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About this lesson

FMEAs are completed using a seven step process. There are minor variations in the process based upon the type of FMEA. The results of the FMEA analysis are recorded on a standard FMEA form.

Exercise files

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FMEA Process
59.9 KB FMEA Process - Solution
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Quick reference

FMEA Process

FMEA preparation normally follows a structured process and uses a standard format.  Many organizations will take an industry standard process or format and customize it based upon their local organization structure and practices.  However, the major steps still occur in the same sequence.

When to use

Whenever completing an FMEA analysis, use your organization’s process and formats.  If your organization does not have its own procedure and formats, use the ones presented in this course.

Instructions

FMEA analysis follows a common process or sequence of steps.

  1. Select the product, system, or process to be analyzed.  Ensure boundaries are clear so the team stays focused.
  2. Identify the FMEA team and schedule meetings.  Based upon the scope of the analysis, subject matter experts should be selected.
  3. Diagram the product or process and decompose it.  Design FMEAs are normally diagrammed with functional block diagrams.  Process FMEAs are normally diagrammed with a process map.
  4. Determine function and failures for each element in the diagram.  A diagram element can have multiple functions and they should be listed separately.  Each function can have multiple failures and they should be listed separately.
  5. Analyze each failure mode for severity, probability of occurrence, and capability to detect it.  Combine the three scores into a RPN value.  If appropriate, aggregate elements into sub-system or processes and repeat the analysis.  The level of aggregation is a judgement call by the team. 
  6. Implement mitigation where appropriate.  After the mitigation, the failure mode should be rescored based upon the changed process.
  7. Document results of the analysis.  On the one hand, you should be documenting everything as you go in the form.  But when the analysis is complete, date and revision control it.  It should then accompany the product or process design package.

These steps align with fields in the typical or generic Design FMEA and Process FMEA formats.

 

Hints & tips

  • Follow your organization’s process and use your organization’s forms.  If they don’t exist, the ones in this course are good examples of typical steps and forms.
  • Pick your team based upon what is in scope for the analysis.  That is why the analysis boundaries are set before the team is selected.
  • Some organizations don’t rescore after mitigation – that is a mistake.
  • The level of decomposition is a judgement call.  Try to decompose so that each functional block performs one or two steps significant to the customer.  If the block is a subsystem, treat it like it is a single component.
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  • 00:04 Hi, I'm Ray Sheen.
  • 00:06 Well, it's time to move from background and context and
  • 00:09 start to discuss how to actually complete an FMEA.
  • 00:14 We'll start with the steps in the process.
  • 00:16 The first step is pretty basic, and that's to decide what product or
  • 00:20 process you're analyzing, but it is critical.
  • 00:23 The best way to analyse complex systems is often to break them into majors subsystems
  • 00:28 so we need to decide what that subsystem architecture would be.
  • 00:31 Likewise, when analyzing a process you need to know where the
  • 00:35 process will start and stop.
  • 00:37 Next, select the analysis team.
  • 00:40 This should include subject matter experts for the product of process being analyzed.
  • 00:45 Normally it's a cross functional team representing both designers and
  • 00:48 users of the product or process.
  • 00:50 If the organization is not good at working together cross functionally
  • 00:54 you may need a facilitator too.
  • 00:56 Next, decompose the product or process normally with a diagramming technique.
  • 01:01 For the design FMEA, we'll use a block diagram and interface matrix.
  • 01:05 And for the process FMEA we'll use a process map.
  • 01:08 More about both of those in other lessons.
  • 01:11 For each part, component, or process step, identify the function it performs and
  • 01:15 the failures that could occur while performing that function.
  • 01:19 Now, analyze each failure mode and score it.
  • 01:22 If appropriate, aggregate the analysis up to a sub-assembly level.
  • 01:26 If your risk priority number for that failure mode exceeds the organizational
  • 01:30 threshold, take mitigation action to lower severity probability or
  • 01:35 to increase the detectability.
  • 01:37 And finally, make sure that you have documented all your decisions on the FMEA
  • 01:41 form or file, and that it is controlled like the other design documentation.
  • 01:46 In fact, let's walk through these seven steps with a typical generic design
  • 01:51 FMEA form and we'll see how the form will lead us through the process.
  • 01:55 In the upper left corner, we specify the part, subsystem or
  • 01:59 process that's being analyzed, that's step 1.
  • 02:02 In the upper right corner, we identify the team, and that's part of step 2.
  • 02:07 This is also where we will show the date and revision number from step 7, but
  • 02:11 since the analysis is often required at several meetings,
  • 02:14 the team will be updating this regularly.
  • 02:16 Next, we use the block diagram to identify all of the functions from
  • 02:19 the components or steps.
  • 02:21 With that list we can identify the failures for each function or component.
  • 02:25 It's common to have multiple failure modes for a component or a function step.
  • 02:29 Now we analyze each of those failure modes for severity,
  • 02:31 probability of occurrence, and detection capacity.
  • 02:35 There could also be multiple causes with different probability and
  • 02:38 multiple detection approaches with different performance levels.
  • 02:42 Now identify the mitigation actions for
  • 02:44 those that have a high risk priority number.
  • 02:47 Once the mitigation is accomplished, update the scoring and
  • 02:50 document the results.
  • 02:51 Now the form is ready to be incorporated into your design documentation for
  • 02:55 the product.
  • 02:56 The process FMEA follows a similar pattern.
  • 02:59 The upper left corner for the process, the upper right corner for the team and
  • 03:03 revision.
  • 03:04 Use the process map to identify the process steps.
  • 03:07 For each process step, identify the possible failure modes.
  • 03:11 Now, analyze the failure modes for severity, probability of occurence,
  • 03:15 and detectability.
  • 03:16 Most process FMEAs will separate the detection scores into a corrective and
  • 03:20 preventative action score.
  • 03:22 Once again, determine mitigation for those steps with the high RPN.
  • 03:26 And as the improvements are incorporated, document the results and
  • 03:29 include this with the process documentation.
  • 03:33 Let's wrap this up with an example that I pulled from my files.
  • 03:36 I've sanitized it slightly so that there's no company identifying marks or
  • 03:40 proprietary material.
  • 03:41 This is part of a Design FMEA for an engine bracket.
  • 03:44 The function is to support the engine and a failure is if it didn't do that.
  • 03:49 Although that failure is quite severe it's unlikely to occur and easy to detect.
  • 03:53 So the overall score is relatively low and while mitigation is not mandatory,
  • 03:57 several mitigation ideas are at least suggested.
  • 04:02 The FMEA process is straightforward,
  • 04:04 you just need to establish the discipline to apply it.

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