Total Quality Management-FMEA, CTQ and Kano Model

1. FAILURE MODES EFFECT ANALYSIS
(FMEA), CTQ, KANO MODEL I.Karthikeyan, AP, Mech/SRIT

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3. Failure Modes and Effects Analysis (FMEA) is a systematic, proactive method for
evaluating a process to identify where and how it might fail and to assess the relative
impact of different failures, in order to identify the parts of the process that are most in
need of change.
FMEA includes review of the following:
Steps in the process
Failure modes (What could go wrong?)
Failure causes (Why would the failure happen?)
Failure effects (What would be the consequences of each failure?)
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4. Teams use FMEA to evaluate processes for possible failures and to prevent them
by correcting the processes proactively rather than reacting to adverse events after
failures have occurred.
This emphasis on prevention may reduce risk of harm to both patients and staff.
FMEA is particularly useful in evaluating a new process prior to implementation and
in assessing the impact of a proposed change to an existing process.
A failure modes and effects analysis (FMEA) is a tool for assessing the risk of
failure within a process. It is used to ensure effective design of new processes and/or
to assess the risk in an existing process.
FMEA provides a structured approach to interrogating every step of a process with
a view to proactively identifying risks. It enables the prioritisation of risks that
should be addressed in the design, redesign or improvement of a process.
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Purpose of the FMEA
Preventive costs to identify potential defects by FMEA’s are relatively low compared to in-house detection
and correction of defects and even much lower than recovery costs in case defects are found by our
Customers.
Identify and eliminate
potential defects
Detection and
correction of defects
Detection and correction
EXTERNAL defects
Customer
Product
development
Project
planning
D-FMEA
Pre-
production
Production Lifetime
Validatio
n
tests
Preventive costs Warranty costs
P-FMEA
Cost of validation
Manufacturer / supplier

6. Purpose of the FMEA:
• Methodology that facilitates process improvement
• Identifies and eliminates concerns early in the
development of a process or design
• Improve internal and external customer satisfaction
• Risk Management tool, focuses on prevention
• FMEA may be a customer requirement (likely
contractual, Level 3 PPAP, ISO 9001)
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7. Objectives:
•To understand the use of Failure Modes and Effect
Analysis(FMEA)
•To learn the steps to developing FMEAs
•To summarize the different types of FMEAs
•To learn how to link the FMEA to other Process tools
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8. FMEA, SUMMARY
FMEA, a mathematical way to identify:
• failure modes, the ways in which a product or process can fail
• the Effects and Severity of a failure mode
• Potential causes of the failure mode
• the Occurrence of a failure mode
• the Detection of a failure mode
• the level of risk (Risk Priority Number)
• actions that should be taken to reduce the RPN
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RPN = Severity X Occurrence X Detection

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Inputs might include other tools such as:
D-FMEA (Part and Assembly level) Defines VOC
• Customer requirements
• CTQ Flow down analysis
• Quality Function Deployment (House Of Quality)
• Risk assessments
P-FMEA (Process level) Delivers VOC
• Process flowchart
• Sequence Of Events
• Process Tooling
• Poka-Yoke list

10. FMEA, APPLICATION EXAMPLES
There are several situations where an FMEA is the optimal tool to identify risk:
•Process-FMEA:
•Introducing a new process
•Reviewing existing processes after modifications
•Introduce new Part Numbers on an existing Production Line
•Design-FMEA:
•Introducing a new Design, Part, Sub Assembly or Assembly
•Use an existing Design for another application
•Reviewing existing Designs after modifications
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11. WHAT IS A FAILURE MODE?
A Failure Mode is:
•The way in which the component, subassembly, product
or process could fail to perform its intended function
•Failure modes may be the result of previous operations or
may cause next operations to fail
•Things that could go wrong INTERNALLY:
 Warehouse
 Production Process
•Things that could go wrong EXTERNALLY:
 Supplier Location
 Final Customer
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12. WHEN TO CONDUCT AN
FMEA
When to Conduct an FMEA?
•Early in the New Product Introduction (A-Build) complete for B
build.
•When new systems, products, and processes are being
designed
•When existing designs or processes are being changed, FMEA’s
to be updated
•When process improvements are made due to Corrective
Action Requests
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13. History of FMEA:
•First used in the 1960’s in the Aerospace industry during
the Apollo missions
•In 1974, the Navy developed MIL-STD-1629 regarding
the use of FMEA
•In the late 1970’s, the automotive industry was driven by
liability costs to use FMEA
•Later, the automotive industry saw the advantages of
using this tool to reduce risks related to poor quality (QS-
9000, VDA and ISO-TS 16949 standard)
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14. CASE STUDY
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Case Study, what could have been avoided using FMEA
AubieSat-1 was the first ever, 4-inch
Cube Satellite to be accepted by
NASA for launch.
It was launched into space 28 th
October 2011 from Vandenberg Air
Force Base in California on a
NASA-sponsored Delta II rocket.

