Design Assurance Important aspects for implementation

Franciska Kjellström

Master Thesis

KTH Industrial Engineering and Management, Production Engineering

Stockholm, February 2017

Abstract

A rapidly changing environment for industrial technology companies operating on a global market has increased the competitiveness and accelerated the rate of new technologies. The demands on companies to be more efficient and innovative without compromising quality are thereby enlarged. To maintain competitiveness and meet customer expectation a well-functioning product development is essential. Correcting product quality issues on newly developed products becomes increasingly more expensive the later it takes place in the development process and problems that arise can often be linked to the product design. In order to secure that new product development projects efficiently can deliver high quality products without compromising cost targets and time-to-market Design Assurance can be applied during the product development. The intention is to uncover and detect problems in the design and prevent errors to occur in the engineering process, by executing controls to assure design has been completed according to standards and policies.

This project aims to investigate Design Assurance to further establish the concept at Alfa Laval BU HSS and describe how product quality is assured in product development. Analysis of literature studies, interviews at Alfa Laval BU HSS as well as benchmarking at three companies; Atlas Copco Industrial Technique, Getinge (Maquet Critical Care division) and Tetra Pak, provide the basis of the results in this study. The results show there are a number of factors greatly influencing an organization’s ability to ensure product quality in product development. Key factors identified in this study are cross functional team work, the internal culture in the organization, firmly established product strategies, product development processes and requirement management and validation capability. These factors can be seen as essential conditions for ensuring product quality during development and prerequisites for establishing Design Assurance at Alfa Laval BU HSS. Key building blocks in the Design Assurance capability are identified and described, which include reviews of actions and project documentation that safeguards continuous improvements and prevent future deficiencies. The Design Assurance activities are identified as documentation management, change management, risk assessments, nonconformance management, product quality follow up and lessons learned.

Keywords: Design assurance, product development, product quality, quality assurance, design process, new product development project, success factors NPD

Sammanfattning

Dagens industritekniska företag verkar i en global miljö med snabba förändringar, vilket har bidragit till ökad konkurrens och accelererat hastigheten för ny teknik. Därmed har även kraven på företagen att bli mer effevtiva och innovativa, utan att kompromissa med produktens kvalitet, ökat. En väl-fungerande produktutveckling är nödvändig för att bibehålla konkurrenskraft och möta kundernas förväntningar. Ju senare produkters kvalitetsproblem upptäcks och rättas till under utvecklings-processen desto dyrare är det och problemen härstammar ofta från produktens konstruktion. För att säkerställa att nyutvecklingsprojekt effektivt kan leverera högkvalitativa produkter utan att påverka kostnadsmål eller time-to-market, kan Design Assurance tillämpas under produktutvecklingen. Avsikten är att upptäcka, identifiera och förebygga brister i konstruktionen som kan orsaka problem senare under utvecklingen, genom att utföra kontroller för att säkerställa att konstruktionen uppfyller standarder, anvisningar och andra krav.

Denna uppsats syftar till att undersöka Design Assurance för att ytterligare etablera konceptet på Alfa Laval BU HSS och beskriva hur produktkvaliteten säkras under produktutvecklingen. Analys av litteraturstudier, intervjuer på Alfa Laval BU HSS samt benchmarking vid tre företag; Atlas Copco Industriteknik, Getinge Maquet Critical Care divisionen och Tetra Pak, utgör grunden för resultatet i denna studie. Resultatet visar att det finns ett antal faktorer som i hög grad påverkar en organisations förmåga att säkerställa produkternas kvalitet i produktutvecklingen. Nyckelfaktorer har i denna studie identifierats som tvärfunktionellt arbete, den interna kulturen på företaget, väl förankrade produkt-strategier, processer inom produktutveckling samt kravhantering och valideringsförmågan under utvecklingen. Dessa faktorer kan ses som nödvändiga förutsättningar för att säkerställa produktkvalitet under produktutveckling och därmed förutsättningar för att framgångsrikt etablera Design Assurance på Alfa Laval BU HSS. Slutligen är de centrala delarna för att genomföra och applicera Design Assurance identifierade och beskrivna, vilka innefattar granskning av handlingar och projektdokument som säkerställer ständiga förbättringar och förebygger framtida brister. Design Assurance-aktiviteter är identifierade som kontroll av korrekt dokumentering, hantering av ändringar, avvikelsehantering, riskbedömningar, uppföljning av produktkvalitet och lärdomar under produktutvecklingsprojektet.

Nyckelord: Design assurance, produktutveckling, produktkvalitet, kvalitetsäkring, konstruktionsprocess, nyutvecklingsprojekt, framgångsfaktorer NPD

Acknowledgments

First of all, I would like to express my deepest gratitude to my supervisor, Erika Skoglund at Alfa Laval Business Unit HSS in Tumba, for guidance and supporting me with expertise in any matter when necessary in this thesis work. A special thanks also to Malin von Knorring for contributing with valuable inputs, encouragement and discussions along the way.

Further, I would like to thank all the participants from the companies Atlas Copco IT, Tetra Pak and Getinge for sharing valuable experiences and knowledge that contributed to the results of this study.

I would also like to thank the respondents from the interviews held at Alfa Laval in Tumba and Eskilstuna, for contributing with extensive knowledge and opinions in their field.

Finally, thanks to my supervisor at KTH, Per Johansson, for supporting me in this thesis work.

Thank you!

Franciska Kjellström

Stockholm, February 2017

Abbreviations

BU – Business Unit

DA – Design Assurance

DOE – Experimental design, also called Design of Experiments

FMEA – Failure Mode Effect Analysis

FTA – Fault Tree Analysis

HSS – High Speed Separator

PD – Product Development

QFD – Quality function deployment

R&D – Research and Development

TQM – Total Quality Management

Table of Contents 1. Introduction ..................................................................................................................................... 1

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

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

1.3 Purpose and Objective ............................................................................................................. 3

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

1.5 Alfa Laval ................................................................................................................................ 3

2 Methodology ................................................................................................................................... 7

2.1 Literature study ........................................................................................................................ 7

2.2 Benchmarking ......................................................................................................................... 7

2.2.1 Atlas Copco Industrial Technique ................................................................................... 7

2.2.2 Tetra Pak .......................................................................................................................... 8

2.2.3 Getinge ............................................................................................................................ 8

2.3 Internal interviews ................................................................................................................... 8

3 Literature study .............................................................................................................................. 10

3.1 Key factors for successful PD ............................................................................................... 10

3.1.1 The New Product Development Process ....................................................................... 10

3.1.2 Top management support .............................................................................................. 11

3.1.3 Cross functional team work ........................................................................................... 12

3.1.4 New product development strategies ............................................................................. 12

3.1.5 Market research activities .............................................................................................. 12

3.2 Methodologies for managing product quality in PD ............................................................. 12

3.2.1 Concurrent engineering ................................................................................................. 12

3.2.2 Lean Product development ............................................................................................ 13

3.2.3 Agile Product development ........................................................................................... 16

3.3 Design Assurance .................................................................................................................. 18

4 Benchmarking ............................................................................................................................... 22

4.1 Atlas Copco Industrial Technique ......................................................................................... 22

4.2 Tetra Pak................................................................................................................................ 23

4.3 Getinge .................................................................................................................................. 25

5 Internal interviews ......................................................................................................................... 28

6 Discussion ..................................................................................................................................... 29

7 Conclusions ................................................................................................................................... 32

8 Recommendations for future work ................................................................................................ 33

References ............................................................................................................................................. 34

Appendix ............................................................................................................................................... 37

Table of Figures

Figure 1. The Iron triangle. ..................................................................................................................... 1

Figure 2. Stages in a PD process (Product life cycle stages, 2016). ........................................................ 1

Figure 3. The Kano model of customer satisfaction (Bergman & Klefsjö, 2010). .................................. 2

Figure 4. A separator from Alfa Laval (Alfa Laval, 2016). .................................................................... 4

Figure 5. High Speed Separator design, in cross section (Alfa Laval, 2016). ......................................... 4

Figure 6. Components inside the separator (Alfa Laval, 2016). .............................................................. 5

Figure 7. Basic model of the phases in product development at Alfa Laval (Alfa Laval, 2016). ........... 6

Figure 8. Concurrent engineering (Zhu, et al., 2009). ........................................................................... 13

Figure 9. The 13 principles of Lean Product Development (Morgan & Liker, 2006)........................... 14

Figure 10. Lean Thinking model (Peterson, et al., 2012). ..................................................................... 15

Figure 11. The cost influence of the product design (Texiera, 2016).................................................... 18

Figure 12. The Deming cycle, Plan-Do-Check-Act (Quality management system, 2016). .................. 19

Figure 13. The influence of a Design Assurance (Aguilar, 2009). ........................................................ 19

Figure 14. The V model (Hall, 2016). ................................................................................................... 20

Figure 15. Design Assurance and its essential pre-conditions. ............................................................. 31

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1. Introduction

1.1 Background Industrial technology companies on the global market faces challenges due to increasing competitiveness and high acceleration rate of technological change, which requires companies to be more efficient and innovative without compromising quality. Product development (PD) is a key factor for industrial technology companies in order to maintain competitiveness and meet customer expectations. Three aspects to maximize customer value, cost, time and quality, are central in product development, see Figure 1. Companies continuously improve strategies and working methods with regard to the three aspects, in order to secure an efficient product development.

