Candela Technology AB
School of Innovation, Design and Engineering
Implementing FMEA for Scaling Start-ups: A Case
Study of Adaptation for Overcoming Novel
Technology Challenges
Master thesis work
30 credits, Advanced level
Product and process development
Robert Kinisjärvi
Supervisor (company): Niklas Nordin
Supervisor (university): Filip Flankegård
Examiner: Sten Grahn
ABSTRACT
Background
A start-up cannot simply be considered a smaller version of an
established company. They often rely on short and informal
development processes because they lack data and experience from
implementing similar projects in the past. These factors are among
those that lead to lower success in organizational performance and
new product launches. The NPD process is well researched, but these
studies are often on larger companies, and the applicability for startups is highly questionable. One of these NPD tools is the FMEA.
FMEA has been proven and established for decades in various
industries. However, these success scenarios often depend on
sufficient resources in terms of staff and project budget. Start-ups
often lack the resources to deal with major NPD project failures,
which can be disastrous for their survival in their market.
Despite the innovative benefits and economic growth that start-ups
contribute to when they are successful with their NPD projects, there
is little research on how established tools for large companies should
be adapted. Therefore, these research questions were formulated to
fill the gap in the current FMEA method:
Research questions
RQ1: What are the challenges for start-ups when implementing
FMEA?
RQ2: How can FMEA implementation be adapted for start-ups
overcoming novel technology challenges?
Method
The study consisted of a literature review and a case study. The
literature review examined the key factors for FMEA implementation
and the differences between start-ups and established companies. The
challenges for start-ups implementing FMEA were the central
question of the literature review.
The case study was conducted in a start-up company. An adapted
FMEA method and template were created there. A workshop and ten
interviews were held with a variety of representatives.
Findings
The results show that the biggest challenge for start-ups
implementing FMEA is that it is too complex, unclear, and often too
extensive. This can be changed by simplifying the FMEA, focusing
on the critical risks, and ensuring that the sessions are not too long.
The proposed FMEA method is easier to use with a simplified risk
assessment and fewer columns. It was found that it also is equally
important to train users, hold short meetings, and limit the size of each
FMEA session.
Keywords: FMEA, start-up, NPD
SAMMANFATTNING
Bakgrund
Ett nystartat företag kan inte enbart ses som en mindre version av ett
väletablerat företag. De förlitar sig ofta på korta och informella
utvecklingsprocesser, ofta för att de saknar data och erfarenhet från
liknande projekt tidigare. Dessa faktorer leder till sämre framgångar
gällande organisatorisk prestanda och introduktion av nya produkter.
NPD-processen är väl undersökt men dessa studier hänvisar ofta till
större företag, och implementeringen hos nystartade företag är
tveksam. Ett av dessa NPD-verktyg är FMEA.
FMEA har varit en välbeprövad och väletablerad metod inom flera
sektorer under decennier. Men dessa framgångsscenarier är ofta
beroende av en tillräcklig mängd resurs i form av personal och
projektbudget. Nystartade företag saknar ofta dessa resurser för att
hantera de stora misslyckandena i NPD-projekt, vilket kan vara
kritiskt för deras överlevnad.
Trots de innovativa fördelar och ekonomiska tillväxt som nystartade
företag bidrar med när de lyckas med sina NPD-projekt finns det lite
forskning om hur de etablerade verktygen för stora företag ska
anpassas. Därför formulerades dessa forskningsfrågor för att ta itu
med luckan för FMEA-verktyget:
Forskningsfråga
RQ1: Vilka är utmaningarna för nystartade företag när de
implementerar FMEA?
RQ2: Hur kan FMEA-implementeringen anpassas för nystartade
företag som utvecklar produkter med nya tekniska utmaningar?
Metod
Arbetet bestod av en litteraturstudie och en fallstudie. Vilka
nyckelfaktorer är viktiga för en lyckad FMEA-implementering och
skillnaderna mellan nystartade företag och etablerade företag
undersöktes i litteraturstudien. Huvudfrågan för litteraturstudien var
de utmaningar nystartade företag har vid implementering av FMEA.
Fallstudien utfördes på ett nystartat företag. Där en anpassad FMEAmetod och mall skapades. En workshop och tio intervjuer
genomfördes med representanter för olika delar av organisationen
Slutsats
Resultaten visar att de största utmaningarna för nystartade företag
med FMEA-implementering är att det är för komplext, är otydligt och
ofta för omfattande. Detta justeras genom att förenkla FMEA-mallen,
fokusera på de kritiska riskerna och se till att mötena inte är för långa.
Det nya FMEA-verktyget är enklare att använda med en förenklad
riskuppskattning och färre kolumner. Det är också lika viktigt att
utbilda användarna, ha korta möten och begränsa omfattningen.
Nyckelord: FMEA, Nya företag, Utveckling av nya produkter, NPD
ACKNOWLEDGEMENTS
First, I would like to thank Candela for the opportunity to write my thesis and conduct the case
study at your company. A big thank you to Niklas Nordin, my supervisor at Candela, who has
been very supportive and trusting throughout the period. I would also like to thank all the
respondents who participated in the interviews. Without you, it would not have been possible to
complete this study.
I want to thank my supervisor at Mälardalens University, Filip Flankegård, who took the time
to read the report and gave me valuable suggestions during the writing process. I would also
like to thank my classmates who gave me helpful advice while writing the report. Thank you,
Sten Grahn, my examiner, for your guidance during the study.
Finally, I would like to thank my family. A special thanks go to my fiancée, who was patient
and let me use the kitchen table to store all printed articles and books during the thesis work.
Thank you!
Robert Kinisjärvi
Stockholm, 4th of June 2023
TABLE OF CONTENT
1
INTRODUCTION .................................................................................................................................... 1
1.1
1.2
1.3
1.4
2
THEORETICAL FRAMEWORK .................................................................................................................. 4
2.1
2.2
2.3
2.4
2.5
2.6
3
ANSWERS TO THE RESEARCH QUESTIONS .........................................................................................................48
GOAL FULFILLMENT ......................................................................................................................................51
DISCUSSIONS ...................................................................................................................................... 53
6.1
6.2
6.3
6.4
7
PHASE 1: COMPANY'S PREVIOUS FMEA EXPERIENCE ........................................................................................35
PHASE 2: EMPIRICAL FINDINGS ......................................................................................................................35
PHASE 3: IDEATE A NEW METHOD...................................................................................................................38
PHASE 4: TEST ............................................................................................................................................42
PHASE 5: LEARN..........................................................................................................................................43
FINDINGS FROM CASE STUDY .........................................................................................................................46
ANALYSIS ........................................................................................................................................... 48
5.1
5.2
6
RESEARCH APPROACH ..................................................................................................................................22
RESEARCH PROCESS .....................................................................................................................................23
LITERATURE REVIEW ....................................................................................................................................24
CASE STUDY AND ANALYSIS ...........................................................................................................................25
QUALITY OF STUDY ......................................................................................................................................33
CASE STUDY ....................................................................................................................................... 35
4.1
4.2
4.3
4.4
4.5
4.6
5
PRODUCT QUALITY AND RISK IDENTIFICATION IN NPD ......................................................................................... 4
FMEA ........................................................................................................................................................ 6
TYPES OF FMEA ........................................................................................................................................... 9
CHALLENGES WHEN IMPLEMENTING FMEA......................................................................................................14
START-UPS .................................................................................................................................................17
CONCEPTUAL FRAMEWORK ...........................................................................................................................19
METHOD ............................................................................................................................................ 22
3.1
3.2
3.3
3.4
3.5
4
BACKGROUND............................................................................................................................................... 1
PROBLEM STATEMENT.................................................................................................................................... 2
AIM AND RESEARCH QUESTIONS ...................................................................................................................... 2
SCOPE AND LIMITATIONS................................................................................................................................. 3
DISCUSSION OF THE PROCESS .........................................................................................................................53
DISCUSSION OF THE ADAPTED FMEA METHOD .................................................................................................53
CONTRIBUTION TO RESEARCH ........................................................................................................................55
CASE COMPANY RECOMMENDATIONS ..............................................................................................................55
CONCLUSIONS AND FUTURE RESEARCH ............................................................................................... 56
7.1
7.2
CONCLUSIONS.............................................................................................................................................56
SUGGESTIONS FOR FUTURE RESEARCH .............................................................................................................56
REFERENCES ................................................................................................................................................ 57
APPENDIX ................................................................................................................................................... 60
LIST OF FIGURES
Figure 1. “Rule of ten” inspired by Punz et al. (2011). ................................................................ 5
Figure 2. Importance of the conceptual design phase, inspired by Punz (2011).......................... 6
Figure 3. Type of FMEA inspired by Sharma et al. (2018) ....................................................... 10
Figure 4. DFMEA information flow, inspired by Carlson (2012) ............................................. 11
Figure 5. PFMEA information flow, inspired by Carlson (2012) .............................................. 12
Figure 6. Illustration of interfaces and interaction considered in an SFMEA, inspired by VDA
(2020) ......................................................................................................................................... 12
Figure 7. Scale illustrating all RPN values with their frequency. .............................................. 17
Figure 8. Relationship between rule, observation, and result (inspired by Säfsten et al, 2020) 23
Figure 9. Research process. Illustrated by the author. ............................................................... 24
Figure 10. Case study process. Illustrated by the author. ........................................................... 26
Figure 11. Picture of the Candela C-8. ....................................................................................... 27
Figure 12. Rendering of the AFS for Candela C-8. ................................................................... 28
Figure 13. Rendering of the FFS for Candela C-8. .................................................................... 28
Figure 14. Case company product structure, subsystem names removed by author .................. 29
Figure 15. Subsystems considered in the FMEA workshop highlighted by the author ............. 33
Figure 16. The research question ties knowledge and purpose with method and validity
(inspired by Säfsten et al, 2020) ................................................................................................. 34
Figure 17. Illustration of the input that generated the new FMEA method, by the author ........ 38
Figure 18. Overview of actions for FMEA columns, inspired by Puente et al. (2002) ............. 40
Figure 19. Start-Up FMEA Template, by author ....................................................................... 40
Figure 20. Illustration of the decision system proposed, inspired by Puente (2001) ................. 42
Figure 21. One part of the filled FMEA sheet from the workshop ............................................ 43
LIST OF TABLES
Table 1. FMEA criteria guideline for Severity, Occurrence, and Detection, inspired by Stamatis
(2003) ........................................................................................................................................... 8
Table 2. FMEA Steps by Krasich (2007), Liew et al. (2019), Sankar et al (2001), and Sharma et
al (2018). ...................................................................................................................................... 9
Table 3. Fields in a standard FMEA report inspired by Puente et al. (2001) ............................... 9
Table 4. Illustration of overlaps of different subsystems, inspired by VDA (2020) .................. 13
Table 5. RPN extreme scenarios, inspired by Stamatis (2003). ................................................. 15
Table 6. Fifteen different scenarios with an RPN equal to 360. ................................................ 16
Table 7. Statistical RPN data, adjusted from Sankar & Prabhu (2001). .................................... 16
Table 8. Recommendations for FMEA adaptation..................................................................... 21
Table 9. Results from the search for literature ........................................................................... 25
Table 10. Summary of themes used in the first round of interview guide and coding .............. 31
Table 11. Summary of themes used in the second round of interview guide and coding .......... 31
Table 12. Extracted data for the first round of interviews ......................................................... 36
Table 13. Challenges and their objectives when performing FMEA ......................................... 38
Table 14. Objectives for FMEA adaptation ............................................................................... 39
Table 15. Actions for modification of FMEA template ............................................................. 39
Table 16. Categories for "S", "O" and "D" indexes, proposed by Puente et al. (2001) ............. 41
Table 17. Categories for the output variable of the decision system, proposed by Puente et al.
(2001) ......................................................................................................................................... 41
Table 18. Extracted data from the second round of interviews .................................................. 44
Table 19. Findings of the new FMEA ........................................................................................ 46
Table 20. Challenges and their objectives from literature review and case study ..................... 48
Table 21. Challenges and their key factors when performing FMEA ....................................... 48
Table 22. Objective fulfillment for FMEA adaptation ............................................................... 50
Table 23. Goal fulfilments and motivation ................................................................................ 51
Table 24. Categories for the output variable of the decision system, proposed by Puente et al.
(2001) ......................................................................................................................................... 53
ABBREVIATIONS
AFS
Aft Foil System
D
Detection
EM
Engineering and Manufacturing industry
EU
European Union
F
Failure
FC
Failure Cause
FE
Failure Effect
FFS
Front Foil System
FMEA
Failure Mode and Effects Analysis
FMECA
Failure Mode, Effects, and Criticality Analysis
H
High
L
Low
M
Moderate
MDU
Mälardalen University
NPD
New Product Development
O
Occurrence
OEM
Original Equipment Manufacturer
RPC
Risk Priority Category
RPN
Risk Priority Number
S
Severity
SE
System Element
SME
Small and Medium-sized Enterprises
U.S.
The United States
VDA
Verband der Automobilindustrie (German Association of the
Automotive Industry)
VH
Very High
VL
Very Low
1
INTRODUCTION
This chapter provides a background to the researched area. Then it describes the problem area
and thereafter the research questions and the aim of the study. Lastly, the scope and limitations
of the study and the procedure will be presented.
1.1
Background
Small and medium-sized enterprises (SMEs) are important to the global economy. Accounting
for more than 99% of all businesses in the United States (U.S.) and the European Union (EU),
they are significant contributors to innovation and economic growth. A better understanding of
the key success factors for SMEs is essential for the recovery and development of the
economies of the U.S. and EU (Ledwith & O'Dwyer, 2008; Marion et al., 2012; Nicholas et al.,
2011; Teng & Ho, 1996). The definition of an SME varies and depends on the industry,
country, or individual involved. For this research, the simplified definition of de Waal and
Knott (2019) is applied – the number of employees must be less than 250 employees. Other
characteristics and constraints for SMEs, in addition to their small size, are typically their
limited resources of time and money. This makes them more vulnerable to dealing with new
product development (NPD) projects that fail. All companies are affected and challenged by
global trends and competition, increasing complexity, and constant technological change
(Marion et al., 2012). SMEs are often in an excellent position to find new product opportunities
in this situation because they can benefit from their close working relationships with customers
and suppliers (Millward & Lewis, 2005). However, the researcher noted that much of the
research on NPD has focused on the situation of large and established companies, while
development for SMEs has been limited. SMEs also lack the resources to implement a formal
process with various cross-functional teams bringing in all the necessary expertise, which is its
biggest obstacle (Millward & Lewis, 2005). Due to this lack of research and knowledge on
NPD for SMEs, the NPD literature for established companies must be used as a framework for
in-depth studies of growth (Marion et al., 2012). SMEs face several challenges, such as a lack
of standardization, incentives, and focus on quality improvement and proper training of their
employees. They are often focused on their customers and fast deliveries. They are successful
if they are able to adapt to frequently changing conditions, train their employees and carry out
well-integrated innovation of products or processes. In contrast, large and well-established
companies are successful if they can maintain the flexibility and responsiveness of an SME.
The most important factors for SME growth are the adoption of technical processes, focus on
total quality, and investment in finding the best practices for their development and production
(Voss et al., 1998). Lacking standardized work instructions, they rely on highly skilled and
motivated employees to maintain or, in the best case, gain market share (de Waal & Knott,
2019; Voss et al., 1998). Start-up companies are according to Luger and Koo (2005), "new,
active, and independent" and often do not meet their customers' expectations, even if they have
a close relationship with them. Due to a lack of knowledge of customer needs, these companies
improve their products reactively to see what works, which amounts to a trial-and-error
approach to product development. A stronger and more risk-oriented focus during the NPD
project can prevent start-ups from failing (Sommer et al., 2009). A common theme among the
failures identified in SMEs and start-ups is avoidance of documented formal procedures, failure
to collect enough relevant data to track development, and an overly optimistic assessment of
their performance (Millward & Lewis, 2005). It is difficult to offer advice on these issues.
There are recommendations that it is better to let organizations make their own experiences and
adapt them internally later, as most tools require at least minor adjustments to meet the needs
of the team and reflect the implementation environment (de Waal & Knott, 2019).
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Failure mode and effects analysis (FMEA) is recognized as an effective method for reducing
the risk of failure in NPD projects and manufacturing processes. Several companies have
implemented this approach into their methodology. The automotive industry has improved the
method and made it a standardized tool throughout the supply chain, improving product
performance, achieving higher productivity, reducing costs, and increasing customer
satisfaction (Stamatis, 2003). Despite the success of FMEA in reducing risks and defects, most
research and experience with FMEA come from large companies, as it requires significant
project resources for efficient implementation. The constraints for SMEs and start-ups are
significant due to a lack of staffing, expertise in all areas, and limited project development
time, as well as inadequate knowledge of NPD management. They simultaneously struggle to
obtain training on quality tools and hire quality experts, which plays an essential role in the
execution of successful NPD projects (Ben Romdhane et al., 2016). FMEA is also influenced
by a standardized process that is well-suited for large companies. However, one of the main
characteristics of start-ups is the flexibility among employees and their approach (Voss et al.,
1998).
As far as the author is aware, no studies specifically address the adaptation of FMEA for startups. A few examined implementations for SMEs, but the author noted that there was no
discussion of how SMEs or start-ups can implement the proposed framework with their limited
resources. This indicates that there is a gap in the existing literature. The thesis study reviews
the barriers that start-ups during NPD and combine this with a literature summary of FMEA.
Then, this is considered along with the findings from a single case company to evaluate the
redesigned FMEA method and template. This evaluation will compare the adapted method to
the traditional method used by the case company, which is a scaling start-up company that
manufactures electric and hydro foiling boats that are a novel technology. The implementation
is tested in a single case study for one subsystem category.
1.2
Problem Statement
Start-ups often do not have the resources to deal with the major failures of NPD projects, which
can be catastrophic for their survival in their market (Marion et al., 2012). Consequently, since
the success and survival of a company are based on minimizing costs, time-to-market, and
improving product quality, these factors must be considered when developing new products
(Moreira et al., 2020). To address the NPD challenges for start-ups and overcome the
maladjustment that traditional risk assessment tools provide, this thesis work proposes an
adapted method and implementation of the FMEA model specifically tailored for typically
disorganized start-ups, specifically for scaling start-ups that want to develop a product with
novel technologies and ramping up their production.
Overall, there is insufficient evidence of the effectiveness of FMEA as a tool to support the
NPD process, and few empirical studies have examined the integration of risk management
practices proposed by various standards into NPD and their impact on project and product
success.
1.3
Aim and Research Questions
This study aims to understand the challenges for start-ups when implementing FMEA as a risk
management technique in their NPD process. The study also aims to develop recommendations
for improving the FMEA method used in start-ups.
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1.3.1
Research Questions
Two research questions were established to fulfill the aim of the study.
RQ1: What are the challenges for start-ups when implementing FMEA?
RQ2: How can FMEA implementation be adapted for start-ups overcoming novel technology
challenges?
1.3.2
Goals
To ensure the research question would be possible to answer, two goals were also established:
Goal 1: Find key factors for successful FMEA implementation.
Goal 2: Investigate differences between start-ups and established corporations for successful
NPD
1.4
Scope and limitations
The deliverable of the thesis work will be an adapted method and template for implementing
FMEA at start-ups. It should be easy to use and adaptable for the NPD projects of the case
company. This scope does not include an entirely new risk analysis method or FMEA strategy,
nor does it include performing a full FMEA analysis on the case company’s products. Rather,
the new FMEA method adapted for start-ups to the general method. The comparison will be
limited to a single risk analysis of one of the subsystems. It will be conducted for the hardware
components that control and adjust the boat's steering and pitch, as the author believes this is a
critical technology area and there have been previous attempts to identify risks in this area.
The adjusted FMEA model is focused on NPD within the context of the development and
commercialization of physical, assembled hardware products. The objective is to understand
FMEA challenges for start-ups and how these can be addressed. If possible, suggested
improvements and recommended design changes for the product affected by the NPD should
be provided. The adapted FMEA method and framework must be tested in an actual NPD
project. Since the scope is to understand the FMEA implementation for start-ups, no other
quality tools will be evaluated and compared to FMEA in this study.
The degree project comprises 30 higher education credits, which corresponds to 20 weeks of
full-time studies.
The thesis work is carried out by one student during the period 20230116–20230604.
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2
THEORETICAL FRAMEWORK
The following chapter will provide the theoretical framework related to the research of this
study. The chapter concludes with a conceptual framework summarizing the research to date.
2.1
Product Quality and Risk Identification in NPD
In the current difficult global economic climate, there are still opportunities for launching new
innovative products, creating new businesses, and even improving customer satisfaction
(Nicholas et al., 2011). Prioritizing innovation is therefore critical for companies that want to
achieve this or maintain their current market share, enter a new market, or simply prevent gross
profit from declining (Nicholas et al., 2011). The benefits of innovation lead to product
benefits, which have been defined as the perceived superiority of a product compared to
competitors or the benefits that customers derive from the product. Regardless of which
definition is preferred and chosen, both relate to the design, features, and quality of the product
(Ledwith, 2000).
For companies that are able to adapt to new markets, technologies, or competitors (or adapt to
current markets in transition), the key factor is the success of their new products. Despite the
importance of new product introduction to business survival, the success rate for new products
is still low worldwide (Ledwith, 2000). To overcome this, the focus must be on product
advantage, i.e., product design, product features, and internal quality to beat competitors and
meet customer value (Ledwith, 2000). This is usually done through NPD. Therefore, it is
important for companies to be successful with NPD because the result is marketable products
from potential market opportunities (Moreira et al., 2020).
In a report by Nicholas et al. (2011), scientists and practitioners find that the most important
element of NPD is strategy. The parts considered to be of medium importance to NPD and
follow the strategy in rank order are research, process, commercialization, and project climate.
The third level of importance is metrics and performance evaluations as key factors for
successful NPD (Nicholas et al., 2011). Other key factors for successful NPD implementation
are the ability of companies to be cross-functional and forward-looking, to continuously
improve themselves and their products by being customer-centric, and to execute a high-quality
process that is predefined in its measurements (Marion et al., 2012; Nicholas et al., 2011).
