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Jan Roelof Veenstra

Focus on shifting regulation possibilities in the production

organization of Cordis Europa N.V.

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Regulation possibilities & shop floor

performance

Focus on shifting regulation possibilities in the production organization

of Cordis Europa N.V.

Jan Roelof Veenstra Groningen, December 2007

Master Thesis Technology Management University of Groningen

Faculty of Economics and Business

Supervisors:

1st Supervisor University of Groningen Prof. Dr. Ir. J. Slomp

2nd Supervisor University of Groningen Prof. Dr. H.B.M. Molleman

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Management summary

This research has been conducted in order of Cordis Europa N.V. at Roden, a business unit of the Cordis Corporation which in turn is a Johnson & Johnson franchise. Cordis Europa N.V. is a producer of catheters. Cordis Roden employs around 650 employees and produces different types of catheters for the global market.

According to the management and the absenteeism ratings, there is a low level of involvement and motivation of the (production) employee’s. Also, the number of support-staff has been decreased due to reorganizations. Cordis’ mission statement states they have to operate cost-effective and meet the yearly productivity growth-demand (8%) of the Johnson & Johnson corporation.

The research described in this thesis is a step in the transition to an organization with an involved and entrepreneurial acting workforce, with a focus on regulation possibilities. At Cordis, the mini-company concept is seen as the means to implement an atmosphere of internal entrepreneurship.

The purpose of this research is:

“To define regulation possibilities, the aspects they influence and there influence on the organizational design.”

Relevant scientific literature is used to support relations and to identify advantages and contextual factors. Aspects that are influenced by regulation possibilities are motivation, involvement, effectiveness and quality of work life. Thirteen descriptions of regulation possibilities are identified: solve product problems, fire members of the team, suggest new product ideas, determine appropriate system quality and assurance procedures, the team's production planning, determine the team's training needs, recruit team members, process and product development, assessment, health care, maintenance, material supply, and personnel planning.

A production line assessment identified seven regulation possibilities for potential shifting: Regulation possibility or task Current owner Possible shifting to

Preventive maintenance Technician Operator Updating performance chart Group leader Operator (Temporary) backup for operators Group leader Operator Shop order check Group leader Operator Calibration coordination Support dept. Group leader Off day regulation/registration Group leader Supervisor

Prioritizing improvement ideas Supervisor Group leader, Operator

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Preface

This thesis is the final goal of a long journey. Who could imagine in 1991 at the start of my study-career that I would end up at the university of Groningen with a Master degree; I could not. It has been a very interesting journey that has given me more insight in the various things of life.

This research that I conducted at Cordis Europa N.V. in Roden concludes my career as a full-time student. After several technical internships at previous studies I have chosen to perform this final research in a more ‘soft’ area, to broaden my scope.

This research would not have been possible for me without the support of others. I want to thank everyone who helped me during my research. The operators, group leaders, technicians and supervisors who provided the necessary information. Jeroen Bastiaan for providing the opportunity to graduate at Cords Europa N.V. and for his coaching during my research. Jannes Slomp for being my first supervisor and for his critical view and useful inputs for my thesis. Eric Molleman for reviewing and feedback on my thesis.

Further I would like to thank the lean engineering team for the joyful time at Cordis and the soccer discussions. Last, I want to thank my fellow graduating student at Cordis Europa N.V., Rob Arndts for being a useful discussion partner during this period.

This thesis concludes a period of being a student. Now I am eager to apply my insights, skills and knowledge and learn more in working life.

Groningen, December 2007

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List of abbreviations and descriptions of terms

PET Production Engineering Team; this team consists of the supervisor, a manufacture engineer and a quality assurance engineer.

FTE Full Time Employee; a term to measure employee working time. One FTE equals the amount of working hours of a full time employee.

Mandrel A small diameter rod that is used to be inserted into the body of a catheter at certain production processes (sealing for example).

NPD New Product Development; a department where new products (and processes) are developed.

FDA Food and Drugs Administration; A part of the American department of public health.

BSI British Standardization Institute; The European counterpart of the FDA. RuG Rijksuniversiteit Groningen; University of Groningen.

WO Work order; a form that describes the work to be performed (for example production orders, maintenance orders, calibration orders)

Maximo A tool management system (for maintenance, calibration) BPCS The material management program.

LP Lean Production.

QWL Quality of Work Life.

Job/task enrichment Increasing the ‘depth’ of tasks/jobs. An increase in tasks along the vertical dimension.

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C O N T E N T S

1 INTRODUCTION TO CORDIS ...8

1.1 History ... 8

1.2 Core Business ... 8

1.3 Organization ... 9

1.4 Current situation Cordis ... 10

2 RESEARCH INTRODUCTION...12

2.1 Introduction... 12

2.2 Basis for research ... 13

2.3 Introduction of the Mini-Company concept ... 13

2.4 Relation of performance criteria, organizational design and tasks ... 15

2.5 Regulation possibilities and tasks ... 15

2.6 Aspects influenced by regulation possibilities... 16

2.7 Résumé ... 17

3 THE RESEARCH ...18

3.1 Research goal ... 18

3.2 Conceptual model ... 18

3.3 Research questions and research methodology... 19

3.3.1 Which regulation possibilities can be identified from the literature? ... 20

3.3.2 How is the concept of regulation possibilities currently deployed at Cordis? .... 20

3.3.3 How should the organization be changed and what effect do those changes have? ... 20

3.3.4 Which aspects (motivation, involvement, effectiveness and QWL) are influenced by shifting which regulation possibility? ... 20

3.3.5 In which way do contextual factors influence the potential shifted regulation possibilities? ... 21

3.4 Research approach... 21

4 THE PRODUCTION PROCESSES ...23

4.1 General notions about the internships ... 25

4.2 Résumé ... 25

5 REGULATION POSSIBILITIES...26

5.1 Regulation possibilities and the literature ... 26

5.1.1 Linkage with empowerment ... 26

5.1.2 Linkage with autonomy ... 26

5.2 Which regulation possibilities are mentioned in the literature?... 27

5.2.1 Actual regulation possibilities from literature ... 27

5.2.2 Resulting descriptions of the regulation tasks ... 28

5.3 Résumé ... 29

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6.1 General function descriptions in the production department ... 30

