FMEA Success Factors: An Effective FMEA Process
Senior Reliability Engineer, ReliaSoft
tools elicit stronger responses from quality and reliability professionals
than Failure Mode and Effects Analysis (FMEA). Reactions around the virtual
"water cooler" range from "waste of time, lack of support" and "don't want
anything to do with it" all the way to "powerful tool, effective way to
prevent problems" and "needs to be done across the board."
Why is there so
much variation in the application of a tool that has been around for many
decades? What can be done to help achieve more uniformly successful results?
There are four
broad success factors that are critical to uniformity of success in the
application of FMEA in any company: an effective FMEA process, strong
management sponsorship, best-practice FMEA application and adequate FMEA
resources. In this article, the first success factor (an effective FMEA
process) will be discussed. The remainder of the success factors will be
addressed in subsequent articles.
Effective FMEA Process
Without an effective FMEA process, actual FMEA results will be
dependent on individual personalities and the whims of varying company
priorities. If participants happen to be knowledgeable in the application of
FMEA and have the time to invest in FMEA team meetings, then it may be
successful. If not, then the FMEA project may not be as successful.
outlines eleven tasks that must be established within any organization that
aspires to achieving uniformly positive results in its application of FMEA.
The entire process is presented graphically in Figure 1.
Figure 1: Effective FMEA Process Diagram
Task 1: FMEA
As with any significant project, it is important to develop and follow a
strategic plan that will guide the organization's efforts. Some of the key
decisions that management must make regarding FMEA policy include the type
of FMEAs to be performed (such as Design, Process, Equipment, etc.), the
timing of FMEAs (for example, prior to design freeze) and the selection
criteria (such as new technology, new applications, etc.).
strategic management decisions related to other aspects of an effective FMEA
process will be described in the following sections.
Task 2: FMEA
Together with the development of the FMEA Strategic Plan, management must
also make decisions to ensure that the required resources will be available
to all FMEA teams. Along with decisions about FMEA software and meeting
facilities, key questions include the use and staffing of FMEA facilitators,
ownership of FMEA documents and FMEA process, and FMEA training.
support of management is vital to the short- and long-term success of FMEAs
in any organization. I would go so far as to say that without solid
management support, FMEAs will fall far short of their potential as an
effective problem prevention tool.
Such support is
often led by an FMEA champion at the executive level who helps to generate
support at the staff level, advocates for FMEA budget and process and sees
to the staffing, training, business process, standards, management reviews
and quality audits.
Generic FMEAs (Optional)
The development of generic FMEAs may be part of the organization's FMEA
Strategic Plan. They contain both historic (empirical) and potential failure
modes, effects, causes and controls, and are done at the generic level of
the system, subsystem or component. It is important to keep them updated
based on test and field data and/or new technology.
accomplished, generic FMEAs can save considerable time in the performance of
program-specific FMEAs. They are also useful in support of concept trade-off
To perform each
generic FMEA, it will be necessary to complete Steps 1 to 4 of the "Basic
FMEA Steps" outlined in Table 1. Note that Step 4 is only completed up to
design or process controls for generic FMEAs.
Table 1: Basic
FMEA Analysis Steps
Program-specific FMEAs are where the bulk of the FMEA work is performed.
They focus on specific applications and can either be done right from the
beginning or tailored from a generic FMEA. They should be performed by a
team made up of the right experts to examine the design or process and
follow the directions from FMEA strategic planning.
To be successful,
FMEA teams should be well staffed (anywhere from 4 to 8 members are
recommended, depending on FMEA scope and complexity), trained, facilitated
and executed. Their work should be done during the "window of opportunity"
that maximizes the impact of the analysis to improve the design or process.
To perform each
program-specific FMEA, it will be necessary to complete all ten steps of the
"Basic FMEA Steps" in Table 1.
Most organizations have a Failure Review Board established to review and
address high risk issues discovered during test or field phases. High risk
issues identified from FMEAs should be included in the review format. This
ensures management understanding, buy-in, support and adequacy. In addition,
FMEA reports and charts can be generated to provide valuable status, per the
FMEA Strategic Plan.
I have found that
it is useful to have the design owner present the high risk issue from the
FMEA to the Failure Review Board in order to bring proper context and
ownership to the issue.
Effective process models inevitably include a feedback loop to improve the
process by incorporating both positive and negative feedback. An effective
FMEA process includes both FMEA quality surveys (of the internal customer of
the FMEA) and FMEA quality audits (in-person audits of completed or nearly
completed FMEAs, done by the FMEA manager).