Developing new products is also costly and involves a great deal of risk. Development costs
can be as high as several million dollars, depending on how new the technology is (Novel
Technology) and its complexity. For extremely complex products, such as in the automotive
industry, the cost can exceed one billion dollars (Marion et al., 2012). To achieve the desired
functional performance of the product during NPD, the quality and reliability of the product are
critical. A well-organized and thorough quality system must be implemented as early as
possible in product development to achieve sufficient product quality. Since the best product
reliability is the designed one, this must be specified in the design requirements. To achieve
this, all engineers involved must consider their influence on product quality with their
development contribution at the system level (Teng & Ho, 1996).
Many NPD projects have to be postponed, the scope of delivery is changed, or the project is
simply abandoned (Bahrami et al., 2012). In developed countries, the success rate of new
products is only 15%, and a more general figure shows that the failure rate for new products is
around 40% (Moreira et al., 2020). To prevent this, scientific methods are becoming
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increasingly popular, as they can prevent product failure and identify risks at an early stage. In
general, the challenges of a project are due to the lack of efficient control of the risks.
Controlling the risks involved is crucial for managing NPD projects; however, the tools used
for these tasks are not yet widely known or commonly practiced (Bahrami et al., 2012). By
reducing risks in NPD, companies increase customer value and can also improve their
processes for future products. Therefore, NPD success is enhanced by identifying, assessing,
and eliminating risks (Moreira et al., 2020). Mitigating product risks that may result in not
meeting customer requirements is crucial. This is called failure and can have fatal
consequences for the success of a product. In addition to the NPD challenges posed by costly
projects and short product life cycles, the key is to develop and produce a product with minimal
failures. The earlier stages of product development have a major impact on this relationship, as
the impacts and costs associated with failure increase disproportionately afterward in the
project. This is illustrated in Figure 1, and this phenomenon is referred to as the “Rule of Ten".
“Rule of Ten” is an attempt to describe the negative effects and the failure costs for
compensating for the failures, which increase disproportionately with the progress of the design
activities (Punz et al., 2011).
Figure 1. “Rule of ten” inspired by Punz et al. (2011).
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Figure 2. Importance of the conceptual design phase, inspired by Punz (2011).
Figure 2 illustrates the high potential for product impact at lower costs compared to the later
stages of NPD. Risks can be classified as acceptable or unacceptable. The classification is
different for each organization, team, and individual and is influenced by financial
circumstances, technological environment, or management strategy. By mitigating risks early
in the NPD project, development teams can deliver the project more efficiently by preventing
the waste of resources in the form of time and money and reducing the risk of discovering
potential serious accidents and user injuries in later stages of development that could stop the
project. Some common methods used in NPD risk management are statistical rating and
ranking, probabilistic risk assessment, and FMEA. FMEA is one of the most well-known tools
in product development. As a tool, the FMEA identifies activities that systematically reduce or
eliminate potential defects and controls the documentation and implementation of the tasks
(Bahrami et al., 2012; Chauhan et al., 2018).
2.2
FMEA
FMEA is a systematic and analytical method used in a variety of industries, including
aerospace, automotive, nuclear, and medical (Bahrami et al., 2012). The tool was developed in
the 1950s for military systems and later adopted by the aerospace industry in the 1960s. Since
the 1970s, it has been used extensively by the automotive industry, which has fully
implemented FMEA for all affected organizations (Bahrami et al., 2012; Boldrin et al., 2009;
Prakash et al., 2017; Sun et al., 2022; Taylor, 1990). The U.S. Automotive Industry Action
Group (AIAG) and the German Association of the Automotive Industry (VDA) collaborated
and published a joint standard FMEA manual to standardize practice in the automotive industry
(Sun et al., 2022). The success of FMEA in developing and managing preventive measures has
been summarized in broader industry standards such as ISO9000:2015 and ISO9001:2015
(Boldrin et al., 2009).
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2.2.1
Functions and goals
FMEA aims to improve the reliability of a product or process and reduce the risk of defects
reaching the customer (Moreira et al., 2020; Sharma & Srivastava, 2018). By introducing
FMEA in the earlier stages of NPD, development teams can capture the complexity and risks of
the product, eliminate defects at the design stage, and prevent an unreliable product from
reaching the market (Ben-Daya & Raouf, 1996). The advantage, then, is to mitigate risks at the
concept stage rather than taking corrective action later, when products may have already
reached customers and the associated costs are higher (Bahrami et al., 2012; Teng & Ho,
1996). The method evaluates the requirements and identifies the failure modes associated with
them through systematic brainstorming to prevent the design, process, or system from failing to
meet the requirements (Chrysler LLC et al., 2008; Puente et al., 2002). This makes FMEA an
important tool because it helps companies reduce costs, minimize lead times, and improve
product quality, which is critical to a company's success and survival (Carlson, 2012). The tool
is used in three different scenarios: the first is when the design, technology, or process is new.
The second is when changes have been made to the design or process and the degree of change
determines the need for an FMEA, where it may be sufficient to focus on the specific changes
to the existing design. The third is when the manufacturing process has been relocated. The
perspective for these three aspects varies a bit, with the first scenario requiring an FMEA that
covers the entire design or process, while the second and third scenarios require a focus only on
the differences and changes applied (Teng & Ho, 1996). In addition, the FMEA method aims to
create, evaluate, and improve the development and verification methods to avoid errors
(Taylor, 1990).
When used as a living document, which means updating it throughout the product’s life, the
FMEA can also deliver input on design evolution and mitigations of the failure modes in the
past. According to Krasich (2007), the primary benefits of the FMEA analysis are:
•
•
•
•
•
•
documentation of failure modes detected in different design stages
records of the actions required and which actions were taken
developing policies and standard operating procedures (SOPs)
data on the action’s success or failure
evidence of risk reduction
a relative measure of risk reduction for individual failure modes
To summarize the role of the FMEA in NPD, Weeden (2015) captures its use as:
“An educated guess to determine the possible impact of a decision or action is far better than a wild guess
or no consideration at all” (P.4).
2.2.2
FMEA Procedure
The framework for the FMEA process is standardized and structured. Typically, it is an
iterative workflow that begins by defining which system, part, or process is to be considered as
part of the FMEA. It is important to define which underlying subparts, functions, or steps
should be considered and then categorized to ensure a focus on the area of concern through a
session of systematic brainstorming. Then, the potential failure modes for the subparts or
functions should be documented, followed by their effects and root causes, which need to be
identified (Liu et al., 2013; Puente et al., 2002; Taylor, 1990). The next part consists of a
criticality analysis of all failure modes. For this purpose, their respective severity is evaluated
7 (60)
and prioritized (Teng & Ho, 1996). The severity level should indicate the worst-case scenario
of the failure mode and represent the highest risk so that the most serious failure is ranked with
the highest number. Next it is time to grade the probability of occurrence of the failure modes,
with the failure that is most likely to occur receiving the highest score. The probability of
occurrence value often represents a relative number of failures to be expected during the life of
the product and should be estimated from known numbers if the product has been used in the
past, otherwise, it is estimated by the FMEA team (Sun et al., 2022). The next step is then to
rank the detection controls to identify each mechanism or cause of failure before the product
goes into production (Teng & Ho, 1996). In this process, the best controls result in the lowest
score and weaker areas should be given a higher score. Since detection is the most subjective of
the three types of ratings, the FMEA team can use the same detection rating for all failure
modes if it is not clear to estimate ratings for each cause (Ravi Sankar & Prabhu, 2001; Sun et
al., 2022). A guide for how the grading of severity, occurrence, and detection rating typically
are graded can be seen in Table 1.
Table 1. FMEA criteria guideline for Severity, Occurrence, and Detection, inspired by Stamatis (2003)
Grade S
1
No effect
2
6
Customer not
annoyed
Customer slightly
annoyed
Customer experience
minor nuisance
Customer experience
some dissatisfaction
Customer discomfort
7
Customer dissatisfied
8
9
Customer very
dissatisfied
Potential hazardous
10
Hazardous effect
3
4
5
O
Failure unlikely
Rare numbers of
failures likely
Very few failures likely
Few failures likely
Occasional number of
failures likely
Medium number of
failures likely
Moderate high number
of failures likely
High number of failures
likely
Very high number of
failures likely
Failure almost certain
D
Proven detection methods
available in concept stage
Proven computer analysis
available in early design stage
Simulation or modeling in early
stage
Tests on early prototype system
elements
Tests on preproduction system
components
Tests on similar components
Tests on product with prototypes
with system installed
Proving durability tests on
products with system installed
Only unproven or unreliable
techniques available
No known techniques available
These three assigned ratings of severity (S), occurrence (O), and detection (D) of defect types
are then combined by multiplying their rating number to produce a risk priority number (RPN).
The higher the RPN number of a failure mode is ranked, the higher the associated design risk
and criticality that should be considered for that failure mode in an FMEA. Thus, the purpose
of RPN is to enable a systematic approach where failures should be ranked according to the
score and to define which failures need to be prioritized in a quantitative approach by starting
with the failures with the highest number (Bahrami et al., 2012; Bowles, 2003; Puente et al.,
2002; Ravi Sankar & Prabhu, 2001; Sun et al., 2022). Lastly, the defining and agreeing on
actions for relevant changes to the current product or process is being performed. Before
starting to define the actions, a threshold must be agreed upon, to know which failure modes
need to be mitigated. To determine which specific RPN number sets the threshold for what is
considered acceptable and what needs to be changed, experience should be considered,
otherwise a recommendation is common sense, but a consistent approach must be taken for all
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individual rankings. Once the threshold has been established and the failure modes requiring a
recommended action have been decided, a response to the action should be assigned to take the
appropriate action. The goal is then to improve the situation so that when the RPN is later
recalculated with an improved design, it is below the accepted threshold. If not, the procedure
is repeated until all correlated and agreed-upon failures have fallen below the accepted RPN
number (Sun et al., 2022; Taylor, 1990; Teng & Ho, 1996).
The FMEA method is divided into the steps shown in Table 2 according to Krasich (2007);
Liew et al. (2019); Ravi Sankar and Prabhu (2001); Sharma and Srivastava (2018). The FMEA
steps to identify failure modes is then usually performed in a worksheet illustrated in Table 3
according to (Puente et al., 2002). Additional FMEA work templates can be found in Appendix
A.
Table 2. FMEA Steps by Krasich (2007), Liew et al. (2019), Sankar et al (2001), and Sharma et al (2018).
Step
1
2
3
4
5
6
7
8
9
Description
Establish the FMEA team
Describe the part name and function
List the potential failure modes, causes of failures, and their effects on the system.
Assign Severity, Occurrence, and Detection rankings to each failure mode.
Calculate RPN by multiplying the Severity, Occurrence, and Detection rankings
Identify high RPN failure modes and develop an action plan.
Define who will do what by when and take actions identified by the FMEA team.
Calculate the resulting RPN after implementation of actions.
Compare RPN before and after implementation of actions, to then re-evaluate each
potential failure once improvements have been made.
The initiative ends when RPN reduction is observed in step 9. Otherwise,
practitioners are required to return to step 7 to develop more robust actions.
10
Table 3. Fields in a standard FMEA report inspired by Puente et al. (2001)
Description, type, and aim of FMEA (Descriptive Information)
2.3
Risk Priority Number
(RPN)
Detection
Severity
Frequency
Action taken
Person in charge of
rectifying failure (13)
Results (14)
Recommended state
and action (12)
Risk Priority Number
(11)
Detection (10)
Severity (9)
Frequency (8)
Present Control
mechanisms (7)
Cause of failure (5)
Potential effect of
failure (4)
Potential failure mode
(3)
The parts function (2)
Part number
Existing Conditions (6)
Types of FMEA
Because FMEA can be used throughout the NPD process, its broad scope has evolved into
specific FMEA models for specific applications. Today, FMEA is often distinguished and
divided into separate parts of the NPD domains and used by separate teams depending on its
purpose. A common division of FMEA is into system FMEA (SFMEA), design FMEA
(DFMEA), and process FMEA (PFMEA). SFMEA examines the product before it is integrated
into a system and is usually used in a conceptual phase, i.e., at the beginning of the design
phase. DFMEA is used in the development phases and examines design flaws in detail.
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PFMEA focuses on the realization phase of a product and looks for failure modes in the
production and manufacturing (Breiing & Kunz, 2002). Illustrated in Figure 3 below, different
FMEA types are shown.
Figure 3. Type of FMEA inspired by Sharma et al. (2018)
2.3.1
Design FMEA
DFMEA is used to identify and prevent failure modes in a product or system related to design
(Sharma & Srivastava, 2018; Stamatis, 2003). The most important function is to identify the
risk of faulty parts that the customers risk receiving, as early in the design phases of NPD as
possible. The reason why the timing is critical for DFMEA is the threshold of the first
production run, related to the “Rule of Ten" (David et al., 2016; Punz et al., 2011). The
DFMEA process consists of reviewing functions, components, or systems against the general
steps. The focus is on reducing defects by defining technical solutions in response to functional
requirements. Therefore, all requirements must be included and based on customer (both
internal and external) needs, wants, and expectations (Carlson, 2012). The better defined the
desired features are, the easier it is to identify the potential failure modes. The design
engineering team must therefore strive to truly understand and define what the design is
intended to accomplish. Then, through brainstorming or using past records, potential failure
modes are identified, followed by their respective impacts and root causes (David et al., 2016;
Stamatis, 2003). Once the RPN numbers are assessed and prioritized actions for the prioritized
failure modes are either requesting a redesign to eliminate the failure, adding a verification test
to be performed, or implementing controls for the PFMEA performed later (Carlson, 2012).
The DFMEA is the summary of the FMEA team’s considerations for designing a component or
system and is also well suited for documenting the concerns raised that the designer typically
mentally goes over during the design process but may forget to mitigate (Stamatis, 2003). It not
only provides a ranked list of potential failure types based on their impact on customers but
also serves as a reference for future iterations or NPD projects. This type of lessons-learned
catalog should then be used to resolve real-world problems, evaluate design changes, and help
develop advanced designs. The FMEA must be a living document that is updated as design
changes are made during the life cycle of the product (Chrysler LLC et al., 2008; Ford Motor
Company, 2004). The typical flow of inputs and outputs of a DFMEA is illustrated in Figure 4.
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Figure 4. DFMEA information flow, inspired by Carlson (2012)
2.3.2
Process FMEA
PFMEA is a methodical strategy for identifying and mitigating potential failure modes that
occur due to production defects (Sharma & Srivastava, 2018; Stamatis, 2003). The best practice
prerequisite for PFMEA is the assumption that the design will meet its intended purpose
(Chrysler LLC et al., 2008). The PFMEA process is initiated by listing what the production
process should do and agreeing on what it should not do. In other words, defining the intent of
the process. An excellent method to assist in identifying the characteristics is flowcharts of the
general process (Ford Motor Company, 2004). The identified product effects found in the
corresponding DFMEA should be used in the calculation (Carlson, 2012; David et al., 2016).
As with the DFMEA, it is important to focus on finding the defects before production begins
because after this threshold, customers are affected, and the associated costs increase (Stamatis,
2003). However, the timing for PFEMA is more difficult because the input depends on the
completion of the DFMEA, and it is difficult to evaluate the production processes in the earlier
stages (Carlson, 2012). Often, the process assessment evolves and is best suited when used as a
living document to receive updates as the process evolves. In addition, feasibility and risk
analyses must be performed as solutions to failure modes are explored throughout the DFMEA
process (Ford Motor Company, 2004). What also makes the process complex are the tradeoffs
that must be made between quality, reliability, maintainability, cost, and productivity at the
expense of the other factors. The PFMEA examines everything from assembly operations,
manufacturing machines, methods, measurements, and tool maintenance aspects to make
process performance as efficient as possible by incorporating various technologies (Stamatis,
2003). The goal, however, is to minimize the potential for manufacturing defects and their
impact on the process or system. The main objective of PFMEA is to define, demonstrate, and
maximize engineering solutions to support the quality, reliability, and cost of the product that
reaches the customer (Chrysler LLC et al., 2008; Ford Motor Company, 2004). The typical
flow of inputs and outputs of a PFMEA is illustrated in Figure 5.
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Figure 5. PFMEA information flow, inspired by Carlson (2012)
2.3.3
System FMEA
SFMEA is a method used to identify and prevent potential failure modes associated with
different functions and subsystems at the system level (Verband der Automobilindustrie, 2020).
The SFMEA is often performed at the early concept phase on requested functions before
hardware is clearly defined. It is also sometimes referred to as Concept FMEA (Sharma &
Srivastava, 2018). The development of the stems from the fact that DFMEA focuses mainly on
potential failure modes at the component level and does not consider failures that result from
the interaction of multiple components. Later it was also clear that the PFMEA focuses on the
production step individually and not the complete manufacturing process, so the final SFMEA
was then an advancement of both the DFMEA and PFMEA (Ford Motor Company, 2004). Due
to its origin, the SFMEA is performed the same way as the DFMEA and PFMEA, but the
major difference is its focus on functions and relationships in the system. The benefit of the
method is that it makes sure the different solutions within the system are compatible with each
other and the interactions have been considered before advancing into complex full-scale
systems (Ford Motor Company, 2004). The identified failure modes are therefore associated
with the interfaces and interactions in the system (Verband der Automobilindustrie, 2020). To
help to illustrate the meaning of interfaces and interactions, Figure 6 has been constructed.
Figure 6. Illustration of interfaces and interaction considered in an SFMEA, inspired by VDA (2020)
12 (60)
The initial phase of the SFMEA involves structuring the entire system into system elements
and the various functions of the system. Later, brainstorming attempts to identify possible
failure modes that need to be analyzed. This helps in categorizing the system requirements and
the correlations between the elements, which are divided into “failure effects”, “failures”, and
“failure causes” for each function. To handle complex systems, it is important to determine the
overlaps of the SFMEA between different system levels. An example of this is when a
subcontractor sets their SFMEA to a specific and agreed-upon area, such as a specific
installation area for a subsystem in a vehicle. This helps the subcontractor understand the
interactions and interferences on the original equipment manufacturer’s (OEM) product and the
implementation of the supplier component in the OEM installation. The specific system
description is referred to as the “system element” (SE) and is used to keep focus for SFMEA
meetings in mind. SE serves as a support for communicating mutual boundaries and
maintaining SFEMAs at different system levels, as this is facilitated by determining overlaps
through the system element. Table 4 illustrates the overlaps and connections of the levels in the
SFMEA. Figure SE is integrated across three levels of its SFMEA, where at Level 1, the
failures of SE at the interfaces are “failure causes” (FC). In the further SFMEA, level 2, the
same fault of this SE is considered a “failure” (F). In level 3 of the SFMEA, the same failure
for this SE is the “failure cause” (FC). Since the method is applicable throughout the product
development and process planning phases, it also frequently overlaps with the other FMEAs
performed. Product system failures should be incorporated into the DFMEA of the affected
individual component, as appropriate. Similarly, failures in production process flows or
assembly steps should be included as input to the associated PFMEA, as appropriate. This
enables collaboration between engineering and manufacturing departments as the overlaps
consider these cross-functional relationships (Verband der Automobilindustrie, 2020).
Table 4. Illustration of overlaps of different subsystems, inspired by VDA (2020)
Lap Joint
↓
SE
FE
F
FC
FE
F
FC
FE
F
←
2.3.4
System
SFMEA, level 1
SFMEA, level 2
FC
SFMEA, level 3
→
FMECA
FMEA is a valuable method for identifying risks in a system and clarifying risk impacts (Ford
Motor Company, 2004). However, it does not always provide an adequate risk assessment for
every need. Extensions to FMEA have been developed to address some of these shortcomings.
One such extension is the Failure mode, effects, and criticality analysis (FMECA) approach,
which is widely used in the engineering and manufacturing industry (EM) (Stamatis, 2003).
FMECA is similar to FMEA but adds additional steps to classify the criticality of failure
modes. The additional criticality grading is the “C” that distinguishes an FMECA from the
FMEA. An example of an FMECA template can be found in Appendix A. Criticality refers to
the severity of failure consequences. It is ranked and categorized based on the potential risks
and hazards. However, these categories should be defined by customers or existing industry
standards. These two methods are common and can easily be used interchangeably, but
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FMECA adds the additional risk categorization and focuses on the criticality of the products
(Chrysler LLC et al., 2008).
2.4
Challenges when implementing FMEA
Although FMEA has proven to be one of the most efficient and important tools to prevent
defects, it has also been criticized. Apart from the fact that many companies only perform their
FMEA because it is a strict requirement of their customer, which is often an OEM. Another
limitation is that the benefits of the tool are not realized if it is only used as paperwork to meet
requirements (Krasich, 2007; Taylor, 1990; Wang et al., 2018). Other complaints were
summarized by Krasich (2007) in some quotes. The following citations show that FMEA itself
is not a measure of reliability, is not an independent method for determining product reliability,
and is not an independent method for reducing the occurrence of defects:
“A qualitative method of reliability analysis which involves the study of the fault modes which can exist
in every sub-item of the item and the determination of the effects of each fault mode on the other subitems
of the item and on the required function of the item”
“… a qualitative method of reliability analysis which involves a fault modes and effects analysis together
with a consideration of the probability of their occurrence and of the ranking of the seriousness of the
faults”
“Failure modes and effects analysis (FMEA) is a bottom-up, qualitative dependability analysis method,
which is particularly suited to the study of material, component and equipment failures and their effects on
the next highest functional system level” (p.278)
2.4.1
FMEA itself – not a measure of reliability
Among the benefits of implementing FMEA in NPD projects is that thoughts and concerns are
put on paper, it also often enables evaluation and finding corrective actions. Its potential as a
method, combined with the synonym of a completed FMEA sheet for dedicated risk mitigation,
has led automotive OEMs to demand it from their suppliers. This can lead to suppliers using
FMEA only as paperwork to meet customer requirements for these specific documents (Taylor,
1990). This is a waste of effort, time, and money, as simply adding the risks to a list does not
improve the product. Therefore, it is important to ensure that the FMEA process goes beyond
the documentation process, which can be supported by clear measures and using it as a living
document to compare improvements (Krasich, 2007; Teng & Ho, 1996).