6.2 Regulation possibilities in the current situation ... 31

6.3 The organization level of each regulation possibility ... 34

6.4 Résumé ... 35

7 SPECIFIC IMPLICATIONS FOR THE SDS LINE ...36

7.1 The SDS production line ... 36

7.2 Organization of the SDS production line... 36

7.3 The technician at the SDS line... 37

7.4 Material management ... 38

7.5 Operator ... 38

7.6 Group leader ... 39

7.7 QA technician and engineer... 40

7.8 Supervisor ... 40

7.9 Summary and discussion of the assessments... 41

7.9.1 Discussion of chapter seven ... 41

7.9.2 Link with regulation possibilities from the literature ... 42

7.9.3 Costs of implementing organizational changes ... 43

7.10 Résumé ... 43

8 REGULATION POSSIBILITIES IN RELATION TO THE FOUR ASPECTS

...44

8.1 Motivation ... 44

8.2 Involvement ... 45

8.3 Effectiveness ... 45

8.4 Quality of Work Life... 46

8.5 The influence of the part-time workforce... 46

8.6 Résumé ... 46

9 CONTEXTUAL FACTORS AND RESEARCH LIMITATIONS ...47

9.1 Contextual factors ... 47

9.1.1 Human factors... 47

9.1.2 Trust and the mini-company ... 47

9.1.3 The lean production system... 48

9.1.4 Quality Assurance department ... 48

9.2 Research limitations... 48

9.2.1 Limited quantitative data ... 49

9.2.2 Representation of all production lines... 49

9.2.3 Utilization of the found regulation possibilities ... 49

9.2.4 Differences in terminology ... 49

9.3 Résumé ... 50

10

DISCUSSION AND RECOMMENDATIONS ...51

10.1 Evaluation of the research goal ... 51

10.2 Alternative for introducing more tasks within a mini-company ... 52

10.3 Cost savings ... 52

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10.5 Performance criteria ... 53

10.6 Place of research relative to future research... 54

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IMPACT OF CHANGED CONDITIONS ...55

11.1 Relevance of the research in the light of the current developments at Cordis... 55

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1.1 History

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In 1959 Dr. Wm. P. Murphy Jr. founded the Cordis Corporation in Miami. The first product was an injector to inject a controllable amount of contrast liquid under pressure into the vascular system. Furthermore, during a three year development process a pacemaker was developed and implanted for the first time in 1962.

In 1966 a small business enterprise in Veenendaal received the agency rights for Europe. A sales organization needed to be established, and a suitable location found for a European factory. This became the Roden plant. In 1969 they started building the new plant, and a year later the first Roden-products left this new company that started with about 45 employees. In 1987 the whole pacemaker production was sold. Cordis originally focused on cardiology, but it became clear that there was also a need for catheters for vascular research in other parts of the body, the so-called radiology. Catheters that could enhance the blood flow in a narrowed vane by inflating a balloon was introduced to the market. Since 1992, these radiology balloon dilatation catheters have been produced at the Roden plant. A year later, Roden was the first to produce cardiology balloon catheters. The development for new products continued. In Miami (USA) stents were developed. These are metal mesh tubes to act as a scaffolding for narrowed vanes. Since July 1997, stents for cardiology and radiology have been produced at the Roden plant.

The Johnson & Johnson Credo is the basic philosophy of the corporation and contains the values and standards that direct the employees. It was formulated by Robert Wood Johnson in 1935 because in his opinion a company had more responsibilities than only to produce and sell products. In the Credo the company responsibilities are defined in respect to the customers, employees, community and stockholders. The Credo can be found in appendix A.

1.2 Core Business

Cordis Europa N.V. is a manufacturer of catheters. The products range from diagnostic catheters, balloon catheters to perform percutaneous angioplasty (‘dotteren’) to catheters with a stent (a metal mesh tube to prevent re-blockage). The Cordis corporation has also drug eluting stents (DES) where the stent is coated with a drug to prevent scar tissue in the artery. The products can be distinguished in endo-(arms, legs & body), cardio-(hart) and neuro-(head)vascular catheters.

The Roden plant is concerned with new product development (NPD) and with endovascular products production. At this moment there are about 660 people working at Cordis Europe

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N.V. at the Roden plant. The production takes place in a conditioned atmosphere, a clean room environment, to prevent contamination of the products.

The nature of the business of Cordis (medical products) demand specific requirements for production and the processes that are involved in production. Governmental regulations, especially those of the FDA (Food & Drugs Administration of the USA) and the BSI (British Standard Institute), dictate traceability as one of the key quality assurance elements. This means that everyone that has worked in the production of a product, can be traced backwards, when there is something wrong with the product. Therefore, there are numerous forms accompanying the final product. This information needs to be stored for several years. To emphasize the amount of paperwork that comes along with production of catheters at Cordis, the phrase ‘we produce more kilo’s of paper than product’ is used. Illustrative for the high quality standard and control procedures is the size of the quality assurance (QA) department, namely about 100 employees.

1.3 Organization

Cordis Corporation was admitted by the Johnson & Johnson company in 1996 and has been a franchise ever since. The presentation to the outside world is: “Cordis, a Johnson & Johnson company”. Johnson & Johnson has 188 companies in more than 52 countries and its products are sold in more than 175 countries.

The position of the Cordis corporation within the Johnson & Johnson company is shown in figure 1. Within the Johnson & Johnson company, Cordis is positioned within the medical devices & diagnostics division. Cordis Europa N.V. (at Roden) is on its turn part of the endovascular division of the Cordis Corporation.

Johnson & Johnson

Pharmaceuticals Medical Devices &Diagnostics Consumer Products

Cordis Corporation

Cardiology Endovascular Neurovascular Biosense Webster

Cordis Europa N.V. (Roden)

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The structure of the Cordis Europa N.V. organization is shown in figure 2. The support departments report to the general manager, but also to their own department vice-president of the Cordis corporation. For example, the HR department of Cordis Europa N.V. reports to the general manager of the plant, but also to the president of the HR departments of the Cordis corporation (located in the USA).

