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1.0 Dfmea PDF
1.0 Dfmea PDF
INDEX
1) INTRODUCTION 3
2) INTRODUCTION TO FMEA 5
3) GROUP EXERCISE – 1 11
4) WHAT IS FAILURE ? 14
5) WHAT IS FMEA? 40
6) TYPES OF FMEA 78
7) HOW TO CONDUCT FMEA? 85
8) RISK ASSESSMENT 90
9) DFMEA 110
10) GROUP EXERCISE – 2 118
11) CASE STUDIES 121
12) VIDEOS 123
13) PROJECT IDENTIFICATION 126
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DFMEA – Design Failure Mode Effect Analysis
1.INTRODUCTION
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INTRODUCTION TO
“FMEA – FAILURE MODE EFFECT ANALYSIS”
• In any industry, the failure of any component or machine
causes catastrophic effects on the production and profits
which leading loss to the company.
• It is expected that the machines are up & working without
any sudden failure / breakdown all the time.
• To achieve this, it is necessary to avoid any failure.
• Process of avoiding or preventing the failure is called
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2.INTRODUCTION TO FAILURE
MODE EFFECT ANALYSIS – FMEA
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INTRODUCTION TO FMEA
• The FMEA is a process that is built on understanding the various
types of failures that
• Have occurred
• Can occur
• FMEA is built on understanding probability of failure occurrence
and ways and means of preventing it.
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3.Group Exercise - 1
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GROUP EXERCISE -1
Make groups of 5 each.
The team should have participants preferably from different
areas of work.
Identify major product failures experienced – in terms of design
and process
Each team to identify at least 3 failures.
Also list present solutions if available and analysis method used,
don’t judge them.
Time Limit : 1) 15 Minutes for workout
2) 5 Minutes each team for discussion
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4.WHAT IS FAILURE?
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6. Develop success from failures. Discouragement and
failure are two of the surest stepping stones to
success. - Dale Carnegi
7. Failure is success if we learn from it. - Malcolm Forbes
8. I’ve missed more than 9000 shots in my career. I’ve
lost almost 300 games. Twenty-six times I’ve been
trusted to take the game winning shot and missed.
I’ve failed over and over and over again in my life. And
that is why I succeed. - Michael Jordan
9. One who fears failure limits his activities. Failure is
only the opportunity to more intelligently begin
again. - Henry Ford
10.Only those who dare to fail greatly can ever achieve
greatly. - Robert F. Kennedy
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• What is FAILURE?
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What is Failure?
• Failure is inability to produce work in appropriate manner.
• For Example: Equipment / machine failure on production
floor – worn out bearing, pump, pressure leaks, broken shaft
bad surface finish etc.
• Equipment failure in office – No power supply, No AC
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Three main aspects need to be understood
A. The Financial impact of Failure
B. The Failure Mode
C. The Cause of Failure
These are not part of this training.
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1. What is Continuous Improvement?
Concept of Continuous Improvement
The concept of Failure, Success and Continuous Improvement are
universal and are applicable to persons as well as processes.
In case of organization the thrust today is to make the processes more
and more robust.
This needs continuous evaluation and more correction.
For continuous improvement, the mistakes, errors and the failures
should be analyzed in details.
The Japanese word – KAIZEN and the process named after the same, is
basically aimed to do this task.
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Continuous improvement is a process of slow, step by step
improvement of the existing processes to reduce the waste and
improve the efficiency there by improving the bottom line!
Various quality standards talk about the continuous
improvement.
It says that the organization should continuously strive to
improve the effectiveness of its quality management system
through use of
Quality policy
Quality objective
Quality Audits and its results
Analysis of data
Corrective and Preventive Actions
Management reviews
The most popular tool available for continuous improvement is –
Kizen.
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Continuous Improvement or Kaizen, Japanese for "improvement."
When used in the business sense & applied to the workplace,
kaizen refers to activities that continuously improve all functions
and involve all employees.