Figure 1. The Iron triangle.

In numerous complex global organizations, cross functional projects run new product development with the design process well integrated with related functions such as production, purchasing and maintenance. The aim of a product development process is to create a “recipe” for producing a product, where the recipe must conform to the requirements deriving from customer or market needs (Browning, 2003). The intention is to have adaptable processes which are used for different PD projects. Bergsten (2007) states that by identifying and describing processes that a company operates according to, further effective ways of performing activities can be identified.

During product development project requirements such as customer needs and expectations are often turned into engineering characteristics such as technical solutions and features which shall be verified and validated. Product development can in general be broken down into a number of specific phases, as shown in Figure 2.

Figure 2. Stages in a PD process (Product life cycle stages, 2016).

During product development projects tend to prioritize the parameters time and cost which are in most cases easier to measure than product quality. According to Basu (2014), there are numerous examples of product development projects which were delivered on time and budget but were not able to meet the customer expectations, for instance product quality.

According to Bergman and Klefsjö (2010) the degree of customer satisfaction is the measurement of quality. Often a product must satisfy several different needs of a customer, both stated and unstated needs. The Kano model, shown in Figure 3, defines three types of customer needs. Basic needs are so fundamental that the customer does not mention them and thus “Must-be quality” of a product. The customer is fully aware of the expected needs which are important for the customer who expects to have them fulfilled. Excitement needs are unspoken needs that the customer is unaware of, not

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knowing what can be fulfilled, but when satisfied, the product have added a surprise element and considerable value to the customer. This often creates faithful and loyal customers to the company. The differentiation of what the core customer values are, such as basic and expected needs, and needs that are more attractive to the customer must be clearly identified for successful PD.

Figure 3. The Kano model of customer satisfaction (Bergman & Klefsjö, 2010).

There are several methods developed and used in the industrial technology industry in order to secure product quality in product development in an efficient manner. One example of such methodology is Design Assurance (DA) which also will be the focus in this study.

DA is based on the execution of appropriate controls to assure design, with the purpose to reduce or eliminate errors, stemming from the design of the product (Aguilar, 2009). The methodology increases the probability of the design to meet or exceed customer expectation as well as product design conformance to requirements. By doing this, DA ensures design integrity as well as robustness while maintaining efficiency.

1.2 Problem definition New product development requires substantial investments in terms of resources and it is crucial that these resources are used in an efficient way. In large, complex organizations it is necessary to understand how the development work can be done in an efficient way to shorten time to market and deliver quality products within financial targets.

For newly developed products it is not uncommon that quality issues are observed at the internal supply chain as well as at the end customer. Examples of this can be certain requirements not reached, flaws in a design solution or design solutions that are problematic to manufacture or maintain. These are problems derived from the product development and the product development working method.

Correcting product quality issues becomes increasingly more expensive the later it takes place in the development process. Poor quality is an inefficient investment which can have a negative economic impact on the business and can also harm the company brand in the long run.

In order to secure that the new product development projects efficiently can deliver high quality products without compromising cost targets and time-to-market there is a need to work with quality assurance. This master thesis has been initiated to further develop the Design Assurance concept at Alfa Laval.

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The project will investigate how the quality of the product is secured during new product development in order to minimize unnecessary rework and customer claims. Key elements and activities during the product development and how these should be executed to secure product quality are to be established.

1.3 Purpose and Objective The purpose of this master thesis is to:

• Identify efficient design assurance activities and methods to use in product development, based on literature in the field.

• Investigate how other industrial technology companies work with design assurance in product development.

• Give suggestions of activities, methods and tools Alfa Laval can apply to further improve design assurance in product development, Business Unit High Speed Separators.

1.4 Delimitations The scope of studying product development from new ideas to launch of products is quite extensive, including various functions in an organization and thus great amounts of people, ways of working and information. Hence, the scope has been limited to study the phases proof of concept and develop solution (design and validation) in more detail, and the whole process with a wide, overview perspective and not examine each function and their way of working in depth. The reason for this decision is to be able, during the time frame of this work, to include the whole process from a design perspective and point out areas which would, according to the methods used, be the most rewarding and important areas to improve to reach a higher level of design assurance throughout the PD process. Then a helicopter view will be achieved, as well as suggestions of first priority improvements. For this reason, focus is kept on the design process and the R&D department of Business Unit High Speed Separators, Alfa Laval. The fact to more or less limit the scope around the R&D department also limits the number of employees at Alfa Laval involved in the study, as interview candidates.

The Quality department at Alfa Laval in Tumba, where this project is conducted, has plans on implementing the concept “Design Assurance”. The idea is to limit the scope from quality assurance, which mainly applies to manufacturing and logistics.

1.5 Alfa Laval Alfa Laval is a world leader within the key technology areas of heat transfer, separation and fluid handling. The company, founded in 1883 and with the head quarter based in Lund, Sweden, is helping customers to optimize their processes in nearly 100 countries around the world. Key products are heat exchangers, separators, pumps and valves (Alfa Laval, 2016).

This project is performed at R&D at Business Unit (BU) High Speed Separators (HSS) in Tumba, where the Business Unit is responsible for the separator business, such as profitability, maintenance, and development of separators. High speed separators, an example seen in Figure 4, are used in a wide range of application areas with various customers, with different needs and expectations.

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Figure 4. A separator from Alfa Laval (Alfa Laval, 2016).

High speed separators separates fluids, solids and gases for industries such as food, pharma, chemical, oil and wastewater treatment and are often part of a larger system with other devices such as pumps and pipes. The separation performance is based on an extremely high centrifugal force separating particles by density differences into light phase and a heavy phase. Key components of the machine are the bowl, bowl spindle, frame, drive, inlet-outlet device and the motor. The separator bowl holds the discharge function and a disc stack, between the discs is where the separation takes place, see Figure 5.

Figure 5. High Speed Separator design, in cross section (Alfa Laval, 2016).

The machine bottom part holds the drive system of the separator, which can be of gear, belt or direct drive type. In total there is a huge amount of parts and articles in a single separator, including bearings, lock rings, screws etc. Figure 6 shows a cross section of a separator.

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Figure 6. Components inside the separator (Alfa Laval, 2016).

Alfa Laval has 42 major production units around the world. The factory in Eskilstuna, Sweden, is a center for production and production engineering where separators are manufactured and delivered (Alfa Laval, 2016).

Since high speed separators consist of several mechanical, heavy and fast-rotating parts, safety, machine dynamics and mechanical strength are central aspects when developing high speed separators. As there are various customers with more or less unique processes, Alfa Laval offers a great variation of products. High speed separators are subjected to both regulatory and commercial demands depending on application region and industry. For example, customers in the pharmaceutical industry have higher hygiene, documentation and material requirements than customers in the marine industry. Customers in the marine industry are generally more focused on price and maximizing level of output.

New product development at Alfa Laval, BU HSS

In Business Unit HSS at Alfa Laval the product development activities are managed in programs and projects working in a matrix structure. According to Ljungberg and Larsson (2001), the matrix organization structure combines function based units with a project team structure. This structure is utilizing the resources, support team work and communication, but can according to the authors, create confusion in the interface betweeen business areas.

There are several components and functions in a separator system that must interact in various operating conditions to create well-functioning products. The line functions consist of design, test, production, maintenance and other essential functions required to develop a functioning product. Each function is responsible for how the task is completed, for example how the design will fulfill the requirements of the product, as well as who performs it. The project manager is responsible for the planning of the project, when and what is achieved in the PD project.

Product development at Alfa Laval is following a stage-gate model where each phase of the PD is separated by gates, illustrated in Figure 7, where gates are marked “TG” for Toll Gate. Each gate is a quality control function, where an evaluation whether the necessary activities have been completed appropriately, is done.

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Figure 7. Basic model of the phases in product development at Alfa Laval (Alfa Laval, 2016).

Product development starts with an idea, which is later evaluated from a business perspective in the Feasibility study, where the market demands are investigated according to the technical possibilities. During the pre-study a decision is taken whether to start a product development project or not. When a PD project is initiated a steering group is appointed, consisting of managers from different functions, and is responsible for the decisions in each gate regarding whether the PD project can pass to the next phase or not. The gate decisions are taken after reviewing the activities and deliverables the projects have to accomplish in each phase. The steering group can choose to stop or kill a project if the deliverables do not conform to what is required.

The organization emphasizes on identifying knowledge gaps to minimize risks during PD. Lack of important knowledge often leads to rework of the product and delays in PD projects, with the result of inferior product quality. To avoid future problems, the projects focus on doing a lot of work and involving people from several functions in the early stage of a project, so called front-end or front-loading. Due to this, a large part of the project is done in the pre-study planning and pre-study execution. When the pre-study is finished and TG3 passed, the PD projects should know exactly what needs to be done at what time in order to create quality products represented by the customer values. In the Realization phase the project develops the prototype, runs field tests and production of the 0 series is started.

