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2. FMEA on FMEA
Mike Silverman
James R. Johnson
Key Words: FMEA, Facilitation, Mitigation, Boundary Interface Diagram, Parameter Diagram, HALT
SUMMARY & CONCLUSIONS so tiresome that people shy away from participating in FMEAs
in the future because it’s just another attempt at some new
Failure Modes and Effects Analysis (FMEA) is a
gizmo theme that no one will adopt anyway.
systematic technique of identifying, analyzing and preventing
product and process problems before they occur. When Mitigation: Break the FMEA up into 1-2 hour blocks of
implemented properly, FMEA’s is one of the most valuable time. The resulting rush job scenario creates problems that it
reliability and design tools. Improperly executed causes is assumed all professionals will aspire to and solve. The
FMEA’s to be at best a waste of resources and time and at Rush Job Scenario is a term the author Jim Johnson coined as
worst, steers you in the wrong direction resulting in missed a root cause to up to 30% of the errors and omissions within a
failure modes. 400 employee organization operating 10 million unit processes
a month; of which one could be a show stopper. The minute
In this paper, we perform FMEA on FMEA, exploring we said “don’t rush; just correct the time to what is best” and
how FMEAs can go wrong and how to avoid these common do it right everything slowed for a month; then sped up way
pitfalls. past prior speeds; everything sped through and didn’t need to
be “pulled or pushed thru.” It was an amazing metamorphosis
1 TEN REASONS FMEAS FAIL and comes almost like entering into the session taking three
deep breaths; releasing all other thoughts elsewhere; taking
In this first section, we will discuss the top 10 reasons control of your own mind and thoughts and travel thru the
FMEAs fail along with the effects of this failure and the smallest, most enjoyable details, undisturbed; it’s like Zen and
solutions to mitigate the failure. the Art of FMEA; the ideas will flow.
1.1 Making one person responsible for performing a FMEA 1.3 No Facilitator/Wrong Facilitator
When we make one person responsible for FMEA, the If you attempt to perform an FMEA without a facilitator,
effect becomes limited stimulation of cross functional or if your facilitator is weak, you will spend an inordinate time
brainstorming as well as reduced learning for next generation on wrong events or subjects while not encouraging new
designs that need to push product specifications further. thoughts, new directions.
FMEA’s require a team approach; a brainstorming process.
Mitigation: Make sure you have someone trained in the
Mitigation: Invite members from several different areas technique of meeting facilitation so that the meeting can stay
of a company to participate. 5-10 people is optimum. Use the on track and on time. FMEAs that run on are likely to cause a
theory that “he/she who is doing the work, has the most drop in attendance or interest. Facilitation itself has failure
knowledge about the work; invite them in; watch the moral modes similar to brainstorming rules. An expert on FMEA
grow to pro-activeness.” This will result in increased learning who is also a manager will speak the language from a fact
for next generation designs that need to push the specs further. based, evidenced based, present time perspective in the room
at the moment showing everyone the connection between
1.2 Trying to perform an FMEA in one session rather than
issues. A sort of guru who guides the flow of thoughts and
stratifying the process and allow soak time
ideas to spawn more. This message delivered by a leader
Many teams like to “plow through the FMEA” to get it drives the organization to the most successful FMEA because
over with and move to the next “fire fight”. This is the core of people respond positively when they are in the presence of a
many reliability issues because it is only a self-perception that leader. Action is the only way people understand another
creates the “rush job mentality” that is identified by “okay, persons’ intention and facilitation is positive, enthusiastic,
let’s get this show on the road; I’ve got other priorities and directed and real. It is a profound discovery to learn
schedules”. The effect of this approach is two-fold 1) you sometimes that those who teach often fail to practice what
address mostly superficial issues, and 2) the exercise becomes they preach; this includes quality professionals, mechanics,

3. doctors and lawyers. The essence of a great leader is the individual cross members that build the trusts that creates
understanding of process, people, programs, performance, etc. strength that holds the train and delivers the product. The
and to have the flexibility to move quickly between one and interoperability of organizations can be quantified to
the other without disturbing the team’s energy but balancing determine the strength of the Trestle; before the train the
out variance with deviation. Then back to the process. comes FMEA of FMEA is the a) delivery and b) acceptance
Sometimes teachers drive lessons down a team’s throat or definition or consideration aka RESPECT. Once in place,
assuming this works, yet we know from experience that it does the heart of success comes from a) resource allocation (time
not; never did in grade school, isn’t going to work post grad and money), b) organizational maturity, c) management’s
school. These are the principles of continuous improvement involvement and d) implementation process that understands
as well. sustainability requires on-going care aka maintenance of the
trestle because chaos comes from entropy.
