on the work of Lekvall & Wahlbin (2007), but has been modified in

order to better fit this masters thesis. This method will provide guidance during the masters

thesis and ensure that the work will be well structured. The work will be carried out with the

focus on a specific object which is defined as a case study according to Lekvall & Wahlbin

(2007).

Figure 2:1 Work process, (Lekvall & Wahlbin, 2007 modified)

Basic Study

To get an overview of the subject, the work starts with a brief study of related literature in

maintenance planning, production planning and information about chemical industry.

Commonly used nomenclature and maintenance procedures and techniques were

examined.

Problem identification

When a basic knowledge of the subject is obtained a problem identification can take place.

In this masters thesis the problem is specified in some basic research areas and in this

phase the purpose of this masters thesis will be specified. It is important in an early phase of

the project to clearly define and formulate the purpose; this is to ensure that there are no

misunderstandings and differences in interpretation of the objectives (Lekvall & Wahlbin,

2007). Because the project is limited to 20 weeks naturally there must be a limited scope to

have the chance to investigate at the kind of depth that a masters thesis requires.

Basic study

Problem

identification

Field study Specify problem

Recommendation

Analysis

Conclusion

Theory

Pre

-stu

dy

Empirical study

Ana

lysis

Methodology | 5

Field Study

This phase includes the information retrieval process. The process will include both open

and semi-structured interviews, studies of internal documents, exploration of AstraZenecas

computer based systems and also to investigate working procedures and processes. The

open interviews will be carried out through conversation, based on maintenance related

problems (Befring, 1994). The semi-structured interviews will be carried out with questions

that are prepared in advance. The order of answering the questions or the correct answer in

the semi-structured interviews will be unbound (Dahmstrm, 2005) (Lekvall & Wahlbin,

2007). Open style format of the questions are aimed at letting people express their views

and ideas to the highest extent possible, because we dont want to influence their answers

by putting to narrow or specified questions in these interviews. This will result in a

description of the current situation at API including identified strengths and weaknesses

Specify problem

Based on the problem and the purpose presented in this masters thesis the field study will

provide input to and result in a more specific and more concrete problem formulation. The

level of detail will be higher which will contribute to a more focused and specific information

gathering process, in the theory phase (Lekvall & Wahlbin, 2007). In this phase both primary

and secondary data will be considered (Dahmstrm, 2005). Primary data are information that

is generated or gathered specifically for this masters thesis while secondary data are

information that not have been produced for this study (Lekvall & Wahlbin, 2007).

Theory

When the problems are identified and the areas of interest are defined, a phase of collecting

theories and information will be initiated. Scientific literature such as research reports and

books written on the subject will be read in the search for relevant information. The

methodology will be to search and try to use as up to date books and reports as possible,

which is the main principle when searching literature according to Befring (1994). The

relevant theories found will be presented in chapter 4.

Given that the data is inconclusive it renders it impossible to conduct a sound analysis, thus

more field study will be carried out in order to gather more information to support and

validate the analysis and the results. (Lekvall & Wahlbin, 2007)

Analysis

The analysis phase includes an analysis of the current situation by applying relevant

theories. This phase also includes the conclusions that can be made and how the situation

can be improved. At last the authors recommendations will be presented on how

AstraZeneca should tackle the weak points and transform the ideas to tangible solutions.

2.2 Ensuring validity and reliability

In all studies there are sources of error. According to Lekvall & Wahlbin (2007) and

Dahmstrm (2005), two commonly used terms for analysing errors are validity and reliability.

Validity is defined as the level that the measurement actually measures what it is supposed

to measure. Reliability is the accuracy of the measurement and how resistant it is against

factors of randomness. It is important that both the reliability and the validity are high to

make sure that the result is accurate and trustworthy.

Methodology | 6

In this masters thesis the field study is largely based on interviews with employees at API.

When gathering information from personnel it is always a risk that it is affected by the

interviewees own opinion, standpoint and interest. To avoid the risk that subjective

information affects the result, at least, two employees have been asked the same questions

when crucial or key information have been gathered.

We have collected information from several sources so that when building the analysis and

the results the reliability and validity of the study will be high. The questions in the interviews

have been formulated not to influence the interviewee in any particular direction. All

information gathered during interviews has also been carefully probed to avoid being too

much influenced by personal opinions.

During the literature study the theories have been interpreted by the authors of this masters

thesis expertise which can lead to a deviation from the original meaning. To reduce that this

affects the results the original article, to a large extent, has been used to avoid another

interpretation. To increase credibility in the theories old sources have been de-prioritized and

the information has been inquired with respect to this. The majority of the theories presented

are supported by several authors independent of each other which increase the validity.

The study can also be considered as objective to the extent that the authors of this masters

thesis dont have any self-interest in the outcome of this work. Since this masters thesis has

been conducted by two individuals the results can be affected by the experience and

expertise possessed. This risk has been avoided by building the analysis and results on

theories which also increases the reliability of this masters thesis.

Company description | 7

3 Company description

This chapter aims to give the reader a brief overview of AstraZeneca. First a description of

the company and its business is presented followed by the companys history. Next the API

at Snckviken will be presented.

