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Department of Science and Technology Institutionen för teknik och naturvetenskap

Examensarbete

LITH-ITN-ED-EX--05/018--SE

How to Achieve a More Efficient

Component Development at St.

Jude Medical AB - Survey and

Improvement Proposals

Louise Ehn

Malin Eklöf

(2)

LITH-ITN-ED-EX--05/018--SE

How to Achieve a More Efficient

Component Development at St.

Jude Medical AB - Survey and

Improvement Proposals

Examensarbete utfört i elektronikdesign

vid Linköpings Tekniska Högskola, Campus

Norrköping

Louise Ehn

Malin Eklöf

Handledare Linda Ahrebo

Handledare Maria Schultzberg

Examinator Carl-Magnus Erzell

(3)

Rapporttyp Report category Examensarbete B-uppsats C-uppsats D-uppsats _ ________________ Språk Language Svenska/Swedish Engelska/English _ ________________ Titel Title Författare Author Sammanfattning Abstract ISBN _____________________________________________________ ISRN _________________________________________________________________

Serietitel och serienummer ISSN

Title of series, numbering ___________________________________

Nyckelord

Keyword

Datum

Date

URL för elektronisk version

Avdelning, Institution

Division, Department

Institutionen för teknik och naturvetenskap Department of Science and Technology

2005-06-09

x

x

LITH-ITN-ED-EX--05/018--SE

How to Achieve a More Efficient Component Development at St. Jude Medical AB - Survey and Improvement Proposals

Louise Ehn, Malin Eklöf

The component development within the product development projects at St. Jude Medical AB (SJM AB*) is considered to be inefficient and is in need for improvements.

This master thesis was initiated by the Material Supply and Mechanical and Leads Development departments at SJM AB and it has been carried out between January and June, 2005.

The purpose for this master thesis is to try to find what is negatively affecting the component development at SJM AB and what needs to be done in order to make it more efficient.

The project consists of an extensive survey phase, where the problem areas negatively affecting the component development have been mapped. It started with a brainstorming session, which resulted in a substantial Ishikawa diagram, where many causes to the inefficient component development were defined. The major causes in the Ishikawa diagram were prioritized by employees within the product development projects, in order to receive information about which of these causes that were considered to be the largest bottlenecks.

In order to visualize the current flow in the component development and to map the problem areas in these flows, workshops were held with three different product development projects.

The results from the Ishikawa diagram and the reflections from the workshops were analyzed and they resulted in the continuous work for the remaining time of the project. The continuous work was decided to include the two problem areas; the Internal Component Management and the Suppliers.

The results delivered by this project are an extensive survey of the problem areas, which negatively affect the component development, a list of improvement proposals for the internal component management and a checklist, which is to be used as an aid when reviewing the design material before

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Abstract

The component development within the product development projects at St. Jude Medical AB (SJM AB*) is considered to be inefficient and is in need for improvements. This master thesis was initiated by the Material Supply and Mechanical and Leads Development departments at SJM AB and it has been carried out between January and June, 2005.

The purpose for this master thesis is to try to find what is negatively affecting the component development at SJM AB and what needs to be done in order to make it more efficient.

The project consists of an extensive survey phase, where the problem areas negatively affecting the component development have been mapped. It started with a brainstorming session, which resulted in a substantial Ishikawa diagram, where many causes to the inefficient component development were defined. The major causes in the Ishikawa diagram were prioritized by employees within the product development projects, in order to receive information about which of these causes that were considered to be the largest bottlenecks.

In order to visualize the current flow in the component development and to map the problem areas in these flows, workshops were held with three different product development projects.

The results from the Ishikawa diagram and the reflections from the workshops were analyzed and they resulted in the continuous work for the remaining time of the project. The continuous work was decided to include the two problem areas; the Internal

Component Management and the Suppliers.

The results delivered by this project are an extensive survey of the problem areas, which negatively affect the component development, a list of improvement proposals for the internal component management and a checklist, which is to be used as an aid when reviewing the design material before ordering prototype components.

The suggested improvement proposals might help decrease the lead-time for the internal component management by eliminating or making many of the steps in the flow more efficient. The checklist can positively affect the component development, since by using this checklist prior to an order of prototype components it will help to make clarity towards the suppliers as well as facilitate the internal management of the components.

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Preface

This master thesis has been a fantastic journey and a perfect closure to our degree in Master of Science in Electronic Design Engineering. We believe this assignment was perfect for us and we have come to realize which areas we want to continue working in.

We have enjoyed our time at St. Jude Medical AB and we would especially like to give an enormous thanks to our supervisors, Linda Ahrebo and Maria Schultzberg. Thank you for your support, help and encouragement throughout this whole project. You have always taken the time to give us advises, answer questions and be supportive. We want you to know how much we appreciate your support and it has been a great pleasure for us to have your assistance throughout this project.

We would also like to thank the assigners, Katarina Sköldengen and Olof Stegfeldt and all the employees at St. Jude Medical AB who have helped us with information and support. Without all of your help, this master thesis would not have been feasible.

A special thanks to our supervisor and examiner at Linköping University, Carl-Magnus Erzell, for your support and enthusiasm for this assignment.

We hope that the results from this project are of great use and inspiration for the continuous work at St. Jude Medical AB.

Our time at St. Jude Medical AB has been nothing but fun and we have enjoyed every minute of it!

Best regards

Malin Eklöf and Louise Ehn

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Index

Index ...IV

1 Introduction ... 1

1.1 Background for the master thesis... 1

1.2 The question at issue ... 1

1.3 The purpose ... 1

1.4 Objectives... 1

1.5 Restrictions ... 2

1.6 The structure of the report... 2

2 St. Jude Medical ... 3

2.1 St. Jude Medical Inc. ... 3

2.2 St. Jude Medical AB ... 4

2.2.1 History ...4

2.2.2 The Products at SJM AB ...4

2.2.2.1 The pacemaker system...5

2.2.2.2 The programmer ...6

2.2.2.3 The PSA Wand ...6

3 Theoretical Frame of Reference ... 7

3.1 Collecting Data ... 7 3.1.1 Secondary Data...7 3.1.2 Primary Data...7 3.2 Quantitative Analysis... 7 3.3 Qualitative Research... 7 3.4 Project Plan ... 8