It is applicable also to processes, such as purchasing & logistics,
that cross organizational boundaries into the supply chain.
It has been applied in healthcare, psychotherapy, life-coaching,
government, banking, and other industries.
By improving standardized activities and processes, kaizen aims
to eliminate waste.
Kaizen was first implemented in several Japanese businesses
after the II World War, influenced in part by American business
and quality management teachers who visited the country.
It has since spread throughout the world and is now being
implemented in environments outside of business and
productivity.
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2. What is process?
Process is a set of interacting activities which
transforms inputs to outputs.
All the activities that take place from the point of
order acceptance till the commissioning of equipment
are called processes.
The processes can be classified in various different
types.
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Classification of processes:
One way of classifying processes is
Manufacturing Processes (Blue Collar Processes) –
These are tangible processes where the input and
output are tangible like welding, painting etc.
Transactional Processes (White Collar Processes) –
These are mostly intangible processes like design,
development, marketing etc.
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Other way of classifying processes is
Value Adding – Processes for which the customer
is willing to pay, or processes where the value gets
added. Like Heat Treatment , machining etc. –
Need to be improved
Non-value Adding Processes – Processes for which
the customer is not willing to pay. E.G. – Storage,
Inspection (Mostly Internal), Transport (For
Commodities) – need to be eliminated
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Such a tool should consider
Possible modes of failure
The possible effects of the defect / nonconformity on
the performance
Prioritize the actions to be taken
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5.WHAT IS FMEA?
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Let us find out the following
What is FMEA?
Some important terms related to FMEA
Why is FMEA important?
History of FMEA
Benefits of FMEA
Limitations of FMEA
How to conduct an FMEA?
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Before we proceed, let us know?
Anyone conducted an FMEA before?
Anyone completed a Risk Analysis
Procedure?
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What is FMEA?
A systemized group of activities designed to:
recognize and evaluate the potential failure of a
product / process and its effects
identify actions which could eliminate or reduce
the chance of potential failure
document the process
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Then please explain
Landing of Apollo
11 landing on
Moon and return
Mangalyan
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We may feel the law is true, but then it can not
explain many successful products and
completed projects.
In case this law is true, there can not be any
success story and the whole world will be in
shambles.
FMEA is the industry’s answer to the Murphy’s
law.
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What is FMEA?
Failure Mode and Effect
Analysis
o A systemized group of activities designed to:
recognize and evaluate the potential failure of a
product/process and its effects
identify actions which could eliminate or reduce
the chance of potential failure
document the process
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VOCABULARY OF FMEA
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FMEA Terms
Failure mode - the way in which
something might fail
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Why do an FMEA?
Preventing problems is cheaper and
easier than cleaning them up.
Some things are too risky or costly to
incur mistakes.
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FMEA Provides the Potential to:
Reduce the likelihood of customer complaints
Reduce the likelihood of campaign changes
Reduce maintenance and warranty costs
Reduce the possibility of safety failures
Reduce the possibility of extended life or
reliability failures
Reduce the likelihood of product liability
claims
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History
An offshoot of Military Procedure MIL-P-1629, titled Procedures
for Performing a Failure Mode, Effects and Criticality Analysis,
dated November 9, 1949.
Used as a reliability evaluation technique to determine the effect
of system and equipment failures.
Failures were classified according to their impact on mission
success and personnel/equipment safety.
Formally developed and applied by NASA in the 1960’s to
improve and verify reliability of space program hardware.
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Benefits
Identify potential and known failures
Reduce the number of engineering changes
Reduce product development time
Lower start-up costs
Greater customer satisfaction
Increased cooperation and teamwork between various
functions
Continuous improvement
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Advantages
Enhance design and manufacturing
efficiencies
Alleviate late change crises
Minimize exposure to product failures
Augment business records
Improve “bottom line” results
Add to customer satisfaction
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Apart from the above, we should guard against following pitfalls.
