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The first three steps of the Design FMEA process set the stage for effective FMEA analysis sessions. Cutting corners on these steps lead to confusion and delays in the analysis.

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Quick reference

Design FMEA Preparation Steps

The first three steps of the Design FMEA process are preparatory steps needed to begin the actual analysis.  These steps must be completed in the order shown for the analysis to proceed.

When to use

These three steps are done at the beginning of every Design FMEA analysis.  They can all be accomplished in a few hours or they can take weeks to complete, depending upon the management practices of the organization.

Instructions

The first three steps of the Design FMEA process create the team and common understanding of the system or part that is being analysed.  These steps are necessary in order to conduct the analysis steps.

Step 1. Select the system or product

This seems to be a very basic step, and it is.  However, when working with large complex products, these should be decomposed into subsystems and each subsystem analysed separately.  This makes the analysis more manageable because the scope of the design being analysed is focused.  However, this will then require an additional analysis of the interaction of the subsystems into the total system.  If working with a product family, it is acceptable to analyse the family in one Design FMEA instead of a separate analysis for each item in the family.  When doing the Design FMEA as part of a development project,  this first step should be initiated as soon as the preliminary design is complete so that the analysis can be completed and mitigation actions incorporated into the design before the Final Design Review.

Step 2. Select the FMEA analysis team

The development team members are selected because of their expertise with the product, product technology, or the customer/user application.  For this reason, they are almost always members of the product development team.  At least one of the team members should be aware of the customer use or application, but that person normally is not a customer due to the proprietary nature of the analysis.  In many organizations, a facilitator is also a team member to help the team reach consensus on each item being evaluated.

Step 3. Prepare the block diagram

The third step prepares a functional block diagram for the part or subsystem being analysed.  This block diagram shows how all the elements of the item, including hardware, software, packaging, and any other element, are integrated to provide functionality for the customer or user.  The level of detail is determined by the FMEA analysis team.  More detail is often needed with inexperienced team members so that they ensure nothing is missed.  For complex system, an FMEA is done for each subsystem and then a high-level FMEA is done for the integration of all the subsystems into the full system.  

Hints & tips

  • Complete the steps in the order shown.  Each one builds on the previous one.  The identification of the system makes it clear who would have the expertise to be on the team.  And the team has the knowledge to create the block diagram which will be needed to start the analysis steps.
  • When determining the level of detail, it is better to err on the side of too much than too little.  Too much detail will just quickly lead to failures that are insignificant.  But too little detail will have a tendency to mask some failures which could be significant.
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  • 00:04 Hi I'm Ray Sheen.
  • 00:06 Well now lets dig deep into the Design FMEA.
  • 00:09 We'll start by looking at the first few steps of the Design FMEA process.
  • 00:13 Those that are part of preparing prior to actually doing the analysis.
  • 00:19 Just a quick review of what the design FMEA looks like.
  • 00:23 This is the form of the design FMEA.
  • 00:27 Now step one, we identify the system, subsystem or part that will be analyzed.
  • 00:32 Next, we need to identify the FMEA analysis team.
  • 00:36 As has been mentioned, this should include subject matter experts,
  • 00:39 customer representatives, and the actual product designers.
  • 00:43 The third step is to decompose the system.
  • 00:45 We normally do this with a block diagram to understand the functions and
  • 00:49 parts of the system.
  • 00:50 We have an entire lesson coming up to explain how to do this.
  • 00:53 These are the three preparation steps needed to begin the actual analysis
  • 00:57 of failures and failure modes.
  • 00:59 We'll cover the other four steps in a later lesson.
  • 01:03 So let's start with the selection of the system or subsystem that will be analyzed.
  • 01:08 Most of the time this is not a hard decision,
  • 01:10 the design FMEA is being prepared as a part of product design and
  • 01:14 development project, so the system is the product being developed.
  • 01:19 However, systems are often divided into subsystems.
  • 01:22 Especially large, complex systems.
  • 01:24 The level of decomposition is a judgement call.
  • 01:27 The more decomposition, the more FMEAs must be done, but the smaller the team and
  • 01:33 the faster each FMEA can be completed.
  • 01:36 If the analysis is done for an existing product line, a key question to answer is
  • 01:41 whether the analysis will be for a single product or for a product family.
  • 01:45 I prefer to work with a product family.
  • 01:48 Although it is a little more complex, it saves time by eliminating the need to do
  • 01:52 multiple similar analysis for each unique product in the product family.
  • 01:58 If instead you are doing the analysis as part of a development project,
  • 02:02 start as soon as you have a preliminary design.
  • 02:05 At that point, you'll have enough design definition to be able to do the analysis.
  • 02:09 You want to complete the analysis before the design freeze.
  • 02:12 So that if you identify changes to reduce technical risk,
  • 02:16 you can get those incorporated in a relatively easy manner.
  • 02:20 Now let's do a quick review of several key points
  • 02:23 about the design FMEA analysis team.
  • 02:26 When doing the FMEA as part of a development project,
  • 02:29 almost everyone on the FMEA team would be part of the product development team.
  • 02:34 As was mentioned in earlier lesson, the team member should be subject matter
  • 02:38 experts on the technology, the product, or the user application.
  • 02:42 This expertise is needed to both identify the failures and
  • 02:46 to understand the cause and effect relationships from the failures.
  • 02:50 Make sure you have someone on the team who understand the customer or user
  • 02:53 application and how the system will be used or misused by the typical customer.
  • 02:59 Normally, you do not have an actual customer on the team
  • 03:03 because of the legal and proprietary nature of the discussions.
  • 03:06 So the individual on the team is usually from sales or
  • 03:09 marketing that has experience with the customer application.
  • 03:13 Also consider using a facilitator,
  • 03:15 especially if you have strongly opinionated cross-functional team members.
  • 03:20 You want each perspective represented, and that can lead to spirited debate.
  • 03:25 The facilitator can help to keep that debate professional and not personal.
  • 03:29 In addition the facilitator can help the team to reach consensus decisions.
  • 03:34 The third step is to create a block diagram in order to
  • 03:37 understand the function of each part or subsystem.
  • 03:40 Block diagrams show the integration of hardware and
  • 03:43 software into a system in a manner that delivers the product functionality.
  • 03:47 This is often organized using the system Drawing Tree or Bill of Materials.
  • 03:52 The level of detail is a subjective decision that must be made by the team.
  • 03:56 Keep in mind, the block diagram is usually organized by functionality.
  • 04:01 So go to the level of detail that provides the team with adequate insight into what
  • 04:05 is happening.
  • 04:06 Depending upon who's on your team, you may need to go to a deeper level of detail
  • 04:11 in order to explain how the subsystem or part works.
  • 04:14 Especially if some of your team members are not familiar with all aspects of
  • 04:17 the design or technology.
  • 04:19 If you do a subsystem analysis, you can look at the full detail functionality for
  • 04:24 all the parts in the subsystem.
  • 04:26 When rolling up to higher level, it is only the primary subsystem functionality
  • 04:31 that rolls up to that next higher level.
  • 04:33 A well crafted block diagram
  • 04:36 will include every item in the subsystem being analyzed.
  • 04:39 So it will include hardware, software, and any other components such as packaging or
  • 04:44 lubricants that are part of the overall system that is being analyzed.
  • 04:49 Well those are the preparatory steps for the Design FMEA.
  • 04:53 With those complete, you're ready to start your analysis.

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