3.4.1 Work Breakdown Structure ...8

3.4.2 Gantt Scheme...8

3.4.3 Mini Risk Assessment ...9

3.5 Brainstorming ... 9

3.6 Cause and Effect Diagram (Ishikawa Diagram) ... 9

3.7 Process Flow Chart ... 10

3.8 Interviews... 12

3.9 Prioritizing... 13

3.9.1 Multi-Voting...13

3.9.2 Other Methods for Setting Priorities...13

4 The Approach and Methods... 14

4.1 Step 1 – SJM AB and the Problem Definition ... 15

4.1.1 The Approach ...15

4.1.2 The Methods ...15

4.2 Step 2 - Design of the Project Plan ... 15

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4.2.2 The Methods ...16

4.3 Step 3 - Brainstorming Session and the Ishikawa Diagram ... 16

4.3.1 The Approach ...16

4.3.2 The Methods ...16

4.4 Step 4 - Prioritizing the Major Causes in the Ishikawa Diagram... 17

4.4.1 The Approach ...17

4.4.2 The Methods ...17

4.5 Step 5 - The Workshops and the Work Flowchart ... 18

4.5.1 The Approach ...18

4.5.2 The Methods ...18

4.6 Decision for Continuous Work in Phase 2 ... 19

4.7 Step 6 - The Internal Component Management... 19

4.7.1 The Approach ...19

4.7.2 The Methods ...19

4.8 Step 7 - The Suppliers... 20

4.8.1 The Approach ...20

4.8.2 The Methods ...20

5 Phase 1 – The Present Situation... 21

5.1 The Ishikawa Diagram ... 21

5.1.1 Suppliers ...21

5.1.2 Order and Purchase of Components ...23

5.1.3 Component Design ...25

5.1.4 Planning and Resources...28

5.1.5 Internal Component Management ...30

5.1.6 Tests and Test builds ...32

5.2 The Collected Priorities Based on the Ishikawa Diagram... 36

5.2.1 Project Managers ...37

5.2.2 Department Managers...37

5.2.3 Project Members...38

5.2.4 Total...38

5.3 The Flow and Problem Areas of the Three Projects... 39

5.3.1 Project A ...39

5.3.2 Project B ...41

5.3.3 Project C ...43

5.4 Analysis Based on the Prioritized Material and the Workshops ... 46

5.4.1 The Four Highest Ranked Alternatives...46

5.4.2 Other Alternatives...48

5.4.3 Alternatives Which Have Not Been Analyzed ...52

6 Phase 2 – The Continuous Work ... 53

6.1 Decision for Continuous Work ... 53

6.2 The Internal Component Management... 54

6.2.1 Charting a Batch of Prototype Components ...54

6.3 Improvement Proposals... 61

6.3.1 Back-and-Forth Flows ...65

6.3.1.1 The metrology engineer is the receiver of the package...65

6.3.1.2 The components to be washed ...65

6.3.1.3 After the metrology session ...66

6.3.2 Functions with Only One Activity or Step ...67

6.3.3 Highly Repeated Tasks ...68

6.3.3.1 The Machines ...68

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6.3.4 Activities or Steps not in Proximity...70

6.3.4.1 Transportation between workstations ...70

6.3.4.2 Distance between workstation and the system...71

6.3.4.3 The component engineer and the metrology laboratory ...71

6.3.5 Decisions Made at the Inappropriate Time or Place ...71

6.3.5.1 Decision about the components, prior to metrology ...71

6.3.5.2 Decision about the usage of the components after the metrology session ...72

6.3.6 Lengthy Cycle Times...72

6.3.6.1 Wait time for the component engineer to collect package ...72

6.3.6.2 The wait time for the rest of the components at the metrology laboratory ...72

6.3.6.3 The wait time for the component to harden ...73

6.3.7 Non-Value-Added Steps That Can Be Eliminated or Minimized...73

6.3.7.1 Non-value-added step 1 ...73 6.3.7.2 Non-value-added step 2 ...74 6.3.7.3 Non-value-added step 3 ...74 6.3.7.4 Non-value-added step 4 ...74 6.3.7.5 Non-value-added step 5 ...74 6.3.7.6 Non-value-added step 6 ...74 6.3.7.7 Non-value-added step 7 ...74 6.3.7.8 Non-value-added step 8 ...74 6.3.7.9 Non-value-added step 9 ...75

