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FMEA Tutorial Lesson 1: Definition of

Failure Mode and Effects Analysis
Failure Mode
The manner in which the product/part or service does not meet the customer’s expectations

Effects Analysis
A study of the effects of failure on the function or
purpose of the product/part or service

The customer could be external to the company, or internal (within the company). It is
considered a reliability planning tool, but it has also become a method for prioritizing alternative
actions (that do not deal with
failure modes), e.g., in the Six Sigma process.

FMEA is a systematized group of activities intended to:

* Recognize and evaluate the potential failure modes

and causes associated with the designing and manufacturing of a product
* Identify actions which could eliminate or reduce the
chance of the potential failure occurring, and
* Document the above process.

It increases the likelihood that potential failures, and their effects and causes, will
be considered prior to the final design and/or release to production. The key to the actions in this
Reliability Analysis method is to plan preventive actions. A completed FMEA, which should be
applied in an iterative process, contains a great deal of information about the product or process.
It can be used as the starting point
for later control plans, trouble-shooting guides, preventive maintenance plans, etc.

Key Things To Keep In Mind

"One of the most important factors for the successful implementation of an FMEA program is
timeliness… Up-
front time spent properly completing an FMEA well, when
product/process changes can be most easily and inexpensively
implemented, will minimize late change crises." AIAG FMEA Instruction Manual (3rd Edition)

When going through the FMEA process, it is also important to remember to base your decisions
on data, not on hunches!
It should occur very early in the planning
cycle. FMEA teams will find themselves
spending more time than usual early on,
which will lead to leveraged savings later on.

The use of data to verify the relationships between root causes and effects, to establish accurate
rating criteria, and to determine effective preventive actions is one of the critical-to-success
factors in the FMEA process.

Costs vs. Benefits

Lots of Tedious Work → Increased success of implementation, & knowledge well captured by
the cross-functional team.

FMEA Tutorial Lesson 2: FMEA Supporting

Tools: Root Cause Identification, Fault Tree
Analysis (FTA)
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FMEA Tutorial Lesson 2: FMEA Supporting

Tools: Root Cause Identification, Fault Tree
Analysis (FTA)

In this lesson you will be learn:

- Root Cause Identification
- Fault Tree Analysis (FTA)

Timing For Applying The FMEA Quality Tools

Legend
D/PFMEA – Design/Process FMEA
FTA – Fault Tree Analysis
DOE – Design of Experiments
SPC – Stat. Process Control
Poka Yoke – Japanese for mistake-proofing

All of the tools, whether they are used in the context of concurrent development or not, should be
applied based on the Voice of the Customer (VOC). The first VOC priority is from the external customer.
Also important is the VOC of the internal customer. Note the typical timing for the tool usage. Also see
the Legend at the bottom for a definition of the acronyms. FMEA and FTA (Fault Tree Analysis) will be
covered in this course. Note the use of D/PFMEA as soon as possible in the Product Design and Process
Design phases, respectively. Design of Experiments (DOE) should also be used in both phases. FMEA is
most effective when other tools are applied at the right time in order to provide the best input to
include in the FMEA. This is not a complete list; there are many other tools which can and should be
used throughout the product and product development processes
Lesson 3
Goal of this Lesson:

Completing the Design FMEA Form:

- Identifying the Product Function
- Identifying Potential Failure Modes
- Identifying Potential Failure Effects
- Determining the Severity of the Effect
- Identifying Potential Cause(s) of the Failure Mode
- Determining the Probability of Occurrence of the Failure Mode
- Identifying Design Verifications for the Causes
- Determining the Probability of Non-Detection of the Failure Mode

Using the Completed DFMEA Form:

- Calculating the Risk Priority Number (RPN)
- Determining Corrective and Preventive Actions
- Prioritizing Actions Based on the RPN

What Is A Design FMEA?

* FMEA is a method for identifying potential or known failure modes and providing corrective
and preventive actions.
* The Design FMEA is a disciplined analysis of the part design with the intent to correct or
prevent the design-based failure modes prior to the first production run.

The FMEA Process:

* Identify potential or known failure modes

* Identify the effects and causes of each failure mode
* Prioritize the identified failure modes based on the frequency of occurrence, the severity of the
failure mode, and the likelihood of detection
* Provide for follow-up corrective and preventive actions
* Follow up
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Design FMEA Example

For this abbreviated example, there are 4 basic functions of the car door. One way (failure mode)
the door could potentially fail to perform the last 2 basic functions listed is by the interior lower
door panels becoming corroded.

The failure mode could potentially lead to deteriorated door panel life (a failure mode effect of
door panel corrosion), resulting in poor appearance and impaired function of the interior door
hardware. Note: it is acceptable to break down the effect in a chain of events as shown if it better
describes the problem being worked on. The effect is described from the perspective of the
customer, although the description need not be in the customers’ language. The severity of the
deteriorated door life effect is rated as a 6 here.

