Quality Process Improvement Introducing items and services

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Quality Process Improvement Introducing items and services

by J.M. Kootstra

first supervisor: Prof. Dr. J. Wijngaard second supervisor: Dr. M. Broekhuis internal supervisor: Mr. Drs. S.D. Bloemsma

Faculty of Management and Organisation University of Groningen

Roden, October 2003

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Summary

From January until June 2003 a research is conducted for the department Supplier Quality Assurance (SQA) of Cordis in Roden. The research evolved out of the following. When the British government conducted an audit at the facility of Cordis in Roden, they made comments on the quality process of introducing items and services. Cordis needed to correct its quality system, based on the comments on the process by the government. The department SQA took this observation of the government seriously and decided that the functioning of the quality process of introducing items and services needed to be checked and improved on both external and internal requirements. The external requirements are set by the legislation.

A preliminary examination is conducted to determine the internal requirements. The internal requirements are set by interviewing the customers of the process. The customers of the process commented the process as being un-functional, ambiguous and not being surveyable.

These three aspects determine the clearness of the process of introducing items and services.

The purpose of this research evolved out of the internal and external requirements and is defined as follows:

“To design an unambiguous, surveyable and functional system for the department SQA with regard to the quality process of introducing items and services until usage in production, that complies with the legislation.”

In this thesis a structured approach is used to work towards this purpose, by dividing the purpose in several research questions:

• How is the quality process of purchased goods and services currently shaped?

• What problems can be identified and what is the cause of these problems?

• Which items and services does the formalised process cover and what are the decision criteria to handle an item or service according to this process?

• What critical measures can be developed and how is the performance on these measures?

• What are the best solutions for the bottlenecks in the quality process?

• How can the process be standardised?

First of all the current process of introducing items and services is described by using flowcharts. The gained knowledge of the process is used for analysing the performance on the three internal requirements (functionality, overview and interpretation). The analysis provides insight in the problems causing the process of introducing items and services not being clear. Functionality has everything to do with the observation written by the British government. The deviations with regard to the legislation are marked. The analysis on overview is a comparison between the current way of working and the procedures in use. The way of working should be equal to the procedures. This sets high requirements for the quality of the procedures. In the current situation the work methods are not covered by the procedures. The ambiguity of the procedures causes the viability of the procedures for one’s own interpretation. The analysis resulted in the special focus for the question, whether or not a supplied item or service falls under the legislation. By conducting the analysis, the weaknesses in the process of introducing items and services came to the surface. These weaknesses are measured and the size of the problem is determined.

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Based on the weaknesses, the process of introducing items and services is redesigned. The deviations observed with regard to the legislation (functionality) are solved. The options for dealing with a deviation are considered, and the best option is chosen. For improving the experienced overview, a description of the activities in the quality process of introducing items and services is necessary (overview). A procedure is written. Choosing the right amount of depth in the procedure reduces the amount of ambiguity to its full potential (interpretation). Another source of ambiguity disappeared by reconsidering the question, whether or not the supplied items and services fall under the legislation. Improving the form that supports this question reduces the experienced ambiguity in interpretation. A decision tree is introduced based on the legislation. The improvements are made quantifiable by conducting the same measurement as in the analysis.

The redesign is introduced in the organisation by introducing the procedure in the quality system and by training the customers of the process. By arranging these two aspects, the change process is complete: CON9999992 is in use; the interested parties are aware of the new procedure and are knowledgeable in applying the procedure.

Arrangements have been made for the assurance of the improvements in the quality system.

The process is now part of the internal auditing process of Cordis and the new procedure is linked to other procedures throughout the organisation. By making these arrangements the quality process for introducing items and services is controlled properly.

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Preface

In front of you lies a final thesis, written with reference to a research conducted at Cordis Europe. The research is conducted for the department Supplier Quality Assurance and relates to the quality process of introducing items and services.

The people whom I worked with at Cordis made sure that the past months have not only been an educative time, but also a pleasant time. Without their co-operation this thesis could not have been written. I will not name them all separately; at this place I want to thank all employees of the department Quality Assurance.

I extend my special thanks to my supervisors at Cordis, Mr. Drs. S.D. Bloemsma and Ing. H.

Huizeling and my supervisors at the University of Groningen, Prof. Dr. J. Wijngaard and Dr.

M. Broekhuis, for their support and directions.

Roden, October 2003 Jannie Kootstra

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Table of Contents

INTRODUCTION...7

1 THE ORGANISATION ...9

1.1 HISTORY... 9

1.2 CORE BUSINESS... 9

1.3 STRUCTURE...10

1.4 QUALITY AT CORDIS...10

2 PRELIMINARY EXAMINATION ... 12

2.1 REASON FOR RESEARCH...12

2.2 PROCESS...13

2.2.1 Process Steps... 13

2.3 COMMENTS ON THE PROCESS...14

2.3.1 Customers ... 14

2.3.2 Comments on the Process ... 15

3 METHODOLOGY... 17

3.1 OUTLINING THE RESEARCH...17

3.1.1 Purpose... 17

3.1.2 Main question... 17

3.1.3 Scope ... 18

3.2 PROCESS EXCELLENCE...18

3.3 VISUALISING THE PROBLEM...19

3.4 APPROACH...21

4 THE CURRENT PROCESS OF INTRODUCING ITEMS AND SERVICES... 23

4.1 MAIN PROCESS: INTRODUCING ITEMS AND SERVICES...24

4.2 QUALIFICATION OF SUPPLIER...27

4.3 QUALIFICATION OF SUPPLIER ITEM COMBINATION...29

4.4 MONITORING OF ITEMS...31

4.5 RECEIVING INSPECTION...33

4.6 MONITORING OF SUPPLIERS...36

4.7 REVISIONS OF AN ITEM...38

5 FUNCTIONALITY OPERATIONALISED... 39

5.1 QUALITY SYSTEM REGULATION...39

5.2 COMPARISON; PROCESS VERSUS LEGISLATION...40

5.3 DEVIATIONS...41

5.3.1 Right range ... 41

5.3.2 Type of purchase ... 43

5.3.3 Component Verification Protocol... 43

5.3.4 Assessment on file for suppliers of items... 44

5.3.5 Revisions of an item... 44

5.4 BASIC MEASURE...45

6 OVERVIEW OPERATIONALISED... 46

6.1 FACTORS INFLUENCING OVERVIEW...46

7 INTERPRETATION OPERATIONALISED... 49

7.1 INTERPRETATION CIRCUMSCRIBED...49

7.3 CLOSING THE ANALYSIS...52

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8 SOLVING THE FUNCTIONAL DEFECTS... 53

