FMEA Failure Mode and Effect Analysis Theory-Case Study

12/9/2016 FMEA
(Failure Mode and Effct Analysis)/ Theory and Case Study
Last update :2014/6/24
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Contents
Click the chapter or step title in the table below for a glance.
Glossary of Key Terms Chapter 4: Who Executes an FMEA? Step4 : Listing Current Controls
41 A Tool for Design Aid 641 Meaning and Purpose
Introduction 642 Process of Reliability Design
(1) The Mystery about the Failure Mode Chapter 5: The Product and Process 643 Case Study of Product FMEA
(2) Infants Cut Fingers with Shredders 51 Designing the Product and Process 644 Case Study of Tablet Bottle Cap
(3) The True Cause of the Derailment 52 Product FMEA 645 The Purpose of Describing "Current
(4) The History of FMEA 53 Process FMEA Controls"
(5) The Defects of the Conventional FMEA
Chapter 6: The Case Study Step5 : Evaluating Three Elements
Reference Step 1 : Preparation of Documents 651 General Criteria
611 In the Case of Product FMEA 652 Evaluating Measures for Severity
Chapter 1 : What Is the FMEA 612 Reliability Design 653 Evaluating Measures for Occurrence
11 The Relevant Concepts 613 In the Case of Process FMEA 654 Evaluating Measures for Detection
12 Outline of the Design
13 Need of the FMEA Execution Step 2 : Listing Failure Modes Step6 : Application of Risk Index
14 The Basic Requirements of FMEA 621 Defining Failure Mode 661 Calculating Risk Index
622 Failure Mode of Product
Chapter 2 : The Purpose of FMEA 623 Failure Modes of Process Step7 : Optimization of RI
21 The Purpose of the FMEA 671 Optimization for Product FMEA
Step 3 : Listing Effects and Factors
Chapter 3: The FMEA Process 631 Introduction Appendix
31 Outline 632 Case Study of Product FMEA Appendix 1 : Factor and Effect Diagram
32 Preparing Documents 633 Meaning of Effect Appendix 2 : Case of Gauze Collection
33 Listing Failure Modes 634 Meaning of Factor (a medical case of FMEA)
34 Listing Current Controls 635 Examples Appendix 3 : Case of Gauze Collection
35 Listing Effects of Failure Mode Process
36 Evaluating from the 3 Viewpoints Appendix 4 : Adding Risk Index
37 Calculating Risk Index
Glossary of Key Terms
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12/9/2016 FMEA (Failure Mode and Effct Analysis)/ Theory and Case Study
Bill of Material (BOM) a complete list of a product's Effect each worst impact of each failure mode
components, subassemblies and assemblies that which is worth evaluation.
comprise a material product (A structural bill of
material consists of a detailed list of all the Factor the evet that may create a failure mode in an
components combined with their quantities, and element of a product or process (This word may be
information as to their relation to one onother.) replaced with "Generating Mecahanism".)

Cause the event that has created a failure mode in Failure malfuncton of a product or process.
a particular element of a product or process (Note the
difference between Cause and Fctor. Cause is a Failure Mode structural breakage that may occur in
causeandeffect relationship that is going on past or an element of a product or process (Structural
present, Factor refers to the causal relationship that breakage can occcur in a part or connection. For
may occur in the future.) example, tthe disengagement of the mating plug, the
screw loosening, the peeling of the adhesive material
Current Controls every systematic means to and the invasion of the obstacles are connection
prevent failure, to ease the influence of failure, or to failure mode. As for a process, a breach against an
detect failure or failure mode (This word may be instruction designated in the process design
replaced with "Reliability Design".) corresponds to a failure mode.)

Customer any person or/and process that utilizes FMEA see "What is FMEA"
the product along the chain of procession and may be
adversely sffecterd by a product faiure FMECA the acronym of Failure Mode, Effect and
Criticality Analisys (a type of FMEA that emphasizes
Detection degree of insufficiency of the measures the nessessity of measures to take to Severity. In
taken to ease identifying failure cause, its consequent most cases, as measures against high Severity
failure mode or failure prior to delivery to the rating, you can adopt any of redundant design,
customer (any followon user) mistakeproof device or failsafe device. The aircraft
equipped with two to four engines is an example of
DFMEA @ the acronym of Design FMEA. It should redundant design.)
be correctly called "Product FMEA"
Function any intended purpose of a product or
process

Occurrence degree of insufficiency of the Rlative Evaluation FMEA @ a type of wrong FMEA

measures taken to reduce the frequency of the analyzing and ranking the risks associated with
failure. various producut failure modes in order to prioritize
the sequence of corrective action (The correct type is
PFMEA the acronym of Process FMEA. the Absolute Evaluation FMEA.)

Poka Yoke Japanese for "error proof" A quality Risk Index (RI) the index which is calculated from
improvement strategy emphasizing preventing human numerical S, O, and D, and shows the risk of failure
errors at their source by making changes so that mode synthetically: RI = (S x O x D)1/3 (This is used
nobody could make a mistake in the Absolute Evaluation FMEA.)

QC Process Table a chart that describes the Risk Priority Number (RPN) the mathematical
process design (QC Process Table shows how to product or the numerical Severity, Occurrence and
control and assure the quality of output from the Detection ratings: RPN = S x O x D (This is used in
process. This is comprised of two parts. The left side the Relative FMEA, which is wrong and impossible to
is socalled "procedure for creating quality" @and the conduct appropriately see Risk Index.)
other is socalled "procedure for quality assurance.")
other is socalled "procedure for quality assurance.")
Root Cause Analysis the process of repeatedly
QS 9000 FMEA @ a conventional type of FMEA that asking why a specific cause occurred until a
has been developed by GM, Ford and Chrysler(The fundamental defect in the management system is
recall number of the car which rose in 2009 was as disclosed (This is conducted in order to prevent
below). recurring of a certain trouble.) @ @Note: Don't ask
@ Toyota: 4,870,000 why a specific problem occurred. It is nothing more
@ Ford: 4,520,000 than a cause investigation and is not related with
@ GM: 2,230,000 recurrence prevention. After the cause clarifies, ask
At the beginning of 2010, Toyota and GM added what is the managerial system defect which resulted
millions of collection. You should immediately abolish it. This is the recurrence prevention.
the conventional Relative FMEA which caused such a
result.
Severity degree of insufficiency of the measures As shown above, FMEA is a tool for evaluating
taken to ease the impact of a certain failure mode relability (i.e., property not to break down) of product
(Note: "Severity" does not mean the degree of the or process.
impact.) @ @In contrast, the conventional Relative Evaluaton
FMEA insists that an FMEA is a systematic method of
What is FMEA FMEA is the acronym of Failure identifying and preventing product and process
Mode and Effect Analysis. Those reading this word problems before they occur. Namely, they say, an
for the first time may think this to be the name of an FMEA is conducted not only for evaluating reliability
technology that they have not experienced. but also for evaluating other possible risks. As a
@ @However, without knowing the language of result, difference among a failure, a failure mode and
FMEA, skilled designers are implementing an FMEA a manufacturing defective, have become vague.
substantially unconsciously. The expert designer @ @The point which is the hardest to understand
studies each screw for its best size, materials, heat especially is that a manufacturing defective belongs
treatment, surface treatment, to prevent the damages to failure mode. However, FMEA is conducted to
that may occur during use by the customer,and evaluate reliability of a design. Do you design a
confirms them. Assuming planned measures, the product includeing a manufacturing defective?
designer should evaluate the severity of effect, the
likelyhood of occurrence and the advance detection Purpose An FMEA is executed:
of the failure.
@ @This corresponds to an FMEA aside from the 1. to predict all failures and disasters that may
form substantially. However, you carried out this occur by use of the product or by running the
activity in your head conventionally. You did not process, and
recorded it according to a constant style, and a third 2. to assess the inadequacy of measures to
party was not able to inspect it. prevent each harmful failure mode.
@ @ FMEA is an activity to express the above
mentioned reliability evaluation or a reliability design
to a worksheet according to a constant style.
Since preventing the unexpected failure is the The kind of FMEA suitable for this purpose is the
purpose of FMEA, you should adopt the Absolute Absolute Evaluation FMEA, whitch leads to the most
Evaluation FMEA. It is because it starts from each suitable reliability. And you can learn it at this home
breakage of each component and connection in the page.
bottomup way and never creates missing failures. @ @In contrast, the conventional Relative Evaluation
@ @In contrast, the conventional Relative Evaluation FMEA insists that the FMEA team which consists of
FMEA starts from the failure on the top and ask how people who were not taking charge of the design
it can occur. This means that you may ommit
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it can occur. This means that you may ommit should performs FMEA. If so, by what kind of method
enumerating some failures which did not come up in should the designer evaluate reliability in the design
mind by chance, and these ommitted failures could process?
become the unexpected failures.
The image below shows that you should start from
Science all failures should be predicted with FMEA each failure mode in bottomup way as in the
and approppriate measures should be taken to every Absolute Evaluation FMEA, and should not start from
failure modes, there must not exist omission or failures in topdown ways as in the Relative
priority in the failure modes. Evaluation FMEA.

@ @In contrast, the conventional Relative Evaluation
@ @In contrast, in the case of the mistaken method,
FMEA rates the priority of failure modes and take you will ask the cause of each failure and answer with
measures only against the priority failure modes and three categories of cause;
unimportant failure and disaster are disregarded. This
@ the structural breakage of each part or
is not approved by our society. connnection,
@ @It is necessary to become clear whether (=malfunction) of each sabfunction,
@ the faiure
sufficient measures have been already taken against and
each problem. Moreover, the designer has to
@ the manufacturing defective.
evaluate the reliability of his own design during the
design process. However, only structural breakage is the right failure
mode. The figure below shows the relation between
these concepts mentioned above.
Failure and Failufre Mode As for a process, each breach against each
@
Failure means malfunction, which must not be instruction corresponds to a failure mode.
confused with failure mode. A failure mode means a
structural breakage of an element consisting a Any manufacturing defective cannot be a failure
product or process. @A function is realised through mode.It is because:
many elements, and each element can have several @ there are no manufactureing defectives in the
manners of breakage (i.e., failure modes). Therefore, design as for an product FMEA.
each malfunction can be caused by many failure @ any manufactureing defective is the results of a
modes. In other words, any failure is a terminal of the malfunction of the manufacturing process, and any
analysis and any failure mode is the starting point. manufacturing defective should be regarded as an
You have to enumerate all failure modes and you can effect of a certain failure mode included in the failed
reach all faiures without missing. process.
@ @In contrast, in the conventional Relative FMEA,
they enumerate failures first and ask why they Why, do you think, manufacturing defectives are not
occurs, and the answers are the failure modes. Then, failure modes? It is because FMEA evaluates only
structural breakages of parts, failures of subfunctions
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structural breakages of parts, failures of subfunctions the design and the design does not include

and manufacturing defectives will be enumareted. defectives.
However, you enumerate what come up by chance @ @In contrast, the conventional Relative Evaluation
and there will be left some enumeration missing in FMEA insists that:
failures and factors as well. @ each manufacturing defective can be a failure
mode of a product, since it causes a failure.
Failure Mode @ each manufacturing defective can be a failure
Each breakage that occures in the structure of each mode of a process, since the process should not
system element is called a failure mode. produce it.
@ As for a product, each breakage of each part or This is a result of the mistaken failure mode concept.
interface correspond to a failure mode.
Evaluation Moreover, judgment of priority is very difficult and is

In the reliabiity design, measures are taken to each unrelated to judgment of yesno, it is not helpful after
failure mode. And you have to confirm the sufficiency. all. You have to perform independently the yesno
For the pirpose of confimation, you have to evaluate decision of the measure for each failure mode.
the insufficiency of the measures taken to each
failure mode from the three viewpoints, i.e., Severity Process FMEA
(S), Occurrence (O) and Dtection (D). What is the structure of a process? @In a product
@ Severity(S) of effect that the customer (any follow design, you define a required function and design
on user) might receive. structure to achieve the function. You design
@ Occurrence(O): the frequency of the failure, structure and it achieves the function. You cannot
@ Detection(D): difficulty of the sign of failure before achieve the function directly. All the designed
reaching the customer. contents are structures. The above is completely the
same also about a process.
Evaluation point of these three will be integrated into
a single index, Risk Index (RI). You must determine Failure modes of a manufacturing process are
the degree of insufficiency of reliability measures in breaches of instructions shown in the QC process
accordance with the index. This decision will indicate table. You should abolish the old type of FMEA in
the insufficiency of the measures for each failure which manufacturing defectives or other accidents
mode. Optimization of the design by evaluation on an are treated as failure modes.
absolute scale is the only useful method.
@ @In contrast, the conventional Relative Evaluation → Quick Accsess to FMEA
FMEA using RPN determines the priority among the
failure modes listed. And the boundary line which
classifies failure modes with an insufficient measure
and failure modes with a sufficient measure does not
exist.
¡
Introduction
(1) A Mystery about the Failure Mode "Failure modes" are the manners in which a
product or process failure may occur, for
My First Encounter with the FMEA example, a crack, a blockage, inaccurate
When I was young, in 1960s, working as a novice movement, and so on.
engineer for a machine manufacturing company in "A failure" is the inability of the product or
Japan, I happened to have an opportunity to read a process to perform as it should.
reference book of the FMEA with a commentary
http://www.geocities.jp/takaro_u/fmea_eng.html#c3 Look at the following table, which is quoted from a 5/78
reference book of the FMEA with a commentary Look at the following table, which is quoted from a
about the meaning of failures mode and failures. certain book.
FMEA Worksheet for an Extinguisher
Line Component and function Potential Failure Mode Potential Effect of Failure
1 Hose;delivers extinguishing agent Craks

7 Charge gauge;determine remaining volume of agent Inacurate reading

A Problem Was Found The Harder Study, the More Problems

I could not reach a complete acceptance, however, at The portion of a FMEA worksheet shown below has
the inconsistency that "Inaccurate reading" is a been quoted from Professor (H. Makabe p.134), who
functional trouble, i.e., a failure, whereas "Cracks" had been one of the leaders of this field. The scope
belongs to structural breakage. Even a reference of the product covers "a brake subsystem" including a
book written in Japanese, my mother tongue, did not pedal assembly and a pressure oil pipe assembly.
improve my sense of satisfaction.
[Note] Blue color and yelow boxes are added by us.
1. "Can't be pushed down" and "Doesn't return" are This is one of the problems caused by the top
functional troubles, which belong to failure. Why down approach. You cannot list the misuse
are they listed in the spaces for failure modes? unless you take the bottomup approach.
2. "A pedal crank broken" must be a failure mode,
however, it is listed in the column of cause. The
same applies to the remaining two. A New Discovery after 40 Years
3. "Joint separations" and "cracks" are acceptable Approximately 40 years passed and I solved the
as failure modes, however, this conflicts with the problem.I have noticed that there are two methods to
contents in the place of (2). reach the failure modes.
4. It is wrong to consider "an incomplete weld" to @ @One is the topdown method: you start at the
be a failure mode, because it occurs prior to failure and go down to the causes. When the top
handing the product to the customer. And it is a down approach is adopted about a certain failure, the
problem which you should handle in a process following matters are certain to be enumerated as
FMEA. Failure modes occur after the product is failure modes without distinction.
handed to the customer, whereas manufacturing
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handed to the customer, whereas manufacturing Breakage in components,
defectives take place beforehand. Dysfunction of subassembly, and
5. Three causes are listed here, but the grounds Production defective.
that there cannot be additional causes are not
clear. Aren't these just what came in mind by The other is the bottomup method: you start from the
chance? If you want to list all causes without damages on components and go up to the results(i.e.
missing, you should enumerate all stuructural effects). In the case of bottomup approach, the
breakages of all parts and interfaces beforehand failure mode concept is comprised of only structural
and select related causes from among these. In breakage of components or interfaces, and never
other words, you should take a bottomup includes dysfunctions nor manufacturing defectives.
approach. @ @The failure mode concept depends basically on
6. They place the end product with a system and which of these two is chosen and the bottomup
perform a topdown approach to subsystems, search is the right choice.
components and parts downward from there. By
the way, where, how can you list the misuse
(very important failure mode) of the customer?
Toward Solving
(2) Finger Cutting Accidents of Infant with In contrast, if an FMEA is executed in a bottomup
Shredders way, failure modes, i.e., breakage in parts and
interfaces become the starting points to look for
The Outline of The Accident failures and disasters, and the search goes up to
In 2006 Japan, the accidents that infants played with components, subsystems, and the final product.
shredders and cut their fingers often occurred. I @ @Furthermore, the bottomup search will go up to
wondered why these could not have been prevented the breaches of the instruction manual for the user
through execution of FMEAs. concerning the use and maintenance. Here everyone
@ @Then, the following thought occurred to me. The will reach the following understanding.
shredders were not designed to include infant's
fingers, and hence no finger cut accidents could be As for a product FMEA, a failure mode
anticipated however deep traditional FMEAs were corresponds to a structural breakage of a part or
executed. an interface. And a failure, i.e., a functional
trouble can not be a failure mode.
Defect of Conventional FMEA In the case of a process FMEA, a failure mode
It is a decisive defect of conventional FMEA. How can corresponds to a breach of an instruction
you necessarily detect the failure mode that an infant (specification) forming a part of the process
is inserting its fingers into a shredder in the topdown design.
way? The person in charge of a final product design
@ @It is merely each potential failure of a shredder should also design the process of use and
as the end products that can be a starting point of maintenance. That is, the user's instruction
analysis as far as topdown FMEA is carried out. And manual, and necessary measures should be
this accident cannot be foreseen even no matter how designed to prevent serious accidents caused
deep you examine it with in a shredder by the top by customer's misuse at the same time.
down method. It is FTA (Falt Tree Analysis) that adopts the top
@ @In order to handle the misuse that a small child down method in which a specific problem placed
inserts a finger in a shredder, breaches of insruction on the top and causes are led downwards from
of user's manual should be listed, and a kind of fool there and enumerated. This is acceptable
proof measures should be taken to prevent serious because FTA does not have the purpose of
results. disclosing unexpected results.

(3) Causes of Derailment Accidents An Unacceptable Description of the Cause
Then the company, after setting up a speed control
The concept of "cause in terms of management" has system of one billion dollars, has resumed the
to be strictly defined and identified. commercial operation. The cause, the government
official reported, was that the driver had exceeded the
Another Serious Accident speed limit. However, I was not able to accept the
On April 25, 2005, near Osaka, Japan, an overturn following railroad managements.
derailment occurred at a sharp curve in the railway of
the West Japan Railway Co. It was the accident that The preventative action was not carried out as a
resulted more than 100 dead people, more than 500 driver was not able to exceed the greatest speed
injured people and compensation amount of money limit intentionally or carelessly.
of more than 1 billion dollars. The preventative action for derailment and an
overthrow of a train not to occur in the case of
speeding was not carried out.
Measures must Be Economic and Effective As mentioned above, designing the process of "use
It is very hard in general, however, to expect a prior and maintenance" of the railway system and its
enforcement of measures on a small local line at the FMEA are necessary for attending to the failure mode
expense of one billion dollars. The point is to develop of overturn, leading to economic and effective
lowcost measures.Probably, such an accident might measures.
have been prevented if the guide fence (a failsafe
system) along the exterior of the curve by the cost of Switzerland Showed a Similarly Absurd
250,000 dollars had been adopted. Settlement
On July 23, 2010, a derailment overturn happened to
Ignorance of the Economic and Effective the rear three cars of the tourist train "Glacier
Measures Express" in the Swiss Alps, and a lot of Japanese
The true cause of this accident from a viewpoint of a tourist were killed or injured. The cause, the
managerial system was that this cheap and effective government official reported, was that the driver had
means was not performed. The Japanese authorities accelerated before the tail vehicle passed the curve.
prosecuted the presidents of the company of three Then the company has resumed the commercial
generations on the suspicion of having neglected operation with no measures against recurrence. And
construction of 100 million dollars, but this public the guide rail was not installed at the curve. Swiss
prosecutor's irrelevance action is remarkable. railway officials has learned nothing from the very
similar accident in Japan five years before.
Managerial Cause The fact means that the negligence of the driver is
This is rooted in the wrong concept of the cause. We not the cause of the accident from the viewpoint of
are not searching the natural cause but the management.The cause is that measures were not
managerial cause (defect). The answer to "what kind carried out.
of defect of the current controls is there?" is the @ @The low cost failsafe measures to prevent a
managerial cause. Thus the cause of the derailment serious result should be carried out as first priority.
havs proved to be the absence of a failsafe guide This is because the absolute method to preventing
rail. derailment is not obtained yet. And derailment in
particular is nonavoidable at a curve yet. It should be
Failsafe Measures Is the Key Technology thought that the true cause of the specific accident is
No effective measures are provided even if they in the negligence of enforcement of the failsafe
investigate the responsibility of the driver, and who is means of budget prices.
responsible becomes clear.
(4) History of FMEA
Beginning in the Aerospace Industry International Automotive Task Force (IATF) added
In the aerospace industry of the mid1960s, the other international quality standards to QS9000 and
safety problem was focused on in particular, and the ISO/TS 16949 was developed. The ISO/TS 16949
FMEA was a key tool to be performed formally for the standard requires that suppliers to the automotive
first time for increasing the safety of the chemical industry conduct product and process FMEAs to
plant. The engineer always looked for a possible prevent failure.
trouble beforehand and analyzed a product and a
process. On the other hand, it is said in general, the Just a Typical Propaganda
procedure of the FMEA was standardized, and Generally it was explained as follows
common language spoken among the employee of conventionally.Unlike a many other quality
various companies and all levels was established. improvements technology, FMEA does not need
complicated statistics mathematics. Moreover, the
Improved by U.S. Auto Industry remarkable business advantage which reduces the
The FMFA was improved by the U.S. auto industry to quality problem resulting from a process design or a
meet a reliability improvement tool. In 1996, the U.S. products design is expectable.
auto industry constructed QS9000 supplier @ @However, the abovementioned reference is only
requirements. mere typical advertisement.