1.4 Team Not Trained or Trained to Different Methods
Training can do more for FMEA by continuing to merge with
Each person on the FMEA team should have some basic management responsibilities and strategic initiatives
training in the concepts of FMEA to understand how each
portion of the process works. Without this, the effects become 1.5 Management Does Not Back Effort
arguments or wasted time during the FMEA on how to
perform one properly. If management does not support the FMEA effort, the
participants will not view it as important and the effect will be
Mitigation: Conduct a short 1 hour training session prior that you will get team members showing up sporadically and
to the start for new team members to the company to have a lose continuity of the process. And when it comes time for
common platform. Even if individuals have been trained in mitigation, you will get pushback in making any changes.
past companies, they should still attend because there are
different ways of performing a FMEA and even these Mitigation: How many times have good ideas been
differences can cause enough dissention and disagreement to stifled by over powering management who basically says
derail a FMEA effort. There is no one right way to perform “hurry up.” Regardless of the perfect rationale and common
one – it is more important that the methods chosen are understandings, that process does, in fact, create a certain
common rather than “right” and agreed to before commencing. culture that has increased errors and omissions due to the rush
There is a distinction too often overlooked called working “in” job scenario. Management does not know, under these
the business and “on” the business. If you are talking ABOUT conditions, what cause and effect they create.
FMEA, you are off track and should have worked “on” that
before the FMEA Process began. In one company that co-author Jim Johnson directed this
thru, he created a procedure called Management 101. In doing
Training has often been looked at as a major burden yet so, he was able to open all the dialogs that used to look like
everyone knows its real value. Though costly with hardly “hurry up” or attitudes like “this ship is sinking” and ask why
recognizable results except to create smarter workers who do you say this? In doing so, the Pareto revealed only fact
move on to better jobs). Training should be looked upon as based reality that links the dots with the team’s reality. Top
Job #1! In fact, the perfect manager is a trainer if he believes priorities are seen over the fog and risks are mitigated by
in Theory Y which states “people are inherently honest, targeting the attention of all. He learned that concern equaled
hardworking and want only success while needing only to be risk and that not everyone’s concerns were making it to the
supported in their work thru good communications both FMEA of Management Process. Without adopting a means to
ways”. For instance, you would think that teachers of FMEA talk about these meta-issues by that Management Process
would want their teaching so potent that it will overcome the Procedure he could not link the SWOT and management
basic elemental forces of the human psyche. Wouldn’t all reality that there is no way of knowing what they don’t know.
teachers love that! Then they somehow stifle creativity [the Management is the look-out looking on the horizon but still
heart of FMEA] and fail to take it to that imaginary place needing confidence in the team to do it right while
where the tiniest of elements causes a trip in a flow that management provides the necessary resources to execute a
disrupts a program and causes defect to be seen by customer; FMEA on the product as they perform FMEA on the Business
and perhaps even the worse scenario - total recall; not of good Management Processes.
ideas; but of shipped products!
Management needs to be trained on FMEA about their
When we teach others about Failure Mode Effects processes as well, but not the same training as the individuals
Analysis, why is it that some companies love it and others just performing the work on products. Management needs to be
can’t seem to get down in to it? Is it because of the FMEA? trained on the effects of a well performed FMEA on design
No. There are failure modes that prevent a stronger FMEA and business processes. They need to be shown the ROI of a
Process. These are the elements of trust in the organization. successful FMEA effort that comes from cause and effect of
Like a grand wooden train trestle over a huge gorge, built on wholly backing the FMEA process.