From the director operations, only the functions relevant for this research are shown. The operator is the lowest function in the organization tree.

Site General Manager Management Secretary Director Operations Support Departments Manufacturing Manager Supervisors Group Leaders Operators

Figure 2. Structure of Cordis Europa N.V. (the relevant functions).

1.4 Current situation Cordis

After years of growth, Cordis has now carried out several reorganizations. This process is still in operation. This is one of the reasons for the decreased trust of the operators in the organization. The prospect of losing a job and/or colleagues causes unrest and uncertainty (for the employees).

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product flow. Since then, on the shop floor ‘lean’ is linked with ‘standing’, and is seen as a deterioration of working conditions.

To get the operators to think about process improvements and solutions for problems, the management strives for ‘entrepreneurship’. Hereby, the operators will become more involved with the production process.

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In this chapter, the introduction of the research is given; the origin of the necessity of this research, the context of the research and an introduction of some key concepts.

2.1 Introduction

Cordis Europa N.V. at Roden has been subject of down-sizing in the last years. According to the management and the absenteeism ratings, there is a low level of involvement and motivation of the (production) employee’s. It is expected that this is partly caused by the down-sizing (fear of losing their job, distrust to management, loss of colleagues).

Also, the number of support-staff has decreased, thus decreasing the support departments. Cordis Europa N.V. has to operate cost-effective according to their mission, and meet the yearly productivity growth-demand (8%) of the Johnson & Johnson corporation.

The managements view of the future is a plant with an involved and entrepreneurial acting workforce. In the research of Molleman et.al. (2001) the need for empowerment at Cordis was revealed with a survey. The management had the following main objectives of delegating tasks to the shop floor:

1. reduce manufacturing costs, 2. raise quality and,

3. enhance workers’ motivation. Management supposes that this will foster a positive long-term ‘continuous improvement attitude’ among workers that will contribute to efficiency and quality (Molleman et.al., 2001).

Some literature (Besser 1996)2 mention a form of waste that is called ‘underutilization of employees’. Underutilization of employees is ‘not using the knowledge of operators for continuous improvement’.

The research described in this thesis is a step in the transition to an organization with an involved and entrepreneurial acting workforce, with a focus on regulation possibilities combined with a reduction of support staff activities.

Lean production

An important contextual factor, is the lean production system that is implemented at Cordis. Lean production (Womack et al., 1990) originates from the production system of the Japanese Toyota company. The core thrust of lean production is that these practices can work synergistically to create a streamlined, high quality system that produces finished products at the pace of customer demand with little or no waste (Shah & Ward, 2003). There is not a single agreed upon definition of lean production, due to differences in terminology (Shah & Ward, 2007).

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Lean production is a broad concept with implications for product design, supplier relations, industrial relations, sales and work organization (Parker, 2003). A relative lack of regulatory tasks on the operations level, are a side effect of LP (Niepce & Molleman, 1998). More background on the lean production system can be found in appendix B The focus of this research will be on the work organization part of lean production.

2.2 Basis for research

This research is based on the MBA thesis of Bastiaan (2007) about critical success factors for productivity and job-satisfaction improvement. The model used in that research to explain the relations between the different factors is shown in figure 3.

Resources Internal entrepreneurship Mental model Personal growth possibilities Company culture Management role Competences Autonomy & self-steering Shared profit & risk Information & communication Productivity

Quality of Work Life

Figure 3. The model used in the research of Bastiaan (2007).

As stated in the thesis of Bastiaan (2007), internal entrepreneurship result in higher productivity and quality of work life (QWL). An atmosphere of internal entrepreneurship is created by a number of critical success factors. The research showed a highly significant relation between the factor of autonomy & self-steering and internal entrepreneurship. In the research of Bastiaan (2007), the autonomy & self-steering factor is divided into nine factors based on theory. The research identified regulation possibilities as one of four sub-factors that in the current situation do not match the theoretical requirements for an atmosphere of internal entrepreneurship.

With ‘regulation possibilities’ is mend, those possibilities that provides an amount of freedom to control one’s activities.

This research takes place within the boundaries of the autonomy & self-steering factor of the thesis of Bastiaan (2007).

2.3 Introduction of the Mini-Company concept

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Suzaki’s (1993) Mini-Company. The mini-company concept can be seen as an organizational structure to support internal entrepreneurship. In appendix C the characteristics of the mini-company are shown. At Cordis the mini-mini-company concept is seen as the means to implement internal entrepreneurship. In conversations about the future of the production organization, the concept of the mini-company is often used. A mini-company has an organization structure like a company, and is situated around a part of the production process.

The scope of the mini-company at Cordis

The scope of the mini-company according to the theory of Suzaki (1993), has a strong resemblance with the current PET (production engineering team) scope. The PET consists of a supervisor, manufacturing engineer and a quality assurance engineer. Each PET has the responsibility for two production lines. Each line has its own technician. The mini-company concept around a production line is shown in figure 4. The mini-company can consist of two production lines; this means (according to the current situation) two technicians, one PET and two groups of operators with their group leaders.

Mini-company Production line (Operators) Quality Assurance Manufacturing Engineer Technician

Figure 4. Image of the (conceptual) mini-company organization around production.

The mini-company of figure 4 consists of the operators of the production line complemented with support tasks/persons for production. This is depicted with a technician, quality assurance person and manufacturing engineer. The colored area can consist of support tasks that do not have a relation with production as direct as the technician etc. The management of the actual production process lies within the figure, and is therefore part of the mini-company. The supplier of the mini-company is the preceded production process (upstream) and the next production process (downstream) is the customer. The top/middle management’s role is that of banker (financer).

De Leede & Looise (1999) present the mini-company concept as an organizational design for continuous improvement. Continuous improvement is a major means to increase productivity. Addressed elements in the continuous improvement program are quality, cost, delivery, safety and motivation (Bastiaan, 2007).

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responsible for his/her daily production target of his/her specific task and the supervisor/group leader is responsible for the group output. Hence the employee is judged on the output of his task and the supervisor is judged on the total outcome. In the mini company concept each employee is responsible for the total group outcome.