3.1 AstraZeneca

AstraZeneca is a world class manufacturer of medicine with well-known products such as

Losec, Nexium and Seloken. It is a multinational corporation, active in over 100 countries,

employing approximately 63 000 people. The employees are distributed with 51% in Europe

and 32% in Americas and 17% in Asia. Sales in 2008 equalled $32 billion and had a net

income of $6.1 billion. With 12 000 people employed in research and development it invests

roughly $5 billion annually (2008) in R&D. (AstraZeneca, Annual Report, 2009a) After 2007 it

has conducted a major downsizing programme, reducing costs and focusing on core

business to become more competitive as a response to the changing market environment.

The focal point is changing from manufacturing to research and development as well as

employing a forward integration strategy and thus outsourcing the manufacturing to external

contractors. As a public company it is noted both on the London Stock Exchange, the New

York Stock exchange and the Stockholm OMX exchange.

3.2 History

AstraZeneca is a merger of the two big pharmaceutical companies Astra AB and Zeneca

Group plc. The merger took place in 1999 as the two companies shared many goals and

were similar in their structure. Astra AB was formed in 1913 as 400 doctors and

apothecaries joined together to form the company. In 1949 the company had a big success

when they launched the local anaesthetic Xylocain. Another big success was the 1994

marketing cooperation with Merck in launching Losec, an ulcer treatment drug.

(AstraZeneca, intranet)

The Zeneca Group PLC was formed in 1993 when the company ICI, released three of its

divisions to form the Zeneca Group. Zeneca was focused on the cancer, cardiovascular,

central nervous system, respiratory and anaesthesia domain. The similarity in sales, profit

and also in research and focal diversification made the two companies complement each

other well.

3.3 Active pharmaceutical ingredient production at Snckviken

The operations at the Snckviken plant is divided into the sub divisions; API (Active

Pharmaceutical Ingredient), Turbuhaler, Liquids and TGS (Technical Governance & Support,

as the combined maintenance support).

API manufactures the active substance and it is chemical process industry. They account for

all active pharmaceutical ingredients for internal and external demand. The finished goods

are refined to tablets, liquids used in injection and powder for inhalation. The produced

products at API are then delivered to internal customers in Sdertlje and to international

manufacturers of medicine.

Theory | 8

4 Theory

This chapter contains the theories relevant for this masters thesis. It aims at giving the

reader a theoretical viewpoint of the problem and these theories will later be applied in the

analysis. The theories presented are; Total productive maintenance, Maintenance planning,

Integrated production and maintenance planning, Maintenance performance indicators,

Maintenance system use followed by Motivational theory.

4.1 Total productive maintenance

Total Productive Maintenance (TPM) was introduced in the 1950s and laid the foundations

for the modern production philosophies. It was condensed from the North American

preventive maintenance ideas and refined by the Japanese to form TPM. (Wireman, 2004).

TPM is the foundation for the Lean concept and is the first step to be mastered if one has an

ambition to successfully incorporate the Lean production methods. The employment of TPM

is to be taken as a long term strategic journey rather than a quick menu. The idea is to gain

competitive advantage by eliminating all disruptions in the process by employing preventive

maintenance, trying to foresee possible breakdowns, logging them and involving both the

operators and the maintenance staff in preventive maintenance work. The concept might

sound simple but the difficulty lies in being disciplined following the teaching and changing

the culture of the company to implement it successfully. To be effective, all related

departments are to be involved in the new mindset. The idea of continual improvements and

involvement of all the personnel must be emphasized. When it comes to the management

support, in this way of thinking, it is no longer accepted for the manager to just dismiss an

employee having amelioration ideas. The manager needs to explain why an idea wont work.

The importance is that one wants the culture of improvement and ideas of people, in all

levels of the organisation, to gain momentum (Wireman, 2004). Total productive

maintenance has a multitude of pillars seen in Figure 4:1 which provides an overview of the

TPM pillars.

Figure 4:1 Pillars of TPM

Improving

equipment

effectiveness

Improving

maintenance

efficiency and

effectiveness

Early

equipment

management

and

maintenance

prevention

Training to

improve the

skills of all

people involved

Involving

operators

(occupants) in

routine

maintenance

Terry Wireman - TPM House

Theory | 9

Wireman (2004) chooses to focus on his five most important pillars.

1. Improving equipment effectiveness

2. Improving maintenance efficiency and effectiveness

3. Early equipment management and maintenance prevention

4. Training to improve the skills of all people involved

5. Involving operators in routine maintenance

There is not one single TPM strategy that fits every company (Wireman, 2004). Experts from

around the world agree that it is difficult to implement a cookbook-style of TPM in any

company. Factors such as the skill, age and complexity of the workforce, age of equipment,

company culture, the current status of the maintenance program, benchmarking and

measurements affect the TPM programme. In implementing TPM, Wireman (2004) outline a

procedure to go about to analyze an implementation in practice.

What are good and sound maintenance practices? There are guidelines on the way to

perform a good maintenance job and some key components are outlined beneath.

1. Preventive Maintenance Program Development

Preventive maintenance is the most important aspect of any equipment maintenance

process improvement strategy. The equipment must be preventively maintained to avoid

consequence cost that surpasses the maintenance cost.