4. 1.6 Scoring System Not Customized group identifies all of the potential failure modes, a subgroup
(can be the same or different) can the score each failure mode
If you don’t customize the scoring system for your using the guidelines set forth during the scoring system
particular product or company, but instead you use a generic creation.
scoring system from one of the many FMEA guideline
documents such as IEC 812, Sematech E14, and MIL-STD- 1.8 Agenda Not Clear from Start
1629, then you either may identify too many or too few of
issues to tackle. Here is an example. Let’s say you borrow a An FMEA can run in a number of different directions
scoring system from your previous company that was making with no clear end point. People will lose interest very quickly.
military equipment and the highest severity item (a 10) What you have here is priorities in conflict with reality.
resulted in death of several people and medium level of
severity (a 5) resulted in severe injury to a single person. If Mitigation: Make sure facilitator clearly identifies agenda
your current product is a mobile phone and the highest and ground rules to all team members and there is consensus.
severity item is a broken phone, that would probably be a Consensus does not mean that everyone must agree but rather
severity of 3 or 4 on the military equipment scale, and the it means that everyone must be aligned to the intentions of the
result is that you would likely not address the issue because FMEA. To reach consensus, do the following:
the score is too low. In fact, this is severe for the product you
 Be open to influence, ideas
are currently producing and it should be addressed. Therefore,
 Contribute, not defend
you must customize the rating scales.
 Actively listen to other points of view
Mitigation: Make sure you customize your scoring  Find out the reasons for other positions
system based on product and environment and that you build  Avoid averaging the differences
in enough granularity so that you can distinguish between  Confront the differences – politely
different failure modes when scoring. It is key to be able to  Stand up for one’s thoughts and opinions
determine which failure modes to work on. You can’t cover To recognize you have reached consensus, ask yourself
all failure modes so you must choose the ones that will offer the following:
the best chance of improvement. Like with HALT, just
because you find the problem doesn’t mean you have to fix it.  Have I honestly listened?
For FMEA’s, let the score guide you (and for HALT, let the  Have I been heard and understood?
margins guide you).  Will I support the decision?
 Will I say “We decided,” as opposed to “My idea
One situation that author Mike Silverman faced was he went through,” or “I decided,” or “I told them and
was working with a semiconductor equipment company and they followed my recommendation”?
when developing the severity scales, he and his client realized
that there were in fact three different and equally important 1.9 Try to Take on Too Big of an FMEA
types of severity – severity to the user, severity to the
If you try to take on too big of an FMEA, you will tend to
equipment, and severity to the end product - the wafer being
focus on only superficial issues and don’t get to the main
manufactured (in semiconductor manufacturing, the processed
failure modes.
wafer can cost as much as some of the equipment used to
produce it). Therefore, we created three separate severity Mitigation: Break FMEA up into logical sessions and
scales. pieces. For example, tackle the manufacturing issues with a
Process FMEA in a separate session with different team
1.7 Scoring System Not Developed Ahead
members than design issues.
If the scoring system is not developed before starting the
Also, don’t just stick with one type of FMEA. Use
FMEA, team members will have a tendency to change the
different types of FMEAs as appropriate – Functional, S/W,
scores up or down depending on whether they think issue is
Test, Technology, User, Process, Design are all types of
worth working on.
FMEAs. You need to understand the problem you are trying
Mitigation: Make sure score system is developed ahead to tackle before you can decide on which is the correct
of time and agreed upon by team before starting into FMEA approach.
process. Otherwise, you will spend a lot of time arguing over
1.10 Identifying failure modes but not prioritizing/mitigating
scores rather than worrying about the failure modes that
the correct ones
caused the problem.
If you approach an FMEA as a “check-the-box” activity,
Another advantage of developing the scoring system
then when you finish identifying issues, you may think you are
ahead is that the entire group does not need to be involved in
done. However, the real value of an FMEA is in mitigating
this exercise. Appoint a subgroup to do this. Then after the

5. the issues you fin so that the end result is a more reliable
e nd e m 2.1 Star Early
rt
oduct. A lot of good work is wasted if you don’t make
pro s
im
mprovements to the product an process by acting on failur
o nd a re Mak sure FMEA is started earl so you have time to
ake A ly
moodes you discoover and mitigaating them. work on mitigations an build this in the schedul Start
n nd nto le.
FMEA a early as possible (even Co
as oncept phase) a revisit
and
Mitigation: Score the FME objectively and using a
EA y FMEA s several times th
hroughout product life cycle. Starting
.
ystem to sort an prioritize. Then take action. I once went
sy nd T t cess too late in the product de
the proc evelopment life cycle - it
e
rough a whole FMEA exercis with a client and they
thr se t may be too late to fix t things that need to be fixe
the ed.
de
ecided not to ta action beca
ake ause their client didn’t require
t e
the to make an changes – on to go throug the exercise
em ny nly gh e. 2.2 Bra
ainstorm
2 OTHER HE
ELPFUL HINT WHEN PER
TS RFORMING AN
N Allo plenty of b
ow brainstorm time at beginning r
e rather than
FM
MEA jumping into spreadsh and trying to fill out. Use tools such
g heet
ndary Interface Diagram and Parameter Dia
as Boun agram.