2.4 Relation of performance criteria, organizational design and tasks

To gain insight of the context of changing organizational design, shifting (regulation) tasks, and performance criteria, this paragraph explains the relation between the three concepts. Shifting regulation tasks (a part of the total amount of tasks) has an effect on the organizational design and on performance criteria used. If a task is shifted from one owner to another, the performance criteria of both will change. The organizational design is also influenced by shifting (regulation) tasks, because the organizational design consists of hierarchical structure, job titles and its accompanying responsibilities and tasks. So performance criteria, organizational design and (regulation) tasks are interrelated. The mini-company concept is seen by middle management as a way to create an atmosphere of internal entrepreneurship. This implies a change of the current production organization and at the same time a change in (regulation) task assignment. (And again, a change in performance criteria).

2.5 Regulation possibilities and tasks

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Organizing means arranging (regulate) something in such a way that different parts form a coherent system that is able to perform as required (the output). Regulation tasks are embedded in different places in the organization. The research of Molleman et al. (2001), showed that respondents (Cordis employees) preferred distinguishing operational tasks,

control tasks and supporting tasks. At Cordis, regulation possibilities are currently mainly

situated within the control tasks (for example supervisor tasks) and supporting tasks (for example technician tasks).

As mentioned in paragraph 2.1 regulation possibilities are the scope of this research. Regulation possibilities lead to regulation tasks. That is, when a regulation possibility is executed it becomes a regulation task. As mentioned in paragraph 2.4.2, a change in the organization means a reassignment of tasks. The focus of this research however, is on regulation tasks which are part of the total task package. For example, hiring employees, work planning, scheduling maintenance activities etc.

The purpose of the reassignment (or shifting) of regulation tasks in the perspective of the initial problems is shown in figure 6.

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Support tasks transfer Shifting regulation tasks Increase Involvement, motivation Reduced support departments Low involvement, motivation

Problems Means Goal

Figure 6. Shifting regulation tasks as means to solve (existing) problems.

In this way, shifting regulation tasks from the current organizational level is a means to solve the initial problems by motivation, involvement and reduced support departments.

Regulation possibilities and lean production

The production part of LP has little room for major empowerment issues (the relation of empowerment with this research is mentioned in chapter five), without compromising the production advantages of the system. To increase regulation possibilities in a LP environment, task enrichment (see for the definition the list of abbreviations and description of terms) by introducing support activities or tasks (maintenance, engineering, planning, etc) to the shop floor seems the right way to do it. Kuipers & de Witte (2005) also mention taking control tasks over from the manager and supporting departments in stage two of their level of empowerment (job enrichment or managerial autonomy (Van Amelsfoort & Van Amelsfoort, 2000)). See appendix D for the model of Kuipers & de Witte (2005). The challenge is to provide the employees regulation possibilities, enrich and vary their jobs without a negative influence on the current productivity and with a positive effect on the upcoming productivity.

2.6 Aspects influenced by regulation possibilities

In this paragraph, different aspects that are influenced by regulation possibilities are derived from literature. In this way, the effect of regulation possibilities on the different influenced aspects is researched, and the regulation possibilities that are beneficial to the research goal can be identified.

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action, evaluate) of work already done by the operators should be prioritized, because they are expected to have the highest motivation potential (Molleman et.al., 2001).

Job enlargement and job enrichment are important for creating a good working environment in which employees feel satisfied and involved (Kuipers & de Witte, 2005b).

Cummings (1978) wrote: existing evidence suggests that self-regulation work groups are productive and satisfying. More recent research of Molleman et al. (2001) stated that local decision making is considered to be a viable means for increasing effectiveness of an organization and the quality of working life for employees.

After analyzing this literature, it can be concluded that motivation, involvement, effectiveness and QWL are the aspects that are influenced by regulation possibilities. The four aspects can be interrelated, like motivation will have an influence on the involvement.

Motivation is related to the job satisfaction of employees. Involvement is the extent of control that employees can exert.

Effectiveness is about the right regulation possibility on the right level; the regulation possibility should do what it is intended to do.

Quality of work life contains motivation and involvement as well as work environment (safety, noise, cleanness).

2.7 Résumé

In this chapter, the background of this research is explained. The motivation for this research is initiated by the research of Bastiaan (2007), who identified regulation possibilities as a factor to create an atmosphere of so-called internal entrepreneurship. Regulation possibilities lead to regulation tasks. An organizational design that fits the approach of an atmosphere of internal entrepreneurship is the mini-company concept. This is a group of employees that are responsible for one (or more) specific production line(s) and act therefore as a company within a company. Shifting regulation possibilities from support departments and management to lower organizational levels increases involvement for the recipients of the regulation possibility and decreases the workload of support departments and management.

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3.1 Research goal

In the previous chapter an introduction on the research was given. By stating the research goal, a conceptual model can be constructed that in turn provides the research questions that need to be answered. The research goal is stated as following:

To define regulation possibilities, the aspects they influence and there influence on the organizational design.

3.2 Conceptual model

The specific aspects that are influenced by shifting regulation possibilities are already defined in the previous chapter and are therefore used in the conceptual model (CM) for this research. This is shown in the figure below. It is the representation of the view of the researcher on the situation. The research questions will emerge from this model.

Figure 7. The conceptual model of the research.

As can be seen, the research scope excludes the relation between the four aspects and productivity (or performance). The complexity of this relation, and therefore the time needed to investigate, is the reason to exclude this relation from this research. It is complex because to examine the relation, long term improvements need to be measured and compared with measurements of an initial state. Besides, measurement of the four aspects is difficult, because of subjectivity. In this research the relation between the four aspects and productivity is assumed.

Regulation possibilities have, as already mentioned in paragraph 2.6, an impact on one or more of the aspects motivation, involvement, effectiveness and QWL. Contextual factors can

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be seen as boundaries for the relations between the elements and the elements themselves and are caused by the actual environment of the organization. The nature of regulation possibility and contextual factors determine which aspect is influenced in what way.