8.1 RIGHT RANGE...53

8.2 TYPE OF PURCHASE...54

8.3 COMPONENT VERIFICATION PROTOCOL...55

8.4 REVISIONS OF AN ITEM...57

8.5 FINAL MEASURE...58

9 CREATING OVERVIEW ... 59

9.1 PROCEDURES...59

9.2 FORMAT...61

9.2.1 The choice for Actor Activity Diagramming... 61

9.2.2 The diagrams in CON9999992... 61

10 CREATING UNITY IN INTERPRETATION... 64

10.1 INTRODUCING RULES...64

10.2 REDESIGNING CFF 11-026...65

10.4 CLOSING THE DESIGN...66

11 CHANGE ... 67

11.1 CHANGE STRATEGY...67

11.2 PRACTICAL ELABORATION OF THE CONFRONTING/COMPELLING APPROACH...68

12 CONTROL... 69

CONCLUSIONS AND RECOMMENDATIONS... 71

CONCLUSIONS...71

RECOMMENDATIONS...72

FINAL REMARKS...72

LITERATURE ... 73

LIST OF FIGURES AND TABLES... 74

APPENDICES ... 75

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Introduction

The last years, quality assurance has become a central topic in a lot of companies. More and more companies are aware of the gains that can be made in the field of quality. One of the companies being aware of the importance of quality is Cordis. Cordis has high quality standards that are implemented throughout the whole company. The products Cordis manufactures are used by the medical world and for that reason the legislation also sets high quality requirements. When the British government conducted an audit at the facility of Cordis in Roden, they made comments on the process of introducing items and services.

Cordis needed to correct its quality system based on the comments on the process by the government.

This final research that is based on finding a solution for the observed problem has the following purpose:

“To design an unambiguous, surveyable and functional system for the department SQA with regard to the quality process of introducing items and services until usage in production, that complies with the legislation.”

For reaching the aim of this research the next question has to be answered:

“How should the quality process of introducing items and services be shaped and which factors need to be changed for the optimal functioning of the quality process?”

For answering this question, it should be divided in a few sub-questions. The next sub- questions are of importance:

The structure of this thesis is deducted from the purpose and the research questions.

Chapter 1 describes the organisation. Besides an overview of the history, the core business and the organisational structure, attention is paid to the importance of quality in the organisation.

In Chapter 2 the preliminary examination of the expected problem is in focus. The reason for research is described and the process the problem relates to is under discussion. The internal customers are asked their experiences with the process. The clearness of the process, according to the customers, is the main driver for the quality of the process of introducing items and services. Process clearness is categorised in Functionality, Overview and Interpretation. It are these three drivers this research is directed to.

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The methodology of this research is the subject of chapter 3. The research is outlined in the purpose of the research and several research questions. Furthermore, the method of research is discussed and the problem is visualised. This chapter ends with a description of the approach of this research. The research questions are answered in the chapters 4 to 12.

In chapter 4 the quality process for purchased items and services is outlined. The activities that need to be performed by the different disciplines are mapped in flowcharts and are described.

In the chapters 5, 6 and 7 the current process for introducing items and services is analysed.

Each of the aspects that are determined as being Critical To Quality, are under discussion in of the three chapters. Chapter 5 analyses Functionality, the process of introducing items and services is compared with the legislation and the deviations are marked. Chapter 6 analyses Overview. The current process of introducing items and services is compared with the procedures in use. The gaps between both are identified. Chapter 7 analyses Interpretation.

The amount of ambiguity that can be observed is defined. The problems that are identified in these three chapters are quantified by conducting a measure.

The chapters 8, 9 and 10 describe the design that is developed for improving the experienced process clearness. The problems that are identified during the analysis are improved. Chapter 5 discusses the improvements to be made with regard to compliance with the legislation (Functionality). Chapter 6 discusses the procedure that has to be introduced to reach an improved Overview. Inputs for this procedure are the flowcharts introduced in chapter 4 and the improvements in chapter 5. Chapter 7 discusses Interpretation. To reduce the amount of ambiguity the depth of the new procedure has to be decided on with care. The improvements made are quantified by conducting the same measure as in the analysis.

Chapter 11 describes the changing process the organisation has to go through. The approach chosen is elaborated.

In chapter 12 it is discussed how the newly introduced design is controlled.

This thesis ends with the conclusions, recommendations and final remarks that can be made after a research period of a half-year.

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1 The organisation

Cordis is a manufacturer of high quality medical devices for vascular diseases. Cordis has an office in Europe; Roden. Besides this office, Cordis has offices in the United States, among others in Miami and Warren. This chapter describes the organisation. First the history of Cordis will be described. The second section covers the core business of Cordis. The third section discusses the organisational structure of Cordis Roden. This chapter ends with an explanation why quality is of the utmost importance.

1.1 History

In 1959 Dr. Wm. P. Murphy founded the Cordis Corporation in Miami (internal publication Cordis, 2000). The first product Cordis developed was an injector, a device with which a certain quantity of contrast fluid could be injected under pressure in the vascular system. At the time doctors made their own catheters, the Cordis Corporation was the first organisation that marketed pre-shaped and sterilised cardiological catheters on the American and Canadian market.

