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Featured Avoid Failure When Using Failure Modes and Effects Analysis (FMEA)

Avoid Failure When Using Failure Modes and Effects Analysis (FMEA)

FMEA is a risk assessment tool. Through the structured approach of an FMEA, improvement teams identify possible ways in which a product or process can fail, specify the subsequent effects, quantify the severity of those potential failures, and assess the likelihood of their occurrence. FMEA can be used to rank and prioritize the possible causes of failures as well as develop and implement preventative actions, with responsible persons assigned to carry out these actions.

Failure Modes and Effects Analysis (FMEA)

Failure Modes and Effects Analysis (FMEA)

A systematic and semi-quantitative tool, an FMEA is usually created with a template (or a spreadsheet). The template, an example of which is shown below, guides the general steps for conducting an FMEA:

  1. Identify the steps of a process, or parts of a product.
  2. Identify possible failures modes. (In what way can the product or process fail? What can go wrong?)
  3. Identify the failure effects. (What is the impact on key process measures or product specifications?)
  4. Assess the severity of the potential failure. (How severe is the problem to the customer? 1 = least severe, 10 = most severe)
  5. Identify the potential causes of the failure.
  6. Assess the occurrence. (How frequently is this failure likely to occur? 1 = low occurrence, 10 = high occurrence)
  7. Identify the current detection modes. (What are the existing controls that either prevent the failure from occurring or detect it should it occur?
  8. Assess the detection of the failure. (How easy is this failure to detect?)
  9. Calculate the risk priority number, or RPN. (RPN = severity * occurrence * detection)
  10. For the potential failures with the highest RPN, create mitigation plans.
  11. Once the actions have been taken, recalculate the RPN to confirm the failure risk has been reduced.

Example of FMEA – graphic excerpted from “Leverage Six Sigma to Manage Operational Risk in Financial Services” at http://www.isixsigma.com/industries/financial-services/leverage-six-sigma-to-manage-operational-risk-in-financial-services/ (Click to enlarge)

Example of FMEA

Besides the obvious benefits of reducing product or process failures, an FMEA also has the benefit of capturing the collective knowledge of a team, documenting and tracking risk-reduction activities, and providing historical records for baseline performance.

To learn more about FMEA and related topics, refer to the following articles, discussions and Cox-Box cartoons on iSixSigma.com:

Additional resources are available for purchase on the iSixSigma Marketplace:

To read more FMEA articles, click here.

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Comments

Nik

Disappointed: Article is basically a high level overview of the process, not much specific guidance on how to “avoid failure” as title promises.

Katie Barry

@Nik — I’m sorry this overview of FMEA wasn’t what you were looking for. I hope that one of the links to other iSixSigma content provides the answers you are seeking.

JLB78

Nik, would you like the article to hold your hand and do your job for you?

In case context clues doesn’t work for you “Avoid Failures” is obviously a play on words. From reading this article, it’s not that hard to understand that it provides info on what a FMEA is, how to construct it, and how to “fill in the blanks.” If you really need more detail than that than perhaps you should not be reading this article.

Amaan Raza

Must admit a touch dissappointed the article does not live up to the promise of its title
I was hoping it would touch upon commonly committed mistakes while deploying the fmea
I will attempt to throw some light out of my experential learning

1) pay special attention to choose the focus group for the brainstorming preferably members grom different subprocesses can give you different perspectives of failure modes

2) The rating of the detection,occurence and severity to be predetermined and made objective as opposed to allowing it to be at the discretion of the group

3) Fmea to be revisted once in 6 months and not to be considered as a one time activity

Katie Barry

@ Amaan Raza — As with Nik above, I’m sorry this overview of FMEA wasn’t what you were looking for. I hope that you find one or more of the links to other iSixSigma content better suited to your needs.

Peter T. To

For articles on technical topics like FMEA for Black Belt audience, I feel that catchy titles often used in tabloids can have significant detrimental effect not only on the author, but also the website/organization. The simple title “Overview of FMEA”, may sound too plain, but I think it’s the most appropriate one.

Katie Barry

@Peter — Thank you for your feedback.

Tom Shepardson

Good reminder of this tool that I learned in college but seldom used throughout my career except when we did the RMP Risk Management Plans for Chlorine System at the water company where I worked. I actually assisted in organizing the Process Safety which this is just one part of. I thought its strengths were using personnel in the organization that knew the process could use that knowledge to brainstorm what could possibly happen under a tutelage of an experienced engineer in the process. They developed scenarios on what could go wrong and then develop process charts to identify failure modes. These then would be part of the training process for prevention, mitigation and lessening the potential should certain events take place.

Probably much similar to some of the product, pharma and other process companies use day in and day out in startups and later in operations to keep themselves out of the news should some of these rar events take place. Ask the people that were involved in the Deepwater Horizon if it could have helped.

(Crossposted from the iSixSigma Network on LinkedIn.)

Dan Bucsko, MBA, MHA, FACHE, CMPE, CPHRM

The FMEA ( or HFMEA in healthcare) is a very useful too in our processes to identify process defects prior to placing a patient in harm’s way. This is primarily the foundation principles of the Patient Safety movement which focuses on proactive approaches system defects that set humans up to fail. Risk Management on the other hand is retrospective to use Root Cause Analysis (RCA) to understand what causal factors led to in incidents. The fishbone is also used with the RCA and is of great help. I’d support the use of the FMEA in every process and the critical involvement of front line staff and customers that see the problems/defects. Great tool!

(Crossposted from iSixSigma Network on LinkedIn.)

Peter Peterka

FMEA is a simple process, but can be complicated without the right training. I believe this article provided a good overview of the concepts, but to truly understand FMEA you need to complete the right Six Sigma training.

JLB78

Regardless of the high expectations that people have regarding this article, it was put together well because I can take from this article what a FMEA is, how to construct it and how to analyyze and prioritize the failures within a process. Simply put, it’s not that difficult to do.

Too many people want hand-holding nowadays instead of taking a nugget of information and running with it on their own.

holly

really helpful which gave me clarity.
Thank U



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