6.3.8 Correct Functions Involved in the Process ...75

6.4 The Suppliers... 76

6.4.1 Summary of the Conducted Interviews for Checklist Input...76

6.4.1.1 Information on the Drawing ...76

6.4.1.2 Measurements and Tolerances...77

6.4.1.3 Suppliers ...78

6.4.1.4 Metrology ...79

7 Conclusions ... 81

8 Discussion and Recommendations for Continuous Work... 82

9 Glossary ... 84

10 Literature ... 87

10.1 References ... 87

10.2 Websites... 88

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Index for Figures

Figure 1 A pulse generator ...5

Figure 2 A lead ...5

Figure 3 An implant of a pacemaker system ...5

Figure 4 A programmer ...6

Figure 5 A PSA Wand ...6

Figure 6 Boxes for the problem areas in the Ishikawa diagram...10

Figure 7 The Ishikawa diagram with causes...10

Figure 8 Symbols used in a flow chart ...11

Figure 9 Illustration of the approach. ...14

Figure 10 Major cause A’s position in appendix 1 ...21

Figure 11 Major cause B’s position in appendix 1 ...22

Figure 12 Major cause C’s position in appendix 1 ...23

Figure 13 Major cause D’s position in appendix 1 ...24

Figure 14 Major cause E’s position in appendix 1 ...24

Figure 15 Major cause F’s position in appendix 1...25

Figure 16 Major cause G’s position in appendix 1 ...25

Figure 17 Major cause H’s position in appendix 1 ...26

Figure 18 Major cause I’s position in appendix 1 ...26

Figure 19 Major cause J’s position in appendix 1 ...27

Figure 20 Major cause K’s position in appendix 1 ...28

Figure 21 Major cause L’s position in appendix 1 ...28

Figure 22 Major cause M’s position in appendix 1 ...29

Figure 23 Major cause N’s position in appendix 1 ...30

Figure 24 Major cause O’s position in appendix 1 ...31

Figure 25 Major cause P’s position in appendix 1...32

Figure 26 Major cause Q’s position in appendix 1 ...32

Figure 27 Major cause R’s position in appendix 1 ...33

Figure 28 Major cause S’s position in appendix 1...33

Figure 29 Major cause T’s position in appendix 1 ...34

Figure 30 Major cause U’s position in appendix 1 ...35

Figure 31 Major cause V’s position in appendix 1 ...35

Figure 32 The Project Managers’ priorities...37

Figure 33 The Department Managers’ priorities ...37

Figure 34 The Project Members’ priorities...38

Figure 35 The total priorities ...38

Figure 36 The goods reception bay ...54

Figure 37 Preparations...55

Figure 38 Pin gauges ...56

Figure 39 The shadow graph ...56

Figure 40 The laser indicator...57

Figure 41 The surface controlling machine ...57

Figure 42 The chemistry laboratory ...58

Figure 43 The Supra machine...59

Figure 44 The component engineer's office...60

Figure 45 Current process flow ...61

Figure 46 Alternative process flow 1.1...62

Figure 47 Alternative process flow 1.2...63

Figure 48 Alternative process flow 2.1...64

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Index for Appendices

Appendix 1 The Ishikawa Diagram

Appendix 2.1 - 2.3 Project A – Process Chart

Appendix 3.1 – 3.3 Project B – Process Chart

Appendix 4.1 – 4.2 Project C – Process Chart

Appendix 5 Summary of the Improvement Proposals for the

Internal Component Management

Appendix 6 Interview Questions

Appendix 7 A Checklist for Reviewing Design Material Before an

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1

Introduction

The following chapter will give a description of the background as well as the purpose, objectives, restrictions and disposition of this master thesis.

1 Introduction

1.1 Background for the master thesis

SJM AB develops new products which often imply that new or updated components are needed. The component development within these new product development projects is complex and it is not considered to be as efficient as possible. Therefore, there is a need for mapping the improvement areas and sort out the most prioritized areas to go further with.

By mapping the problem areas within the component development and improving them, the work within the projects will be more efficient.

The authors’ background for this master thesis is courses such as Electronics Manufacturing Methods and Processes, Project Management and Group Dynamics, Product Development, and Quality Control and Development.

1.2 The question at issue

Which are the main aspects negatively affecting the component development and what can to be done to make the component development more efficient?

1.3 The purpose

The purpose of this project is to try to find what is negatively affecting the component development and what needs to be done in order to make it more efficient.

1.4 Objectives

The objectives for this project are to provide SJM AB with proposals of improvements for the component development. These improvement proposals will be the result from an extensive survey where the component development within the product development projects will be mapped, which, in itself, is a result as well.

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1.5 Restrictions

The component development starts when there is an order for a new product, in which the component will be a part, and it ends when the component has been qualified and verified within the product.

As a result from the survey phase, the restriction for the continuous work is the problem areas which include the Internal Component Management and the Suppliers. In the problem area, which includes the suppliers, the focus is on the components when they are early prototypes.

There has not been taken any consideration to financial aspects during the analysis.

1.6 The structure of the report

Chapter 1 This chapter describes the background for the project, the problem to be solved, the purpose, objectives and the restrictions.

Chapter 2 A description of SJM and some of its products is given in this chapter.

Chapter 3 Here, the reader can find the theoretical frame of reference where all the tools and techniques, which have been used in this project, are described.

Chapter 4 This chapter includes the approach and the methods for the work

throughout the course of this thesis and each step towards the objectives, is presented.

Chapter 5 In this chapter, there is a description of the current state at SJM AB in terms of component development. It is described according to the survey made during the first half of this project. The chapter also contains the authors’ analysis of the present situation with respect to the priorities done on the Ishikawa diagram and the flows and problem areas described during the workshops.

Chapter 6 The continuous work is described in this chapter and contains the problem areas involving the Internal Component Management and the Suppliers.

Chapter 7 The authors’ conclusions are presented in this chapter.

Chapter 8 Discussions about the result can be seen in this chapter, together with the authors’ recommendations for continuous work for SJM AB in order to receive a more efficient component development.

Chapter 9 The chapter contains a list of glossaries for words, expressions and

abbreviations which are in need for explanation. The first time they are mentioned in the report, they are marked with *.

Chapter 10 The last chapter lists the references used in the report.

Some of the appendices in this report are written in Swedish, since many of them are results from brainstorming sessions, workshops and interviews, which were held with the Swedish personnel at SJM AB.

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2

St. Jude Medical

A description of St. Jude Medical and some of the products will be described in this chapter. Focus will be on St. Jude Medical AB and the products being developed in Veddesta, Sweden.

Key words: St. Jude Medical AB, St. Jude Medical Inc, Pacemaker, Lead, Programmer,

PSA Wand

2 St. Jude Medical

2.1 St. Jude Medical Inc.

SJM is one of the worlds leading companies within the area of medical technology. They manufacture mechanical and tissue heart valves, pacemakers, implantable cardioverter defibrillators and electrophysiology catheters. SJM has almost 7900 employees around the world (2005) and the main office is located in St. Paul, Minnesota, USA. [2]

The main areas where SJM is geographically located are USA, Western Europe, Brazil, Japan and Canada [Verksamhetsguiden St. Jude Medical AB, 2004].

The group is divided into six units; Cardiac Rhythm Management Division, Atrial Fibrillation Division, Cardiology Division, Cardiac Surgery Division, St. Jude Medical US Division and St. Jude Medical International Division. The six divisions will be described in short below:

• Cardiac Rhythm Management Division (CRMD*) contains new cardiac resynchronization therapy devices for heart failure implantable cardioverter defibrillators (ICDs), advanced pacemakers and a wide range of diagnostic and therapeutic electrophysiology catheters to treat cardiac arrhythmias.

• Atrial Fibrillation Division (AFD*) develops products to diagnose, treat and seek a cure for atrial fibrillation. This division was established in 2005 and includes catheters offering approaches for managing Atrial Fibrillation and a proprietary surgical ablation device using High Intensity Focused Ultrasound (HIFU) energy.

• Cardiology Division was established in 2005 to offer innovative products and technologies for cardiovascular catheterizations

• Cardiac Surgery Division (CSD*) develops and manufactures mechanical heart valve, tissue valves and heart valve repair products.

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• St. Jude Medical US Division contains more than 900 sales and technical representatives to sell the clinical and cost-effective benefits of the entire SJM product and services portfolio.