(5) Defects of Conventional FMEA However, it is necessary for the designer to check
reliability by carrying out FMEA while pushing forward
Merit Is Extremely Poorer than Officially the design. How do you show reliability if the designer
Publicized must not carry out FMEA?
FMEA technology contains many problems in spite of @ @This is similar with the custom that the carpenter
the shining history. In order to carry out FMEA, a measures the size of wood. The FMEA is a process
certain amount of resources are required. However, to dentify the reliability of the designed product or
the conventional FMEA wastes time and human process. However, this expertiselike duty is not so
resources too much. Furthermore, the strong point is easy as a makeshift team can perform successfully.
very poorer than having been announced officially. @(b) Failure and Failure Mode
@ @This is caused by the mistakes of content About the difference between a failure and a failure
instructed by book authors, workshop trainers and mode, the explanation is uncertain, and hence many
colleges mainly. engineers lose their ways in the desert. Although an
FMEA neede to be performed in bottomup way from
Robin E. McDermott p.4 introduces itself saying; parts up to a completed product, the wrong theory
goes conversely. This mistake produces an uncertain
"This booklet was designed to help shorten the learning curve concept of failure mode.
for FMEA teams and to help them conduct effective and
efficient FMEA even if it is their very first FMEA."
@(c) RPN Is an Inappropriate Index
It is useless to show the risk priority numbers (RPNs),
because lack of measures for each failure mode
Commentary: cannot be identified. A risk evaluation should be the
This is not true. The people who learned the outdated answer to the question whether the measures are
FMEA wear the front as the end that it succeeded. short or enough against a specific failure mode.
The main errors of outdated FMEA are those points Otherwise, measures against each failure mode
from following (a) to (f). might run short or excessive.
@(a) Designer's Duty @(d) TenPoint Ranking
It is said that FMEA is activity of the teams consisting The conventional FMEA uses the RPN method, and a
of the members of the experts of the various quarters lot of chairs are needed for a queue in order of
that are not in charge of the design. priority of failure modes, and the tenpoint scoring is
helpful for this purpose, as follows;
Severity × Occurrence × Detection = 10 × 10 × 10 = 1,000
Thus one thousand chairs are prepared. On the other (f) Failure Mode Concept Is not Clear
hand, accurate evaluations of severity, occurrence Should we look for defects of an actual product or
and detection are quite difficult and cannot avoid an process? Or should we look for those of a design?
error of 1 or 2 points at least for each evaluation. This The misunderstanding of this point produces a funny
results in an error of around 100 points in terms of idea called an FMEA of "a de facto process" which
RPN, thus a practical use becomes hard. has not been designed formally in the field of medical
FMEA in particular.
(e) Business Retention
The order of priority is not clear unless the overall This mistake is due to the fact that the failure mode
evaluation is over. Thereby even a good idea is concept of process is not clear. This homepage
forced to hold. In addition, even when the priority in touches the serious problems of the conventional
the whole is determined, the shortage of measures FMEA, showing case examples. And all mistakes of
for each failure mode is not clarified; hence the delay the conventional FMEA can be reviewed in this
of work becomes hard to accept. homepage.
Reference
http://www.geocities.jp/takaro_u/fmea_eng.html#c3 Publisher 10/78
Authors Title Publisher Year

(Language)
Robin E. McDermott THE BASICS OF FMEA CRC Press
Raymond J. Mikulak (2nd Edition) (English) 2009
Michael R. Beauregard
Kenneth W. Dailey The FMEA Pocket Handbook D W Publishing Co. 2004

(English)
Hitoshi Kume Quality Management of Design and Development Union of Japanese Scientists And Engineers 1999

(Japanese)
D.H. Stamatis Failure Mode And Effect Analysis ASQ Quality Press 1995

(English)
Hajime Makabe The Basic of Reliability Engineering Japanese Standards Association 1995

(Japanese)
Contents
Step 1: Preparation of Documents
Introduction
Step 2: Listing the Failure Modes
Chapter 1: What Is FMEA
Step 3: Listing Effects and Factore
Chapter 2: Purpose of FMEA
Step 4: Listing Current Controls
Chapter 3: FMEA Process
Step 5: Evaluating three Elements
Chapter 4: Who Executes an FMEA ?
Step 6: Calculating RI
Chapter 5: Product and Process
Step 7: Optimization
Chapter 6: The Seven Steps / Case Study
Chapter1: What Is FMEA
11 The Relevant Concepts and we ask what failure or disaster can be
caused by each of these breakages.
Not Easy to Foretell Failures of New Designs
About a new product or a newlydesigned process, it The reason why functions or malfunction should not
is not easy to foretell what kind of function accident be the starting points is because failures beyond
and disaster may happen. To that end, what kind of prediction cannot be the starting points.
method is thought about? You cannot enumerate all @ @The reason why functions or malfunction should
failures and disasters if you merely look at not be the starting points is because failures beyond
specifications or the actual products. prediction cannot be the starting points. You cannot
but recognize it if you watch the number of recalls
The Two Typical Methods that Toyota and GM have caused in the past.
There are two representative ways of thinking as @ @This homepage adopts the latter contrary to QS
follows. 9000. As a result, various difficulties caused by the
past method of the topdown approach are overcome.
1. In the topdown method, all the functions are
developed from the end products, each failure or Definition of Reliability
a disaster is drawn, and the routes in which The quality of a product or a process that can
each failure or a disaster occurs are asked. This maintain the intended functions under specific
has supported the alignic FMEA coming from conditions and within a prescribed period is called
QS 9000 and has led to the wrong procedure. reliability. Here,
2. In the bottomup method, we enumerate all
breakages of the minimum structural elements. "Under the specific condition" means that an
For example, area of special environment, e.g., desert or the
South Pole is excluded.
such part breakages as rust of screws,
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such part breakages as rust of screws, "A defined period" means the life of the product.

broken electric wires, deformed pins, worn This condition is not usually applied to
gears, etc., and processes.
such interface breakages as blockage,
slack, separation, disengagement (of floor
mat of a car), etc.
What Is Failure? In 2005, several employees of a certain maker joined

A functional problem of a product or a process is in our align. We answered their question by an Email
called a failure. for several times after the align, but were not
understood. We visited them in their factory at last
As for a product, after the use of a certain time, it may and had a talk with them for explanation.
be caused by damaging parts or interfaces
(connections) in the product. As for a process, The problem was that the automatic machine which
breaches of instruction cause failures producing they had designed and produced often had stopped
output troubles. during use. We asked how many months it had taken
from the installation to the outbreak of the
Distinction between Failures and Manufacturing phenomenon, and they answered that it had begun at
Defectives the beginning of use. The existing trouble at the
On the other hand, a malfunction of a product before beginning of use is usually a defect of the production
use is not a failure but a manufacturing defective or the design, not trouble by the use. In other words,
(including an assembly defective). Similarly, a failure this is not a theme treated in FMEA.
of a process may happen later because of a breach
of an instruction of the process specification or the
equipment maintenance even if the process works
normally at first.
As for a Process In general, a breakage of a part or an interface is a

The reference above applies also to a process. If the failure mode of the product. And a violation of an
design of function of the process is poor, it will instruction of a process is a failure mode of the
produce various failures even if there is no breach of process.
the instructions. Moreover, this is not a problem to be @ @This technical term usually is easily
treated in FMEA. misunderstood because of the careless definition that
has existed for a long time. This definition does not
Definition of Failure Mode always lead to the bottomup approach and it is
Manners in which a product or process may fail are inclined to produce the wrong way, the topdown
called failure modes, which should be identified by a approach, in which they ask why the failure occurs.
bottomup approach. @ @The typical wrong definition is as follows:
"Ways in which a product or process can fail are called failure modes."
As a result, malfunctions, manufacturing defectives The Right Definition

and failure modes are listed in the failure mode The Failure mode concept should be definede as
description column without distinction. follows.
"What are the ways a product or process can fail, and are identified bottomup are called failure modes."
Even when a failure occurs in a complicated product, Moreover, a crack, a jam, commingoff, etc. are

the product is accompanied by breakages of some mentioned as failure modes of a hose.
kind of parts or connections by all means. And @ @A skilled designer knows what changes parts
failures or disasters can never be prevented unless and connections may receive after the product is
these are prevented, and hence, only the failure handed to the customer and used for long.
mode of that meaning are worthy targets of FMEA. @ @All failures can be trodden by enumerating all
these changes of parts and connections, and making
Usefulness of the Failure Mode Concept them starting points of search for malfunctions and
It is not difficult for a skilled designer to enumerate all disasters.
failure modes of parts and interfaces of his own @ @As for failure modes of a process, they are easily
design. For example, rust, deformation, form enumerated as breaches of instrutions.
collapse, etc. are immediately visualized as failure
mode of the item called a screw.
Starting Points It is hard even for experts to list up potential failures

After all, the starting points (failure modes) of FMEA of a complicated product directly without overlooking.
are always decided as the breakage of the smallest @ @However, it is not difficult for experts to list up
structural element of the system as follows. And changes (failure modes) that may occur in parts and
neither malfunctions nor manufacturing defectives are interfaces while being used long.
included.
What Does Topdown Approach Bring?
With respect to the product FMEA, the smallest In the case of a complicated product, a lot of
structural element is a part or interface, and subordinate functions exist in the product.
breakages of parts and interfaces correspond to @ @If a topdown approach is taken, both the theory
failure modes. and the practice will certainly fail, because all of
As for the process FMEA, the smallest structural failure modes, failures and manufacturing defectives
element is an process instruction designated in are mixed and confused.
the design documents like the QC process table,
and breaches of these instruction correspond to
failure modes.
Objection Theory
Kenneth W. Dailey p.6:
"What is FMEA?
Definition: A systematic method of analyzing and ranking the risks associated with various product failure modes (both existing and potential),
prioritizing them for remedial action, acting on the highest ranked items, reevaluating those items, and returning to the prioritization step in a
continuous loop until marginal returns set in."
Commentary (What is wrong?):

Only Important Problem?
Necessary Information Cannot Be Obtained This is an opinion of people ignorant about
Because this way of FMEA does not directly design business. In actual design activities, you
indicate whether measures are enough or not, do not think that it is neglected except important
excessive measures may be performed, or accidents.
necessary measures may fail to be added. @ @Since cracks, such as a body of a
Business Retention passenger plane, an engine, and a hydraulic
This type of FMEA attends to the highest ranked circuit, draw a serious accident, they are
items only, and all improvement actions are prevented. On the other hand, since coffee only
suspended until the whole ranking is
http://www.geocities.jp/takaro_u/fmea_eng.html#c3 leaks, is the crack of the paper cup for13/78
suspended until the whole ranking is leaks, is the crack of the paper cup for
determined. It takes too long to determine the passenger service neglected?
highest ranked items, and the duties will be Vague whether Measures Are Lack or Exessive
delayed remarkably. Even if overall priority is decided, it does not
become clear if prevention is enough.
Robin E. McDermott p.1

"An FMEA is a systematic method of identifying and preventing product and process problem before they occur. FMEAs are focused on
preventing defects, enhancing safety, and increasing customer satisfaction."
Commentary:

Reliability Issues Only The FMEA is not a It should be emphasized that engineering technology
method of identifying all kinds of problem, but its peculiar to each field can prevent problems, and
subject is a reliability issue only. This mistake is FMEA can only help it.
caused by asking how a specific trouble
happens in a topdown direction. And the right FMEA has to be focused not only on safety and
answer is always a design of the function defect customer satisfaction, but also on quality, cost,
not a reliability defect. delivery (time and quantity), and environmental
protection(Five Elements of Output) Simultaneously.
FMEA Does not Prevent Problems FMEA is not For example, if a breach of a certain instruction
a method of preventing problem, but only a maight lead to a outflow of poison, it has to be listed
method of determining the lack of measures for in the process FMEA and necessary measures have
each failure mode (cause and effect). to be taken to it.
D. H. Stamatis p.25
"A failure mode and effect analysis (FMEA) is an engineering technique used to define, identify, and eliminate known and/or potential failures,
problems, errors, and so on from the system, design, process, and/or service before they reach the customer."
Commentary: (2)The practice of an FMEA helps management only,
(1)FMEA is a management technique, and can help but cannot eliminate defects by itself. An engineering
discover the existence of problems and evaluate technology for each field is necessary to remove
them, but cannot eliminate them. defects.
12 Outline of Design Procedure
(1) In General (2) Simultaneous Activity

There are two purposes in a design. The first purpose The designs of the function and reliability have to be
is to give a function required for a product or a performed at the same time and pushed forward
process. The second purpose is giving reliability in gradually. In other words you push forward some
order not to fall into a functional disorder or function designs and check reliability immediately and
misfortune simply. take necessary measures. Then you push forward
some function designs again and check reliability
This means that the design of a function and immediately and take necessary measures. You
reliability must be performed simultaneously. repeat this cycle after this.
Therefore, although a skillful engineer's design has
very few defects of reliability, amateur or a beginner When the design of a function precedes too much,
engineer is in the tendency to think only a function as accumulation of the previous work may be turned for
important and to neglect many reliability defects.
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correction of the reliability defect discovered after

that.
(3) The Function Design

You have to design the structure of a product or 1. Quality: A faulty product or service must not be
process to work appropriately.It has to be carried out produced at all.
to prevent dysfunction that might happen during use. 2. Delivery (time and quantity): The daily
production quantity will advance as planned.
The Five Elements of Output 3. Cost: The quantity planned on the date
The required outputs of the design procedure are according to a plan must be produced.
related to five elements listed on the right. And 4. Safety: There must not be any risk of getting
troubles of a product or process occur when all these injured for workers or a customer.
requirements are not satisfied. The designer should 5. Environment: The environmental impact should
examine the effectiveness of measures to achieve be restrained as planned.
those requirements before the completion of the
design.
(4)The Reliability Design

The designer (the designer in charge, or the group in About the process, submit process
its duty) has to submit the following documents to the specifications (QC progress schedule) and
section manager. FMEA worksheet.
About the product, submit pruduct specifications In contrast to function design, reliability design is to

(drawings and structured part lists, or BOM or give durability to the structure and take measures to
P/L) and FMEA worksheet. reduce the risk of failure. And various reliability tests
support this accordingly.
(5) Confirmations by the Division Manager Disclosure of evidence of Function Design

When a subordinate engineer submits a process When the subordinate designer replies to the
specifications to the section manager as the question in the affirmative, the manager has to
completion of a process design, how should the demand the display of proof. Do not recognize the
manager act? The manager has to ask the designer design, when a subordinate does a negative reply or
and confirm about the five elements. when the section chief discovers a matter which is
@ @The designer has to submit "the characteristic not acceptable in proof.
and factor diagarams for management" and the
measures list for prevention to insist that any problem Disclosure of evidence of Reliability Design
cannot happen about quality or other At the next stage, similar confirmation is necessary
requirements. @When the designer answers "All about reliability. If the designer submits the QC
necessary conditions are fulfilled", the head of the process table and the process FMEA worksheet and
design division has to demand proof. When the passes the manager's check, the manager should
designer answers "He is uncertain", the head of the declare the start of the Design Review (DR)
design division has to refuse the receipt of the design procedure. However, the design plan should not be
proposal. accepted unless FMEAs are already completed.
13 Need of the FMEA Execution
(1) Role of FMEA, and Designer's Duty Even without an FMEA execution, however,
FMEA is a tool for a designer to check reliability while experienced designers have added measures to the
designing, and helps the designer assess reliability to weak points where tests, calculations, experience,
ensure that no reliability defect exists. The means of knowledge or intuition indicates.
verification for reliability includes the prototype @ @On the other hand, the fact is widely known that
testing, strength calculation, simulation, and others. a serious failure or disaster does not necessarily
arise even without enforcement of FMEA if a expert
(2) Before the Introduction of FMEA designer designs. Why does it turn out such?
Without an execution of an FMEA, a systematic @ @This is a firm evidence that their unconscious
approach of reliability is impossible. activities mentioned above are very much like
FMEAs. That is, FMEA is exactly performing
examination performed unconsciously also
conventionally with a clear fixed system.
(3) Peace of Mind

Various Changes Worry the Designer
In the case of a product, a physical or chemical However, some important failure modes may be
change may occur in a part or an interface as a result overlooked and lead a serious result because these
of use. conventional activity does not obey a constant format
@ @For example, when a certain component is procedure.
attached to the main part of a product with bolts, the
bolts may loosen by transmitting a strong continuous Designer's Peace of Mind
vibration. Or exchange of the component may Even when a design passes verification, its strictness
become difficult because of the corrosion of the bolts. may not be sufficient, and the designer can not
always get peace of mind. If an FMEA is conducted,
The Designer will Apply Measures the designer can maintain the current controls at an
When such a tendency as above is felt, the designer appropriate level. And he can get a peace of mind
will apply measures to the bolts to prevent those unless a remarkable shortage of measures is shown
failure modes, for example, the bolts made of for any failure mode.
stainless steel which applied adhesion material may
be used.
1. It is a customer's essential duty to check that the
(4) Toyota's Big Recall floor mat is being fixed to the floor when using a
For example, a lot car. In this case, violation of directions used
of verification tests corresponds to a failure mode of the use
are implemented process.
by Toyota, but 2. The parts securing the mat to the floor may be
sometimes very broken, and hence the brakage of them
small tests are corresponds to the failure modes of a part.
overlooked. On 29 3. The fixing may become loose and the floor mat
September, 2009, may come off, and hence this corresponds to
Toyota announced the failure mode of an interface.
the largest recall
of 3.8 million cars. The Failure Mode of Use and Maintenance
@ @The reason was that the removable floor mat In this actual case, Toyota must have neglected
under the driver's seat might have interfered with the
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under the driver's seat might have interfered with the FMEA about use and maintenance. Generally, it can
movement of the accelerator, and might have lead to be said that responsibility for problems by misuse,
serious accidents. such as an increase in fuel cost, degree of comfort or
operativity, belongs to the user.
The failure modes
@ @However, the world does not seem to admit the

Three failure modes can be identified about the case Toyota's claim that the user's misuse caused the fatal
of the Toyota's floor mat accident, and this failure or accident. The fact that the free repair was possible
accident can be predicted from those failure modes, If can be regarded as an evidence of Toyota's having
the right FMEA had been executed, the result could been able to prevent the accident by enforcement of
have been prevented perfectly. an appropriate FMEA.
(5) Number of Recalls in 2009: (6) Recent Advancement of FMEA

The improvement of FMEA has accomplished notable
Toyota 4,870,000 progress recently in Japan. As a result, the Absolute
Ford 4,520,000 Evaluation Method (AEM) has been established by
GM 2,230,000 OTL Institute in Japan, and many companies have
abandoned old FMEA. The designers have come to
At the beginning of 2010, Toyota and GM added carry out FMEA of Absolute Evaluation Method
millions of collection. And the collection of the car of (AEM) now voluntarily and positively. This fact proves
the United States of America reached a vast number. the following matters which designers feel.
This fact shows that Relative Evaluation
Method(REM) of FMEA which they had carried out is Usability,
not anything else except the simple decoration The effectiveness of the evaluation,
vividly. The liberation from many questions about
FMEA.
14 Basic Requirements of FMEA

Based on the abovementioned study, the conclusions are as follows.
(1) Designer's Tool to Check Reliability

FMEA is a tool for a designer to investigate the reliability of the product or process of own design. In other words, the person
who conducts a design should perform its FMEA simultaneously.
If a team takes charge of a design, it should carry out an FMEA at the same time, but it should not be called an FMEA team. It
is a design team that executes an FMEA. Don't give priority over FMEA by a designer to an FMEA team which consists of
outsiders of a specific design. The reason is as shown below.
The manner in which the designer omits check of own work is unacceptable anyway.
Outsiders cannot easily understand the details of a specific design to such a degree as it can perform an FMEA, even if
which of a crossfunctional and multifunctional team takes charge.
If the purpose of FMEA by an FMEA team is the interference by a specialist in each field, rather in the first place you
should adopt a design by a design team.
A special section of the Design Review team can perform a team based review after the designer's FMEA.
(2) Using a Fixed Format

The procedure is important to FMEA and you have to learn the format of the FMEA worksheet to prevent mistakes of the
procedure.
The Worksheet Format for the Product FMEA

Product:Gas kitchen range Product FMEA Review
Article or
Line Article or
Interface Failure Mode (Breakage) Effect Mechanism Current Control (Grounds) a b c RI Action Added a b c RI
1
2
3
The meaning of the identifying information of the FMEA worksheet is explained as shown in the table below.
Identifying
(↓Order of the column almost reflects the procedure of FMEA)
Information
Part or Interface Location for failure modes ( Here must not be a column of "function" )
Failure Mode Manners of failure: such as rust, breakage, transformation, melt, comingoff, etc.
Effect Consequences of each failure mode, i.e. potential failures and/or disasters.
Factor Potetial cause: For example, fall to floor, collision, child's mischief, etc.
Measures for each factor: for example, reliability tests, inspection, strength calculation, simulation, foolproof instruments,
Current Controls
failsafe system, redundant design, etc.
Severity (a) Insufficiency degree of measures to ease severity of effect
Occurrence (b) Insufficiency degree of measures to decrease frequency of occurrence of effect
Detection (c) Insufficiency degree of measures to detect factors, a failure mode or effect, according to the situation
Risk Index RI=(a × b × c)1/3 : Insufficiency degree of measures as a whole
Caution
You must not put the column of "Function of Component" in a worksheet. Otherwise you may fall into the topdown method.
The details are explained in Appendix2.
(3) Design Expressed on Documents

FMEA technique is systematic means to investigate the reliability of a designed product or process. FMEA is carried out only
about a design written in the document and cannot be carried out unless the design by the document exists.
A document that describes the actual situation of a workplace is not a design document, but a mere copy document. The
wrong FMEAs based on a abovementioned copy document are frequently seen in hospital risk management. The recognition
of hospitals seems to be related to it.
A custom to recognize that a medical act is a process is missing.
A custom to distinguish a subjective medical judgment from an objective medical procedure is missing.
(4) Difference between Failure and Failure Mode
Concept of Failure
A functional trouble is called a "Failure" in terms of FMEA.
Concept of Failure Mode