2. Evaluate the Preventive Maintenance Program

Evaluating the preventive maintenance program insures proper coverage of the critical

equipment of the plant or facility. The program should include a good cross section of the

following:

Inspections

Adjustments

Lubrication

Proactive replacements of worn components

The program should support the goal of no unplanned equipment downtime.

1. Have a continual review if it is effective.

2. Review the maintenance stores

Inventory and purchasing must be analyzed; the equipment spares should be identified and

documented in a purchasing system. The purchasing system should be able to track the

maintenance schedules. Also the data of cost and usage of all spare parts must be complete

and accurate.

3. Are the stores effective?

The service level measures the percent of time that a part is available when requested. The

spare parts must be on hand at least 95% of the time for the stores and purchasing systems

to support equipment maintenance activities. Unless the maintenance activities are

proactive, the stores and the purchasing groups cannot be cost effective in meeting

equipment maintenance spare part demand.

4. Review the work order systems

The work order system must be designed to track all equipment maintenance activities. The

activities can be anything from inspections and adjustments to major overhauls.

Theory | 10

4.2 Maintenance planning

A modern industrial company contains a large number of technical equipment which all

interacts to achieve the business objectives. Maintenance contributes more than ever to the

achievement of these objectives. (Waeyenberg & Pintelon, 2002) The manufacturing

process demands a high level of performance, availability and reliability from the machinery

installed. This appears even more important in the chemical batch process industry where

the process time from inception to completion could last several days. (Rajan & Roylance,

2000) The value of a batch is also very high and increases during the production cycle. A

break-down during a production cycle may cause high monetary losses. The production may

need to be stopped which can lead to quality problems and in some cases it is necessary to

discard the whole batch which is very expensive since a batch value can amount to millions

of SEK. This type of production also has a high level of automation, which leads to a plant

with more maintenance workers than production workers (Noemi & William, 1994). The total

cost of maintenance could be visualized by an iceberg, Figure 4:2, where the direct

maintenance costs are the ones that are recognized by everyone and therefore taken into

account. Managers however, often forget the indirect maintenance costs, the underwater

part of the iceberg. These costs may be even larger than the maintenance cost. (Pintelon &

Gelders, 1992).

The maintenance cost differs for different kind of maintenance tasks. If a machine breaks

down the indirect costs in terms of idle production time can be very large. In planned

maintenance task this cost may be very small as it can be conducted during nights but the

Direct maintenance costs

Manpower

Materials

Tools

Overhead

Indirect maintenance costs

Equipment

Accelerated wear because of poor

maintenance

Excessive spare parts inventory

Unnecessary equipment redundancy

Production

Rework because of badly aligned

equipment

Excessive scrap and material losses

Idle workers due to breakdowns

Late shipment because of unplanned

down-time

Products

Quality and reliability issues

Lost sales because of long down-time

periods

Warranty claims from dissatisfied

customers

Figure 4:2 The maintenance total cost picture, (Pintelon & Gelders, 1992, modified)

Theory | 11

direct cost still exits. Maintenance activities can be divided into the two broad categories;

preventive and corrective maintenance (Vassiliadis & Pistikopoulos, 2001), see Figure 4:3.

Preventive maintenance

To prevent equipment from break-down one utilize preventive maintenance. It comprises

maintenance activities such as periodic inspection, prevention of deterioration and

equipment diagnosis. Preventive maintenance can further be divided into periodic

maintenance and predictive maintenance (Vassiliadis & Pistikopoulos, 2001).

Periodic maintenance may include activities such as lubrication, cleaning, parts replacement,

tightening and adjustment which are repeated in a predefined time period or amount of

machine use.

Compared to periodic maintenance, predictive maintenance is condition based. It manages

trend values by measuring and analyzing data gathered from the equipment. For instance

one could measure the vibrations in a machine and when the value falls outside an accepted

value, a maintenance work order is initiated.

Corrective maintenance

Corrective maintenance is maintenance that is carried out after equipment has failed or an

error has been detected. Some equipment is critical for the production process and these

failures need to be fixed immediately. Since the process is affected by this kind of error the

initiated work order must have the highest priority in order to get the production stop as short

as possible.

Some corrective maintenance, that dont cause stop in production or that should be

performed on non-critical equipment, can be planned for future execution. Depending on the

importance, the planned work order could be assigned with different priorities and is then to

be scheduled with the preventive maintenance work.

A facility may use all of the above mentioned policies at once. The different maintenance

policies are used depending on the characteristic of the equipment. Waeyenberg and

Pintelon, (2002) proposes a maintenance policy decision model to identify the correct

maintenance policy for a particular component, Figure 4:4.

Maintenance

Preventive

maintenance

Corrective

maintenance

Periodic

maintenance

Predictive

maintenance

Figure 4:3 Categories of maintenance

Theory | 12

In each step of the decision model there is a technical question concerning the technical

possibility. If the answer is yes, the economic implications have to be regarded.

In the first step the criticality of the equipment or component is considered and the possibility

of the run to failure policy. In the case of a critical component, first the technical issue has

to be considered. Even though equipment is critical, a failure may be easy to repair.