• St. Jude Medical International Division’s team sells the entire SJM product line in over 130 countries worldwide. [2]

2.2 St. Jude Medical AB

SJM AB is located in Veddesta, outside of Stockholm, and is part of the Cardiac Rhythm Management Division (CRMD). At SJM AB there are approximately 570 people (2004) working with research, development, manufacturing and distribution of pacemaker systems such as pacemakers, programmers and leads. [Verksamhetsguiden St. Jude Medical AB, 2004]

2.2.1 History

SJM AB has its roots in a Swedish company that developed the first implantable pacemaker in 1958. The inventor was Dr. Rune Elmqvist (1906–1996) and the surgeon was Åke Senning (1915–2000). It was implanted on October 8th, 1958 at Karolinska Sjukhuset in Stockholm. The patient, Arne H. W. Larsson lived with 26 different pacemakers for 43 years. The company was purchased by the company Siemens and became Siemens-Elema. SJM later united with the American Pacesetter Inc. which had its origin in the space industry. In 1994, SJM AB became a part of one of the world leading companies in medical technology, SJM Inc. [1]

The world’s smallest pacemaker was introduced by SJM in 1995. [1] 2.2.2 The Products at SJM AB

As mentioned earlier the main products developed at SJM AB are included in the pacemaker system such as pulse generators* (pacemakers), programmers and pacing leads. [Verksamhetsguiden St. Jude Medical AB, 2004]

These products are complex and need to be adjusted individually according to the patient. The pacemaker system has the aim to supervise the activities in the heart and make sure that it beats just as fast as necessary.

Damage or illness may develop in the cardiac conduction system which could lead to various functional defects. These defects are referred to as arrhythmias and can be divided into two parts:

• Brady arrhythmia* (when the cardiac function proceeds more slowly than usual)

• Tachyarrhythmia* (when the heart operates more rapidly than normal) Both of these arrhythmias contribute to the body having difficulties keeping up, since the oxygen is not transported out of the body as it is supposed to. In the case of Brady arrhythmia, a pacemaker system is used to help the heart find the right rhythm.

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The tachyarrhythmia is helped by an Implantable Cardioverter Defibrillator, ICD. [Lindgren and Jansson, 1992]

2.2.2.1 The pacemaker system

The part of the pacemaker system that emits the stimulations pulses is called the pulse generator and can be seen in figure 1.

Figure 1 A pulse generator [2]

The lead is the part which transmits the stimulation pulses to the body tissue (figure 2). A pulse generator and lead(s) are jointly referred to as a pacemaker system.

Figure 2 A lead [2]

An implant of a pacemaker system is a simple procedure and the patient can often leave the hospital on the day of the surgery. During the implant one or more leads are put into the heart via the vessel system trough a vein. The pacemaker is then placed under the skin right beneath the collar bone and the lead(s) is connected to the pacemaker (figure 3).

It is the leads that are conducting the electrical impulses from the pacemaker to the heart and it also brings information back from the heart to the pacemaker.

Figure 3 An implant of a pacemaker system [Lindgren and Jansson, 1992]

The pacemaker waits until its function is needed and when it is active it has to sense if the patient is resting or performing a physical activity since the frequency of the pulses is adjusted according to those factors. [Lindgren and Jansson, 1992]

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2.2.2.2 The programmer

An implanted pacemaker system has to be tested periodically. A checkup test controls if the pacemaker is sensing and stimulating the heart correctly, if the remaining battery capacity is enough and also assures that no infections have developed around the implanted pacemaker system.

Figure 4 A programmer [2]

To be able to communicate with the pacemaker system, a programmer is needed (figure 4). It is used for the transferring of information to and from the pacemaker and is done through telemetry technique. The programming head is placed on the skin right above the implanted pulse generator for the best possible telemetric contact. [2]

2.2.2.3 The PSA Wand

Electrical tests at implant are performed with the help of a Pacing System Analyzer, PSA (figure 5). The PSA is a threshold analyzer and it operates like a pulse generator, whose essential parameters are all variable. [2]

Figure 5 A PSA Wand [2]

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3

Theoretical Frame of Reference

Presented in this chapter is the theoretical frame of reference that the authors have studied for their master thesis. Some of the tools and techniques are used at St. Jude Medical AB, in their work to improve the quality.

Key words: Brainstorming, Ishikawa diagram, Project Plan, Process Flow chart,

Prioritizing, Interviews, Collecting Data, Quantitative Analysis, Qualitative Research

3 Theoretical Frame of Reference

3.1 Collecting Data

Walliman [2004] believes that no matter what subject to be studied, collecting

secondary data will be a must. Collecting primary data is a more subjective form of data collection.

3.1.1 Secondary Data

All subjects require secondary data and come in the form of literary sources, such as histories and letters, and can be quantitative or qualitative in nature. Some of the principal sources to find secondary data are: the library, archives, and the Internet. 3.1.2 Primary Data

Collecting primary data entails going out and collecting data by observing, recording and measuring the activities and ideas of real people or inspecting objects and experiencing events. [Walliman, 2004]

3.2 Quantitative Analysis

A quantitative analysis deals with numbers and uses mathematical operations to investigate the properties of data. The most straightforward process to describe data is in the form of tables, graphs and diagrams. This will order and display the data in a compact form so that one can make comparisons, detect trends and measure amounts and combinations of amounts. These tables and graphs need to be explained in order for the reader to know how to interpret them. [Walliman, 2004]

3.3 Qualitative Research

When ones research does not involve counting and dealing with numbers but contains information expressed in words based on opinions and descriptions, it can be considered a qualitative research. When doing a research it is not always a process where every

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step is completed before the next one begins. In the qualitative research there is often a need to go back and reconsider former made decisions or re-edit and elaborate the work. This is because one gains more knowledge and has obtained more skills during the project, which will be enriching for the research.

Often, it is not possible to determine the correct data since the process is not sufficiently described. Collecting data in periods and analyzing it provides direction to further data collection. This approach of reiteration and interpretation is a distinguishing feature of the qualitative research.

In a qualitative research the analysis of data is carried out continuously throughout the project, concurrently with more collection of data. [Walliman 2004]

3.4 Project Plan

Nordberg [2000] describes a project plan as just as an important tool for the participants in the projects as the map is for the orienteer. The project plan should be written for several reasons:

• To create a clarity about what the project will bring about;

• So that everyone involved in the project have the same starting point.

• It will be a document for decision with information for the stakeholders of the project.

• It is a description of the work and it contains a time schedule. • Gives a basis for future reports.

The project plan aims to give the authors and the project, the best conditions to reach the final goal of the project.

A project plan should contain the following parts; 1. Foreword

2. Introduction, purpose, objectives and restrictions 3. Method and means

4. Organization and time plan

5. Information about the presentation of the material 3.4.1 Work Breakdown Structure

According to Wenell [2002] the project structure is the basis and the frame for the project. There are some different types of structures, and the most common one is the Work Breakdown Structure (WBS*). The work structure gives a basis for the planning of the project that is soon to come. The structure should be unbiased in terms of time and flow which gives a freer and more creative picture of the project. The work breakdown structure can be illustrated in a structure matrix. [Wenell, 2002]

3.4.2 Gantt Scheme

A type of time plan that can be used is the Gantt scheme, where the activities and points of time are indicated. It indicates start time, follow-up points and the carrying out time for each activity compared to the fixed plan. [Nordberg, 2000]

The Gantt scheme is often based on the WBS.