In 1966 a small business enterprise in Veenendaal got representation for Europe. They sought a location to establish a European plant. In 1970 the first Roden-products left this new plant.

The main products Cordis manufactured were pacemakers. The fundamental research was carried out in Miami. The strict legislation in the United States and the development of the European market made it necessary to start the research and development of new products in Roden. The pacemaker production was sold in 1987. The Research and Development department in Roden got the responsibility for the whole design and development of diagnostic catheters. In Roden catheters were produced that could improve the stricture of a blood vessel, by inflating a balloon on the place of the stricture. Later developments made sure that strictures in vessels are prevented from slipping again.

In 1996, Cordis became a franchise in the Johnson & Johnson (J&J) family.

1.2 Core business

The core business of Cordis consists of:

• Product development;

The department product development is occupied with the development of new products or improvements on existing products

• The manufacturing of new products;

The products Cordis makes are produced under strict requirements. To meet these requirements the organisation possesses 9000m² cleanroom. A cleanroom is a dust- reduced area. In these dust-reduced areas production can take place under controlled circumstances. Unique for Cordis Roden is the presence of an Ethylene Oxide steriliser, by which the products can be sterilised in-house.

• The warehousing and distribution of products.

Cordis warehouses all products manufactured in Roden. All Cordis products that are produced outside Roden, but are intended for the European market, are also stored in the warehouse in Roden before further shipment.

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Other tasks Cordis carries out are quality assurance and customer support (internal publication Cordis, 2000).

1.3 Structure

Cordis Roden is managed by site management. This means management is responsible for all general and operational issues related to the plant in Roden. Site management consists of the management team led by the chairman. All directors of the main departments are part of the management team. The main departments have sub-departments led by department managers.

The sub-departments are divided in groups.

Cordis distinguishes the following departments:

1 Operations 2 Engineering

3 Supplier management 4 Supply Chain Management 5 Product Development 6 Safety and environment 7 Regulatory affairs 8 Quality Assurance

9 Information Management 10 Human Resources

11 Finance

1.4 Quality at Cordis

Cordis has high quality standards that are implemented throughout the whole company. The products Cordis manufactures are used by the medical world to save the lives of people that suffer from cardiovascular diseases, therefore they require very high quality standards.

The American and European legislation also sets high quality requirements. The Good Manufacturing Practice (GMP) contains legislation to secure the manufacturing of quality- products. The American legislation is deducted from the GMP and is described in the Quality System Regulation, published by the Food and Drug Administration (FDA). The Quality System Regulation indicates the required end result rather than specifically prescribing how a manufacturer has to comply with this regulation. It is the responsibility of Cordis to use good judgement when developing a quality system, which appropriately applies the QSR to their specific products and operations. Cordis bears overall responsibility for the production of high-quality products.

The Food and Drug Administration (FDA) and the British Standards Institution (BSI) are examples of institutions that execute audits for the government to see if Cordis is in compliance with the legislation. The FDA represents the United States and the BSI represents the European Union. The goal that drives the institutions is equal; they assure that the inhabitants of the countries concerned are provided with safe products.

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The department Quality Assurance

The department Quality Assurance is concerned with the Quality System being in compliance with the legislation, as it is discussed above.

The department Quality Assurance of Roden is divided in three groups:

• QA Operations;

• QA Logistics and Purchasing; and

• Complaint Analysis.

The tasks of these groups make sure that Cordis works according to the generally received opinion. As a medical device manufacturer high requirements have to be met in order to guarantee the safety of the catheters manufactured.

The assignment discussed in this thesis is carried out for the group Supplier Quality Assurance (SQA), which is part of the sub-department QA Logistics and Purchasing. SQA contributes to the quality assurance in the field of purchasing. Quality is important in the purchase of physical items as well as in the purchase of services. Both have an effect on the quality of the overall product shipped to the customer.

The activities of SQA can be divided in three main activities:

• Qualification of suppliers and materials, based on specifications;

• Monitoring and Corrective Action Management;

• Evaluation, Development and Certification.

By carrying out these three activities the supply of qualitative good items and services is assured.

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2 Preliminary examination

This chapter is a preliminary examination of the problem. A problem can be described as a situation of subjective dissatisfaction of the person who has a problem, together with the desire to take action (De Leeuw, 2000). The aim of this preliminary examination is to verify whether the problem is experienced by the people who have to work with the process, that is object of study, in a day-to-day situation.

The structure of this chapter is as follows. In section one the reason for research is discussed, a problem is observed. Section two gives a short description of the process that is object of study. Based on this process, the customers of the process are asked whether or not they experience the problem. The conclusions that can be drawn from these remarks can be found in section three.

2.1 Reason for research

As mentioned in section 1.4, the American and European legislation sets high quality requirements. The FDA and the BSI conduct audits for the American Government and the European Union. During these audits the institutions check whether Cordis is in compliance with the legislation.

When the institutions are not convinced that safe products are delivered they have the power to stop the sales of Cordis’ products. The worst-case scenario is that the FDA promulgates import restrictions, with the consequence that Cordis can no longer export products to the United States. It can be concluded that passing the audit is of great importance.

During the audits the auditor writes observations on issues that have to be corrected. The employee to whom the observation is directed has to come up with a corrective action and a plan how the disciplinary action can be introduced.

This research evolved out of an observation of the British government¹. During the audit the auditors could not find evidence that certain fluids have been assessed for risk or validated for use.

The disciplinary action SQA reported was that all items for which there is no qualified supplier item combination determined would be reviewed for correctness. While this is only a corrective action and no preventive action, it was decided to follow a different approach. The process of introducing items and services has to be reviewed. The process of introducing items and services is the process flow between the specification of items and services and the allowance to use the items and services. It is this process that determines if a supplier item combination has to be qualified.

1observation number 191

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2.2 Process

The process of introducing new and revised items is being viewed from a Quality Assurance perspective. In this section the main process steps will be described.

