5 Stages of an FMEA

How to Get More Out of Your FMEAs

by Richard A. Harpster

Organizations have used the failure mode and effects analysis process for years.
Recently, however, QS-9000's mandate that suppliers utilize FMEAs during new
product design and development has shed new light on this useful tool. In addition
to the automotive industry, many other industries, including aerospace and
electronics, now use FMEAs.
Unfortunately, despite the countless training classes and numerous books written
on its use, many organizations have failed to fully realize the benefits of the FMEA
process. Informal surveys with more than 100 companies reveal that the majority
of people using FMEAs do not perceive them as powerful tools but as something
that must be done to meet a quality audit or customer requirement. One of the
major reasons for this perception is that most FMEAs are performed and used
incorrectly.
FMEAs can and should be a key element in any organization's advanced quality
planning process. Organizations that properly use FMEAs have saved hundreds of
thousands of dollars and report higher levels of customer satisfaction.
Understanding the differences between those who use and do not use FMEAs
correctly can help your organization become one of those who experience the
immense benefits that FMEAs can bring.
What are FMEAs?

Although several derivatives of FMEAs have been developed, there are two basic
types: design and process.
Organizations utilize design FMEAs to verify that a product has been properly
designed to meet all of the customer's requirements and that it can be manufactured
at a target rate, cost and yield.
Design FMEAs capture the relationship between customer requirements, how a
product can fail to meet the requirements, the effects of the failures, problems with
the design that cause the failures and how the design will be validated to prove it
will not fail. Rating columns exist for the effects of failure, probability of failure

and the effectiveness of the design validation. These ratings are multiplied together
to achieve a risk priority number (RPN) for each product failure and cause
combination. Rating numbers typically range from one to five or one to 10 for each
of the columns, with higher numbers designating unacceptable conditions.
A class column serves to identify design characteristics that require special
attention. An improvement section exists to identify and track attempts to improve
the design.
Organizations utilize process FMEAs to assess the adequacy of a process in
producing the product whose design the design FMEA has validated. Process
FMEAs also identify the process and product controls that must be implemented to
ensure that the product can be produced within specifications.
Process FMEAs capture the relationship between each process step, the
unacceptable process outputs that can be created at each step, the effects of the
unacceptable process outputs, causes of the unacceptable outputs and how the
unacceptable outputs will be either prevented or detected in the event they occur.
Rating columns exist for the effects or severity of the unacceptable process
outputs, probability of outputs occurring and the effectiveness of the prevention
and detection methods. As with the design FMEA, these ratings are multiplied
together to achieve an RPN for each unacceptable output and cause combination.
A class column serves to identify design characteristics that require special
attention. An improvement section exists to identify and track attempts to improve
the process.
For both types of FMEAs, RPNs above a certain level trigger recommended
actions to address the problem.
Successful and unsuccessful FMEA implementation

Organizations that use FMEAs can normally be categorized in one of five

implementation stages. Organizations that achieve measurable monetary benefits
operate in stages four or five. Unfortunately, most organizations remain in stages
one through three, with most in stage one.
Stage one

Typically, the organization in stage one uses FMEAs because it has to meet a paper
requirement for a customer or quality standard. Personnel perform the FMEA right
before it is due to be turned in to the customer, usually too late in the process to be
useful.

Quite often, the wrong people perform the FMEA. The quality department ends up
developing the documents rather than making design engineers responsible for
design FMEAs and operating personnel responsible for process FMEAs.
Management does not understand the FMEA, and a lot of confusion and
disagreement exists as to how to fill out the FMEA form. Debate occurs when
individuals attempt to develop the ratings for occurrence and detection numbers.
Because accurate feedback systems don't yet exist to base the ratings on, they're
based on inaccurate guesses. Using inaccurate ratings, the organization calculates
erroneous RPNs and identifies an RPN level at which recommended actions are
needed. If the number of recommended actions required based on this level is too
high, the organization "adjusts" the ratings to bring the RPNs down below the
trigger level, which reduces the number of recommended actions. Obviously, this
makes the entire FMEA process meaningless.
As a result, the organization fulfills its FMEA paper requirement, but the value of
the FMEA is greatly diminished. Problems still remain unsolved at a high cost to
the organization. The individuals performing the FMEAs believe they are doing
them correctly because the customer or auditor is accepting them. Eventually,
everyone sees the FMEA process not as a tool but as something that has to be done.
Stage two

