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Quick reference
FMEA Team
An FMEA is normally completed by a cross-functional team. The accuracy and thoroughness of an FMEA will be based upon the individuals on the team and how well they work together.
When to use
Whenever an FMEA needs to be completed, a cross-functional team should be used to ensure all appropriate perspectives are considered in the analysis.
Instructions
The FMEA team conducts the analysis and completes the FMEA forms and documents. While FMEA appears to be a quantitative analysis because of the scoring and RPN calculation, the three rating scores are based upon a qualitative or subjective assessment of the severity, probability, and detection attributes of the design or process. Therefore, it is important that the team includes subject matter expertise concerning the design and process so that the scores are accurate. In addition, it is critical that both internal and external perspectives for the product and process are represented on the team so that a thorough assessment is done. Everyone has “blind spots.” The cross-functional nature of the team minimizes those blind spots.
However, a challenge that many teams encounter is that the team of subject matter experts addressing the situation from different perspectives cannot agree on the score for a particular failure mode. While the team may not be unanimous in its decision, it should always strive for a consensus. A “majority vote” or “leader decide” decision making style can lead to the team overlooking a critical technical risk simply because some of the team members have never experienced it.
Team members need to engage with active listening skills and cause and effect thinking to understand the risks and performance threats that are identified by others. At times the team must get creative to determine the impact of different failure modes. Teams that are not experienced and adept at completing FMEAs will often benefit greatly from the use of a facilitator for the analysis.
Design FMEA team
The Design FMEA team needs representatives from the different perspectives on the product use and product development. Some individuals may have multiple categories of expertise. This can help to shrink the size of the team. By the same token, complex products may require multiple individuals to fulfil one of these roles – such as product technology expertise. The roles or functions normally represented on a Design FMEA team are:
- Customer use representative such as marketing, sales, or actual customer reps.
- Product designers such as hardware designers and software designers.
- Subject matter experts in any critical or emerging technology used on the product.
- Customer service, complaints, or warranty representatives
- Facilitator
Process FMEA team
The Process FMEA team needs representatives from the different perspectives on the process design and operational management. Some individuals may have multiple categories of expertise. This can help to shrink the size of the team. By the same token, complex processes may require multiple individuals to fulfil one of these roles – such process technology expertise. The roles or functions normally represented on a Process FMEA team are:
- Process/industrial designers of the process being analysed.
- Product designers who understand the critical performance characteristics of the product.
- Process technology subject matter experts.
- Process operators responsible for this or similar operational processes including processes used for inspection, test, and quality control.
- Facilitator
Hints & tips
- Team members need to have subject matter expertise to identify failure modes and explain the cause and effect relationships to other team members.
- Team members will often disagree on the correct score for a particular failure mode due to their different experiences. That is why a facilitator is often needed to help them reach consensus for the current product or process under consideration.
- On a large or complex product or process, it will likely take numerous meetings to complete the analysis.
- Keep track of mitigation ideas that the team generates when discussing a failure mode for later use in the analysis.
- 00:04 Hi, I'm Ray Sheen.
- 00:05 The second step in the FMEA process is to select the FMEA analysis team.
- 00:11 Let's look at several factors to consider when selecting your team.
- 00:15 I'll start with a description of the team.
- 00:18 A key to successful FMEA will be the analysis team.
- 00:22 And while the FMEA has appearance of being an objective, numerical analysis, it
- 00:27 is based upon subjective assessments made by the team that is doing the scoring.
- 00:33 For this reason,
- 00:34 it's critical that the team members are experienced with the product or process,
- 00:38 or at least with aspects of the technology used in the product or process.
- 00:42 If the Design FMEA team members are not aware of material incompatibilities
- 00:46 leading to harmful chemical reactions, well,
- 00:49 then they will not know to assess that failure.
- 00:52 If the Process FMEA team members do not understand the abilities of their
- 00:55 inspection equipment to detect defects, they will not score those accurately.
- 01:00 The team members need to be experienced and
- 01:02 the team needs to have a representative from the appropriate business functions
- 01:07 to identify and assess the impact of failures.
- 01:10 An inexperienced team or one with gaps in membership
- 01:14 will likely create an FMEA that is missing critical failure modes.
