9/29/15 10 Steps to Creating a FMEA

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10 Steps to Creating a FMEA Never Miss New Content

June 28, 2007 By Ron Pereira 17 Comments
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A Failure Modes Effect Analysis (FMEA) is an extremely powerful tool that anyone can, and Enter your email address:
will, benefit from no matter your occupation or status in life.

Tonight, we’ll discuss the history of the FMEA, the different types of FMEA, and finally how Subscribe
to actually construct one. At the end of the post is a free FMEA template for your
downloading pleasure.

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History
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The FMEA is not a new tool. The aerospace industry used the FMEA during the Apollo
missions in the 1960s. Later in 1974 the US Navy developed MIL-STD-1629 which discussed
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the proper use of the tool. And around this time the automotive folks latched onto the tool
and never let go. Today, the FMEA is universally used by many different industries.

Type of FMEA
There are three main types of FMEA in use today.

1. System FMEA: Used to analyze complete systems and/or sub-systems during the
concept of design stage.
2. Design FMEA: Used the analyze a product design before it is released to
manufacturing.
3. Process FMEA: Used to analyze manufacturing and/or assembly process.

The Process FMEA is probably the most commonly used and is also the least complex, in
most cases.
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10 steps to creating a FMEA
GA 077 | How an Engineering Manager
1. List the ke y proce ss ste ps in the first column. These may come from the Practices Lean with Rob Connelly
highest ranked items of your C &E matrix.
Missing the Soil, or The Inadequacy of
2. List the pote ntial failure mode for e ach proce ss ste p. In other words, figure
Our Lean Management Metaphors
out how this process step or input could go wrong.
3. List the e ffe cts of this failure mode . If the failure mode occurs what does this Standard Work Saved a Company
mean to us and our customer… in short what is the effect? GA 076 | The Courage to Lead with
4. Rate how se ve re this e ffe ct is with 1 being not severe at all and 10 being Simon Sinek
extremely severe. Ensure the team understands and agrees to the scale before you
start. Also, make this ranking system “your own” and don’t bother trying to copy it out
of a book.
5. Ide ntify the cause s of the failure mode /e ffe ct and rank it as you did the effects
in the occurence column. This time, as the name implies, we are scoring how likely
this cause will occur. So, 1 means it is highly unlikely to ever occur and 10 means we
expect it to happen all the time.
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6. Ide ntify the controls in place to de te ct the issue and rank its effectiveness in
the detection column. Here a score of 1 would mean we have excellent controls and Search
10 would mean we have no controls or extremely weak controls. If a SOP is noted
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9/29/15 10 Steps to Creating a FMEA

here (a weak control in my opinion) you should note the SOP number.
7. Multiply the se ve rity, occurre nce , and de te ction numbe rs and store this value
in the RPN (risk priority number) column. This is the key number that will be used to
identify where the team should focus first. If, for example, we had a severity of 10
(very severe), occurrence of 10 (happens all the time), and detection of 10 (cannot
detect it) our RPN is 1000. This means all hands on deck… we have a serious issue!
8. Sort by RPN numbe r and ide ntify most critical issue s. The team must decide
where to focus first.
9. Assign spe cific actions with re sponsible pe rsons. Also, be sure to include the
date for when this action is expected to be complete.
10. Once actions have be e n comple te d, re -score the occurre nce and de te ction.
In most cases we will not change the severity score unless the customer decides this is
not an important issue.

Dynamic Document
The single biggest failure people make with FMEAs is to spend time completing the
document and then storing it in a file cabinet somewhere. The FMEA is the ultimate
dynamic document meaning it lives as long as the process or product it is associated with
does. Please use them!

Free Template
Here is a free FMEA Te mplate for your use. Simply “right click” the link and choose “Save
Target As.”

Feel free to share this template with as many people as you like. Also, please e mail me if
you have any questions about this or any other continuous improvement topic.

Learn More
If you’re interested in learning much more about creating FMEAs and other problem solving
tools please be sure to explore Gemba Academy’s School of Six Sigma where we now
offer more than 200, highly engaging, training videos.

We also offer formal Black Be lt C e rtification for those interested.

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Comments

Jon says:
June 28, 2007 at 8:07 pm

Great post. Very useful. Thanks.

Reply

Ron says:
June 28, 2007 at 8:36 pm

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9/29/15 10 Steps to Creating a FMEA

No problem. Glad you liked it Jon.

Reply

vern greene says:

July 2, 2007 at 7:43 am

It may be easier to understand and keeping with the high numbers being bad, if you
look at 6. above as being the “probability” or chance that the error will reach the
customer. From teaching many Green Belts, I find that they generally find it easier to
understand.

Reply

Gar says:
July 2, 2007 at 6:58 pm

Excellent post. Having recently moved from a very large and strictly controlled
organisation, process wise and with a heavy focus on quality, to a ‘less focused’ and
much smaller organisation, its uselful for me to see the workings behind decisions I
previously took for granted.

Reply

Ron Pereira says:

July 2, 2007 at 7:30 pm

@ vern – Great point and one I should have mentioned. Thanks for pointing it out.

@ Gar – Thanks for the compliment. I am glad you found it useful. Please let me know
if you ever have any questions or have an idea for a future topic that may help you out.

Reply

Rosalina says:
September 16, 2008 at 11:33 am

I recently attended to a FMEA 4th edition training and the trainer said that the Key
date in the PFMEA header must be keep updated, I did not know this, but he said that
every time we update the PFMEA to implement new actions adding the promise dates
for implementation, these dates shall not exceed the new key date.
Can somebody tell me if this is true. I read the FMEA manual and I did not find any
comment regarding this.

Reply

Ron Pereira says:

September 16, 2008 at 9:06 pm

Hi Rosalina, this sounds logical but I wouldn’t get too worried about details such as
this… you’ll be better off focusing your energy on driving actions based on the results
of FMEA. Good luck!

Reply

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9/29/15 10 Steps to Creating a FMEA

Joachim says:
October 13, 2008 at 12:06 pm

The key date can’t be any later than the PPAP due date.
Any revisions made to the fmea should be dated in the Revision Date.

Reply

cisca says:
October 17, 2008 at 2:22 am

Do this 10 steps still valid for new 4th FMEA? I think we should consider step 7 and 8,
since now, we can use another focus than RPN, e.g. SOD, SO and SD. Correct me if I’m
wrong. http://cisca.co.nr

Reply

Ken says:
April 29, 2009 at 12:36 am

Excellent post. Simple and very helpful. Tks.

Reply

suresh kaikadi says:

August 9, 2009 at 7:40 am

I take training fmea from you,

Reply

Jeff says:
April 18, 2012 at 11:02 am

Hey there’s some great FMEA info here I love it. I’m wondering though if there are any
other websites where I can find FMEA worksheets or FMEA templates to download?

Reply

Varun says:
June 5, 2013 at 1:50 am

what is the minimum rpn that requires our attention?

Reply

Ron Pereira says:

June 5, 2013 at 7:34 am

Hi Varun, this will depend on each situation… you’ll want to start at the highest and
work your way down… the team will need to decide when “no action needed” is an
acceptable decision. Thanks for the comment!

Reply

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9/29/15 10 Steps to Creating a FMEA

Varun says:
June 5, 2013 at 7:59 am

Hi Ron..Thanks a lot for the reply..

Reply

Eric says:
May 23, 2015 at 4:48 pm

Great post!

Here is another handy FMEA template: http://www.hitdocs.com/fmea-template-xlsx/

Reply

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