Regulation possibilities are part of organizational design and thus have an impact on the design of the production organization (for example, when management tasks are delegated to the shop floor level, the organization will be different). The organization design on its turn has an influence on the regulation possibilities by the designed hierarchy and function descriptions. The nature of the regulation possibility and contextual factors determine which part of the organization design is influenced in what way.

To focus some more on regulation possibilities, a more specific conceptual model about regulation possibilities is now presented.

The possibility (or feasibility) to shift regulation possibilities depends on several factors. First the level of education of the recipient of the regulation possibility needs to be sufficient to cope with the new task and responsibility. Second, the training time for the new regulation task has influence on the costs, and it needs time to perform. The amount of training time needed might also be dependent on the level of education of the employee. Finally, the associated costs for shifting a regulation possibility. Work orders might be rewritten, training costs, and possible initial degrade of effectiveness of the regulation task are examples for the associated costs. The three factors that influence the shifting of regulation possibilities are shown in figure 8.

Figure 8. The concepts that influence the shifting of regulation possibilities.

These factors that are of importance for the feasibility and suitability of shifting regulation possibilities are also recalled in this research as contextual factors.

Shifting regulation possibilities Level of education Amount of training time needed Associated costs

3.3 Research questions and research methodology

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3.3.1

Which regulation possibilities can be identified from the literature?

Further division of the first question is not necessary, because the question speaks for itself. A literature search is conducted to find actual regulation possibilities that can be used in this research.

3.3.2

How is the concept of regulation possibilities currently deployed at

Cordis?

This question is divided into two sub-questions:

• What kind of regulation possibilities can be determined at Cordis at this moment? • At which organizational level lies the regulation possibility?

With the regulation possibilities that are extracted from the literature search, the current situation is assessed. Regulation possibilities that are not mentioned in the literature but are specific for the Cordis situation are also determined.

The organizational level of the regulation possibility (which employee in the organization has the regulation possibility and what is the employee’s function) is also determined. This is necessary to identify the regulation possibilities that are qualified for shifting.

To answer the sub-questions, interviews were held. In addition, observations were executed.

3.3.3

How should the organization be changed and what effect do those

changes have?

This question is divided into three sub-questions:

• What is the current situation of the production department organization?

• Which organizational changes should be made according to the shifting of regulation possibilities?

• What is the expected effect of the organizational changes?

The current situation of the organization is assessed by using organization charts and by information from interviews.

The impact of shifting a regulation possibility on the current organization can be determined by assessing the shifting of the accompanying task(s). To do so, it is necessary to know where the current tasks (connected with the regulation possibilities) are located.

The resulting new organization will have an effect on some of the jobs in the production organization. This is based on the theory of the influenced aspects (to recall: motivation, involvement, effectiveness and QWL) and predictions of the researcher.

3.3.4

Which aspects (motivation, involvement, effectiveness and QWL)

are influenced by shifting which regulation possibility?

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and the four aspects becomes clear. To answer this question, observations of the researcher and literature is used.

3.3.5

In which way do contextual factors influence the potential shifted

regulation possibilities?

This question is divided into two sub-questions:

• Which contextual factors have an influence on what? • How should be dealt with each contextual factor?

The contextual factors will be determined by comparing the prerequisites from the aspect theories, the organization model theories, governmental regulations and the actual situation at Cordis. This will provide information which relation (regulation possibility Æ aspects, or regulation possibility Æ organization design) is influenced.

To limit the effect of a contextual factor, its source need to be known. This also follows from the previous comparing of prerequisites.

3.4 Research approach

In order to understand the production processes of the different production lines, get a feeling of the Cordis culture and to determine the motivation and involvement of the operators by observation and conversation, small internships were performed. This means an internship of a day for every production line. This creates a better understanding of the current situation; as well as the production processes, the motivation, involvement and general opinions of the operators concerning their job, the management and the company in general. This is described in chapter four.

A desk research was performed and literature about theories concerning motivation, job satisfaction, involvement, productivity, teams, autonomy, empowerment, self steering, mini-company and regulation tasks and possibilities provides theoretical input and background for this research.

These two inputs, small internships and literature research, are used to create a mindset for the researcher. In that way future judgements on qualitative terms can be made. The CM as shown in paragraph 3.2 is also a result of the literature research.

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Contextual factors that could hinder changes in organization or shifting regulation possibilities will be discussed (when relevant) in the different chapters. More general contextual factors are discussed in chapter nine.

This all together will result in a recommendation for the management of Cordis and in a more general discussion about the applicability of shifting regulation possibilities in light of the implementation of the mini-company concept.

The research approach as just described is shown in figure 9, with the linkages between the chapters and the research questions.

Figure 9. The structure of the research in chapters.

Ch.9 Contextual factors and research limitations Ch.4 Introduction to Cordis’ production activities Ch.5 Identify regulation possibilities from literature Ch.6 Regulation possibilities at Cordis Ch.7 Specific implication

for the SDS line Ch.8

Regulation possibilities in relation to the four

aspects

Ch.10

Discussion and recommendations

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This chapter will describe the introduction with the production processes at Cordis. It does not provide an answer to a specific research question, but it is mend to create a mindset (together with the information that will be gathered in chapter five) for the researcher to make future judgements on qualitative terms in this research. Indications of the four aspects (motivation, involvement, effectiveness and QWL) in the current situation will be identified.

To get involved with the production processes, one day introductions for different production lines were done. These small internships were arranged for the researcher at the start of the research. There are eight supervisors who are responsible for one or two production lines. These internships were requested in the weekly supervisor meeting. The lines that were visited for a day are shown in table 1. See appendix E for a short description of the production of each these lines.

Production line Activity

Balloons Heatsetten/pleaten Feederparts Observe

Coat & pack Package Maxi/savvy Observe Pro/P3 Swagen SDS Observe TMS Observe

Table 1. The production lines that were visited for the small internships.

There are some differences between the lines, but in general the atmosphere is quite the same within all the production lines. The impressions of processes, cooperation and attitude towards work environment in each line is shown in the table below.