1. Prioritizes, Doesn’t Correct
The initial output of an FMEA is the prioritizing of failure
modes based on their risk priority numbers.
This alone does not eliminate the failure mode. Additional
action that might be outside the FMEA is needed.
2. Only as Good as the Team
Identifying failure modes is a team brainstorming activity.
If the team forgets to list it, an important failure mode could
be left alone, waiting to occur.
3. Time Consuming
It takes time to get into the details.
4. Unknown Unknowns
Might miss a failure mode or an effect outside the
experiences of the company.
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5. Not Customizing Rating Scales
Rating scales should be meaningful to everyone in the
organization.
The generic rating scales might be confusing to some teams.
Management will not be able to compare RPNs in order to
prioritize activities between teams.
6. Not Starting in the Design Stage
The earlier in the design process an FMEA is started, the
better.
A DFMEA can catch where design verification is needed.
7. Taking on Too Large a Scope
Taking on an entire process may be a daunting task.
Break a large process down into manageable chunks.
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8. Not Including Operators
Experienced operators should be on the team to add their
perspective.
They often have good information on failure modes and on
the effectiveness of control systems.
They might have information on occurrence as well.
9. Not Including Customers
Customers, especially end-users, often have a better view on
failure modes than internal personnel.
10. Not Including Suppliers
Suppliers also bring an outside perspective to the team.
Might be able to tie your process in with theirs.
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11. Becoming a Full-Time Job
Sometimes people use an FMEA as an excuse to get out of
doing their regular job.
You can’t afford to have people who are just conducting
FMEAs.
Won’t get their regular work done.
Even if FMEAs are made their “regular” work, they will lose
touch with the process and the FMEA will become mere
paperwork.
12. Not Using Concept of a Process
This will cause the team to forget some failure modes.
The team should brainstorm failure modes in each of People,
Methods, Equipment, Materials, and Environment.
13. Not Getting into the Details
A superficial look at the process will miss many
failure modes.
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14. Forgetting there are Internal- and External-Related Failure
Modes
Many FMEAs focus only on the customer requirements
(specifications).
Sometimes internal productivity losses, equipment damage,
scrap, and rework have very severe effects on the company.
15.Confusing Root Cause and Failure Mode
Teams often have root causes as failure modes.
A failure mode is the failure to perform the intended
function.
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16. Not Looking at Each Product
Templates are great but every product being made in a
process is not exactly the same.
The template should be used as a starting point and each
product should be evaluated:
Could this failure mode occur with this product?
Would this effect occur?
Is this the correct root cause?
Are these controls applicable?
Should any of the three ratings be changed?
17. Assuming Detection Controls Are Better Than They Are
Some controls are not as good as they are perceived to be:
High repeatability and reproducibility.
Don’t test for what we think they test for.
Only test part of the product.
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18. Assuming Detection Controls Apply When They Don’t
A control might apply to one effect of a failure mode but not
another.
For example, final inspection is a control against a defect
impacting a customer, but it may not be a control scrap.
against rework
19. Not Linking with Mistake-Proofing
FMEA is a prioritization tool. It doesn’t eliminate failure
modes or effects by itself.
Companies need to apply tools such as mistake-proofing to
eliminate the root causes of failure modes.
This is especially true with failure modes that have very
severe effects.
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20. Not Tying into Control Plans
The control plan tells people how to react when a failure
mode occurs.
The FMEA will not be a living document if it is not tied to the
control plan.
21.Failing to Update the FMEA
As new potential failure modes are identified, they should be
added to the FMEA and control plans developed for them.
It is critical that the template also be updated.
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6. TYPES OF FMEA
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Types of FMEA
We will see
detailed
procedure
for each
later.
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Concept FMEA
Used to analyze concepts in the early stages before
hardware is defined (most often at system and
subsystem)
Focuses on potential failure modes associated with
the proposed functions of a concept proposal
Includes the interaction of multiple systems and
interaction between the elements of a system at the
concept stages.