2.4.2
Subjective
Another disadvantage of FMEA, and one reason why it cannot be a guarantee of product
reliability, is that it contains only the failure modes that the FMEA team has considered. There
is also a risk that the estimates and evaluations are subjective and based on experience,
brainstorming, or technical judgment. This risk is especially critical when developing a
completely new product for which there is no experience or previous data on which to base
estimates. Therefore, the estimated value approach may not reflect the actual parameters for the
parts produced (Krasich, 2007). In addition, there are often several viable solutions that can
reduce the RPN that the FMEA team must choose between. Since the FMEA model does not
rank the possible alternative recommended actions, the decision is often made subjectively by
the loudest meeting participant or simply by the manager (Bluvband et al., 2004). Thus, in
current methods, improved product reliability and quality are a comparison to the current state
or previous iteration. When attempting to quantify the impact of the improvements, it can be
14 (60)
difficult to motivate the detailed evaluation because the subjective variance in each evaluation
is stronger than the variance between items. The goal of FMEA is also to reduce RPN values
below the sometimes arbitrary threshold without improving the quality of the product design.
This is because the identified problems with RPN values below the threshold are pushed aside
because they have been classified as not to be considered (Bowles, 2003; Krasich, 2007).
2.4.3
Prioritization through RPN
The FMEA is effective and fulfills its objective when the RPN values of the correct topics fall
below the required target. Nevertheless, using RPN to prioritize between failure modes may not
be appropriate (Liew et al., 2019). The RPN principle can provide consistent results when used
correctly, is well established, and is considered straightforward and easy to understand from a
management perspective (Bowles, 2003). From a technical perspective, the method is
problematic because there are some challenges in analyzing and interpreting the data. In
implementing the common recommendations, which typically consist of the team taking
corrective action on the top 20-30% of RPN values or a certain absolute number of highest
priority issues (Bluvband et al., 2004). The problem is that the targets for which failure modes
must be considered can be arbitrarily selected because RPNs do not measure the potential
effectiveness of corrective actions and often the actions are not even measurable (Ben-Daya &
Raouf, 1996; Liu et al., 2013). Table 5 shows the extreme cases of RPN scenarios where it
would have been easier to pre-define actions, but this is not the case when performing an
FMEA assessment on real products (Stamatis, 2003).
Table 5. RPN extreme scenarios, inspired by Stamatis (2003).
Assessment rating
S
O
1
1
1
1
10
1
10
1
1
10
1
10
10
10
10
10
Causes of failure
D
1
10
1
10
1
10
1
10
Ideal situation (goal)
Assured mastery
Failure does not reach user
Failure reaches user
Frequent fails, detectable, costly
Frequent fails, reaches the user
Frequent fails w/ major impact
Trouble!
Action taken
No action
No action
No action
Yes
Yes
Yes
Yes
Yes, Yes, Yes, Yes
In the literature review by Liu et al. (2013) the biggest criticism of the RPN method for
prioritization is the fact that a precise rating of S, O, and D factors is nearly impossible. Also,
different combinations of the three factors often produce the same RPN value, and the relative
weighting between the three factors is not taken into account. For illustration, in Table 6,
fifteen different failure scenarios are presented and they end up with the same RPN value.
15 (60)
Table 6. Fifteen different scenarios with an RPN equal to 360.
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
Severity of
Problem
Hazardous
Hazardous
Hazardous
Hazardous
Hazardous
Hazardous
Hazardous
High
High
Moderate
Moderate
Moderate
Moderate
Moderate
Moderate
(S)
10
10
10
9
9
9
9
8
8
6
6
5
5
4
4
Likelihood of
Occurrence
High
Moderate
Moderate
Very High
High
Moderate
Moderate
High
Moderate
Very High
Moderate
High
High
Very High
High
(O)
9
6
4
10
8
5
4
9
5
10
6
9
8
10
9
Likelihood of
Detection
Moderate
Low
Very Remote
Mod High
Moderate
Remote
Impossible
Moderate
Very Remote
Low
Impossible
Remote
Very Remote
Very Remote
Impossible
(D)
4
6
9
4
5
8
10
5
9
6
10
8
9
9
10
The FMEA method relies on quantifying the three failure factors contributing to the product
being the RPN value. The problem with it being considered a quantified method is the lack of
precision of the input data. As an example, there is no defined rule to guide when the rate for
Severity value should be selected. Also, the Detection is traditionally only based on the
probability of the non-detection of failure or deviation for the produced part (Puente et al.,
2002; Ravi Sankar & Prabhu, 2001).
Table 7. Statistical RPN data, adjusted from Sankar & Prabhu (2001).
Incorrect assumptions
The average of all RPN = 500
50% of RPN values are above 500
There are 1,000 possible RPN values
Actual statistical data
The average RPN = 166
6% of RPN values are above 500
There are 120 unique RPN values
At first glance, the RPN values appear to be continuous and on a linear scale from 1 to 1,000.
But the 1,000 scenarios that result from the product of severity, occurrence, and detection yield
only 120 unique numbers. This means that there are many duplicate products within the 120
possible RPN values, with RPN values of 60, 72, and 120 being generated from 24
combinations of S, O, and D, respectively. In addition, there are 7 different RPN values that
can be obtained from 21 different combinations of S, O, and D. This also means that there are
many gaps between the different possible RPN values. Table 7 illustrates the normal wrong
assumptions about the RPN scale based on the actual statistical data and Figure 7 illustrates the
distribution of RPN values and the existing gaps between them. Since 88% of the values
between 1 and 1,000 are blank and the average RPN value is 166, interpreting the difference
between failure modes is difficult. Higher numbers are always considered more important than
lower numbers, but it makes it more difficult to compare the difference between 63 and 64 than
between 64 and 70. 63, 64, and 70 are the following possible RPN values, but the gap between
70 and 64 is much larger than between 64 and 63 (Bowles, 2003; Liu et al., 2013; Ravi Sankar
& Prabhu, 2001).
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Figure 7. Scale illustrating all RPN values with their frequency.
Another disadvantage of the RPN method is that it does not take into account the respective
importance of the three factors, S, O, and D (Liu et al., 2013). Since the estimation of the
different scores is ambiguous and there are several combinations of the three factors that give
the same RPN value (Bowles, 2003). There is a risk that lower defined RPN numbers are
potentially more dangerous compared to other combinations with a higher RPN value . For
example, a failure mode with a severity of 5, an occurrence of 4, and a detection of 6 may have
an RPN value of 120, giving it a much higher priority for action than another failure mode with
a severity of 9, an occurrence of 3, and a detection of 2, which has an RPN value of 54 (Ravi
Sankar & Prabhu, 2001). Even though in this example the risk from subsequent failure is
dangerous. So, the thinking must be that failures with a lower RPN ranking, but potentially
catastrophic consequences if they occur, must be at the top of the ranking (Puente et al., 2002).
This casts doubt on RPN as a reliable method. Therefore, RPN alone cannot be relied upon to
check each of these error types (Bowles, 2003).
2.4.4
Lack of Competence in Execution
Some consider the FMEA team to be the most critical success factor for a meaningful FMEA
implementation. In a list of the top ten reasons for FMEA failure, Johnson (2013) identified
four team-related reasons. The team-related problems are that only one person is responsible
for conducting the FMEA, the wrong facilitator (or no facilitator at all) leads the session, the
team is not trained in the method, and finally, management does not support the effort,
resulting in a loss of commitment. It is important to take a broad perspective to include not only
the knowledge and history of the internal development team, but the team should also consider
external stakeholders through customer feedback and internal staff, such as from production.
The last important capability for the FMEA team is knowing when to initiate and perform the
FMEA implementation. Starting the FMEA too late, when the design has reached a mature
stage, will make it more difficult and costly to implement the required changes (Johnson, 2013;
Puente et al., 2002; Taylor, 1990; Teng & Ho, 1996).
2.5
Start-ups
When the literature describes start-ups, it defines them with a combination of three criteria:
“new”, “active” and “independent”. New is the main distinguishing feature, i.e., the creation of
a completely new enterprise, which cannot have existed before in another enterprise. The next
criterion, active, refers to the fact that it must be engaged in trade in goods or services. The
necessity of the criterion of active inheritance establishes companies that exist only to avoid
17 (60)
taxes. The criterion of independence means that a company must not be a branch of a parent
organization, which is defined as a spin-off and not a start-up, even if it is legally independent.
From the three criteria discussed combined, Luger and Koo (2005) summarize a start-up as a
business entity:
“which did not exist before during a given time period (new), which starts hiring at least one paid employee
during the given time period (active), and which is neither a subsidiary nor a branch of an existing firm
(independent)” (P. 19).
In combination with the definition presented by Luger and Koo (2005) above, another
definition can also be defined that a start-up being a project. Which starts with a single idea and
an entrepreneur, that vests funding to start the start-up company. Thereafter the development
starts with a timeline, with milestones for the development and operations (Marion et al.,
2012).
2.5.1
New product development at SMEs & start-ups
Aside from size, the typical differences between larger companies and SMEs are that SMEs
often benefit from more organic decision-making processes, less resistance to change, and an
atmosphere that supports new ideas through good collaboration among functional groups. The
disadvantages for SMEs are the lack of resources (human and financial), external contacts that
are not yet established, and the unpredictable uncertainty associated with complexity and short
development timelines. In addition, SMEs often rely on learning through trial and error during
development. These disadvantages are among those that lead to less success in organizational
performance, new product introduction capability, and new product performance. Therefore,
SMEs cannot simply be viewed as a smaller version of incumbent firms (Ledwith & O'Dwyer,
2008; Nicholas et al., 2011; Sommer et al., 2009). It is obvious that small, new companies are
very different from large corporations, and therefore their NPD methods must also differ
(Marion et al., 2012).
The NPD process is well-researched and has been addressed in several studies. These studies
refer to larger corporations, which often employ thousands of full-time employees to carry out
the recommended actions (de Waal & Knott, 2019; Millward & Lewis, 2005). The strategies
are most appropriate when unpredictable uncertainties are low and sufficient resources are
available for the projects (Sommer et al., 2009). For large companies, NPD efficiency is
achieved by accelerating lead times for product development projects (Millward & Lewis,
2005). Literature reviews for SME NPD show that the main difference is the informal and
unstructured processes and the lack of adequate data. Due to these factors, the applicability of
best practices for SMEs can be highly questionable and is often not well implemented (Ledwith
& O'Dwyer, 2008; Nicholas et al., 2011).
According to Lyles et al. (1993), small businesses improve their decision making and gain a
more comprehensive understanding of their challenges when they adopt a more formal and
iterative planning process. Because SMEs already have short development processes compared
to large companies, which is the main improvement factor in the NPD best practices studied,
they run the risk of experiencing only the disadvantages of using short-cut activities because
they can lead to lower product quality. Especially because SMEs often lack data and
experience from implementing similar projects in the past. Therefore, using formal processes,
including an iterative process, gives SMEs a competitive advantage. This is because it allows
prototyping and testing to verify products rather than relying on proper design or learning
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through trial and error on customer products (Millward & Lewis, 2005; Sommer et al., 2009).
The excessive cost of NPD and uncertainty of market acceptance are the most common barriers
to innovation in SMEs. In addition, SMEs often struggle with informal and less structured
development processes, limited financial resources, and difficulties in attracting or retaining a
highly skilled workforce. These factors lead to major disadvantages, especially in the early
stages of NPD. For new product introductions to be executed with commercial success,
systematic planning to coordinate requirements, activities, and decisions is essential (De Toni
& Nassimbeni, 2003). The driving incentives are usually time-to-market, and evaluation
accuracy is often overlooked when development time is too short to know whether the
developed product will provide what the market demands. Thus, companies must choose
between “evaluation accuracy” and “speed to market” (Yahaya & Abu-Bakar, 2007).
2.6
2.6.1
Conceptual Framework
Synthesis of literature review – summary and additional contributions
FMEA has been proven and well-established in various sectors for decades. However, these
success scenarios are often associated with larger companies that have sufficient resources in
terms of staff and project budget. They are also associated with companies that have product
knowledge and historical data to incorporate into their NPD, where there are opportunities to
learn from past mistakes or align with established standards (Nicholas et al., 2011). The
literature review conducted covers FMEA adaptations for a few different sectors and
applications. In reviewing the most recent literature, to the researcher’s knowledge, no FMEA
model is described for start-ups and only a few for SMEs. Sharma and Srivastava (2018) has
performed a literature review of adapted FMEA implementations, but it lacks research on how
FMEA should be adapted to SMEs or start-ups with limited resources (Sharma & Srivastava,
2018). However, the literature has covered some of the various attempts to overcome the
limitations of FMEA by adapting the traditional method. Some of these methods include multicriteria decision-making, fuzzy if-then rule bases, and expected costs. These presented
solutions with their argued advantages have not been applied in real-world scenarios due to
their overly academic approach with advanced mathematical modeling and have not been
proven effective due to weak validation (Liew et al., 2019; Liu et al., 2013). These results have
also often been made even more complex by adding more steps, which is not valuable to SMEs
because the already large time commitment of FMEA may discourage them from using it.
Other suggestions relate to cost, although cost is not the most important factor for start-ups to
market or severity may be most important to having satisfied customers.
Existing literature on general risk management has largely focused on the use of FMEA to
identify risks during new product development (Carbone & Tippett, 2004). A recent review of
risk management research found only nine articles that specifically used FMEA for risk
assessment and evaluation in the context of new product development. These articles aimed to
extend traditional FMEA methods and develop new risk management frameworks for NPD
projects and systems (Carbone & Tippett, 2004; Moreira et al., 2020). Despite these efforts,
FMEA has been criticized for its limited use in design improvement, even though it has the
potential to identify high-risk problems and take preventive action before problems arise. Since
there is not sufficient evidence on FMEA
In general, the available evidence on the effectiveness of FMEA as a tool to support the NPD
process is insufficient. In addition, there are only a limited number of empirical studies that
have examined the incorporation of risk management practices from various standards into
NPD and their impact on project and product success. However, adapting the FMEA method
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by adjusting the RPN score and examining the relationship between S and O has shown that
additional failure modes are possible. Although FMEA can be challenging to implement, it is
shown to be suitable for NPD when used correctly (Moreira et al., 2020).
Moreira et al. (2020), in their case study of FMEA-based improvements, also state that the best
way is to prioritize problems mainly by severity and occurrence, either focusing the equally
rated risks on the highest severity or considering the detection rating as a divisor among the
risks. This is done using a chart in which the two rating scales have the same length and scale
size to represent S and O, respectively.
Liu et al. (2013) point out that FMEA becomes more effective in a variety of industries if the
selection of risk factors and the method of risk prioritization are appropriate and suitable for
specific problems. The major shortcoming of the literature review conducted was that the
relative importance of S, O, and D was not considered, which was the case in 60% of the
papers. It is therefore necessary to review the weighting method.
Moreira et al. (2020) suggest using a five-point scale instead of the usual ten-point scale when
selecting risk factors. This is to achieve greater consensus among team members on the scoring
values. Moreira et al. (2020) also suggest naming the priority rates with names rather than
numbers, such as high, medium, and low, to increase agreement. Regarding the relative
importance of failure types between S, O, and D, Teng and Ho (1996) opine that no matter how
low the probability of a high-severity failure is, it should still be on the priority list of problems
to be mitigated.
To summarize the findings in the literature, Johnson (2013) has conducted a list of the top ten
reasons why FMEA fails:
1. Making one person responsible for performing an FMEA
2. Performing FMEA in one session rather than stratifying the process to allow soak time
3. No Facilitator/Wrong Facilitator
4. Team Not Trained or Trained in Different Methods
5. Management Does Not Back Effort
6. The scoring system is not customized
7. The scoring system was not developed ahead
8. Agenda was not clear from the start
9. Try to take on too big an FMEA
10. Identifying failure modes but not prioritizing/mitigating the correct ones
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2.6.2
Key Takeaways and Recommendations
The main takeaway regarding RQ1 from the summary of the literature review is that
classifications become too subjective without adequate background information or data. The
FMEA method is complex and time-consuming, which does not fit start-up NPD processes in
the initial phase, where especially the discovery assessment is difficult to quantify. The
proposed solutions are then based on the synthesis of different literature results and gaps in
existing research. To overcome the identified weaknesses, the recommendations for a proposed
implementation model adapted to start-ups aim at the following solutions in Table 8.
Table 8. Recommendations for FMEA adaptation
Identified weaknesses and literature results
In the literature review by Liu et al. (2013) the
biggest criticism of the RPN method for
prioritization is the fact that a precise rating of
S, O, and D factors is nearly impossible.
Moreira et al. (2020), in their case study of
FMEA-based improvements, also state that the
best way is to prioritize problems mainly by
severity and occurrence.
Bowles (2003) suggests removing the detection
value since it is the most subjective out of the
three factors.
Due to lacking standardized work instructions,
start-ups rely on highly skilled employees (de
Waal & Knott, 2019; Voss et al., 1998). But
Johnson (2013) showed that FMEA the “Team
Not Trained or Trained in Different Methods”
so the FMEA fails.
In the list Johnson (2013) conducted,
“Performing FMEA in one session rather than
stratifying the process to allow soak time” and
”Try to take on too big an FMEA” was on the
top list of why FMEA fails.
FMEA Adaptations
Subjective grading (Simplify the grading
and categorize between failures)
RPN grading (pivot to more Severity
prioritization grading)
Detection, rating a standard value
The FMEA method is complex (make the
method easier, color columns, fewer
columns)
Limit scope to fewer amounts of failures
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3
METHOD
This chapter presents the research method used in the study. It starts by explaining the
research approach used and which process was implemented. Followed by an explanation of
the literature review conducted by explaining what search words had the biggest impact on
that part. Furthermore, the case study and case company are covered. The last part discusses
the methodologies’ reliability and validity.
3.1
Research Approach
The thesis project consisted of two parts, with a literature review forming the initial phase and
a two-month-long case study conducted in one company. Before the case study could be
completed, the literature review analyzed the information to find possible gaps in scientific
coverage. The literature review summary was also used to triangulate the findings from the
interview data to answer the first research question. These findings and conclusions then
formed the basis for the adapted FMEA method that provided the framework for data collection
once implemented in the case study. The qualitative data was then used to analyze the case
study later and the final phase was the evaluation.
The research approach for the case study was a qualitative method because the study focused
on the individual’s interpretation of the truth. To overcome the weakness of using individuals’
perceptions, the representatives were selected with different roles and FMEA experiences. This
fits well with the high degree of flexibility and allows for the deep immersion that the
qualitative method offers. The amount of appropriate data was small, which fits better with the
qualitative method, also known as the interpretive method. Qualitative methods often rely on
verbal methods for data analysis, and for this case study there were no observational studies
that could be conducted or the number of documents to be reviewed was too small. This project
relied on responses from developers, managers, and professionals from interviews conducted at
the case company. Therefore, since the interviews were conducted to answer the research
questions of this thesis, the data collected and processed were primary. There was also some
triangulation of results as the secondary data was compared to the case study results. The
secondary data came from a previous risk assessment conducted by the case company.
Triangulation helps to avoid relying solely on interview responses and comparing the number
of risks identified. This is because different techniques can balance each other's weaknesses
and strengths (Säfsten et al., 2020).
The literature review found that there is very little research on FMEA implementation for
SMEs and no adaptations for start-ups, which confirms the literature review by Sharma and
Srivastava (2018). No other work was found on this topic, so the results of Sharma and
Srivastava (2018) are still considered valid. In the current literature, there is a gap between the
impact and results of implementations of an adapted FMEA, which makes a case study an
appropriate method as the lack of knowledge in this area was defined (Williamson & Bow,
2002). The case study chosen was the main method to collect the primary data needed. The
results of the case study were the main source of information to answer the research questions.
A single-case design was used. This was chosen because of the advantages of the single-case
approach, which allows for learning, understanding, and knowledge to be gained through a
more detailed examination of a specific situation (Williamson & Bow, 2002).
The study was initiated with the observations from the literature review, from which RQ1 was
answered. This also helped develop the solution that was tested and measured in the case
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company to answer RQ2. The results were reviewed and transformed into rules based on
experience. This is an inductive study that aims to create a general rule from individual
observations. Figure 8 illustrates the relationship and was used to support the choice of study.
Compared to a deductive study that starts with a rule, followed by observations, and then
defines a rule, an abductive study starts with the outcome, then comes the rule, and finally the
observation (Säfsten et al., 2020).
Figure 8. Relationship between rule, observation, and result (inspired by Säfsten et al, 2020)
3.2
Research Process
A literature review and a selected case study were conducted to help answer the research
questions and fulfill the purpose of the study, thus fulfilling the purpose of the thesis.
Specifically, the reason why research is important to professional practice is to advance
knowledge and solve problems within a narrow domain (Williamson & Bow, 2002). The
strategy was to collect findings and knowledge from the literature review and case study
separately. To match them later when both domains were properly combined. The initial
findings from the literature review were supported when the scope of the case study was
determined and later managed. An illustration of the entire process and the relationships
between the literature review and case study can be found in Figure 9. The updated FMEA
method is also compared to the existing risk assessment results to determine if the new method
is better at ending up determining recommended actions to mitigate the potential failure modes.
The main comparison consisted of in-depth interviews. The interviews were conducted with
key stakeholders who have had a great influence on NPD and insight into product risks in the
past and were a part of the review of the updated method.
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Figure 9. Research process. Illustrated by the author.
3.3
Literature Review
A review of previous research on FMEA, NPD, and Start-ups to provide a foundation of
existing knowledge in the field. This provides an overview of the field and the state of the
research. A more detailed review was then conducted to provide a summary of the literature
that served as the basis for the case study (Säfsten et al., 2020).
The literature framework relied heavily on peer-reviewed articles. It was challenging to rely
entirely on scholarly articles, as the detailed explanations of the theory were mostly found in
books. The low validity of books is well known due to the lack of peer reviews and was
considered. The use of books was limited to FMEA methods and product realization phases.
Peer-reviewed articles were searched in the Mälardalen University (MDU) digital library
database. The books used were either found through the library database LIBRIS or identified
when articles were used as references in their research.
The keywords and search terms were formulated as combinations of the following: “Start-up”,
“SME”, “quality”, “NPD”, “risk assessment”, “FMEA”, “adopted”, and “integrated”. How
the combination matrix was arrived at can be found in Table 9.
The search results were first separated by their title names and relevance to the study. The next
step was then to read the abstract and summary to get a better understanding of the context of
the work and the relevance of the information to this study. The final step was then to fully
read the existing articles to determine which articles addressed topics related to the research
questions. The results can be found in Table 9.