2.2.1 Process Steps

The main process steps in the process of introducing new items can be determined from a Quality Assurance perspective. A high-level process map (SIPOC) has been created to give an overview of the process (appendix 1). A SIPOC is a high-level process map that includes Suppliers, Inputs, Processes, Outputs, and Customers. In this section only the process steps are discussed. The three main process steps in the process of introducing items and services are:

Figure 2.1: the process of introducing items and services

Sub 1. Qualification of suppliers

To assure the quality of the supplied items, a supplier has to be qualified. Suppliers that meet the criteria Cordis has set, will be added to the approved supplier list. The legislation prescribes the items and services for which a supplier needs to be qualified.

Sub 2. Qualification of the supplier/item combination

In the former process step the suppliers are qualified. In this process step the combination of the item and the supplier is qualified. During this process the supplier has to prove its reliability as a qualified supplier of the qualified item, by delivering three lots according to specification.

Sub 3. Monitoring of qualified suppliers and items

To assure that the quality of the supplied items is on an acceptable level the qualified items are monitored. Each physical lot supplied is inspected. There are multiple levels of inspections:

-Level A is an inspection based on an inspection protocol;

-Level B is an inspection on documents; and

-Level C is dock to stock, no inspections are executed.

2. Qualification of the Supplier/Item-

combination

3. Monitoring of Qualified Suppliers

and Items 1. Qualification of

Suppliers

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The level of inspection depends on the performance of a supplier. Periodically a supplier is assessed and based on the assessment a supplier can be re-qualified to a higher or lower level or disqualified. When items are inspected or when they are used in production, the necessity to change inspection protocols and specifications becomes obvious.

2.3 Comments on the process

To get a clear overview of the problems being experienced by the customers and to get an impression of the improvement possibilities for the process described above, comments of the customers on the process are put together in the voice of the customer. In the next two sections the customers of the process are described and the comments on the process they gave are summarised.

2.3.1 Customers

The following departments are of relevance: Supplier Management, New Product Development, Packaging Technology, Material Management and the Production Engineering Team. These five groups are considered customers of at least one process step distinguished in the SIPOC. Supplier Quality Assurance (SQA) is not a customer of the process, because she is the process owner.

Supplier Management

Supplier Management is responsible for the availability of the right material at the right time at the right price. Supplier Management is a customer in all three process steps.

Arrangements can only be made with a supplier if SQA approves the quality system of the supplier. The qualification of the Supplier/Item combination and the monitoring also affect Supplier Management, because these two process steps can influence the relationship with the supplier.

Product Development

Product Development develops new and revised products. Product Development is a customer in the process of introducing new items. To order new purchased items for production purposes, not only the item has to be qualified but the supplier has to be qualified also (step 1). If the items are permitted in production (the item and the supplier are qualified) the Product Development-team transfers all responsibility to the Production Engineering Team.

Packaging Technology

Packaging Technology is occupied with the development of new and revised packaging.

Packaging Technology is also a customer in the process of introducing new items. To order new purchased items for production purposes, not only the item has to be qualified but the supplier has to be qualified also (step 1). Packaging Technology maintains responsibility, and is also customer of the other two process steps. When the Supplier/Item combination is qualified inspections can be performed according to inspection protocols and the items can be used in production.

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Production Engineering Team

The Production Engineering Team (PET) is responsible for the throughput of production according to the criteria that are set and to improve the standard. The PET is customer of the last two process steps, the qualification of the supplier/item combination and the monitoring.

The PET is a customer, because she can only use items in production that meet the inspection criteria.

Material Management

Material Management orders the products from the qualified suppliers. Material Management is a customer of the first process step, because products for production can only be ordered from a qualified supplier.

Receiving Inspection

Receiving Inspection executes the inspections on supplied materials. For this reason she is a customer of the last two process steps. Without inspection protocols Receiving Inspection cannot execute any inspections. Based on the monitoring of qualified suppliers and items the inspection levels can be changed.

2.3.2 Comments on the Process

By conducting interviews the opinions of the customers on the process of introducing new items became clear. The comments of the customers are included in appendix 2. The comments of the customers can be categorised in a few drivers. In the figure below these drivers are shown together with the number of comments.

DRIVERS NUMBER OF COMMENTS

Process Clearness 43

Assurance 35 Interaction 29 Learning 4 Speed 9

Figure 2.2: drivers of the process and the number of comments

By categorising the comments of the customers, the drivers are translated into quantifiable requirements for the process, the CTQ’s (Critical To Quality). The categorisation is based on elements that the comments have in common. The three main issues together with the CTQ’s are as follows:

• The process clearness is low

The process of introducing new purchased items is difficult to work with:

- Procedures are viable for one’s own interpretation;

- No good overview of procedures exists; and

- The functionality of process steps is not always clear.

• The assurance of the process is not good The requirements are not controlled properly:

- Requirements are not identified; and - Requirements are too loosely controlled.

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• The interaction between the parties concerned is not optimal

The involvement of the different disciplines in the process of introducing items and services is not considered optimal. The lack of involvement of the departments concerned slows down the introduction of new products and causes corrective actions, unnecessary costs, and sub- optimisation.

Other comments that were made could be classified under the headings learning and speed.

These comments are such a small percentage of the whole that they are neglected.

To narrow the scope of this research, the focus will be on process clearness. Improving the clearness will also affect the experienced assurance and the interaction between different disciplines. Process Clearness is a precondition for Assurance and Interaction. Assurance and Interaction are taken into consideration on the fields they have in common with process clearness. The CTQ Functionality is related to Assurance and the CTQ Interpretation is related to Interaction. The drivers Assurance and Interaction itself may not be in the scope of this research, but can very well be in the scope of a following research. The CTQ’s for process clearness together with the number of comments are defined as follows:

PROCESS CLEARNESS

CTQ’s Number of comments

1. Procedures should not be viable for one’s own interpretation 7

2. A good overview of procedures 26

3. The functionality of process steps has to be clear 10

Figure 2.3: process clearness categorised and the number of comments

ctq 1: The effect of the procedures being viable for one’s own interpretation is that a grey area occurs. This research should clarify these areas.

ctq 2: The majority of the comments were based on a bad overview of procedures. By describing what activities are necessary in the process of introducing purchased items and services, the experienced overview can be improved.

ctq 3: The functionality not being clear has everything to do with people not knowing why certain actions are required or have to be performed in a certain way. By determining what the purpose of a certain action is, the necessity of the action can be decided on.