Secondary damage is also taken into account in the judgement. For non-critical and

technical feasibility of FBM (Failure based maintenance) the economic implication is

evaluated. The run to failure policy may be appropriate for noncritical or easily repaired

machines (Noemi & William, 1994). If FBM is not justified the question of the possibility of

DOM (Design-out maintenance) will be considered. The focus of DOM is to improve the

component or design to make maintenance easier or even eliminate it. This can be achieved

by for instance changing to more durable parts If DOM is not appropriate the decision

process look further for hidden failures. Many failures are not age related and can occur

randomly (Waeyenberg & Pintelon, 2002). However, most of these failures tend to have

given some kind of warning before they occur. The follow-up of this phenomenon is called

condition monitoring. In many cases the operators will be able to detect some irregularities

through looking, hearing, feeling and smelling, detective based maintenance. This also plays

an important role in TPM where the operators are more involved in the maintenance work. If

the cases where the symptoms are undetectable by human senses there are high-tech

monitoring devices to use. These are represented in the next step of the decision model,

CBM (Condition based maintenance). Here, one must consider the possibility of measuring

the needed data to predict a failure. Measurements can be costly which may make this

policy too expensive. This technique is gaining popularity due to the fact that it is becoming

Failure based

maintenance

Design-out

maintenance

Detective based

maintenance

Condition based

maintenance

Further

investigation

Critical? FBM? FBM?

Redesign? Redesign?

Hidden

failure? Detectable?

Condition

measurable? CBM?

Use based

maintenance

Condition

predictable? UBM?

Technical

Economic

Yes

No

(Corrective)

(Predictive)

(Periodic)

(Prevention)

Figure 4:4 Maintenance policy decision model (Waeyenberg & Pintelon, 2002)

Theory | 13

more widely available and the price for measurement equipment is decreasing. The last

option is UBM (Use based maintenance) or periodic maintenance. Here maintenance is

carried out after a predefined period of time or working hours. UBM assumes that failures

behaviour is predictable. If this option is not proper there is a need for further investigation or

reviewing the decision criteria.

4.2.1 The scheduling problem

Maintenance can be seen as a job shop scheduling problem. The complexity of maintenance

planning is though higher because of some characteristic that distinguish from other types of

scheduling (Noemi & William, 1994).

Preventive and corrective maintenance work is non-repetitive

Even if it occurs to be the same job it could differ from one execution to the next. During a

routine maintenance task, it will not be known which parts that need to be replaced or

repaired until it have been examined.

Preventive maintenance is ever-changing

A schedule cannot be assumed to remain current. The production process requires that

maintenance is responsive to the current need of production.

Preventive maintenance policies need to guard against over maintenance.

Under maintenance will become known if errors and breakdowns increase. Over

maintenance can occur if maintenance improvements have been made but the maintenance

frequency hasnt been modified to take the changes into account.

Preventive maintenance tasks have an implementation window.

Maintenance tasks dont have a rigged due date. The due dates are often specified as a

preferred time interval or preventive maintenance cycle.

Preventive maintenance tasks may be rescheduled

Maintenance task that are planned may be rescheduled early if a breakdown has occurred

making it convenient to schedule the task now instead of forcing another downtime later.

This is called opportunistic maintenance.

Preventive maintenance policies can make use of idle time in the production

schedule.

The maintenance planner will ideally schedule maintenance during the idle times in the

production schedule. However, this time may not be long enough or resources such as

maintenance worker may not be available at the correct time.

4.3 Integrated production and maintenance planning

Manufacturing, and the maintenance of manufacturing plant, is far more complex today than

a few years ago and will be even more complex in the future (Sherwin & Jonsson, 1995).

Manufacturing will be more focused on cost reduction and this will therefore require a

maintenance system that works. Author Sherwin and Jonsson (1995) state that the battles

between production and maintenance have to stop by broadening the perspective of

maintenance and integrating the two systems into a complete market-oriented system.

Theory | 14

The integration with production is important and crucial because the production and the

maintenance have a direct intertwined relationship. A break-down in a machine results in

disruption of production and thus leads to cost due to downtime, loss of production,

decrease in productivity and quality. It also leads to inefficient use of employees, equipment

and facilities (Budai et al. 2006). A good maintenance plan that is integrated with the

production plan can result in considerable cost savings (Levrat et al. 2008).

In litterateur the integration between production and maintenance planning is reviewed by

different mathematical optimization models that aim at for instance minimizing cost like the

one presented by Aghezzad et al. (2007). This model however is based on a number of

known parameters like cost for carry out corrective maintenance, cost for each preventive

maintenance task and costs associated with production. In order to implement an

optimization model and be able to use these parameters must thus be known.

4.4 Maintenance performance indicators

The efficiency and effectiveness of a system plays an important role in an organizations

success. Therefore performance needs to be measured using performance measurements.

(Parida & Kumar, 2006). Neely et al (1995) defines performance measurements as the

process of quantifying the efficiency and effectiveness of action. However measuring and

improving a feature that the customer does not value is a waste of time and resources.