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Table 9. Results from the search for literature
Keywords
“Start-up” OR “SME”
AND “Quality”
“NPD” AND “Risk
assessment”
“FMEA” AND “Adopted”
OR “Integrated”
Total number of articles
The total
amount of
articles
5227
Relevant Relevant abstracts Relevant
titles
and summaries
articles
47
12
8
169
27
13
5
602
64
30
13
5998
138
55
26
When reading the literature and interesting references was presented, these were further
examined and added to the scope. This method of investigating literature in relevant articles’
reference lists is defined as the backward snowballing (Jalali & Wohlin, 2012). No limitations
have been set in the backward snowballing method, but the same keywords have been of
interest when looking for articles in the references. When several of the keywords have been
combined in the backward snowballing the reference has been reviewed. Some of the backward
snowballing findings proceeded after the original literature review period ended, these findings
have not been counted in the results (Booth et al., 2022).
The collected findings from the literature were first summarized, then categorized and
concretized, to build the conceptual framework for the second half of the thesis project. The
framework was then analyzed and the results from the literature overview were used when the
adapted template was created and after its implementation trials, also to formulate relevant
questions that were used in the conducted interviews for the case study.
3.4
Case Study and Analysis
A case study was suitable for this thesis study research questions since it supports answering
the research question starting with “how”. A case study also enabled the study to be performed
in detail in its natural environment, which means that the theories tested were relevant to the
actual conditions in the research question. One other benefit of case studies is that they tend to
be exploratory and enable the studying of less researched phenomena. This was the case for
this study before the summary was created after the literature review and conceptual
framework, thereafter the execution of the final part of the study was then descriptive research.
This single case study was inductive since inductive studies are capable of testing and refining
ideas made from the literature summary (Säfsten et al., 2020).
After selecting the most appropriate method, the design of the case study had to be determined.
The questions of this study and the summary of the literature were created, and then interviews
were to be the main source of data collection. It was important that this was a real-time study to
be able to make direct observations related to the tests performed. Secondary data will be
collected in a retrospective study of the risk assessments already conducted by reviewing
project documents (Säfsten et al., 2020).
The steps shown in Figure 10 were performed chronologically in the case study. The first phase
was the observation, which involved understanding the current situation of the company and
what challenges existed. This was followed by the next phase, the Understand phase, which
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consisted of the first rounds of interviews and the analysis of the interview data. The results of
the interviews, along with the findings from the literature review, then served as the basis for
Ideate of new solutions. When the method was developed, the input data was then combined
into categories to identify objectives for the adapted method, see appendix C for the outcome of
the method.
The new solution resulted in an FMEA method and template. The new solution was then tested
in the next phase, an FMEA workshop. The final steps of the case study were a second round of
interviews and an analysis of the results.
Figure 10. Case study process. Illustrated by the author.
3.4.1
Case Company and case selection
The selected case company was chosen primarily because the researcher has unique insight into
the situation in terms of its benefits and challenges. But the company also provided the
opportunity to answer the research question because it is representative to the research
question. The company was found suitable because it is an SME that has the ambition to grow
its business from a normal start-up. Their NPD is not yet standardized and is developing a
product based on a novel technology. The case company is working to scale its organization in
terms of size, production output and product quality. This will lead to a faster pace of
production and increased use of advanced technologies. The goal is to become a robust and
reliable boat manufacturer with novel technology compared to the existing industry.
Previous attempts to conduct risk assessments have been conducted at various stages of NPD
phases and various projects. These will be reviewed and used as a benchmark of what has been
achieved to date and compared to later input from the interviews. The identified failure modes
will also be compared to the later results of a workshop. Field data is also lacking to compare
the accuracy of the estimates with previous attempts.
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3.4.2
Case company background
The case company was Candela Technology AB, a start-up company that was founded back in
2014. The case company was founded by a Swedish entrepreneur that was determined to find
new ways of making electric boats, with a combination of enough top speed and range that is
competitive with the traditional boating industry. The mission of the case company is according
to Candela Technology AB (2023):
“to make an electric boat with better performance than the fossil fuel competitors”.
In 2016, the first prototype was launched in full-scale size. With a range of 50 nautical miles
per charge at the speed of 22 knots. This led to the start of production in 2019 when the
technology and design were finalized, of what would be the first electric hydrofoil boat, the
Candela C-7. The C-7 was the best-selling electric boat in Europe, and the best-selling
premium electric boat in the world in 2020, and it resulted in 32 boats built. When the concept
was proven and tested in markets, the next iteration project was launched. This project was the
Candela C-8(Candela Technology AB, 2023; Northvolt AB, 2021). Figure 11, by Mangez
(2022) shows a picture of the product.
Figure 11. Picture of the Candela C-8.
Note. By Mangez, P. (2022) CANDELA C-8 X PIERRE MANGEZ - 182829-151022 [Photograph]. candela.com.
https://media.candela.com/CandelaC-8/C-8/i-9vNxNsd/A
The benefit of the concept is its hydrofoil that removes 50% of the drag compared to a planing
boat, the C7 design uses 80% less energy at 20-plus knots compared to gasoline boats. Coupled
with a 40 kWh lithium-ion battery, the reduced energy consumption means the vessel has a
range of more than 50 miles at 20 knots – nearly three times the range of the next-best electric
boat on the market. The case company's engineering team has achieved all of this by designing
the technology in-house from scratch. This includes the electronics and software which enables
active stabilization of the vessel, such that it can fly on its hydrofoils (Candela Technology AB,
2022, 2023). Pictures of the aft foil system (AFS) and front foil system (FFS) are illustrated
below in Figure 12 and Figure 13.
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Figure 12. Rendering of the AFS for Candela C-8.
Figure 13. Rendering of the FFS for Candela C-8.
The case company is working to scale its organization in terms of size, production output,
product quality and number of products in its portfolio. This will lead to a higher pace of
production and increased use of advanced technologies. The goal is to become a robust and
reliable boat manufacturer with novel technology compared to the existing industry. Their
platform development is categorized into a product structure illustrated in Figure 14 and
Appendix B.
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Figure 14. Case company product structure, subsystem names removed by author
Previous attempts to conduct risk assessments have been conducted at various stages of NPD
phases and on various projects. These will be reviewed to serve as a benchmark of what has
been achieved and compared to later input from the interviews.
3.4.3
Document Review
A document review was performed to gain knowledge on the historic performance of the case
company’s products and what attempts of risk assessments were made in the past. The
documents consisted of issue data from the previous boat model, an early FMEA attempt, and
some FMECA from a third-party company that supported the compliance certifications, as well
as internal risk assessment lists. This to decide which constraints the FMEA should be limited
to. To allow comparison with previous FMEA attempts, it was necessary to conduct an FMEA
session on a product for which documentation already existed and for which a reasonable level
of development was available.
When reviewing the previous FMEA and FMECA results, they varied in completion rate. The
two categories were distinguished between internal attempts and FMECA sheets provided by
external consultants. The focus was on the internal attempts since they were conducted on the
same project and with the same technical type of components.
The case company’s documents contained confidential information and are thereby not detailed
referenced in this study.
3.4.4
Interviews
The interview was the most appropriate method for this thesis project. This is because to
answer the research questions, it was necessary to gather information about how several
participants perceived a particular phenomenon. It can be summarized as a professional
conversation in which the researcher’s goal is to gather perceptions, views, and opinions about
the phenomena of the research question. Even though both the interviews and their subsequent
transcription are time-consuming, the method is sensitive to the validity and reliability of the
interview effects or if the wrong samples are interviewed. The judgment was that the
advantages of the interview method triumph over the disadvantages. The advantages are
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flexibility and great expertise with high validity because the relevance of the data can be
assessed in relation to the interviews. Semi-structured interviews were considered the best
suitable for this study. It is not as fixated as the structured questionnaire, and not as open as the
unstructured, but still has the possibility to have open discussions but with more common
questions from an interview guide. Semi-structured interviews are also the most common
among type within the engineering science (Säfsten et al., 2020).
Interviews conducted with case company representatives were used to supplement the
document review to provide more information about product performance and past NPD
processes and to provide nuances of current risk perceptions. Detailed interviews were also
used to provide a comparative measure of the updated FMEA method versus previous attempts
at risk assessment. The population used for the interview was formed by non-probability
sampling and more detailed random sampling. This is because the representatives interviewed
were selected either because of their association with the previous risk assessments or because
they had participated in the workshop conducted. This limited the available sample size.
Therefore, the interviews were not representative of all potential FMEA implementation
constellations but covered the majority of recommended representatives for an FMEA session.
Ten semi-structured interviews were conducted with representatives of project managers,
mechanical engineers, electrical engineers, compliance engineers, and product managers. The
first round of interviews consisted of the roles of Product Owner 1, Mechanical Engineer 1,
Compliance Engineer 1, Electrical Engineer 1 and Project Manager 1. The second round of
interviews consisted of the participants of the FMEA workshop conducted, and the roles were
Manufacturing Engineer 1, Production Supervisor 1, Quality Engineer 1, Engineering Manager
1 and Service Manager 1. Five of the interviews were conducted in English and five in
Swedish. Interview guides were used, and the interviews lasted between 45 and 60 minutes.
During the interviews, the conversations were recorded, and notes were taken by the
researcher. Recordings of the case study interviews were saved as raw audio files to
supplement the report. In addition to the interviews, documents from the development project
and the company were collected. The questions asked during the interviews can be found in
Appendix E.
3.4.5
Measuring the interview data
To answer the research questions with the interview results, it was critical to define how the
responses would be measured. The approach taken is to categorize the responses based on the
themes in the interview questions. Responses to the challenge questions were grouped under
the category of “challenges in risk assessment to date", while responses to the FMEA
improvement suggestion questions could be grouped under the category of “suggestions for
improvement" etcetera. Coding was also based on the frequency of themes and categories. In
measuring the interview, the approach taken was to use open-ended questions asking about the
overall quality of the interview and feedback on possible improvements (Säfsten et al., 2020).
3.4.6
Interview Guide
The first step in creating the interview guide was to list areas and topics to be covered in the
interviews. The topics used to categorize the questions can be found in Table 10 and Table 11
below, where the amount of questions related to each theme is counted. The full list of
interview guide questions used to support the assessment and evaluation of the thesis and to
analyze the interviewee group's perceptions of implementation can be found in Appendix E. In
the tables the tags related to each theme is also counted in Table 10 and Table 11. The tags
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were used to easier analyze the interviews and pick out quotes, the codebook can be found in
Appendix F. In creating the questions for the interview guide, the transitions between the
different topics were considered to ensure sufficient sequencing of the questions (Säfsten et al.,
2020).
Following a method of analysis described by Säfsten et al. (2020), called coding, data were
extracted from the transcribed interviews and inserted into tables to identify key phenomena.
Each column in the tables corresponds to a theme, and the themes of the first round of
interviews were: “Challenges with previous risk assessment”, “Evaluation of FMEA-method”,
“Improvement suggestions”, and “Meeting company needs”. The topics were selected based
on their ability to answer the first research question. The topics used in the second round of
interviews were: “Evaluation of the new FMEA method and template”, “Implementation
challenges and opportunities”, “Impact on Risk Assessment”, and “Meeting company needs”.
The topics were selected based on their ability to answer the second research question. Five
questions in each interview guide were linked to a sheet where the respondents were supposed
to grade their answers from 1 to 10. In the first round of interviews it was questions 12-16, and
for the second round of interviews it was questions 11-15. The sheet with the lines where the
respondents filled in their grading of the method can be found in Appendix F.
Table 10. Summary of themes used in the first round of interview guide and coding
Themes
“Challenges with previous risk
assessment”
“Evaluation of FMEAmethod”
“Improvement suggestions”
“Meeting company needs”
Questions related to theme
in round 1 of interviews
6
Tags related to theme
7
6
3
8
1
7
8
Table 11. Summary of themes used in the second round of interview guide and coding
Themes
“Evaluation of the new FMEA
method and template”
“Implementation challenges
and opportunities”
“Impact on Risk Assessment”
“Meeting company needs”
3.4.7
Questions related to theme
in round 2 of interviews
8
Tags related to theme
3
6
2
6
3
8
8
Analyze interview data
After data collection, the interviews were recorded and transcribed so that the data could be
analyzed. First, the researcher read the transcribed interviews to familiarize herself with the
overall content and began noting themes and patterns. The reason for dividing the data into
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themes and patterns was to structure the data. Later in the analysis, the researcher used the
assistance of the case company to code the transcripts accordingly. As the analysis progressed,
additional categories were identified in the transcripts that appeared to play an important role in
interdepartmental collaboration. To assist with coding, a codebook was used to keep track of
codes and make coding more systematic. After categorization and coding, a comparative
analysis of similarities and differences in responses was conducted to compare themes and
patterns. This was to ensure that the themes identified were relevant to answering the research
question.
The interviews conducted were recorded with the consent of the interviewees. The
transcriptions were then put into written form. This was done verbatim, except for the removal
of filler words and sentence repetitions, which the researcher removed from the transcripts to
make the text easier to read. In addition, the length was reduced from 12-15 pages per
interview to 5-8 pages. This made it easier to analyze the material and extract data. In the
transcripts, the names of colleagues and other companies were replaced with roles, functions,
or [XXXXX]. A second analysis of the transcribed data was conducted. It provided a deeper
understanding of the interviewees’ expressed problems with previous risk assessments, their
evaluation of the FMEA method, and their suggestions for improving the FMEA. Quotes were
extracted and translated from Swedish for the reader to show examples of what was said
without having to go through the entire transcribed text. The secondary analysis resulted in a
list of challenges and suggestions for improvement that were mentioned in the interviews. This
was then the input data from the case study when an adapted FMEA version was to be
developed, as one-half of two separate collections of decision factors. The summary of the
interviews can be viewed in Appendix G.
3.4.8
FMEA Workshop
To evaluate the updated method and template, an FMEA workshop was executed. A workshop
is an alternative technique to collect data, and played an important role where the researcher
and practitioners could evaluate the FMEA method. The workshop’s benefit is the ability for
collaboration of development efforts, at the same time as the researcher collects data regarding
the studied phenomenon (Säfsten et al., 2020). The workshop consisted of performing a
session similar to how the case company could have done it if they already had the template
and method. The selected participants were chosen to receive cross-functional input from the
company, and the second criterion was that they had not participated in previous FMEA
attempts in the case company. So, the purpose for the workshop was to introduce and test the
new FMEA method, to later have input for the interview data from respondents. The second
purpose was to identify and analyze potential failure modes, to develop recommendations to
mitigate them, to compare with the FMEA sessions conducted earlier at the case company. The
workshop was structured to include brainstorming and discussion sessions in which team
members worked together to identify potential failure modes for a pre-defined subsystem. The
resulting recommendations were then evaluated and prioritized based on their potential impact.
Following the FMEA workshop, semi-structured interviews were conducted with five of the
participants to gather feedback and evaluate the effectiveness of the updated FMEA
methodology. The interview questions focused on the participants' perceptions of the FMEA
workshop, their understanding of the updated FMEA method, and their thoughts on its
potential impact on the organization. The results of the FMEA workshop and subsequent
interviews are analyzed and documented in this thesis report. The goal was to provide insight
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into the effectiveness of the updated FMEA method, and its potential benefits to the case
organization, and summarize areas for further improvements.
The case company has two platform projects, with the C-8 project being the project where the
least amount of FMEA performed. There are efforts to perform iterations of the system design
when lessons have been learned since development and some boats have been delivered to
customers. Therefore, the scope for the FMEA session was conducted on a subsystem where
previous efforts had been done in the past, and plans for redesign are in the loop. See Figure 15
and Appendix B, for an illustration of the subsystem selected. Six people participated in the
workshop, with the researcher serving as the facilitator of the FMEA session. Participants
included mechanical engineering, manufacturing engineering, quality engineering, production,
and aftermarket.
Figure 15. Subsystems considered in the FMEA workshop highlighted by the author
3.5
Quality of study
The literature summary covers quality assurance (such as FMEA, used in this scope), start-ups,
and research methods. To further strengthen and improve the reliability of the literature review,
established FMEA textbooks were reviewed and used to supplement the research articles, as
the FMEA heritage comes from industry guides from the automotive industry. The summary of
the thesis work strengthens the benefits of implementing the proposed methodology and
adaptations but requires further validation and data review before the results can be proven to
be fully applied to similar cases. In addition to the primary data used in the case study,
secondary data were extracted from previous activities of the case company and compared to
the workshop, the main purpose of which was to form the basis for the interviews. The main
purpose of this secondary data collection was to achieve triangulation within the thesis project,
to achieve multiple data source comparisons (Booth et al., 2022; Säfsten et al., 2020).
To ensure the reliability and validity of the interviews and their data, a standard coding scheme
was used, and a separate coder was asked to review the interpretations. Where the reliability
was ensured by the coding so the results would be repeated when the known and pre-defined
codes are known before the interviews were conducted. The validity of the results is tougher to
ensure, but relies on the accuracy of the definitions of the questions, and is supported by the
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interview guide. The researcher also kept interview notes to supplement the recordings and add
further context and impressions from the interviews. The final method used to measure the
interview was the use of an interview guide, which is important to be able to repeat the study
with different individuals and also allows for data management (Booth et al., 2022; Säfsten et
al., 2020). Figure 16 illustrates how the research question links current knowledge in the field,
the purpose of the study, the methodology, and the validity of the research.
Figure 16. The research question ties knowledge and purpose with method and validity (inspired by Säfsten
et al, 2020)
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4
CASE STUDY
This chapter presents the case study execution. All steps of the case study are presented, being
five phases followed by the findings.
4.1
Phase 1: Company's Previous FMEA Experience
When previous FMEA documents were reviewed, it was not conducted on all subsystems or
components. The performed FMEA sheets varied a lot in completion rate and how extensive
the scope of the investigation was. The previous FMEA that is equivalent to the scope of this
thesis can be found in Appendix B. The used example was one of the sheets that had been
performed on a more serious note and only an internal attempt. This is to get a good
comparison later in the study.
The FMEA resulted in 5 functions with 53 failure modes. However, the grading was only
performed for 2 of the failure modes, and no recommended actions were defined. Thirty-one of
the failure modes also had failure effects identified, and 18 had a root cause connected, but
after this step, the information was missing.
4.2
4.2.1
Phase 2: Empirical Findings
First Round of Interviews
All of the respondents recognized some strengths and potential of the FMEA method. Product
Owner 1 suggested including the right stakeholders in FMEA meetings and pointed out the
importance of resource management to increase effectiveness within the organization.
Mechanical Engineer 1 emphasized the importance of finding the right level of detail and
scheduling appropriate time. In addition, he stressed the importance of FMEA meeting
participants being in the right state of mind to focus on the tasks during the meeting and
working on the FMEA to achieve effective meetings. Compliance Engineer 1 pointed out the
challenges encountered in previous risk assessments due to a lack of data that resulted in
getting stuck in the discussions. He suggested defining global impacts in advance, studying
similar products, and inviting experts from the field to the meetings. Electrical Engineer 1
pointed out the importance of maintaining focus during the meeting, involving experienced
participants, and incorporating a structured approach into FMEA meetings to improve risk
assessment. Project Manager 1 pointed out that previous risk assessments in the case company
were informal, but still provided benefits in identifying risks and improving product
knowledge. She suggested allowing sufficient time for the meetings, depending on the product
scope. Also integrating the FMEA output into the development process, with clear persons
responsible for the actions. In the previous sessions, further clarification was needed on the
next steps after the FMEA sessions.
Since all participants were selected based on their participation in previous FMECA sessions at
the case company, this did not play a role for the interviews. The tables with all extracted data
for each topic can be found in Appendix G, and key quotes can be seen in Appendix H. The
summarized data from the first rounds of interviews can be seen in Table 12 below.
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Table 12. Extracted data for the first round of interviews
FMEA Adaptation
Extracted data
Key quotes
FMEA is essential for evaluating systems not
regulated by standards and regulations. (G.1.
Product Owner 1)
PO1 – " it's important I think to have
people from service, from production, a
safety manager, or functions that can
have an objective view."
Thoroughly examine each component and
understand the consequences of failure when
identifying and prioritizing risks. (G.2.
Mechanical Engineer 1)
Focus on high
criticality
Aligning risk assessment with company
objectives, such as safety and high risks are
important. (G.3. Compliance Engineer 1)
Limited focus on formal risk assessments,
with more emphasis on testing and
verification activities. (G.5. Project Manager
1)
Determining the appropriate timing for
conducting FMEA is a challenge, balancing
the need for design changes and avoiding
significant deviations from the FMEA
conducted earlier. (G.5. Project Manager 1)
Emphasize the importance of using FMEA as
a method to improve the product, not just as a
mandatory task. (G.1. Product Owner)
Easy template
(example for column)
Clear instructions and time allocation from
management are necessary to prioritize
FMEA activities and documentation. (G.2.
Mechanical Engineer 1)
Balancing FMEA work with daily delivery
tasks can be challenging, so need to be easy
to use. (G.2. Mechanical Engineer 1)
Step-by-step (guide
for depth)
Difficulties in progressing effectively and
getting stuck in excessive detail during
previous FMEA sessions. (G.2. Mechanical
Engineer 1)
Need for comprehensive analysis at a higher
level rather than focusing on minor details.
(G.4 Electrical Engineer 1)
Influence of individual optimism or
pessimism on risk assessment. (G.1. Product
Owner)
Easier grading of
SxOxD (lacking data
to precise each)
Comp Eng 1 – “Safety is ultimately what
is interesting. The interesting thing is that
it doesn't go wrong there. Those are the
risks that are interesting to look at”
PM1 – “before doing certain steps, you
must have done verification before
making releases on critical subsystems
and component level, whole system”
PO1 – “You should have easy templates.
A clear step-by-step method.”
Mech Eng 1 – “we didn't really made any
progress. We kept getting stuck on
various details "
Mech Eng 1 – “We had this FMEA
session with [XXXXX] who came here,
then it was clear that now we book in that
time and we do it like this. And we did.”
PO1 – “You should have easy templates.
A clear step-by-step method.”
Mech Eng 1 – “we didn't really made any
progress. We kept getting stuck on
various details "
El Eng 1 – “It's better to make it more
complete at a higher level than to sort of
get stuck on small details and then just
mess around there.”
PO1 – “It improves the quality by
implementing corrective actions and
failures that haven't even happened”
Lack of objective opinions and input from
stakeholders outside the design team. (G.1.