- 01:18 The FMEA analysis that they create is almost worthless.
- 01:23 There are some additional challenges this team faces.
- 01:25 In many cases, the team is an ad hoc group that is collected for just this analysis.
- 01:31 They're all approaching the analysis from a different technical perspective and
- 01:35 they may not even know each other.
- 01:37 Yet, they must debate the merits of this design and
- 01:40 reach consensus on design attributes and weakness.
- 01:44 This in an environment that is ripe for problems with team dynamics.
- 01:49 The team needs to work effectively across a number of team characteristics,
- 01:53 one is active listening.
- 01:55 Each team member is an expert in their area, and they need to respect
- 01:58 the expertise of others and actively listen to their comments and concerns.
- 02:03 Another team dynamic that must be practiced is team decision-making.
- 02:07 The team needs to be able to reach consensus on their analysis of
- 02:10 each failure mode.
- 02:12 Several attributes that can approve an FMEA team performance is creativity and
- 02:16 cause and effect thinking.
- 02:18 The creativity is for each team member to be able to see the technical challenges or
- 02:21 weaknesses from another team member's perspective.
- 02:24 And the cause and effect thinking allows the team
- 02:27 to recognize the ultimate consequence of a failure mode.
- 02:30 Finally, with a room full of opinions and experts approaching a design from multiple
- 02:35 perspectives in order to find the design weaknesses requires a strong facilitator.
- 02:41 The goal of the analysis is to get it right so
- 02:44 team members should not give in and compromise on a point in which they
- 02:48 believe they have the correct technical understanding of the situation.
- 02:52 But when there are multiple opposing views, the facilitator is needed
- 02:56 to find the points of agreement and resolve the differences.
- 03:00 Let's take a look at the recommended composition of the FMEA team.
- 03:03 By the way, as we review these roles, it's okay for
- 03:07 one person to wear multiple hats and to split a role between several people.
- 03:12 First, let's look at the membership of the Design FMEA team.
- 03:16 You want at least one person representing the customer or user of the product or
- 03:19 service.
- 03:20 This person should be familiar with all the normal uses of the product.
- 03:24 Then you also want a person with an overall knowledge of the system and
- 03:28 how everything works together.
- 03:30 If it's a simple product, this role is not needed, but with complex systems,
- 03:34 it's often crucial.
- 03:36 You'll need a subject matter expert for
- 03:38 the critical technologies used in the product.
- 03:41 These individuals will know the limitations of the technology and
- 03:44 when it may fail.
- 03:45 The number needed will depend upon the product complexity.
- 03:48 If the number is too big and team becomes unwieldy,
- 03:51 consider decomposing the system into several more focused FMEAs.
- 03:55 In addition to the technologists, you want the designers of the actual components or
- 03:59 products, who understand how this product is supposed to work.
- 04:03 And if the product or a similar one is already in the market, you should have
- 04:06 someone from service or warranty there to ensure that the real world failures and
- 04:11 their consequences are included.
- 04:13 Finally, for the reasons already mentioned,
- 04:15 an unbiased facilitator is often a big help to the team.
- 04:19 We have a similar list for the Process FMEA team.
- 04:22 We need the different process experts for the process,
- 04:24 including the process designers, and the subject matter experts for
- 04:28 any critical processes or equipment that are used in the process.
- 04:32 And we need experienced operators from this process or
- 04:35 at least from a similar process.
- 04:38 And that would mean operators from all disciplines who are conducting steps in
- 04:41 the process that is being analyzed, such as manufacturing,
- 04:44 quality, purchasing, IT, customer service, or whatever.
- 04:49 It is also important to have the product or service designers
- 04:53 to represent what is critical about the product or service design and why.
- 04:57 If the process representatives don't know that a particular component feature is
- 05:01 critical to product performance, they're not likely to correctly assess the score
- 05:06 associated with fabrication, assembly, inspection, or test of that feature.
- 05:10 And just as with the Design FMEA,
- 05:12 an experienced team facilitator can be a big help for this analysis team.
- 05:18 The FMEA will only be as good as the expertise and
- 05:21 the team dynamics of the analysis team.
- 05:24 So build a good team, and then use them to get to a true understanding of product or
- 05:28 process performance.
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