Below are a few other help hints to as
pful ssure that FME
EAs
In t Boundary I
the Interface Diagrram, we break complex
are performed pr
e roperly.
systems up into specif blocks in or
s fic rder to examine the
e
interface between each of the blocks Some of the blocks may
e h s.
even be equipment oth than your o but you mu still
her own ust
evaluate how your equ
e uipment interfaaces with these In the
e.
example shown in Fig
e gure 1, we have shown a Load Lock and
e d
ways it interface with other parts of the
identifie 4 specific w
ed es
systems (other blocks) – through a P
s ) Physical connec ction, an
Energy connection, a M Material conneection, and a D
Data
connecti ion. We then bbrainstorm fail
lure modes speecific to
each con nnection. For example, for th Energy conn
he nection, we
can com up with a fai
me ilure mode suc as Vibration from the
ch n
Transfer Module causi an error wi the Load Lo
r ing ith ock.
Figure 1 - Boundary I
Interface Diagr
ram
In t Parameter D
the Diagram, we bbreak up the sys stem into
differen types of failu – Piece to Piece Variations
nt ures
(manufa acturing variati
ions), Environm
mental, Custom mer
Usage/D Duty Cycle, and Deterioration By doing thi we can
n. is,
break th FMEA up in 4 smaller FMEAs and con
he nto ncentrate on
each of these as part o their individu FMEA. Fo example,
of ual or
if we are evaluating on Deterioration failures of t Load
e nly the
Lock, w would identi specific com
we ify mponents that may
deteriora over time. This focused e
ate effort will allow us to
really di deep into th one issue w
ive his without bringin in other
ng
issues at this time. Lat we will look at other issue such as
t ter k es
Environnmental and Cu ustomer Usage but not during this
g
portion of the FMEA. The result is a modular type of e
brainsto
orming in which each module is more focus rather
e sed

6. tha an FMEA comprised of a random amoun of
an nt liability Integra
2.4 Rel ation
bra
ainstorming in which a) it ma be difficult to know when the
n ay
ex plete, and b) it usually results in missing
xercise is comp u egrate into the process other t
Inte tools such as fi failure
ield
de
etailed FMEA items because there is no focu to the effort
i t us t. analysis for previous f
s failures as well as competitive
l
benchm marking to stimu ulate the comp petitive drive to find
o
solution The unknow unknowns m be turned to known
ns. wn may
unknow using the di
wns isciplines of R
Reliability and Q
Quality
Assuran We do not know what we do not know and that is
nce. t e
why bra storming pr
ain rocesses work s well to gene
so erate
thoughts for closing co
s omplex project We are crea
ts. ating
navigatiional tools to fi the unknow The areas w
find wn. where the
Physics of Failure (ma aterial and prod robustness and
duct s
tribolog issues), meet the Science o Reliability (Q
gy t of Quality
Assuran Manageme Process, In
nce, ent, ncentives and SScripts
toward c corporate robuustness) and sur rprisingly, the overlap of
using th same processes.
he
2.5 Fai
ilures are Good
d
Chaange the way y think about failures so tha you can
you t at
Fig
igure 2 – Param
meter Diagram
m discover how failures can happen. C
r Creating daily p
processes
that are actually focused on “not fail
ling” could help change
p
2.3 Vertical Thinking
3 the way we do busines
y ss.
Work FMEA spreadsheet vertically rathe than
A v er In u
using the discip
plines of Failur Reporting, A
re Analysis and
ho
orizontally. Thi way, you can score all failu modes at th
is n ure he Correcti Action Sys
ive stems (FRACA and Corrective and
AS)
sam time rather than filling ou all attributes of each failure
me r ut e Preventi Action (CA
ive APA) we have learned that m
mistakes are
mo before mov
ode ving to the nex This will re
xt. esult in a more making the same mistake is no okay. Preve
okay; m ot enting
niform scoring plus it will allo you to utilize the team
un ow mistake s is better.
meembers’ time better because the scoring can be performed by
b t n d
assubset of the en
ntire team. Wh plans for mistakes? Who b
ho believes they w make
will
mistake s? Who can ex
xtend thoughts beyond to find the failure
s
mode an talk about it
nd t?