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3.4.3 Mini Risk Assessment

In the beginning of each project one should always ask oneself what can go wrong during the project. A mini risk assessment is a useful tool to use when mapping the possible causes for trouble in the project.

1. List the possible occurrences that might complicate the work. 2. List possible consequences for each of these occurrences.

3. Make a total valuation of these occurrences by setting a number; small effect 1 2 3 4 5 large effect

4. Estimate the probability for each occurrence to occur by setting a number: small probability 1 2 3 4 5 large probability

5. Multiply the valuations.

There should be a plan for each risk occurrence, in case they occur. [Olsson, 2001]

3.5 Brainstorming

Gitlow et al. describe in the book Tools and Methods for the Improvement of Quality [1989] different techniques that can be useful when an organization wants to improve and stabilize a process. One of these methods is brainstorming which generates a large number of ideas from a group in a short period of time. Together as a group the members elicit ideas and thoughts. Brainstorming can be used for determining problems, to find causes for a problem, to find solutions for a problem and to find ways to implement solutions.

When used correctly, brainstorming encourages creativity and “out of the box” thinking. A common way to use brainstorming is in conjunction with Cause and Effect diagrams and Affinity diagrams. There are two types of brainstorming; structured brainstorming and unstructured brainstorming.

Structured brainstorming maximizes the participation and tends to generate more ideas since each participant, in turn, presents an idea. In contrary to the unstructured brainstorming where the ideas can be given at any time by anyone without following a structured rotation, this type is quicker to use. The two types can be combined as well. [Adams et al., 2004]

According to Gitlow et al. [1989] an effective brainstorming should be structured. They also believe that the composition of the group should depend on the issue being discussed and that it should include a variety of people. The leader of the group should be experienced in brainstorming and should keep the group focused, prevent distractions, keep ideas flowing and record the outputs.

3.6 Cause and Effect Diagram (Ishikawa Diagram)

According to Kiemele et al. [2000] certain causes of poor quality must be identified and corrected. For this purpose there is a very useful tool which identifies displays and examines the causes of any condition observed. This tool is named the Cause and Effect Diagram, also called the Ishikawa diagram after Dr. K Ishikawa of the University of Tokyo. He was the first to formalize its use in the 1940s. The Ishikawa diagram also goes under the name Fishbone diagram, an obvious name from its structure.

The tool is effective to use when a team wants to find the root cause of a chosen problem or effect [Kanji and Asher, 1996]. This problem or effect should be placed at

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the head of the diagram. By using brainstorming and the experience of knowledgeable people several major problem areas can be generated that affect the problem. These problem areas are then placed in boxes in the diagram as shown in figure 6.

Figure 6 Boxes for the problem areas in the Ishikawa diagram

This helps the team to focus on subsets of variables instead of all possible variables at the same time. When all the major problem areas are identified the team should identify the causes to each class. These causes should be drawn horizontally into the major class as seen in figure 7.

Figure 7 The Ishikawa diagram with causes

Ideally the diagram should display every possible cause that could affect the problem or effect. [Kiemele et al. 2000]

Bergman and Klevsjö [1991] consider the Cause and Effect diagram to be an excellent basis for the continuing problem solving and the diagram can often point out probable causes for the observed problem or effect. Sometimes the Cause and Effect diagram could indicate where a greater basis of data is needed and how these data should be collected.

3.7 Process Flow Chart

A process flow chart is a pictorial representation of all the major operations or activities and decisions in a process. By breaking the process down into simple visual steps it improves the understanding of the process. This is done to facilitate the identification of the problem areas and also the improvement possibilities. A process flow chart should be used when analyzing the current state before commission for improvement proposals and can describe the flow of material, information or knowledge. It is important that every operation of the process is captured during the process survey. Since the aim of the process flow chart is to facilitate the understanding of the process, the use of fewer

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and less complicated symbols are recommended as shown in figure 8. [Adams et al., 2004]

Figure 8 Symbols used in a flow chart [Adams et al., 2004]

The completed flow chart can provide important information about the process. This information can be useful and help the manager, design engineer, analyst or anyone else who wants to understand, modify or improve the process. By indicating the strong and weak points in the flow chart, the finding of opportunities to improve the process has begun. [Gitlow et al., 1989]

Adams et al. [2004] shows in Lean Six Sigma: A Tools Guide that a process flow chart can be drawn vertically as well as horizontally.

Cassidy and Guggenberger [2001] state a range of analysis points to consider when reviewing a flowchart and indicate improvements that should be made. These points are:

! Are there back-and-forth flows?

One of the most common characteristics of poor process flow is the tendency to bounce back and forth between one person or function and another. To address these back-and-forth flows it is necessary to redefine work responsibilities, integrate tasks under the same function and blend or eliminate activities altogether.

! Are there functions with only one activity or step?

This is when one person or function does only one single activity or step and is another characteristic of a poor process. Solutions to functions that have only one step involve training individuals with more involvement in the process to take on the single step activity, validate the need for approvals and authorizations, and reposition equipment and assets underneath functions with greater roles in the process. Eliminating single activity functions will help streamline the process and prevent delay.

! Are there highly repeated tasks?

Highly repeated tasks are a sign that the process needs to change. The sources of the repeated tasks are often quality issues that require steps of the process to be redone or additional information and work that is needed each time throughout the step. These can be addressed by modifying the job function, step, or process and eliminate the need for repetition.

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! Are there activities or steps not in proximity?

When people or functions are in proximity with each other, they relate in a more effective and efficient manner. Often the constraints of buildings and surroundings, the location of people participating in the process, or the dependency on stationary equipment prevent the process steps from being in proximity. These can be addressed by moving people or functions involved in a process closer together, shift activities and steps or reposition the hardware. ! Are decisions being made at the inappropriate time or place?

There are often a few critical decision points within a process and it is important to locate those decision points in order to ensure that they are being made at the appropriate time or place. During an analysis the need for each decision and who should be making that decision should be considered.

! Are there lengthy cycle times?