Management ensures that the personnel who will perform and use the FMEA data
are trained in the proper technique. They realize that the people who perform
design FMEAs must be experts in the product and that the people who perform
process FMEAs must be experts in the process. Rather than being confused by the
FMEA terminology, they realize they have used the FMEA methodology before but
never called it FMEA. They also learn that although they have used the
methodology, they have not used it rigorously enough to achieve its full benefits.
In stage two, everyone involved gains an understanding of what the ratings and
class column mean and how to use them to prioritize what must be worked on first.
They understand that the class column is the most important factor and not the
RPN. (See "The Problem with Risk Priority Numbers.") Management also realizes
that they don't have systems in place that will give them data to accurately
determine the failure probability occurrence ratings, detection ratings and class.
Using the limited objective data they have, they know they will have to use their
knowledge of the product and process to arrive at the ratings. Due to the lack of an
objective basis, they know that it is a waste of time to argue for long periods about
the ratings.
When leaving this stage, those who have been using FMEAs believe they can be a
powerful tool. Unfortunately, the people who perform the FMEAs doubt whether
management will provide the time and resources necessary to support their

successful implementation. They also question how they will explain the new
approach to their auditor or customer, who may still be at stage one in their
understanding of the FMEA implementation process.
Stage three

The organization begins to use FMEAs correctly on a targeted product. Early on

there is excitement that the FMEAs are finally going to be done correctly. As the
implementation continues, worry starts to set in as the FMEA uncovers and
documents the complexity of the product and process being analyzed. Everyone
knew the complexity existed but had never seen it documented. The FMEA grows
from the five to 10 pages that used to be normal to 100 or more pages. The
organization must overcome its fear of the increased length and complexity of the
complete FMEA if FMEAs are to be used successfully. "FMEAs can and should be
a key element in any organization's advanced quality planning process."
As the FMEA process continues, many problems may be uncovered that must be
solved if the company is to become as good as it can be. There may not be enough
resources to solve all of these problems and still meet the launch deadline.
Knowing this, people begin to proclaim that FMEAs will never work. They believe
that all the hard work has been a waste of time. What good is it to know what is
wrong and not be able to correct it? Life was a lot easier when all the problems
were not documented. If organizations don't overcome this obstacle they may slip
back into stage one.
Stage four

Management realizes that the length of an FMEA cannot be predetermined. The

complexity of the product and process being analyzed determines the FMEA's
length. Management understands that all of the problems uncovered in the FMEA
can't be solved in one product launch. They understand that the product will be
launched with known problems and that they will have to make objective decisions
as to what to work on during this launch and what must be delayed. When a
problem occurs in an area that management decided not to work on, it is handled
without emotion. This is possible because the FMEA identified that it might
happen and management chose not to work on it so that other problems could be
prevented.
Once the organization launches the product, management creates a long-term plan
to improve the design and manufacturing systems. This plan minimizes the times
the company must make difficult decisions when doing FMEAs in the future.
Stage five

The organization has implemented new design and manufacturing systems to

answer the majority of the problems identified in the FMEAs. Systems now exist
to provide data to accurately set occurrence and detection ratings. Due to the
accuracy of the new ratings, predictions about field failures and process yields can
be made. The class column can now be accurately determined and actions required
for improvement prioritized.
Design engineers review design FMEAs before making design changes. If a
change must be made, operating personnel review the process FMEA and control
plan to determine the impact the change will have on the process.
When a problem occurs, the appropriate personnel consult the FMEAs. If the
FMEA inadequately addressed the problem, engineers make changes to the design
and manufacturing system to ensure that all possible steps have been taken to
prevent a similar problem in the future.
The organization uses the FMEAs as training tools because they contain the
collective knowledge of the company's experts.
Conclusion

The FMEA process can be a powerful tool when properly used. As with any tool,
before it can be used well it must be understood. Once organizations fully
understand and commit to the FMEA process, they may be pleasantly surprised
with the money they save and the product and process improvements that result.