Manners in which a product or process may fail are called "Failure Modes," which are needed to be identified in bottomup
ways. When pointed out concretely, the smallest structural element of a product or process may receive a physical or
chemical change due to a use or running, and this structural change is called a "Failure Mode."
In the case of a product, a crack may occur in a shaft, and an electric wire may break. And in the case of a process, by
breaching an instruction, a wrong speed setting of a lathe may occur. An FMEA execution enables you to identify all harmful
failure modes.
Reason for the Strict Distinction

Reason for the Strict Distinction

The reasons why a failure must be distinguished from a failure mode strictly are as follows.
The topdown approach mentions a failure previously and investigates from what kind of potential failure modes the
failure may be drawn. In this case, three kinds are enumerated as candidates. In the right understanding, two of the
beginnings do not belong to the failure mode concept. Only the last thing corresponds to the right failure mode concept.
1. Failures of the subordinate functions,
2. Manufacturing defectives, and
3. Breakages in structural elements.
The phenomenon in which failure modes and failures are mixed up means that the topdown identification (it is wrong) is
performed.
Manufacturing defectives also are listed in the worksheet as failure modes if a topdown identification is taken, because
manufacturing defectives can cause failures.
(5) Evaluating Lack of Measures

Failure modes and its effects are identified and enumerated in an FMEA practice. Then, measures to the effects described in
the current controls column are evaluated in terms of the following viewpoints.
How insufficient are the current measures,
to soften the severity of the effect of the potential failure?
to prevent the occurrence of the potential failure?
to detect the failure mode, its cause or effect prior to the serious result?
(6) Purpose of FMEA

FMEA must be carried out to predict all failure and disasters, and to judge whether measures for every failure are enough or
not. The purpose of FMEA is not to decide priority of the importance of the failure mode. Otherwise measures become
insufficient or excessive.
Contents
Introduction
Chapter 1: What Is the FMEA
Step 3: Listing Effects and Factor
Chapter 6: Seven Steps / Case Study
Chapter2: Purpose of FMEA
21 Purpose of FMEA

The purpose of FMEA is to check reliability of a product or process that he designs, in order to enable himself to ensure
reliability by a rational cost. In other words, the designer has to check his own design about whether measures are sufficient
to prevent the potential failures and disasters beforehand.
Hence, it is the necessity of additional measures to failure modes that has to be clarified by FMEA. It is not priority order of
failure modes. This will be explained concretely as follows.
To Clarify the Potential Failure and

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To Clarify the Potential Failure and Disaster

It is difficult to imagine what kind of potential failures or disasters may be cause in the future when you design a new product.
And the same applies to a manufacturing process and other processes in general.
The FMEA technology has been intended to identify potential failures and disasters. Hence these potential failures and
disasters are the targets of an FMEA, but not the starting points. This means that you must not treat these failures or disasters
as starting points of an FMEA. Starting points must be the failure modes.
To Clarify Failure Modes not Enough in Control

To prevent failures, you have to identify failure modes not enough in control. In order to ensure the reliability, failures and
disasters must be predicted by means of searching from failure modes (the starting points). And hence, the failure modes
should be enumerated first.
And the current design controls should be listed and evaluated for each failure mode (cause and effect) in terms of severity of
effect, frequency of occurrence, and probability of detection. And if necessary, measures should be added to the current
controls for each element.
Searching Failure Modes Is not the Purpose

Because the measures are impossible to take unless a failure mode is clear, they are apt to think that the purpose of FMEA is
to clarify potential failures first, and to search for potential failure modes from there. However, this is the biggest mistake of the
topdown method.
The purpose of FMEA is not to search failure modes from failures. Conversely, it is right approach to look for failures and
disasters from each failure mode enumerated first.
When FMEA Is Helpful

The execution of an FMEA will help prevent reliability problems. For example:
Even a product that works smoothly at first may come to produce frequent function troubles later by reliability defects.
Even a manufacturing process that produces a good output at first may come to produce frequent output trouble later by
reliability defects.
When FMEA Is Useless

Execution of an FMEA will not help prevent troubles other than mentioned above, which should be improved by attending to
the design of function itself. For example:
Troubles due to a poor function design
Troubles of a product or process, without a written design, and
Trouble of the process that a copy of the shop floor work becomes the procedure book
Objection Theories
Robin E. McDermott p.3:
"Preventing process and product problem before they occur is the purpose of Failure Mode and Effect Analysis (FMEA)."
Commentary:
This description is not precise, and cannot avoid a correction about the next two points. And this recognition is extremely
important to understand FMEA.
FMEA is a tool to evaluate reliability and judge effectiveness of measures to prevent reliability troubles, but cannot
prevent any problem by itself. It is the expertise that play the role of preventing process and product problems.
FMEA is not useful to other problems than reliability. Judging lack and excess of measures for reliabiity is the only
purpose of FMEA.
Robin E. McDermott p.4:(About documented procedures)

"This is especially critical with a process FMEA. In the absence of documented procedures, people working in the process could be introducing
significant variation into it by operating it slightly differently each time the process is run. In this case, the FMEA is aiming at a moving target
because each time the process is run, it produces different results."
Commentary:
This opinion should be corrected as follows. If there is no document :
the process specification is indefinite, hence existence of the design is not recognized, and
the breaches of the process instruction cannot be enumerated, and FMEA is impossible.
S. Iida. P.34:(About a process of the hospital without documented procedures)
"All factors of the medical accident exist in the medical shop.It is essential to grasp who performs what how when precisely in preventing a
medical onsite accident. The grasped things become the base of the process table." (Translated by OTL Institute)
Commentary: This description is wrong at a basic point.
(1) Which should follow the other?

Which of process design and the onsite action should follow the other? If the onsite work is not performed as instructed in
the process design, the process control is quite impossible.
It is often carried out that staffs in charge of FMEA copy processes which occur at the shop. "The copied process table" made
in this way is a copy till the last and it is not a designed specification. The evidence is as follows:
"The grasped things become the base of the process table." means that the onsite work is the leader and the copywriter
receives guidance. Then, "the process table" follows the onsite work and cannot become the tool of management.
The person who does not know the onsite work well makes the copied process table, which has the tendency of
mistake and specification lack.
When work contents or procedures are needed to be changed, the process table should be changed first, and onsite
work shoud follow it.
The way of thinking that the factor of the medical accident exists in the shop of the medical service reflects a way of
thinking that the spot precedes than a design. The factor of the medical accident exists in a process design definitely.
And FMEA has a role to find a weak point of the reliability of the design.
(2) The Difference between Copying and Designing

Think of the difference between copy and design. An FMEA should not be performed based on the document which is
comprised of copy of onsite work.
Since what is grasped on the site is not necessarily accompanied by a design of reliability, it should not be copied into QC
process table.
Internet site: Click Failure Modes and Effects Analysis (FMEA) ASQ
The purpose of the FMEA is to take actions to eliminate or reduce failures, starting with the highestpriority ones.
Commentary:
There are three mistakes in the opinion above.
1. The main purpose of the FMEA is to predict serious failures or disasters.
2. FMEA is a technique for management, and points out defects of a designed product or process. The actions to eliminate
or reduce failures are taken, however, by the expertise peculiar to each field, not FMEA.
3. The priority is nonsense after all because all necessary measures must be carried out. The reason why the opinion
mentioned above requires priority is because wrong FMEA which cannot examine the degree of the need of measures
every failure mode is adopted.
Contents Step 1: Preparation of Documents

Introduction Step 2: Listing the Failure Modes
Chapter 1: What Is the FMEA Step 3: Listing Effects and Factor
Chapter 2: Purpose of FMEA Step 4: Listing Current Controls
Chapter 3: FMEA Process Step 5: Evaluating three Elements
Chapter 4: Who Executes an FMEA ? Step 6: Calculating RI
Chapter 5: Product and Process Step 7: Optimization
Chapter3: FMEA Process
31 Outline of FMEA

Process of FMEA consists of seven steps as follows.
1. Preparing Documents
2. Listing Failure Modes
3. Listing Current Controls
4. Listing Effects of Failure Mode
5. Evaluating Current Controls from Three Viewpoints
Severity (a) of Effect
Occurrence (b) of Failue
Detection (c) of Effect, Failure, Failuree Mode, or Factor
6. Calculating Risk Index
7. Optimizing Measures
32 Preparing Documents

The purpose of FMEA is prediction of failures and disasters from failure modes and the evaluation of insufficiency of
measures against them. Hence,
As for a product, the necessary documents are as follows.
FMEA worksheet
Drawings of product from a part to the final product
Structured BOM (Parts List, P/L)
Materials specifications and other reference materials
Verification plan
As for a process, you need documents that prescribes detailed requirements about the following 5M process elements:
equipment, people, materials, measurement, and ways of work.
FMEA worksheet
QC process table
Activity standard (instruction sheet)
Equipment maintenance plan
The Worksheet for the Product FMEA

Line Article or
Interface Failure Mode (Breakage) Effect Mechanism Current Control (Grounds) a b c RI Action Added a b c RI
Interface
1
2
3
The Worksheet for the Process FMEA

Process: Medicine Bottle Ass'y Process FMEA Review
Line Step
Name
No. Failure Mode (Violation) Effect Mechanism Current Control (Grounds) a b c RI Action Added a b c RI
1
2
3
33 Listing Failure Modes
331 Concept of Failure Mode The Starting Points

An FMEA process starts with listing potential failure modes of a product or process. In other words, the failure modes are
starting points of the FMEA.
Failure and failure mode completely belong to a different concept mutually, and should never be confused. We need to know
all failures that may occur by use in the future. There are two ways to search failures. One of them is topdown approach and
the other is bottomup approach.
The Definition of Failure and Failure Mode

A failure occurs when a product or a process does not function properly. A failure can occur in a variety of manners. And
ways, found when searched by a bottomup approach, in which a product or process may fail are called failure modes.
For example:
As for a product, gas leakage from a kitchen gas range after handing to a customer is one of the Failures of the the
product.
Some gas may leak out of cracks in the hose while being used for a long time, and the cracks in the hose can be a
Failure Mode of the gas leakage.
As for a process, the smallest element of the structure is each specification about the process condition. In other words,
breaches of process specifications are called Failure Modes of the process. When instructed to tighten a screw at a
certain torque, omitting the work or tightening at a wrong torque either by intention or by mistake belongs to a Failure
Mode.
If products with screws tightened at a wrong torque are produced, these are defective products caused from a failure of
the process.
Caution
The error is not a failure mode without the violation for instructions written in QC process table or other associated documents
even if it leads an accident that somebody did some kind of errors.
332 Bottomup Approach

Bottomup Search
The most important point in listing up failure modes exists in the bottomup search. One of the reason is to prevent
overlooking of failure modes. Breakage in the smallest structural elements are defined and identified as failure modes and
treated as starting points of searching failures.
In other words, the damages of parts or the connections (with a product) or breaches of instructions (by a process) are the
failure modes and are the starting points of all FMEA activities.
Failure modes can easily be listed from a parst and connections or a process instructions, if expert designer is in charge.
Topdown Search
Topdown Search
In the topdown approach, the failures are necessarily the starting points to search failure modes, and efforts are paid to
investigate downward from the potential failures. This is because failures are listed first, and the questions how they does
occur are considered next. As the result,
dysfunctions of the subordinate functions,
manufacturing defectives, and
structural breakages,
are enumerated without distinction all as failure modes. On the other hand, the failues which are missed become what you call
unexpected failures that no precautions are taken beforehand.
The Merits Brought by Bottomup Approach

The expert designer can enumerate all possible potential damage about parts and the connection that oneself adopts without
exception in the future.For example, there may be enummerated such thinsg as;
disconnection of the motor winding,
shortstop of the cord,
abrasion of the switch point of contact,
transformation of the arm,and
slack of the screw.
Because an FMEA starts with a question what failure will be caused if this failure mode occurs, failures are not included in the
starting points. A failure (even a dysfunction of the subfunction) does not belong to the failure mode concept.
The Problems with Topdown Approach

When topdown, failures are enumerated first. Next, it shifts to investigation of the routes in which failure occurs for every
failure. And the activity which looks for failure modes starts. Various phenomena are listed as failure modes as follows if the
failure of the windshield wiper of a car is taken as an example.
The turn of the wiper shaft may not be smooth. (A failure or manufacturing defective)
The switch may not work. (A failurfe or manufacturing defective)
The motor may not work. (A failure or manufacturing defective)
The wiper shoe may be deformed. (A failure mode)
The arm of the windshield wiper may be broken. (A failure mode)
When failure is shown as above, it is not the end of the search of failure mode, and you have to continue looking for the failure
modes of the failures further. This means the failures are not failure modes.
When a manufacturing defective is pointed out as above, this is not the end, too. You have to search defects existing in the
manufacturing process, further. You notice that you do not know which of a product FMEA and process FMEA you are in
charge of.
Failure Mode must Be Starting Point

Failure modes (structural breakeges) should be the starting points because:
1. The purpose of FMEA is to look for all failures and disasters, and hence failures or functions must not be starting points.
2. It is not difficult for an expert engineer to enumerate failure modes of a part or interface that is adopted in the own
design. And from the failure modes enumerated, it is not difficult to approach all of the corresponding potential failures or
disasters by bottomup search.
3. Without these starting points, it would be very difficult to imagine all failures and all disasters that are potential.
4. Disasters are not always caused by failures (nonfunctions or malfunctions). Hence starting from failures will not cover
all the disasters. For example, even if leakage of electricity occurs, it is not necessarily accompanied by functional
disorder, but is in danger of a fire.
333 A Useful Theory by H. Kume: p.142: (Translated by us from Japanese)
Difficulty in Predicting Failures

The difficulty in prediction of potential failures is caused by necessity of qualitative prediction. In contrast, a weather forecast gives a quantitative
prediction to the events which are limited to several like fine weather, cloudy weather, rain, snow, and the storm, etc.
For Example
Concerning new technologies or new products, listing of potential failures is not an easy task. For example, Japan is proud of the Tokaido
Shinkansen System, which is a high technical level railroad train. Initially, however, they encountered many unexpected problems.
Solution
Failure range is diverse and systematic analysis needs a special concept which represents as much diverse failures as possible. It has enabled
us to predict potential failures by establishing the failure mode concept. Failures (= effects) of those failure modes are different depending on
products. And picking all failures in general is impossible and meaningless. However, once a system (= product or process) is decided,
searching failures will become easy starting at the failure modes. On the other hand, it also will become easy to identify causes and effects.
Commentary:
The abovementioned theory by Professor Kume (the former professor of University of Tokyo, Japan) is appropriate and
splendid truly.
34 Listing Current Controls

Identification and Listing of Current Controls
The current controls (i.e., measures) to improve the severity of effect, the frequency of occurrence, and the provability of
detection should be identified and listed respectively.
One description space

In many cases, one measure is effective in more than one of severity, occurrence, and detection. The measures written are
treated as the measures for each of severity, occurrence, and detection, and hence one description column is enough.
35 Listing Effects of Failure Mode

Identification and Listing Effects
All failures and effects resulting from each failure mode should be identified, however, only effects that are obviously harmful
should be listed.
36 Evaluating from the Three Viewpoints

Three viewpoints
Current controls for each failure mode are evaluated in terms of three viewpoints i.e.,
severity of effect,
frequency of occurrence, and
probability of detection.
The evaluation is carried out on the absolute fourpoint scale regarding necessity in adding measures to the current controls.
Evaluation by the Engineering Technology

The current controls to each failure mode should be evaluated from the three viewpoints on the fourpoint absolute scale
which is based on the engineering technology for each field. In other waords, this rating is not related wity management
technology.
Severity (a)
Evaluate the degree of insufficiency of measures in current controls to ease the severity of the effect. If a failsafe system is
taken, the severity takes a very low value.

Occurrence (b)

Every cause, evaluate degree of the lack of measures of the current controls to reduce outbreak frequency of the failure. If a
foolproof system is taken, the occurrence takes a very low value.
Detection (c)

Every cause, evaluate the degree of insufficiency of measures in current controls to improve the probability of detection of
failure. However, as an object of detection, the thing that detection is the easiest can be chosen among potential cause,
failure, and effect by circumstances.
The influence of the trouble mode may gradually develop into serious influence according to the flow of the process under
light influence first. You may choose the method before developing into a serious accident by the detection of early light
influence if measures are possible.
Exceptional Evaluation Criteria

When the frequency rating is low, the necessity of detection is also low. Hence when occurrence takes such low evaluation as
2 or 1, the detection takes the same rating as that. And this exceptional treatment accelerates FMEA very much.
37 Calculating Risk Index

Numerical value of Risk Index (RI) is calculated using the ratings as shown above and an expression shown below.
Severity value= a
Occurrence value= b
Detection value= c
Thr ratings a, b, and c are obtained on the basis of engineering technology for each field, and RI is the index from the three
viewpoints of management technology to indicate the necessity of additional measures. The outline of this principle is shown
in the figure below.
38 Optimizing the Measures

Getting RI Closer to the Optimal Value 2
The numerical value of risk index (RI) must be appropriate, i.e., as close as possible to its optimal value 2. And its measures
are adjusted, and this treatment is called optimization. However, the content of optimization varies according to the value of RI
as shown below.

When RI Exceeds 2.3

As RI exceeds 2.3, the need of additional measures increases.

When RI Is around 2.3

Actions will be suspended, until the result of test is obtained or a better measures is found.

When RI Is Considerably Lower than 2

Because reliability is superabundant, consider whether therefore extra cost does not exist. When reduction of the cost is
difficult, aim at valueadded increase appropriate for the cost increase. Consider how to create a sellingcharm (for example,
improvement of appearances, convenience of use, or safety) to compensate for the cost increase.
Defect of the Conventional Evaluation

Since RPN, which the conventional FMEA is proud of, does not indicate the necessity for measures, adjusting of measures
can not be performed on the basis of this numerical value. Besides, the comparison between first RPN and RPN after the
improvement is totally nonsense because neither the cost nor the time delay is considered.
Objection Theories Robin E. McDermott p.9:
"The objective of an FMEA is to look for all of the ways a process or products can fail."
Commentary:
This opinion cannot be said to be a mistake. However, McDermott's is missing the turning point of bottomup or topdown
approach about "looking for ways a process or a product can fail". This book itself has taken the wrong choice, and as a
result, all ways (trouble mode) are not found and other failures and manufacturing defectives are mixed with failure mode.
"Failures are not limited to problems with the product. Because failures also can occur when the user makes a mistake, those types of failures
should also be included in the FMEA."
Commentary:
This description is correct, but has missed some explanation points. For example:
This description does not identify the failure mode. Correctly, a breach of an instruction about how to use is the failure
mode.
Failure mode is not identified in the above description. Correctly, failure mode is a breach of the directions of how to use,
i.e., this is a process FMEA. Above description seems not to know this point.

"Ways in which a product or process can fail are called failure modes."
Commentary:
This mention is also true; however, the turning point "topdown or bottomup" has been missed. And this book itself has
chosen topdown identification. The mistake of this choice seems to have led to the mistake of the whole FMEA.
"The relative risk of a failure and its effect is determined by three factors:
Severity: The consequence of the failure, should it occur.
Occurrence: The probability or frequency of the failure occurring.
Detection: The probability of the failure being detected before the impact of the effect is realized."
Commentary:
Commentary:
Explanation mentioned above has serious mistakes as follows.
(1) What should be determined?

