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The Failure Mode Effects Analysis (FMEA) tool highlights areas of high product design or process execution risk. This tool provides insight into possible causes for observed failures.
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Quick reference
FMEA Principles
The Failure Mode Effects Analysis (FMEA) tool highlights areas of high product design or process execution risk. This tool provides insight into possible causes for observed failures.
When to use
The FMEA can provide insight during the Measure phase concerning the likely causes of observed failures. This can be used to focus the data gathering and measurement activities. Depending upon the nature of the improvement, an FMEA should be created during the Improve phase.
Instructions
Developing an FMEA is addressed in a separate GoSkills training program, so in this program the focus will be on how to use the results of the FMEA to assist a Lean Six Sigma project team.
Measure Phase
The FMEA identifies and scores possible product or process failures. As part of the analysis, the FMEA identifies potential causes for failures and the inspection/test/control techniques that are embedded within the product or process to eliminate or contain the failures.
If a failure mode or customer complaint is one that was identified on the FMEA, data from the potential causes should be collected to determine which of these contributed to the problem. Also, data from the inspection/test/control attributes of the product or process should be collected to determine if they are adequate to identify and contain the problem.
Improve Phase
Solution for identified root causes often include redesign of product or process attributes. If an FMEA for the original product or process exists, it should be updated. If no FMEA exists, the Lean Six Sigma team should either complete an FMEA or conduct other design risk analyses to ensure that the product and process that are released are robust and not likely to create critical failures for the customer.
Hints & tips
- To learn how to create an FMEA, take the GoSkills FMEA course.
- Many organizations have treated an FMEA as a “check the box” item on a compliance checklist and have not used it as a legitimate design risk analysis tool. If you are working with that type of FMEA, it will be of little value to you.
- To use the FMEA in the Measure phase, find the failure(s) that corresponds with the problem(s) you are analysing. Then collect data on the causes and detection systems for those failures.
- 00:05 Hi, I'm Ray Sheen.
- 00:06 There's an excellent risk management tool called the failure mode effects analysis
- 00:10 or FMEA.
- 00:11 They can help a Lean Six Sigma team know where to focus their process measurement
- 00:16 and data gathering activities.
- 00:18 Now let's take a look at it.
- 00:20 A failure mode and effects analysis is a technique developed by NASA during
- 00:24 the 1960s as they were working on the Apollo mission.
- 00:28 So I guess you could say it's rocket science, but don't let that worry you.
- 00:32 It's not overly complex.
- 00:34 FMEA is a documented and well established methodology that has been around for
- 00:38 50 years.
- 00:39 An FMEA identifies the documents what could go wrong on a product or
- 00:43 a process and what the organization has done to design the problem away or
- 00:48 to find them fix it before they ask the customer.
- 00:51 FMEA does this by asking what multiple times.
- 00:55 The first what is what could go wrong?
- 00:58 Building on the first what is the second what.
- 01:01 What is the impact of effect of that going wrong?
- 01:03 Essentially asking, so what?
- 01:06 The third what is to ask the question, what could cause that?
- 01:09 There may be multiple answers to that question and
- 01:12 each will need to be analyzed.
- 01:14 Another key question to ask then is what countermeasures are in place.
- 01:18 Some risk can't be avoided, but the business can take numerous actions to be
- 01:22 prepared and protect itself from that risk.
- 01:25 This question is to identify all of those responses, and
- 01:29 if the response is inadequate, the FMEA methodology asks the question
- 01:33 what can we do to improve the product or process to avoid or mitigate that risk.
- 01:39 A powerful aspect of the FMEA methodology
- 01:42 is that it is recording the answers to all these questions and scoring those answers.
- 01:46 Those scores can serve to prioritize the likely causes of problems and the need for
- 01:51 improvement actions.
- 01:51 Let me show you a picture of how this works.
- 01:55 The FMEA is normally documented in a customized spreadsheet.
- 01:59 It starts with the list of all of the product or process functions.
- 02:03 Then for each of those functions, failure modes have been identified.
- 02:07 It is important to list all of the failure modes even if they have not occurred yet,
- 02:11 or even if some of the team thinks that the failure is irrelevant.
- 02:14 The great thing about this methodology is that if that failure mode is irrelevant,
- 02:20 the scoring will quickly identify that and
- 02:22 give the team the analytical rationale for why they can ignore it.
- 02:26 Now each of those failure modes is scored in three ways.
- 02:30 First, a failure mode is scored for its severity.
- 02:33 When the failure occurs, what is the impact to the customer?
- 02:36 This score is normally from 1 to 10, with 10 being the score for
- 02:40 a calamitous crisis, and 1 being the score for
- 02:43 something that is not even noticed by the customer.
- 02:46 Next, each of the potential causes of that failure mode are listed.
- 02:51 And they are score based upon the frequency of occurence of those causes.
- 02:55 If it happens frequently it gets scored at 10.
- 02:58 If it has never occurred and is only hypothetical, well it's scored to 1.
- 03:02 The third score is a score of the building, of the product or
- 03:06 process user to detect the cause or the failure and control the impact.
- 03:11 A failure mode that could not be recognized until the disaster has occurred
- 03:15 is scored a 10 and a failure mode that is prevented from ever occurring is a 1.
- 03:22 The scores are then multiplied together to create a risk priority number for
- 03:25 each failure mode and cause combination.
- 03:29 All of this is documented on a form or spreadsheet.
- 03:32 There are many different variations of this form and
- 03:34 most companies create their own unique one.
- 03:36 If you want to know more about this technique we have a GoSkills course that
- 03:40 teaches this methodology.
- 03:43 With all of this as background let's look at how we use FMEA
- 03:46 in a Lean Six Sigma project.
- 03:48 There are several types of FMEAs but
- 03:51 the two most commonly used ones are the design FMEA and the process FMEA.
- 03:56 The design FMEA focuses on the customer user of a product and
- 04:00 what could go wrong for them.
- 04:02 The process FMEA is typically internally focused
- 04:06 considering the failures of the process steps, equipment and procedures.
- 04:10 If your organization uses FMEAs,
- 04:13 they're a big help to the Lean Six Sigma team in the measure phase.
- 04:17 It will list all the types of failures and
- 04:19 in particular, how the failure will likely manifest itself.
- 04:22 This can focus the data collection activities for
- 04:25 the Lean Six Sigma team, helping them to avoid wasting time collecting data that
- 04:30 is not going to be relevant to the problems or complaints that you have.
- 04:34 FMEA has also a great tool for prioritizing improvement actions. That is
- 04:38 one of the reasons that I recommend that Lean Six Sigma teams do an FMEA for
- 04:42 their process improvement even if the organization does not require it.
- 04:47 But that's something that will apply in the Improve phase of the project.
- 04:51 FMEA is also a great means of documenting the impact of a lean six sigma improvement
- 04:57 by using the FMEA scores in the before case and
- 05:00 the after case to show the reduction in the business risk.
- 05:06 If you have access to an FMEA, it can guide your work during the Measure phase.
- 05:11 And creating an FMEA will be a big help to teams in the future.
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