The organization has implemented lean methods such as visual planning and has established regular pulse meetings to lift issues cross functionally that could affect the product quality. In the chain of decomposing customer values challenges arise when defining technical requirements corresponding to a customer value such as “robustness”, which can be interpreted differently in various applications. There is also a great amount of documentation to consider when assuring standards, regulatory, technical and other requirements are fulfilled by the design.

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2 Methodology This project is conducted at Alfa Laval, Business Unit High Speed Separators, at the Quality department within R&D, with the objective to identify the most important aspects of Design Assurance in product development.

Identified key elements of Design Assurance applicable for the R&D department at Alfa Laval in Tumba are based on literature, knowledge among the employees and best practice by benchmarking.

Through investigating success factors and important aspects of design in product development according to the literature and other companies, the theoretical and practical recommendations of what works well and not will be secured. Success factors of new product development should be considered from a design assurance perspective, and can be seen as fundamental for implementing Design Assurance successfully. Learning experiences from other companies give an opinion about best practice in the field. Finally, internal interviews held with employees involved in product development at BU HSS, Alfa Laval give insight and use of the knowledge of the people working with different aspects of product development.

2.1 Literature study A literature study was performed to build the foundation and knowledge about the relevant areas for this thesis work and acquire conclusions from previous studies in related fields. The result of the literature study is used for reaching a conclusion of this thesis work. Focus areas for the literature study have been Design assurance/product quality assurance, quality in PD, success factors for product development and PD processes.

The collection of literature was searched for on the Internet, at libraries and in databases provided through the library of the Royal Institute of Technology, KTH. Some literature sources also came up as suggestions by people during discussions or interviews during the project. The collection of literature sources includes books, scientific articles, websites and internal material and information from Alfa Laval. References and source information to the cited literature can be found in the end of this report.

2.2 Benchmarking Three companies were benchmarked to get an understanding about best practice and experiences of other organizations and industries. The purpose of the benchmarking is to highlight success factors and areas of each company, according to what they see as important factors to ensure product quality.

Companies selected for the benchmarking was Atlas Copco Industrial Technique, Tetra Pak and Getinge. The aim of the benchmarking was to collect key factors of what works well for assuring product quality in the product development process at the companies. The focus area for each meeting was decided beforehand together with each company. The result of the benchmarking is analyzed and used for reaching conclusions of this thesis work.

2.2.1 Atlas Copco Industrial Technique Atlas Copco has many similarities with Alfa Laval; they are both Swedish industrial technology companies, founded in the late 19th century and have progressed into successful global companies with several business areas. Due to this development Atlas Copco is also facing similar challenges as Alfa Laval, as how to tackle increasing competitiveness and high acceleration rate of technological change in an efficient way without comprising quality in an expanding organization.

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Due to similar challenges it is of great interest to benchmark with Atlas Copco in order to compare and identify factors that make them successful in securing high quality products on the market.

Atlas Copco Industrial Technique (IT) is one of five business areas of Atlas Copco, based in Nacka, Stockholm. Atlas Copco Industrial Technique is working on a project with the aim of improving their PD process and structuring the related activities which made the benchmarking highly relevant. The benchmarking was conducted during three meetings with project managers represented from PD projects and improvement projects as well as one representative from regulatory compliance. During the first meeting the focus was general challenges in product development and requirement management, the second meeting targeted how market demands, as well as regulatory requirements are handled and integrated in product development. In addition, a phone meeting was held with the project manager for PD improvement projects in order to gain further knowledge regarding important areas for assuring quality products identified by Atlas Copco IT.

2.2.2 Tetra Pak Tetra Pak is global and world leading company within food processing and packing solutions. Other than packaging equipment for liquid food products Tetra Pak also offers a variety of processing and packaging technologies for numerous other products such as ice cream, cheese, vegetables etc. (Tetra Pak, 2016). Tetra Pak is one of three companies in the Tetra Laval Group – a privately owned group with origin from Sweden, where the other two companies are DeLaval and Sidel.

Both Alfa Laval and Tetra Pak started out developing products to the dairy industry and have a close connection even today. In 1991, Alfa Laval was acquired by Tetra Pak and made an independent industry group of Tetra Laval, but sold in year 2000 (Alfa Laval, 2016). Today Tetra Laval still remains the largest owner of Alfa Laval and due to the history as well as the existing ownership, Tetra Pak and Alfa Laval are working close together in several areas.

As Tetra Pak is a successful world leading company within their industry and also has similarities with Alfa Laval, the company was considered interesting to benchmark against. The benchmark focused on design assurance and the importance of processes and working methods in PD to ensure product quality as well as how the requirements are managed throughout the PD process. For the benchmarking a whole-day-meeting was arranged at the office of Tetra Pak in Lund, with a Technical Product Manager in Centrifugal Separation and a Global Process owner in Product Creation at Tetra Pak.

2.2.3 Getinge When approaching the third benchmarking company, Getinge, Maquet Critical Care division, the intention was to study a company operating in an industry with strict product demands. Getinge is developing and manufacturing medical systems for demanding hospital departments, and the Maquet Critical Care division is one of several product brands in Getinge Group (Maquet, 2017).

One meeting was held at their office in Solna, Stockholm, with the Director of System verification, responsible for a quality assurance team at the company. Focus on the meeting was traceability and management of requirements, validation and verification.

2.3 Internal interviews To make use of the solid knowledge among the employees at Alfa Laval, interviews were conducted with people at different positions within the Business Unit HSS with insight in PD. Most of the interviewees work at R&D in areas such as project management, design, test and product care, and are involved in the PD projects. To get perspectives on the handover to and from R&D, interviews

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included respondents from operations as well as product management, among others. To have a general and wide perspective, managers in different areas were also found to be interesting interview candidates for the study. In total 17 interviews were held.

The interviews were conducted with a semi-structured interview method, with predefined questions openly discussed during the interview to enable the respondent to bring up additional information relevant for the subject. Predefined interview questions were adjusted according to the interview respondent’s work and involvement in PD. A set of standard questions were asked to all interviewees, which can be found as examples in the end of this report. The interviews were performed with one respondent at a time and recorded if approval was given by the respondent.

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3 Literature study Design Assurance is not a globally recognized concept, although it is more widely used in some industries and countries. However, there are numerous methods and approaches within Quality assurance that are also applicable in DA.

3.1 Key factors for successful PD Research shows that there are several critical success factors for PD, though the rank order of importance for some factors can vary in different studies. The success factors are important to consider in Design Assurance, as they are fundamental for successful product development. The factors are drivers of performance, where performance is evaluated based on measures such as profitability in relation to competitors as well as spending, success rate of the development projects and technical success rating, among others. According to the study made by Cooper and Kleinschmidt (1995) there are five central blocks that determine a company’s overall new product performance, which are summarized as:

- Process: The firm’s New product development process and the specific activities within the process

- Organization: The way the program is organized - Strategy: The firm’s new product strategy - Culture: Internal culture and climate for innovation - Commitment: Involvement of senior management and corporate commitment in PD

Another, more recent study on critical success factors in PD (Fazilah, et al., 2014) summarizes the top five factors as:

- Product development process - New product development strategies - Top management support - Cross functional teamwork - Market research activities

Both studies have many similarities in the identified factors for successful PD. Both emphasize on the PD process, strategies and commitment and involvement of top management as critical success factors for PD, while cross functional teamwork as well as market research activities are present in the latest study. These are possibly areas that play an increasingly important role in today’s fast changing global world, with organizations operating on a global market, meeting customers worldwide.

Basu (2014) underlines the fact that factors such as communication, leadership and customer involvement are embedded in the culture of the organization.

3.1.1 The New Product Development Process Several studies show that in order to achieve more efficient and value creation product development requires better process flows. The existence of a formal process and the quality of execution of the activities in the new product development process, are strongly associated with project outcomes, according to research conducted (Cooper & Kleinschmidt, 1995; Cooper & Kleinschmidt, 2007).

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According to Nepal, et al. (2011), there is “undeniable evidence that an efficient and effective PD process is key to the survival of any manufacturing company in today’s globalized economy”. The article further argues that the effect of best practices, design activities, tools and techniques for improving performance only can be mazimized if these are integrated into an effective central system. Therefore, PD processes must be developed and integrated as coherent systems. Further, integration of suppliers and customers in the process will give the full benefits of a PD process. Internal material from Alfa Laval (2016) states that clear processes will enhance customer experience by having the right skills, roles and responsibilities at the right place and create clarity and efficiency inside and across the company. Having standard processes in place allows delegation and empowerment which helps build a customer focused business. In a study by Cooper and Kleinschmidt (2007), where 161 business units from Europe and North America participated, the strongest denominator among high performance businesses was a high-quality new product process. Specifically, it is the quality of the process and building in best practice that drive performance, according to the study. The quality of the process is based on six aspects, namely:

• Emphasis on up-front homewor, (both market and technical assessments) before projects moved into the development phase, resulting in a business case. Insufficient assessments is a major cause of failure in product development.