Too often we feel we are blindsi
o l ided by tunnel vision, near
sightedn
ness, ego goals agendas, hidd agendas, jo security,
s, den ob
competiition, good, bad or ugly bosse and we feel we are just
d es
pawns in a game of ch that we are not making th strategic
n hess e he
moves. End all of that first!
t
ange the Proce
2.6 Cha ess
Fig
igure 3 – Fillin out FMEA Spreadsheet Vertically
ng Sp
Reaalize that every
ything is a proc and findin If you
cess ng.
can’t de escribe the proc you are wo
cess orking in now, you know
,
Co
ompletion of th FMEA is do in 4 steps
he one
little abo it. There is no one process; there is onl one
out s ly
 Initial te (3-4 indiv
eam viduals) comple the pre-wo
etes ork
organiza ation and missiion. What ther is in all of th is the
re his
and the 1st 4 columns (e.g. Function, Fails, Effects &
,
science of Process. Th interconnected operations within and
he
Severityy)
between functions; def
n fined by input and output, co
ontrols and
 All Fail rated 9-10 on severity (e.g. Critical Zone 1)
ls n
resource [machine, m method, et
es man, tc.]. Whatever processes
r
are addrressed 1st by elliminating and/ protecting the
/or t
you are working under making them flow with inc
r, m creased
custome form the eff
er fect.
knowled (as oppose to withholds helps the flow
dge ed s) w.
 A secon set of focuse teams (3-4 people each)
nd ed p
complet the causes an likelihoods of the remaini
te nd ing Lea arning to talk p
process during the process hel
lps
failures everyon connect the d
ne dots. We find t what looks like
that s
 The thir set of focuse teams identi the action to
rd ed ify o human e error is really p
process error. The Japanese c it Poka
call
eliminate the causes fo those fails most likely to
or m Yoka (mmistake proofin knowing hu
ng umans make mi istakes).
occur This is t level we mu travel to ge into FMEA o FMEA
the ust et on
and why it can succeed or fail.
y d

7. The best approach to solving problems, according to failure modes in mind. Good manager is the operable phrase.
Covey’s Seven Habits of Effective People is to stamp it out What makes a good manager or otherwise may have its root
before it grows. FMEA tends to want not to stamp it out; but definition in the ability to get past failure mode and into
rather process it out thru change. success.
Solving little problems before they grow is great. But You’ll note a number at the end of each one of the
logging them so that they are identified and simply “done” suggested failure modes prepared by the team of managers.
will alert new designers of the same problem and thusly This number in parenthesis reflects The level of risk/closure;
accomplish what FMEA is about—teaching and capturing higher being safer. It is a no brainer for Management,
knowledge. Shareholders, Board Members, Directors, VP’s and
Supervisors to understand that the focus of all resources
Understanding how some people and organizations are should be on the lower numbers with dialog discussing
successful and others are not can be found in this solutions. Any variation from that is deviation from
understanding of how to deal with day to day issues while specifications. While responsible parties are people and
operating within a process and strategy. people will be people, it is best to learn when some people are
better off competitors.
The FMEA of FMEA requires a culture that loves to
break it down and get into the matter here and now. The plan
Business Failure Modes:
[Reliability Plan] defines the requirements and is built from
FMEA of FMEA because it understands that processes and
1. Failure of concept / product / idea – The technology
people breakdown; under the Chaos Theory.
may not have the benefits anticipated or it may not be possible
To bring you and your team thru a Change Process to to implement it in a practical product (3)
meet these requirements takes about six months of almost Solution: Perform a technology FMEA to ensure the risks
daily focus [two hours a week] discussing processes; just a can be overcome.
practice. The language of FMEA is important because it is
defined by standards and leaves little room for variation. 2. Failure to secure funding – Given the current climate
in the financial markets, there is considerable risk that the firm
A list of Failure Modes to Monitor does not only pertain will be unable to secure the needed funding, especially at
just to a part. It pertains to the process, the people, the terms favorable to the firm. (6) Solution: Working with
machines, etc. A corporate culture that speaks of this process several budget sources.
and improvement with updates and training is successful.
