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Six Sigma

10 Steps to Creating a FMEA

By Ron Pereira Updated on January 23rd, 2024

A Failure Modes Effect Analysis (FMEA) is an extremely powerful tool that benefits anyone, no matter your occupation or status in life.

In this article, we’ll discuss the history of the FMEA, the different types of FMEA, and finally how to actually construct one.  At the end of the post is a free FMEA template for your use.

FMEA History

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 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 the design stage.
  2. Design FMEA: Used to analyze a product design before it is released to manufacturing.
  3. Process FMEA:  Used to analyze manufacturing and/or assembly processes.

The Process FMEA is probably the most commonly used and is also the least complex, in most cases.

10 steps to creating an FMEA

  1. List the key process steps in the first column.  These may come from the highest-ranked items of your C&E matrix.
  2. List the potential failure mode for each process step.  In other words, figure out how this process step or input could go wrong.
  3. List the effects of this failure mode. If the failure mode occurs what does this mean to us and our customers… in short, what is the effect?
  4. Rate how severe this effect is with 1 being not severe at all and 10 being 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. Identify the causes of the failure mode/effect and rank it as you did the effects in the occurrence column.  This time, as the name implies, we are scoring how likely this cause will occur.  So, 1 means it is doubtful to ever occur, and 10 means we expect it to happen all the time.
  6. Identify the controls in place to detect the issue and rank its effectiveness in the detection column.  Here a score of 1 would mean we have excellent controls and 10 would mean we have no controls or extremely weak controls.  If a SOP is noted here (a weak control in my opinion) you should note the SOP number.
  7. Multiply the severity, occurrence, and detection numbers 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 number and identify the most critical issues.  The team must decide where to focus first.
  9. Assign specific actions to responsible persons.  Also, be sure to include the date for when this action is expected to be completed.
  10. Once actions have been completed, re-score the occurrence and detection.  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 Excel FMEA Template

Here is a free Excel FMEA Template for your use.

Feel free to share this template with as many people as you like.

Learn More

If you’re interested in learning much more about creating FMEAs and other problem-solving tools, be sure to explore Gemba Academy’s FMEA Course.

We also offer Lean Six Sigma certifications for any skill level or budget.


  1. Jon

    June 28, 2007 - 8:07 pm
    Reply

    Great post. Very useful. Thanks.

  2. Ron

    June 28, 2007 - 8:36 pm
    Reply

    No problem. Glad you liked it Jon.

  3. vern greene

    July 2, 2007 - 7:43 am
    Reply

    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.

  4. Gar

    July 2, 2007 - 6:58 pm
    Reply

    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.

  5. Ron Pereira

    July 2, 2007 - 7:30 pm
    Reply

    @ 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.

  6. Rosalina

    September 16, 2008 - 11:33 am
    Reply

    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.

  7. Ron Pereira

    September 16, 2008 - 9:06 pm
    Reply

    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!

  8. Joachim

    October 13, 2008 - 12:06 pm
    Reply

    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.

  9. cisca

    October 17, 2008 - 2:22 am
    Reply

    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

  10. Ken

    April 29, 2009 - 12:36 am
    Reply

    Excellent post. Simple and very helpful. Tks.

  11. suresh kaikadi

    August 9, 2009 - 7:40 am
    Reply

    I take training fmea from you,

  12. Jeff

    April 18, 2012 - 11:02 am
    Reply

    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?

  13. Varun

    June 5, 2013 - 1:50 am
    Reply

    what is the minimum rpn that requires our attention?

    • Ron Pereira

      June 5, 2013 - 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!

    • Varun

      June 5, 2013 - 7:59 am

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

  14. Rodney

    December 28, 2020 - 4:34 pm
    Reply

    The FMEA process is a lot like the TWI Job Methods process. In addition, by adding the Risk Priority Number (RPN), you get a good sense of where to start making improvements. I have to wonder if there are situations where companies are using JM, PDSA or PPS, where they could have just as well used an FMEA. What do you think?

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