• Early and sharp product definition, before development work begins. It will increase the likelihood of an successful launch as well as a shorter time-to-market.

• Though Kill/Go gates in the process, where projects actually do get killed in order to prevent too many projects which will starve the meritorious ones.

• Focus of quality of execution. Top performing businesses work on improving the execution quality of key task and project activites in the PD process.

• Thorough and complete PD process; every necessary activity is carried out, no corner cutting. • A flexible PD process; stages and decision points can be skipped or combined, as dictated by

the risk and nature of the project. One method for evaluating and improving the product development process is Capability Maturity Model Integration (CMMI) (Browning, 2003). The model defines five maturity levels for processes with collections of best practices that can help organizations to improve their processes (David, 2013). The levels have a set of process goals and higher levels can only be achieved if lower levels have been reached. Capaldo Amaral and Rozenfeld (2007) describe a PD maturity model according to CMMI. Level 1 is the basic step, when the company systematically carries out essential practices for management of product development such as a sufficient organizational structure, project detailing, definition and deployment requirements. Level 2 is reached when practices are standardized, and therefore results are predictable. Level 3, called Measurable, has indicators that assist in assessing the performance of activities and the quality of results. Level 4 is reached when the company works systematically to correct practices where the indicators have deviated from expected values. The last level is called Continuous improvement. Here processes are institutionalized to improve the business process itself, i.e. the product development process.

3.1.2 Top management support Top management support and initiative is one of the key aspects in order to achieve new product success (Fazilah, et al., 2014). Through developing an open minded, supportive and professional leadership the corporate culture will contribute to new product development success. The leadership is

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important for the employees to feel they are supported in their work and there is allowance for creativeness.

The probability of success is also higher the more resources, such as adequate people and money, and attention top management allocates to a PD project (Fazilah, et al., 2014; Cooper & Kleinschmidt, 2007). Also, R&D spending in relation to sales distinguish better performance businesses in a strong way, which is linked to top management support.

3.1.3 Cross functional team work Businesses that consistently use cross functional teams had a higher profitability in general and the assigned team who executed the projects included members from R&D, manufacturing, marketing, engineering etc. The best performing teams have short frequent project meetings to ensure the whole team is updated. Communication is a key and integrating different functions to make sure their inputs and aspects are covered in the development of new products.

3.1.4 New product development strategies The main aspects of a positive new product strategy include product goals, communicating the role of the new products to all, defined focus area such as type of products, markets or technologies the business will target as well as having a long term thrust and focus.

New product strategies should define a common purpose for the organization and something to work on together. If the areas specified in the strategy describe many different markets, technologies or product types the project portfolio might become unfocused over time since it’s containing unrelated projects. The project portfolio should be linked to the strategy and the strategy is fundamental for the effort of a business’ new product.

3.1.5 Market research activities To understand the customer and their needs and expectations it is crucial to conduct market research. This information will be the foundation of the new products and to ensure and verify that the product conforms to what the market wants.

3.2 Methodologies for managing product quality in PD

3.2.1 Concurrent engineering Concurrent engineering (CE) is a systematic strategy as well as management and engineering tool that can be used to improve quality and to reduce costs and lead time for new product development. (Nepal, et al., 2006). Furthermore, CE implies that the design and development processes of the product are done concurrently as the manufacturing processes, with the involvement of cross-functional teams. In this way, the method takes Design for Manufacturing and Assembly into account. The usefulness of CE for improving quality of the product and process design has been widely addressed in the literature. A study of 244 manufacturing firms showed that the concurrent engineering has a significant and positive effect on product quality (Nepal, et al., 2006).

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Figure 8. Concurrent engineering (Zhu, et al., 2009).

Cross functional teams bring developers in direct contact with manufacturing engineers and others with important inputs to the product development. Also, early supplier involvement, ESI, is captured with CE. The expression also refers to involvement of customers. Incorporating suppliers in the PD projects are adding important knowledge about new technology and allows for early identification of potential problems. During Concept design ESI can occur while discussing targeting markets, key products and process technologies and also contribute when specifying the product to eliminate misrepresentation, identify early changes or key components required. Later in the design process ESI are provide valuable input when selecting parts and components for the product as well as quality control and assurance perspectives. Involving the key supplier early in the process will reduce rework, costs and improve the quality of the product (Zhu, et al., 2009). Further, as Figure 8 shows, the manufacturing process can start before the design phase is finished, with prototype production concurrently from the detailed design stage. The early design phases can involve manufacturers for updating on new technologies to be incorporated in the product and important production factors to consider when designing. Later in the process during the detailed design stage knowledge of manufacturers can provide solutions of suitable materials or components etc. In Set-Based CE, an approach with origin from Toyota, the company develops a set of design alternatives from multiple perspectives. Critical design decisions are deliberately delayed until the last moment and sufficient knowledge about the design’s conformance to requirements has been gained. As the progression continues to the next stage, the poor alternatives based on several criteria’s such as quality, reliability, manufacturability and cost are gradually eliminated, converging to a final design (Nepal, et al., 2011).

Summary

Concurrent engineering centers cross-functional integration and team work in the effort to enhance product quality. The design process demands for various types of expertise and when functions work in parallel to develop products coherently it puts even higher demands on communication to succeed.

3.2.2 Lean Product development More and more organizations are applying the principles of “Lean” in an effort to improve company operations and their results, both when it comes to manufacturing and systems engineering processes (Browning, 2003). Focus shifted more towards improving product development processes when companies realized only limited amount of problems could be solved in production, which lead to higher costs when the manufacturing has already reached a larger scale (Häkkinen, 2016).

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Lean Product development aims to maximize the value adding activities in an organization through identifying and eliminating non value adding activities, so called Wastes (Browning, 2003).

Browning (2003) emphasizes on that maximizing value may require doing more activities, not fewer, especially in product development. Also, since a process is a lot like a system, a systems view is helpful which means keeping in mind that the value of a system is more than the value of its individual components. In other words, the value of the product development process is more than the value of its individual activities, and the whole system is creating larger customer value.

In Lean PD the knowledge is considered the key component, establishing concepts like Knowledge based engineering (Häkkinen, 2016). In product development at Toyota, the origin of Lean PD, senior engineers are guiding the younger in the projects and questioning decisions in order to create a deeper understanding of the problem.

Morgan and Liker describes Toyota’s product development model with 13 principles divided into three categories, Process, Skilled People and Tools & Techniques, as drives of performance, see Figure 9.

Figure 9. The 13 principles of Lean Product Development (Morgan & Liker, 2006).

The most crucial principle is to create a definition of customer value, since this is a prerequisite for the relevance of the other principles. The foundation is to build a deep knowledge and understanding about the targeted customer. Not only is it important to understand what customer values today, companies must also try to predict the market and define future demands, since it takes time to develop a finished product. The best way to establish this understanding is to be present in the same environments and context as the targeted customer.

The understanding and ability to define customer value is one part of a successful product development, however, ensuring customer value is actually built into the product is another. To be able to do that, robust processes and control functions should be in place, where clear defined roles and responsibilities are one important aspect of it. At Toyota, roles as Chief engineers have been developed, which emphasize on the fact of having people who are ultimately responsible for building in customer value into the product and responsible for the product’s success, and not only allocates resources. This also applies to the role of a project manager, who should be skilled within the technology developed (Morgan & Liker, 2006).

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Another important principle of Lean PD according to Morgan and Liker, is to front-load the product development process, which refers to allocating much time and resources in the early stage of the product development process before the design concept is finished, and keeping the design open for as long as possible. When the design concept is completed, most of the costs are fixed.

A front-loaded process is dependent on methods and processes which can handle several design alternatives in parallel. With only one option there is a risk that the design will have flaws which are too late to fix, while more alternatives gives the possibility to choose the one correlating to the target (Morgan & Liker, 2006).

According to Peterson, et al (2012) successful Lean strategy requires that values and principles are mutual and shared throughout the organization. The intention is that they shall radiate the whole organization and lead the organization to flow orientation. Lean strategies also imply the most important task of top management is to educate and coach the whole organization in what these values and principles are and the full meaning of them. In this way conditions are created for the organization to establish improvements on their own. Establishing a Lean culture demands an extensive understanding about Lean methodology and a leadership which request consistent behavior according to the values and principles. The right leadership creates a Lean culture throughout the organization which is the starting point for future improvements. Therefore, creating a Lean culture in the organization is crucial, in a higher extent than achieving specific goals. This is done by implementing activities which harmonize with the business’ values and the Lean principles.

The Lean thinking model, seen in Figure 10, describes that methods and ways of working shall be formed from the values, and the principles. By practicing the right methods in the right way, the right result will be achieved.

Figure 10. Lean Thinking model (Peterson, et al., 2012).

If the results are not satisfying, the questioning will primarily concern how the methods was applied, and secondly if the chosen methods were good enough. The principles are used to provide guidance to further develop or change methods (Peterson, et al., 2012).