It is wrong to determine the relative risk of failure, because it does not become clear which failure modes need additional
measures and which need not. Correctly, the way that a failure mode needing additional measures is clarified, in other words,
the absolute risk evaluation must be carried out.
(2) The Relative Risk Evaluation is Useless

The relative risk evaluation is useless because the necessity of addition of measures for each failure mode does not become
clear. Only for the reason that the risk of failure mode A is larger than that of B, measures should not be immediately added to
A. Excessive measures lead to waste of resources (person, time, equipment), and shortage of measures also increase waste
for the troubles.
(3) We Want to Know the Absolute Necessity of Measures
Evaluating the Degree of Risk Is Absurd

It is absurd to evaluate the "relative degree of risk" of failure modes.
For example, the effect of the crack of the airplane body should be estimated at a high level (probably "10"). However, the
effect of the cracks of the paper cups for passengers will be evaluated by a low level as the very trifling problem, compared
with an aircraft accident. However, on the other hand, the paper cup maker shuold give the greatest point to the crack.
The same inconsistency is seen also by evaluation of frequency. Suppose that frequency is once a year. The crack of the
airplane body in the frequency should be evaluated at a high level (probably "10"). Moreover, it in the paper cup in the
frequency should be evaluated at a low level.
Because of such complex conflicts, it is difficult to establish common criteria and make smooth use. In addition, each
numerical value obtained by the relative evaluation can not be utilized as the data to determine excess or shortage of
measures.
How to Calculate RPN

"Using the data and knowledge of the process or product, each potential failure mode and effect is rated in each of these three elements on a
scale ranging from 1 to 10, low to high. By multiplying the ranking for the three factors, a risk priority number (RPN) will be determined for each
potential failure mode and effect."
"RPN=Severity × Occurrence × Detection"
Purpose of RPN
"The risk priority number (which will range from 1 to 1,000 for each failure mode) is used to rank the need for corrective action to eliminate or
reduce the potential failure modes. Those failure modes with the highest RPNs should be attended to first, although special attention should be
given when the severity ranking is high (9 or 10) regardless of the RPN."
Resulting RPN
"Once corrective action has been taken, a new RPN for the failure is determined by reevaluating the severity, occurrence, and detection
rankings. This new RPN is called the 'Resulting RPN.' Improvement and corrective action must continue until the Resulting RPN is at an
acceptable level for all potential failure modes."
Commentary:
In the above description, six major flaws are pointed out as follows;
1. Absence of Common Criteria
As mentioned above, the relative scale method has no common scale which can be applied to all products and
processes, and hence smooth evaluation is quite hard to conduct.
2. Absence of Reproducibility
The 10point relative rating method is very hard to execute and the result is extremely crude without reproducibility.
3. Business Retention
Because addition of the improvement is reserved to the end of all RPN calculations and priority decision, the large delay
of the work cannot be avoided.
4. How can "an acceptable level" be determined?
"An acceptable level" mentioned above is vague about how to decide, and the executer cannot judge which failure mode
to work on. In fact, there is no means except intuition.
5. Priority Is Nonsense
If "an allowable level" can be determined, it should be determined first. And it will become unnecessary to examine the
priority. As the result, it becomes clear that the absolute evaluation method is the only evaluation method that FMEA
should take.
6. Cost and Time Delays
The judgment is impossible whether RPNs after the improvement are superior to RPNs before the improvement
because you do not consider cost and delay in the relative rating system.
Robin E. McDermott p.47

Case Study Step 8 : Prioritize the Failure Modes for Action
One of the team members created a Pareto diagram of the failure modes so that it would be easy to distinguish virtually between the items. The
team decided it would work on any item that had an RPN of 200 or higher. Two hundred was set as the cutoff point because it encompassed
over half of all of the potential failure modes.
The team rationalized that an improvement in more than half of the failure modes would be a significant step in the right direction. With the
criteria of an RPN of 200 or higher, there were eight items they would need to attend.
Commentary:
1. The reason why the cutoff point which encompasses over half of all of the failure modes is rational is not shown. This is
totally measures without grounds.
2. About the design without need of improvement of the reliability, RPN which encompasses half of all failure modes is set
as the cutoff point, and further actions will be added irrationally.
3. Because RPN is defined for numerical value indicating the priority, it is against the definition to use it for numerical value
indicating the additional need of measures.
Internet site: Click Failure Modes and Effects Analysis (FMEA) ASQ
"Failure modes" means the ways, or modes, in which something might fail.
Commentary:
The abovementioned definition is not touching on whether to be topdown or bottomup in identification of failure modes. As
the result, it has fallen into the topdown approach which is a serious error.
Contents
Introduction
Chapter4: Who carries out an FMEA?
41 A Tool for the Design Aid

41 A Tool for the Design Aid

Real Time Execution of an FMEA
The designer of a product or process can give it appropriate reliability through real time execution of an FMEA. It is possible to
perform FMEA, after all design proposals are completed. However, if an improvement of reliability is needed after a design
progresses there, it may develop into a largescale change of design, and this is not a wise method.
Furthermore, when the design results in a high cost because of excessive reliability, a large scale change of design similarly is
needed. As a result, a remarkable delay can not be avoided.
Simultaneous FMEAs
This problem is solved only by performing FMEA simultaneously with a design. In other words, FMEA is a tool with which a
designer checks the reliability while designing.
FMEA team
The thought that an FMEA team who are not in charge of the design should take charge of FMEA is essentially wrong.
Reason:
1. Supposing an outsider's team carries out, while a designer designs, there will be no method of checking reliability.
2. It is too much difficult work that an outsider's team understands a design, and FMEA by an outsider's team wastes time
and a labor notably.
Objection Theories
"Although one person typically is responsible for coordinating the FMEA process, all FMEA projects are team based. The purpose of FMEA
team is to bring a variety of perspective and experiences to the project. It is helpful also to have people on the team who have different levels of
familiarity with the product or process. Those who are most familiar with it will have valuable insight, but may overlook some of the most obvious
potential problems."
Commentary:
(1) Nobody but the expert designer can point out failures most precisely.
The description "Those who are most familiar with it (the design) may overlook some of the most obvious potential problems."
is a groundless assertion, because overlooking of problems is due to the defects of the conventional FMEA. It is nobody but
the designer that can point out failures and disasters from failure modes most precisely.
(2) As for Variety of Knowledge and Experience

The opinion which supports the teambased FMEA has the tendency to assert various knowledge and experience as the
reason. If various knowledge and experience are needed, however, not only FMEA but also design should be performed by
the same team. It is more suitable to have sufficient capability beforehand rather than compensating man's lack of ability
about a design later.
We can not find the reason why a special FMEA team is necessary in addition to a Design Review team which is similar to an
FMEA team.
Hitoshi Kume p141: (Translated by us from Japanese)
"Design review (DR) enlarges the width of check of the product design. In contrast, FMEA increases the depth. DR and FMEA are activities to
be carried out both by groups, but DR performs examination about the whole of the product. In contrast, FMEA examines the prevention of the
trouble of the product, safety improvement mainly, and participants are engineers mainly."
Commentary:
Professor H. Kume has explained a failure mode concept by a wonderful theory. In contrast with it, his theory about who
performs an FMEA is very poor.
(1) Why does Only Reliability Need a

http://www.geocities.jp/takaro_u/fmea_eng.html#c3 Deep Rview? 30/78
(1) Why does Only Reliability Need a Deep Rview?

The design review can include a FMEA review. It is not fully explained why the review of FMEA of the designer by DR team is
irrational. It is hard to accept the idea that a deep examination is required only for FMEA and the depth is not required for
other matters.
(2) Reliability Check by the Designer

The upper description has forbidden the natural procedure of performing a reliability design, while a designer checks reliability
at the time of a design. This is not rational. However, when a team designs, the design team should perform FMEA. In this
case, you should not call it a FMEA team.
D. H. Stamatis p.32:
"Who conducts the FMEA? The FMEA is a team function and cannot be done on an individual basis."
Commentary:
There are two grate mistakes. This is a extremely poor opininon that does not examine even such extremely rudimentary
problems as shown below.
(1) How Can the Designer Check Reliability?

If the FMEA cannot be done on an individual basis, how could a single designer check the reliability of regarding his own
design? The answer is not shown.
(2) Which Is More Difficult, Designing or Executing FMEA?

If the FMEA cannot be done on an individual basis, why can design be done on an individual basis? The answer is not shown.
Which is more difficult to perform, an FMEA or a design? Of course design is ten times more difficult than conducting an
FMEA, because the designer must contrive function mechanisms and structure to support these taking into account
production methods, quality, costs, timequantity demands, safety for workers and customers, environment, and reliability.
If a team executes an FMEA, the same team should take charge of the design. Similarly, if design is done by one person, the
same designer should execute the FMEA alone. In addition, even if a design is executed by a team, an FMEA for each
member's portion of design should be performed by each designer beforehand.
Contents
Introduction
Chapter5: The Product and Process
51 Designing the Product and Process
511 General Description For the Benefit of All People

The product must be designed to be appropriate to the benefit of customer, manufacturer, cooperating company,
neighborhood inhabitants, and environmental protections. Hence, the outcome of the design must meet the demand about
quality, time and quantity, cost, worker's safety, user's safety, and environment.

Purpose of Design (Function and Reliability)
Design is carried out so as to ensure functions and reliability of a product or process to meet the design intent and
requirements. The design of function and reliability should be performed simultaneously. If a defect of reliability is detected
after the design of function advances too much, previous accumulation gets overturned, and duties delay remarkably.

Definition of Design
A product is an artificial object designed with detailed structural specifications which are defined to obtain specific
functions with appropriate product life. In other words, a product design is a plan to create a durable structure of an
product which performs functions to meet design intent and requirements.
About a process design, it is similar. A process is a service designed with detailed structural specifications which are
defined to obtain specific functions with appropriate durability. In other words, a process design refers to a plan with
detailed structural specifications to create a durable structure of a service which performs functions to meet design intent
and requirements.
Design Is Bunch of Measures

Why do both the product and the process appoint detailed structure specifications by a design? The design must consist of
measures to prevent all defects. In other words, not only the product design but also the process design must be a bunch of
measures. Otherwise incoherent works are carried out, and innumerable troubles happen.
Structure of Process
The process consist of specifications of the fiveM resources as shown below. These are the requirement about,
Machine the equipment and its maintenance
Man the people in charge or related
Method the work, operation, engineering, management
Measurement the collection, recording and treatment of information
Material the subject which receives processing
Generally, the consideration about the element of five resources is necessary so that a process functions.These placement
and preparations to carry out a process constitute the structure of the process.
Definition of Function
Function is the ability of a product or process to work and output based on the design intent. Output of function consists of five
elements as described in the table below.
Quality Q Products should have quality conforming to requirements, and processes should have quality appropriate to output products of
quality conforming to requirements.
Delivery
(time and D As for product design, sale time and the volume of the product should be considered. As for process design, daily amount of
production should be considered.
quantity)
Cost C Initial cost and running cost should be considered in both product and process design.
Cost C Initial cost and running cost should be considered in both product and process design.
Safety S Both of worker's and customer's safety should be considered in both product and process design.
Environment E Environment protection should be considered in both product and process design.
Principle of QDC Inseparability

The details of 5M resources are strictly and definitely specified as design specification so that the five required characteristics
shown above are completely satisfied. The design specification of a product is mainly expressed by drawings or
specifications. The design specification of a process is mainly expressed by QC process tables.
It is necessary to manage the characteristic as what five results cannot divide. If only one of these is managed, the other 4 will
fall into a noncontrolled state. When these five characteristics are managed by the separate administrator, each plan collides
and problem always arise.
Verification of Functions
About a product, you have to verify that the output (function and reliability)of a design fulfills a necessary condition.
Verification is performed mainly by doing function and reliability tests, which use the prototype (trial product) under the
usual and special condition. Trial products can be handmade trial products, automatic machine manufacture trial
products, production trial products, metallic mold inspection trial products, and so on.
Verification is also implemented by simulations using the computer technology. FMEA is a means of verification, too.
About the function of a process, fulfilling output requirements is verified mainly by performing test operation. Various
data is collected and analyzed at each step, and a function is checked. It is also the part to obtain the data of a process
capability index.
Definition of Reliability
The quality of a product or a process that can maintain the intended functions under specific conditions and within a
prescribed period is called reliability.
Verification of Reliability
As for a product, reliability is verified mainly by strength calculations, or conducting reliability compliance tests using
prototypes. For example, endurance tests, life tests, impact tests, vibration tests, field reliability test, etc. FMEA is also a
means of reliabirity verification.
As for a process, reliability is verified mainly by means of test running for data collection, probability of condition change
in particular. FMEA is also a means of reliabirity verification.
Definition of Failure
The inability of a product to work properly after normal use for a time is called a failure (nonfunction or malfunction). This is
what we call a failure which should be prevented by reliability design, and reliability should be evaluated by conducting an
FMEA to check whether reliability is sufficient or not. In this case, an FMEA can play an important role.
Poor Function Existing before Use

When by contrast not functioning appropriately already prior to handing to the user, it is a defect to which it comes not from
failure but from a poor manufacturing process. These problems are unrelated to reliability or FMEA.
How to Start an FMEA
When a product falls into a failure, a harmful breakage of the smallest structural element, namely a part or interface (a
connection), exists by all means. Hence, all harmful breakages should be enumerated as failures modes.
We can reach all potential failures and disasters by bottomup approach from those failure modes (the starting points).
Treating failure modes, which are the structural breakage occurring after use, as starting points of FMEA is rational.
When a process falls into a failure, a harmful breach (failure mode) of the smallest structural element exists by all means
as long as the instruction for preventing that failure is specified in the process design. And hence, all these harmful
breaches should be enumerated as failure modes.
We can reach all potential failures and disasters by bottomup searches from those failure modes (the starting points).
Thus treating structural breakage occurring after use as failure modes and as starting points of FMEA is rational.
If Prevention Is not Sufficient

How can we identify all failure modes when instructions for preventing failures are not sufficiently specified in the process
design? In that case, the failure modes which can be enumerated will also run short corresponding to shortage of
instructions.This is the defect of design, and it is necessary to do the following thing prior to creating the QC process table so
that all necessary instructions are described.
All the factors (potential cause) about all output characteristics should be enumerated to the causeeffect diagram. And all
necessary measure about those factors should be taken in the QC process table to be created.
Factor and Effect Diagram (FED)

All failures (function troubles) about output should be enumerated first. And at the next stage, all factors (potential causes)
should be enumerated toward each failure to form a factor and effect diagram (FED).
FED and CED

The factor effect diagram (FED) and the cause effect diagram (CED) are fundamentally different.
FED is created for the purpose of prevention of trouble.
Hence, many effects and many factors are enumerated based on knowledge and experience, because the process data
are not yet available.
CED is created for the purpose of pursueing the cause of an existing trouble.
Hence, a few candidate causes for the specific trouble are enumerated based on the process data.
Creation and Use of FED

The process design which has not sufficient instructions for the satisfactory result is called an imperfect process design. In the
case of an imperfect process design, listing of failure modes cannot fully be performed. It is necessary to begin the solution by
creating perfect FEDs.
1. Enumerate all potential trouble from knowledge and experience.
2. Enumerate all factors (potential causes) of each trouble from knowledge and experience.
3. Plan suitable measures to all the factors according to the importance.
4. Describe factors and their controls concretely and definitely in each step of the QC process table.
512 Failure and Failure Mode
Failure
Malfunction or nonfunction is called a failure. Both of a product and a process can produce failures by breakages of the
smallest structural components.
For example:
About a product
The effectiveness of the brakes of the car usually declines slowly as the shoes wear down. The the proper product life of
the shoes is not considered to be a failure mode. However, the abrasion to cause abnormal short life should be listed in
the FMEA worksheet as a failure mode. Furthermore, the factors and the prevention measures should be listed in each
description space.
The identification column of a FMEA worksheet must not consist of order of Item, Function, Failure mode, and Influence.
Moreover, don't draw failures from a function or don't treat them as failure modes. Correctly, the order of Item, Failure
mode, and Effect is required.
About a process
Failure mode may lead to problems of some of quality, delivery (time and quantity), cost, safety, or environment. In this
case, FMEA is an effective action. However, these problems are caused not always by the failure modes but also by the
poor functional design. In this case, FMEA will not be effective.
The process may bring an unexpected result or a disaster not only a predicted result. That is why FMEA does not begin
with a function or the trouble and must begin with the trouble mode (violation of the process design). Specifically, it is
necessary to begin it at enumeration of the violations of instructions written on the QC process table, and, as the result,
failure modes should be enumerated in the beginning of the worksheet.
Opposite Views
"The principles and steps behind all FMEAs, whether they are focused on the product or the process, are the same even though the objectives
may differ."
Commentary:
Correctly, steps vary depending on which of a product or process is treated.
Difference of Means and Timing of Detecting Failure Modes
Product FMEA
The main means of detection are strength calculations, reliability tests with prototypes, and computor simulations. These
primarily are performed during design control stage. And the second is a certain periodical inspection by the user (or a
trustee) after sale acording to the user's manual.
Process FMEA
Timing
The failure method of the process is found during process preparations and running.
1. Detection of a small effect may be enough if you can find the small influence that can be easily settled before developing
into the serious effect.
2. It is necessary to detect the stage of the trouble mode if too late by the detection of the stage of the influence.
3. It must be found at the time of the factor (potential cause) of the failure mode if too late by the detection at the stage of
the failure mode. Or a mechanism which the failure mode does not occur is necessary.
Means
Most means of detecting failure modes or reducing need of detection are as follows.
1. Means of detecting failure mode

The confirmation of meeting a process condition in most cases is carried out using checksheet.
2. Means of reducing need of detection
The means shown below prevent errors perfectly, and as a result, reduces the necessity of detection.
Foolproof devices
Automated machines (fully, or partially)
Fixed setup of machines
3. Means of detecting abnormality
When the abnormalities of the characteristic are detected at an opportunity as shown below, generating of failure mode
may be detected.
inspecting samples,
statistical data analyses, and
execution of graphic techniques.
52 Product FMEA

521 General Description
52 Product FMEA
521 General Description

Purpose of Product FMEA
Product FMEA is conducted for the purpose of uncovering potential failures and disasters and evaluating the insufficiency
degree of measures for prevention.
Failure Modes is Easily Misunderstood

Failure modes are manners in which a product can fail. This definition is the generally received view and is right. However, it
is easily misunderstood, and in fact, most of the researchers and trainers misunderstand it. And the misunderstanding leads to
greater mistakes further.
Should manners in which a product may fail be searched in a topdown approach or bottomup? This is the most important
turning point. However, few researchers have been aware of this. As a result, they have fallen into the wrong way, the top
down approach.
522 Bottomup Approach

Trying a Bottomup Search
Ask like in the following way : what (a failure and disaster) may happen if a crack (a failure mode) is created in this part? This
way of asking is the bottomup approach. In this approach, an approach to a failure starts from a breakage that may occur in
parts or interfaces (connections). This kind of breakage belongs to the structural defect and is called a failure mode of a
product.
The failure mode of a product is limited to a structural defect and is definitely distinguished from a failure (functional defect).
Enumerates All Harmful Failure Modes

The failure mode has to be the starting point of searching failures or disasters which is the object of FMEA. The designer
should be an expert capable of enumerating all harmful failure modes easily without overlooking. The bottomup approach will
lead to the failure and disaster which should be prevented.
For example, when attaching a certain unit to a main part of a machine using bolts, the expert designer must immediately
enumerate the failure modes of the bolts as follows.
Bottomup Approach
Potential Cause ← Failure → Potential Effect
Mode
Vibration Slack
Unit may move and electric wires may cut.
Repetition of Broken And what?
Impact load What may cause this What may be caused by this
Excessive dead failure mode? failure mode?
load Bent It may become hard to loosen bolts and to
replace unit.
Dew condensation Rust Repair may become hard at last.
A Novice Engineer
It may be worried that all harmful failure modes are not enumerated if difficult for a novice engineer. However, it is not a
problem which arises only about FMEA that it is impossible to leave a design to beginners. Beginners have to work under an
expert supervisor.
The Principle of the FMEA

All the failure and the disasters which are due to a certain failure mode can be searched for from that failure mode. This is the
technical foundation stone of FMEA.
523 The Topdown Approach Is Wrong

Trying a Topdown Search
"What is the failure mode which draws this failure or disaster?" This way of asking is a topdown method, and unexpected
failure or a disaster will show a tendency for measures to leak.
Let's think of the topdown approach to the manners in which the windshield wiper may fail. What can be cause? The answer
may be the defects as shown below.
The Topdown Approac (Wrong)

Article Function Failure → Failure Mode
→ → → Subfunction Failure Structural Breakage Manufacture Defectives
Intermittent motion Battery voltage drop Wiper arm bent
Wiper shoes worn
Heat wrong
Material mistake
Wiper Wipes window
ASSY smoothly Switch contacts worn Short circuits
Does not move Battery voltage drop Electric wire broken Damaged wire insulation
Coupling screw slack
Problems → ↑ Othee failures might fave ↑ These are failures ↑ These are failure ↑ These belong to the process
been overlooked. (wrong). modes (right). FMEA (wrong).
Note : The resulting topdown feature:
The failure mode concept consists of three kinds of defects as follows,
structural breakage,
dysfunction, and
manufacturing defective.
Thus right understanding of the failure mode escapes to a distance.
Some failures leak from the enumeration at the start of FMEA. And the road to the failure modes branches and will result
in overlooking of failure modes.
Objection Theories
D. H. Stamatis. P.74:
Failure : The inability of the system to perform based on the design intent. Examples of failures are Broken, Worn, Noise, and Rust.
Failure mode : This is the physical description of the manner in which a failure occurs. Examples of failure modes include the following: Broken,
Grounded, Corroded, and Leak.
Commentary:
Any of "Broken, Worn, and Rust" cannot be a failure, because they are not "the inability of the system." This is one of the
typical theories which take the topdown approach, and evidences of confused concept of failure mode are clearly uncovered.
For example, "Broken" belongs to both of failure and failure mode. This is the proof of theory collapse. The boxed comments
shown below the table with arrows are the correct understanding.
Robin E. McDermott p.45 :

Examples of filure modes of a product (Fire extinguisher) are shown, and we have pointed out some mistakes of alignification.
Component and function Failure Mode Correct alignification

Cracks ○ Failure mode
Hose ; Pin holes × Manufacturing defective
delivers extinguishing agent
Blockages ○ Failure mode
Canister ; Paint coverage uneven × Manufacturing defective
resrvoir for extinguishing agent Label not properly applied × Manufacturing defective
Charge gauge ; Inaccurate reading × Failure
determin remaining volume of agent Broken crystal ○ Failure mode
Valve mechanism ; Safety pin missing ○ Failure mode
release agent Handle jams × Failure
Commentary:
Commentary:
A wrong product FMEA worksheet case is shown above. Some wrong words are listed in the column of "Failure mode". And
the correct concepts are shown by us at the right end column.
Look at the left edge column. The word hose and the function are listed there. The function is to supply extinguishant. How
can this function be spoiled? Yes, the cracks, the pinholes and the blockage can spoil the function of the hose.If you take this
way of approach, however, other important failure modes can be overlooked. For example, comingoff of the hose from the
connector can be another failure mode.
Furthermore, those pinholes are production defectives. Because they are not matters caused by the use of the product, they
are not failure modes.
Because beginners are instructed to conduct the traditional FMEA by their leader, they tend to conduct a topdown FMEA.
They are not grown up enough to consider things independently, and are easily affected by the people around. They are
familiar with the traditional FMEA, and repeat errors without hesitation or doubt.
524 Manufacturing Defectives

The manufacturing defectives including assembling defectives are one of the results derived from the process design or the
workshop management, and cannot be failure modes for the three reasons shown below.
1. Products must Conform to the Design
A product FMEA checks a performance of a product design in the aspect of reliability and hence the product under the
evaluation of an FMEA is limited to one that conforms to the design. And nobody designs manufacturing defectives. In
other words, a manufacturing defective cannot be a failure mode.
2. Failure Modes Are Caused by the Use
Manufacturing defectives are produced prior to use, in contrast to failure modes.
3. The Role Outside of Product FMEA
Limitlessly enormous numerical potential failure modes can be enumerated if manufacturing defectives belong to the
failure mode concept of a product. And FMEA comes to a deadlock.