(Anupindi et al. 2008)

Maintenance in discrete units factoring industry differs from maintenance in the process

industry. The differences cause a need for other performance indicators. This industry is

often a very capital intensive which makes the availability of the production unit very

important. (Arts et al. 1998)

Measurements can be divided into external and internal measurements. External

measurements are related to the external effectiveness of a process. External effectiveness

could be measurements such as customer satisfaction and fulfilment of the competitive

priorities. Service level and quality measures are often used for measuring the external

effectiveness of a company (Jonsson & Lesshammar, 1999). A manager can not directly

control customer satisfaction or financial performance. In order to meet customer

expectations and improve financial performance, a manager requires internal operational

measurers that can be controlled. These must be detailed and ultimately correlate with

product and financial performance (Anupindi et al. 2008). When knowing the external

measures expected by customers the process manager must translate them into appropriate

internal measures that affect the externals. Anupindi et al. (2008) highlights two conditions

that need to be met in order to be effective.

1. They must be linked to external measures that customers deem important.

2. They must be directly controllable by the process manager.

The performance indicators can be classified as lead or lag. A lead indicator acts as a

warning system. At the operational level it could be indicators such as vibrations and

particles in oil. These would help analyzing the condition of equipment and take early action

before failure. A lead indicator is of the statistical and non-financial type. Lagging indicators

are measures that provide the basis for studying deviations after completion. Cost of

maintenance and mean time between failures (MTBF) can be used as lagging indicators.

The performance of maintenance depends on decisions at different levels e.g. strategic,

Theory | 15

tactical and operational. The strategic level (level 1), handles decisions in centralised or

decentralised maintenance, organisational structure and level of outsourcing. Maintenance

budget for plants, skills, inventories and decision on preventive or condition based

maintenance are taken at the tactical level (level 2). The operational level (level 3)

determines maintenance intervals, inspections, repairs etcetera. A lagging performance

indicator at level 3 could relate to a leading indicator at level 1. For example; the lagging

indicator, maintenance cost per ton at operational level can be used for monitoring

maintenance cost and budget at level 2. This could control the future provision for

investment in plant maintenance, a leading indicator at level 1. (Parida & Chattopadhyay,

2007)

Criteria for measurement can be qualitative and quantitative. Quantitative measurements are

for instance downtime, number of stops etcetera. Qualitative measures include e.g.

employee satisfaction and environmental aspects. Without any formal measures of

maintenance performance the maintenance work is difficult to plan, execute and improve.

The effectiveness of maintenance and its performance needs to be measured also for the

justification of investment in maintenance. That is why a proper maintenance performance

measurement (MPM) framework is important (Parida & Chattopadhyay, 2007). Arts et al.

(1998) proposes a number of maintenance performance indicators among them the ratio of

PM which is calculated like:

This monitors the relative amount of PM done by the unit. A benchmark of the chemical

industries in Louisiana showed that 85% was an appropriate value. (Arts et al. 1998)

4.5 Computerized maintenance management system

In a modern process and manufacturing plant most of the companies use a computerized

maintenance management system to help manage the maintenance performed in the plant.

It is vital that these systems have the ability to document history events that have occurred

within the maintenance work. It is therefore necessary to have a documented work process

for gathering data that ensures that the data are collected properly. (Latino, 2004) In order to

obtain world-class maintenance, a system for data collection is required, that can handle

data related to breakdown frequency, duration of maintenance and so on. It is advantageous

to have a system that can record data in real-time which continually updates the information

in the system. (Labib, 1998).

Using a Computerised Maintenance Management System (CMMS) does not guarantee

results (Palmer, 2006), as it is only 50% of the CMMS implementations that are successful. It

is important to view the CMMS tool not only as a maintenance staff tool, but a tool for the

entire company. The CMMS is usually called an asset management system because of the

fact that the system helps with information for more than just the maintenance staff. It is

important to view the system as an information system or a tool, as it should not dictate the

maintenance strategy. Furthermore it should be a quick CMMS system (Palmer, 2006). It

should not take more than a few milliseconds to retrieve information; because all the search

time due to faulty programming of the program adds up to high costs if it stops productivity

during an extended period of time. If needed to wait for a quarter of a second or more to

retrieve information from the CMMS it might be worth it to get a faster more efficient CMMS

software suit.

Theory | 16

4.6 Motivational Theory

The motivational theory is important because it can help understand the mechanisms of

motivation. It tries to explain the route from wanting to do something all the way to tangible

action. If managed correctly motivational management can exercise tremendous leverage on

individual and organizational performance. This translates to a more productive output which

in turn saves both valuable time and money. Motivational theory is connected to

organizational theory and human resources strategy. These concepts are intertwined and

affect each other. The motivational theory is a key concept to grasp if one wants to have a

profound impact on organizational behaviour.

Intrinsic motivation is the motivation that comes from inside an individual rather than from an

outside reward (Deci E. , 1971). An intrinsically motivated individual will play the guitar or

solve a math problem simply because it provides enjoyment not because he or she is

looking to have a reward in conjunction with the activity. The activity performed is the reward

itself.

Extrinsic motivation is a motivation that comes from outside an individual (Deci & Ryan,

1985). An individual will work with an activity even though they have little interest in it,

because of an anticipated reward for performing the activity.