Production line Short impression of the researcher

Balloons The trainer knows well why an activity has to be performed. The operators (almost all female) can choose their workstation in consultation with each other. My coworker had a positive approach and mentioned 'people should have (had) their own company; then they would know what sick leave means for a company'. There is a positive attitude towards working in another line. The weekly update talk by the group leader is not attended with high interest. The atmosphere and the working conditions in the line are perceived to be good.

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by. I miss that social behavior'. At the injection molding department, the research goal received skepticism. Although between the operators the atmosphere is good, there is a lack of trust in the company. As mentioned: ‘it is always about money, so this will disappear too'. The overall atmosphere at injection molding feels cynical, probably caused by continuous down sizing of the department.

Coat & pack The atmosphere is good and the work leaves room for conversation. The amount of part-timers is high, and people who had to leave from other departments work here. This is seen as a degradation, but the there are positive signals about the possibilities for other work (outside Cordis) like Cordis supported courses (truck license for example). They are conscious about the current situation and seem to have resigned themselves to this. This line is used to reassign employees that have lost their previous job by an internal reorganization.

Maxi/savvy In this line there is very little conversation, probably caused by the level of concentration that is needed for the tasks. Task rotation takes place per day or even per shift. The operators do not have much trust in the value of their improvement ideas; ‘they (management) think: it works now, why should we listen to their input?'. By watching a lot changeover it is noticeable how much paperwork needs to be processed. There is quite some variation in the performed tasks.

ProP3 Almost everyone in the line can perform all tasks. This will change however, due to an internal reorganization operators will have to leave. Other untrained operators (from another department) will replace them. There is a low sick leave rate and they are proud of that. The group leaders are on top of things and there is an emphasis on productivity. SDS The layout of the line is very compact. This is because of a novel line

layout and tool-exchange system. For different products, different tools can be exchanged including the worktable. A lot of visual inspections are done. A special part of the process, the plasma tool, is somewhat isolated from the line. Rotation between the tasks is possible, but there are also preferences for certain tasks. It is an updated 'new' production line with operators involved with the tools 'I prefer to do this'.

TMS The runner/kitter in the line is the contact person for problems in the line. The group leader dictates the rotation in tasks. The operators are skeptical about the daily gym exercise. Also, the opinion of lean equals standing is heard (because since the LP system is implemented, the operators can not sit at their work anymore). Working with takt times is experienced to be unpleasant.

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4.1 General notions about the internships

Every production line has to participate in the daily gym (ergonomics). This is an activity that is meant to prevent health issues that could occur by the repetitive production activities. The atmosphere among the operators in the lines is good. There is a difference in the impact concerning current and past reorganizations per line; some lines (ProP3, Coat & pack) are in some way (in)direct affected, others not.

Observations

Positive or negative observation

operators can choose their workstation by consultation with each other +

positive attitude towards working in another line +

people should know what sick leave means for a company' +

weekly update not attended with high interest

-atmosphere and working conditions perceived to be good +

in the past the manager said hello, now he just runs by'

-lack of trust in the company

-it is always about money, so this will disappear too'

-atmosphere feels cynical

-positive signals about Cordis supported courses (driving license) +

conscious about the current situation +

they (management) think: it works now, why should we listen to them?'

-proud of the line's low sick leave rate +

operators involved with the tools: 'I prefer to do this' +

skeptical about the daily ergonomics (gym)

-negative about standing at their job

-working with takt times is perceived to be unpleasant -Table 3. The most important observations found in the production process research.

4.2 Résumé

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This chapter will provide an answer on research question 3.3.1: Which regulation possibilities

can be identified from the literature?, by providing theoretical background and regulation

possibilities that can be found in the literature. A literature research was performed by searching the databases that are accessed by the electronic library of the RuG.

5.1 Regulation possibilities and the literature

The term ‘regulation possibilities’ is not literally used in the literature. There are two concepts in the literature that are closely involved with regulation possibilities as used in this research. These concepts are empowerment and autonomy. The literature research made clear that the literature is ambiguous about these concepts, and therefore they are not used in this research. However, regulation possibilities have a resemblance with both concepts. The following two sub-paragraphs describe the linkages of regulation possibilities with empowerment and autonomy. This is discussed more extensively in appendix F. The definition and description of ‘team’ can also be found in appendix F.

5.1.1

Linkage with empowerment

Attributes of an empowered team are the broadening of technical skills to perform a wider subset of team tasks (task enlargement), and self-management that will take over many operational responsibilities from managers and supervisors (Cooney, 2004). Self-management is to regulate one’s own tasks, so regulation possibilities can be seen as an element of an empowered team. Womack (1996, p.120) stated team work in lean manufacturing as (…)reorganize work by transferring indirect tasks to the primary work

team(…). Empowerment in a lean manufacturing environment can therefore be defined as:

transferring indirect tasks to the work team, while part of the indirect tasks are regulation tasks.

5.1.2

Linkage with autonomy

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5.2 Which regulation possibilities are mentioned in the literature?

The literature that is available on job regulation tasks is ambiguous in determining which of these tasks are of importance (Kuipers & de Witte, 2005). There are many papers that in some way discuss the matter of regulation possibilities. The impact on and relation with productivity, motivation etc. is mentioned in the literature, as well as statements about how to measure the amount of regulation possibilities on an operational level. This is important for contextual matters and reasoning for focusing on regulation possibilities, but it does not provide actual job regulation possibilities (or tasks) that can be used to identify these in a real organization. However, two papers do use actual job regulation possibilities in their research and are discussed in the next sub-paragraph.

5.2.1

Actual regulation possibilities from literature

The results of the study of Janz et al. (1997), offers practical implications for design of team-based knowledge work. For example, conventional wisdom suggests that the more autonomy a manager provides to a team of knowledge workers, the greater the team's perception of job motivation (Janz et al., 1997). The term ‘team’ can here be interpreted as the group of operators of a production line. The results of the research of Janz et al. suggest that in order to maximize team member motivation, managers need to consider what type of autonomy they are willing (or able) to give. Providing discretion over goals, budgets, training needs, and scheduling (i.e., autonomy for planning) may be an especially effective means of instilling job motivation (Janz et al., 1997).