"Failures are not limited to problems with the product. Because failures also can occur when the user makes a mistake, those types of failures
should also be included in the FMEA."
Commentary:
This is explanation in the sections of product FMEA and this explanation is based on a wrong theory. The mistake of the user
must be handled in use process FMEA not product FMEA. This book does not seem to understand it.
Designer's Duty
Accidents caused by incorrect use or maintenance can not always be prevented without an FMEA of the customer's
instruction manual. The designer of the final product must design a customer's instruction manual and should carry out its
FMEA further.
Case of Finger Cut Accident by Shredder

The product of shredder has to be safe even if a small child inserts a finger. A warning label to put on the product is
insufficient as means of prevention. It is necessary to determine whether means of the accident prevention is enough by
carrying out FMEA.
Examples of Measures
Some concrete plans over the accident of such a product shredder can be devised easily.
1. A couple of parallel switch buttons to be held down at the same time,
2. The narrow loading slot which inserts the paper to discard into,
3. Structure where its finger which a small child inserts does not reach a cutter,
4. One leg is attached to the bottom of a product shredder in order to protect from being put on the floor. On the other
hand, the attachment for fixing it to a desk is attached.
In conclusion, to attend to the measures as above, a design should be considered about use and maintenance. And an FMEA
about use and maintenance should be performed to judge the degree of insufficiency of measures.
53 Process FMEA

Failure Modes of a Proces
Failure modes of a process correspond to a breaches of each process specification. All specifications of the fiveM resources
are defined at the stage of process design and are realized at the stage of setting and running of the process. And all fiveM
requirements have to be maintained faithfully for the process to work properly and meet all output requirements about quality,
delivery, cost, safety, and environment.
For example, a wrong torque setting of an electric screwdriver is a failure mode if it is a violation of process design (i.e., QC
process table). The outcome of the manufacturing defective shows that a failure is taking place in the process. And this defect
may lead to the next effect that is more serious.
Dysfunction of Equipment
When a machine using in a certain process broke down, is it a failure mode of the processes? It is not a failure mode, but a
failure of the process, because process does not work properly. Then, what is the failure mode in this case?
Equipment Maintenance Process

Equipment should be maintained in accordance with maintenance plans, in which requirements are defined in detail.
Breaches of instructions of the maintenance plan is called failure modes. When a failure arises without violation of
maintenance plan directions, failure mode does not exist. In this case, the omission in regulation of instructions exists in the
maintenance plan.
In the case of 5M alignification, the facilities maintenance belongs to "Machne".However, the facilities maintenance can make
a alignification independent of preparations for use. In that case, the alignification becomes six, and the name of 5M is
exchanged for 6M.
Objection theories
Process
"Process FMEAs uncover process problems related to the manufacture of the product. For example, a piece of automated assembly equipment
may misfeed parts, resulting in products not being assembled correctly. Or, in a chemical manufacturing process, temperature and mixing time
could be sources of potential failures, resulting in an unusable product.
It is helpful when conducting a process FMEA to think in terms of the five elements of a process: people, material, equipment, methods, and
environment. With these five elements in mind, ask: How can process failure affect the product, processing efficiency, or safety?"
Commentary:
This is all of explanation of Mr. Robin E. McDermott about process FMEA. If he cannot describe process FMEA other than
this, it is thought that he has neither the understanding of process FMEA nor the experience. Such troubles may occur and
should be prevented. That is right, but the author of this book should learn process FMEA from the first step again.
The upper description has four basic mistakes.
(1) Any definite answers to the questions below are not found, even through whole of the book.
When a piece of automated assembly equipment may misfeed parts, it is a problem of product reliability.
It is when conducting a process design, not FMEA, to think in terms of the five elements of a process.
Any failure modes are not defined nor identified in the above mentions at all. What is failure mode of a process? What
will be the failure mode in the case that an automated assembly machine may misfeed parts and may result in products
not being assembled correctly? What is failure mode in case temperature and mixing time are the potential causes of
failure?
The five elements of a process are not "people, material, equipment, methods, and environment."
(2) Replace "Environment" with "Measurement"
Among the five elements, it is right to eliminate "Environment", because environment conditions should be controlled by use of
equipment. This belongs to the requirement of machines (or equipment). "Environment" should be taken into consideration as
an object of protection, and is one of the five process output characteristics. That is, the five result characteristics of a process
are quality, delivery (time and quantity), cost, safety, and environment.
On the other hand, "measurement" should participate the five elements of process condition, because it is an important
element meaning the information management. Measurement of,
requirements,
process conditions, and
outputs
are indispensable for management. For example, process conditions and process results should be measured for control. In
addition, the time of measurement, analysis of a measurement result, check, calibration of measuring apparatus, etc. are
included in this process element.
(3) Think of the Five Requiremenys When Designning
It should be thought in terms of five condition elements and output elements of a process at the time of a process design, and
it is not a time of carrying out process FMEA. The requirements of the following five elements should be decided at the time of
process design to meet requirements of the result.
Man: Requirements which those who take charge of processing should satisfy
Machine: Requirements which equipment, machines, tools, etc. which are used for processing should satisfy
Material: Requirements which what receives processing should satisfy
Method: Requirements about how to perform processing
Measurement: Requirements about: information gathering, measurement, record, and analysis required for execution of processing
On the other hand, the process FMEA is the stage where the designer evaluates the effect that may result from the breaches
of the five element requirements determined in the design stage.
D.H.Stamatis.p.75:
Level 1 Failure mode :
For a product FMEA: "Cannot generate pulse."
For a process FMEA: "Poor material feed."
Commentary:
This book misunderstands the meaning of failure mode basically.
"Cannot generate pulse" is not a failure mode but a failure (dysfunction).
The description of "Poor material feed" is vague.
The breach is failure mode when "poor material feed" occurs by a breach of a process instruction. However, the problem
which arises even when workers follow process instruction is a defect of the functional design of a process.

Introduction Step 2: Listing the Failure Modes
Chapter 3: FMEA Process Step 4: Listing Current Controls

Chapter 4: Who Executes an FMEA ? Step 5: Evaluating three Elements
Chapter 5: Product and Process Step 6: Calculating RI
Chapter 6: Seven Steps / Case Study Step 7: Optimization
Chapter 6. The Seven Steps / Case Study

Step 1. Preparation of Documents
611 In the Case of the Product FMEA
For an product FMEA, the product design documents such as below should be prepared.
Drawings,
Structured BOM (Parts List, P/L)
User's instruction manual, and
FMEA worksheet.
(1) Drawings
An example of assembly drawing shown below indicates the "introduction hose and gas range assembly", which is comprised
of a gas kitchen range set and such connection parts as the introduction hose and the hose band subassembly.
The number in the parentheses shows the necessary number of the part.
The introduction hose (1)
The hose connector (1)
The hose band (1)
The retaining screw (1)
(2) Structured BOM (or, P/L)

These parts are enumerated to a part list as shown below. Each part should be listed in the place indicating assembly or
component it belongs to.
(3) User's Manual

The manual for users is the document which listed a process of use and the maintenance of the product. It should be made
under the guidance of the designer of the end product, and hence the designer should also perform FMEAs of those
processes.
A Case of Panasonic's Recall

A breach of instruction about detergent by a user of the dishwasher made by Panasonic (Japan) caused generating of the
superfluous air bubbles which invaded the coil domain of the fan motor and caused a fire, 2020. Since the same accident
occurred several times, Panasonic began a free part exchange as measures of the accidents of the fire.
Necessity of Reconsideration of FMEA

Panasonic (Japan) realized the appropriate solutions in a short time with an outstanding technology. However, because it has
been responsible for similar incidents about many kinds of products, Panasonic's FMEA seems to have a problem.
(4) FMEA Worksheet for Product FMEA

A form of FMEA worksheet for the absolute evaluation method is shown next.
The Worksheet for the Product FMEA

( a:Severity, b:Occurrence, c:Detection, RI: Risk Index )
Article,
Line Interface Failure Mode (Breakage) Effect Mechanism Current Control (Grounds) a b c RI Action Added a b c RI
1
2
3
This form is simpler and more sophisticated compared with the traditional form shown bellow. The differences will be
explained in details in the Step 4 (current controls).
612 Reliability Design
Do not Depend on Correction

The reliability of a system like a product or process is defined as the property of being hard to fail in short. A product or
process must be designed so that failures do not happen by normal use under a certain scope of conditions. An FMEA must
be performed in order to ensure reliability in the design of every product or process by the designer.
The reliability should be evaluated to determine whether additional measures are necessary. Otherwise, products which have
low reliability may often be shipped, and a variety of process trouble may happen. And it becomes the tendency that
engineers perform temporary measures such as "BandAid" frequently.
Two Types of Failure Mode of a Product

The details of the reason are mentioned afterwards, but only two kinds of failure modes can exist for the product FMEA.
1. The failure mode which happens in a part in the form of physical or chemical change, for example, cracked, bent, rust,
worn, melted, etc.
2. The failure mode which happens in the form of physical or chemical change in a interface (connection) between parts or
part and its surrounding. For example, wet, dirt, separation, comingoff, blockage, slacked, etc.
Thus, the parts list and the drawings are important in carrying out a product FMEA.
Objection Theories
(Quoted format from Robin E. McDermott p.24)
Commentary:
This worksheet is accompanied by some serious difficulty in enforcement. The details are as follows.
Items Identified Criticism

Line It is the number of the line, and there is not the problem.
Component and Function The purpose of indicating a function is to draw failure from it. As a result, failures get mistaken as if failure
modes.
Potential Failure Mode Failures will be listed here by mistake.
Since it is original to carry out FMEA at
Potential Effect (s) of Failure This column has no problem. the time of a design, all are potential, and
hence, it is more desirable not to use the term
Severity Degree of lack of measure should be written here, not the "potential."
degree of severily. This is useful for the simplification of the
format of worksheet.
Potential Cause (s) of Failure This column has no problem.
Occurrence Degree of lack of measure should be written here, not the degree of probability or frequency.
Occurrence Degree of lack of measure should be written here, not the degree of probability or frequency.
Current Controls, Prevention These two columns should be combined. Moreover, since one measure may affect all the severity of
effect, frequency of occurrence and, difficulty of detection, all measures should be described in one column.
You should not rate degrees of severity of effect, frequency of occurrence, nor difficulty of detection.
Current Controls, Detection The objective of evaluation has to be measures (Current Control)and lack of measures should be evaluated.
Detection Degree of lack of measure should be written here, not the degree of dificulty or detection.
RPN The numerical value of RPN shows the size of a risk. However, since the success value of RPN is completely
unknown, it is unsuitable as an index.
Recommended Action
Since FMEA is a tool for a designer to rate his own design and add measures if necessary, the term
Responsibility and Target "recommendation" nor "responsibility" is not suitable.
Completion Date
613 In the Case of the Process FMEA
(1) Documents for Process FMEA

For the process FMEA, the process design documents such as below should be prepared.
The QC process table
Factor and effect diagram for prevention
Drawings and specifications of equipment
Maintenance plan of equipment
FMEA worksheet
The principle of the quality control that forms the base of these documents is explained next briefly. The explanation about the
contents of documents will be shown after that.
(2) The Principle of Process Management

A process is comprised of fiveM resources, namely, Man, Machine, Method, Material, and Measurement. And these
requirements about fiveM conditions should be designed to meet the predetermined output requirements.
The design of a process is constituted in a QCprocess table as follows.
1. The left half:
In order to fulfill the 5M resource conditions necessary to produce the prescribed results, provide the relevant
specification concretely and in detail. In other words, show how to use 5M resources, to control all of the quality, time
quantity, cost, safety, and environment.
2. The right half:
The following matters are specified on the righthalf of a QC process table about output quality concretely and in detail.
Identification,
Valuation basis,
The system of evaluation,
Record of evaluation result,
Creation of a graph,
Check of measurement implements,
Calibration of measuring equipment, and
Person in charge (or section),
Precaution.
The process design should take the form of QC process table. Moreover, in order to manage a process, maintain the 5M
conditions and output characteristics, and modify continuously for improvement or correction.
(3) Factor and Effect Diagram (for Prevention)

The specifications of process condition comprise two kinds of measures.
1. Positive Conditions:
5M details which surely realize the result with the intended characteristics are specified.
2. Negative Conditions:
You have to add the measure which prevents the negative characteristic like quality defects to the current controls of
each step of the process. For example, it is required to prevent cost rises, timefordelivery delay, injuries, and
environmental pollution besides quality problems.
The Factor and Effect Diagram (FED) should be created in order to prevent all the problems, and for that purpose, all the
factors related to undesirable results should be enumerated.
Notes
There are two types of diagrams that are similar to each other. and special attentions are necessary because purposes, methods of creation,
and methods of use are totally different from each other.
The Factor and Effect Diagram (FED)

This is used to enumerate the potential causes for the purpose of prevention. Since the troubles is not existing, related work process data
do not exist, too. Hence, you must create it in a topdown approach supposing all the troubles and factors which are likely to happen
based on knowledge and experience.
For all factors listed here, it is necessary to take measures accordingly. This makes it possible to design a fully functional process.
Cause and Effect Diagram (CED)

When a trouble occurs, this is created in order to enumerate the candidates suspected as causes in order to perform correction. Since it is
the correction purpose, the trouble is existing and related work process data also exist. Hence, you should creates in a bottomup
approach supposing the cause candidate based on data, using knowledge and experience.
The following diagram indicates that the FED is composed of the same structure as the process table QC.
(4) Outline of QC Process Table

A process design is created in the form of the QC process table comprising the following sections:
1. The section to list bibliographic data (general description),
2. The section of 5M specifications, which are described for the purpose of creating the prescribed outcome characteristics,
and,
3. The section to prescribe the results and describe how to confirm the results.
(5) A Case Study of the Process FMEA

Here is shown the outline of an assembly process of a medicine bottle with a certain fixed number of tablets in it. The screw
cap is assembled to a medicine bottle at a fixed torque at the step No.3.
The QC process table comprises two sections except the general description as follows.
(a) The Part of QC Process Table for Producing

The 5M requirements, the check matters and the record method are listed.
QC Process Table for Producing, Case study
No. Equipment Man Material Method Check Record
Cap tightenning machine (6) Time: A1, P1
(1) Spindle:60 RPM Oneday Fed from the last Shown Form:
step below Item: (1),(2),(3),(4),(5),(6), R41
(2) Torque: 5kgcm experience (7),(8)
(3) Lubricant:#23
(4) Put cushions to appointed places to prevent Method of work
3 acratch, dent Pick up work from preceding step
(5) Cleaning to prevent dirt Put work on tightenning machine, switch on
Confirm signal buzzar, and take out
Product Feeder Put work on feeder
(7) Wear gloves when touching product
Maintenance ST124 (8) Bring itemds falling to appointed box
(In this QC process table, only a function is designed and the reliability design is not carried out. Click here, in order to refer to the measure which
needs to be filled up for reliability.)
(b) The Part of QC Process Table for Confirming Results

A detailed description is described in the designated space, about each of below.
The requirements of the results,
The confirmation of the results, and the record,
The check and calibration of the inspection tools.
QC Process Table for Confirming Results, Case study
Spec./Limit Inspections Record Time QA Section
Number of samples : 5
Measure torque by hand torque wrench (10kgcm) Process capability chart A2, P2 0/18 (AOQL=2%)
Tightening torque 5±1 kgcm Plot data on process capability chart
Calibration Form : R5 W1 ←
Dirt,scratch,dent are not acceptable 0/18 (AOQL=2%), visual Form : R4 A2, P2 0/18 (AOQL=2%)
These two tables mentioned above are standardized into one oblong QC process table.
(c) Design of Reliability Is Suspended for the Present

The function of the process that contents vary with instructions violation easily is not maintained well. It is necessary to carry
out a reliability design so that the contents of the process are hard to change. Otherwise, workers may often commit an error
and the various makeshift measures may be frequently performed by engineers.
The designer must carry out FMEA to confirm whether the reliability design that oneself performed is appropriate. It goes
without saying that reliability must not be insufficient, but it is necessary to avoid an excessive reliability by an excessive cost.
However, the example of the process design without a reliability design is shown below for study. We transfer to FMEA prior
to improving reliability defects, which are corrected after performing this FMEA case study.
(d) FMEA Worksheet for Process FMEA

An FMEA worksheet should be created simultaneously with a QC process table by the process designer. The form of Process
FMEA worksheet for the absolute evaluation method is shown below. While the designer supplements the weak pointe of the
reliability through the FMEA evaluation, this worksheet helps to push forward the design.
The Worksheet for the Process FMEA

Step
Line Name No. Failure Mode (Violation) Effect Mechanism Current Control (Grounds) a b c RI Action Added a b c RI
1
2
3
Objection theories
Objection theories
Robin E. McDermott :
"For a process FMEA, the team should physically walk through the process exactly as the process flow." (p.25)
"The best way to create a flowchart is to walk through the process as if you were the thing being processed or created. The process steps
should be followed sequentially, and notes should be taken during the walkthrough." (p.55)
Commentary:
The Phisical "Walkthrough" Is Impossible

Since execution of a process FMEA and creation of a QC process table are performed before actually arranging a process,
following the steps of a process physically could not be performed.
What Is the Failure Mode for a Process?

Since 5M specifications of the process are not determined yet, listing of failure modes is completely impossible.
"If a print or flowchart is not available, the team will need to create one prior to starting the FMEA process."
Commentary:
There are three great mistakes in the upper description.
1. The Absence of Design Documents
It is an unbelievable story, but the above description says as follows. When the designer neglects indispensable design
documents, it is instructed that the FMEA team consisting of outsiders should create necessary documents in behalf of a
designer. But, the FMEA is to the designer what the ruler is to the carpenter. Since the designer pushes his work when
checking reliability by an FMEA as a carpenter works checking dimensions with a ruler, an FMEA team comprised of
outsiders must not try to create those documents or cannot create appropriate documents.
2. Appropriate Documents for Processes Design
"A print or flowchart" quoted from the upper description is not clear in content because any example is not shown in the
whole book. Because the QC process table or the fiveM process specifications are not touched at all, Mr. McDermott
does not seem to know the meaning of the process design.
3. Conventional Process Design without Document
When a virtual process without specific design documents has been generated in a longtime convention, the wrong
instruction may often be given that the FMEA team should prepare necessary documents. However, by following reason,
these should not be adopted.
Design consists of function design and reliability design.
Function Design
The designer must contrive means for the process to work as it should. Various function tests, simulations may be
implemented to for the confirmation of meeting function requirements. And if any negative outputs which are not
intended are considerable, measures appropriate for each trouble must be taken.
Reliability Design
The designer must contrive means for the process to prevent failure. Various reliability tests and strength calculations
are carried out to achieve the purpose. And the desin of reliability must be carried out simultaneously with the function
design, not separately. Mostly, conventional processes do not have sufficient reliability.
Copying a Process
Can you believe that an FMEA team can design the same contents only by an observation of an actual process?
Probably the person who can believe that will be only an amateur or a beginner. Even if an expert observes it, as for the
modern process that is complicated and full of high technique, it is considerably difficult to grasp precise contents.
S. Iida, p.88. (A Case of Medical FMEA)
An FMEA Worksheet for the Gauze Supply and Collection Process
(O; Occurrence, S; Severity, D; Detection)
Line Small alignification Unit Duties Failure Mode O Potential Effect S D RPN
1 Preparation Suply of gauze Not done Little effect
2 (The operation performer will point out) 1 1 2
2 Not done 2 Little effect
(After suture, body is checked by Xray) 2 1 4
Preparation Write down number of suplied
3 Wrong 2 Serious
(Abdominal pain and fever) 4 4 32
4 Operation Collected gauze Not done 2 Little effect
(Start collection) 1 2 4
5
Commentary:
Many hospitals have received wrong FMEA instruction and are performing FMEAs using based on the copy of field
operations.
The upper example of a model was quoted from Shuhei Iida.p.88. This is an FMEA case of abdominal surgery for preventing
the accident in which a piece of gauze is left behind to a patient's body. And two serious mistakes are pointed out.
Outline of Worksheet
Let's try the interpretation of the top three lines of the worksheet mentioned above. It seems to be based on the Fourpoint
Relative Evaluation Methods.
Line 1: The nurse's duty is to supply the opetation performer with peaces of gauze. Because the opetation performer
demands them even if it is forgotten, the effect is negligible. Hence;
Occurrence (2) × Severity (1) × Detection (1) = RPN (2)
Line 2: Duty is to write down the number of the supplied gauze. However, it is forgotten. Since record does not exist, there is
not other way than checking gauze by Xrays after suture. This method of detection is effective. Hence;
Line 3: Duty is to writing down the number of supplied gauze. Howefer the number is wrong. And when the number of the
collection accords with this wrong number, an accident happens. The stomachache and heat by the gauze remainder are
expected and the effect of the record mistake is serious. Hence;
Because similar work and evaluation continue, after that it is omitted, and we have the following questions.
1. Why Xrays Check Is Not Performed Always?
As shown in the line 2, if a good evaluation is provided by an examination through Xray, you should treat all cases
likewise.
2. Reliability Design Has Been Omitted
This medical process includes a serious problem. As long as this procedure is seen, only functional design fas been is
performed and the desin of reliabilityis has not been performed at all. It is clear because the identification columns dof
"Current Controls" is not found in the top of the worksheet. This fact shows that it is necessary to learn a process design
from a beginning again before describing FMEA.
Recommendation for Process Design and FMEA:

The leader of the medical process FMEA should study how to design a process, prior to starting FMEA execution. According
to the importance of work, you have to design a process to be hard to generate a human error. Do not think that a poor
process design can have sufficient reliability by enforcement of Process FMEA. The duty of FMEA only is the evaluation of
reliability and FMEA does not have the power of changing the framework of a process design.
The Example of a Model Process design

The gauze delivery and collection process should be designed as follows.
In the case of this design,
the record,
count of the number of the collection,
the record, and
confirmation of the agreement between records
become all needless, and there becomes little possibility that the mistake happens. It is right to do an evaluation by FMEA
after having done such a reliable design.
Contents
Introduction
Step 2: Listing Failure Modes
Chapter 6. Seven Steps / Case Study

Step 2. Listing Failure Modes
621 Definition of Failure Mode
Manners in which a product or process can fail are called failure modes, however, you should identify them in the bottomup
way, on account of the reason shown below.
1. According to the bottomup method, failure modes are easily extracted from a product design or process specifications.
As for a product, breakages of parts or interfaces are the failure modes, and as for a process, breaches of process
instruction are the failure modes. Moreover, it is very rare to overlook those failure modes which are defined as above.
2. The purpose of the FMEA is to look for all failures and disasters. Among those failures and disasters,some are unknown.
Hence, failures cannot be the starting points of an FMEA. The unknown failures and disasters are identified as the result
of searching from failure modes as the starting points.
Otherwise (if a topdown approach is chosen), the following defects will appear as serious problems.
1. Failure Mode Concept will Be Confused