Since this research is carried out for the department SQA, functionality is mainly a compliance issue.

It are these three CTQ’s this research is directed to. The process clearness is improved when the Functionality, Overview and Interpretation are improved. In the next chapter the structure of this research is discussed.

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3 Methodology

In the preliminary examination the problem this research is based on is discussed. In this chapter the structure of the research will be discussed. The structure of this chapter is as follows. In the first section the problem description this research is based on is formulated, taking the comments of the customers into consideration. Determining the scope circumscribes the research. In the second section Process Excellence (the research method) is discussed. This chapter ends with a visualisation of the problem. The model introduced gives a global view on the fundamentals of this research.

3.1 Outlining the research

According to De Leeuw (1996) the formulation of a problem consists of the purpose of research and the main question. Based on the reason for research (section 2.1) and the comments of the customers (section 2.3), the purpose of this thesis is specified.

3.1.1 Purpose

In section 2.3.2 it was said, that the focus of this research will be on process clearness.

Process clearness has to do with the CTQ’s interpretation, overview and functionality. The purpose of this research can be specified as follows:

“To design an unambiguous, surveyable and functional system for the department SQA with regard to the quality process of introducing items and services until usage in production, that complies with the legislation.”

3.1.2 Main question

For reaching the aim of this research the next question has to be answered:

“How should the quality process of introducing items and services be shaped and which factors need to be changed for the optimal functioning of the quality process?”

For answering this question it should be divided in a few sub-questions. The next sub- questions are of importance:

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3.1.3 Scope

The scope of this project is the process of qualification of suppliers and the supplier/item combination for new purchased items and revisions, and the monitoring process for qualified items and services. The process only handles purchases that according to the legislation (Quality System Regulation) should be supplied by a qualified supplier. This means that items and services that have a relationship with production are only taken into consideration.

3.2 Process Excellence

Previous projects in the organisation are carried out according to the philosophy of Process Excellence. Process Excellence strongly resembles other research methods described in the literature. In this section Process Excellence is placed within the diagnosis, design, change- model (DOV) of De Leeuw. This DOV-model is well known by organisation experts and has a strong design-oriented approach. Since this research is a design-oriented research the DOV- model is a good method for this research.

In the figure below the phases recognised in both methods are shown. The DOV-model recognises three phases and Process Excellence recognises five phases, Improve and Innovate together are seen as one phase.

De Leeuw (DOV) Process Excellence (DMAI²C)

Diagnosis

Design Change

Define Measure Analyse Improve/

Innovate Control

Figure 3.1: the DOV-model compared with Process Excellence

Between both research methods there are a lot of similarities. The Define, Measure and Analyse phase can be seen as a more detailed description of the Diagnose phase of De Leeuw. The Improve phase of Process Excellence equals the Design Phase of De Leeuw and Innovate, a sub-phase of Improve, equals the last phase of the DOV-model (change). Process Excellence adds a phase on top of the three phases De Leeuw recognises, the control phase.

Both methods are described.

The DOV-model is a problem-solving technique consisting of three phases, Diagnosis, Development and Change. The beginning of the problem-solving process is a signal. The diagnosis is the transformation of this signal into a diagnosis. The diagnosed problem (or mess of problems) is brought into a concrete solution in the design phase. In the last phase (change) the design is introduced in the organisation. The organisation needs to change.

Change is a transformation of a design into a concrete system (De Leeuw, 2000).

Process Excellence is an approach to process improvement consisting of five phases: Define, Measure, Analyse, Improve (& Innovate) and Control. For each phase the purpose is clearly defined. The first phase is define. The project’s purpose and scope are defined. Background information on the process and the customers is collected. The goal of the measure phase is to

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focus the improvement effort by gathering information on the current situation. The goal of the analyse phase is to identify root cause(s) and confirm them with data. The output is a theory that has been tested and confirmed. The goal of the improve phase is to try out and implement solutions that address root causes. The output is planned, tested actions that should eliminate or reduce the impact of the identified root cause(s). The goal of the control phase is to evaluate the solutions and maintain the gains by standardising the process.

The DOV-model has its origins in the management theories available and can be seen as a framework for this research. Process Excellence has a more practical background. It is not that much a theory as it is a collection of techniques that can be used during a certain phase in the project. The methodology of Process Excellence is used as the elaboration of the DOV model. The following reasons support this choice. The first reason is that Cordis is familiar with the methodology and the techniques that can be used. Another reason for using Process Excellence is the additional phase (control) that is recognised on top of the three phases recognised in the DOV model. The last reason for using Process Excellence is the practical applicability of the method. The research itself is rather practical, for that reason practical tools are desirable.

3.3 Visualising the problem

The problem that is in focus during this research is visualised in figure 3.2. This figure gives a global view of the fundamentals of this research. In the figure two main blocks can be distinguished. These two blocks, SQA (the process owner) and the Customers, are the main players in the process of introducing items and services. Both blocks will be discussed in this section.

Block 1 SQA

SQA is the process owner of the process in focus during this research. The process as it is discussed in section 2.2 consists of three steps each shown in the figure:

• the qualification of suppliers;

• the qualification of supplier/item combinations; and the

• monitoring of qualified suppliers and items.

For shaping and controlling the process, procedures have been established. These procedures should be in compliance with the legislation.

