FMEA Principles

Quick reference

• 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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