Product Owner)
PO1 – "The design only exists on paper.
We just don't know whether it will
perform."
Difficulty in assessing occurrence of failures
without historical data, particularly for novel
technologies. (G.3. Compliance Engineer 1)
Comp Eng 1 – “for me personally, it's
just occurrence, that is, "how big is the
risk of it happening?"”
Comp Eng 1 – “the occurence part is
what I see as the hard part, if you don't
have some data to base it on, it's hard to
know the first time how many times it will
fail you don’t implement certified parts”
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Clear action list,
with a single owner
There may be uncertainty about
implementing actions identified in previous
FMEA session. (G.2. Mechanical Engineer 1)
El Eng 1 – “Invite those who have
designed the system or parts, so they
know what needs to be fixed”
Involving the individuals responsible for
designing the system in the FMEA analysis
and own mitigation of actions. (G.4.
Electrical Engineer 1)
PM 1 – “but I believe the next steps are
not really clear from our side”
Present FMEA in a condensed and easily
understandable format for better sharing and
awareness. (G.1. Product Owner 1)
FMEA actions and failure modes should be
included in product requirements
specifications and verification plans. (G.5.
Project Manager 1)
The need to compare risks and equivalence of
the novel technology with existing solutions
or standards. (G.3. Compliance Engineer 1)
Connect failures to
the global effects
Analyze similar cases or utilize standardized
solutions from other industries. (G.4
Electrical Engineer 1)
Draw on past experiences and intuition when
data is limited. (G.4 Electrical Engineer 1)
Emphasis on time management during FMEA
sessions to maintain quality and attention.
(G.4 Electrical Engineer 1)
Allocate dedicated time and off-site sessions
for FMEA activities. (G.2. Mechanical
Engineer 1)
The FMEA method was considered timeconsuming but efficient. (G.2. Mechanical
Engineer 1)
Limited scope for
each FMEA session
Determining the appropriate timing for
conducting FMEA during product
development is a challenge, balancing the
need for design changes and avoiding
significant deviations from the FMEA
conducted earlier. (G.5. Project Manager 1)
Allocate sufficient time for FMEA sessions,
considering the size of the product and the
amount of data to be analyzed. (G.5. Project
Manager 1)
Balancing the timing of FMEA to align with
strategies, timelines, and delivery plans is
emphasized. (G.5. Project Manager 1)
Challenges in determining the system
boundary for the FMEA, how deep to go into
the analysis. (G.3. Compliance Engineer 1)
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Comp Eng 1 – “In some way, it is
probably possible to compare most things
with previous things, that is, that the
combination and use is new.“
Comp Eng 1 – “the occurence part is
what I see as the hard part that if you
don't have some like data to base it on,
it's hard to know the first time how many
times this is going to fail unless you
implement a bunch of certified part,
El Eng 1 – “You can take it from other
industries or other standardized
solutions, check other stuff. Where you
might encounter semi-similar things”
PM 1 – “we have to start somewhere to
identify which of these actions based on
the global errors should go into the
requirements specification and which
actions should go into the verification
plan to work with them based on that.”
Mech Eng 1 – “Important to come with
the right state of mind.”
Mech Eng 1 – “It takes a lot of time, but
it is 100% justice in my opinion. It is
rather the opposite that more time should
be spent on it.”
El Eng 1 – “It's better to make it more
complete at a higher level than to sort of
get stuck on small details and then just
mess around there.”
El Eng 1 – “Alternatively, you can focus
on the most important things going
forward in the design work”
PM 1 – “I felt that it was helpful along
the way that we started with longer
sessions than one hour, then perhaps half
a day rather than a full day. Because the
energy also goes out of you quite a lot
when you just talk about everything that
can go wrong”
PM 1 – “I would say that we have to do
an FMEA, that's really what I base it on
and that we also have to dedicate time to
it. You can't do this mediocre, because
then you won't get anything meaningful
out of it. It is better to do the most
important parts properly.”
4.3
4.3.1
Phase 3: Ideate a new method
Adapted FMEA-method
The combined input value from the literature review and interview round 1 is illustrated in
Figure 17 below.
Figure 17. Illustration of the input that generated the new FMEA method, by the author
An analysis of the summarized data was performed to deeper understand the evaluation of the
FMEA for start-ups. These findings were then used to determine the potential adaptations for
the FMEA process, by supporting data for decision-making and identifying areas for
improvement. The gathered challenges and ideas can be found in Table 13, where they are
categorized if they are found from literature review (L) or from empirical findings (E).
Table 13. Challenges and their objectives when performing FMEA
Challenges and ideas
The FMEA method is too complex (L)
Easier template (E)
Remove unnecessary columns (L)
Step-by-Step (E)
Detection rating standard value (L)
Easier grading of SxOxD (E)
Clear action list, with single owner (E)
Subjective grading (L)
RPN grading pivot to Severity (L)
Focus on high criticality (E)
Connect failure to a global effect (E)
Limit to fewer failures (L)
Limited scope for each session (E)
Success objectives
Simplified FMEA method
Prioritize the most critical risks
Narrowing the scope
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The key objectives, seen in Table 13, for adapting the FMEA method and process were to
simplify the FMEA, focus on the critical components and risks, and ensure effective risk
mitigation through regular meetings that aren’t too long. The descriptions of steps to ensure
this is found in Table 14.
Table 14. Objectives for FMEA adaptation
Success objectives
Simplify FMEA template
Prioritize the most critical risks
Narrowing the scope
4.3.2
Description
Simplify the FMEA template to focus on the critical parts
of the process. Make it easier to understand and finalize
Data is probably missing, to conduct better rating the RPN
value should be replaced with a simpler rating scale
Due to the lack of resources to mitigate all risks, adapt the
prioritization to focus on the most critical ones. More pivot
towards high severity risks
Make sure FMEA team consist of members from across
organization, like engineering, operations, quality. Startups may not have risk management teams.
Conduct regular reviews to ensure that risks are being
managed and mitigated effectively
Simplify FMEA template
To further adapt the FMEA method for a more successful implementation for start-ups in NPD,
the template used was also modified. The main goal was to simplify the template, to be easier
to understand and finalize. The purpose was to help these companies focus on the critical
components and risks of the product, to mitigate those risks by informed decisions. SMEs and
start-ups can benefit from the FMEA without being overburdened by non-value-added
complexity.
A typical FMEA template includes many columns that are not relevant for smaller
organizations. For typical columns in the FMEA templates see Appendix A. Therefore, some of
the columns were removed to make the template and implementation more manageable. The
actions taken for some of the columns and the reasoning by the researcher can be found in
Table 15 and an overview found in Figure 18. Figure 18 illustrates a normal set-up for an
FMEA template with columns written vertically. The red stripes represents removal of the
column and green represents a major update.
Table 15. Actions for modification of FMEA template
Column
Reference number of part
Present Control mechanism
Detection
RPN
Reasoning
Removed since it doesn’t add value to the
session
Control mechanism not relevant when
discussing design failures
The detection value should be set to a
nominal value in the middle, and to be
adjusted if further prioritization is needed
RPN value will be remained but replaced
with categories
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Action taken
Updated Frequency, Severity and Detection
Actions taken will be removed from FMEA
template and followed up outside of the
FMEA session
Remove the extra fields for new S, O, D and
RPN since the follow-up will be performed
outside of the initial FMEA session
Figure 18. Overview of actions for FMEA columns, inspired by Puente et al. (2002)
When the actions were mitigated from Table 15 and Figure 18 above, the new template had
been designed. The different columns had also been divided into five segments, which are
colored to visually separate them to be used as a visual aid. The purpose of the visual aid is to
make it easier to understand and follow the process by providing a clear overview. The full
template is illustrated in Figure 19 and can also be found in Appendix C.
Figure 19. Start-Up FMEA Template, by author
4.3.3
Simplify the grading
Bowles (2003) suggests deleting the D rating because the term “detection” is misleading. It
refers to whether or not the defect exists, not to the likelihood that it will be detected. It is one
of the three ratings that is most subjective, which is even a problem when there is training or
when data is available. Another disadvantage is that if the verification program only detects the
error, it still has to reactively correct the error. This is more costly than avoiding the problem in
the first place. Instead of eliminating D rating, as Bowles (2003) suggests, detection is retained
but subtracted from a predefined nominal value only when the situation either clearly goes to
one extreme or the other, or when prioritization between similar values is required.
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To further simplify the ratings, the 1-10 scale for S, O, and D is replaced by letter categories
assigned instead, the number of categories is reduced to 5 per factor. This since Moreira et al.
(2020) suggest reducing the factor options to achieve greater consensus on the scoring values.
The categories are Very Low (VL), Low (L), Moderate (M), High (H), and Very High (VH).
The purpose to use letters instead of for instance a 1-5 scale is to distance the method from
RPN method of multiplying the factors. But the evaluations in the FMEA correspond to the
numerical correspondence assigned to the S, O, and D indices of the traditional model. The
letters and their corresponding index to the classical numbering can be found in Table 16.
Table 17 illustrates the equivalent RPN value to the categories (Puente et al., 2002).
Table 16. Categories for "S", "O" and "D" indexes, proposed by Puente et al. (2001)
S
1
2,3
4,5,6
7,8
9,10
Rating
O
1
2,3
4,5,6
7,8
9,10
Categories
D
1
2,3
4,5,6
7,8
9,10
VL
L
M
H
VH
Table 17. Categories for the output variable of the decision system, proposed by Puente et al. (2001)
RPN
1-50
50-100
100-150
150-250
250-350
350-450
450-600
600-800
800-1000
4.3.4
Class Score
25
75
125
200
300
400
525
700
900
Categories
VL
VL-L
L
L-M
M
M-H
H
H-VH
VH
Prioritize the most critical risks
To pivot the prioritization of the failure modes, the usage of the product of the factors is
replaced by a matrix proposed by Puente et al. (2002). The matrix is based on an intuitive
decision system based on risk priority class. Unlike the traditional approach using the product
of these factors to calculate the risk associated with a failure, a rule-based category is used. The
proposed system provides a single model for a given problem. New rule bases can be easily
created based on the model, analysts' experience in similar problems, and the problem under
study. When prepared, the method is rational and quick to implement, requiring only a single
spreadsheet or Excel formula.
The rules start with the lowest rating in the “VL” severity category at the start of the matrix,
which is the lowest level found in Figure 20. Moving along the main diagonal, the risk priority
increases in category sequentially. Each matrix is symmetrical to the main diagonal, and the
risk priority increases as detection and frequency variables increase. Moving up to a higher
severity level involves a similar matrixial structure, with the root cell given a rating identical to
the severity level it is at. For example, the root cell for a matrix at severity level “L” would be
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given a rating of “L” if the root cell for the matrix at severity level “VL” was “VL” (Puente et
al., 2002).
Figure 20. Illustration of the decision system proposed, inspired by Puente (2001)
The proposed method by Puente et al. (2002) addresses the main criticism of the traditional
model by providing a rule system that enables significant weighting of the severity index S for
the failures. This is done by replacing the method of calculating the product of the three factors
S, O, and D, using the matrix’s rules. This also gives the flexibility for adjusting the controls
when problems are being studied and the weighting benefits from further adjustments. The
method is also adaptable and easier to implement, making it a valuable method for various risk
classification issues. So, the RPN will be replaced by Risk Priority Categories (RPC).
When the model is implemented in the FMEA template, the user does not need to consider the
matrix when using the FMEA template. This is because the formula for the RPC columns
matches the values for S, O, and D with the rules in the matrix in Figure 20. Even though the
logic behind the RPC is more complex than multiplying the factors of the RPN, it is not more
complicated to use because it is automated. The template can be found in Appendix C.
4.4
4.4.1
Phase 4: Test
FMEA Workshop
The workshop began with an introduction to the new template and an explanation of the pilot
FMEA session related to the study of this work. This was followed by a technical review of the
components of the subsystem that was the subject of the FMEA workshop. All introductions
took about 15 minutes of the total session time of 150 minutes. The next step was the first part
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of the FMEA template, which are the brainstorming and discussion sessions in which team
members collaborated to identify potential failure modes, their effects, and their root causes.
After scoring and ranking with the RPC system, the team began defining recommended actions
for the highest-scoring items. In this case, the meeting only had time to add actions and
responsible parties for the worst failure mode, which had the RPC grade "VH". The last 15
minutes were allotted to summarize the session and create a follow-up list. The completed
FMEA sheet can be found in Figure 21 and seen in Appendix D, where sensitive information
has been blurred due to company confidentiality.
Figure 21. One part of the filled FMEA sheet from the workshop
According to the participants, the grading of severity and occurrence was convenient to
specify. Where the pre-assigned global effect was the main contributor to the severity rating
and the pre-defined detection rating helped to focus on the failure modes where the detection
circumstances were special. However, one big obstacle was the occurrence rating. There was
also some confusion regarding some of the failure modes since the information regarding the
system interference was missing. One participant suggested that a P diagram or similar system
description aid was needed to be performed to resolve the confusion. The completion rate was
higher than previously performed FMEA sheets made in-house. The lanes were easy to follow
according to the comments in the session. The meeting notes taken in the meeting can be found
in Appendix D.
4.5
4.5.1
Phase 5: Learn
Second Round of Interviews
The three respondents who had not attended an FMEA session prior to this workshop were
positive about the session and the potential benefits of this method. The respondents were
Manufacturing Engineer 1, Production Manager 1, and Service Manager 1. Manufacturing
Engineer 1 found the new FMEA method and template useful in solving problems and meeting
the company's risk assessment requirements. The classifications had the potential to be further
adapted with more knowledge and experience. Production Manager 1 acknowledged the
potential of the FMEA method by improving internal communication and increasing product
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quality. He did not cite any particular implementation challenges but felt that the method
needed to be better understood. Thus, training would be needed before full implementation.
Service Manager 1 was positive about the FMEA method in terms of managing risk and
ensuring product safety. He also emphasized the importance of a diverse team, with
stakeholders, designers, and end-user representatives playing an important role in ensuring a
comprehensive understanding of potential failures. The two representatives with extensive
FMEA experience were Quality Engineer 1 and Engineering Manager 1. They were positive
about the new method, with Quality Engineer 1 recognizing the potential to improve quality
and meet the case company's specific requirements. She emphasized the importance of training,
proper implementation, and collaboration within the company to maximize the benefits of
FMEA. Engineering Manager 1 suggested using numbers instead of letters, to link
classifications more easily to requirements definitions and risk assessment. However, he
stressed the importance of a systematic approach, regardless of which method is used. This
could be overcome with more specific guidelines and rules to ensure consistent and effective
implementation of FMEA.
When comparing results between respondents, there was a difference in responses based on
whether they had experience with traditional FMEA methods or not. Respondents who had no
experience with traditional FMEA thought the 2.5-hour training was too long, while
respondents with years of experience thought the training thought it was effective and produced
results quickly. Another difference was the use of the new way of grading, where respondents
who were used to grading with numbers from 1 to 10 were somewhat confused and could not
directly tell what the letters meant, while respondents who had never tried the traditional
method found it easy to grade these failure modes. The tables with all extracted data can be
seen in Appendix G, and key quotes can be seen in Appendix H. The summarized data from the
second interview rounds for each theme can be seen in Table 18 below.
Table 18. Extracted data from the second round of interviews
Objectives Extracted data
Key quotes
Template easy to read:
the new template was helpful in providing context
and guiding the analysis. (G.6 – Manufacturing
Engineer 1)
Valuable in preventing recurring issues and
improving communication. (G.6 – Manufacturing
Engineer 1)
ME1 – “Help us to remember and to all align on
what we're talking about, which for me was
really good, like the visual introduction was
really great and after so the document was here
with all the columns and then we an explanation
was given about what we will do globally so we
have a bit more context again.”
Effective identification of potential failures with the
new method. (G.10 – Service Manager 1)
QE1 – "The format of the FMEA template to be
acceptable"
Addressing easily achievable improvements or risk
mitigation measures. (G.10 – Service Manager 1)
QE1 – “but I think the format is user friendly for
everyone “
user-friendly structure of the FMEA template. (G.9 –
Quality Engineer 1)
Simplified
FMEA
method
ME1 – “it was also easy to fill it … and then we
revised it and it was easy to revise the
document.."
More training of method needed before
implementation:
Challenge in distinguishing between failure modes
and local effects, requiring discussion and
clarification. (G.6 – Manufacturing Engineer 1)
New grading is easier (more training needed). (G.7 –
Production Supervisor 1)
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QE1 – "I think for all the tools I know, this is the
one that could help us."
ME1 – "defining the failure mode or the kind of
the local effects on how precise you need to be on
each of them. Because sometimes the failure
mode can or sounds really close to a local effect”
QE1 – "First, I think they need to keep training
for everyone that never worked with FMEA."
Familiarity with process and components identified
as a challenge. (G.9 – Quality Engineer 1)
Expression of the need for training sessions to ensure
understanding of the FMEA process. (G.9 – Quality
Engineer 1)
Pre-filled information is good:
Appreciated the pre-defined examples (G.6 –
Manufacturing Engineer 1)
Facilitates detection of risks, understanding their
effects, and considering failure detection methods.
. (G.6 – Manufacturing Engineer 1)
Possibility of spending excessive time on
contemplating potential failures, but severity levels
helped prioritize and categorize risks. (G.10 –
Service Manager 1)
New grading is easier:
Need for well-defined rules and specifications based
on severity, occurrence, and detection levels (G.8 –
Engineering Manager 1)
Provides a detailed summary of failures, enabling
deeper investigation and analysis on prioritized
topics. (G.7 – Production Supervisor 1)
Prioritize
the most
critical
risks
Pivot and adapt the RPC to S :
Challenge of lacking experience in risk assessments
specific to case company's new product. (G.8 –
Engineering Manager 1)
FMEA can be adapted to prioritize risks and focus on
high safety standards. (G.10 – Service Manager 1)
Need to clarify rules of RPC:
Customization of the template to specific areas or
problems can better meet the company's needs. (G.6
– Manufacturing Engineer 1)
QE1 – "We should present this and sell this in a
way that everyone understands the value of the
tool."
ME1 – “because some of them were pre filled
then you discuss a bit about it and then you are
like okay, which of those five propositions are we
the closest to? And it helps you to recenter the
discussion and I think this is helping.”
EM1 – “if we have anything that's life
threatening, the amount of safety that you need
against the requirement.”
PS1 – “I truly believe that this document is going
to to be very resourceful in future as well as as
well as a pilot project and which will help us in
future to build more reliable boats in short“
ME1 – “I think this document helped to organize,
detecting and prepare. To act and know what to“
EM1 – "High severity failures are the first ones
to look for”
SM1 – "FMEA can be adapted to prioritize risks
and focus on high safety standards."
EM1 – "Using numbers in FMEA makes it easier
to set requirements and define the safety needed."
EM1 – "The P diagram could help map out
inputs, outputs, and subsystems that can hinder
achieving the desired output."
EM1 – "The number in RPN helps prioritize high
severity failures and ensures proper control
measures are in place."
EM1 – "As long as the next steps are properly
defined, whether using numbers or letters, it
doesn't matter."
Emphasis on defining consequences and safety
measures based on failure severity. (G.8 –
Engineering Manager 1)
Importance of clearly defining and agreeing on the
grading system used in FMEA. (G.8 – Engineering
Manager 1)
Importance of considering subsystem-level failures
and their impact on the parent system and failure
chains. (G.8 – Engineering Manager 1)
2-hour FMEA sessions enough – split into
sessions:
Good facilitation of productive brainstorming and
discussion during the workshop. (G.6 –
Manufacturing Engineer 1)
Narrowing
the scope
Lack of previous focus on FMEA might be attributed
to other priorities and the desire to make things work
before considering potential failures due to time
(G.10 – Service Manager 1)
Split sessions into pre-defined global effects:
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ME1 – “But it really tells you, I feel, where to
take care and where to spend more resources
later to improve it.“
SM1 – "We need to address low-hanging fruits,
easily achievable improvements or risk
mitigation measures."
QE1 – "The challenge was to understand what
parts, steps or like names of each individual
subcomponent we were talking about."
Streamlining the process by focusing on specific
areas and involving input from internal stakeholders
and customers. (G.10 – Service Manager 1)
SM1 – "Dividing the focus into specific areas,
such as addressing specific types of failures,
could help streamline the process."
Suggestion to focus on analyzing one failure mode at
a time. (G.10 – Service Manager 1)
In a final step, the collected data from the case study were categorized as “simplified FMEA
method”," “prioritization of the most critical risks”, and “Narrowing the scope". The results
were then translated into factors to consider when implementing FMEA, see Table 19 below.
This can be seen as a summary of all the empirical data collected, which will form the basis for
the analysis in the next chapter.
Table 19. Findings of the new FMEA
Success objectives
Simplified FMEA method
Prioritize the most critical
risks
Narrowing the scope
4.6
Objective findings
Template easy to read (color lane and fewer columns)
More training of method needed before implementation
Pre-filled information is good – use more pre-defined
examples if possible
New grading is easier
Pivot and adapt the RPC to S
Need to clarify rules of RPC (explain how they refer to RPN
values)
2-hour FMEA sessions enough – split into sessions
Split sessions into pre-defined global effects
Findings from case study
Evaluation of the adapted FMEA template and method at the case company revealed several
important points. All five respondents provided valuable insights, from different business
perspectives and with a variety of previous FMEA experience. The respondent’s found the
FMEA template sufficient, user-friendly, and guided the analysis step-by-step. It was seen to
potentially improve design, increasing reliability, preventing recurring problems from the past,
and in general being a valuable tool that met the case company’s needs.