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Design FMEA
Aid in the objective evaluation of design requirements
and design alternatives
Aid in the initial design for manufacturing and
assembly
Increase the probability that potential failure modes
have been considered
Provide additional information to aid in the planning
of efficient design testing
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Process FMEA
Indentify potential product related process failure
modes
Assess the potential customer effects of the failures
Indentify the potential manufacturing causes on
which to focus on
Develop a ranked list of potential failure modes
Document the results of the manufacturing
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Resources Needed
Commitment of top management
Knowledgeable individuals
Individuals attentive to FMEA timelines
People resources may be internal or external to the
business or a combination of both
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FMEA Timing
FMEA should be updated:
at the conceptual stage
when changes are made to the design
when new regulations are instituted
when customer feedback indicates a problem
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FMEA Steps
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8. RISK ASSESSMENT
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What is Risk Management?
Risk management is a continuous and iterative
decision making technique designed to improve the
probability of success. It is a proactive approach that
Seeks or identifies risks
Assesses the likelihood and impact of these risks
Develops mitigation options for all identified risks
Identifies the most significant risks and chooses
which mitigation options to implement
Tracks progress to confirm that cumulative project
risk is indeed declining
Communicates and documents the project risk status
Repeats this process throughout the project life
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Necessity Problem Effects How bad Causes How Likely? Score Steps
“Process “Failure is it? to
Function” Mode” “Severity” “Occurrence” Prevent
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Necessity Problem Effects How bad Causes How Likely? Score Steps
“Process “Failure is it? to
Function” Mode” “Severity” “Occurrence” Prevent
Put PB on
bread
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DFMEA – Design Failure Mode Effect Analysis
Necessity Problem Effects How bad Causes How Likely? Score Steps
“Process “Failure is it? to
Function” Mode” “Severity” “Occurrence” Prevent
Put PB on No PB
bread
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DFMEA – Design Failure Mode Effect Analysis
Necessity Problem Effects How bad Causes How Likely? Score Steps
“Process “Failure is it? to
Function” Mode” “Severity” “Occurrence” Prevent
Put PB on No PB Jelly
bread Sandwich
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Necessity Problem Effects How bad Causes How Likely? Score Steps
“Process “Failure is it? to
Function” Mode” “Severity” “Occurrence” Prevent
Put PB on No PB Jelly 5/5
bread Sandwich
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Necessity Problem Effects How bad Causes How Likely? Score Steps
“Process “Failure is it? to
Function” Mode” “Severity” “Occurrence” Prevent
Put PB on No PB Jelly 5/5 Out of
bread Sandwich Stock
Past
Expiration
Necessity Problem Effects How bad Causes How Likely? Score Steps
“Process “Failure is it? to
Function” Mode” “Severity” “Occurrence” Prevent
Put PB on No PB Jelly 5/5 Out of 2/5
bread Sandwich Stock
Past
Expiration
Necessity Problem Effects How bad Causes How Likely? Score Steps
“Process “Failure is it? to
Function” Mode” “Severity” “Occurrence” Prevent
Put PB on No PB Jelly 5/5 Out of 2/5 10
bread Sandwich Stock
Past
Expiration
Necessity Problem Effects How bad Causes How Likely? Score Steps
“Process “Failure is it? to
Function” Mode” “Severity” “Occurrence” Prevent
Put PB on No PB Jelly 5/5 Out of 2/5 10 Check
bread Sandwich Stock Pantry
Past Check
Expiration Expirat
ion
Date
11.Case Studies
12.VIDEO
FMEA
MISTAKES
13.PROJECT
IDENTIFICATION
IDENTIFICATION OF IMPROVEMENT
AREAS
Identify the areas for improvement based
on the discussion and the guide lines
List out the areas
Discuss with shop managers and
management