It becomes impossible to distinguish a trouble mode from failure, and FMEA comes to a deadlock.
2. Overlooking will Increase
When the number of people in the company begins with the president and is counted, the numbers of people to belong
to each hierarchy as rank falls down to directors, managers, section managers, employees increase. As above, the
progress to the direction where numbers increase is called topdown approach.
When topdown is adopted for the activity that all matters belonging to a certain range are enumerated, it is easy to
produce enumeration omission. Hence, on the occasion of the enumeration of failures and tfailure modes, the topdown
approach must not be adopted.
622 Failure Mode of Product
Expert Designers Easily Find All Failure Modes

The designer of a product can imagine easily through an appropriate effort all future changes that may happen to the
components which oneself have adopted. For example, if screws, shafts, bearings, electric wire coils, keys, gears, boards,
wire connectors or others are designed or adopted in the design, the designer in charge knows what kinds of change those
components may catch in the future in detail.
Amateurs (Novices)
Amateurs (Novices)
The designer who does not know all of these is not a fullfledged designer. Novices confuse failures and failure modes, and
cannot point out failure modes easily. They tend to demand performing the brainstorming to make up for the ability lack.
However, brainstorming only induces the custom of guessing things without a basis. Furthermore, even by performing
brainstorming. beginners cannot do the same work as professional engineers.
It should be prohibited that outsiders or novices of design hold a brainstorming meeting and that they enumerate a large
number of groundless failure modes. Amateurs easily miss important targets of failure modes by firing rifles blindly.
Starting Points
The failure mode in a product is defined as the breakage of a component (part or interface) that is the smallest unit of a
product.
Examples of Product Failure Mode

Part Breakage: Interface Breakage:
Crack, Comingoff, or peeling off (of an assembled or adhered part),
Broken (wires, shafts, screws, pins), Blockage (in a pipe or under a brake pedal),
Fusion (of metal parts, rubber parts), Pulled up (of a plug, a nock pin, or a clamp),
Corrosion, Slack (of a screw, a rivet, or a clamping),
Abrasion, worn (sliding parts, brake shoes), Adhesion (of liquid, or dirt),
Transformation, Pressure change (inside or outside),
Deterioration (of material), and so on. Getting with water, and so on.
Listing Failure Modes The Case Study of the Product FMEA

Line Article or Failure Mode (Breakage) Effect Mechanism Current Control a b c RI Action a b c RI
Interface (Grounds) Added
1 Introduction
hose Cracks
2 Retainer screw Slack
3 Ruswt
Hose band Introduction hose coming
4 Cracks
off
Rust,
5 Hose
connector Collapse of
shape
623 Failure Mode of Process FMEA

Starting Point to Failures
Failure modes of a process are defined as a breachs of instructions that are the smallest units to constitute a process, and
they are the starting points of approach to failures.
No Failure Mode without Violation

There are important cautions. The work error in the process does not correspond to a trouble mode unless it violates the
instructions of the process design (i.e., the QC progress table).
For example, an operator may begin a work without turning on the switch of the machine and this may cause a trouble.
However, unless the right action is shown in the written procedure, the operator's action is not a failure mode since there is
not a breach. And this problem is not associated with the FMEA at all. It is a problem of a poor functional design of the
process.
On November 05, 2008, Central Japan International Airport was making a great uproar. The security inspector realizes that he
was inspecting the passengers without turning on the power switch of security inspection equipment. All the passengers of the
airplanes before a takeoff were taken down, and the additional inspections were carried out in a great hurry.
The security inspection is conducted in order to prevent passengers carrying dangerous objects into the airplane. In this case,
the functional design of the process was perfect. However, since there was no reliability design, violation arose easily.
The inspector had been directed under the rule as follows. Before he begined the security inspection, he had to perform a test
of the metal detection performance. However, neither the reliability design nor an FMEA had not been performed. Directions
had been able to be broken even if specified by a rule. Furthermore, there had been also no mechanism in which generating
of a breach of the rules was displayed.
Expressing this state of reliability in terms of FMEA, the following measures are insufficient:
measures to ease the severity of the effect of the failure,
measures to reduce the frequency of failure, and
measures to improve probability or necessity of detecting the failure mode.
The entrance of conveyer should not be able to open before the metal detection examination is finished. The fact that even an
extremely easy foolproof system which prevents start of the conveyer unless the power supply is turned on is not provided
with reveals the fact that FMEA has not been carried out.
Case Study of Process FMEA

The failure modes of the case study process are shown below.
Listing Failure Modes The Case study of the Process FMEA

Line Step No. Failure Mode (Violation) Effect Mechanism Current Control (Grounds) a b c RI Action Added a b c RI
Name
1 Change of 60 rpm
2 Breach of 5 kgcm
3 Step 3
Cap twisting Wrong oil
4 Using up oil
5 Omitting work
Objection Theories
"Once everyone on the team has understood the process (or product), team members can begin thinking about potential failure modes that
could affect the manufacturing process or the product quality.
A brainstorming session will get all of those ideas out on the table. Team members should come to the brainstorming meeting with a list of their
ideas. In addition to the ideas members bring to the meeting, others will be generated as a result of the synergy of the group process."
Commentary:
This description is the same as the contents which not only this book but also many other researchers describe. However, it
contains three errors.
1. Impossible without QC Process Table

This description is about an execution of FMEA under the conditions without creation of a process design document, i.e.,
QC prcess table. The members who are outsiders of the process design are unable to understand the process design,
and it comes to be in overlooking the great portion of the failure modes.
2. Brainstorming Is Unsuitable
Brainstorming may be useful as a method of producing a completely new novel idea, when all possible ideas are
examined and it does not succeed. It is a method for conceiving freely without being restrained by the established
concept, and inducing a novel idea.
On the other hand, any criticism is forbidden to others' idea and creation of another idea which uses others' idea is
recommended. Since the idea created there does not need to be useful, brainstorming is liked by the incompetent.
However, it will be very rare to obtain useful fruit probably. The procedure of creating an idea carefully by FMEA later
without considering good ideas sufficiently in the stage of a process design is an entire error.
Delay of Duties
3. Delay of Duties
It may take several months for the FMEA to understand the design of a process or product in detail, even if the team
members stop their own original duties. The complex duties like designing contain few things which outsiders can easily
understand even if the outsiders are researchers of each special field.
Since the time limit of the design comes before FMEA team reaches a conclusion, the remarkable time delay arises as a
serious problem.
D.H. Stamatis. p.166:

"For each process function identified you must list the corresponding failure of the function. There can be more than one failure from one
function. To help identify the potential failure mode one may think of the negative or loss of the function.(1)"
Examples include(2)
No pressure
Fails to open
Cannot control speed
Part leaking
Hole is not round (eccentric)
Broken
Part undersized, oversized, porous, damaged
Another way to identify the failure mode anticipated is by asking the following questions (partial list).(3)
How could this process fail to complete its intended function?
Why could this part be rejected at this operation?
What does the customer find unacceptable?
How would the part not conform to specifications at this operation?"
Commentary:
This description is entirely wrong because:
1. According to the abovementioned way, failures are derived from functions, and the failure modes are derived in turn from the failure. And
"there can be more than one failure from one function" mean the tendency that some failufres may be overlooked. However, the main
purpose of FMEA is to anticipate enexpected failures and disasters. Hnece, if you start an FMEA with enumerating functions or failures,
unexpected trouble hide behind and these lead to big disasters.
Correctly, failures have to be derived from failure modes listed beforehand in the bottomup way.
2. Examples include function troubles and structural breakages, and these can be failures, manufacturing defectives, structural breakages.
Thus concepts are confused.
3. Those questions should be asked at the time of designing process. If such a thing is taken into consideration in this stage (after a design),
you have to reply to the question what to take into consideration at the time of a design. A design is a bunch of measures for trouble
solutions.
Because there can be more than one answer to each question, overlooking occurs easily. This is the defect peculiar to the topdown
approach, and hence FMEA should adopt the bottomup approach.
Robin E. McDermott: p.44: (A portion of the worksheet has been quoted.)

Product FMEA of a Fire Extinguisher
Line Conponent and Function Potential Failure ( Our opininons ) Potential Effect(s) of Failure Severily
Mode
1 Hose; Delivers extinguishing agent Cracks ( ○ Failure mode ) Misfire 10
2 ↓ Pinholes ( Χ Manufacuring defective Low discharge pressure 8
)
3 ↓ Blockages ( ○ Failure mode ) No discharge 10
Canister: reservoir for extinguishing
4 agent Paint coverage uneven ( Χ Manufacuring defective Bare spots rust weakening 10
) metal; possible explosion

9 Charge gauge;determine
remaining volume of agent Inacurate reading ( ΧFailure ) Overfill if gauge reads low;
underfill if gauge reads high 10
10 ↓ Broken crystal ( ○Failure mode) Injury to user from cut glass 8
(The indications in the parenthesis are our opinions.)
Commentary:
Looking at the description column of "Potential Failure Modes", it is understood that there is a mixture of failure mode, failure,
and manufacturing defective. Naturally, things other than a failure mode must not be described here.
Manufacturing defectives should be treated in a process FMEA, not in a product FMEA.
Each failures should be listed as an effect of a failure mode.

Introduction Step 2: Listing Failure Modes
Chapter 3: FMEA Process Step 5: Evaluating three Element
Chapter 4: Who Executes an FMEA ? Step 6: Calculating RI
Chapter 5: Product and Process Step 7: Optimization

Step 3. Listing Effects and Factors
631 Introduction
In this third step, a potential effect of failure modes is listed in each appointed column.
First think about a failure mode as a starting point,
second extract its effects harmful to some degree, and
third, extract all of its factors (potential causes).
632 Case Study of Product

(1) The Product FMEA
The worksheet for the product FMEA with descriptions of effects and their factors (mechanisms) in it is shown below.
Listing Failure Modes The Case Study of the Product FMEA

Line Article or
Interface Failure Mode (Breakage) Effect Mechanism Current Control a b c RI Action a b c RI
(Grounds) Added
1 Introduction
hose Cracks Gradual gas
leakage Aging
2 Retainer
screw Slack Collision with cooking
devices
3 Hose band Ruswt
4 Cracks Introduction hose Sudden gas Spilling salty broth
comingoff leakage
Rust,
5 Hose
connector Collapse of Child's mischief
shape
Line 1:
Some cracks are generated and raised by aging in an introduction hose, and fuel gas comes to leak from there gradually.
Line 2 to 4:
The introduction hose may come off from the hose connector sometime after all. And the fuel gas comes to blow suddenly.
Failure modes are put between failures and causes in order to serve to narrow a distance between a failure and causes, and
hence these three are usually listed at the same time.
As shown above, the intervals between (1), (2), (3), (4) and (5) are very short. However, that between (1) and (5) is very long.
This is actually the very important role of the failure mode concept. If the role of failure mode is understood, it becomes clear
that neither a failure nor a production defective belongs to the failure mode concept.
Factor and Effect Diagram

When there are various factors, it is useful to create a Factor and Effect Diagram (FED) about every effect in order to prevent
overlooking of factors.
(2) Process FMEA

The process FMEA worksheet in which a descriptions fills in the space of "effect and cause" column is shown below.
Listing Failure Modes The Case study of the Process FMEA

Line Step
Name
No. Failure Mode (Violation) Effect Mechanism Current Control (Grounds) a b c RI Action Added a b c RI
1 Breach of 60 rpm
2 Breach of 5 kgcm
3 Step 3
Cap twisting Wrong oil Slack of screw cap Human error
4 Using up oil
5 Omitting work
Line 1 to 5:
All the failure modes are brought about by the same factor of a human error, and bring about the same effect called slack of a
screw cap. In fact, not only the case where the tightening is loose but when too tight, it should be taken into consideration, but
it has been simplified on account of space.
633 Meaning of Effect

Issues in this step are as follows.
What is an effect?
What is a factor (potential cause)?
(1) Difinition of Effects

The disadvantageous result which stakeholders including customers receive is called Effect in FMEA terms.
The disadvantage that customers receive includes not only the actual harm but also the potential harm that may cause
the real harm in the future. Hence, what we call Effect includes potential Effect. For example, "the slack (it is a simple
failure mode or a production defective itself and is not a actual harm) of the screw cap" of the bottle with the cold
medicine tablets in it is considered to be an Effect in a sense. This is because the slack is connected with deterioration
of the commodity value of the tablet by humidity or it comes to be alike of huge economical damage by rumor depending
on the case. In other words, the result that evaluation of a loss is possible may be an effect.
The effect can be divided into the first effect that is slight and the final effect that is serious. Sometimes, the first effect is
detected and the final effect is avoided.
For some of the failure modes there may be only one effect, while for others there may be several effects.
(2) Multiple Effects

(2) Multiple Effects

When there are several independent effects that are not suitable to be described in the same space for a failure mode, they
are divided into separate mention spaces of the worksheet if given different measures. For example, the abrasion of a bearing
in a instrument will lead to following effects.
A decline of the precision of the instrument.
Shortening of the life.
Outbreak of the noise.
If same measures are given to these failure modes, the measures can be described in the united explanation space.
Supposing these failure modes are given separate measures respectively, the measures are indicated to a separate space
respectively.
(3) Tandem Chain

When the tandem chain continues so that failure mode A may generate another failure mode B and B may generate another
failure mode C, and so on, where is the boundary of failures mode and effects?
The example of the electric washing machine is shown below. This chain seems to show many effects, but, in fact, the chain
of the failure mode merely exists towards one final effect. Of these, only changes to occur in parts and interfaces of the
product are the failure modes.
Factor (A) : Aging of the water tank gasket,
(B) : Gasket cracks,
(C) : Leakage of liquid detergent (C is not a failure mode, but a function trouble),
(D) : A drop of detergent attachment to the motor wires,
Tandem chain of failure modes (E) : Penetration from cracks of electric wire covering,
(F) : Adhering to core wires,
(G) : Penetration inside the wire by capillary action,
(H) : Corrosion of the electric wire,
( I ) : Breakage of electric wires by vibration.
(J) : Outbreak of the sparks by the vibration, which is the initial effect.
(K) : Heat generation by the spark,
Effect (L) : Melting of the coating,
(M) : Generation of flammable vapors,
(N) : Ignition by the apark,
(O) : Generation of a fire, which is the final effedct.
Where to take measures

This pursuit ends at the stage where it becomes able to evaluate the potential worst effect. In this example case, evaluation of
effect is terminated when some detergent liquid reaches an electric component area where the potential worst effect can be
anticipated. And measures should be taken for the failure mode not to reach B or at the latest D.
Determine the effect

When a certain failure mode x leads to its worst effect y, y is an effect if it is a function trouble or a disaster which is worth
evaluating. If y is not worth evaluaing, it is one of the trival failure modes and can be neglected. When many failure modes are
derived in a queue, this is called a chainreaction (a billiardsphenomenon, in Japan) of failure modes.
634 Meaning of Factor
In the field of management technology, when a phenomenon may cause a specific result, it is called a potential cause or a
factor of the specific result or effect. More than two factors can coexist about one effect.
However, factos and result have to have the quality to be controled by a company. Neither a natural phenomenon nor a social
phenomenon cannot be a factor of a specific result, if it cannot be controled by a company.
635 Concept of Cause
When a certain potential result is realized by one of the potential causes, only this cause is identified as a true cause. Other
potential causes are still potential.
(1) A Big Disaster in Japan

(1) A Big Disaster in Japan

On March 11, 2011, a big earthquake and tsunami occurred in East Japan, and it attacked the Fukushima Japan Nuclea
Power Plant of TEPCO (Tokyo Electric Power Co.). After the automatic stop of the nuclear reaction, as an unexpected
accident, the electric power supply necessary for cooling the fuel stopped entirely and hydrogen generation and explosion
happened. This explosion began to blow a large quantity of radioactivity and caused a serious social problem.
It was well known among geologists since ancient days that a major earthquake and huge tsunami as big as those of this time
attack this district every 1,000 years. And a geologist clarified after the construction of the nuclear power plant, the fact that a
tsunami of more than 10 meters above sea level was generated about 1,200 years ago, in an investigation done 10 years
before the tsunami day.
Was the earthquake or the tsunami a cause of the disasters? The answer may changes by how an answering person was
concerned with this problem. Geologists may answer that the tsunami was the cause, however from the viewpoint of
management, it is not correct.
1. It was a ridiculous story, but Nuclear Safety Commission of Japan (NSCJ) announced since before the construction of
the nulear power plant that risk management should be performed by each electric co. independently and NSCJ could
not decide what to do.
2. TEPCO built the nuclear power plant so as to endure a tsunami up to 5 meters in height saying that this height was
decided in consideration of the recordhigh tsunami in this district having margin.
TEPCO itself had predicted a tsunami of over 10 meters in height by computer simulations three years before this
earthquake, but did not report either to NSCJ nor to the nation, for the reason that it was an uncertain fact.
3. The media reported an abovementioned fact after the disaster, but hardly reported anything before the disaster.
In consideration of the abovementioned situation, will it be proper to think that still it is caused by an earthquake? All that
matters here is not a physical factor. From the viewpoint of management, the cause of collapse of a nuclear power plant is as
follows.
1. Negligence of NSCJ,
2. Negligence of TEPCO, and
3. Negligence of media.
The major earthquake and the tsunami are natural phenomena without the measures to prevent and should not be
understood as a cause in the field of the management technology.
If it is judged that the cause of collapse of the nuclear power plant is the tsunami, the cause of it is the earthquake, and the
cause of it is the continental drift, and the cause of it is the convection inside the earth, and the cause of it is the astronomical
collision at the time of the earth generation, and it continues in a similar manner hereafter. We will enter deeply the world of
geophysics and astronomy unrelated to management.
Human Errors Are Inevitable

About a problem caused by an operator's error in a process, the way of thinking mentioned above is important. When an error
occurs because you do not carry it out enough though measures are relatively easy, the neglect of the measures is the cause
of the error. This is because it is wellknown that anyone commits errors.
(2) An Example of Educational Issue

In 2006, finger cutting accidents of children with the shredders occurred in succession in Japan. What the cause of this kind of
accident was is the problem. A teacher of a certain elementary school thinks that the main cause of the accident was to be
inferior in the discipline of the parents to children. This teacher considers it to be a problem of the education responsibility,
rather than a problem of the product security.
Neglect of Measures Was the Cause

From the standpoint of product safety, the accidents were caused by the fact that any of well known easy measures had not
been carried out in the designs of shredders. Because the measures need cost, it is not proper to require measures
unconditionally. A prevented disaster should be compared with the cost for measures, and it is necessary to determine how
much price hike consumers expect the safety measures in exchange for.
A legal standard or regulation is desirable in this connection.
(3) A Case of a Subway Derailment

On March 8, 2000, a derailment of a subway in Tokyo occurred at a sharp curve near a station. It was the derailment of the
type that a flange of a wheel raised its body on the rail when going slowly at a sharp curve. It had been known that this type of
derailment is relatively easy to occur when the jet of the lubricant to the flange doesn't go well.
What was the Cause in Management?

In this case, was the low speed one of the causes of the derailment? If it was so, the measures to prevent it must have been
carried out. However, such a way of thinking is impractical. The low speed was doubtless one of the causes of the derailment
from the viewpoint of physics. However the causes should be considered from the viewpoint of management, because the
place of derailment was very close to the station and the low speed was inevitable.
Contents
Introduction

Step 4. Listing Current Controls
641 Meaning and Purpose
About an FMEA worksheet for a kitchen gas range shown below for example, what is the meaning and purpose of Current
Controls ?
Let's evaluate the failure mode of this example, to answer the abovementioned questions. The next evaluation standard for
rating of the current controls is applied to the "severity" of effect. The score indicates the necessity of additional measures to
the current controls about the severity of this effect. The measures provided in the current design control are as shown in the
table below.
General Evaluatuon Criteria
Score Dedree of Control
4 Insufficient very much
3 Insufficienth
2 Approximately enough (the best)
1 Perfect
A problem for beginners is shown below.
Which score from 1 to 4 is appropriate in each of spaces x and y shown below?