Although several of the respondents had no previous experience with FMEA, they found the
method interesting and expressed a desire to learn more about it. The FMEA method was seen
as a valuable method to support risk assessment, improve decision-making, and prevent
accidents. It was also widely recognized as increasing risk awareness within the organization
and providing detailed insight into failure modes, their effects, and root causes. Another benefit
cited by respondents was that FMEA can contribute to better product quality for the company's
products. Respondents did not cite any significant weaknesses in the FMEA method or
template they used. However, they mentioned that they need more training. Respondents who
were used to the normal severity, occurrence, and discovery rating called for more training on
the new assessment system. They also stressed the need for clear rules and predefined
guidelines for grading and to know when action is needed for consistent implementation. They
highlighted the customization of the FMEA method to meet the needs of the case company,
such as the new risk prioritization method and the focus on high-severity failure modes. The
involvement of a multidisciplinary team and management buy-in was critical to the success of
the implementation of FMEA. They emphasized the importance of a diverse FMEA team and
the critical importance of inviting responsible design engineers, user representatives, and
stakeholders to gain a comprehensive understanding of the potential failure modes and a
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commitment to mitigating them. Other improvements consisted of further streamlining the
process and dividing meetings into specific focus areas where pre-defined failure modes or
global effects should be targeted, especially when the components are extensive. Overall, the
data indicate a positive attitude toward the new FMEA method and template. Respondents
emphasized the value of the method because of its ability to identify and manage risks, improve
decision-making, and increase product quality. Related improvements included further training
of the method, customization of guidelines, and further streamlining of the process. With
additional experience and customization, the FMEA method has the potential to become a
valuable tool in the NPD process for the case company or similar companies.
When comparing interview results for FMEA method ranking questions. Respondents with
FMEA backgrounds tended to be more positive about the resources and time that the sessions
with the new template took. Respondents without an FMEA background felt the 2.5-hour
session was long. However, in terms of risk assessment and risk prioritization, respondents
with experience were more skeptical. This was because they could refer to the usual 10-scale
system and had used these numbers for comparison and previously applied them to predefined
boundaries. Those who had no experience felt that the system was easy to use and helped them
select the right criteria. The results can be seen in Appendix G, and the results from the grading
used during the interviews can be seen in Appendix I.
The completed FMEA sheet can also be compared to the previously evaluated FMEA sheet
created for a similar subsystem. The two main differences are that the old FMEA sheet contains
more columns, but also covers more components and areas. Therefore, the result is that it
contains more rows with a larger number of failure modes. However, the other difference is
that the sessions ended or got stuck in the severity classification phase, with the failure cause
added to some failure modes and a recommended action assigned to some. The last FMEA
sheet was less comprehensive, but all failure modes rated higher than "M-H" had a responsible
owner and a recommended action. The FMEA sheets can be found in Appendix B and
Appendix D.
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5
ANALYSIS
This chapter presents the analysis of the study. First, the research questions are answered, then
the goal fulfillments are presented.
5.1
Answers to the Research Questions
The research questions in the study were:
RQ1: What are the challenges for start-ups when implementing FMEA?
RQ2: How can FMEA implementation be adapted for start-ups overcoming novel technology
challenges?
The two research questions are answered below.
5.1.1
What are the challenges for start-ups when implementing FMEA?
The objective of RQ1 was to identify areas where start-ups may struggle when implementing
FMEA. RQ1 was mainly based on a literature review and triangulated by data from interviews
conducted in a case study. It was found that there are several potential challenges when trying
to implement an FMEA, which affects the success of the whole product development process.
From the literature review, the study identified several areas where FMEA implementation
might struggle. These areas were subjective gradings, detection rating, the complexity of the
FMEA method, a too-overwhelming scope, and the RPN grading. The case study identified
some additional areas where start-ups find it challenging and risk failing in their risk
identification if they do not adapt to the following adjustments. These include a need for a
simpler template, a method with step-by-step guidance, simpler RPN grading, and limiting the
scope to the most critical failure risks. Table 20 below illustrates a comprehensive list of the
findings for FMEA challenges, categorized by literature review (L) or empirical findings (E).
Table 20. Challenges and their objectives from literature review and case study
Identified challenges from literature review
Subjective grading (Simplify the grading and
categorize between failures) (L)
RPN grading (pivot to more Severity prioritization
grading) (L)
Detection, rating a standard value (L)
The FMEA method is complex (make the method
easier, color columns, fewer columns) (L)
Remove unnecessary columns (L)
Limit scope to fewer amounts of failures (L)
Identified challenges from case study
Easier template (E)
Step-by-Step (E)
Easier grading of SxOxD (E)
Clear action list, with single owner (E)
Focus on high criticality (E)
Connect failure to a global effect (E)
Limited scope for each session (E)
Table 21 below summarizes the findings and presents the key factors to overcome the findings
from the literature review and the case study when implementing an FMEA at a start-up.
Table 21. Challenges and their key factors when performing FMEA
Challenges and ideas
The FMEA method is too complex (L)
Easier template (E)
Remove unnecessary columns (L)
Success objectives
Simplified FMEA method
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Step-by-Step (E)
Detection rating standard value (L)
Easier grading of SxOxD (E)
Clear action list, with single owner (E)
Subjective grading (L)
RPN grading pivot to Severity (L)
Focus on high criticality (E)
Connect failure to a global effect (E)
Limit to fewer failures (L)
Limited scope for each session (E)
Prioritize the most critical risks
Narrowing the scope
So, in short, the challenges for start-ups implementing FMEA are that the FMEA template is
usually overwhelming with many columns and not being user-friendly. The rating in the FMEA
also depends on data to accurately determine the factors to rate the failure modes, which also
makes it difficult to prioritize the right failure modes. For start-ups, it is difficult to conduct
reviews on a regular basis with an appropriate FMEA team consisting of cross-functional skills.
The combination of these issues leads to inaccurate risk assessments, a lack of key risks to
prioritize, and misunderstandings about the FMEA process.
5.1.2
How can FMEA implementation be adapted for start-ups overcoming novel technology
challenges?
The second research question, RQ2, of this thesis, addressed the specific adaptations needed for
FMEA implementation for start-ups. The result was a proposal for a simplified framework for
the implementation. The first step was to create a simplified FMEA template that focuses only
on critical columns to get actions to mitigate the risks associated with the products. This was
done by reducing the amount of columns and categorize them with colored lanes. This will
make the template easier to understand, follow, and complete. Liu et al. (2013) pointed out that
FMEA efficiency of risk prioritization is increased when being suitable, and the major
shortcoming was the relative importance of S, O, and D. Therefore, next step was to prioritize
the most critical risks by ranking them primarily by the failure mode severity. The pivot to
severity was proposed to be done by replacing the RPN method, by RPC where the input is
extracted by a pre-defined matrix instead of multiplying the factors, inspired by Puente et al.
(2002). Also, the detection is only considered when the discovery of a detection situation is
clearly on the outer spectrum of the range according to Bowles (2003). This helps smaller
organizations focus their limited resources on the risks that pose the greatest threat and can
significantly impact the start-up’s success. In the absence of quantitative data, RPC grading
will also be limited to fewer options for severity, occurrence, and detection, as there are 5
options instead of 10, according to Moreira et al. (2020) this lead to greater consensus on the
scoring. Using a simpler rating scale will help improve the consistency of the risk assessment
and simplify the process, which will also save time. Regular reviews should also be conducted
to ensure that risks are being effectively managed and mitigated. These reviews are
recommended to involve cross-functional teams comprised of members from engineering,
quality, and customer representatives. By involving cross-functional teams, start-ups can
effectively collaborate on FMEA even if they do not have dedicated risk management teams.
This approach will help start-ups improve their communication, and share common goals, for
better decision analysis. You can see how the 3 main objectives were achieved in Table 22,
below.
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Table 22. Objective fulfillment for FMEA adaptation
Success
objectives
Simplified FMEA
method
Prioritize the
most critical risks
Narrowing the
scope
Fulfilled
[yes/no]
Yes
Yes
Yes
Motivation
Use simpler template:
The case study results showed that the participants confirmed that
the new FMEA method and template was easy to use. Two of the
respondents highlighted this and quoted that: ME1 – “it was also
easy to fill it … and then we revised it and it was easy to revise
the document.." and
QE1 – “but I think the format is user friendly for everyone “
Use simpler rating:
The updated rating was perceived as easy to use and implement
by the part of the group that didn’t have FMEA experience prior
to this study. While the two participants who was familiar to
traditional methods from years of experience at large corporations
in the automotive industry complained about the confusion with
the new method. They requested further training or a more
clarified instruction. EM1 – "As long as the next steps are
properly defined, whether using numbers or letters, it doesn't
matter."
RPC instead of RPN:
Similar to the “simpler rating”, the participants that were new to
the FMEA as a concept perceived it as easy to use, and the other
half requested more training: QE1 – "First, I think they need to
keep training for everyone that never worked with FMEA."
Pivot and adapt the RPC to S:
The method was adapted according to Puente et al. (2002) to
weight of the severity index S for the failures by replacing the
method by calculating by using pre-defined rules. This was done
in combination with the suggestion by Bowles (2003) to eliminate
the D rating, since it is one of the three ratings that is most
subjective. But for the sake of the matrix, the detection value is
instead set to a nominal value.
Limit the sessions into 2 hours blocks:
From the recommendations from the first round of interviews the
workshop was limited to 2,5 hours, in line with this quote: PM 1 –
“I felt that it was helpful along the way that we started with
longer sessions than one hour, then perhaps half a day rather
than a full day. Because the energy also goes out of you quite a lot
when you just talk about everything that can go wrong”.
Conduct regular reviews:
No investigation has been done for this objection. But the
recommendation that the reviews should be performed on a
regular basis.
Result:
3/3
= 100% fulfillment
Overall, this study shows the importance of implementing these three areas to achieve the
success goals of implementing FMEA in a start-up company. By doing so, start-ups can
improve their risk management capabilities, increase their ability to identify and correct
potential failures, and ultimately improve their chances of success.
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5.2
Goal fulfillment
Additional goals of this study were to understand the key factors for successful FMEA
implementation and the differences between start-ups and established corporations for
successful NPD. Both goals were fulfilled. Where the first goal was fulfilled by the literature
review, but the findings was confirmed in the case study interviews. The second goal was
fulfilled, only by the literature review. The goal fulfilment was therefore 100%. The goals of
the study, and a motivation of their fulfilment can be seen in Table 23.
Table 23. Goal fulfilments and motivation
Goal
Goal 1: Find key
factors for
successful FMEA
implementation.
Goal 2:
Investigate
differences
between start-ups
and established
corporations for
successful NPD
Fulfilled
[yes/no]
Yes
Yes
Motivation
First goal was fulfilled in the literature review where the three key
factors were mentioned by several authors:
1. Used as a living document to improve products in NPD
(Krasich, 2007; Taylor, 1990; Wang et al., 2018).
2. Relying on data or history for prioritization or conducting
recommended actions for failure modes (Bowles, 2003; Chrysler
LLC et al., 2008; Ford Motor Company, 2004; Liu et al., 2013;
Puente et al., 2002; Ravi Sankar & Prabhu, 2001).
3. Perform the FMEA in right time (Johnson, 2013; Puente et al.,
2002; Taylor, 1990; Teng & Ho, 1996).
This was also confirmed in the case study, where results showed
that engineers who had participated in previous FMEA sessions
began to think more about risks in their design process. In
addition, the sessions relied on facilitators with the right expertise
to guide participants in prioritization and recommended actions.
However, the third argument was controversial because the case
study interviews only referred to the benefits and drawbacks of
conducting the sessions before or after the initial freeze of the
system design.
This goal was also fulfilled in the literature review. The three
main differences are:
1. Decision-making processes and resistance to change: Start-ups
often benefit from more organic decision-making processes and
encounter less resistance to change compared to larger companies.
This allows for greater agility and flexibility in adapting to new
ideas and market conditions (Ledwith & O'Dwyer, 2008; Nicholas
et al., 2011; Sommer et al., 2009).
2. Limited resources: Start-ups typically face challenges related to
limited resources, both human and financial capabilities. This
might impact their ability to invest in NPD activities and
overcome uncertainties associated with complexity and short
development timelines (de Waal & Knott, 2019; Millward &
Lewis, 2005; Nicholas et al., 2011; Sommer et al., 2009).
3. Informal and unstructured processes: start-ups, often rely on
informal and unstructured NPD processes because they lack
adequate data and have little experience. This is in contrast to
larger companies, which tend to use more formal and structured
processes. However, adopting a more formal and iterative
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planning process can give start-ups a competitive advantage by
enabling them to make better decisions, fully understand
challenges, and ensure product quality through prototyping and
testing (De Toni & Nassimbeni, 2003; Millward & Lewis, 2005;
Sommer et al., 2009; Yahaya & Abu-Bakar, 2007).
Result:
2/2
= 100% fulfillment
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6
DISCUSSIONS
This chapter will discuss the result of the analysis, along with the study’s contribution to
research and the value for the case company.
6.1
Discussion of the process
The study was an inductive study that created a general rule from individual observations.
From the observations found from the literature review and initial case study interviews, there
were results generated. The process used to get results in the case study was a combination of a
workshop and following semi-structured interviews. The processed input from the workshop
was also compared to previous attempts at FMEA sessions. This created rules that answered
the research questions. This way of testing the FMEA method for start-ups has not been done
before to the researcher’s knowledge, so it is unknown how well the process worked. For future
research, it would be recommended to validate the process or analyze how the results would
differ from another research approach. If the study had included an investigation of different
approaches, less time could have been spent on the development of the FMEA tool,
transcribing and analyzing interview data.
There was a lack of quantitative and measurable data in the research scope, so it was, therefore
crucial to gather interview quotes from the respondents to validate the findings. It was helpful
getting the transcriptions written down to extract quotes from the respondents to analyze and
compare statements. If this part would have been skipped, the results would have been based
on the researcher's gut feeling, but the results would probably have been similar. But the only
way to know this is to redo the process, but with a different research strategy. Alternative
strategies could then be more quantitative studies with more parallel FMEA sessions, with
more technical areas simultaneously. Followed by comparing data by the workshop outcome in
the FMEA output, in combination with structured interviews or questionnaires.
6.2
Discussion of the adapted FMEA method
The idea of simplifying the RPC selection by reducing the number of choices from 10 to 5 per
factor would reduce the number of options to be considered for each failure mode. This could
make the evaluation easier and less time-consuming. Moreira et al. (2020) suggest this to also
achieve greater consensus on the scoring values. The detection rating should also nominally be
a predefined value and adjusted when needed so that the total number of choices is further
reduced. This is recommended by Bowles (2003), because it is one of the three ratings that is
most subjective. One drawback is that the detection rating might be misused by being adapted
for failure modes that want to be skipped. But this is always a general risk with FMEA since all
assumptions can be set lower or higher when previous FMEAs or data is missing. A valid
criticism is that the numbers used in RPC selection are not clearly defined in terms of a specific
level of risk or placed in an interval. This lack of clarity can lead to further subjectivity and
inconsistency in the evaluation process, making it difficult to accurately compare and prioritize
risks. This could be solved by a clear agreement before the start of the FMEA meetings, where
each category corresponds to a certain number of figures from the classical RPN selection. One
example could be a table similar to the one illustrated in Table 24.
Table 24. Categories for the output variable of the decision system, proposed by Puente et al. (2001)
RPN
1-50
Class Score
25
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Categories
VL
50-100
100-150
150-250
250-350
350-450
450-600
600-800
800-1000
75
125
200
300
400
525
700
900
VL-L
L
L-M
M
M-H
H
H-VH
VH
In addition, it is worth noting that the logic in the matrix used in the FMEA method is more
complex than a simple multiplication of the three factors of severity, occurrence, and detection.
While this complexity may be due to the mathematical representation of the relationship
between the factors, it does not have a significant impact on the practical application of the
FMEA template. In most cases, the multiplication of the matrix is straightforward and requires
no adjustments during the assessment. If it is necessary to adjust the matrix for specific
meetings or situations, it is acceptable to make appropriate adjustments. Nevertheless, it is
important to emphasize that the development of the matrix should ideally be completed in
advance to ensure consistency and avoid unnecessary changes. But the advantages still
triumphs the risks since it is important to address high-severity risks, no matter how low the
probability, according to Teng and Ho (1996). One risk with the removal of the follow-up parts
from the traditional FMEA template is the missing part of continuously improving. There are
workarounds where the normal sheet can be easily updated if the recommended actions are
mitigated. This is also a weakness of FMEA, that subjectivity remains even when the number
of choices available is limited.
In the first rounds of interviews, the participants highlighted that some of the challenges with
the sessions in the past were to maintain focus during the full session and to come with the
right mindset to be present in the session. However, this concern was not mentioned in the
second round of interviews. Instead, participants described the session as focused and easy to
follow. To address this concern, it could be recommended to ensure that participants are aware
of the importance of maintaining the right attitude and staying focused during the FMEA
process. Clearly communicating expectations regarding active participation and attention can
help create an environment conducive to productive discussions. Emphasizing the importance
of being in the right frame of mind can help participants better understand the value of their
contributions and actively participate in the FMEA meeting. This, in turn, can lead to more
meaningful and effective outcomes.
The initial plan was also to compare the results between the previous FMEA to the results from
the method presented in this project. However, since the amount of finalized RPN values and
recommended actions was a few each, a comparison could not be done fairly. Reasons why
previous sessions never ended up in clear actions, even if the list of potential failure modes was
longer than on the adapted version, can be that the participants thought it was too
overwhelming, and the dedicated time had not ended up in any actions, just the list of failures.
The findings indicate that many of the challenges and problems associated with using FMEA
are related to skills present, proper attitude, and prioritization rather than the method or
template itself. Therefore, the researcher strongly recommends that practitioners approach the
FMEA process with the right mindset. This includes being open-minded and actively
participating in the FMEA process. In addition, the recommendation is to book sessions that are
2 – 3 hours long to make sure the team is engaged during the session.
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6.3
Contribution to Research
The literature review mainly examined articles related to "FMEA" and "start-ups". However,
most of the articles dealt with a deeper and more complex FMEA method or how it can be done
differently than for start-ups. For example, both Liew et al. (2019) and Liu et al. (2013)
presents summaries of adaptions focused on multi-criteria decision-making, fuzzy if-then rule
bases, or costs. These proposals add more steps, which takes them out of the scope of the
research for this paper. Only one article found in the literature search considered FMEA from
the specific perspective, but that was for SMEs, which is not necessarily the same as a start-up
(Sharma & Srivastava, 2018). Moreira et al. (2020), shows how FMEA in general can be
adapted to be a more user-friendly, timely, and cost-conscious tool. These benefits could solve
the problems identified in the literature review, such as the challenges of start-ups. In this
paper, the findings from the literature are integrated into the summary of existing findings for
NPD projects of start-ups. This is then further evaluated in the FMEA implementation by the
researcher, adapted for start-ups. The thesis study also explores the method resulting from
combining the summary of start-up NPD and FMEA by using it in a workshop at the case
company to compare the results from a traditional method.
6.4
Case company recommendations
This thesis contributed to the case company by introducing an adapted FMEA method
specifically designed for start-ups. The new FMEA method proved to be easier to use and
allowed for a more focused effort. The results of the FMEA performed led to a more
comprehensive action plan to mitigate the risks of the subsystem. This is a critical outcome of
the FMEA process, providing a clear roadmap for addressing the identified failure modes. The
results also showed that meeting duration is critical to maintaining good focus and
commitment, which is achieved through properly prepared and scheduled FMEA meetings.
Based on the results and the experience gained since the product launch, the case company is
recommended to use the new FMEA method as a key tool for the iteration of the boat product
design. The main objective is to identify and proactively mitigate failure modes, resulting in a
more reliable product, lower warranty costs, and higher customer satisfaction. To facilitate
implementation, it is suggested that R&D teams and project team members be trained in the
new method and template. They should be able to hold regular meetings of about two hours.
The training should also aim to explore the benefits and differences of the adapted FMEA
method compared to the previous method to which they may be accustomed. For NPD projects,
the completion of FMEAs should be included in the project plans, especially for the highest
failure risks and for the safety-related subsystems.
By adopting the recommended approach, the case company can take advantage of the new
FMEA method to improve its product development process. Using FMEA as a proactive risk
management tool will contribute to more reliable and robust product design, ultimately leading
to cost savings and higher customer satisfaction. Implementation should be accompanied by
targeted training and regular FMEA meetings to ensure the successful integration of the new
method into the company's workflow.
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7
7.1
CONCLUSIONS AND FUTURE RESEARCH
Conclusions
The results show that FMEA is too complex and not very user-friendly for start-ups. The lack
of data complicates the assessment and makes it more difficult to prioritize the correct failure
mode. Since the FMEA template recommended in most of the literature only addresses the
needs of larger companies. It can be concluded that the FMEA method needs to be adapted for
successful start-up implementation. These adaptations are necessary to better fit start-ups. The
adaptations should help shorten FMEA meetings by making them easier to manage and track,
limiting the scope by the number of failure modes to address, and finally, facilitating the
prioritization of failure modes to mitigate.
It is critical that start-ups have a method that is easy to use. Otherwise, there is a risk that
meetings will not move forward or that key risks will not be considered, as indicated by
interviewees. The new method is easier to manage through a simplified risk estimation, as
suggested by Moreira et al. (2020). As important as it is to adapt the template and the method,
it is equally important to train the users of the new FMEA method. Also, short meetings should
be conducted in combination with the template, which is less complicated to use.
7.2
Suggestions for future research
For future research, it is proposed to conduct further case studies on the implementation of
FMEA in start-ups. This is to evaluate the results and compare them with the findings in this
report. In these case studies, the newly adapted FMEA method could be tested on the entire
product level and not only on a single subsystem. The reason for this is to evaluate the results
from other technical areas and to ensure that the results are not dependent on technical
requirements or specifications that only apply to one subsystem. This will also show if there is
a consistent improvement in FMEA results compared to previous attempts.
Since this study failed to compare the results to previous attempts with a traditional method,
even though all results indicate increased execution efficiency. The new FMEA method should
be compared to evaluate the number of risks found and see which method finds the most
amount of failure modes and the most serious ones. This can also be followed up at the end of
the product life cycle to count and compare the number of problems during the life of the
product depending on which FMEA method was used. It would also be interesting to test the
new FMEA method in a larger company to see if it can benefit from the adaptations, even if the
template and method are adapted for start-ups. In addition, future research could focus on
involving the end users of the products, such as users and customers, early in the FMEA
process. This could lead to an even better understanding of the product requirements to be
considered in the FMEA process and improve the detection of potentially unmet requirements
in the FMEA method. In addition, the new FMEA method could be tested on more complex
products or tasks to further evaluate its effectiveness. The scope of FMEA meetings could also
be further limited to increase efficiency and reduce complexity.
Overall, future research could focus on the practical implementation of the new FMEA method
and its potential impact on both start-ups and larger companies. It would also be interesting to
conduct quantitative studies to examine the impact of different scenarios. One specific study
could be to compare the grading unit between groups using the classic RPN method and the
method proposed in this study.
