Intro to FMEA

Quick reference

• 00:04 Hi, I'm Ray Sheen.
• 00:06 There's an excellent risk management tool called the Failure Mode Effects Analysis,
• 00:11 or FMEA, that can help a Lean Six Sigma team know
• 00:13 where to focus their process measurement and data gathering activities.
• 00:18 Now, let's take a look at it.
• 00:20 The failure mode effects analysis is a technique developed by NASA during
• 00:24 the 1960s as they were working on the Apollo missions.
• 00:27 So I guess you could say it's rocket science, but
• 00:31 don't worry, it's really not that hard to work with.
• 00:34 FMEA is a documented and well-established method that has been around for 50 years.
• 00:40 And FMEA identifies and documents what could go wrong on a product or
• 00:45 process, and what the organization has done to design away the problem or
• 00:50 to find and fix the problem before it impacts the customer.
• 00:54 FMEA does this by asking what multiple times.
• 00:58 The first what is, what could go wrong?
• 01:01 Building on that, the next question is,
• 01:04 what is the effect or impact when it does go wrong?
• 01:07 Essentially asking the question, so what?
• 01:10 The third what is to ask the question, what could cause that?
• 01:15 There may be multiple answers to that one, and each one will need to be analyzed.
• 01:20 Another question we asked about each of those causes is,
• 01:24 what countermeasures are in place?
• 01:26 Risks can't be avoided, but
• 01:28 businesses can take numerous actions to be prepared and protected from the risks.
• 01:33 This question is to identify all of those responses.
• 01:37 And if the response is inadequate, the FMEA methodology asks the question,
• 01:43 what can we do to improve the product or process to avoid or mitigate the risk?
• 01:49 A powerful aspect of the FMEA methodology is that it is recording the answers to
• 01:54 all of those questions and scoring those answers.
• 01:57 These scores can serve to prioritize the likely causes of problems and
• 02:02 the need for improvement actions.
• 02:04 Let me show you a picture of how this works.
• 02:07 The FMEA is normally documented on a customized spreadsheet.
• 02:11 It starts with the listing of all the product or process functions.
• 02:16 Then for each of those functions, the failure modes have been identified.
• 02:20 It's important to list all the failure modes even if they've not occurred yet, or
• 02:25 even if some of the team thinks that the failure is irrelevant.
• 02:28 The great thing about this methodology is if that failure mode really is irrelevant,
• 02:33 well, the scoring will quickly identify that and
• 02:36 give the team the analytical rationale for why they can ignore it.
• 02:40 Now, each of these failure modes is scored in three ways.
• 02:44 First, the failure mode is scored for its severity.
• 02:47 When the failure occurs, what's the impact on the customer?
• 02:51 The score is from 1 to 10, with 10 being the score for a customer crisis,
• 02:57 and 1 being the score for something that is not even noticed by the customer.
• 03:02 Next, each of the potential causes of the failure mode are listed, and
• 03:07 then they are scored based upon the frequency of occurrence of those causes.
• 03:12 If it happens frequently, it scores a 10.
• 03:15 If it's never occurred yet, but
• 03:17 theoretically possible, well, it scores only a 1.
• 03:21 The third score is a score of the ability of the product or
• 03:25 process user to detect the cause of the failure and control the impact.
• 03:29 A failure mode that could not be recognized until the disaster has
• 03:34 occurred is score a 10.
• 03:36 A failure mode that is prevented from ever occurring by the inherent design
• 03:41 of the product or process is scored a 1.
• 03:43 The scores are multiplied to create a risk priority number for each failure mode and
• 03:48 cause combination.
• 03:49 All of this is documented on a form or spreadsheet.
• 03:53 There are many different variations of this form, and
• 03:56 most companies create their own.
• 03:57 If you want to know more about this technique,
• 04:01 we have a GoSkills course that teaches the methodology.
• 04:04 With all that background, let's look at how we would use the FMEA in
• 04:08 a Lean Six Sigma project, in particular, during the Measure Phase.
• 04:12 There are several types of FMEAs, but
• 04:15 the two most commonly used types are Design FMEA and Process FMEA.
• 04:20 The Design FMEA is focused on the customer or user of a product and
• 04:23 what could go wrong for them.
• 04:25 The Process FMEA is typically internally focused considering the failures of
• 04:30 the process steps, equipment, and procedures.
• 04:33 If your organization uses FMEAs,
• 04:35 they're a big help to the Lean Six Sigma team in the Measure Phase.
• 04:38 It will list all the types of failures, and in particular,
• 04:42 how that failure will likely manifest itself.
• 04:45 This can focus the data collection activities for the Lean Six Sigma team.
• 04:50 FMEA is also a great tool for prioritizing improvement actions.
• 04:54 This is one of the reasons that I recommend Lean Six Sigma teams do an FMEA
• 04:58 for their process improvements, even if the organization doesn't require it.
• 05:03 But that's something we'll talk about more when we get to the Improved Phase of
• 05:06 the project.
• 05:07 FMEA is also a means of documenting the impact of a Lean Six Sigma
• 05:11 improvement by using the FMEA score to show a reduction in business risk.
• 05:17 Let me show you an example of a Process FMEA for assembly of a ballpoint pen.
• 05:22 The first few columns are the process steps and
• 05:25 functions performed at each step.
• 05:27 Any given step could have multiple failure modes, and
• 05:30 each of these is listed separately.
• 05:33 Then it moves to the scoring.
• 05:35 The effect is scored for severity.
• 05:37 The underlying cause of the failure is scored for its likelihood.
• 05:42 Then in this case, the process step is reviewed for prevention and
• 05:46 detection of that failure mode.
• 05:48 You can see there are several causes that are in the red,
• 05:51 meaning that they are high risk and require action.
• 05:54 The last few columns are then the resolution actions taken, and
• 05:58 the impact of those actions.
• 06:00 Once again, when I'm in the Measure Phase, I can look to my FMEA to find where
• 06:05 are all the different causes of the kind of failure modes that I have observed,
• 06:09 and it will tell me what I should be collecting data about.
• 06:13 If you have access to an FMEA, it can guide your work during the Measure Phase,
• 06:18 and creating an FMEA will be a big help to teams in the future.

Lesson notes are only available for subscribers.