Block 2 Customers

Block 2 contains the customers of the three process steps mentioned in block 1. The customers are determined in section 2.3.

Relationship between SQA and the Customers

The customers have set requirements for the three process steps. The extent to which these requirements are met determines the level of satisfaction the customers have with the process.

The current process does not meet the requirements. The current process is not clear, the assurance is not good and the interaction is not optimal.

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Focus of this research

The focus of this research will be on process clearness, because process clearness is a precondition for the other requirements of the customers and most comments were based on process clearness. Process clearness can be divided in three aspects that are Critical To Quality (CTQ) of the process, these are:

• Interpretation;

• Overview: and

• Functionality.

In section 2.3.2 these CTQ’s are discussed

Process Excellence

Through analysis and redesign of the procedures according to the Process Excellence method (Define, Measure, Analyse, Improve and Control) the process will be improved for clearness and the quality process will be more satisfying to the customers.

Block 1 Block 2

Figure 3.2 a rich model of the problem Quality System Regulation Supplier Quality Assurance Qualification of suppliers

Qualification of Supplier/

Item combination

Monitoring Qualified Suppliers and items

Customers

Process Clearness Assurance

Interaction

Functio- nality

Over- view

Interpre- tation

Purchasing PET Receiving Inspection Material Management NPD/PT

Define Measure Analyse Improve Control

requirements satisfaction

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3.4 Approach

The approach of the research consists of the five phases recognised in the Process Excellence methodology, each phase is discussed below:

• Define

In the Define phase the organisation of Cordis is mapped and the problem is defined based on the customers’ needs, and the knowledge of the process that needs to be improved. The first three chapters of this thesis are the elaboration of the define phase. Chapter 1 is an introduction to the organisation. Based on an introduction course the information for this chapter is gathered. Every employee of Cordis has to follow this course to get acquainted with the product manufactured by Cordis and the organisation. The second chapter is the preliminary examination. Based on an audit observation a problem in the process for introducing items and services is observed. By reading reports and documentation a first (high level) description of the process is generated. This process description is used to determine the internal customers of the process. By interviewing the customers it is confirmed that the process of introducing items and services does not function properly. The comments made by the customers are categorised to aspects that are the drivers of quality.

These drivers are further categorised to aspects that are Critical To Quality (CTQ).

Considering the comments on the process and that this research evolved out of an audit observation, it is decided that the focus of this research is on the driver process clearness.

Process clearness consists of three CTQ’s: Functionality, Overview and Interpretation.

Chapter 3 discusses the methodology of this research.

• Measure

Based on the problem formulated in the Define phase, measurement tools are developed. The goal of these tools is to measure the size of the problems that are observed and that this research aims to solve. By measuring, the experienced problems can be made objective and goals for improvement can be set. This research is directed to process clearness. For all three CTQ’s of process clearness (Functionality, Overview and Interpretation) a tool is developed based on the aims of this research. The information necessary for executing the measurement is not all present at the time. The following phase, Analyse, provides the necessary information. For this reason the basic measure for every CTQ is discussed in the chapter dealing with the analysis of the CTQ.

• Analyse

By reading the current procedures and reports a primary overview of the quality process for introducing items and services has been generated. Based on that knowledge interviews are held with the employees working with the process to be improved in a day-to-day situation.

Combining the current procedures and reports with the knowledge gathered in the interviews, a solid view of the activities in the process has been reached and flowcharts are drawn up.

Chapter 4 describes the current process of introducing items and services based on these flowcharts. The gained knowledge of the process is used for operationalising the three CTQ’s that are in focus. One chapter is devoted to one of the three aspects. Chapter 5 covers Functionality, the deviations with regard to the legislation are described. Chapter 6 discusses the factors influencing Overview, the relationship between procedures and work methods is emphasized. The operationalisation of Interpretation is discussed in chapter 7. Based on literature the elements that are of importance for the experienced Ambiguity are in focus. All three chapters start with an operationalisation of the content of the CTQ that is being discussed. This operationalisation is directed to the gaps that can be observed in the process.

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The tools developed in the measure phase measure the gaps that are observed and that this research aims to solve.

• Improve

Following the same format as the analysis, the design is also built up out of the three CTQ’s recognised in this research. One chapter covers one aspect of process clearness. By interviewing the employees closely involved in the process and by discussing the generated ideas with the process owner a process that complies with the legislation is developed (chapter 8). The Functionality of the process is improved by closing the deviations described in the analyse phase. The format in which this process has to be introduced in the organisation is based on the literature available on procedures and the analysis of overview.

Improving the overview is discussed in chapter 9. Chapter 10 covers the interpretation. The depth of the new procedure is decided on and a new form for determining whether a supplier has to be qualified is designed. In the analysis of the current situation each chapter ends with a basic measure that makes the CTQ objective. This measurement is repeated at the end of each chapter (final measure). The improvements are shown based on the results of the basic and the final measure.

It is the practical elaboration of the design that brings together the three CTQ’s. The practical design, the outcome for the organisation, is enclosed as appendix to this thesis. The practical design is introduced in the organisation by training the customers. Through training, the customers of the process are informed about the existence of the procedure and are able to apply the procedure. The changing process is discussed in chapter 11.

• Control

To assure that the improvements are maintained, control needs to be exercised over the process. The procedure introduced in the improve stage is a good stepping-stone for the controlling of the process. Further actions need to be taken for assurance in the future.

Through the internal auditing system and the procedures in use for document control, the design is controlled. The process is now part of the internal auditing process of Cordis and the new procedure is linked to other procedures throughout the organisation.

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4 The current process of introducing items and services

In this chapter the current process of introducing items and services is described. For mapping this process, flowcharts are used. A process can be described in a written story.

According to De Heer and Ahaus (1992) a written description of a process is not desirable.

Discussing the control over the process is difficult, because a story is not that accessible. For that reason a process should be represented in diagram form.

The reasons for drawing flowcharts are as follows:

• to create a tool that makes communication possible about separate process steps and the control over the process; and

• to gain common insight into the process.