56 (60)
REFERENCES
Bahrami, M., Bazzaz, D. H., & Sajjadi, S. M. (2012). Innovation and Improvements In Project
Implementation and Management; Using FMEA Technique. Procedia, social and
behavioral sciences, 41, 418-425. https://doi.org/10.1016/j.sbspro.2012.04.050
Ben Romdhane, T., Badreddine, A., & Sansa, M. (2016). A new model to implement Six
Sigma in small- and medium-sized enterprises. International Journal of Production
Research, 55(15), 4319-4340. https://doi.org/10.1080/00207543.2016.1249430
Ben-Daya, M., & Raouf, A. (1996). A revised failure mode and effects analysis model. The
International journal of quality & reliability management, 13(1), 43-47.
https://doi.org/10.1108/02656719610108297
Bluvband, Z., Grabov, P., & Nakar, O. (2004, 2004). Expanded FMEA (EFMEA). Piscataway
NJ.
Boldrin, M., De Lorenzi, A., Fiorentin, A., Grando, L., Marcuzzi, D., Peruzzo, S., Pomaro, N.,
Rigato, W., & Serianni, G. (2009). Potential failure mode and effects analysis for the
ITER NB injector. Fusion Engineering and Design, 84(2), 466-469.
https://doi.org/10.1016/j.fusengdes.2009.02.010
Booth, A., Sutton, A., Clowes, M., & Martyn-St James, M. (2022). Systematic approaches to a
successful literature review (Third edition. ed.). SAGE Publications Ltd.
Bowles, J. B. (2003, 2003). An assessment of RPN prioritization in a failure modes effects and
criticality analysis.
Breiing, A., & Kunz, A. M. (2002). Critical consideration and improvement of the FMEA.
Candela Technology AB. (2022). Electric vs. combustion engine boats; (all you need to know).
Candela Technology AB. https://candela.com/electric-vs-combustion-engine-boats-allyou-need-to-know/
Candela Technology AB. (2023). Candela purpose. Candela Technology AB.
https://candela.com/purpose/
Carbone, T. A., & Tippett, D. D. (2004). Project Risk Management Using the Project Risk
FMEA. Engineering Management Journal, 16(4), 28-35.
https://doi.org/10.1080/10429247.2004.11415263
Carlson, C. (2012). Effective FMEas: achieving safe, reliable, and economical products and
processes using failure mode and effects analysis (Vol. 1). WILEY.
https://doi.org/10.1002/9781118312575
Chauhan, A. S., Nepal, B., Soni, G., & Rathore, A. P. S. (2018). Examining the State of Risk
Management Research in New Product Development Process. Engineering
Management Journal, 30(2), 85-97. https://doi.org/10.1080/10429247.2018.1446120
Chrysler LLC, Ford Motor Company, & General Motors Corporation (2008). POTENTIAL
FAILURE MODE AND EFFECTS ANALYSIS (FMEA) - Reference Manual. Chrysler
LLC, Ford Motor Company and General Motors Corporation.
David, B., Barrie, G. D., & Ton van der, W. (2016). Managing Quality, 6th Edition. Wiley.
De Toni, A., & Nassimbeni, G. (2003). Small and medium district enterprises and the new
product development challenge. International journal of operations & production
management, 23(6), 678-697. https://doi.org/10.1108/01443570310476672
de Waal, G. A., & Knott, P. (2019). Drivers of thoroughness of NPD tool use in small hightech firms. Journal of Engineering and Technology Management, 53, 19-32.
https://doi.org/10.1016/j.jengtecman.2019.05.002
Ford Motor Company. (2004). FMEA Handbook (Vol. Version 4.1). FORD MOTOR
COMPANY
57 (60)
Jalali, S., & Wohlin, C. (2012, 2012). Systematic literature studies: database searches vs.
backward snowballing.ESEM '12 Empirical Software Engineering and Measurement,
Johnson, M. S. J. R. (2013). FMEA on FMEA.
Krasich, M. (2007, 2007). Can Failure Modes and Effects Analysis Assure a Reliable Product?
Ledwith, A. (2000). Management of new product development in small electronics firms.
Journal of European Industrial Training, 24(2/3/4), 137-148.
https://doi.org/10.1108/03090590010321106
Ledwith, A., & O'Dwyer, M. (2008). Product launch, product advantage and market orientation
in SMEs. Journal of Small Business and Enterprise Development, 15(1), 96-110.
https://doi.org/10.1108/14626000810850865
Liew, C. F., Prakash, J., & Ong, K. S. (2019). An FMEA-based integrated framework to
quantify and improve operational performance in advanced manufacturing
environments: a case study. International journal of productivity and quality
management, 28(3), 318-339. https://doi.org/10.1504/IJPQM.2019.103527
Liu, H.-C., Liu, L., & Liu, N. (2013). Risk evaluation approaches in failure mode and effects
analysis: A literature review. Expert Systems with Applications, 40(2), 828-838.
https://doi.org/10.1016/j.eswa.2012.08.010
Luger, M. I., & Koo, J. (2005). Defining and Tracking Business Start-Ups. Small Business
Economics, 24(1), 17-28. https://doi.org/10.1007/s11187-005-8598-1
Lyles, M. A., Baird, I. S., Orris, J. B., & Kuratko, D. F. (1993). Formalized planning in small
business: increasing strategic choices. Journal of small business management, 31(2),
38.
Mangez, P. (2022). CANDELA C8 X PIERRE MANGEZ - 2022 - 182829-151022. In C. C. X.
P. M.-.-. 182829-151022 (Ed.). candela.com: Candela Technology.
Marion, T. J., Friar, J. H., & Simpson, T. W. (2012). New Product Development Practices and
Early-Stage Firms: Two In-Depth Case Studies. Journal of Product Innovation
Management, 29(4), 639-654. https://doi.org/10.1111/j.1540-5885.2012.00930.x
Millward, H., & Lewis, A. (2005). Barriers to successful new product development within
small manufacturing companies. Journal of Small Business and Enterprise
Development, 12(3), 379-394. https://doi.org/10.1108/14626000510612295
Moreira, A. C., Ferreira, L. M. D. F., & Silva, P. (2020). A case study on FMEA-based
improvement for managing new product development risk. International Journal of
Quality & Reliability Management, 38(5), 1130-1148. https://doi.org/10.1108/ijqrm-062020-0201
Nicholas, J., Ledwith, A., & Perks, H. (2011). New product development best practice in SME
and large organisations: theory vs practice. European Journal of Innovation
Management, 14(2), 227-251. https://doi.org/10.1108/14601061111124902
Northvolt AB. (2021). Candela launch of C-8. Northvolt AB.
https://northvolt.com/articles/candela/
Prakash, S., Soni, G., & Rathore, A. P. S. (2017). A critical analysis of supply chain risk
management content: a structured literature review. Journal of Advances in
Management Research, 14(1), 69-90. https://doi.org/10.1108/jamr-10-2015-0073
Puente, J., Pino, R., Priore, P., & de la Fuente, D. (2002). A decision support system for
applying failure mode and effects analysis. The International journal of quality &
reliability management, 19(2), 137-150. https://doi.org/10.1108/02656710210413480
Punz, S., Follmer, M., Hehenberger, P., & Zeman, K. (2011). IFMEA – INTEGRATION
FAILURE MODE AND EFFECTS ANALYSIS.
Ravi Sankar, N., & Prabhu, B. S. (2001). Modified approach for prioritization of failures in a
system failure mode and effects analysis. The International journal of quality &
reliability management, 18(3), 324-336. https://doi.org/10.1108/02656710110383737
58 (60)
Sharma, K. D., & Srivastava, S. K. (2018). Failure Mode and Effect Analysis (FMEA)
Implementation: A Literature Review.
Sommer, S. C., Loch, C. H., & Dong, J. (2009). Managing Complexity and Unforeseeable
Uncertainty in Startup Companies: An Empirical Study. Organization science
(Providence, R.I.), 20(1), 118-133. https://doi.org/10.1287/orsc.1080.0369
Stamatis, D. H. (2003). Failure mode and effect analysis : FMEA from theory to execution (2 ,
rev. and expanded ed.). ASQ Quality Press.
Sun, L., Li, Y.-F., & Zio, E. (2022). Comparison of the HAZOP, FMEA, FRAM, and STPA
Methods for the Hazard Analysis of Automatic Emergency Brake Systems. ASCEASME J Risk and Uncert in Engrg Sys Part B Mech Engrg, 8(3).
https://doi.org/10.1115/1.4051940
Säfsten, K., Gustavsson, M., & Ehnsiö, R. (2020). Research methodology : for engineers and
other problem-solvers. Studentlitteratur AB.
Taylor, J. R. A. J. (1990). The Application of Failure Mode and Effects Analysis at an
Automotive Components Manufacturer.
Teng, S.-H., & Ho, S.-Y. (1996). Failure mode and effects analysis: An integrated approach for
product design and process control. The International journal of quality & reliability
management, 13(5), 8-26. https://doi.org/10.1108/02656719610118151
Verband der Automobilindustrie. (2020). Quality Assurance in the Process Landscape. Section
4: Process Models (Vol. Volume 04 Section 4).
Voss, C., Blackmon, K. L., Cagliano, R., Hanson, P., & Wilson, F. (1998). Made in Europe:
Small Companies. Business strategy review, 9(4), 1-19. https://doi.org/10.1111/14678616.00078
Wang, W., Liu, X., Qin, Y., & Fu, Y. (2018). A risk evaluation and prioritization method for
FMEA with prospect theory and Choquet integral. Safety Science, 110, 152-163.
https://doi.org/10.1016/j.ssci.2018.08.009
Weeden, M. M. (2015). Failure Mode and Effects Analysis (FMEA) for Small Business Owners
and Non-Engineers : Determining and Preventing What Can Go Wrong. Quality Press.
Williamson, K., & Bow, A. (2002). Research methods for students, academics and
professionals : information management and systems (Second edition. ed.). Centre for
Information Studies.
Yahaya, S.-Y., & Abu-Bakar, N. (2007). New product development management issues and
decision-making approaches. Management decision, 45(7), 1123-1142.
https://doi.org/10.1108/00251740710773943
59 (60)
APPENDIX
APPENDIX A: FMEA TEMPLATES ..................................................................................................................... I
APPENDIX B: CASE COMPANY – DOCUMENT REVIEW.................................................................................... IX
APPENDIX C: MODIFIED FMEA TEMPLATE....................................................................................................XIII
APPENDIX D: FMEA WORKSHOP .............................................................................................................. XVIII
APPENDIX E: INTERVIEW GUIDE ................................................................................................................. XXI
APPENDIX F: INTERVIEW CODEBOOK AND DEFINITIONS............................................................................ XXVI
APPENDIX G: EXTRACTED DATA FROM INTERVIEW FIRST ROUND OF INTERVIEWS .................................... XXIX
APPENDIX H: KEY QUOTES FROM INTERVIEWS ...................................................................................... XXXVII
APPENDIX I: INTERVIEW GRADINGS ............................................................................................................ XLI
60 (60)
Appendix A: FMEA Templates
DFMEA examples
I (XLV)
II (XLV)
III (XLV)
PFMEA template examples
IV (XLV)
V (XLV)
VI (XLV)
FMECA template examples
VII (XLV)
VIII (XLV)
Appendix B: Case company – Document review
Full product structure
IX (XLV)
Product structure with highlighted part of focused subsystem
X (XLV)
Previous FMEA results from case company.
Sensitive information has been blurred due to company confidentiality.
XI (XLV)
XII (XLV)
Appendix C: Modified FMEA Template
FMEA Sheet
XIII (XLV)
Grading decision system
XIV (XLV)
Excel sheet to look up RPC, with Formula from row “I10”
XV (XLV)
Excel sheet with input data from matrix to RPC value
XVI (XLV)
XVII (XLV)
Appendix D: FMEA workshop
Meeting notes
XVIII (XLV)
Filled in FMEA sheet.
Sensitive information has been blurred due to company confidentiality.
XIX (XLV)
XX (XLV)
Appendix E: Interview guide
The purpose of the interview guide is for each interview to be structured in a similar way so
that the interviews can be compared equivalently. However, the interviews are only semistructured, which means that different follow-up questions can be asked to different
respondents based on the answers. The text within parentheses behind the questions will not be
read out to the respondent but only explains the background as to why the question is
interesting.
Hello!
Thank you for taking the time to meet with me for this interview. I can start by introducing the
scope of this study. I am currently writing my thesis for Candela Technology at Mälardalen
University, where I will develop an adapted FMEA methodology for start-ups with novel
technology. The thesis is mainly about the FMEA implementation, so I will compare your
answers, to the theory, and a new round of interviews after implementing the adapted version.
As I wrote to you in the chat, and as you have approved, I will record the interview, but the
recording will only be used for transcription and for analysis. The data that I collect during the
interviews will only be used for research purposes in my thesis. If you ever want to stop your
participation during or after the interview, just let me know and I will delete all data related to
you and your participation.
You are completely anonymous in your answers, but your statements can maybe be linked to
your title and your professional background, but not your name or other references you
mention will be removed. Is it okay for me to use your title and background in my report?
XXI (XLV)
Interview guide – Pre-Workshop – Research Question 1
Introduction:
1. Can you tell me a bit about yourself. What is your professional background and your
role here at Candela? (demographic and experience)
2. Can you tell me about your experience working with FMEA? (demographic and
experiences)
3. How familiar are you with different FMEA methodologies? (knowledge and facts)
Challenges with the previous risk assessment:
4. How familiar are you with the previous risk assessments performed at Candela?
(knowledge and facts)
5. How do you typically identify and prioritize potential risks in a technology company,
like Candela (where we are challenged by novel technology and lacking historical
data)? (Knowledge and Facts)
6. What were some of the biggest challenges that you faced when working on the previous
risk assessment sessions? (Experiences)
7. How would you involve stakeholders, such as management or regulatory subject
experts, in the FMEA process when dealing with novel technologies? (experiences)
8. What were some of the biggest challenges that you faced if you were involved in the
previous risk assessment sessions? (experiences)
9. How did the previous methods fall short in addressing Candela’s needs? (Opinions and
values)
10. How did the previous method support Candela to identify and manage risk?
(experiences)
11. In your opinion, what improvements do you think could be made to the previous FMEA
method? (Opinions and values)
Grading of method:
12. Would you consider the FMEA method justifiable from a resource perspective?
(Opinions and Values)
13. How time efficient is the method regarding time needed to perform the sessions?
(Opinions and Values)
14. How does the method directly or indirectly support product quality improvement?
(Opinions and Values)
15. How the method increases the risk awareness levels in the organization? (Opinions and
Values)
16. How does the method meet the needs of Candela or similar companies? (Opinions and
Values)
Conclusion:
17. Is there anything else that you would like to share regarding potential improvements of
the FMEA method? (feelings)
18. Can you share any other insights that you have regarding the use of FMEA in your
organization? (opinions and values)
XXII (XLV)
Interview guide – Post-Workshop – Research Question 2
Introduction:
1. Can you tell me a bit about yourself. What is your professional background and your
role here at Candela? (demographic and experience)
2. Can you tell me about your experience working with FMEA? (demographic and
experiences)
3. How familiar are you with different FMEA methodologies and the previous risk
assessments performed at Candela in the past? (knowledge and facts)
Adapted FMEA Method/Template:
4. Can you describe the new FMEA method/template that was tested in the workshop?
(knowledge and facts)
5. What do you see as the key strengths of the new FMEA method/template in comparison
to the regular risk assessment method? (opinions and values)
6. In what ways do you think the new FMEA method/template can better support
Candela's needs? (opinions and values)
7. How did the new FMEA method/template help Candela to better identify and manage
risks? (experiences)
8. What feedback do you have regarding the user friendliness of the FMEA
method?(opinions and values)
9. Was there any challenges that occured during the implementation during the workshop,
and if so, how were they addressed? (experiences)
10. How can Candela adjust to use the new FMEA method/template presented, and is there
any changes to the organization's approach to risk management if you do? (opinions and
values)
Grading of method:
11. Would you consider the FMEA method justifiable from a resource perspective?
(Opinions and Values)
12. How time efficient is the method regarding time needed to perform the sessions?
(Opinions and Values)
13. How does the method directly or indirectly support product quality improvement?
(Opinions and Values)
14. How the method increases the risk awareness levels in the organization? (Opinions and
Values)
15. How does the method meet the needs of Candela, or similar companies? (Opinions and
Values)
Conclusion:
16. Is there anything else that you would like to share regarding the new FMEA
method/template, or its potential implementation in your organization? (feelings)
17. Can you share any other insights or feedback that you have regarding the use of FMEA
in your organization? (opinions and values)
XXIII (XLV)
Interview guide – Swedish translation – Pre-Workshop – Research Question 1
Introduktion:
1. Kan du berätta lite om dig själv? Vad är din professionella bakgrund och vilken roll har
du här på Candela? (demografi och erfarenhet)
2. Kan du berätta om din erfarenhet av att arbeta med FMEA? (demografi och
erfarenheter)
3. Hur väl bekant är du med olika FMEA-metoderna? (kunskap och fakta)
Utmaningar med den tidigare riskbedömningen:
4. Hur väl bekant är du med de tidigare riskbedömningarna/FMECA som utförts på
Candela? (kunskap och fakta)
5. Hur identifierar och prioriterar du potentiella risker i ett teknologiföretag som Candela,
där vi utmanas av ny teknik och saknar historiska data? (Kunskap och fakta)
6. Vilka var de största utmaningarna ni stod inför när ni arbetade med de tidigare
FMECA-sessionerna? (Erfarenheter)
7. Hur skulle du involvera intressenter, såsom ledningen eller reglerande ämnesexperter, i
FMEA-processen när det gäller ny teknik? (Erfarenheter)
8. Vilka var de största utmaningarna ni stod inför när du var involverad i de tidigare
riskbedömningssessionerna? (Erfarenheter)
9. Hur brast de tidigare metoderna i att hantera Candelas behov? (Åsikter och värderingar)
10. Hur hjälpte den tidigare metoden Candela att identifiera och hantera risker?
(Erfarenheter)
11. Enligt din åsikt, vilka förbättringar tror du kan göras på den tidigare FMEA-metoden?
(Åsikter och värderingar)
Bedömning av metoden:
12. Hur rättfärdigad skulle du anse att FMEA-metoden är ur ett resursperspektiv? (Åsikter
och värderingar)
13. Hur tidskrävande är metoden när det gäller tiden som krävs för att genomföra
sessionerna? (åsikter och värderingar)
14. Hur anser du att metoden direkt eller indirekt stöder förbättring av produktkvaliteten?
(Åsikter och värderingar)
15. Hur ökar metoden riskmedvetenheten i organisationen? (Åsikter och värderingar)
16. Hur uppfyller metoden Candelas behov (eller liknande företag)? (Åsikter och
värderingar)
Slutsats:
17. Finns det något annat du vill dela med dig av angående FMEA-metoden eller dess
potentiella implementering på Candela? (Känslor)
18. Kan du dela med dig av andra insikter eller feedback som du som du har gällande
användandet av FMEA i Candela? (Åsikter och värderingar)
XXIV (XLV)
Interview guide – Swedish translation – Post-Workshop – Research Question 2
Introduktion:
1. Kan du berätta lite om dig själv? Vad är din professionella bakgrund och vilken roll har
du här på Candela? (demografi och erfarenhet)
2. Kan du berätta om din erfarenhet av att arbeta med FMEA? (demografi och
erfarenheter)
3. Hur bekant är du med olika FMEA-metodiker och tidigare riskbedömningar som har
utförts på Candela? (kunskap och fakta)
Anpassad FMEA-metod/mall:
4. Kan du beskriva den nya FMEA-metoden/mallen som testades under workshopen?
(kunskap och fakta)
5. Vad ser du som de främsta styrkorna med den nya FMEA-metoden/mallen jämfört med
den vanliga riskbedömningsmetoden? (åsikter och värderingar)
6. På vilka sätt tror du att den nya FMEA-metoden/mallen kan bättre stödja Candelas
behov? (åsikter och värderingar)
7. Hur hjälpte den nya FMEA-metoden/mallen Candela att bättre identifiera och hantera
risker? (erfarenheter)
8. Vilken feedback har du angående användarvänligheten för FMEA-metoden? (åsikter
och värderingar)
9. Uppstod det några utmaningar under implementationen av den nya FMEAmetoden/mallen under workshopen, och i så fall, hur hanterades de? (erfarenheter)
10. Hur kan Candela anpassa sig för att använda den nya FMEA-metoden/mallen och finns
det några förändringar i organisationens tillvägagångssätt för riskhantering om man gör
det? (åsikter och värderingar)
Bedömning av metoden:
11. Hur rättfärdigad skulle du anse att den anpassade FMEA-metoden är ur ett
resursperspektiv? (Åsikter och värderingar)
12. Hur tidskrävande är metoden när det gäller tiden som krävs för att genomföra
sessionerna? (åsikter och värderingar)
13. Hur anser du att metoden direkt eller indirekt stöder förbättring av produktkvaliteten?
(Åsikter och värderingar)
14. Hur ökar metoden riskmedvetenheten i organisationen? (Åsikter och värderingar)
15. Hur uppfyller metoden Candelas behov (eller liknande företag)? (Åsikter och
värderingar)
Slutsats:
16. Finns det något annat som du vill dela med dig av angående den nya FMEAmetoden/mallen eller dess potentiella implementering i din organisation? (känslor)
17. Kan du dela med dig av andra insikter eller feedback som du har angående
användningen av FMEA i din organisation? (åsikter och värderingar)
XXV (XLV)
Appendix F: Interview codebook and definitions
First round of interviews
Challenges with previous risk assessments:
•
•
•
•
•
•
•
•
Previous risk assessments
Challenges
Risk identification
Risk prioritization
Involving stakeholders
Novel technology
Lacking historical data
Stakeholder involvement
Evaluation of FMEA method:
•
•
•
•
•
•
FMEA methodologies
Resource perspective
Time efficiency
Product quality improvement
Risk awareness levels
Meeting company needs
Improvement suggestions:
•
•
•
•
•
•
•
•
Previous method shortcomings
Improvements
FMEA method enhancements
Resource perspective
Time efficiency
Product quality improvement
Risk awareness levels
Meeting company needs
Meeting company needs:
•
•
•
•
•
•
•
FMEA method
Company needs
Resource perspective
Time efficiency
Product quality improvement
Risk awareness levels
Stakeholder involvement
XXVI (XLV)
Second round of interviews
Evaluation of the new FMEA method and template:
•
•
•
•
•
•
•
•
New FMEA method
New FMEA template
Comparison with regular risk assessment method
Key strengths
User-friendliness
Feedback
Risk identification
Risk management
Implementation challenges and opportunities:
•
•
•
•
•
•
Implementation challenges
Workshop implementation
Addressing challenges
Adjusting to new FMEA method/template
Changes in risk management approach
Opportunities
Impact on Risk Assessment:
•
•
•
•
•
•
Risk assessment
Risk identification
Risk management
Risk awareness levels
Product quality improvement
Meeting company needs
Meeting company needs:
•
•
•
•
•
•
•
•
FMEA method
FMEA template
Meeting company needs
Resource perspective
Time efficiency
Product quality improvement
Risk awareness levels
Changes in risk management approach
XXVII (XLV)
XXVIII (XLV)
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INTERVIEW:
10
Interview guide – Scale for discussion
Appendix G: Extracted data from interview
First round of Interviews
G.1. – Data from Product Owner 1
Challenges with previous
risk assessment
Evaluation of
FMEA-method
Improvement
suggestions
Meeting company
needs
When design only exists on
paper, making it difficult to
accurately assess risks.