There are different ways in motivating people; some of them are Towards goal motivation

also known as pleasure motivation (Robbins, 1991). Away from is referred to as pain

motivation, go with the stream motivation and go against the stream motivation. Different

people are appealed by different motivational strategies, see Figure 4:5. (Robbins, 1991)

state that the majority of people are away from (or pain) motivated.

The Towards goal motivation is the if you do this thing you will have a reward type of

strategy. And the opposite is the so called Away from motivation strategy if you dont do this

there will be a punishment strategy. The two others are self explicatory; Go with the stream,

is following the law of least resistance, as with the Go against the stream needs to argue

with everyone and everything. In TPM the focus is based on the Towards goal strategy.

Different people are influenced by different strategies. The reason why a person is more

towards one square of the block can be the temperament that one is born with, but to greater

extent the way one is has been rasied.

There is almost always resistance to change and to translate this to a TPM programme the

TPM responsible has two objectives; step one is to convince the top management and the

second step is to quickly employ a secondary anchorage to the shop floor. The secondary

anchorage can be anything from information charts to a foreman that drives in the culture

Towards goal motivation

(Pleasure motivation)

Away from motivation

(Pain motivation)

Go with the stream Go against the stream

Figure 4:5 The Motivation Quadrant (Pagan, 2006) Hybrid with (Robbins, 1991)

Theory | 17

and when somebody might say it is not my problem the rest of the group replies it is their

problem and resolves it directly without bureaucracy. An organization that gives their

employees a feeling of participation will in return augment workers commitment to the task if

the organization shares its goals and also the information on how the organization is doing

relative their goals (Bowen & Lawler, 1992). The idea is to share information and create

participation and let the employees have the skills and the power to go outside their

traditional role (Bowen & Lawler, 1992). An example of this is involving operators in routine

maintenance. The secondary anchorage is to make sure that the new idea is absorbed at

the shop floor and give a feeling of commitment to the path and strategy chosen. But also

from the top to understand the importance of sharing information for commitment and

motivation and not withholding information as means of power in the organization (Wilson,

2004).

The motivational theory is about why peoples behaviours emerge, maintains and ends

(McClelland, 1955). Motivation theory states or explains why people act the way they do. He

states that a behaviour theory must contain both personal variables and external variables.

The personal variables are divided into (1) motivational variables, (2) abilities or character

based aspects and (3) cognitive variables (beliefs, values or comprehension). Opportunities

represents external variables. Both motives and values affects the behaviour. It is possible to

think that there are general human motives and that these are expressed in different ways.

McClelland (1995) differentiate between values and motives and what energizes their

behaviour.

The behaviour model, Figure 4:6, is a tool to visualize how the cognitive factors, the habits,

skills and the possibilities affects the chain from motivation to tangible action. Further

Abrahamsson and Andersen (2005) states that groups cannot be motivated, only individuals

can be motivated.

4.6.1 The theory of X and Y

The theory of X and Y was has its origins in the 1960s (McGregor, 2006). He argued that

companies employ two different types of strategies in their workforce motivation programme.

The X theory states that people are lazy by nature and needs to be yelled at by a supervisor

for things to be done. The X strategy takes an authoritarian viewpoint and comes as a

natural instinct to many people given the cause and effect nature between yell at someone

and see the results of temporary improvement (McGregor, 2006). If the manager continues

with the X strategy the moral might dry up to become bad. Even the ones that were

optimistic from the start are now ambivalent and seem to want to go nowhere. As the moral

decreases and people get sucked down into the spiral, the boss is really setting an example

and screams more at the employees. The boss can say that it was not his or her fault

because at least he did something.

Motives Actions

Cognitive

Factors (Values)

Habits

and skills Possibilities

Actions

Figure 4:6 The Behaviour Model (Abrahamsson & Andersen, 2005)

Theory | 18

The Y concept states that people are happy to work by nature and take pleasure in the

process. It is a strategy of the patient one but there are rewards to be reaped. It is a so

called towards goal theory and takes an optimistic outlook that people, given the right

support and motivation, finds their ways of fulfilling their own goals (aligned to the

organizations) or many times superseding them. The patience to let a cultural change

process has its turn, requires non-instant gratification thinking and it puts leadership skills as

well as character to the test. It is necessary for a leader to avoid to be controlling and/or to

be afraid if the process is out of control. A leader that is controlling and/or micro managerial

is effectively taking away the mandate from the employees below. A leader should be in

control but avoid being controlling.

4.6.2 Maslows theory of motivation

Maslows theory of need explains the needs of one person and it is not a theory to predict a

specific behaviour in a specific situation. Maslow divided his theory into five groups (1)

physiological needs, (2) safety needs, (3) social needs, (4) need for status and prestige and

(5) need for self actualisation into a pyramid structure of hierarchy. (Abrahamsson &

Andersen, 2005)

Maslow admits that sometimes aggregated needs gets stronger than their under aggregated

base so that in special cases for instance, safety needs, might be more important than

physiological needs. But the hierarchy of needs is the default norm as viewed in Figure 4:7.