3. Product not manufacturable at the cost target – The
2.7 Direct Your Actions costs of goods, packaging, or other costs may be so high and
not amenable to reduction that the product cannot be
A good FMEA will NOT be agnostic. It will be directed! profitably produced. (2)
Just as the Board of Directors direct the company, so too does Solution: Preliminary quotes reflect tolerances within
your FMEA Process. Just don’t chase $10 solutions to solve normal mfg.
$1 problems. FMEA must present the numbers; even if it is
“guestimates” and not taking the time to fully understand 4. Lack of market acceptance – The anticipated market
process impact with each failure mode is a failure mode. may not develop if the product is found unacceptable for any
reason, including price, usability, effectiveness, or other
The FMEA is a list of things that could fail and a reasons. (4)
responsible analysis that includes qualification and Solution: Met with consumer, government and tested
quantification of risk and improvement. If you can’t quantify responses. The uncertainty comes only because product has
how much improvement will be made, then it is likely not been released; not from technical centers.
management will not agree to the change and then the FMEA
will have been a waste of time. 5. Failure to secure channels – The plan assumes that
effective marketing and distribution channels can be secured
at modest cost. Should these channels be unavailable or
3 FMEA OF A COMPANY – A CASE STUDY disinterested, marketing and distribution costs could be so
high as to make the business unviable. (7)
Use FMEAs not just to analyze how a product or process
Solution: We have initiated strategic partnerships with
can fail but how a company can fail. Here is a case study of
channel leaders and the FCC and major manufacturers. In
how one individual went through a FMEA to make sure he got
securing approval from these groups, we will ride on existing
the product to market successfully. You’ll note in the list
channels at virtually little cost.
herein, there is little discussion that can’t be resolved with
good managers managing day to day operations with these
6. Growth too slow – If growth rates are substantially

8. below those projected, investors or essential partners, flows. Should such funds become unavailable, or should the
suppliers, and others may become uncooperative. (7) cost of such funds be uneconomic, this could result in
Solution: This relates to three concurrent factors: termination of operations. (4)
Product Development (9), Sales Process (6) & Manufacturing Solution: Product Pricing and costs are strictly controlled
Process (6). To a degree in early start-up modes these are at this point and a cash flow management program is under
often combined on the spot and spur of the moment. There are development. In doing so, we can predict long term impacts
overhead factors driving this and as business progresses they on minor changes today.
know they will. Still, they need to deliver in a Rush Job
Scenario. This is a cultural condition set up by top 12. Failure to reach agreement on business issues –
management as a driver of resources. Fractionation or unresolved disputes within the organization
could lead to an inability to effectively conduct a profitable
7. IP is successfully challenged – Failure to successfully business. (3)
defend the protective intellectual property in a challenge could Solution: This in fact did happen where the original
open the door to effective competition. (6) owners agreed only to selling in early niche market; a safe and
Solution: There is little action that can be done to prevent proven strategy] while upper management [suits] wanted to
this; however, if such a hole in the patent exists, our shoot for their wads quickly and make a bunch of money;
competitive nature for cost, delivery and service will support assuming that is reality. The cancelled all agreements,
our recovery from this. This is fact was the catastrophic contracts and liquidated the company.
failure mode and knowing and recording actually stopped it
from occurring. The mark of a good Failure Mode and Effects 13. Cash depletion – Any of a number of scenarios that
Analysis. result in unexpected expenditures or in adverse cash flow
could lead to depletion of cash resources and the inability to
8. Failure to secure IP – Lack of protection of the continue business activities. (4)
fundamental intellectual property both in the United States as Solution: See item 11.
well as throughout the world could provide openings for
effective competition. (6) 14. Failure to locate and retain key people – Certain
Solution: Patent searches and analyses on various patents people will be essential to the success of the enterprise.
appear similar but not to current product. Failure to locate and hire them in a timely manner, or failure
to retain them once hired could be fatal to the firm. (3)
9. Long IP fight – If the IP is challenged, a protracted Solution: We only seeks top end leaders who understand
legal battle could exhaust the firm’s resources and result in that the details are so important, it’s hard to realize there is any
failure by default. (6) big picture.