Summary

Lean Product development focuses on customer value, knowledge and continuous improvement. Values are incorporated in the methods and processes of a company and companies working according to Lean principles are also integrating suppliers in their PD processes to maximize customer value and knowledge. Thorough processes and control functions must be in place to be able to build in quality in the products. Roles and responsibilities are defined accordingly. Methods and processes are constantly optimized, where maximizing adding value activities are central. To successful establish the whole

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methodology literature findings emphasize on creating the right culture, where leadership is essential. Organizational learning and cross functional team work are important factors, with examples of using senior engineers to support new ones.

3.2.3 Agile Product development Agile Product Development is described as a philosophy where the goal is to become more competitive through increased flexibility in the development processes (Thomke & Reinertsen, 1998). Flexibility refers to what impact an external or internal change in the definition or specification of the product has on the cost of development. In other words - the higher cost a product modification causes, the lower is its flexibility. Thomke and Reinertsen argue that the costs of product modifications can be traced to at least one of four categories; increased development costs, higher price, lower performance and slower development process. Agile methodologies are based on the thought that companies should effectively be able to adapt when demand is changing, and the methodologies are widely used today, especially within software development. Self-organizing teams are central in agile PD, where the assurance of quality is the team’s responsibility, not a designated person. According to Thomke and Reinertsen, agile PD describes particularly three strategic areas: Work process and organization, the level of flexibility in the techniques used and the product architecture. These are important to increase the flexibility of a company in terms of product development. Work process and organization Traditionally, product development has demanded a complete specification prior to design or construction work could begin. This approach has in many cases resulted in that a product have been specified based on incomplete information, which in turn leads to the need of making changes in retrospect when the information has become available. In contrast to this, agile PD advocates a process where developers gradually establish specifications (Fogelström, et al., 2009). The approach implies a product's final specification is emerging through a number of iterations. For each of these iterations the previous product version is improved based on the feedback and analysis that the current product version generated. Because issues will arise several times, verification and validation steps are needed. This will result in refinement of requirements during the development process. This approach obtains two positive effects, namely, the process creates customer value within a short time from the idea generation and, it allows higher flexibility even at a late stage of the production process. The fact that the final product is created by continuously updates makes it possible to change the product specification without great expense or delays. Further, agile PD is highlighting the importance of using at least one alternative design concept, which is developed in parallel, during the product development process. Instead of deciding for one specific design in an initial stage of the product development process, organizations should strive to work with at least one alternative to the product developed. By not ruling out alternative solutions the risk of unforeseen problems or changes in demand will be reduced. Especially in development projects where the test cycles are long, this method of work proved to be efficient. In extensive and costly test processes, it is devastating in both a cost and time perspective if a product fails in final phase before launching (Thomke & Reinertsen, 1998).

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Agile development point out testing as a key principle and part of the iteration process, and by establishing test methods and acceptance tests as early as possible in the process, regular inspection of the product as it develops is enabled. This gives an early perception of quality issues and allows for making adjustments if necessary. While inspecting and adapting, quality metrics are established with “bug counts” and prioritize test cases based on parameters such as risks. Each bug is analyzed to understand the root cause, and the process is then improved to handle it properly in the future. Methods such as test driven development, TDD, and exploratory testing are examples of methods derived from agile methodologies (Waters, 2016; Thomas, 2016). Finally, agile PD advocates two further actions relating to organization and process (Thomke & Reinertsen, 1998). It is of great importance that a company should have stated aims to be flexible, and that they should have developed metrics to follow up stated goals. Also, the importance of effective and structured development organization is emphasized. The structure shall be designed to minimize problems related to communication or transparency, through implementation of cross-functional teams. Such structures will ensure that expertise from several areas of development work is represented. Technology used should be flexible Product development today has a faster pace than before which require higher flexibility. An important part of increasing flexibility is to rapidly and cost effective develop prototypes as development work progresses. This is especially important in agile PD where the way of work is based on an iterative process where it is a constant need for new models and prototypes. For this reason, Thomke and Reinertsen argues it is important that companies use different forms of computer support, tools that can reduce costs and time spent at changed specifications. Product Architecture The last strategic area agile PD highlights is the importance of how components in a complex product are linked to each other. A common problem when making changes in design is that several components are interdependent, resulting in that it is difficult to modify an individual component without also having to modify associated components. Negative synergies like these are one reason that specification changes are costly. To counter these problems and thereby improving the flexibility, agile PD suggests a modular product structure. Thus, it is important in the early stages of the product development work to actively create a design that can handle product changes and updates. This can be done in part by enabling the use of a module or component in several applications. Especially important for achieving these features is that there are well-defined interfaces and ownership of any single module (Thomke & Reinertsen, 1998). Summary

Agile product development is a flexible and efficient way of adapting to new demands and circumstances. The philosophy emphasizes on to gradually develop the product through iterations and refinement of requirements during the PD, and large focus on verification and validation. To minimize risks it is important to develop alternative design concepts in parallel. The regular inspection requires quality metrics and analyzing the root cause resulting in continuously improving the process. The team effort assures quality in product development and also allows for knowledge sharing and transfer within the organization. Cross functional teams are crucial, as well as effective communication and tools, in agile product development.

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3.3 Design Assurance Historically, product quality and the quality control activities were considered to be a factory job, inspecting parts and removing incorrect ones after manufacturing. However, industrial managers later realized that efforts were needed to prevent manufacturing of incorrect parts, i.e. securing quality in an earlier stage. Problems caused by the actual design and flaws in the engineering information are more serious and costly to correct than the problems occurring in production. Engineering shortcomings might not be discovered until the product is in production or in service and can then be very costly and time-consuming to correct (Burgess, 1988).

As illustrated in Figure 11, the product design is shown to have the largest cost influence on total cost of a product, even though it typically is a lower cost than other elements such as material and labour.

Figure 11. The cost influence of the product design (Texiera, 2016).

Also, according to Zhu, et al (2009), the design phase in the development stage is more important than other phases of product development and production from a product quality perspective, stating that design quality is a key determinant on the final product quality. Quality control activities often have a large focus within manufacturing and production. However, those activities usually cannot solve problems rooted in design deficiencies. Therefore according to Zhu, et al (2009); Texiera (2016), improving the design is the most effective way to improve final product quality. From a financial perspective the quality of product design should be the first aspect to consider when optimizing new product development. A study on development projects of four swedish companies showed that the causes of drawing deficiencies are linked to lack of management and planning, lack of quality awareness, lack of information and vague requirement specification (Olsson, 1997). Guidelines and recommendations have been developed in many industries over the years to improve the quality of product design, evolving from drawing control into other aspects of “good engineering practices”. The methodology became known as “Design Assurance” and specifies a disciplined approach for design and development activities, with the aim to improve the quality and reliability of the end product, uncovering and preventing errors or defects to occur in the engineering process (Burgess, 1988). IGI Global (2016), a leading international academic publisher, defines Design Assurance as:

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“Executing the appropriate controls to assure design has been completed according to stated policies and standards as well as assuring the necessary outputs have been completed.”

Since design quality is decisive to product quality, it is crucial to manage quality from the design process to maximize value for the customer. Design quality implies that design requirements reflect the voice of the customer or the demands of the market (Zhu, et al., 2009).

Figure 12. The Deming cycle, Plan-Do-Check-Act (Quality management system, 2016).

A well-known method used for managing quality in processes is the Deming cycle (Quality management system, 2016), illustrated in Figure 12. By planning, executing, evaluating and follow-up activities over time a process can be continuously improved and adapted.

Design Assurance takes some of the resources that the organization would use to correct design flaws and use those resources earlier to prevent design deficiencies (Aguilar, 2009). Figure 13 below shows how structured and successful applied DA can affect the cost of a program or project.

Figure 13. The influence of a Design Assurance (Aguilar, 2009).

The overall cost are lower than if DA is not used, since critical design deficiencies are identified and fixed early, rather than dealing with them later in the lifecycle. Figure 14 below illustrates the V-model and how tracing each level of the solution to the original idea validates that what is developed will provide what is required of the end product. It is also important to specify test methods etc. already when defining the design because it early creates understanding and emphasizes on the verification and validation of the product requirements. For example by asking questions like “How are we going to test this requirement to be able to confidently say it is fulfilled?”, where the dialogue between functions are highly relevant.

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Figure 14. The V model (Hall, 2016).

Zhu et al. (2009) emphasizes on the design-manufacturing chain and the quality management of it has the philosophy to control product quality from its roots, by supervision and control all activities on the chain. The study concluded that to optimize the design quality successfully it is crucial to collaborate with suppliers throughout the whole product development. The study further describes that well-trained technical employees, administrative standards and cooperation will lead to increased supplier involvement. Partner companies, both suppliers and manufacturers, should focus on quality information and resource sharing as well as on exchanging of manufacturing and testing information, rather than negotiating prices. Also, design engineering tools such as QFD, FMEA, tolerances analysis, DOE etc, should be implemented in the PD process and it is essential to establish cross-functional teams for facilitating collaboration. For the whole product development it has been found that softer technical skills such as Just-in-time, total quality management (TQM), management methods and the extent of collaboration have more influence than technical capabilities.