In the paper of Janz et al. (1997), there are four distinct autonomy facets sought; planning, product, people and process-related. Eight items (two for each facet) were used in their research to determine the amount of autonomy:

“Solve product or service problems”, "Suggest new product or service ideas" (autonomy for products);

"Schedule the team's work", "Determine the team's training needs" (autonomy for planning);

"Fire members of the team", "Recruit/hire team members" (autonomy for people); and "Determine appropriate system quality and assurance procedures", "Specify

which development methods will be used by the team" (autonomy for process).

These regulation facets are also shown in table X. The result of the survey in the research of Janz et al. (1997) showed that the autonomy facets of planning and process were highly correlated and therefore seemed to have a conceptually overlap.

The research of Kuipers & de Witte (2005) about the control structure of team-based organizations, uses twelve job regulation tasks. In that research, the twelve job regulation tasks where defined by interviews with (seven) team managers about initially 24 job regulation tasks derived from the basic tasks of eight functional areas in the researched plant. These twelve job regulation tasks where chosen to be fundamentally related to the performance of their teams; appraisal, health care, maintenance, material supply, personnel

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engineering, recruitment personnel, training and working methods. These regulation tasks are

also shown in table 4.

Authors Regulation tasks (or facets)

Janz et al. (1997)

Solve product or service problems; Suggest new product or service ideas; Schedule the team's work;

Determine the team's training needs; Fire members of the team;

Recruit/hire team members;

Determine appropriate system quality and assurance procedures; Specify which development methods will be used by the team.

Kuipers & de Witte (2005) Appraisal; Health care; Maintenance; Material supply; Personnel planning; Process development; Product development; Production planning; Production engineering; Recruitment personnel; Training and working methods.

Table 4. Regulation tasks (or facets) from the two papers.

The regulation tasks mentioned above were found in literature from two specific research papers. However, the different regulation possibilities are somewhat universal formulated, so they can be used to assess the production department at Cordis.

5.2.2 Resulting

descriptions of the regulation tasks

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Solve product or service problems; Solve product problems

Fire members of the team; Fire members of the team;

Suggest new product or service ideas;

Suggest new product ideas Determine appropriate system quality

and assurance procedures;

Determine appropriate system quality and assurance procedures;

Schedule the team's work; Production planning; The team's production planning Determine the team's training needs; Training and working methods. Determine the team's training needs Recruit/hire team members; Recruitment personnel; Recruit team members

Specify which development methods will be used by the team.

Process development; Product

development; Production engineering; Process and product development

Appraisal; Assessment

Health care; Health care

Maintenance; Maintenance

Material supply; Material supply Personnel planning; Personnel planning

Resulting descriptions Kuipers & de Witte (2005)

Regulation tasks (or facets, or statements) Janz et al. (1997)

Table 5. The resulting descriptions from the found literature.

As can be seen in table X, there are some regulation possibilities from the literature that have overlap. Others are somewhat rewritten to formulate a description that is workable in this research.

5.3 Résumé

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In this chapter, the research question of 3.3.2: how is the concept of regulation possibilities

currently deployed at Cordis?, will be answered by assessing the current situation at Cordis

with the use of the regulation possibilities that were identified in the previous chapter. Not only the regulation possibility itself, but also the organizational level where it is located.

6.1 General function descriptions in the production department

In the production department, there are several function descriptions within the production organization. To connect regulation possibilities with a certain function, it is necessary to define the functions.

In a production line, operators are the employees that actually perform the basic production (assembly of catheters). Each production line has a group leader, who monitors the production progress and manages the production line organization. The group leader also can perform operator tasks. The so-called runner (and/or kitter) is responsible for the replenishment of materials in the production line. This function is circulated by (trained) operators. A line technician is on standby for technical problems in the production line. The technician is also responsible for improvements of the tools in the line. The supervisor is in charge for one or two production lines. His/her tasks are productivity improvements and overall production reports. The supervisor is a member of the PET (production engineering team), together with a manufacturing engineer and a quality assurance engineer. They are part of the Manufacturing Engineering department and the Quality Assurance department respectively.

The manufacturing manager is the link between the supervisors and the plant management. However, this function is not taken into account for the determination of organizational level of regulation possibilities.

Level of education per function

The level of education per function in the production organization is structured as follows: an education level of lower vocational education (LBO) for the operator level;

an education level of intermediate vocational education (MBO) for the technician level;

and an education level of higher vocational education (HBO) for the supervisor & engineer level.

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6.2 Regulation possibilities in the current situation

The regulation possibilities from the literature have been identified, so now the regulation possibilities in the current Cordis situation can be identified and discussed. This will provide an answer on the question how the concept of regulation possibilities is currently deployed at Cordis.

Solve product problems;

This regulation task can be broadly interpreted. If there is a problem with the manufacturing of the product which can be linked with a faulty process, the PET will first assess the problem. If there is a need for major improvement, the PET can deploy the Manufacturing Engineering department to solve the problem. If there is a temporary or minor problem, the line technician will solve the problem in cooperation with the engineer. In both cases, the line technician is closely involved in the process. The operators are not allowed to perform adjustments (outside tolerances) to tools of processes.

Fire members of the team;

Every production line has a certain amount of employees (part- and full-time) The SDS line has 5 part-timers and 5 full time employees (see also appendix G). There is some room in FTE’s for illness. When there is an over capacity of FTE’s within the line due to process improvements or reduced product demand, an employee can be reassigned to an other production line, where extra capacity is needed. This is coordinated by the supervisors, or in some cases the group leaders of two lines can arrange a transfer themselves (the group leaders can arrange this when they have experience with employee transfers between them). A structural overcapacity of FTE’s in the total production department will be countered by more cross functional training or eventually, by authorization of the production manager, communicated to the HR department for dismissal.

Suggest new product ideas;

Basically, everyone at Cordis can suggest new (product) ideas. For general ideas there is a so-called Smartbox present where literally everyone in the organization can turn in his/her idea(s). Specific ideas for a process or product in a production line can be suggested by the line’s operators, group leader, technician, engineer and supervisor. The PET has a list of improvement suggestions and has the task of prioritizing those.