Consideration to the process cycle time need to be taken into consideration when analyzing the process. Process delay, excessive steps, or a lack of a cycle time focus and measurements can cause a lengthy cycle time. It is necessary to reduce or eliminate wait times either before or after each step or activity, shorten the process, have a defined start and stop, or implement a measure that demonstrates the importance of cycle time.

! Are there non-value-added steps that can be eliminated or minimized? Identifying the wasted steps (such as delays, transportation problems, and quality errors) is important and eliminating them from the process will lead to increased process performance.

! Are there correct functions involved in the process?

The people involved in the process may not be necessary and it is important to question who or what functions are involved in the process. Questions should be posed that challenge what functions or people are involved. [Cassidy & Guggenberger, 2001]

3.8 Interviews

Interviews are an indirect method to collect information, which means taking part of observations already done by someone else [Ekholm and Fransson, 1979].

An interview is a very flexible tool and is a useful method of obtaining information and opinions from experts in an early stage in the project. It is especially useful when qualitative data is wanted. [Walliman, 2004]

According to Ekholm and Fransson [1979] the interviewer is only controlled by a roughly understanding of what kind of areas to touch and the respondent is free to formulate the answers to the questions in the way he or she wants to. This method can be very useful when just getting to know a new area and gives increased opportunities to enter deeper into the areas that seem more interesting. Since the respondent gives his

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or hers personal opinion, these subjective element of the interview needs to be taken into account in the interpretation of the information gathered during the interview.

Trost [2005] explains that there are two different types of methods for interviews; quantitative and qualitative interviews. If the question concerns how often, how many or how common one should use a quantitative study. On the other hand if the problem concerns the ability to understand or to find patterns one should perform a qualitative study instead.

Depending on the information one wish to receive from the interview there are different approaches [Walliman, 2004]:

1. A structured interview is useful when one want very precise answers to very precise questions. This form of interview is tightly structured with closed questions and is similar to a questionnaire. 2. An open interview is the opposite of the structured one. It is used if

one wants to explore information that one can not foresee. This is an unstructured form of interview.

3. Semi-structured is a combination of the open and the structured forms of interviews. With this technique one can achieve answers to defined questions as well as include more open-ended questions.

Trost [2005] also talks about standardization and by standardization he is referring to the extent, that the questions asked and the situation for all respondents, are the same.

According to Ekholm and Fransson [1979] it is important that the interviewer is well prepared and is clear of his or hers responsibilities. The interviewer should inform the respondent what the purpose of the interview is, motivate the respondent to reveal the information that is asked for, ask questions and follow up the answers. It is also important to register relevant information and systemize as well as analyze the received information.

3.9 Prioritizing

3.9.1 Multi-Voting

Multi-voting helps prioritizing a large list of items, separate the “vital few” from the “trivial many” and gain group consensus. This is done by giving the group members a number of votes that is equal to half the number of alternatives on the list. The members vote individually and place the vote next to the item on the list. Then select the top four to six items (depending on the size of the list) and discuss these and prioritize again. [Adams et al., 2004]

3.9.2 Other Methods for Setting Priorities

A method that is described in Facilitator Tool Kit – Office of Quality Improvement [3] is similar to the multi-voting. The difference is that each of the members in the group receives 10 votes. They should use all the votes but not place more than 4 votes on one item on the list. This means that 4 votes placed on one single item would indicate their top priority. Some items might not receive any votes. (For instance, a priority could be: 4 2 2 (=10 votes) where votes have been placed on three alternatives

or

3 3 2 1 1 (=10 votes), where votes have been placed on five alternatives)

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4

The Approach and Methods

The chapter will present the different steps of the approach and the methods used in each step throughout the project. The project has been divided into two phases where the results from the first phase were the basis for the continuing work in phase two.

Key words: Phase 1, Phase 2, Step 1 – Step 7, Approach, Method

4 The Approach and Methods

The first phase (Phase 1) of this project included an extensive survey of the present situation at SJM AB in order to identify and prioritize the problem areas affecting the component development. An analysis based on this extensive survey was conducted and in a half time presentation, recommendations were given for the continuous work in Phase 2. A decision was taken to continue with the two problem areas that contained the Suppliers and the Internal component development in Phase 2. Based on that decision, the authors made a mapping of the flow within the internal component management, which resulted in a list of improvements proposals. In addition, a checklist was designed with the purpose to facilitate the review of the design material when ordering prototype components.

The approach is illustrated below, in figure 9.

Figure 9 Illustration of the approach.

The approach of this project is not according to a specific theoretical method, since the main analyze of the project was conducted between Phase 1 and Phase 2 and smaller

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analyzes have been performed in the seven steps. The authors consider this project to be a qualitative research, where the collecting data of feelings, descriptions and opinions have been analyzed continuously in order to provide further directions for data collection.

The authors have chosen to divide this project into seven steps. Steps 1-5 are performed in the first phase of the project - the present situation at SJM AB.

Steps 6-7 are performed in the second phase of the project– the continuous work. The main analysis in this project was implemented after the first phase since the second phase was based on this analysis.

The approach and the methods used in each of the seven steps are discussed below and the theory behind these methods is described in chapter 3.

4.1 Step 1 – SJM AB and the Problem Definition

4.1.1 The Approach

In the first step, the authors received a better understanding for the purpose of the project and were getting to know the company and some of its employees. This was valuable since the project would require contacts with the employees within the product development projects, the metrology laboratory and other functions and departments. The authors received tours in the metrology laboratory, the lead production as well as in the pace production for a better understanding of the products and the daily line activity. Moreover, the authors studied internal documents and procedures in order to understand the structure of SJM.

During this step, useful literature was studied, to receive a deeper knowledge for the continuous approach in order to solve the issue.

4.1.2 The Methods

Collection of Secondary Data

The authors have studied internal documents from the intranet such as QPR process

guide, SRO procedures and Lessons learned* reports as well as literature about tools

and techniques for quality and process improvement.

Collection of Primary Data

To get a better understanding for which functions the employees at SJM AB had, open interviews with design engineers, component engineers, material engineers and metrology engineers within the product development projects were held.

4.2 Step 2 - Design of the Project Plan

4.2.1 The Approach

When the authors had a better understanding for the purpose of the project, a project plan was designed. The purpose with the project plan was to clear the purpose and the objectives with the project and to design a time plan. With the help of the project plan, the project could be divided into sections, which made it easier to chart the approach.

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The project plan answered the questions; what to do, how to do it and when to do it. The project plan was written to facilitate the work but was also a compendium of information for the assigners in order to update them on the upcoming activities.

4.2.2 The Methods Project Plan

A WBS was designed to divide the project into smaller activities.