FMEA quality surveys and audits are based on FMEA Quality Objectives, such
as the ones outlined in “Design FMEA Quality
Objectives." They provide valuable information to strengthen what works
and address shortfalls.
done hundreds of FMEA quality audits, I believe this is one of the most
important steps to achieving uniformly successful FMEA application. Each
audit takes about one hour and I always learned ways to improve the FMEA
Task 7: Supplier FMEAs
Potential higher risk system- or subsystem-level failures can have their
root causes in components provided by independent suppliers. FMEA strategic
planning should determine how to address supplier FMEAs, and how to identify
which suppliers require formal FMEA review. For suppliers of parts that are
identified as higher risk (critical parts), it is recommended that the
supplier be required to perform and submit an FMEA for review and approval
by a qualified company representative.
Reviewing supplier FMEAs should be based on the FMEA Quality Objectives. I
suggest returning inadequate FMEAs to be redone by the supplier until they
meet the Quality Objectives.
Task 8: Execution of Recommended Actions
FMEAs have little value unless the recommended actions are fully executed.
Each recommended action must be followed up to ensure completion to the
satisfaction of the FMEA team and the risk has been eliminated or mitigated
to an acceptable level. The Failure Review Board must ensure that all high
risk actions are successfully executed.
It is my experience that the FMEA team should stay intact during the
execution stage. Many companies want to disband the team once the FMEA has
been completed up to the Recommended Actions step (Step #4 of the "Basic
FMEA Steps" in Table 1). The FMEA team needs to be responsible for and
empowered to reduce the risk to an acceptable level. The execution stage is
fraught with variables that can derail the important work of reducing risk.
Task 9: Linkage to Other Processes
FMEAs can and should be linked to other important processes to leverage
their effectiveness. For example, ReliaSoft’s Xfmea software for FMEA
analysis, data management and reporting integrates with requirements from
Advanced Product Quality Planning (APQP) guidelines, and has the potential
to generate new Process FMEAs based on existing Design FMEAs. Xfmea can also
be used to create integrated Design Verification Plan and Reports (DVP&Rs),
Process Control Plans (PCPs) and Process Flow Diagrams (PFDs).
FMEAs can provide important input to other processes, such as Design
Reviews, Design Trade Studies, Reliability Growth Analysis, etc. The FMEA
Process should be integrated with the overall Product Development Process.
Linking the FMEA with other key processes improves quality, and saves time
Task 10: Test and Field Failures
One of the common mistakes when implementing an FMEA process is to omit
subsequent test and field failures. If generic FMEAs are used, they can be
updated with information from the organization’s Failure Reporting, Analysis
and Corrective Action System (FRACAS). This is invaluable when FMEA
documents become input to future design programs. When feedback from
subsequent test and field failures is omitted from the FMEA process, future
designs are at risk for repeating past failure modes.
Task 11: Software Support
To be most effective, the FMEA process should utilize software that provides
database functionality, such as ReliaSoft’s Xfmea (http://www.ReliaSoft.com/xfmea).
The Xfmea software does an excellent job of managing multiple FMEA projects
and databases, and also provides the plots/reports and linkage to other
processes that are essential to successful FMEA outcomes.
One of the most important factors for the success of FMEA in any
organization is an effective FMEA Process. It takes a focused strategy to
bring about the infrastructure that is necessary to support effective FMEAs,
but it is well worth the time and effort.
Companies are faced with intense global competition, and must shorten
product development times and reduce costs. Preventing problems with an
effective FMEA process is essential to success in reducing warranty and
increasing customer satisfaction.
About the Author
Carl S. Carlson is a consultant and
instructor in the areas of FMEA, reliability program planning and other
reliability engineering and management disciplines. He has 20 years experience in
reliability engineering and management positions at General Motors,
most recently Senior Manager for the Advanced Reliability Group. Mr.
Carlson co-chaired the cross-industry team to develop the Society of
Automotive Engineers (SAE) J1739 for Design/Process/Machinery FMEA and
participated in the development of the SAE JA 1000/1 Reliability
Program Standard Implementation Guide. He has also chaired technical
sessions for the Annual SAE RMSL Symposium, was a four-year member of
the RAMS Advisory Board and served for five years as Vice Chair for
the SAE's G-11 Reliability Division. He is an ASQ Certified