According to Olsson (1997) important activities to detect weaknesses or flaws early in the PD process are:

• Calculations and analyzes with different independent methods • Comparison of earlier solutions • Consider manufacturing aspects early in the design process • Test components and sub-systems • Failure mode and effects analysis (FMEA) • Fault tree analysis (FTA) • Design review and production review with critical assessment • Open corporation with suppliers • Initial sample tests, with critical assessment • Prototyping with critical review and analysis

Aguilar (2009) developed a guide on Design Assurance, as a roadmap for defining and implementing a design assurance process in aerospace programs. The intention of a DA process is to accompany systems engineering and management processes and utilize existing elements to the maximum extent.

DA independently assesses the development of engineering specifications as well as models and analyzes required to physically and functionally describe the product. It also includes engineering documentation required to support the acquirement, production, test, delivery, use and service of the

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product. Aguilar states that discovery, prevention and correction of engineering process errors must be continually performed before, during and after project milestones.

Further, in order to provide unbiased and uncompromised assessment, free from conflicts of interest, the DA activities must be performed by experts that are independent. A DA plan should be documented action plan, specifying who, what, when, how, where is DA carried out and tied to risk management plan. Risk management is integrated and continuously evaluated throughout the process with risk management plans, assessments and analyzes. New risks which have been identified in the DA process should be included into the risk list for monitoring and tracking. Also, it’s crucial to have up-to-date design guides with lessons learned captured, thus lessons learned and actions that significantly limit risks are incorporated into design guides, standards, trainings or other practices so they become part of the way of working.

DA elements also include management of corrective actions, nonconformance and noncompliance processes, such as identification of the problem, containment, root cause determination, corrective and preventive action verification with metrics to evaluate the effectiveness, and also should handle feedback to improve the corrective action process. Problems that reoccur indicate that the corrective action was not appropriate or incorrect root cause identified. Developing standard metrics to measure performance is in focus in the implementation of DA, to ensure internal and external customer needs are being met, and knowing what to improve. Even measuring performance of the DA process itself, such as number of open actions during review, missed milestones, number of engineering changes after build phase has begun. DA also strives for process and tool commonality, with consistency between documented processes and practice. A common set of design and analysis tools is a key to success, according to Aguilar (2009). Further, having robust structure of engineering data ensures efficient and early design integration and limits late discovered issues. Processes should be in a form that is utilized by the employees, readily accessible. When employees understand the processes they are responsible for and have documented the best practice of it, they not only follow the process with more discipline but also improve the process documents.

According to Aguilar, the effective implementation of DA requires reliance between a program/project and the organization. When a DA gap analysis exposes preventive and corrective action opportunities the functional organization and/or the program have to take ownership. Also, responsibility, accountability and authority agreements between different roles must be clearly defined.

DA also assesses processes and management of requirements such as traceability, allocation and decomposition at various phases since it can negatively affect downstream activities, and requirements should be traced from customers to suppliers or other partners. Supplier-related issues should be reviewed and DA activities should be adjusted according to the metrics.

Other examples of DA activities are test witnessing, approved supplier list, thorough review of development process, documentation as well as requirements or design traceability. DA activities should produce findings, actions and lessons learned.

Summary

The design is a key determinant on final product quality and improving the design is the most effective way to improve product quality. Design Assurance takes some of the resources the organization would use to correct design flaws later in product life cycle and uses the resources early to prevent design deficiencies through independent assessments. It is crucial to validate that the evolving product will provide what is required and discovery, prevention and correction of engineering process errors must

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continuously be performed. Updated documentation with lessons learned and other actions captured limits the risk by integrating these actions in the way of working. Metrics enables evaluation of where improvements are needed, such as nonconformance management. Tools and process commonality ensures efficient and early design integration and limits late discoveries. Processes should be easily accessible for the employees including clearly defined responsibilities and accountabilities.

4 Benchmarking

4.1 Atlas Copco Industrial Technique Atlas Copco IT is developing and manufacturing industrial power tools and assembly solutions, supported by controllers and software. The tools are used to tighten bolts and screws, material removing, adhesive and self-riveting for several industries such as the vehicle and aerospace industry. There are several regulatory requirements and requirements for traceability as well as rigorous reliability requirements on the products depending on applications where they are used, for example what tool and torque a certain bolt has been tightened with in an airplane or a car. Some traceability requirements are very customer specific, some requirements are industry specific and some are internal requirements.

Atlas Copco IT is continuously improving their processes and methods to ensure quality products. The PD process is a governing process, based on a gate structure where specific documents and reports have to be completed reviewed before each gate. Atlas Copco IT acknowledges that development processes are important for collaboration between functions, for everyone to have a shared view on working methods and to avoid problems that could affect product quality. By harmonizing and standardizing support processes, the risk of a large spread in the quality of the deliverables is reduced. Some of the support processes under revision are the business case process, risk management process, requirement management process and design process. Except for standardizing documentation and clarifying process owners for each process, they see a need for providing material for a training package, to be able to offer training for employees.

A large initiative has been started the in the latest years where the organization has implemented a methodology called the Value Model, which is based on several methods, including lean and six sigma principles, with the purpose of creating value for customers, employees and owners throughout the PD process. Through this methodology front-loading and doing a large part of the research and development in the beginning of a process, has been implemented. A new perspective on the product development process has been developed, where product development is considered to start as soon as there is an opening for a business opportunity, and therefore the process now includes more phases.

Another part of the Value Model is product planning, where the customer values are central to safeguard product quality. The customer needs are the basis which must be verified throughout the PD process. This is highly relevant when choosing what projects and initiatives to run, instead of focusing on what technical solutions the company offers.

In the work of creating a unique product portfolio Atlas Copco IT has the ambition to include functions like service and operations, by cross-functional integration of different parts of the organization, in order to get opinions and inputs at an early stage. By involving people that work close to the product once it is out in the market, valuable knowledge and the product’s whole life cycle is

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considered early in PD when a new project is started, which increase customer value. They also see a need for involving suppliers, and the right suppliers, early in the process. Changing supplier between the prototype and 0 series can cause several issues late in the process, such as increased cost, quality and certification issues.

The company experiences great advantages with the method Voice of the customer, to get to know their customers. For example by arranging meetings with the customer and using a specific interview technique to acquire knowledge of what the customer prioritize and value the most. With this method the company representatives also tries to notice unspoken needs, which the customer might not be aware of themselves. Voice of the customer as well as research and technology are used as an input to the projects. During the projects product requirements are managed using a software tool.

Atlas Copco IT has made large efforts to improve and further define the role of the steering group. Clear roles and responsibilities are significant in the organization. Today there is a close collaboration between the steering group and the project group in product development, for example by setting up the plan for the project together, which means that everyone gets involved and a realistic view on what to be achieved. This has resulted in a more efficient product development with improved transparency.

Moreover, quality control activities on development projects are occasionally carried out, for example by examine how many projects have completed a specific document properly and the metrics highlight were improvements are needed.

Atlas Copco IT is focusing on effectively communicating information through visualization in several aspects. The project office is a physical room where the information is updated and easily accessible, to visualize and effectively communicate what decisions has been made, how resources are allocated and prioritization status. The room is accessible for all employees who are interested of the updates. To effectively communicate the project plan a summary of the project plan is visualized and the organization also distributes a monthly report of the progress of development projects, which is an efficient way of keeping the organization updated in the development work.

Summary

Atlas Copco IT experiences great benefits of the continuous improvement done in the organization regarding product development. Their work on defining processes, roles and responsibilities, creating commitment within the organization and enabling cross functional teamwork as well as management support has proved valuable so that a better consensus is created in the project work.

Further areas where they prioritize improvements are the requirement management process and further involvement of functions such as service and compliance.

4.2 Tetra Pak Tetra Pak is developing solutions for packaging and processing of food products, and there are many regulations and requirements on traceability, hygiene, energy consumption etc. The company has established a global product development process that is used within the whole organization for all products. The stated aim is to have a PD process that assures quality is built into the products.

Design engineering is done in the early PD process, knowing exactly how and what will be developed, so the rest of the process can focus on verification and validation of the product requirements.

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Tetra Pak highlights that it is vital to understand what the customer needs, which might not be the same as what they say they need. Before starting the work of defining a product, the customer needs have to be understood. Assessments about previous quality issues must be done and include these issues into new projects, to do right from the start.

Requirements on products are increasing, and violating a traceability requirement in their industry could result in termination of production for Tetra Pak’s customers. Therefore more focus and continuous improvements are demanded of the organization to handle requirements, i.e. systems engineering. Tetra Pak states that organizations able to meet new requirements fast have a great competitive advantage, and therefore they emphasize on embracing new requirements.

To manage the PD process they use a tool developed by the company. Engineering tools for models and drawings handles traceability and enable export control between systems as well as version management, preventing engineers to make mistakes.

