Dealing adequately with technical uncertainties

Statistics, RAMS & Quality Management
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Problems with FMEA
  FMEA, Introduction
  Example 1: Mil-STD-1629 Piece Part FMEA
  Example 2: Mil-STD-1629 Criticality Analysis
  Example 3: Automotive FMEA
  General concerns with FMEA

The more persons involved in a FMEA session, and the more degrees of freedom allowed during the FMEA process, the more difficult the FMEA is to handle, and the longer it takes until the FMEA team begins to take momentum.

The editor's experience suggests the following clues:

1. 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 predefined, foreseeable, or can be derived from requirements specifications. Hence it is almost certain 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 knowledge on component level. In particular for electronic systems, the ability of reading schematics is the limiting factor that reduces the group of people capable for performing piece part FMEAs to a small number.

However it can be advantageous to have a second person in the FMEA process with insight from a different viewpoint, 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. Practical experience however shows that FMEA paperwork (including consistency) is even more work compared to the work that remains for the developer, so it is rather the moderator than the developer being the bottleneck in the FMEA process.
With a moderator participating in a piece part FMEA, the developer can settle back and concentrate on transforming his detail knowledge into FMEA content.

Taking into account FMEA preparation, conduction, evaluation and reporting, circa 90% of the whole workload attribute to the FMEA moderator, while only 10% attribute to the developer. The developer's workload is mainly characterized by the time spent during the FMEA session.

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

2. General 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. For such FMEA teams, a moderator is a must in any case. 

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. This scenario is the most difficult one any 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. So 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 boss share the same FMEA meeting.

Typical groups performing a general FMEA look like this:
Such scenarios are often not limited to a single FMEA session and are therefore called FMEA process. 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 document for improvement/mitigation actions. This is a so called live FMEA process with a life FMEA worksheet.

Unfortunately there are some issues related with general 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 Microsoft Excel, 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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