Maslow says that the human being never gets satisfied; she always searches for something

new. In his theory we are formed less by the environment and more of internal aspects such

as personality traits. The continual search for something new is in the need for status and

prestige (4) and self actualisation (5) at the top of the box of the pyramid. (Abrahamsson &

Andersen, 2005)

Figure 4:7 Maslow's pyramid (Abrahamsson & Andersen, 2005)

Physiological needs

Safety needs

Social needs

Need for status & prestige

Self

actualisation

(5)

(4)

(3)

(2)

(1)

Unsatisfied need Motivation Action Satisfied need Finish

Unsatisfied need Motivation Action Satisfied need

Lower order needs (Social, Safety and Physiological needs)

Higher order needs (Self Actualisation & Need for status and prestige)

Figure 4:8 Motivation Loop

Theory | 19

4.6.3 McClellands motivational theory

The motivational loop describes how Maslows top two The Need For Status and Prestige

and the Self Actualization need is in a looping manner and the lower order needs are

hygiene factors that can only motivate to action if not present as seen in Figure 4:8. Lighting

conditions is an example; if the working place is well lit the need is satisfied but if bad lit it

creates a motivation to buy new lamps. When the lighting conditions improve after the action

is taken the need is satisfied and we dont think about it anymore.

McClelland stated that each individual has a need for achievement, a need for belonging

and a need for power. The three needs are mostly learned so it is possible to change them.

It is emphasized that the need for achievement, belonging and power are learned and also

more or less hidden. The effect of his theory, that the need of a person is learned, implies

that they are possible to change for the better. Neither does he claim that these needs are all

the needs that exist, but wants to highlight those that are important for his scope.

The need for achievement means a positive attitude to performing and mastering something.

A person with a strong need for achievements (1) wants to work long to make something

good or achieve something special. (2) Do something better than others. (3) Achieve or

supersede those requirements put up by what he/she has formulated in terms of quality,

performance or results. (4) To do something unique and extraordinary.

In his book (McClelland, 1955) state that a persons achievement is not only based in her

abilities, genome, skill and knowledge, but to a great extent her achievement need. That

said; a person with a big need for achievement almost always translates into great

performance. The need for achievements must be nurtured. A person with low achievement

need translates to a low effort put in and thus bad performance output as a result. By

tackling the psychological aspect of achievement need, the motivational foundation emerges

to move from low to high output. McClelland believes that there is a strong connection

between the achievement motive and economic growth (Wilson, 2004) implicit motives for

achievement needs are developed early before learning to speak and tend to be semi-

unconscious.

Theory | 20

4.6.4 Expectancy Theory

Victor Vroom published his Expectancy Theory of motivation in 1964 and it constitutes of

three parts. (1) Expectation that an effort leads to performance, (2) instrumentality, that a

performance leads to results and (3) valence measures the attractiveness of the result to the

individual, as depicted in Figure 4:9.

Expectation has to do with a persons perception of the probability that a certain effort will

lead to results. A person that does not see the connection between her effort and the results

will finally totally disconnect the motivational action chain and have no expectancy.

Instrumentality refers to the individuals perception of the probability that an effort boils

down to a certain determined result, positive or negative. If a person believes that she will

get a higher salary if she makes an effort; she demonstrates instrumentality (Abrahamsson &

Andersen, 2005).

Valence has to do with a persons perception of the value in the expected result. That would

be how much the person likes or dislikes the result that emerges from the effort. The

expectations of the relation between effort and results are multiplied with respective

valences. The valence is condensed to the question is the outcome I get of any value to

me? (Abrahamsson & Andersen, 2005)

Figure 4:9 Victor Vrooms Expectancy Theory (Abrahamsson & Andersen, 2005)

Expectation

That an effort

leads to result

Instrumentality

Expectation that

an achievement

leads to result

Valence

What value one

credit the results

EFFORT ACHIEVEMENT RESULTS

What is the probability that if I do a good job that there will be some kind of outcome in it for me?

Is the outcome I get of any value to me?

Present situation | 21

5 Present situation

A review of the current situation at AstraZeneca will be presented in this part of the masters

thesis. The text presented is chosen with respect to the areas of interest but with some

complementing areas to make it possible to get the whole picture. The information is

gathered in interviews with the employees and from studies of internal systems and

documents.

5.1 Active pharmaceutical ingredient production site

API is the abbreviation for Active Pharmaceutical Ingredient and represents the chemical

substance in medicines that affects the human body. Every pill manufactured weights a lot

more than its active component due to the fill substance. The weight of the active part is

stated on the blister and the wallet, for instance 20 mg when the pill actually weighs two

gram.

The API production is the first step of the manufacturing process and situated upstream in

the supply chain. It is a chemical factory producing large volume batches for further

processing or exporting to other of AstraZenecas international organizations. The plant

constitutes of two major factories of interest, the SYFA (Syntet fabrik) and the EFA

(Ersttningsfabrik)

SYFA was built in 1974 and it is a multipurpose chemical mixing plant capable of producing

a wide range of substances. It is being used as a back-up plant in case outsourced plants

are experiencing difficulties in their operations. The SYFA plant is currently working at about

30 % of its capacity and the spare capacity also works as a buffer for the organizations

internal demand. In SYFA there are four sections which are independent of each other. A

single section is reported taking one year to master.

