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Common Issues with FMEA

  FMEA, Introduction
  1. Mil-STD-1629 Piece Part FMEA
   2. Mil-STD-1629 Criticality Analysis
  3. Automotive FMEA
  Concerns with FMEA
While the gereral principles of FMEA seem to be intuitive, FMEAs are difficult and work intensive in practice.

the more difficult the FMEA is to handle, and the longer it takes until the FMEA team begins to take momentum.
My experience suggests the following:

Piece Part FMEA

The most important factor is the FMEA experience of the hardware developer. It takes typically between one hour and one day until the developer feels comfortable to conduct piece part FMEAs on his own. Undesired effects on system level are either a no-brainer, foreseeable, can be derived from requirements specifications., or are just given by the customer.  Therefore there is a good chance that the developer will be able to complete the FMEA without forgetting substantial topics.
Additionally, the hardware developer is typically the only person with thorough technical knowledge. In particular for electronic systems, the ability of reading schematics limits the potential participants for piece part FMEAs to a small number.

However, it may be advantageous to have more participants in the FMEA process, especially if they have different insight, for example a service technician, a customer engineer, or the senior of the developer.

Independent from the FMEA experience of the developer, it is almost always a good idea to have an FMEA moderator in the team. 
If the developer is unexperienced, it is the moderator's job to teach the developer until he feels comfortable with the FMEA process.
But a moderator can add value to the FMEA process even for experienced developers by easing the workload: The moderator can take all the paperwork and therefore ensure FMEA consistency.
With a moderator participating in a piece part FMEA, the developer can settle back and concentrate on transforming his detailed knowledge into FMEA content.

(Practical experience shows that FMEA paperwork (especially maintaining consistency) can sometimes be even more work-intensive than the work of the developer).

Taking into account FMEA preparation, conduction, evaluation and reporting, circa 80% of the whole workload attribute to the FMEA moderator, while only 20% attribute to the developer. The developer's workload is basically the time spent during the FMEA session.

The FMEA moderator must fulfil the following prerequisites in order to make a good job:

FMEAs with many participants

In contrast to piece part FMEAs, most FMEAs are more general, with participants coming from different departments.
Practical experience suggests that the maximum group size of the FMEA team should not exceed 8. However, with disciplined and experienced team members, groups of even 12 may be successful.

In some cases, when companies ask for FMEA consulting service, participants not only come from different departments, but for some of them it's even the first time being in the same meeting with their fellows. This scenario is the most difficult one a moderator could face. Some group members may have difficulties in accepting alternative viewpoints, whereas other members must learn that their knowledge is welcome and that they are required to utter their thoughts. Therefore the FMEA moderator must not only combine different viewpoints and interests, he must also help the group in becoming an efficient FMEA team.

Depending on the company culture it can be advantageous or disadvantageous when staff members and their bosses share the same FMEA meeting.

Typical groups performing a general FMEA look like this:
Such FMEAs are often not limited to a single session. These so called FMEA processes are quite common in automotive industry.
During product development life cycle, FMEA sessions will be repeated at specific time points, and the FMEA worksheet will be used as a tracking tool for improvement and mitigation actions. This is a so called live FMEA process with a life FMEA worksheet.

Unfortunately there are some issues related with these FMEAs.

With increasing FMEA team size, increasing time intervals between FMEA sessions, changing team members and increasing degrees of freedom of the FMEA process, the following problems will almost certain appear:
While the first problem (inconsistency) suggests the use of dedicated FMEA software instead of a spread sheet,  the second problem is a perfect justification for having an FMEA moderator being responsible for the FMEA process. FMEA moderators are usually located in the quality management department.

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