15. CASE STUDY
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What was the failure mode?
Once the satellite was deployed:
• the team had problems making contact
with the satellite
• One of the 2 antennae failed to deploy
• The signal transmitter at the control
center did not have enough power to
communicate with the satellite
How was it solved?
• The team used another signal
transmitter from an earlier flight
which had enough power to enable
communication
Lessons learned:
• Plan for errors!
The use of an FMEA most likely had avoided
the malfunction involving people from the
earlier flight
• Teamwork!
The collaboration relationship between teams
enabled the team to use the alternative
equipment. Without it, the mission could have
failed.
Why Do I Care?
First Time Right, Calculated Risk, Rights
Team will safe resources!

16. TYPES OF FMEAS
Design FMEA
• Analyzes product design before release to
production, with a focus on product function
• Analyzes systems and subsystems in early concept
and design stages
Process FMEA
• Used to analyze manufacturing and assembly
processes before they are implemented
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17. FMEA: A TEAM TOOL
•A team approach is necessary, see example AubieSat-1
communication problems could have been avoided by involving a practical
experienced team!
•Team should be led by the Right person, Design, Manufacturing or Quality
Engineer, etc…familiar with FMEA
•The following Team members should be considered:
 Design Engineers
 Process Engineers
 Supply Chain Engineers
 Line Design Engineers
 Suppliers
 Operators
 Practical Experts
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18. THE FMEA FORM
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Identify failure modes
and their effects
Identify causes of the
failure modes
and controls
Prioritize Determine and
assess actions
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19. FMEA PROCEDURE
1. For each process input determine the ways in which the input can go
wrong (failure mode)
2. For each failure mode, determine effects
Select a Severity level for each effect
3. Identify potential causes of each failure mode
Select an Occurrence level for each cause
4. List current controls for each cause
Select a Detection level for each cause
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RPN = Severity X Occurrence X Detection

20. FMEA PROCEDURE (CONT.)
5. Calculate the Risk Priority Number (RPN)
6. Develop recommended actions, assign responsible
persons, and take actions
•Give priority to high RPNs
•MUST look at highest severity
7. Assign the predicted Severity, Occurrence, and Detection
levels and compare RPNs (before and after risk
reduction)
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21. RATING SCALES
•Preferred Scales are1-10
•Adjust Occurrence scales to reality figures for your company
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Severity:
1 = Not Severe, 10 = Very Severe
Occurrence:
1 = Not Likely, 10 = Very Likely
Detection:
1 = Easy to Detect, 10 = Not easy to Detect

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23. THE FMEA FORM
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Identify failure modes
and their effects
Identify causes of the
failure modes
and controls
Prioritize Determine and
assess actions
A Closer Look
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24. Risk Assessment with FMEA
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25. How capable are we of
detecting the failure mode
with our current controls?
Document current process controls!
Potential for occurrence!
Identify potential root causes of failure mode!
Determine Severity of failure mode!
Identify consequences of that failure!
Identify failure modes at each process step!
Risk Assessment with FMEA
Risk Priority Number (RPN).
Highest # equals Highest Risk!
Severity x Occurrence x Detectability = RPN
Use Like Pareto Chart to identify what items to address first.