The flowcharts find their roots in the work methods used. These work methods differ from the procedures in use. Comparing the pros and cons of both work methods and procedures it is obvious to use the work methods for mapping the current situation. The work methods are better developed than the procedures, and the procedures are not covering the whole process.

Furthermore the improvements introduced in this thesis have a greater possibility to be accepted by the people, when they are compared with the process as it is actually functioning in the current situation.

The structure of this chapter is visualised in the figure below:

Figure 4.1: the structure of chapter four

The first section covers the main process. The flowchart shows the main process steps together with the decisions that have to be made in the process. The following flowcharts are detailed descriptions of the process steps discussed in the main process. The qualification process is covered in the sections 4.2 and 4.3, the monitoring process is covered in the sections 4.4 and 4.6. Section 4.5 deals with the receiving inspection process. Receiving inspection is part of the qualification process of a supplier/item combination and is part of the monitoring process for items. Section 4.7 shortly describes the impact of a revision on the process of introducing items and services.

4.5 Receiving Inspection Monitoring Process Qualification Process

4.1 Main process

4.2 Qualification of supplier

4.3 Qualification of supplier/item

combination

4.4 Monitoring of items

4.6 Monitoring of suppliers

4.7 Revision of an item

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4.1 Main process; introducing items and services

2. qualify supplier?

CFF 11-026

3. qualification of supplier Supplier

Management

4. qualified?

8. monitoring of qualified

supplier 1. selection of

supplier

SQA

Yes

5. Type of purchase

7. monitoring of supplied item

Yes

No

9. End

dequalified supplier

6. Qualification of Supplier/Item

Combination

service suppliers

& contractors physical item

Need for purchase of item/service is gone

Figure 4.2 main process

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The main process covers the whole process of introducing items and services, until they are used for their purpose. In the first flowchart the main process is visualised.

1. Selection of supplier

The department Supplier Management triggers the process. Among others engineering has the need for an item or a service that has not been purchased before. They contact supplier management who selects possible suppliers. Supplier Management determines to qualify the supplier, step 2.

QUALIFICATION

2. Qualify supplier?

For every product or service that is being purchased, the need to qualify a supplier has to be questioned. In the current situation this decision is based on a Cordis Franchise From (CFF 11-026, appendix 3a). There are two possible outcomes of the form, either the supplier has to be qualified or there is no need to qualify the supplier. Qualification is needed when there is a possibility that the purchase will have a direct effect upon the quality of the products, labelling, the manufacturing environment or the quality system of Cordis. When there is no need to qualify the supplier the quality process of introducing new items comes to an end (9.).

When the supplier has to be qualified, the process called Qualification of supplier is triggered (3.).

3. Qualification of supplier

This process step assures that only suppliers with a sufficient quality system can supply Cordis with products that have a possible effect upon the quality of products, labelling, the manufacturing environment or the quality system of Cordis. Cordis has set criteria that have to be met by suppliers. Suppliers that meet these criteria will be added as qualified suppliers to the approved supplier list. A more detailed flowchart of this process will be described in the next section (4.2 Qualification of suppliers).

4. Qualified?

There are two possible outcomes of the process step qualification of supplier. SQA determines whether or not the supplier meets the criteria of Cordis. When the criteria are met, it was said in the former process, this supplier will be added to the approved supplier list. If the supplier does not meet the criteria, Supplier Management selects a new supplier. It is obvious that the new supplier needs to be qualified, like the supplier that had not been approved. This loop repeats itself until a supplier is approved by SQA.

5. Type of purchase

The process proceeds in two directions. A distinction is made between:

• suppliers of physical items; and

• service suppliers and contractors.

These directions differ from each other; the process for physical items contains two extra steps that are not recognised for service suppliers and contractors:

Step 6 Qualification of supplier/item combination; and Step 7 Monitoring of supplied items.

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6. Qualification of supplier/item combination

In order to make sure that the items supplied meet the specifications, the supplier/item combination needs to be qualified. The items supplied are inspected by Receiving Inspection based on a test protocol. The supplier/item combination is qualified, when the items pass the inspections several times. The activities carried out during this step are described in section 4.3 (Qualification of supplier/item combination).

MONITORING

The monitoring of supplied items and the monitoring of suppliers are the last two steps in the process of introducing new items. These two process steps take place separately, but parallel to each other.

7. Monitoring of supplied items

In this step the supplier is monitored on the performance during receiving inspections. These inspections do not improve the quality of the products, but make sure only qualitative good items are used in production. Every lot received is inspected. The level of inspection is based on the performance of the supplier. The monitoring of supplied items comes to an end when there is no longer a demand for the item. More detail on the activities to be executed can be found in section 4.4.

8. Monitoring of suppliers

The performance of the supplier is judged periodically. The quality system of the supplier is being assessed, and for suppliers of items the performance during receiving inspections is also looked at. In section 4.6 the activities carried out during this process step are described.

There are two ways this process step can end:

1. the need for the item/service does not exist anymore; or

2. the supplier is disqualified, because of their bad performance. A new supplier has to be selected.

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4.2 Qualification of supplier

3.1. request for Concurrence to specification specification

3.2. request for No Change Agreement

3.3. Assessment on Suppliers Quality System

CTS

NCA

Audit Report Specification

SQA Supplier Management

Vendor History File

4.

2.

Type of purchase

Physical item

Service supplier

Figure 4.3: qualification of supplier

This section covers the qualification process for suppliers. The aim of this process step is to assure that only approved suppliers can supply Cordis with an item or service that is demanded.

3.1 Request for Concurrence To Specification (CTS)

Supplier Management contacts the selected supplier and requests a CTS. A CTS is a document in which a supplier states that he is able to make a specification. A signed CTS is returned to Cordis. A CTS is only required for the qualification of suppliers of items.