Line Article or Failure Mode Effect Mechanism Current Control a b c RI Action a b c RI
Interface (Breakage) (Grounds) Added
Introduction
1 hose Cracks Gradual gas Aging x y
leakage
hose leakage
About Severity, a large majority answers that it is x=3 for the following reason. Since a gas leak is inevitable after prolonged
use, it is not x=2. But since aging of the current high quality hose is slow, it is not x=4, either. Also about Occurrence, a large
majority shows the similar reason and answers that it is y=3.
They do not pay attention to explanation space of the Current Controls being a blank. It is evidence of not understanding the
object of the evaluation. The problem above is asking which score is appropriate to be given to the current controls of the
severity and occurrence. It is the insufficiency (or necessity) of measures to ease the severity of the effect in this problem
case. However, the evaluation is impossible because the description place for current controls is blank, and object of
evaluation does not exist.
The absence of the current controls means that of the reliability design. If measures are unnecessary, it means no harmful
effect are produced and the failure mode should be eliminated from the worksheet.
642 Process of Reliability Design

An expert designer performs a design of function and reliability simultaneously, so that both go successfully. In the product
design, a variety of means are planned like strength calculations, testing with prototypes, computer simulations, and durability
tests to ensure the reliability.
As for the process design, various measures are taken like an foolproof system, a failsafe system, an autoalert, a color
marking, fixation of setting, automatic inspection equipment, prototype production, pilot production, and so on.
When such preventive actions are planned for the reliability before the design, these measures are called Current Controls.
643 Case Study of Product FMEA

Line 1:
Annual inspection of the introduction hose was adopted as the measure against cracks due to aging.
Listing Current Controls of the Product FMEA

Line Article or
Interface Failure Mode (Breakage) Effect Mechanism Current Control
(Grounds) a b c RI Action a b c RI
Added
1 Introduction
leakage Aging
2 Retainer
screw Slack Collision with cooking Annual check
devices
3 Hose band Ruswt Stainless steel cover
4 Cracks Introduction hose Sudden gas Spilling salty broth
comingoff leakage
Rust,
5 Hose
shape
↑ These measures should be listed during the stage of
the reliability design.
Line 2 to 5:
Annual inspection of these failure modes was planned. In addition, child mischief was thought about depending on home and,
in consideration of the seriousness of the result, it was decided to use the cover made of stainless steel to cover up the whole.
As a result, the introduction hose of line 1 also was covered together.
644 Case Study of Tablet Bottle Cap

Line 1:
The gearshift lever of the twisting machine was planned to be fixed by means of screws or a knock pin not to move and the
speed arrangement of 60 rpm will never change. This failure mode may occur, for example, when a worker temporarily
changes the selector position for the cleaning of the machine and forgets to be returned carelessly afterwards, or when
somebody may touch the lever for some purpose.
Line 2:
Line 2:
This failure mode may occur mostly in cleaning or repair mending of the machine. The setting of the torque was planned to be
fixed by means of screws or a knock pin.
Listing Current Controls of the Process FMEA

Line Step
Name
No. Failure Mode
(Violation) Effect Mechanism Current Control (Grounds) Action
a b c RI Added a b c RI
1 Breach of 60 rpm
Fixation of the gearshift lever
2 Breach of 5 kgcm
3 Step 3
Cap Wrong oil Slack of screw Human Color marking
4 twisting Using up oil cap error Automatic oil dropper
5 Omitting work Feeder starts with the processing
completion signal
↑ These measures should be listed before rating a, b, or c.
Line 3:
The color identification method was planned in order to prevent use of wrong lubricating oil. The cans, oilers, oilcups, and
nipples of oil of the same grade were planed to be painted in the same color, and were mutually distinguished using the colors
of the traffic light.
Line 4:
In order to prevent exhausting oil, attachment of an automatic oil dripper was planned.
Line 5:
In order to prevent the accident that the worker does not tighten the screws to the end, it was planned to install an errorproof
system into the feeder, which catches the signal that is emitted when the screw cap is tightened to the end, and starts sending
the product to the next step automatically.
Memorandum for Correction

Elementally, these measures should have been planned at the step of the reliability design. In the case that these measures
are added as a result of the design review, however, these correction plans are temporarily written briefly on a copy of the QC
process table in red for a memorandum as shown in the examples below with the mark "✽", and then concrete measures
such as equipment improvements are implemented and finally the QC process table should be corrected appropriately.
QC Process Table for Producing, Case study
No. Equipment Man Material Method Check Record
Cap tightenning machine (6) Time: A1, P1
(1) Spindle:60 RPM Oneday Fed from the last Shown Form:
(2) Torque: 5kgcm step below Item: (1),(2),(3),(4),(5),(6), R41
(3) Lubricant:#23 experience (7),(8)
(4) Put cushions to appointed places to prevent Method of work
acratch, dent
3 (5) Cleaning to prevent dirt Pick up work from preceding step
* Gear shift levewr to be fixed Put work on tightenning machine, switch on
* Lubricant auto-drippig Confirm signal buzzar, and take out
* Unification and color marking about oil Put work on feeder
Product Feeder (7) Wear gloves when touching product
* Erro-proofing against omission (8) Bring itemds falling to appointed box
Maintenance ST124
Click here to refer to the original QC process table.
645 Purpose of Describing Current Controls
(1) Object of Evaluation

The FMEA involves evaluating insufficiency of measures against each failure mode in terms of severity of effect, frequency of
occurrence and difficulty of detection. Most of the researchers and university teachers lecture that it is necessary to evaluate
the severity of effect, the frequency of occurrence, and the difficulty of detection, not to evaluate the degree of necessity of
additional measures for these.
That lecture, however, has the error which a person of a slight work experience is apt to fall into. Do not evaluate the severity
of effect, the frequency of occurrence and the difficulty of detection, without consideration of the Current Controls. The objects
of evaluation is the degree of Current Controls against those. The problem is related whether Current Controls are enough.
(2) How to Decide Current Controls

As for a reliability design of a product, measures should be taken so that :
each failure mode (either physical breakages or chemical changes) can hardly occur,
the severity of the effect of each failure mode is eased should it occur, or
each failure mode can easily be detected should it occur.
As for a reliability design of a process, measures should be taken so that :
each failure mode (breach of instruction) can hardly occur,
the severity of the effect of each failure mode is eased should it occur, or
the effect, the failure mode or the potential cause, according to the situation, can easily be detected should it occur.
In most cases, one measure can be effective to any of three elements, that is, severity of effect, frequency of occurrence, and
probability of detection. For example, an errorproof device prevents errors, and this contributes to improve all of the three
elements.
(3) Number of Column for Current Controls

Description space for current controls may seem to be necessary to Severity, Occurrence and Detection respectively. There
are some researchers who insist that blanks of "Current Controls" for "Severity" are not necessary. As a reason, they seems
to think that Severity of the effect of a certain failure mode is decided, and is not influenced by the measure.
However, this is an error by the people who have not acquired enough experience. By the abovementioned reason, one
description space is enough. Failsafe technique exists to reduce influence even if a failure mode rises. An example of the
worksheet based on this wrong theory is shown below.
(Quated from Robin E. McDermott.p.44)
Well experienced engineers will probably think as follows:
If a check of gas hose is carried out once a year, cracks of the hose do not grow so as to cause the gas leakage of a
dangerous level. However, if left unattended for many years the cracks invite a severe result.
Measures for Severity called the failsafe system are used well for the purpose of relaxing Effect. For example, a helmet,
the grinder cover, a fuse, a breaker, many examples including the guide fence of the expressway, etc. can be
enumerated.
Objection Theories
"The severity ranking is an estimation of how serious the effects would be if a given failure did occur. In some cases it is clear, because of past 61/78
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"The severity ranking is an estimation of how serious the effects would be if a given failure did occur. In some cases it is clear, because of past
experience, how serious the problem would be. In other cases, it is necessary to estimate the severity based on the knowledge and expertise of
the team members."
Commentary:
This opinion is not acceptible.
1. This description will probably give basic misunderstanding to many engineers. It is not the right design procedure that a
designer omits the reliability design which must be performed essentially, and evaluates the risk in each failure mode by
FMEA based on someone's experience and technical knowledge.
2. If it is necessary to estimate the Severity based on the knowledge and expertise that the team members have, the
designer should have received instruction from the members during the design work.
3. In other words, according to the opinion mentioned above, this FMEA team has to play a role of the designer. Probably
the abolition of this kind of team will become the big one step to restore the function that a designer should originally
have.
The boss has to superintend a designer, in order to prevent each designer's negligence and carelessness. Furthermore, you
should promote the design by teamwork. On the other hand, you have to abolish the FMEA team as soon as possible.
Contents
Introduction

Step 5. Evaluating Three Elements
651 Common Criteria

Measures which constitute current controls are evaluated from three viewpoints.
Severity
Evaluate insufficiency of measures to ease the severity of each effect caused by each failure mode. Do not evaluate the
severity itself.
Occurrence
Evaluate insufficiency of measures to reduce frequency of occurrence of each effect caused by each failure mode. Do
not evaluate the frequency itself.
Detection
Evaluate insufficiency of measures to improve the difficulty of detection of each effect, failure mode or potential cause.
Do not evaluate the difficulty itself.
The evaluation is carried out based on the fourpoint scale common criteria shown below.
Common Evaluatuon Criteria
3 Insufficienth
1 Perfect
There is an exception to the abovementioned general standard. The exceptional standard is applied to the evaluation of
"Detection", which will be explained in the section 654.
Objection Theories
Objection Theories
Takayoshi Narimatsu:
A certain Japanese (Takayoshi Narimatsu) comments as follows on his homepage.
"An FMEA is performed to narrow down subjects that need measures. If measures are to be performed for all problems, the ranking will be
unnecessary. In that case, measures must be performed for all of factors included in the cause and effect diagram, and there is no need for an
FMEA. To obtain the maximum effect of limited resources such as time and money for solving problems, the prioritization of the problem is
inevitable. FMEA is the tool for that purpose."
Commentary:
This opinion accepted by some people, however, should be denied by the three reasons as follows.
1. A Few Problems for Experts
Amateur designers are apt to do only a functional design without a reliability design. They use some screws to attach a
component, but do not almost consider the reliability problems ( such as the rust or slack of screw which may occur
later). Thus their designs are inclined to include a lot of defects.
In the design by a specialist, all the detailed reliability is examined from one screw even to one pin. Hence, experts do
not adopt the policy of taking means according to the priority of a defect.
2. Measures should Be Taken If Necessary
Experts perform measures for all of factors included in the factor and effect diagram (FED), as far as the defect might
hurt reliability and cause a cost that cannot be ignored later.
3. Prioritization Is Meaningless
The people who felt a sign of the influenza infection will go to the hospital and have an examination. Suppose that the
results of medical examinations for a certain patient are as follows.
The temperature ranking 7,
The cough ranking 6,
The temperature ranking 8,
The Risk priority number 7×6×8 = 336,
The order of priority counts from the head and is the 13th.
In such a way, the patient can know neither their illness nor the necessary measures. Do you ever have looked at such a
hospital?

"The team must now decide which items to work on. Usually it helps to set a cutoff RPN, where any failure modes with an RPN above that point
are attended to. Those below the cutoff RPN are left alone for the time being. For example, an organization may decide that any RPN above 200
creates an unacceptable risk. This decision sets the cutoff RPN at 200."
Commentary:
There is not the explanation at all about the base of the cutoff point. How could the cutoff RPN decide at 200? In other words
it is a poor theory that everything is decided groundlessly. As for this turning point, the Absolute Evaluation Method (AEM) is
rational and should take the place of the conventional Relative Evaluation Method (REM).
652 Evaluating Measures for Severity
Note for evaluating Effect

Under the assumption that the failure mode occurs in spite of the measure indicated in the Current Controls, evaluate the
insufficient grade of the measure which eases the severity of the result predicted.
(1) Case Study of the Product FMEA

Line 1:
Under the assumption that aging and cracks occurs in spite of the measure indicated in the Current Controls (that are annual
check, and stainless steel covering), this failure modes (that are aging and crack) do not grow quickly. Since it is thought that
a big problem does not arise even if an oversight of very shallow cracks arises several times, the annual check with the naked
eye is enough as a measure. Since it is expected that the result is light even if failure mode occurs in this state of Current
Controls, 2 is a suitable score of the Severity.
Rating Severity of the Product FMEA

Line Article or
Interface Failure Mode (Breakage) Effect Mechanism Current Control a b c RI Action a b c RI
(Grounds) Added
1 Introduction
leakage Aging 2
2 Retainer
devices
3 Rust Stainless steel cover
Hose band Introduction hose Sudden gas Spilling salty broth 4
4 Cracks comingoff leakage
Rust,
5 Hose
shape
↑ These measures should be listed before rating a,
b, or c.
Line from 2 to 5:
As for Line from 2 to 5, the failure modes (rust, slack, cracks, and collapse of shape) is expected to grow slowly. But the
failure mode of comingoff of the hose occurs suddenly and the expected result is serious. Hence, measures to ease the
Severity of the effect are very lack, and score 4.
Relations between "Severity" and "Current Controls"

If the Severity of the effect is defined as the impact taking place when the failure mode occurs, that is inclined to be
misunderstood as unrelated to the current controls.
The gas range includes an introduction hose, in which cracks caused by aging are identified as a failure mode. The current
controls include conducting an inspection of the hose once a year, and this seems to be enough to detect the crakks before
growing to a dangerous level, should it occur.
However, when the design controls are changed into an inspection that is conducted every five years, the effect should
present different severity from the case of an inspection once a year. The depth of cracks, the quantity of the gas leakage,
and Severity of the effect become different considerably. In the case of the failure mode of slow advance, generally, Severity
changes by measures. It is necessary to evaluate measures to describe in the column of Current Controls in consideration of
this point.
(2) Case Study of the Process FMEA
Rating Severity of the Process FMEA

Line Step
Name
No. Failure Mode
1 Breach of 60 rpm
Fixation of the gearshift lever 4
2 Breach of 5 kgcm
3 Step 3
Cap Wrong oil Slack of screw Human Color marking 4
4 twisting Using up oil cap error Automatic oil dropper 4
5 Omitting work Feeder starts with the processing 4
completion signal
↑ These measures should be listed brfore rating a, b, or c.
Line from 1 to 5:
The outbreak of the failure modes leads to the slack of the screw cap. It is unlikely to cause a disease but it seems not
appropriate to leave untouched. Then, the severity scores "3" from this aspect.
However, this score may be criticized, because the moisture absorption of the tablet may spoil the product value, the recall
loss is expected to be vast, and the company may suffer an enormous damage by rumors. Then, the severity should score 4,
which indicates that the measures taken in the current controls are very short.
Objection Theories
Objection Theories
"The severity ranking is an estimation of how serious the effects would be if a given failure did occur. In some cases it is clear, because of past
experience, how serious the problem would be. In other cases, it is necessary to estimate the severity based on the knowledge and expertise of
the team members."
Commentary:
Indication of the Basic Problem

At first, Severity will surely score 10 from the possibility of crash, assuming that the failure mode of a crack arises on the
wings of a passenger plane first. Next, how is evaluation of Severity about the crack assumed to produce in the paper cup for
passengers' meal?
The severity ranking of a crack will score as follows, when the tenpoint method of relative evaluation estimates.
10 for the airplane.
6 for the paper cup for passenger's meal, which is the matter of secondary function of the airplane service.
If ranking is determined by the seriousness of effect itself, the airplane may be made strongly. In contrast, goods like a paper
cup, an earphone, a radio set or a paper cup will be treated as a trifling problem. However, is the crack of the paper cup trifling
or serious to the user of the paper cup, or the paper cup maker?
May a paper cup be designed rudely? The paper cup has to be designed and manufactured as it should be. The same can be
said also about other goods. As a result, evaluation criteria have to be determined for every product, and it becomes
impossible to obtain the criterion common to all the products.
The Correct Understanding

The abovementioned problem is certainly solved by the Absolute Evaluation Method.
An evaluation of Severity should be the evaluation of insufficiency of the Current Controls to ease it. The Severity evaluation
of the cracks of the plane is to evaluate a shortage of the current management for it. And similarly, the Severity score of a
crack of a paper cup is an evaluation of how insufficient the current controls to relax it. And hence, you must not evaluate how
serious effect would be and must not compare the seriousness of the result between products.
"Utilizing the Failure Mode Effect description and the applicable Severity Criteria, assign and record a Severity Ranking. Remember this is an art
not a science. There is no Correct Ranking."
Commentary:
The upper explanation is frank testimony about the defects of Relative Evaluation Method. However, still why is it that he
maintains the wrong method?

A ranking standard for Severity is quoted below.
Commentary:
Let's examine the usefulness of this standard . Even if anything happens in a paper cup for plane passenger's meal services
according to this standard, the worst marking is 6. Depending on this standard, the degree of the lack of measures cannot be
evaluated. Correctly, the degree of the lack of measures for the paper cup crack has to be evaluated at 10 if measures are
short very much. This problem is solved very naturally by Absolute Evaluation Method(AEM). The thought that function and
reliability must be designed appropriately whatever kind of product it may be is received generally.
653 Evaluating Measures for Occurrence
Line 1: The score of occurrence is b=2.
Checks performed once a year for the introduction hose have been planned as described in the blank of the Current Controls.
The cracks of the hose do not grow deep fast. And the gas leakage of a serious level would not be generated even if slight
cracks passed the check by mistake several times.
Line from 2 to 5: The score is b=1.

As described in the current controls column, a stainless cover has been installed to protect things around the introduction
hose from the collision with the kitchen utensil, from the overspill drops of salty broth and from the child's mischief.
Rating Occurrence of the Product FMEA

Article
Line Interfaceor Failure Mode (Breakage) Effect Mechanism Current Control a b c RI Action a b c RI
(Grounds) Added
Introduction
1 hose Cracks Gradual gas Aging 22
leakage
Retainer
2 screw Slack Collision with cooking Annual check
devices
3 Ruswt Stainless steel cover
Hose band Introduction hose Sudden gas Spilling salty broth 41
Hose Rust, Child's mischief
5 connector Collapse of
shape
b, or c.
Line 3: The score is b=2.
Lubricating oil is provided with many grades. However, usually three grades are enough in the same workshop. All the oil
canisters, the oilers, nipples, the oil supply cups and so on are distinguished by painting in the three traffic light colors. This
grade distinction is effective to prevent mistakes.
Rating Severity of the Process FMEA

Line Step
Name
No. Failure Mode
1 Breach of 60 rpm
Fixation of the gearshift lever 41
2 Breach of 5 kgcm
3 Step 3
Cap Wrong oil Slack of screw Human Color marking 42
4 twisting Using up oil cap error Automatic oil dropper 41
5 Omitting work Feeder starts with the processing 4 1
completion signal
Other Lines: The scores are b=1.
Measures taken in the Current Controls will prevent the failure modes nearly completely.
The Objection Theory

Step7. Assign Occurrence Ranking
"From the Cause Description, the group's knowledge and experience, and the applicable Occurrence Ranking Criteria, assign and record an
Occurrence Ranking."
Commentary:
1. The Object of Evaluation Is Wrong
According to this opinion which is full of mistakes, assignment of Occurrence Ranking is performed depending on the three
things shown below.
Cause Description,
The group's knowledge and experience,
The applicable Occurrence Ranking Criteria.
The question which many people bear about this description is not touching on the Current Controls description. Correctly, the
most important key point in evaluation is that the measure described in the Current Controls is the object of evaluation.
Recomended Rankings for FMEA Occurrence (Design)

Ranking Description Failure Rate
10 P 20%
Very High Failure is a Continuous Problem
9 P 10%
8 P 5%
High Frequent Failure
7 P 2%
6 P 1%
5 Moderate Sporadic Failure P 0.2%
4 P 0.04%
3 P 0.0067%
Low Relatively few Failure
2 P 0.0007%
1 Remote Failure is unlucky O 0.0007%
(Quaterd from Kenneth W. Dailey p.31)
2. The Criteria are Useless for Evaluation
It is quite impossible to perform rating according to these criteria. "FMEA is an art, but not a science" is Mr. Kenneth W.
Dailey's thought. The FMEA here refers to the Relative Evaluation Method. These criteria cannot hold rational contents
essentially. For example, according to this standard, when the failure rate of the crack of a passenger plane is 0.04%,
evaluation is set to b= 4, but if common sense is followed, you have to give b=10. On the other hand, as for the crack which
arises in the paper cup for a passenger's meal, if a failure rate is 0.04%, evaluation also looks appropriately by b= 4.
In other words, evaluation should be done not by frequency, but by the degree of necessity for adding measures to improve
frequency.
"The best method for determining the occurrence ranking is to use actual data from the process. This may be in the form of failure logs or even
process capability data. When actual failure data are not available, the team must estimate how often a failure mode may occur. The team can
make a better estimate of how likely a failure mode is to occur and at what frequency by knowing the potential cause of failure. Once the
potential causes have been identified for all of the failure modes, an occurrence ranking can be assigned even if failure data do not exist.
Commentary:
Several mistakes are pointed out as below.
1. Process Data do not Exist
Before a process design and FMEA are completed, the actual process does not exist yet, and hence actual data are not
available generally.
2. Do not Use Actual Data
You should not always evaluate based on actual data, even if a similar process exists, because most human errors
happen in the operation where mistakes have not happened for many years. For example, it is clear from the facts of the
driver's mistakes in the recent railroad derailment rollover accidents which occurred in Japan and Switzerland.
3. Measures Are to Be Evaluated
The object of the evaluation is measures in the Current Controls description as a result of reliability design. You should
not evaluate outbreak frequency of the failure without considering Current Controls description.
4. Applying Frequency Ranking Is too Difficult
It is too difficult to apply frequency ranking from 1 to 10 from knowledge and experience based on a standard shown
above, when, in particular, a new product or a new process is designed.
654 Evaluating Measures for Detection
(1) Outline
The general meaning of evaluation of Detection in the Absolute Method is a judgment whether the means of detection in the
Current Controls description are enough or insufficient. Be aware that the object of detection varies according to
circumstances of the product or the process.
In the case of a product; failure modes or their effects are found by strength calculations or reliability examinations. Then
the factors, that is, generating mechanisms have to be examined and measures for prevention have to be taken.
In the case of a process: any of the failure modes, their potential causes and effects can be the target of detection. The
detection of an initial small effect may lead to the prevention of the final serious effect.
Measures in the Current Controls described obtain a evaluation score corresponding to the common criteria as shown below.
Common Evaluatuon Criteria
3 Insufficienth
1 Perfect
In the Absolute Evaluation Method, a very convenient Exceptional Standard is applied to Detection. Evaluation b=2 Exceptional Criteria
leads to estimation c=2 automatically, and b=1 leads to c=1 automatically again. Occurrence Dtection
The theory which draws the abovementioned conclusion is shown below. 4
3
4 2
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1 68/78
For the question of whether a firebrick burns at temperature of 400 degree C, you should estimate it as b=1. In such 1
a case as an essential nature is the basis, no measures are described in the Current Controls. If measures are 4
unnecessary, however, it is necessary to describe it and its reason. 3 3
2
Detection is evaluated at the same time as c=1, that is, the combustion examination is unnecessary. If the judgment 1
that the firebrick does never burn is based on enough grounds, the verification is accepted as unnecessary. 2 2
1 1
This exceptional standard facilitates FMEA practice very much. However, in the case that occurrence c is 3 or 4, the
evaluation for the detection should be based on the common standard.
(2) Evaluating the Measures for Detection in the Product FMEA
1. Measures for Detection
In the case of a product design, the following typical means for the detection of failures are often performed.
strength calculations,
reliability examinations with the trial product,
examinations using the miniature,
computer simulations, and
computer aided design (CED)
In late years computers have come to help strength calculations and the production of resin trial products remarkably.
Opportunity of Detection
In many cases, detection of defecst in a product is performed during the design controls, that is, before submitting of
drawings or specifications. Sometimes, periodic inspections of the product by the user or a specialized supplier may be
planned.
2. Case Study of the Product FMEA
In the worksheet shown below, an equal score is given for Occurrence (b) and Detection (c). Here, you can watch the
usefulness of a special standard.
Line 1: The score (c) is 2, in accordance with the occurrence score (b).
Line 2 to 5: The score (c) is 1, in accordance with the occurrence score (b).
Rating Detection of the Product FMEA