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Risk Assessment with FMEA
Severity
Occurrence
Detection

27. CASTING ATTACH
TORQUE
OVER TORQUE
UNDER TORQUE
CROSS THREAD
CASTING
FRACTURE
CASTING
SEPARATION
CASTING
SEPARATION
10
9
9
TORQUE WRENCH
NOT CONTROLLED
TORQUE WRENCH
NOT USED/
CONTROLLED
NO LEAD IN ON
BOLT THREAD
4 DC TORQUE
WRENCH USED /
LINKED TO OMS
3 120
ADD TORQUE
ALARM AND
CALIBRATION AT
START UP.
JENNY TONE 10 2 20
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Risk Assessment with FMEA

28. RISK PRIORITY
NUMBER (RPN)
 RPN is the product of the severity, occurrence, and detection
scores
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Severity Occurrence Detection RPN
X X =
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29. FMEA, 10 STEPS
CHECKLIST
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10 Steps to Conduct a PFMEA
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1. Review the process—Use a process flowchart to identify each process component
2. Brainstorm potential failure modes—Review existing documentation and data for
clues
3. List potential effects of failure—There may be more than one for each failure
4. Assign Severity rankings—Based on the severity of the consequences of failure
5. Assign Occurrence rankings—Based on how frequently the cause of the failure is likely
to occur
6. Assign Detection rankings—Based on the chances the failure will be detected prior to
the customer finding it
7. Calculate the RPN—Severity X Occurrence X Detection
8. Develop the action plan—Define who will do what by when
9. Take action—Implement the improvements identified by your PFMEA team
10. Calculate the resulting RPN—Re-evaluate each of the potential failures once

30. SUMMARY
An FMEA:
 Identifies the ways in which a product or process can fail
 Estimates the risk associated with specific causes
 Prioritizes the actions that should be taken to reduce risk
FMEA is a team tool
There are two different types of FMEAs:
 Design
 Process
Inputs to the FMEA include several other Process tools such
as C&E Matrix and Process Map.
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Key Points

31. LET’S GET TO KNOW
CTQ is an acronym that stands for Critical-To- Quality. Customer
requirements, which are identified as CTQs, are actually a handful of elements
that are considered critical to the executive team in determining the success of the
project/product/process.
For Example
 ‘Improve customer service’ is too broad to do much with it. However, by using
a CTQ Tree, you can drill-down this general goal, identify specific and
measurable requirements that you can use to improve performance.
Determining Critical-to-Quality customer requirements is a part of Lean Six
Sigma training,
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32. CTQs are the internal critical quality parameters that relate to the wants and
needs of the customer.
The (internal and external) customer requirements get translated into Critical-To-
Quality (CTQ) features.
These CTQs define the criteria to evaluate what good looks like i.e., how well the
project scope and deliverables meet requirements. CTQ is a simple, yet powerful
tool that translates customer needs into a Meaningful, Measurable, and
Actionable metrics for people or group of people.
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33. It is a step-by- step process to identify CTQs for critical customer requirements.
Notice the order of the events that help to identify QTCs. Here the process is broken
down into seven steps:
VoC Six Sigma: It has been noted in the words of the customer
CTQ Name: It has been noted in the words of the organization
CTQ Measure: As identified by the organization
CTQ Specification: As specified by the organization
Defect: As defined by the organization
Unit: It is an organizational / a process metric
Opportunity: As determined by the company/process
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34. How to develop a CTQ Tree?
1. Identify critical customer needs
We first need to identify the critical needs that the product or service has to meet.
Please make sure to do a CTQ Tree for every need that you identify. During this first
step, we’re essentially asking: ‘What is critical for this product or service?‘ It’s
best to define these needs in broad terms.
If it is not possible to directly ask customers about their needs, then the project team
can brainstorm their needs with people who deal with customers directly – Sales
people and Customer Service Representatives – as well as with your team.
2. Identify quality drivers
It is important to identify the specific quality drivers that have to be in place to meet
the needs that we identified in the previous step. Please remember, these are the
factors that must be present for customers to think that you are delivering a
high-quality product.
Note that it is very much necessary that we identify all of the drivers that are
important to the customers. Tools such as KANO Analysis will be useful here. KANO
model will help you identify product features that will delight your customers. 34

35. Identify performance requirements
Finally, we need to identify the minimum performance requirements that we must
satisfy for each quality driver, in order to actually provide a quality product. Here it’s
important to remember that there are many things that will affect organization’s ability to
deliver these.
Once we’ve completed a CTQ Tree for each critical need, we’ll have a list of
measurable requirements that we must meet to deliver a high-quality product.
CTQ Tree Examples
Have a look at a CTQ example. On the basis of this case study, we’ll prepare a CTQ tree
for one of the critical customer requirements.
Before you begin with preparing a CTQ tree you have to:
Identify your customers
Collect Voice of Customer data
Analyze VoC data
Prepare a list of CTQs
Choose one CTQ and prepare a CTQ tree only for that CTQ. 35