3.2 Request for No Change Agreement (NCA)

Supplier Management contacts the selected supplier and asks for a No Change Agreement (NCA). A NCA is a document in which the supplier agrees not to make changes in the design, raw materials, testing, manufacturing location or method of manufacturing without written notification and written agreement by Cordis. These kinds of modifications may lead

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to deviations of the product during the manufacturing process, which can endanger the safety and efficiency of the product and hence the safety of the patient. The CTS and the No Change agreement are requested at the same time.

3.3 Assessment on Suppliers Quality System

In order to get a good understanding of the quality system of the supplier the quality system of the supplier is being assessed. These assessments can have two different forms; the audit and the self survey. In many cases, Cordis will audit the supplier. An audit is a quality inspection during which a number of relevant issues will be assessed. Cordis has specialised quality auditors to conduct such an audit. In some cases, sending out a “Self Survey” to the supplier will be sufficient. The supplier has to complete the self-survey and return it to Cordis. A survey or facility audit must be filed for all suppliers.

The result of the process steps discussed above is three documents. The Concurrence

To Specification, the No Change Agreement and an Audit report. These documents are filed in the Vendor History File.

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4.3 Qualification of Supplier Item combination

7.

6.4. draw up inspection

protocol 6.3.

Three lots conform?

inspection report 6.2. Receiving

Inspection by CVP

5.

Receiving Inspection

Engineering Yes

No CVP

6.1. Draw up test protocol Engineer

Specification

6.5. place supplier item combination on

QSIL

Figure 4.4 qualification of Supplier Item combination

When the supplier is qualified the next process step for items, called Qualification of Supplier Item combination, is triggered.

6.1 Draw up test protocol

All dimensions that are of importance for a specific item are specified in an engineering drawing or a specification of another kind. Based on these specifications test protocols are drawn up. In a test protocol all critical dimensions are covered for inspection. The test protocols are composed according to a standard format, which finally results in a document called Component Verification Protocol (CVP). These protocols are transferred to the department Receiving Inspection.

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6.2 Receiving Inspection by CVP

Receiving Inspection is the department that carries out the inspections on the incoming goods. The process of carrying out these inspections is covered in the fifth flowchart (section 4.5). The result of the receiving inspections is the passing or failing of a lot supplied.

6.3 Three lots conform?

If three lots are conform (passed the inspections), the process proceeds. If the conform lots do not amount to three, the inspections proceed according to the CVP.

6.4 Draw up inspection protocol

The three conform lots trigger an engineer to draw up an inspection protocol. The inspection protocol determines what needs to be inspected by Receiving Inspection, just like the CVP. It is this inspection protocols that is used during the monitoring of items. The monitoring of items is discussed in section 4.4.

6.5 Place supplier/item combination on Qualified Supplier Item List (QSIL)

By delivering three conform lots, the supplier has proven himself a reliable supplier of the item. With the existence of an inspection protocol, all requirements for the qualification of the supplier/item combination are met and the supplier can be placed on the Qualified Supplier Item List (QSIL).

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4.4 Monitoring of items

In essence a split can be made in the main process between the qualification process and the monitoring process. With the placement of the supplier/item combination on the QSIL the qualification process comes to an end. Where the qualification process ends, the monitoring process starts. The monitoring of items is visualised and discussed in this section.

9.

6.

7.1. Determine level of inspection (QSIL-code)

7.2. Receiving inspection according to

QSIL-code

7.4.

Change inspection

level

Engineering specification

Inspection protocol

7.3. Phase- out item?

Yes Engineering/ No

SQA No

Yes

Audit reports/

supplier ratings etc.

Figure 4.5: monitoring of items

7.1 Determine level of inspection

There are three levels of inspection a supplier can receive. These three certification levels are as follows:

1. Level A- analyse code 7

Qualified production suppliers receive inspection of incoming product and accompanying lot documentation

2. Level B- analyse code 4

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Certification authorises the reduction of incoming material inspection to “skip lot”

inspection or as a minimum only inspection of lot documentation 3. Level C- analyse code 9

Certification authorises “dock to stock” where assignment of Cordis lot number and labelling of material can be done by the production supplier before the material is shipped to Cordis or distribution centres.

The minimum requirements for Level A, B and C suppliers are set. SQA nominates the items for certification. Selection for candidacy is based upon quality ratings, Material Review Records, process capability, audit history, future purchase objectives and cost effectiveness of certification.

7.2 Receiving inspection according to QSIL-code

Based on the level of certification the receiving inspections are conducted. The inputs for the inspections are the specification and the inspection protocol, drawn up by engineering in the former section. In section 4.5 the process of inspection is described. The inspections result in the passing or failing of a lot.

7.3 Phase out item?

The decision to phase out an item is made by engineering. Phasing out an item means the end of the process described (step 9). The need for an item or service no longer exists. This process step is not a conscious step made every time a lot is received. By placing a new order with the supplier this step is carried out implicitly and the process proceeds.

7.4 Change inspection level?

Based on the performance of the supplier, SQA can determine to change the level of inspection to a higher or lower level. In order to put a supplier to a higher level the requirements Cordis has set on franchise level must be met.

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4.5 Receiving Inspection

7.1 &

7.4

A. Determine location of lot

B.

Identification correct?

Yes

Back to receiving

Adjust UBD No

C. Check Use Before Date

(UBD)

D. UBD

correct? No

E.

QSIL?

F. Inspection by CVP G1. Inspection

by inspection report (Level A)

G2. Reduced inspection by doc. control

(Level B)

No receiving inspection

"Dock to stock"

(Level C)

No, Analysecode O

Yes, Analysecode 7

Yes, Analysecode 4

Yes, Analysecode 9

H.

Conform?

I. MRR Write MRR No

Yes J.

Release and transfer lot

6.3 Receiver Ticket

6.1

7.3

PET/

Supportgroup Component

Verification Protocol Inspection

Protocol

Yes

Inspection report

Figure 4.6: receiving inspection