Determine appropriate system quality and assurance procedures;

The system quality and assurance procedures are determined by the QA (quality assurance) department. QA on its turn, is enforced by FDA and BSI regulations about quality and assurance procedures.

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aspects of planned improvement projects and discusses the product fall out and/or rejection with the line technician.

The team’s production planning

The production planning determines the work for a production line. The planning department makes a plan for five days (week) in advance. This planning is based on sales expectations and the amount in-stock. Within the boundaries of this plan, the group leader determines the exact production sequence of the different products. This can be beneficial in relation to setup times (if an identical product has to be produced on two different days according to the plan, the group leader can decide to produce that product simultaneously, to reduce the total setup time). When the actual tasks are considered, the operators are free to determine with each other who will perform what task within the production line. This allocation of tasks is often changed after a coffee break or a setup cycle.

Determine the team’s training needs;

Training is necessary to enhance production flexibility. Every production line has a chart where the names of the operators are shown and the tasks they are trained for. It is the group leader’s responsibility to make sure that there are enough people trained for a certain task. Although an operator can request training for a certain task or workstation, it is the group leader who decides if this is desirable and feasible (availability of time). So the group leader determines when the production planning and line utilization leaves time for training, and who will be trained.

Recruit team members;

The supervisor or group leader can transfer an employee within lines when there is a need of extra FTE in one production line and a surplus of FTE in another production line (the group leaders can arrange this instead of the supervisor, when they have experience with employee transfers between two specific production lines). For structural changes in the amount of employees for a production line, the supervisor will consult the other supervisors if a permanent transfer can be made from another line. If there is overall a need for an extra FTE, then the supervisor can contact the HR department which can hire a temporary workforce.

Process and product development

The development methods are specified by the Manufacturing Engineering and the NPD (new product/process development) department. Within the Manufacturing Engineering department, development methods can be dictated by the global organization of Cordis and/or the Johnson & Johnson corporation. So the operators, group leaders and supervisors have no regulation possibilities for methods of development.

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Smartbox can also be used for input for process development ideas). The supervisor is responsible for prioritizing the process development ideas.

The NPD department is in charge of product development. This is a companywide process and there are also NPD departments in the USA.

Assessment;

The assessment of the production employees is done by their manager. This means that the supervisor is assessed by the manufacturing manager, the group leader by the supervisor and the operators by the group leader (see also figure 2, the organization chart of the production line). The assessment of the operators can also be done by the supervisor if the situation is less standard (in case of severe cooperation problems between production employees).

Health care;

A special department for health care is situated at Cordis (the Environmental, Health and Safety, EH&S department). Their responsibility is the reduction of hazardous situations in the work environment. There is also a focus on the general wellbeing of the employees. As a part of the EH&S policy, every employee undergoes a Cordis franchise introduction training about health and risk issues. This means that everyone has to be aware and keen on dangerous situations and/or accidents. So the control on the overall work environment concerning health care is everyone’s task; however the health care regulations are determined by the EH&S department and the regulations from the global Cordis and/or Johnson & Johnson corporation.

Maintenance;

Maintenance of the tools in the production lines is performed by the line technician(s). Preventive maintenance is regulated by a companywide computer system (called Maximo, see the list of abbreviations) where the different maintenance tasks are generated on their specific intervals. Changes in maintenance frequency and/or maintenance operations are performed by the technician, by altering work orders in the Maximo system.

The operators are not allowed to perform any kind of maintenance. However, currently a project about Operator Asset Care (OAC) is active, where (small) preventive maintenance and failure tasks are delegated to the operators. When this project is implemented, the operator will have an extra task and the accompanying regulation possibility of this task (the operator can assess when the maintenance is performed best).

Material supply;

The materials that are assembled in the production line, are supplied by a two-bin system. A so-called ‘runner’ provides the supplies within the line, from a line side warehouse. The line side warehouse on its turn, is supplied by a material management runner who collects every four hours the empty bins and provides the warehouse with new(full) ones.

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Personnel planning;

On the short term, day to day planning of the operators in the production line is done by the group leader. Operator requests for a day off are also approved by the group leader.

On the long turn, the planning of personnel is determined by the supervisor; the expected production output, FTE’s needed and expected illness and absenteeism ratings are used to determine the amount of personnel in the production line. Changes in productivity, production output or otherwise, that influence the FTE’s needed, are discussed in the supervisor meeting. Transfer of personnel between lines is a means to cope with the changes in the requested output.

When a part-time worker works two specific days a week and on economical reasons it is recommended to change the two days, the supervisor can change this (there is a period of six weeks incorporated to allow the operator to adjust his/her ‘personal live’ to the change).

6.3 The organization level of each regulation possibility

By the assessment of the regulation possibilities in the previous paragraph, the organizational level where these possibilities are situated are identified. By presenting the organizational level of each of the regulation possibilities, it becomes clear what the potential is to shift certain regulation possibilities to other (lower) organizational levels.

The summary of the organizational levels of the regulation possibilities is presented in table 6.

Regulation tasks Operator Group leader Technician Supervisor Support

department

Solve product problems; x x x

Fire members of the team; x x

Suggest new product ideas; x x x x x

Determine appropriate system quality and

assurance procedures; x

The team's production planning; x x

Determine the team's training needs; x

Recruit team members; x x

Process and product development; x x

Assessment; x x Health care; x Maintenance; x Material supply; x x Personnel planning; x x x

Table 6. The organizational level of the regulation tasks.

The regulation task the teams’ production planning is regulated by both the group leader (actual day schedule) and the planning department (weekly planning).

The level of the regulation tasks of recruit team members depends on the nature of the change; if it is a temporary transfer from another production line or a structural transfer between lines, or actual new recruitment.

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be identified in the organization at Cordis. It is found that most regulation possibilities lie at the organizational level of group leader, supervisor and some support departments. This is conform the initial expectations about the level of the regulation possibilities.

6.4 Résumé

In this chapter it is identified how the regulation possibilities currently are deployed at Cordis. Of each regulation possibility it is described where it can be found within the organization. The organizational level of the regulation tasks has also been determined. The group leader, supervisor and some support departments are the organization levels that have the most regulation possibilities.

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