36. THIS FIGURE SHOWS WHAT YOUR
CTQ TREE WOULD LOOK LIKE
FOR ONE OF THE CRITICAL
NEEDS IDENTIFIED I.E. “I NEED
MY PIZZA NOW”
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38. It’s a horizontally-placed critical to quality tree. You can also prepare a CTQ tree so that
is vertically-placed. This is just a representative CTQ tree and is not complete in every
respect..
How do we read or comprehend the tree? ‘I need my pizza now’ has three quality
drivers. The first one is ‘Whenever I want’. Customer says I need my pizza whenever I
want. It means I want it anytime during the day.
That is the VoC. Over here, VoB (Voice of business) says that the service is available
between 11 AM and 12 PM. It means that if the customer needs pizza at 8 AM, he/she
will not get it at all.
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39. The standard expectation is that every call that all calls that the pizza store receives
should be answered on the 1st ring. The business problem may be related to this
performance requirement.
The Six Sigma project needs to validate the non-performance towards answering the
call on the 1st ring. The team may need to look into the historical calls data, for the past
six months, to check how many calls were actually made at each counter in the pizza
store, how many calls actually rang but; were not picked up, how many calls were
abandoned because they were not picked up in the first ring etc. The data has to speak
the performance story.
The question for the business is: How to get it done? Critical questions, at this stage,
could be:
Do we need to increase the number of people on board?
Do we need to increase the number of telephone lines?
Do we need to appoint one person just to pick up the call?
Providing answers to these questions might end up in having a new CTQ. That is how,
you need to read and prepare CTQ tree.
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40. KANO MODEL
The Kano model is a theory for product development and customer satisfaction
developed in the 1980s by Professor Noriaki Kano, which classifies customer
preferences into five categories.
The Kano model is a way of analyzing customer requirements by diagramming
user's wants across 2 axis; satisfaction with your output and how much of your
goals you achieved. Depending on how you perform on those axis, your clients
can be classified as delighted, neutral, or dissatisfied.
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41. Must-be Quality - Simply stated, these are the requirements that the customers
expect and are taken for granted.
When done well, customers are just neutral, but when done poorly, customers are
very dissatisfied. Kano originally called these “Must-be’s” because they are the
requirements that must be included and are the price of entry into a market.
Examples: In a hotel, providing a clean room is a basic necessity. In a call center,
greeting customers is a basic necessity.
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42. One-dimensional Quality- These attributes result in satisfaction when fulfilled and
dissatisfaction when not fulfilled. These are attributes that are spoken and the ones in
which companies compete.
An example of this would be a milk package that is said to have ten percent more milk
for the same price will result in customer satisfaction, but if it only contains six percent
then the customer will feel misled and it will lead to dissatisfaction.Examples: Time
taken to resolve a customer's issue in a call center. Waiting service at a hotel.
Attractive Quality- These attributes provide satisfaction when achieved fully, but do not
cause dissatisfaction when not fulfilled. These are attributes that are not normally
expected, for example, a thermometer on a package of milk showing the temperature of
the milk. Since these types of attributes of quality unexpectedly delight customers, they
are often unspoken.
Examples: In a callcenter, providing special offers and compensations to customers or the
proactive escalation and instant resolution of their issue is an attractive feature. In a
hotel, providing free food is an attractive feature.
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43. Indifferent Quality-These attributes refer to aspects that are neither good nor bad, and
they do not result in either customer satisfaction or customer dissatisfaction. For
example, thickness of the wax coating on a milk carton. This might be key to the design
and manufacturing of the carton, but consumers are not even aware of the distinction. It
is interesting to identify these attributes in the product in order to suppress them and
therefore diminish production costs.
Examples: In a callcenter, highly polite speaking and very prompt responses might not
be necessary to satisfy customers and might not be appreciated by them. The same
applies to hotels.
Reverse Quality-These attributes refer to a high degree of achievement resulting in
dissatisfaction and to the fact that not all customers are alike. For example, some
customers prefer high-tech products, while others prefer the basic model of a product
and will be dissatisfied if a product has too many extra features.
Examples: In a callcenter, using a lot of jargon, using excessive pleasantries, or using
excessive scripts while talking to customers might be off-putting for them. In a hotel,
producing elaborate photographs of the facilities that set high expectations which are
then not satisfied upon visiting can dissatisfy the customers.
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