The FMEA method
is considered timeconsuming but
generally efficient.
Include more
objective opinions by
involving
stakeholders from
different functions.
FMEA is essential
for evaluating
systems that are not
regulated by
standards and
regulations.
Risk assessment can be
influenced by the optimism
or pessimism of individuals
involved.
Facilitation during
sessions helps
maintain focus and
prevent discussions
from derailing.
It enables early
detection of potential
failures, allowing for
corrective actions
before failure occur.
Lack of objective opinions
and input from stakeholders
outside the design team.
Visual support, such
as drawings or 3D
models, can enhance
understanding and
communication.
Emphasize the
importance of using
FMEA as a method
to improve the
product and not just
a mandatory task.
Present the results of
the FMEA in a
condensed and easily
understandable
format for better
sharing and
awareness.
FMEA increases risk
awareness within the
organization and
helps prioritize
safety and customer
satisfaction.
G.2. – Data from Mechanical Engineer 1
Challenges with previous
risk assessment
Evaluation of
FMEA-method
Improvement
suggestions
Meeting company
needs
Previous FMEA sessions
faced challenges in terms of
getting stuck in details and
not being able to progress
effectively.
Expressed limited
familiarity with
different FMEA
methods.
Suggested that
identifying and
prioritizing potential
risks at case
company requires a
thorough
examination of each
component and
understanding the
consequences of
failure.
Balancing FMEA
work with daily
delivery tasks can be
challenging, so need
to be easy to use
Emphasized the need for
moderation by someone with
expertise and an external
perspective to guide the
process.
Being more
acquainted with
criticality focused
FMEA.
Acknowledged that
this process is timeconsuming and can
be perceived as
tedious but
necessary.
Emphasized the need
for clear instructions
and time allocation
from management to
prioritize FMEA
activities and
documentation.
XXIX (XLV)
Mentioned that it was
important to come into the
FMEA meeting in the right
mode.
Highlighted the
importance of
reasoning and
thinking through the
issues rather than
relying solely on
testing.
Expressed some
uncertainty regarding
the implementation
of suggested actions
following previous
FMEA sessions.
Emphasized the need
for dedicated time
and off-site sessions
to focus on FMEA
activities.
G.3. – Data from Compliance Engineer 1
Challenges with previous
risk assessment
Evaluation of
FMEA-method
Improvement
suggestions
Meeting company
needs
Mentioned difficulties in
going into detail during the
risk assessment process.
Stated that he was
not familiar with
different FMEA
methods.
Mentioned the
importance of
aligning the risk
assessment with the
company's
objectives, such as
ensuring safety for
users and high risks.
The team struggled to
determine the system
boundary for the FMEA,
specifically regarding how
deep it should go into the
analysis (e.g., processor-level
or entire unit failure).
Mentioned the need
to compare the risks
and equivalence of
the novel technology
with existing
solutions or
standards.
Highlighted the
difficulty in
determining the
occurrence of
failures when
historical data is not
available. Suggested
using certified
components or
processors that
promise certain
specifications to
simplify the
assessment.
It was suggested to
involve stakeholders
such as designers,
experts from related
fields, and
management to
enhance the
knowledge and
expertise in the risk
assessment process.
It was challenging to assess
the occurrence of failures
without historical data,
especially when developing
novel technologies.
Emphasized the
importance of
involving experts
who can provide
insights into the risks
associated with the
technology.
Having a facilitator
who is not an area
expert but can take
on the role of a
devil's advocate
during the FMEA
discussions was seen
as valuable.
XXX (XLV)
It was stated that the
previous risk
assessments did not
fully meet Candela's
needs, possibly due
to the use of less
mature designs or a
lack of specificity
regarding the product
being assessed.
G.4. – Data from Electric Engineer 1
Challenges with previous
risk assessment
Evaluation of
FMEA-method
Improvement
suggestions
Meeting company
needs
One of the challenges
mentioned was the
importance of having a
moderator who can maintain
the focus of the discussion
and prevent getting stuck in
excessive detail.
Expressed familiarity
with DFMEA
It was suggested to
have experienced
engineers involved in
the risk assessment
process.
Recommended
involving the
individuals
responsible for
designing the system
in the FMEA
analysis and own
mitigation of actions.
It was suggested that it is
better to have a more
comprehensive analysis at a
higher level rather than
getting caught up in minor
details.
DFMEA was
considered more
concrete, focusing on
individual
components and
potential failure
modes.
Drawing on past
experiences and
intuition, even in the
absence of extensive
data, was considered
valuable.
Suggested to include
stakeholders such as
product owners and
customers to ensure
transparency and
allow them to form
their own opinions.
The need for time
management during FMEA
sessions was emphasized, as
prolonged sessions could
lead to decreased quality and
attention.
It was mentioned that
design maturity plays
a role in determining
which method to use
Analyzing similar
cases or utilizing
standardized
solutions from other
industries was
recommended.
The involvement of
the management
team was seen as
beneficial, as they
are stakeholders and
can contribute to
assessing risks and
consequences.
The importance of
considering both the
likelihood and
consequences of
risks and evaluating
potential solutions or
actions was
emphasized.
G.5. – Data from Project Manager 1
Challenges with previous
risk assessment
Evaluation of
FMEA-method
Improvement
suggestions
Meeting company
needs
Mentioned that previous risk
assessments at case company
were not formal and
primarily consisted of other
risk assessment sessions.
There was no mention of a
structured risk assessment
Was not familiar
with different FMEA
methods and stated
that this was their
first experience
working with FMEA.
Suggested that
dedicated time
should be allocated
for FMEA sessions
to ensure proper
focus and reflection
on potential risks.
Mentioned that
Highlighted the need
to integrate FMEA
into the company's
planning and
development
processes. Suggested
including FMEA
actions and failures
XXXI (XLV)
methodology like FMEA
being used before.
Noted that risk management
in previous projects was
mainly focused on testing
and verification activities
rather than formal risk
assessments.
Mentioned that the
FMEA sessions
conducted at Candela
were helpful in
identifying potential
risks and improving
the understanding of
the product.
longer sessions, such
as half-day sessions,
were preferred over
shorter ones.
in product
requirements
specifications and
verification plans.
Suggested
considering
alternative
approaches to keep
participants engaged
during lengthy
sessions, such as
incorporating breaks
or allowing
discussions outside
of a traditional
meeting room
setting.
Mentioned the
challenge of
determining the
appropriate timing
for conducting
FMEA during the
product development
phase. Starting
FMEA early allowed
for potential design
changes, but there
was also a risk of the
final product being
significantly
different from the
FMEA conducted
earlier.
Emphasized the
importance of
planning FMEA
sessions based on the
size of the product
and the amount of
data to be analyzed.
He mentioned that it
was challenging to
estimate the required
time for FMEA
sessions accurately.
Balancing the timing
of FMEA to ensure
enough time for
handling changes
and avoiding
surprises that may
impact the
company's strategies,
timelines, and
delivery plans was
emphasized.
XXXII (XLV)
Second round of Interviews
G.6. – Data from Manufacturing Engineer 1
Evaluation of the new
FMEA method and
template
Implementation
challenges and
opportunities
Impact on Risk
Assessment
Meeting company
needs
The template facilitated
brainstorming and
discussion, allowing for a
wide range of ideas to be
considered and then
narrowed down to relevant
points.
One challenge
mentioned was
distinguishing
between failure
modes and local
effects, which
sometimes required
discussion and
clarification during
the meeting.
Suggested that
experience with
FMEA meetings
would help in
developing a better
understanding of
differentiating
between failure
modes, local effects,
and root causes.
The new FMEA
method was seen as a
valuable method for
identifying and
managing risks
Believed that the
FMEA method could
help Candela by
enabling a focus on
root cause analysis
and understanding
the purpose of tasks
or requirements.
It was noted that the
method facilitated
going beyond fixing
immediate issues and
encouraged
addressing root
causes, which could
lead to solving
multiple problems.
The method was seen
as valuable in
preventing recurring
issues and ensuring
that tasks aligned
with the intended
requirements
Proposed the use of
specific language or
action-oriented
instructions in the
template to aid in
differentiating
between failure
modes and local
effects.
The template helped
in detecting risks,
understanding their
effects, and
considering failure
detection methods
Suggested that as
experience with the
method grows, the
template could be
further customized to
specific areas or
problems, adapting it
to better meet the
company's needs.
The template's structure and
organization were
appreciated, making it easy
to read and follow during the
meeting.
Appreciated the pre-filled
information. Use more predefined examples if possible
G.7. – Data from Production Supervisor 1
Evaluation of the new
FMEA method and
template
Implementation
challenges and
opportunities
Impact on Risk
Assessment
Meeting company
needs
No previous experience with
FMEA but found it
interesting and wanted to
learn more about it.
New grading was
easier. But would
need more training
for better
implementation.
Believed that FMEA
would provide a
detailed summary of
failures, enabling
deeper investigation
and analysis on
prioritized topics.
FMEA was seen as a
valuable tool for
improving designs,
identifying issues
with subassemblies,
and enhancing the
overall reliability and
efficiency of the end
product.
XXXIII (XLV)
Template easy to read (color
lane and fewer columns)
Mentioned the lack
of testing rigs to
check the
functionality and
quality of parts.
Indicating a potential
opportunity for
improvement to
mitigate actions.
The use of FMEA
was seen as a way to
identify and manage
risks more
effectively, helping
to avoid accidents
and incidents.
Highlighted the
potential benefits of
FMEA in improving
communication.
G.8. – Data from Engineering Manager 1
Evaluation of the new
FMEA method and
template
Implementation
challenges and
opportunities
Impact on Risk
Assessment
Meeting company
needs
Found the FMEA template
used in the workshop to be
quite standard for a
subsystem FMEA.
Pointed out the
challenge of lacking
experience in risk
assessments specific
to case company’s
new product, which
operates in different
conditions and
environments.
Mentioned the need
to gather more data
on the specific
operating conditions
to improve the
accuracy of
occurrence and
failure assessments.
Stated the
opportunity to
implement a topdown approach,
starting with a
relationship tree to
understand the
interdependencies
between subsystems
and their impact on
the overall system
failure
Importance of
considering both the
subsystem-level
failures and their
impact on the parent
system to have a
comprehensive
understanding of
failure chains.
Mentioned the need
to assess the
interactions between
subsystems and their
contributions to
failure modes
Highlighted the
importance of clearly
defining and
agreeing around the
grading system used
in FMEA, whether it
be numbers or
grades.
Suggested using a P
diagram to map the
inputs and outputs of
the system,
identifying potential
subsystem failures
that hinder the
achievement of
desired outputs
Suggested that the
grading system
should align with the
design safety
requirements and the
necessary checks
during production.
More used to working with
numbers in FMEA rather
than grades.
Using numbers to make it
easier to set requirements
and specifications for
components and subsystems
Emphasized the importance
of clearly defining the
consequences and safety
measures based on the
severity of failure modes.
XXXIV (XLV)
Emphasized the need
for well-defined
rules and
specifications based
on severity,
occurrence, and
detection levels.
G.9. – Data from Quality Engineer 1
Evaluation of the new
FMEA method and
template
Implementation
challenges and
opportunities
Impact on Risk
Assessment
Meeting company
needs
The interviewee found the
format of the FMEA
template to be acceptable and
more user-friendly.
Familiarity with the
process and
components was
identified as a
challenge during the
session.
Considered the new
FMEA method as a
valuable tool that
fulfills the needs of
Candela.
Suggested to focus on
analyzing one failure mode
at a time instead of mixing
multiple failure modes.
Suggested having
actual parts or 3D
representations to aid
in the analysis.
The FMEA method
was seen as a way to
detect and prevent
failure modes,
ultimately improving
product quality
during production.
The method was
recognized as
increasing risk
awareness within the
organization by
conducting thorough
analyses.
Expressed the need for
training sessions to ensure
everyone understands the
FMEA process.
It was recommended
to separate the
analysis of processrelated failures from
design-related
failures.
Suggested to present
and sell the value of
FMEA to the entire
company, including
top management
Emphasized the
importance of
involving a
multidisciplinary
team in the FMEA
process, including
engineers, quality,
and safety
representatives.
G.10. – Data from Service Manager 1
Evaluation of the new
FMEA method and
template
Implementation
challenges and
opportunities
Impact on Risk
Assessment
Meeting company
needs
No experience with FMEA
before the workshop
Did not perceive any
significant
weaknesses with the
FMEA method used.
The new FMEA was
seen as a valuable
tool for supporting
risk assessment
processes.
The new FMEA method
enabled identifying potential
failures and their effects well
A possibility of
spending too much
time contemplating
potential failures, but
severity levels were
used to prioritize and
categorize risks
Suggested that
dividing the focus
into specific areas,
such as specific types
of failures, could
Believed that this
FMEA could help
identify and manage
risks more
effectively.
Expressed the need
to address lowhanging fruits, i.e.,
easily achievable
improvements or risk
mitigation measures
FMEA could be
adapted to meet the
specific needs of
Candela, such as
prioritizing risks and
focusing on high
safety standards.
Believed that FMEA
and similar processes
were essential, even
though it may not
have been
Found it interesting to
consider the potential effects
of various problems, even if
it seemed minor at first.
New FMEA could
contribute to better
decision-making,
especially in terms of
XXXV (XLV)
Crucial to gather a
knowledgeable team,
including designers and user
representatives, to get a
comprehensive
understanding of the system
and its potential outcomes
help streamline the
process.
Input from internal
stakeholders and
customers could also
help limit the scope
and prioritize risks
effectively
safety and product
quality.
Could have positive
impacts on
marketing and sales
by assuring higher
safety standards and
reducing the
likelihood of serious
incidents
XXXVI (XLV)
emphasized
previously.
Lack of previous
focus on FMEA
might be attributed to
other priorities and
the desire to make
things work before
considering potential
failures due to time
Appendix H: Key quotes from interviews
Key quotes from first round of interview
H.1. – Product Owner 1
"the design only exists on paper. We just don't know whether it will perform."
"There's a risk in the risk assessment that we have assessed certain things wrong."
“it's important I think to have people from service, from production, a safety manager, or
functions that can have an objective view”
“but I believe the next steps are not really clear from our side”
"You need to block a lot of time from all these people that have many other important things to
do."
"It enables to detect risks of failure quite early on in the process."
“You should have easy templates. A clear step-by-step method.”
“It improves the quality by implementing corrective actions and failures that haven't even
happened”
H.2. – Mechanical Engineer 1
“we didn't really made any progress. We kept getting stuck on various details "
"We need someone with expertise and an external perspective to moderate the process."
“It takes a lot of time, but it is 100% justice in my opinion. It is rather the opposite that more
time should be spent on it.”
"Reason and think through the issues rather than relying solely on testing."
"Dedicated time and off-site sessions are important for FMEA activities."
"Balancing FMEA work with daily delivery tasks is challenging."
“Important to come with the right state of mind.”
“We had this FMEA session with [XXXXX] who came here and then it was clear that now we
book in that time and we do it like this. And we did.”
"Uncertainty regarding the implementation of suggested actions from previous FMEA
sessions."
H.3. – Compliance Engineer 1
“the occurrence part is what I see as the hard part that if you don't have some like data to base
it on, it's hard to know the first time how many times this is going to fail unless you implement
a bunch of certified part,
“In some way, it is probably possible to compare most things with previous things, that is, that
the combination and use is new. “
“for me personally, it's just occurrence, that is, "how big is the risk of it happening?"”
“Safety is ultimately what is interesting. The interesting thing is that it doesn't go wrong there.
Those are the risks that are interesting to look at”
"The more knowledge in the room, the better. The designer should be there, and there should
be an expert who looks at the whole object."
"Having a facilitator who is not an area expert but can take on the role of a devil's advocate
during the FMEA discussions was seen as valuable."
XXXVII (XLV)
H.4. – Electrical Engineer 1
“It's better to make it more complete at a higher level than to sort of get stuck on small details
and then just mess around there.”
“Alternatively, you can focus on the most important things going forward in the design work”
"Time management during FMEA sessions is crucial to maintain quality and attention."
"Involving experienced engineers in the risk assessment process is highly recommended."
"Drawing on past experiences and intuition, even with limited data, is valuable."
“You can take it from other industries or other standardized solutions, check other stuff. Where
you might encounter semi-similar things”
“Invite those who have designed the system or parts, so they know what needs to be fixed”
"Involving stakeholders like product owners and customers ensures transparency and diverse
perspectives."
H.5. – Project Manager 1
"Previous risk assessments at Candela were not formal”
"Risk management in previous projects at Candela was primarily focused on testing and
verification activities rather than formal risk assessments."
“before doing certain steps, you must have done verification before making releases on critical
subsystems and component level, whole system”
“I would say that we have to do an FMEA, that's really what I base it on and that we also have
to dedicate time to it. You can't do this mediocre, because then you won't get anything
meaningful out of it. It is better to do the most important parts properly.”
“I felt that it was helpful along the way that we started with longer sessions than one hour,
then perhaps half a day rather than a full day. Because the energy also goes out of you quite a
lot when you just talk about everything that can go wrong”
"It is important to integrate FMEA into the company's planning and development processes."
“we have to start somewhere to identify which of these actions based on the global errors
should go into the requirements specification and which actions should go into the verification
plan to work with them based on that.”
"Starting FMEA early allows for potential design changes, but there is a risk of the final
product being significantly different from the earlier FMEA."
"Further clarification is needed on next steps after the FMEA sessions."
XXXVIII (XLV)
Key quotes from second round of interview
H.6. – Manufacturing Engineer 1
“it was also easy to fill it once when we got the idea. And then we came back later after a few
discussion and a different point of view, and then we revised it and it was easy to revise the
document."
“because some of them were pre filled then you discuss a bit about it and then you are like
okay, which of those five propositions are we the closest to? And it helps you to recenter the
discussion and I think this is helping.”
"defining the failure mode or the kind of the local effects on how precise you need to be on
each of them. Because sometimes the failure mode can or sounds really close to a local effect”
“I think this document helped to organize, detecting and prepare. To act and know what to “
“But it really tells you, I feel, where to take care and where to spend more resources later to
improve it. “
“Help us to remember and to all align on what we're talking about, which for me was really
good, like the visual introduction was really great and after so the document was here with all
the columns and then we an explanation was given about what we will do globally so we have a
bit more context again.”
"As experience with the method grows, the template could be further customized to specific
areas or problems, adapting it to better meet the company's needs."
H.7. – Production Supervisor 1
“I truly believe that this document is going to to be very resourceful in future as well as as well
as a pilot project and which will help us in future to build more reliable boats in short“
"The impact of the new FMEA method on risk assessment has been significant, providing a
more comprehensive understanding of potential risks."
H.8. – Engineering Manager 1
"The P diagram could help map out inputs, outputs, and subsystems that can hinder achieving
the desired output."
"Using numbers in FMEA makes it easier to set requirements and define the safety needed."
“if we have anything that's life threatening, the amount of safety that you need against the
requirement.”
"As long as the next steps are properly defined, whether using numbers or letters, it doesn't
matter."
"The number in RPN helps prioritize high severity failures and ensures proper control
measures are in place."
"High severity failures are the first ones to look for”
H.9. – Quality Engineer 1
"The format of the FMEA template to be acceptable."
"All need to understand when we have some failure that has a high level of severity and very
low level of detection, we should have something to detect the issue and not just accept it."
“but I think the format is user friendly for everyone “
XXXIX (XLV)
"The challenge was to understand what parts, steps or like names of each individual
subcomponent we were talking about."
"First, I think they need to keep training for everyone that never worked with FMEA."
"Depends on the focus, but this one was efficient."
"I think for all the tools I know, this is the one that could help us."
"We should present this and sell this in a way that everyone understands the value of the tool."
H.10. – Service Manager 1
"One strength was that you obviously gather many people who are knowledgeable about the
systems and use this product themselves."
"I didn't perceive any significant weaknesses with the FMEA method used."
"Dividing the focus into specific areas, such as addressing specific types of failures, could help
streamline the process."
"Seeking input from internal stakeholders and customers could help prioritize risks effectively."
"FMEA can help identify and manage risks more effectively."
"FMEA contributes to better decision-making, especially in terms of safety and product
quality."
"FMEA assures higher safety standards and reduces the likelihood of serious incidents."
"We need to address low-hanging fruits, easily achievable improvements or risk mitigation
measures."
"FMEA can be adapted to prioritize risks and focus on high safety standards."
"FMEA and similar processes are essential, even if they may not have been properly
emphasized previously."
XL (XLV)
Appendix I: Interview gradings
The first round of interviews
Product owner 1
Mechanical Engineer 1
XLI (XLV)
Compliance Engineer 1
Electrical Engineer 1
XLII (XLV)
The second round of interviews
Manufacturing Engineer 1
XLIII (XLV)
Production Supervisor 1
Engineering Manager 1
XLIV (XLV)
Quality Engineer 1
Service Manager 1
XLV (XLV)