There are 4 potential design-based root causes of the door panel corrosion (the failure mode
here) listed. Note that while these causes may show up in fabrication or assembly, they are
design-based, that is, the designers specify their values or settings. Each cause receives its own
probability of occurrence rating score, based on the likelihood of the cause happening and its
resulting in the failure mode.

The only design verifications (DVs) presently in place are the Design group’s phase design
reviews. The ability of the design reviews to prevent the design-based cause (or detect the
potential failure mode) from happening is assessed for each of the causes listed.

Then the RPN is calculated for each cause so that their corrective/preventive actions can be
prioritized. The highest scores become the highest priorities. The fact that none of the scores is
close to the maximum possible score (1000) does not mean anything. Just the relative scores are
meaningful.
Design FMEA Process Flow

These steps of the FMEA will be discussed and explained later in detail, but it is helpful to see
the overall flow, at this overview level, for now. Try to match the additional following examples
to this flow to give you a feel for how Design FMEAs can be used.
The Design FMEA (DFMEA) needs to be done early in the product design cycle, after the design concept
has been selected since it needs detailed part functions; it should be continually updated as the program
develops.

* FMEA can be applied as a supporting method as part of the Concurrent Engineering development
process.

* Try for some concurrency between the Design and Process FMEAs.

The information developed from the DFMEA will provide excellent input for the earlier phases of the
Concurrent Engineering or Integrated Product Development processes, and vice versa. Having some
timing overlap (concurrency) between the DFMEA and the PFMEA will further reduce the Time to
Market.

If an existing design, on which there is already a DFMEA, is applied in a different environment or usage,
then the FMEA should be focused on the impact of the new environment or application.

The DFMEA process will be explained and demonstrated using the numbering scheme shown on the
preceding blank DFMEA form. You may want to periodically refer back to this blank form as each step
and column of the process is described. There will also be a flowchart that progressively develops in
sequence with the numbered steps.

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Effect of Failure Mode | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 | 13 |

DFMEA Definitions

Function of the Part

* The function of the part is the task that it must perform to meet
its design intent. it should be described in a way that is:
- Concise
- Exact
- Clear to all participants and users

* Use a verb-noun format

Examples:

- Isolate electrical data signals

- Provide mating surface to part B
- Provide dielectric material for impedance
- Provide engaging tab for cam
- Last for 40,000 cycles
- Operate within specified environmental
conditions
- Be manufactured at specified productivity
and quality rates
Right about now in the FMEA process would be a good time to perform the Fault Tree Analysis
FTA. Then you would transfer the information to the FMEA form as you go through the steps.
Note that
you will likely adding to that information, but it is an excellent way to make the FMEA more
thorough.
Although the DFMEA assumes the part
will be manufactured to the design intent,
it should still take into account realistic limitations of the manufacturing and assembly processes,
e.g., clearances for tooling, achievable tolerance capabilities, realistic parts/hour rates, etc.
Design FMEA - Use this blank form to develop your own example.
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FMEA Process Flow - Failure Mode and

Effect of Failure Mode

Potential Failure Mode of the Function

* The ways in which the part could fail to perform its intended design function.. it should be described in
a "negative" way.
* Stress how the part could fail, not whether it will fail, to conform to the design specification
* Try asking what could happen to cause a loss of function:
- "How could this part fail?", or
- "Could it
break, deform, wear, corrode, bind, leak, short,
open, etc.?"
* Examples of failure modes:
- Isolate electrical data signals → loss of dielectric
- Provide mating surface to part B → worn mating surface
- Provide dielectric material for impedance → loss of signal transmission integrity
- Provide engaging tab for cam → bent tab
- Corrosion - Cannot assemble - Over-deflection

Assume that the failure could occur for now. Later we will deal with the likelihood of its occurrence.
Refer back to the list of functions when asking the What If questions. Also refer back to the FTA to help
ensure completeness here.

List each potential failure mode for the part. Note that for these examples, the failure modes are shown
following the part’s basic functions (optional).

Other possible failure modes could be a part oxidizing, fracturing,

sticking, loosening, not transferring a force, not assembling readily with a mating part, drift, disengaging
during operation, etc.

FMEA Process Flow - Effect of Failure Mode

Potential Effect(s) of the Potential Failure Mode

* The outcome of the occurrence of the failure mode on the part or assembly (system).
* Describe the effect of the failure specifically, and in terms
of customer reaction: "What does the customer (external
or internal) experience as a result of the failure mode of..."
or "Will the component or assembly be inoperative, intermittently operative, noisy, not durable, etc.?"
* Consider whether the effect can also impact other functions
or parts.