Tetra Pak stresses the importance of requirement management and has seen great improvements since a large program on systems engineering was initiated throughout the organization, establishing clear roles and responsibilities, steering groups, the extent of quality assurance reviews etc. Everyone in the organization, both engineers and on the commercial side has been educated about requirement management and verification and validation, and trainings are held regularly. The V-model has also been built in the PD process, to break down the requirements and focus on system thinking. Traceability of requirements is established in supporting systems, enabling decomposition tracking, standards, system, stakeholder requirements and validation and keeping everything is in one system. Requirements can also be reused for other products, creating efficiency in the process. Test strategies and architecture strategies are also established early in the process to be sure of the testability of the requirement, which can result in the insight that the requirements were not measurable and therefore should be further decomposed. It has to be clear what the requirements must fulfill.

The organization also has implemented agile working methods, though they argue that to be able execute in an agile way it demands for a structure and total control over the requirements, to be able to fast adapt to new requirements.

Tetra Pak’s complete PD process is structured and quite detailed, with clear principles and several functions working in parallel to ensure the development work is done according to the strategies established, and with the possibility to do modifications if needed. The dialogue between the line functions, project manager and steering group is essential. Tetra Pak has key principles to secure quality in the PD work, such as functions working in parallel which also shorten time-to-market, ask and discuss the right questions at the right time and use the knowledge and resources in an efficient way.

Projects are started as soon as resources are allocated. The evaluation of quality lies on the system engineer, where meetings are held repeatedly in the PD process to review the design. The steering group is reviewing the projects from a commercial standpoint throughout the PD process and earlier involvement of product management has recently been added when specifying product requirements.

Technical reviews of documents are carried out and results in a recommendation to the steering group as a basis for their gate decision. Tetra Pak emphasizes on that a “no go” recommendation from the technical reviews is important when finding insufficient quality levels, because reversing the project and sorting out the issue will avoid costly claims in the future. The main responsibility of the PD project lies on the steering group, since they make the decisions of the projects.

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The line managers must take the responsibility to balance the organization by assigning less experienced engineers into projects while having support from the senior ones that then can support and coach several projects with their knowledge at the same time. In this way the senior engineers act mentors in their area of expertise in the organization. It also enables knowledge transfer in the organization in an efficient way. Tetra Pak sees this is a driver of developing quality products in the long run. Networks are also established with knowledgeable employees to educate others in a certain technology for example.

In case of large knowledge gaps before initiating a development project, technology concepts can be developed, to build knowledge, reduce the risk of starting a development project too soon and increase the maturity of the technology. Project development projects can then start when the technology is mature enough and to some extent run in parallel with the technology development project or start as the technology development has finished. For assessment of the technology readiness in product development Tetra Pak uses a general method called Technology Readiness Level (TRL). Sometimes the same people work in a technology concept and in product development project, to facilitate the handover. In the recent years a cross company tool has been implemented to screen new possible projects.

Further, Tetra Pak see an advantage with having the same engineers working in product development as with quality issues on installed base. In that way the knowledge of previous quality issues are used when creating new products, and the project members see the gain in doing right from the beginning.

Many initiatives and programs have been implemented by request of the management of Tetra Pak, to improve their processes, build quality into the process and work with continuously improvements. The structure of the organization is important to effectively handle the processes. They have also done several benchmarking and assessments of their performance.

Summary

Tetra Pak has established thorough processes with clear roles and responsibilities and regular trainings, to create a shared view on product development within the whole organization. The cross functional dialogue in PD as well as having senior engineers as mentors efficiently uses the knowledge within the organization. A structured and efficient requirement management with verification and validation is a great driver of product development and gives the company competitive advantages. Also, common support systems and tools are important to provide traceability.

4.3 Getinge Getinge is a world-leading provider of medical systems and the Maquet Critical Care division is developing anesthetic systems, ventilators and other equipment for hospitals and health care environments. The technology is highly complex with tough requirements and regulations on safety and performance. In their industry there are huge demands on documentation from agencies such as the American Food and Drug Administration (FDA).

The company has established a global product development process that is linked to the PD process at Getinge in Solna, for enabling a better process flow and fast, easy and efficient communication between different functions in the organization. It also makes it easy for following up and comparing results between departments. The PD process used is quite detailed and also has several support processes. The processes are continuously improved with respect to ease of use.

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There is an established formal test process where each step is described. There are many formal steps in the test process, and it includes the basic test flow of planning the tests, writing tests, running tests, reporting results and summarizing the whole test run. All artefacts, e.g. plans, test, test runs etc. are reviewed by either another tester, a system architect or quality engineer, and thus the test design is reviewed before the test can be run. The company also works with methods such as exploratory testing, where test engineers freely explores the system and openly design the test from their system knowledge and their domain knowledge as testers, to ensure the product is reliable and fulfill all requirements.

They are using a requirement management software tool, for managing the product requirements as well as risk management. Further, they work actively with defining what a requirement is and what the appropriate requirement for the system is, in order to test the system in the most efficient way.

A test tool is used, which can be synchronized with the requirement management system, for establishing connection to the requirements and clearly visualize what requirements are fulfilled and the result of the testing. It is a great advantage to have the connection of risks and requirements to the test results, and allows for traceability as well as visibility of the complete result. In addition, visual reporting of e.g. test results, requirement coverage etc. can easily be created.

The organization has implemented agile working methods to help teams respond to unpredictability through incremental, iterative work, and they see that the organization now is more tolerant and can adhere to changes better and in that way more efficiently deliver value to the customer with shorter lead times.

Significant for management is the needs of the company as a whole, instead of focusing on individual groups or functions, to best achieve its goal. When implementing agile methods an important aspect was to focus on teams delivering value. In the past they had experienced challenges with handovers and deliveries in the interfaces between the functions. Now the whole organization is working in teams, and the product development projects are built from the teams. By integrating a complete team in the product development, moving away from assigning a specific person to a specific task according to that person’s knowledge, they see great advantages. A whole team is working on a specific task in a project, and the team together is responsible for the delivery and the quality of that delivery. Sometimes only one in the team is working on a specific activity, in other cases it could be that all members of the team must learn something new, but the responsibility is always shared. The effort of establishing well-functioning cross functional teams is continuously a high priority of the organization.

The teams work in sprints, often 2-3 weeks, and the whole team is involved in planning for each sprint. In the end of the sprint there is time for reflection, where the team is stating learning points of what worked well and not so well. In this way continuous improvements in the projects are established. During the project a lot of quality assurance is done, preferably as early as possible in the development cycle and well before the System verification phase. Within the project there is a clear priority of what needs to be done and the scope is reconciled with management and marketing department.

Pulse meetings are established, and visualized in a pulse room. Team leaders and project managers can bring up any obstacle or problem for the progress of the project work. Also resources and the product portfolio management are done using pulse meetings.

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Summary

Getinge has experienced many advantages with agile methods and working in teams to share workload and increase efficiency of the organization. By using agile working methods and by efficient teamwork to share workload, Getinge manages to proactively design for quality. Furthermore, an improved product reliability and quality is achieved thanks to their requirements verification and validation process. The company is continuously improving their processes and has thorough methods and systems to handle requirements and connect them to verification and validation to guarantee traceability during product development.

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5 Internal interviews Very valuable information and insight in the strengths and improvement areas in product development at HSS R&D emerged from the internal interviews. There was a wide range of areas of discussion, both as an effect of the open interview questions and that the organizational affiliation of those interviewed was widespread. Some interviews were on a more detailed level in a specific area and some in a more general form. During the interviews it was observed that many of the respondents appreciated and valued the extensive technical competence and knowledge among the employees in BU HSS at Alfa Laval.

Several areas were highlighted by many interviewees as important for assuring product quality, and which could serve as areas for improvements. These included:

• Testing – Not only testing the known risks and requirements but also test for unknown risks and test the limits of the product. Verification needs to be done early and continuously in product development. Field tests are crucial for validation with the customer.

• Requirement management – There is improvement potential in how the requirements are defined and how these are verified and validated. It must be possible to trace the requirements, i.e. being able to find the source and origin of each requirement and track changes that have been made to the requirement. Design/test plans etc. must start from measurable requirements and the output, such as test reports, must correspond to these, to ensure the product fulfills technical and market requirements.

• Interaction between functions – Communication and cross functional team work is a key to preventing problems in the PD, therefore incorporate functions like product care and operations earlier in PD and throughout the process. Also misunderstandings and insufficient information can be prevented or efficiently handled with effective communication which reduces costs. The dialogue is crucial to keep everyone updated and provide conditions to do right from start.

• Commitment and clarity of important activities from managers – It was clear in the interviews that if there is no one demanding a certain task/information, the result is often that it will not be done. As stated in the literature study of this report, top management support and commitment is one of the key factors for successful product development.

• Clear processes in the PD – It is clear that the knowledge about design and development work is extensive, but the procedure of efficiently accomplish the task needed in the product development needs to be further defined. There is a need of defining clear activities, inputs, outputs, roles and responsibilities for each function to raise awareness and create a thorough understanding of what needs to be done in the development work. A clearer common picture throughout the product development which shows how various activities are linked would improve consensus.

• Documentation – The documentation such as design guidelines and reports needs to be updated and handled in a more efficient way and enable reuse of the documented knowledge.

