History of FMEA

FMEA has been around for a very long time. Before any documented
format was developed, inventors and process experts would try to
anticipate what could go wrong with a design or process before it was
developed or tried. The trial and error and learning from each failure
was both costly and time consuming. For example: Each individual
iteration of an invention might fail without a thorough thought
experiment by a group of engineers or inventors and take advantage
of their collective knowledge to reduce the likelihood of failure.

FMEA Cause and Effect Diagram

FMEA was formally introduced in the late 1940s with the introduction
of the military standard 1629. Used for Aerospace / rocket
development, the FMEA and the more detailed Failure Mode and
Effects Criticality Analysis (FMECA) were helpful in avoiding errors on
small sample sizes of costly rocket technology.
The primary push for failure prevention came during the 1960s while
developing the technology for placing a man on the moon. Ford Motor
Company introduced FMEA to automotive in the late 1970s for safety
and regulatory consideration after the disastrous "Pinto" affair. Ford
Motor Company also used FMEA effectively for production
improvement as well as design improvement.

The current advancement of FMEA has come from the automotive

sector as FMEAs are required for all Designs and Processes to assure
the prevention of problems. Integrated into Advanced Product Quality
Planning (APQP), FMEA in both Design and Process formats provide the
primary risk mitigation tools in the prevention strategy. Each potential
cause must be considered for its effect on the product or process and
based on the risk, actions determined and risks revisited after actions
are complete. Toyota has taken this one step further with its Design
Review Based on Failure Modes (DRBFM) approach. DRBFM moves the
user through the FMEA process by considering all intentional and
incidental changes and their effects on the performance of a product or
process. These changes drive potential causes which require follow-up
action to resolve the risk. Design reviews are the primary place to
review progress and address these risks.

FMEA Methodology
Robustness analysis from Interface Matrices, Boundary Diagrams and
Parameter Diagrams are extremely helpful prior to FMEA development.
Noise factors and interfaces with other parts and/or systems are where
a large number of failures can be found as design engineers typically
focus on what they control directly. Shared interfaces are an area
where many failures occur today.

FMEA Development
FMEAs are developed in three distinct phases where actions can be
determined. It is also imperative to do pre-work ahead of the FMEA to
assure that the Robustness and past history are included in your
analysis.

Step 1 is to determine all failure modes based on the functional

requirements and their effects. If the severity of the effect is a 9
or 10 (meaning safety or regulatory in nature) actions are
considered to change the design or process by eliminating the
Failure Mode if possible or protecting the customer from the
effect.
Step 2 adds causes and Occurrences to each Failure Mode. This
is the detailed development section of the FMEA process.
Reviewing the probability or occurrence number in order of the
highest severity and working downwards, actions are determined
if the occurrence is high (> 4 for non safety and regardless of
occurrence >1 when the severity is 9 or 10)
Step 3 considers testing, design verification and inspection
methods. Each combination from steps 1 and 2 which are
considered at risk requires the detection number to be selected.
The detection number represents the ability of planned tests and
inspections at removing defects or excite failure modes to fail.

After each of these steps actions are developed. Next, Risk Priority
Numbers (RPN) are calculated. Please note that RPN's are calculated
after three possible action opportunities have occurred. Actions are not
only determined based on RPN values. RPN threshold values do not
play an important role in action development, only in action evaluation
when completed.

Selecting an arbitrary RPN to fall below is both ineffective at driving

change and foolhardy if the order of the improvement is not controlled
(severity, occurrence, detection) steps 1,2,3 as described above.
In past years, setting an RPN would immediately be met with lower
numbers without any real change or improvement. This is not
preventing failure, but in fact driving bad behavior of the design and
process teams required to perform the FMEA.
Process Failure Mode and Effects and Analysis
The second part of a collaborative FMEA deployment is the Process
FMEA. Process Failure Mode and Effects Analysis takes a product or
service design and considers all the steps that are necessary to be
successful. Each step is considered as to its impact on the product or
service to be provided with the idea that each step may inhibit or
cause the product/service to fail. As the Process FMEA progresses,
each potential cause which has risk (measured with severity,
occurrence (criticality) and detection capability) is the topic of actions
which are counter measures to the risk. When completed, these
actions reduce risk and increase the probability of success. Process
FMEA is an integral part of the Lean Product Development process
and APQP (Advanced Product Quality Planning). Process and
Design FMEA are linked and should be used in coordination of timing
and collaboration in feedback. The proper time to do a Process FMEA is
just after the Design FMEA has indicated certain Special
Characteristics which are at risk that are likely related to a process
or delivery step. These characteristics, special or otherwise should be
investigated and finding fed back to the product/service design team
prior to design completion. This provides and excellent opportunity for
the product or service design to take full advantage of the knowledge
of the process experts. This collaboration can have benefits such as
cost savings, Design for Assembly and Manufacturing, and increased
use of Error Proofing required to avoid problems as opposed to
detecting and sorting.
Process FMEA can be prompted by one of several events:

New Design Special Characteristics

New Product Design Drawing or Design record
Process Changes due to Lean events or Six Sigma Projects
Process Changes due to upgrades in machinery, personnel or as
a result of a corrective action process

Fourth Edition FMEA Manual Changes

AIAG has recently released the Fourth Edition FMEA manual. To read
an executive summary of the changes to the new manual, visit our
Fourth Edition FMEA page.
FMEA Exercise
Can you determine the order of need for change in the following three
examples:

FMEA and the Control Plan

Severity (5), Occurrence (4), Detection (2) = 40

Severity (9), Occurrence (2), Detection (2) = 36
Severity (8), Occurrence (1), Detection (8) = 64

(The correct order for action is #2, #1, #3.)

FMEA in selecting Special Characteristics
FMEA is used to refine special characteristics that the design
community may be concerned about as these characteristics may
affect performance. These characteristics are translated into
dimensions or features and provided for the Process design activity to
error proof and/or develop mitigation plans to reduce risk of poor
performance. The timing for this is critical to get the best benefit.
Advanced Product Quality Planning (APQP) provides the concurrent and
collaborative structure to accomplish this effectively. Eventually,
process capability and evidence of proper Process Controls found in a
control plan are required.

Benefits of FMEA
Improves the quality, reliability, and safety of products / services
/ machinery and processes
Improves company image and competitiveness
Increases customer satisfaction
Reduces product development timing and cost / support
integrated product development
Documents and tracks action taken to reduce risk
Reduces potential for Warranty concerns
Integrates with Design for Manufacturing & Assembly techniques
Applications for FMEA
Process - analyze manufacturing and assembly processes.
Design - analyze products before they are released for
production.
Concept - analyze systems or subsystems in the early design
concept stages.
Equipment - analyze machinery and equipment design before
they are purchased.
Service - analyze service industry processes before they are
released to impact the customer.
FMEA use in Medical
Failure Mode and Effects Analysis is being deployed in many more
industries than just Automotive and Aerospace. Medical device and
drug delivery has added FMEA as a means to understand the risks not
considered by individual design and process personnel. FMEA allows a
team of persons to review the design at key points in product
development and make comments and changes to the design of the
product or process well in advance of actually experiencing the failure.
The Food and Drug Administration (FDA) has recognized FMEA as a
design verification method for Drugs and Medical Devices. (21 CFR
820) and typically wishes to review the effort put into the FMEA
activity during scheduled reviews.
Hospitals also have begun to use FMEA to prevent the possibility of
process errors and mistakes leading to incorrect surgery or medication
administration. This use is driven from the Joint Commission of
Accreditation of Health Care Organizations (JCAHO).
QAI has many years of experience with process driven FMEA and has
trained and facilitated FMEAs for Medical Device design, drug delivery

systems and hospitals wishing to prevent failure in its processes.

Contact us to see how we could help you as well.
FMEA in Machinery Development
The reliability and maintenance of machinery is critical to many
manufacturers as down time for maintenance or repair must be kept to
an absolute minimum. FMEA is a tool which assists the designers and
builders of tooling and equipment to determine when to improve
reliability of components and where to use common parts. All R&M
activities must consider the cost of ownership or total Life Cycle Costs
(LCC) which must be determined well in advance of building the
equipment. FMEA is an integral part of this LCC determination.

FMEA Working Model

FMEA in Aerospace and Defense
Failure Mode and Effects Analysis has always been a part of the
Aerospace industry since its first use in rocketry. FMEA continues to be
an integral part of the development of Aircraft, Missile systems, Radar,
Communications, Electronics and other key interfacing technologies.
New innovations in this prevention technology have increased its
effectiveness. Technical Kickoff (TKO) combines many tools including
robustness considerations into the process yielding more detailed
results and leads to improved designs and processes.

QAI is firmly committed to the use and innovation of FMEA. We are not
only a major part and input into future FMEA process, we invent
processes like LEAN FMEA to help our customers use the process
more efficiently. We have developed faster and more thorough
techniques which provide an excellent FMEA output, while achieving
the superior output faster. Please contact us to find out how we can
make your FMEA experiences more valuable.
"Green" FMEA
FMEA can also be used to assess the environmental impact of a
product or process. The "Green" FMEA can identify where corrective
and preventive actions can be taken to mitigate the environmental
burden of a product.
Free Failure Mode and Effects Analysis Downloads
QAI has a selection of FREE FMEA reference cards available for
download. Now available are reference cards explaining Design FMEA
and Process FMEA methodology as well as reference cards explaining
the different severity, detection, and occurrence rankings. Click on a
link below to begin your free download:

Design FMEA Methodology reference card

Design FMEA reference card
Process FMEA Methodology reference card
Process FMEA reference card
FMEA for Health Care reference card
Green FMEA reference card