Examples of effects:
* Loss of dielectric → low withstanding voltage → assembly shorts out
* Bent tab → cannot assemble mating part
* Worn mating surface → mating part does not engage
* Loss of signal transmission integrity → incorrect data transmission
* Tab edge does not engage cam → auxiliary bolt sticks
* Cannot assemble → lost time and wasted costs in Final Assembly
* Corrosion → part loses yield strength, with a lower MTBF

The loss of dielectric is an example of a failure mode resulting in a low withstanding voltage, which in
turn results in the assembly shorting out (the effect). Using a chain of events is a good technique if it
helps you better explain the failure modes and their effects.
Look for the outcomes or consequences of the failure mode on the part, assembly, other parts, end
user, etc. You should also include safety or regulatory non-compliance outcomes.
Other examples include unpleasant odor, unstable, regulatory non- compliance, intermittent operation,
or poor appearance.
Assuming that the failures have occurred, give specific descriptions of the ways in which customers
could observe each failure. Use the perspective of the external or internal customer, but it isn’t
necessary to use the customer’s terminology here.
Note that there could be more than one effect for a given failure mode, or, an effect could be the result
of several failure modes. Don’t forget to refer back to your FTA.
Note: MTBF stands for mean time between failures.

The severity or estimated consequence of the effect

on a 1 to 10 scale, where a 1 is a minor nuisance
and a 10 indicates a severe total failure of the system.

When weighing the consequence (effect) of the failure,

ask "How serious would the effect of this failure be to
the customer, assuming it has happened?"

To reduce the severity of the effect of a product failure

mode, a part design action is usually required.
The part design action to reduce a high rating may include design additions or revisions that
mitigate the resultant severity of the failure, e.g., seat belts in a car.
Severity is the first of the 3 Risk Priority Numbers (RPN) rating criteria. Think of the estimated
consequence or seriousness of the effect, assuming it does exist*, on the external and/or internal
customer. If the effect is critical, the severity is probably high. *Do not consider the likelihood
that the defect will occur in scoring this criterion; this will be evaluated in the second criterion
(Occurrence).

A sample of a Severity ranking scale is shown here:

Severity Ranking
Ranking Description
The effect of the failure is of such a minor nature as to be
undetectable by the customer. For example, the part may be
1
out of specification on a non-key quality characteristic but not
have any noticeable effect on the system.
The failure's effect is of a minor nature, although it is detectable by the customer, it
2-3 causes only slight annoyance without any noticeable degradation in the system
performance.
4-6 The failure's effect causes some customer dissatisfaction and some system degradation.
The failure's effect causes major customer dissatisfaction and major system
7-9
degradation. serious safety/legal implications.
10 Sudden, catastrophic failure without any prior warning. very serious legal implications.
The company should adapt these sample ratings to
what is appropriate to their industry.
This table of a Severity ranking scale provides guidance for assigning criteria values to the
failure mode effects on a consistent basis. It is only a sample and should not be used without
adaptation to the industry and company.

It is an indication of a design weakness, the consequence

of which is the failure mode. Consider the possible design
mechanisms and/or causes of each failure mode. Analyze
what conditions can help bring about the failure modes.
Make sure the list of causes is thorough. This helps
point the way toward preventive/corrective actions for
all pertinent causes. Consider the difference between effects, contributing causes, and root
causes.

Examples of causes:
* Wrong polymer specified → moisture absorption → loss of dielectric
* Excess annealing → malleable base material alloy → bent tab
* Maximum material condition stack-up → worn mating surface
* Insufficient gold plating specified → loss of signal transmission integrity

* Least material condition stack-up → gap → Tab edge does not engage cam

Here you are looking for the potential design-based root causes of the potential failure modes.
This includes causes that occur in production but are due to the design. Do not include causes
that are due strictly to errors or flaws in the production process – save these for the PFMEA.
Again, refer to the completed FTA to help ensure the list of causes is as thorough as possible,
and that the root causes are identified.

Other possible causes could include improper material specified for process or end-use operating
environment, incorrect algorithm, incorrect software specification, insufficient re-lubrication
capability, incorrect cam path, etc. Other possible failure mechanisms could include creep,
fatigue, wear, galvanic action, EMI (electromagnetic interference), etc.
FMEA Tutorial Lesson 4: Performing a
Process FMEA
You will learn:

Completing the Process FMEA Form:

- Identifying the Process Purpose
- Identifying Potential Failure Modes
- Identifying Potential Failure Effects
- Determining the Severity of the Effect
- Identifying Potential Cause(s) of the Failure Mode
- Determining the Probability of Occurrence of the Failure Mode
- Identifying Process Controls for the Causes
- Determining the Probability of Non-Detection of the Failure Mode

Using the Completed PFMEA Form:

- Calculating the Risk Priority Number (RPN)
- Determining Corrective and Preventive Actions
- Prioritizing Actions Based on the RPN
- Using the Maintenance FMEA