A Gantt scheme was implemented in order to receive an efficient time approach for the continuing work. All the activities and points of time for the project were indicated in the Gantt scheme.

To map the possible problems and causes for problems that might appear during the project, a mini risk assessment was made. The possible causes were technical issues, personal issues and other issues concerning time, availability and misunderstandings.

The methods used were chosen since they were familiar methods for the authors from courses at the university and the authors have used these methods in earlier projects. A literature study was made before the project plan was written, where appropriate methods were found.

4.3 Step 3 - Brainstorming Session and the Ishikawa Diagram

4.3.1 The Approach

The authors began the third step by arranging a brainstorming session with the purpose to identify causes to why the component development process at SJM AB is inefficient. The brainstorming session included appropriate employees and functions, provided by the authors’ supervisors. The causes identified during the brainstorming session were summarized in an Ishikawa diagram in order to visualize it in a comprehensible way. 4.3.2 The Methods

Brainstorming

In order to receive as many causes as possible from many different points of view on why the component development is inefficient, a brainstorming session was arranged with fourteen representatives from some of the product development projects. Since the people within the projects experience the issue differently, the authors wanted the people to think outside the box and generate new ideas and new ways of seeing things.

In the first step of the brainstorming, each participant was asked to find the major problem areas for the inefficient component development. The results were summarized into six areas. In the next step, the participants were divided into four groups where each group was allotted two of the problem areas. On the basis of these categories they answered the question “Why is the component development at SJM AB inefficient?”

Ishikawa Diagram

A tool was needed in order to organize the result from the brainstorming session and to gather the causes connected to the different categories. The information needed to be structured, clear and consequent, and consideration had to be taken to the people who did not attend the brainstorming session and were to be included in the prioritizing of

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the major causes. The authors choose to arrange the information in an Ishikawa diagram since it is a tool that makes it easy to see the relationship between the causes of the problem and to find the root causes of the issue. Consequently, the Ishikawa diagram is a useful tool in order to identify which of the major cause contributing to the largest bottlenecks in the component development at SJM AB.

4.4 Step 4 - Prioritizing the Major Causes in the Ishikawa

Diagram

4.4.1 The Approach

When the information in the Ishikawa diagram had been clarified, a prioritizing of the major causes in the diagram was conducted. The selected participants in the prioritizing were employees who had attended the brainstorming session as well as others involved in the product development projects. The prioritizing gave a better understanding for which of the causes were considered most important and the largest bottlenecks.

The authors e-mailed the participants detailed information about how the prioritizing was supposed to be performed and attached the completed Ishikawa diagram, which was the base for the prioritizing. The participants were asked to vote with respect to their role within the projects. There were three different categories of roles;

! Project Managers ! Project Members ! Department Managers

The three different roles were taken into consideration when collecting the data, in order to see if there was a variance in priorities between the groups.

By involving the participants in the prioritizing, they were given a chance to contribute with their personal view on the component development. The collected priorities were managed anonymously.

An analysis was performed in order to find which of the major causes that were considered to be the main bottlenecks in the inefficient component development.

4.4.2 The Methods Prioritizing

The technique chosen for prioritizing had to be intended for a large number of issues. The technique also had to be easy and not be a time-consuming activity, since the participants would receive the instructions for the priority via e-mail. The authors chose a method for setting prioritizes, similar to the multi-voting (see in chapter 3). This alternative method was easy to describe in an e-mail, it would not take too long and it was not considered to be too controlled. The authors found multi-voting to be too controlled, since the participants had to rank the chosen causes in a descending order. In this particular case half the number of alternatives would give the participants too many votes and by using this technique, the priority would take time.

There was a total of twenty two alternatives to choose from, numbered from A to V. These letters represented the twenty two major causes identified during the brainstorming and visualized in the Ishikawa diagram (appendix 1). It would be easier

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to prioritize on the basis of the major causes prior to their root causes, since all these major causes have many root causes. The prioritized material would be difficult to handle if it was based on the root causes. However, the participant could consider the root causes when selecting among the major causes to prioritize. All participants were given ten votes to distribute on the different major causes. They could place their votes in any way they wanted to, with only one restriction; they could only place a maximum of four votes on one major cause.

The more votes a major cause received, the higher the priority was. Because of the restriction, the highest votes a major cause could receive were four.

Quantitative Analysis

The data from the prioritizing was arranged in different tables and was analyzed quantitatively since the authors considered this method to be the best way to illustrate the prioritized material.

4.5 Step 5 - The Workshops and the Work Flowchart

4.5.1 The Approach

In the fifth step, the authors arranged for workshops with three different product development projects; Project A, Project B, and Project C, together with support from the Continuous Improvements department. The three projects were chosen since they have developed different types of products. Suitable representatives from the three projects attended the workshops where the flow of the work and the problem areas in each project were charted. The purpose of charting the work flow was to receive a better understanding for how the flows differed between the projects and where in the flow that the major causes from the Ishikawa diagram appeared. Moreover, other problems that had appeared in the projects, which were not identified in the Ishikawa diagram, were also identified during these workshops.

The workflow of these three product development projects, were visualized in Microsoft Visio and were reviewed and analyzed.

4.5.2 The Methods Process Flow Chart

The authors choose to visualize the flows of the component development in the three projects in process flowcharts in order to receive a better understanding for in which way these flows differed from one another. The major causes from the Ishikawa diagram, if they had occurred, were also mapped in these flows. Process flow charts are considered an efficient tool to use when the flow of projects will be mapped. In order to receive a wide input from the projects, representatives from the relevant roles in the projects attended the workshops.

1. In the first step the functions in the project that had been involved in the component development were identified.

2. In step two the flowchart was created by identifying the activities conducted throughout the projects.

3. In step three the flow of information between the different activities was found.

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4. In step four the amount of time each of the activities had taken was set.

5. In step five the problems which had occurred in the activities throughout the component development were identified. These problems were identified in flow on the basis of the Ishikawa diagram as well as other problems which had occurred.

The flowchart gave a good idea on how the work had proceeded during these three product development projects.

4.6 Decision for Continuous Work in Phase 2

A halftime presentation was held where the authors made recommendations for suitable categories for the continuous work in the next phase of the project, Phase 2. The recommendations were based on the analysis made on the priorities of the Ishikawa diagram and the reflections from the flowcharts mapped in Phase 1. The authors, the supervisors and the assigners at SJM AB as well as the supervisor at Linköpings University, discussed the recommendations and decided which problem areas to continue working with. The objectives for Phase 2 became to design a list of improvements proposals concerning the internal component management and a checklist to facilitate the review of the design material and input when ordering prototype components.