Generally, the respondents thought that the quality aspect of the product should be assured in the line functions. However, it was also suggested that support can be provided by a quality function in the project to highlight certain areas to accomplish thoroughly.

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6 Discussion The biggest challenge making quality a philosophy in product development is not related to the technical competence or technology development, but rather to improve the flows of information and knowledge by making the processes visible and clear and create a consensus in the organization. In addition, as the efficiency and productivity increases, there is a need to make these flows more flexible and agile. A number of areas have proved particularly important prerequisites for successful product development and thereby create a basis for Design Assurance. The areas that stand out in the literature are also the same as those highlighted by benchmarking against other companies. Also, there are several similarities with the identified areas from the internal interviews. A summary of each area is provided below:

Product strategy

As described by Cooper & Kleinschmidt (1995); Fazilah, et al. (2014) new product strategies should define a common purpose for the organization and something to work on together. If the areas specified in the strategy describe many different markets, technologies or product types the project portfolio might become unfocused over time since it’s containing unrelated projects. Benchmarking at Atlas Copco, Getinge and Tetra Pak all described clear product strategies that radiate product development. The project portfolio should be linked to the strategy and the strategy is fundamental for the effort of a business’ new product.

Internal culture

Through developing an open minded, supportive and professional leadership the corporate culture will contribute to new product development, as shown in success studies such as Cooper & Kleinschmidt (2007); Fazilah, et al. (2014). Cooper & Kleinschmidt (2007) also states that the probability of success is higher the more resources, such as adequate people and money, and attention top management allocates to a PD project. Peterson et al (2012) describes that the most important task of top management in Lean strategies are to educate and coach the whole organization of what the values and principles are and request consistent behavior in the organization. Basu (2014) states that factors such as communication, leadership and customer involvement are embedded in the culture of the organization.

To establish a climate for innovation Fazilah, et al. (2014) advocate it is crucial that organizations accept and allow risk, encourage experimentation and failure.

Well established processes

The product development process itself is a tool for assuring quality products are achieved in an organization. PD processes with focus on quality of execution is found to be one of the key drivers of performance in new product development as shown by Cooper & Kleinschmidt (2007); Fazilah, et al. (2014); Nepal, et al. (2011). Clear and easy visualized processes is a central system and enable improvement of performance by integrating best practice, design activities, tools etc. in the system. Lean and agile methods also require robust and flexible processes to provide a structure that enable continuous improvements. Aguilar (2009) states that easily accessible processes are utilized by the employees, and employees will follow the process and improve the process documents once they understand the processes they are responsible for and have documented the best practice of them. Experiences from all the companies Atlas Copco IT, Getinge and Tetra Pak confirm the importance of clear and visualized processes with roles and responsibilities to effectively clarify what each function

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in PD should accomplish as well as creating a consensus in the organization. There is also a large focus on continuously improving PD processes at the companies.

Cross functional team work

Morgan and Liker (2006); Peterson et al (2012) explain the importance of having shared and communicated values and principles within the organization. The intention is that they shall radiate the whole organization and lead the organization to flow orientation. Lean, agile methodologies and concurrent engineering as described in the literature all focus on cross functional team work. The importance of effective and structured development organization is emphasized by Thomke and Reinertsen (1998); Morgan and Liker (2006); Zhu, et al. (2009); Nepal, et al. (2011) with the intention to minimize problems related to communication or transparency, through implementation of cross-functional teams and incorporating suppliers in PD. The effort ensures expertise from several areas of development work is represented to enhance product quality. Benchmarking at all three companies in this study confirmed this, where communication is described as key and integrating different functions at the right time to make sure their aspects are covered in the development of new products is a high priority. Also the internal interviews suggest further integration of certain functions such as service, operations etc. Cross functional teams with short frequent project meetings ensure the whole team is updated and is a crucial factor for PD according to Cooper & Kleinschmidt (1995), Fazilah, et al. (2014).

Requirement management and validation capability

As experienced by Atlas Copco IT, Tetra Pak and Getinge product requirements must be efficiently handled during PD, and the requirements and validation capability aim to provide a holistic view across product software and hardware requirements. It enables teams to manage the impact of change by associating requirements with specific product structures and design content. As described by Aguilar (2009); Hall (2016) as well as the benchmarking companies, with bidirectional traceability between customer needs, market requirements and the underlying technical requirements, you can ensure that customer and market requirements are satisfied by designs and properly verified during development. Benefits:

• Improves productivity — Easily understand the relationships between requirements and product structures and leverage a single, common change process for managing both requirements and hardware and software components.

• Facilitate collaboration — Ensure groups and departments have a unified definition and selection of requirements.

• Accelerate time-to-market — Identify requirements that are not being met or do not have appropriate verification plans.

• Improve market success — Monitor how well a product complies with customer expectations.

The conditions described above enables a more efficient product development, creating more value and thus forming the basis for Design Assurance. As seen in this study, these areas are managed in different ways in methodologies such as Lean and agile product development, and it’s important to recognize that these factors remain the focus for different methodologies, that tend to be formed around these identified factors, making sure they are taken care of in a proper way.

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To discover, prevent and correct process errors or escapes earlier in the product life cycle, Design Assurance efforts are central (Aguilar 2009). When maturity levels enhances, DA activities are embedded in various processes of a company. The key Design Assurance elements identified in this study are:

• Document management – A secured documentation system with product requirements linked to quality goals, all project documentation properly stored.

• Change management – Effectively handle and integrate changes that affect the product or processes.

• Nonconformance management o Corrective and preventive actions – Prevent problems from reoccurring through

efficient and structured handling, reporting and follow-up. • Risk management – Objective and regular evaluations of risks in the project. • Lessons learned – Experiences from old projects and an overall description of how the project

developed and met its objective must be summarized to benefit future projects. • Product quality follow up – Describe product quality benefits to be gained from the project

and evaluate product performance efficiently and structured once it is closed for further improvements.

Figure 15 below illustrates Design Assurance with these aspects and actions in the center, while the overall success factors for the concept that are considered essential to successfully be able to implement DA, are illustrated in the outer circle.

Figure 15. Design Assurance and its essential pre-conditions.

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7 Conclusions This master thesis has discussed several aspects fundamental for ensuring product quality in the design stage of new product development processes. Design Assurance is one of many concepts which focus on this area. In the literature the concept Design Assurance leaves much to be desired, though it is wide and adaptable concept which enables each organization to develop it in their adequate discretion.

During this study it has been clear that there are several factors influencing the product quality. There are many similarities in highlighted areas by the literature as well as companies developing new products. Factors that are concluded as essential and prerequisites for successful Design Assurance in an organization are:

• Product strategy • Internal culture • Well established processes • Cross functional team work • Requirement management and validation capability

This study concludes Design Assurance with a number of key factors identified as:

• Document management • Change management • Nonconformance management

o Corrective and preventive actions • Risk management • Lessons learned • Product quality follow up

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8 Recommendations for future work The target for this project was to create an overview of how product quality is ensured during product development and how to implement a Design Assurance perspective. Next step for any organization interested in improving assurance of product quality during development is to apply these findings and optimize the identified areas from the result of this study into their specific business. Different organizations have their own unique conditions and critical aspects, therefore an evaluation of how to apply Design Assurance in the most suitable way must be done by considering the existing organization, working methods and critical activities.

For example, as seen in the result of this study, processes in product development are identified as an important support for managing information and knowledge flows in an organization. For that reason, any organization that concludes low process maturity must prioritize enhancement of that area, rather than starting with controlling DA activities. Another example is the importance of cross functional teamwork in multinational organizations, which often is a challenge that needs to be prioritized to ensure successful product development.

Since the study had a wide overview perspective, there is great potential for future work in narrowing the viewpoint and in more detail evaluate and establish guidance in how Design Assurance is managed and applied in specific functions and departments.

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Appendix Interviews, dates

Manager Product Maintenance 11/10 2016

Compliance Process Manager 4/10 2016

Quality Improvement Specialist 9/11 2016

Project Office Manager 18/10 2016

Project Manager, Marine 18/10 2016

Senior Project Manager 22/11 2016

Quality Engineer & PTD Claim Process Owner 14/10 2016

Manager Design & Product Quality Improvements 19/9 2016

Manager Product Management 1/11 2016

Platform R&D Manager 5/10 2016

Platform Manager, Food & Industry 5/10 2016

Quality and Environmental Manager, Eskilstuna 26/10 2016

R&D Manager 18/11 2016

Business Centre Manager 24/10 2016

Development Engineer, Testing Technology 21/11 2016 Design Manager 31/10 2016

Supplier Quality Assurance Manager 22/12 2016

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Appendix Standard interview questions, examples

- What is your role in new product development?

- What, in your opinion, is most important to develop high quality end products?

- What do you think are Alfa Laval’s strengths when it comes to product development?

- What areas could be improved when it comes to product development?

- How, in your opinion, is the acquired knowledge taken care of in product development?

- How is the previous acquired knowledge used?

- What areas could be improved to enhance quality of the end products?

- What do you think need more focus to better ensure the right product is developed?

- If you had the possibility the change one thing with the purpose of improving the quality of the products developed, what would that be?