The EFA is a modern state of the art installation and it is highly automated with little attention

required by its operators. The EFA is a multipurpose facility comprised in three sections.

Each one of these contains a reactor hall with four reactors. It is an eight story building with

the control room placed at the sixth level. The factory is built with a gravitational flow so the

raw materials are inserted at the top floor and the finished substance comes out at the

bottom floor.

To understand the concept of the EFA one has to view the underlying philosophy. EFA is

built around a cell philosophy of which they separate the products in separate production

facilities, inside the factory. The cell structure is to minimize the risk of cross contamination.

The production units can then be interconnected to produce different substances. Also it is

easier to perform maintenance in one cell block meanwhile production continues in the

others. A benefit with three sections with identical equipment is that the speed of

implementation and the learning process is augmented when a new substance is introduced.

To connect the different cells a manual operated jack panel is being used. This makes it

easy to clean in comparison to a more complex, automated valve. The principles of the

production flow are shown in Figure 5:1. In the reaction process substances are mixed with

solvents to start a chemical reaction in-between the ingredients. This liquid is then

processed to the next manufacturing phase, the separation process. Here the liquid is

layered, separating solvents (called mother liquid) from the product. The product is now

viscous, like milkshake, which is to be dried out so it will be a dry powder. This is done in the

Present situation | 22

drying process. At last the powder is filled to barrels and shipped to the finished goods

inventory ready for use. The powder can for instance be used in the tablets production.

It is important not to spread dust and gases from different chemical substances and

solvents, thus all chemicals are being handled in separate rooms to ensure integrity and risk

of contamination. There are rooms for the dispensing of dry commodities, for batching of dry

commodities and for dispensing liquids. Due to the fact that the rooms are dedicated for

chemical filling, they are abstemiously decorated. This is to make the rooms easy to clean

and to reduce the risk of contamination.

For the thermal processes in the EFA there are several machineries which require intensive

maintenance. The heat exchangers, pumps and condensers are all placed in separate

thermal process rooms. This does not only help the maintenance staff but also produce a

better working environment for the operators making it almost noiseless outside the

machinery rooms.

5.2 Maintenance strategy

Figure 5:2 TPM Pyramid (AstraZeneca, TPM pyrmid, 2009d)

Substance

Inventory

Solvent

Inventory

Charging

Reactor

Process

Reactor Centrifuge Dryer Filling to

Barrels

Finished Goods

Inventory

Drying Process Separation Process

Mother Liquid

Drainage

Reaction Process

API production schematics

Figure 5:1 Schematic view of the active ingredient substance production process

Present situation | 23

The maintenance department follows a pyramid structured maintenance schematics which is

based on a vision to be world class in maintenance management, Figure 5:2. At

AstraZeneca this means being green in all of the boxes in the TPM-Pyramid. It requires at

least 80% completion in a box for it to become green. The Pyramid is a blueprint on how to

manage and change the daily routines in the operational base to move upward as each box

go from red to yellow to green.

The methodology is to start in the base and move upward. The concept is derived from TPM

(Total Productive Maintenance), a sibling of the TQM concept and the continuous

improvement philosophy as explained in chapter 4.1. This is the main strategy of the

maintenance management. It is difficult to study their work and to model exactly where TPM

applies in reality but they do measure key figures in order to map how the maintenance work

is improving. The maintenance department is encouraging a cultural change where

everything is reported back in the CMMS system. They stress the fact that a job is not done

until it is also reported in as finished. This is important for the maintenance engineer to follow

up on performance.

Another issue is the cultural aspect of TPM. It comes down to what kind of motivational

strategy is being employed. One of the most important factors in the strategy is continuous

improvements by all personnel. However TPM specialist priority is to convince the top

managers first and then convince the middle managers. When he a has reached the line

managers then have the line managers convince the operators that they need for instance;

to adopt an operator maintenance mindset.

5.3 Standard operation procedures

A standard operating procedure (SOP) is the framework of the way the work is conducted.

The purpose of SOPs are to make sure that the work, in this case the maintenance work, is

conducted within the boundaries of Swedish and international law. The SOP states that the

maintenance work needs to be done with a certain degree of documentation due to the

traceability requirements in the pharmaceutical industry and in particular the Food and Drug

Administration (FDA). It starts with defining maintenance, corrective maintenance and

preventive maintenance. The definitions are important because mixing up terminology can

lead to misunderstanding and thus mishap. In the maintenance management there is a

hierarchical structure of the SOPs, Figure 5:3.

Present situation | 24

The first thing stated in the highest aggregated maintenance SOP; the Plant Registry (ANL).

To achieve control in the facility it is crucial to have an understanding of the structure and

where the equipment is located, given the 250 000 items only at the Snckviken facility. Next

there is the documentation of the items. Such documentations can be the blueprints of

facilities and machinery. The SOPs also state the handling of the machines test report. The

importance is that the work is conducted in obedience to the best practice procedure.

As the maintenance work is broken down to its components the SOPs are getting more

specific regarding facility documentations, safety, health and environment, buildings and

process equipment and control systems.

The SOPs of AstraZeneca are based on best practice procedures to ensure that the

requirements supersede both the legislative conditions imposed by authorities but also good