Solution: There is little action that can be done to prevent
this; however, by aligning ourselves with two of the world’s 15. Regulatory issues – An adverse regulatory
leading law firms and including legal expenses in the business environment or ruling could make the product unviable. (3)
plan as part of the process MJI believes that ultimately, Solution: For our product, the US Govern 508
prudent approaches would prefer initiating an IP agreement as Implementation for ADA Requirements are helping introduce
an effort to position themselves in the market. This could the product. Implementation of regulatory support to FCC
work to MJI’s advantage since MJI is clearly advanced in the Harmonization Efforts via petitions reveal our product is
development and release. This actually did work and MJI leadership and disruptive and that all regulatory agencies are
used Silicon Valley’s top IP and litigation law firm driven by a aware and have ruled on support; one way or another.
senior partner. It did indeed reflect the highly competitive
nature of life.
REFERENCES
10. Effective competition – Despite IP coverage, a
competitor may discover an alternative solution to the problem 1. Silverman, Mike. “How Reliable Is Your Product: 50
or may simply elect to manufacture and sell a competing Ways to Improve Product Reliability”, Superstar Press,
product and assume the risk of suit. (4) Dec 2010.
Solution: As long as you are on top in a growing market,
BIOGRAPHIES
you can’t avoid competitors so just hold the course and make
sure you stay ahead. Mike Silverman
Ops A La Carte
11. Cannot secure operating and production funds – In 990 Richard Ave., Suite 101
order to grow at the projected rates, we will need to secure Santa Clara CA 95050
operating funds for supporting production purchases, etc. (408) 654-0499 x201
These funds should come from customer sales only and based
e-mail: mikes@opsalacarte.com
on projected sales price, volumes and net profit and cash

9. Mike Silverman is Managing Partner of Ops A La Carte, a first sustainable ISO 9000 Management System for a CM in
Reliability Consulting firm. He has over 25 years of 1993 that became an international benchmark capturing and
experience in reliability engineering, reliability management holding most of the Valley’s major contracts for medical
and reliability training. He is an experienced leader in robotics, proton accelerometer positioning tables, human
reliability improvement through analysis and testing. Mike is network audio video and virtual reality theatres to name a few.
also an expert in accelerated reliability techniques, including Jim’s experience in embedded cell phone technology,
HALT and HASS. Through Ops A La Carte, Mike has had embedded fingerprint readers and supplying the Bay Area
extensive experience as a consultant to high-tech companies, with the first portable video recorders and mobile phones in
and has consulted for over 500 companies in over 90 different the 70’s has given Jim a well-rounded understanding of
industries. Mike just completed his first book on reliability product realization from the board decisions to the shipping
entitled “50 Ways to Improve Your Product Reliability”. Mike clerk’s procedure. After his honorable discharge serving
has also authored and published 20 papers on reliability Nuclear Arms and Auto Flight and Stability Augmentation
techniques and has presented these around the world. He has Systems during Viet Nam, Jim has served unendingly on the
also developed and currently teaches over 30 courses on principles of continuous improvement. In 2000, he perceived
reliability techniques. Mike is a Certified Reliability Engineer a solution and patented the world’s first micro interferometric
(CRE) through American Society for Quality (ASQ). Mike is array cell phone antenna by pulling consortiums of engineers
a member of ASQ, IEEE, SME, ASME, PATCA, and IEEE together in support of the 100’s of millions of hard of hearing
Consulting Society. Mike is currently the IEEE Reliability people using cell phones around the world. In taking this
Society Santa Clara Valley Chapter Chair. branded “Vortis” to Washington, Jim then assisted in the
removal of exemptions given to antenna designers while
James Johnson
demonstrating how to mitigate half of the lost and wasted
Ops A La Carte
energy to the 4 billion customer’s heads. Jim has given
990 Richard Ave., Suite 101
technology talks around the world and has a simple message:
Santa Clara CA 95050
“an ounce of prevention does, actually save a pound of cure.!”
(408) 654-0499 x206
As a Professional Forensic Management & Reliability Expert
e-mail: jimj@opsalacarte.com
Jim has developed for Ops A La Carte an "Ounce of
James (Jim) R. Johnson has over 30 years executive Prevention Strategy" Program designed as a comprehensive,
management and High Technology business leadership qualitative and quantitative solution to 1) risk management, 2)
experience in small and large Original Equipment failure mode and warranty analysis, 3) cost of quality plan
Manufacturing (OEM) and Contract Manufacturing (CM). dash boards and 4) training toward a sustainable culture of
Jim has served in areas of engineering design, supply chain preventive action while preventing catastrophic failures.
management and corporate quality assurance. Jim’s work has
led to many record breaking implementations including the