Article or
Line Interface Failure Mode (Breakage) Effect Mechanism Current Control a b c RI Action a b c RI
(Grounds) Added
1 Introduction
leakage Aging 22 2
Retainer
devices
Hose band Introduction hose Sudden gas Spilling salty broth 41 1
shape
b, or c.
(4) Means for Detection in the Process FMEA

What are the object of detection in a process FMEA? Let's consider the process of manufacturing a shaft with strict allowable
width of surface roughness with a lathe.
You must perform the exchange of the tool every constant numerical processing to maintain surface roughness constantly. In
this case it corresponds to a falure mode not to perform tool exchange at fixed time. Next is considered as measures.
Watching that the person in charge leaves the post and talks with other workers, and attention is missed (detection of
the factor).
Detecting negligence of the tool exchange automatically (detection of the trouble mode).
Measuring surface roughness frequently and watching the change in process capability diagram (detection of the initial
effect).
There are various detection means according to process specifications. For example, the pilot inspection done prior to running
a process everyday, the automatic alarm systems against the abnormal process conditions, the product sample inspections of
each step and the shipment inspection, etc.
The means for the detection of the failure modes are decided in a process design, and the detection is carried out during the
preparation for running and running of the process. The objects of detection (e.g., a factor, its sign, a failure mode or its initial
effect) and the detection means should be concretely decided at the stage of the process design.
It may be appropriate to prevent serious outcome by the detection of the small effect.
If the detection at the stage of an effect is not acceptable, the defect has to be detected at the stage of a failure mode.
If the detection at the stage of a failure mode is too late, you have to secure the prevention of the failure mode by
controlling potential causes.
If prevention of a human error is required, "errorproof system" is very effective and recommended.
Breaches of a user's manual which may be generated after a product is handed to a user can be predicted easily.
Furthermore, it is necessary to take suitable measures about breaches which may lead to a serious danger.
(5) Case Study of Process FMEA
Line 1 to Line 5:
The detection score (c) is from 1 to 2 in accordance with the occurrence score (b)respectively. Such handling as above
extremely accelerates FMEA process.
Rating Occurrence of the Process FMEA

Line Step
Name
No. Failure Mode Effect Mechanism Current Control (Grounds) a b c RI Action a b c RI
Added
1 Breach of 60
rpm
Fixation of the gearshift lever 41 1
2 Step 3 Breach of 5 kg
cm Slack of screw Human
3 Cap
twisting Wrong oil cap error Color marking 42 2
4 Using up oil Automatic oil dropper 41 1
5 Omitting work Feeder starts with the processing completion 4 1 1
signal
Objection Theories
"The detection ranking looks at how likely we are to detect a failure or the effect of a failure. We start this step by identifying current controls that
may detect a failure or effect of a failure.(1) If there are no current controls, the likelihood of detection will be low, and the item would receive a
high ranking, such as a 9 or 10.(2) First, the current controls should be listed for all of the failure modes or the effect of the failures, and then the
detection rankings assigned."
Commentary: The abovementioned description cannot be admitted.
The worksheet by Robin E. McDermott has a description space for generating and detection separately. The following
problem is caused by this.
(Quated from Robin E. McDermott.p.44)
1. Identifying Current Controls
It is sometimes dufficult to start a step by identifying current controls that may detect a failure or effect of a failure.
One measure does not always function for one of the three elements exclusively. Since controls which may prevent
outbreak may work for detection at the same time, you cannot always decide which description space you should use.
A description space is not provided for controls of severity, hoever, a certain measure which is expected to improve both
of severity and frequency has no space to be described. For example, an inspection to detect cracks in a gas hose
performed once a year may detect cracks, and may prevent gas leakage and may ease severity of effect.
From the abovementioned consideration, there should be prepared one mention column for "Current Controls" , and it is
right to list all measures taken for the failure mode here in this column.
2. The blank Description Space
If there are no current controls, do not evaluate the likelihood of detection. Is it approved that a description column of
"Severity" is missing or the blank description column of "Occurrencr" or "Dtection" occurs? If the designer judges that
means is not necessary at all, he should list it in a blank column with an "Unnecessary".
Contents
Introduction

Step 6. Calculating Risk Index (RI)
661 Calculating Risk Index (RI)
(1) Significance of RI
Estimation of 3 Elements ( a, b, and c)

The score of each element is estimated by the expertise.
a. SeverityMeasures to relax the severity of the effects of the failure,
b. OccurrenceMeasures to reduce the frequency of occurrence of the failure,
c. DetectionMeasures for detecting each failure mode or its factors or initial effect, while restoration is easy.
Common Criteria for Estimation of Elements

Common Criteria for Estimation of Elements

If measures are taken for elements, and if evaluation are given as shown on the left side, each score is given as shown on the
right side.
Common Criteria for Element Scores

Estimation of Current Controls by Expertise Element Score
Very short 4
Insufficient 3
Sufficient ( the optimal control level) 2
Perfect 1
The Exceptional Criteria for Detection The Exceptional

When occurrence b is 2 or 1, detection c is equal to b. This is according to the exceptional criteria as shown in the table Criteria (again)
on the right (refer to 651). Occurrence Detection
4
The Global Evaluation 4 3
When rating of any element exceeds 2, measures are insufficient or very insufficient. Conversely, when score does not 2
1
exceed 2, measures are sufficient or excessive. 4
3 3
Necessity of a New Numerical Value Index 2
When each element takes respective value, however, the global assessment needs a special calculation from the 1
viewpoint of management. For example, when a combination shown next is coming out, how should the global 2 2
evaluation be done? 1 1
a=3, b=3, c=1, RI = 2.1
(2) The Calculation of Risk Index (RI)

New index and technique are necessary in consideration of a viewpoint of the control technology. Furthermore, we announce
a new technique to calculate a value of risk index (RI) as follows here.
Risk Index
Each element's score a, b and c is obtained from the expertise of the product or the process, and is transformed in to the new
synthetic evaluation index RI, which is a numerical value indicating the degree of lack (i.e., additional need) of measures from
the view point of control technology.
The optimal RI
Since the optimal score of each element is 2, the optimal RI is also 2. When each element obtains the score which does not
exceed 2, current control passes reliability assessment promptly. For example, the failure mode that obtains the score shown
below passes evaluation smoothly.
a=2, b=2, c=2
Necessity for Special Index and Formula

However, it is difficult for the case where the combination of a score is
a= 3, b= 3, c= 1
to make an overall judgment based on expertise of each field.
The following formula will be obtained when this problem is dealt with using control technology.
You can substitute the element scores into this expression and get a synthetic evaluation score, based on the next reasons.
The Reason for the Dimensional Return

The elements a, b, and c are onedimensional values which show the necessity for measures. In order similarly for RI to serve
as a onedimensional value which shows the necessity for measures, the threedimensional value needs to be returned to a
onedimensional value.
The Reason for the onedimensional value

The calculation of RI should make not an arithmetic average but a cubic average. It is because each score a, b, and c has a
mutually different meaning.

All failure modes have come to pass the evaluation as shown in the worksheet below. However, a study of optimization is
necessary because
IR = 1.6 < 2.0
implies surplus measures.
Line 1:
" a= 2"
is the optimal point and the evaluation is a "Pass."
Line 2 to 5:
" RI=1.6"
is not the optimal value and some optimization is needed (refer to the step 7).
Calculating RI of the Product FMEA

Article or
(Grounds) Added
1 Introduction
leakage Aging 2 2 2 2.0
Retainer
devices
Hose band Introduction hose Sudden gas Spilling salty broth 4 1 1 1.6
shape
All Lines except Line 3:

The failure modes have come to pass the evaluation as shown below. However, because of IR=1.6, some optimization should
be considered (refer to the step 7).
Line 3:
IR=2.5 means that measures are not sufficient, and additional measures should be contrived (refer to the step 7).
Calculating RI of the Process FMEA

Line Step
Name
No. Failure Mode
(Violation) Effect Mechanism Current Control (Grounds) a b c RI Action a b
Added c RI
1 Breach of 60 rpm
Fixation of the gearshift lever 4 1 1 1.6
2 Change of 5 kgcm
3 Step 3
Cap Wrong oil Slack of screw Human Color marking 4 2 2 2.5
4 twisting Using up oil cap error Automatic oil dropper 4 1 1 1.6
5 Omitting work Feeder starts with the processing 4 1 1 1.6
completion signal

Introduction Step 2: Listing Failure Modes
Chapter 3: FMEA Process Step 5: Evaluating three Elements
Chapter 5: Product and Process Step 6: Calculating RI

Chapter 6: Seven Steps / Case Study Step 7: Optimization

Step 7. Optimization
671 Optimization for Product FMEA
(1) Significance of optimization
Adjust the Current Controls

Optimization is to adjust so that the Current Controls may approach RI=2. It is required to adjust Current Controls in
consideration of all the elements about a result including quality, a cost price, delivery (time and quantity), security, and
environmental protection, so that the best may be gained. At this stage, the advantage of the Absolute Evaluation Method
appears with a very clear form. You can judge the surplus and lack of measures about every failure by an Absolute Evaluation
Method. And you should recognize that this is totally different from the traditional Relative Evaluation.
Know the Situation of Current Controls by RI

By value of RI, the designer sees the situation of the Current Controls in real time. Then necessary measures are taken early,
and Concurrent Engineering is enabled.
(2) What Does RI Indicate

By numerical values of RI, Current Controls are judged as follows.
Numerical Judgment
Value of RI
4.0 3.6 3.3 3.2 Rejection More effective measures are needed. The closer to 4 RI gets, the more effective measures you should add to
3.0 2.9 2.6 2.5 Current Controsl.
Stand by until the result of a test comes out.
2.3 Reservation If the test result is a failure, a small improvement has to be continued until it passes. However, when a suitable
means is not found, it may be treated as temporary success for the time being. Or it may be regarded as a
success, according to the contents of the test result.
2.0 Pass. Current controls are at the optimal lebel.
If RI is within this scope, the current controls also pass the evaluation. However, measures might be excessive,
and it is necessary to consider actions as below are needed in order to regain the cost to pay.
1.6 1.4 1.3 1.0 Pass A device to decrease cost, or/and
A device to increase sales charm.
( The borders are not strict. For example, 2.5 may be treated like 2.3 depending on contents of the potential influence. )
When RI = 2.3
Actions are decided by examining the numerical values of the elements "a, b, and c" that compose RI (refer to the table
below). If RI is approximately 2.3, the judgment is postponed for a while. In many cases, the result of the examination about
this failure mode is waited for. And in other cases, actions are postponed until a better idea appears.
A number of actions are considerable as shown in the table below.
The Possible Combination of a, b, and c for RI=2.3

Combination
Line Product FMEA Process FMEA
a b c
a b c
1 1 3 4
Exclude from consideration, because Severity score is 1.
2 1 4 3
Wait for the result of the reliability inspections (trial product tests,
3 2 3 2 simulations, strength calculations, etc. may be included), because "c= 2 or You should postpone detrmination
c= 1" means that actions according to the result of reliability inspections are until an effective idea of low cost
appropriate. appears. You have to continue to try the
changes to the way until it succeeds.
4 3 2 2 1. If the reliability test is rejected, you have to continue to add the
changes to the way until it succeeds. If solution suitable in the case of a= 3 is
If solution suitable in the case of a= 3 is not found, you may not found, you may determine as
determine as success for the time being. And action for solution is success for the time being. And action
postponed until a good idea is found. However, in the case of a=4, for solution is postponed until a good
5 3 4 1 you should take an effective measure even if costly. idea is found.
2. Additional measures are not required when the Current Controls However, in the case of a=4, you should
passes the examination. Moreover, both b= 4 and b= 3 should be take an effective measure even if costly.
6 4 3 1 rewritten b= 2.
7 4 1 3
Exclude from consideration, because b=1 leads to c=1, and these combinations never happen being based on the
exceptional criteria,
8 3 1 4
If Current Controls for Severity are very short (that is, a=4), and this may result in a serious result, you should apply FMECA, which is
mentioned at the explanation (4). → Click here.
(3) The Case Study of the Product FMEA

The abovementioned ways of thinking applies to the case study of the following product FMEA.
Optimizing Reliability of the Product FMEA

Article or
(Grounds) Added
1 Introduction
leakage Aging 2 2 2 2.0 Pass
2 Retainer
devices
Hose band Introduction hose Sudden gas Spilling salty broth 4 1 1 1.6 Pass
Rust,
5 Hose
connector Collapse of
Child's mischief
shape
Line 1:
RI = 2.0 indicates that the Current Controls are probably optimal and no more actions are necessary.
Lines 2 to 5:
The protective effect of the stainless steel cover seems a little excessive, because of RI=1.6. However, you cannot find
substitute means to protect from the things shown below;
damage by mischief of the child,
drops of salty broth, or
collision with kitchen utensils.
The whole including the introduction hose which was not planned at first was covered with a stainless steel cover.
On the other hand, the device was designed to have sale charm such as beautiful appearance, simple cleaning, convenient
use and safe improvement with the additional cost.
Back
(4) Failure Mode, Effect and Criticality Analysis (FMECA)
FMECA mentions FMEA of the kind to attach great importance to Severity in particular. In the absolute rating method, the
score a=4 means that the measures are very short, however does not always show seriousness of the effect. For example, as
for the crack not only of the paper cup, but also of the passenger plane, Severity will get a=4 if measures are very shourt.
About the crack of the paper cup, you can push forward a normal FMEA to go in principle, but should apply FMECA about the
crack of the plane, the result of which is particularly serious. FMECA is applied when the result of the failure is as important as
a death accident. When the result is estimated to be extremely serious, the need of measures is judged in severity alone
regardless of RI. If point of severity is 4 and the result turns out critical, it is necessary to apply the FMECA. In many cases,
the special measures taken besides usual measures are as follows.
A foolproof system,
A failsafe system,
A redundant design, or/and
Frequent examination in use.
(4) The Case Study of the Process FMEA

Similarly, the abovementioned ways of thinking applies to the case study of the process FMEA.
As for RI = 1.6:
Three measures to be shown below were adopted by the reason of low cost and the effectiveness.
Line 1 to 2: Fixation of the gearshift lever with screw or a knock pin.
Line 4: An automatic oil dropper unit is to be attached to the twisting machine.
Line 5:The automatic start of the feeder by the processing completion signal of the cap screw bundle machine.
Calculating RI of the Process FMEA

Line Step
Name
No. Failure Mode
(Violation) Effect Mechanism Current Control (Grounds) a b c RI Action Added a b c RI
1 Breach of 60 rpm
Breach of Fixation of the gearshift lever 4 1 1 1.6 Pass
2 5 kgcm
No.3 4 3 3 3.3
3 Cap Wrong oil Slack of screw Human Color making 4 2 2 2.5 Monthly check
of oil 4 4 4 4
twisting cap error 2.2
4 Using up oil Automatic dripping, 4 1 1 1.6 Pass
Automatic alarm
5 Omitting work Feeder starts with the completion 4 1 1 1.6 Pass
signal
As for RI = 2.5:
The color marking system is one of the methods of identifying grades of lubricant and preventing the mistakes in grades by
color painting of the containers or instruments. However, this was estimated to be a little insufficient, and the addition of the
following measures was determined.
The Method of Adding RI

It was decided that in addition to the color marking system (the current measure A), a new measure (B) of a monthly check of
oil grade by the chief of the manufacturing section was performed.
Calculation of the new RI

In this case, how should the RI calculation be treated?
The numerical value of each element of Severity, Occurrence, Detection, Production of these and RI for the countermeasures
A and B are shown respectively in the table below. So far, it is clear by the already described explanation.
Here, a virtual countermeasure delta Δ is introduced. The numerical values comes to be shown in the following table. It is
because the virtual countermeasure is a countermeasure which is not helpful at all in fact.
Severity a=4
Occurrence b=4, and
Detection c=4.
Naturally, the production is 64 and RIΔ=4.0.
Substitute those numerical values to the formula, and get the improved result RIc= 1.9.
(5) Design Review and Concurrent Engineering
Completion of the FMEA

You perform functional design first about the suitable small range which constitutes a product or a process. Next, you begin
the reliability design of the portion. Then, you begin FMEA, you add a countermeasure if necessary, and you complete the
design of that range, and advance the similar steps till the whole range is covered.
Eventually, as a whole, a design and an FMEA are performed simultaneously. Moreover, it can be said that it is carried out in
order of a functional design, reliability design and its FMEA.
Design Review
The design review (DR) team should assess the design plan including the FMEA executed by the designer.
Concurrent Engineering
It becomes very easy to carry out concurrent engineering as a result of the design management in which designers perform
design and FMEA simultaneously. Since it takes time too much, it is very difficult to carry out concurrent engineering at the
factory which carries out traditional FMEA.
Objection Theories
"The resulting RPNs can be organized on a Pareto diagram and compared with the original RPNs. In addition, the total RPNs of the beforeand
after product or process can be compared and contrasted. You should expect at least a 50 percent or grater reduction in the total RPNs after an
FMEA."
Commentary:
The explanation above is totally meaningless about the matters shown below.
Creating the Pareto diagram from the resulting RPNs,
Comparing the beforeandafter Pareto diagrams with each other,
Expecting the 50 percent or more reduction in the total RPNs after an FMEA.
Since RPNs do not indicate necessity of measures but mere priority, reduction in the total RPNs does not indicate that it is an
appropriate improvement. Countermeasures may be insufficient or maybe excessive. Hence, the optimization is quite
impossible in the abovementioned method.
Furthermore, it is a mistake to compare only RPNs without an overall judgment considering of all elements including cost.
Robin E. McDermott p.39 :
"There is no target RPN for FMEAs. It is up to the FMEA team and the company to decide on how far the team should go with improvements."
Commentary:
Commentary:
The upper explanation confesses that the relative evaluation method cannot distinguish the insufficiency of measures from the
surplus. And this explanation is an evidence that the relative way of FMEA should be abolished immediately.
(The End)

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12/9/2016 FMEA

E-Mail : takaro_u@yahoo.co.jp → Quick Access

Glossary of Key Terms

Occurrence ­ degree of insufficiency of the Rlative Evaluation FMEA @­ a type of wrong FMEA

structural breakages of parts, failures of subfunctions the design and the design does not include

Evaluation Moreover, judgment of priority is very difficult and is

A Problem Was Found The Harder Study, the More Problems

(4) History of FMEA

Severity × Occurrence × Detection = 10 × 10 × 10 = 1,000

Authors Title Publisher Year

Kenneth W. Dailey The FMEA Pocket Handbook D W Publishing Co. 2004

Hitoshi Kume Quality Management of Design and Development Union of Japanese Scientists And Engineers 1999

D.H. Stamatis Failure Mode And Effect Analysis ASQ Quality Press 1995

Hajime Makabe The Basic of Reliability Engineering Japanese Standards Association 1995

Chapter1: What Is FMEA

such part breakages as rust of screws, "A defined period" means the life of the product.

What Is Failure? In 2005, several employees of a certain maker joined

As for a Process In general, a breakage of a part or an interface is a

As a result, malfunctions, manufacturing defectives The Right Definition

Even when a failure occurs in a complicated product, Moreover, a crack, a jam, comming­off, etc. are

Starting Points It is hard even for experts to list up potential failures

Commentary (What is wrong?):

Robin E. McDermott p.1

1­2 Outline of Design Procedure

(1) In General (2) Simultaneous Activity

correction of the reliability defect discovered after

(3) The Function Design

(4)The Reliability Design

About the product, submit pruduct specifications In contrast to function design, reliability design is to

(5) Confirmations by the Division Manager Disclosure of evidence of Function Design

1­3 Need of the FMEA Execution

(3) Peace of Mind

(5) Number of Recalls in 2009: (6) Recent Advancement of FMEA

1­4 Basic Requirements of FMEA

(1) Designer's Tool to Check Reliability

(2) Using a Fixed Format

The Worksheet Format for the Product FMEA

Part or Interface Location for failure modes ( Here must not be a column of "function" )

Failure Mode Manners of failure: such as rust, breakage, transformation, melt, coming­off, etc.

Severity (a) Insufficiency degree of measures to ease severity of effect

Occurrence (b) Insufficiency degree of measures to decrease frequency of occurrence of effect

Detection (c) Insufficiency degree of measures to detect factors, a failure mode or effect, according to the situation

Risk Index RI=(a × b × c)1/3 : Insufficiency degree of measures as a whole

(3) Design Expressed on Documents

(4) Difference between Failure and Failure Mode

Concept of Failure Mode

Reason for the Strict Distinction

Reason for the Strict Distinction

(5) Evaluating Lack of Measures

(6) Purpose of FMEA

Chapter2: Purpose of FMEA

2­1 Purpose of FMEA

To Clarify the Potential Failure and

To Clarify the Potential Failure and Disaster

To Clarify Failure Modes not Enough in Control

Searching Failure Modes Is not the Purpose

When FMEA Is Helpful

When FMEA Is Useless

Occurrence degree of insufficiency of the Rlative Evaluation FMEA @ a type of wrong FMEA

Even when a failure occurs in a complicated product, Moreover, a crack, a jam, commingoff, etc. are

12 Outline of Design Procedure

13 Need of the FMEA Execution

14 Basic Requirements of FMEA

Failure Mode Manners of failure: such as rust, breakage, transformation, melt, comingoff, etc.

21 Purpose of FMEA

31 Outline of FMEA

32 Preparing Documents

33 Listing Failure Modes

331 Concept of Failure Mode The Starting Points

332 Bottomup Approach

The Merits Brought by Bottomup Approach

The Problems with Topdown Approach

333 A Useful Theory by H. Kume: p.142: (Translated by us from Japanese)

34 Listing Current Controls

35 Listing Effects of Failure Mode

36 Evaluating from the Three Viewpoints

37 Calculating Risk Index

38 Optimizing the Measures

41 A Tool for the Design Aid

41 A Tool for the Design Aid

51 Designing the Product and Process

511 General Description For the Benefit of All People

512 Failure and Failure Mode

52 Product FMEA

521 General Description

522 Bottomup Approach

523 The Topdown Approach Is Wrong

The Topdown Approac (Wrong)