4.7 Step 6 - The Internal Component Management

4.7.1 The Approach

The objective for the internal component management was to design a list of improvement proposals with the purpose to decrease the lead-time for the components from their arrival to SJM AB until they can be used in a test build*.

The authors made a study where they followed a batch with prototype components from their arrival to SJM AB (the goods reception bay) until they could be used in a test build. This was done to be able to chart the flow of the components and in order to see if there were any unnecessary activities performed which could be eliminated or, if something could be changed to facilitate the work.

Employees who came in contact with the batch during the flow were interviewed. These people were representatives from the goods reception bay, a metrology engineer and a component engineer. The purpose with the interviews was to receive these employees’ view on the Internal Component Management and creative ideas in order to find solutions for the problems identified during the charting of the batch.

The working flow and the interviews were analyzed and are presented in a list with improvement proposals.

4.7.2 The Methods Process Flow Chart

When the authors followed the batch of components, they made notes and took photographs of each step in the flow. The authors found it easy to visualize and describe the flow of the batch with a process flow chart. The process flow chart was based on the

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notes and the photographs taken in the mapping. The flow was mapped according to what happened to the batch and its physical change.

In order to find improvement proposals, the activities were analyzed according to the analysis points mentioned in chapter 3.

Interviews

The authors conducted semi-structured interviews with the people in contact with the batch in order to be able to come up with improvements proposals and creative ideas. The authors chose the semi-structured interviews to be able to complement the questions since they might generate new discussions or ideas for other questions.

4.8 Step 7 - The Suppliers

4.8.1 The Approach

The objective for the problem area containing the suppliers was to make a checklist in order to facilitate the review of the design material prior to an order of prototype components.

The authors interviewed component engineers, design engineers, a material engineer, a metrology engineer and representatives from the quality department in order to receive information about the possible contents of the checklist.

The interviews were analyzed and transformed into a checklist. 4.8.2 The Methods

Interviews

The authors chose to interview one person at the time since the discussions that semi-structured interviews might generate could be difficult for the authors to understand if more than one person attended the interview. The interviews were recorded to get a high validity and the summarized interviews were sent to the interviewee in order for them to control the material. By doing this, the authors decreased the risk of the material being incorrect.

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5

Phase 1

-

The Present Situation

The present situation within the component development at St. Jude Medical AB is described in this chapter. The chapter contains information derived from the Ishikawa diagram, the prioritizing and a description of the flowcharts charted in the workshops. The chapter will be summed up with the authors’ analyse on the current state at St. Jude Medical AB.

Key words: Problem Areas, Major causes, Ishikawa diagram, Prioritizing, Workshop,

Flowcharts

5 Phase 1 – The Present Situation

5.1 The Ishikawa Diagram

Six different problem areas were identified during the brainstorming session (Appendix 1);

! Suppliers (5.1.1)

! Order and Purchase of Components (5.1.2) ! Component Design (5.1.3)

! Planning and Resources (5.1.4)

! Internal Component Management (5.1.5) ! Tests and Test Builds (5.1.6)

These problem areas contain a various range of major causes and their root causes will be described below.

5.1.1 Suppliers

A:

Incorrect Selection of Suppliers (figure 10)

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When ordering new components the projects select known suppliers prior to new and alternative ones. This is partly because SJM AB is bound to some suppliers through closed contracts or agreements but is also due to the lack of time set off within the projects to find new and alternative ones. There is a lack of knowledge about other existing suppliers which also contributes to the incorrect selection of suppliers. Not In addition, there exist very few suppliers who want to manufacture components for implantable products.

There exists a limited knowledge about the suppliers’ manufacturing processes and capacity to manufacture the components requested. This leads to the projects failing to make a fair appraisal of the supplier in question.

The projects do not always specify and evaluate the correct criteria for supplier selection, such as the right quality requirements for a certain level of prototype or the right precision of delivery.

B:

Delayed Deliveries of Correct Prototypes (figure 11)

Figure 11 Major cause B’s position in appendix 1

This is a complex area that contains a range of root causes and could all contribute to the delayed deliveries of correct prototypes.

Since the projects use a limited range of suppliers, a heavy load of component orders is placed upon these suppliers, which leads to a serial process development for the supplier and therefore a long wait for its equipment.

A lack of communication internally as well as towards the suppliers when SJM AB changes the priorities for deliveries contributes to the delayed deliveries. The projects do not receive this information about the changes and therefore still expect their components to arrive at the originally set date. The orders of components for the daily line activity have the highest priority and therefore the projects often get caught in the middle.

The projects seldom ask for a confirmation for the supplier’s resources. The confirmation should answer for the suppliers’ machine hours and resources for the order. Since this confirmation is not always questioned the projects have limited understanding for the suppliers’ work load of other orders as well.

The suppliers sometimes deliver prototypes that do not agree with order and evidently this contributes to delayed deliveries. This variance is due to the suppliers delivering fewer entities than specified in the order as well as the prototypes not

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fulfilling the specified drawing requirement. The prototypes mismatch with the requirements could depend on a selection of reasons. Firstly, it could be that the design is not mature enough when sent to the supplier for manufacturing of components. This forces the projects to provide the supplier with immature drawing on risk. Secondly the projects do not always provide the supplier with sufficient data along with the component order which leads to misunderstandings. The third reason is that too many irrelevant critical dimensions are sometimes specified. The supplier may not have the capacity to fulfill these requirements that are not necessary in the first place. Last but not least the supplier’s processes might not be able to handle the requirements specified. The supplier could fail to predict its own capabilities or ignore the fact that they can not handle the component order but hopes that it will work out anyway.

The suppliers sometimes fail to keep the specified delivering dates which evidently leads to delayed deliveries of correct prototypes. This could happen because the supplier receives delayed material from its subcontractor or because the supplier has a tendency to estimate their development of new manufacturing processes optimistically.

A defensive attitude towards the suppliers probably ends with continuing delayed deliveries. The projects are not always clear with what kind of means and mandate they have of bringing pressure to the supplier when receiving delayed components and to avoid future delays.

5.1.2 Order and Purchase of Components

C:

The Projects Can Not Start their Suppliers’ Preparations Before a Formal Purchasing Order Is Established (figure 12)

Figure 12 Major cause C’s position in appendix 1

The purchase process is serial and requires several steps of approval which can be very time consuming for the projects. They wish to be able to prepare their suppliers of an upcoming order.

References

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