FMEA Success Factors: An Effective FMEA Process

[Please note that the following article — while it has been updated from our newsletter archives — may not reflect the latest software interface and plot graphics, but the original methodology and analysis steps remain applicable.]

Guest Submission - Carl S. Carlson, Carlson Reliability

Few reliability 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.

This article 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 Strategic Plan
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.).

Additional strategic management decisions related to other aspects of an effective FMEA process will be described in the following sections.

Task 2: FMEA Resource Plan
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.

The strong 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.

Task 3: 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.

Once accomplished, generic FMEAs can save considerable time in the performance of program-specific FMEAs. They are also useful in support of concept trade-off studies.

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

Task 4: Program-Specific FMEAs
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.

Task 5: Management Reviews
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.

Task 6: Quality Audits
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. They provide valuable information to strengthen what works and address shortfalls.

Having personally 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 process.

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 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 and money.

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 XFMEA (/content/hbkworld/global/en/products/software/analysis-simulation/reliability/xfmea-failure-mode-effects-analysis-fmea-software.html). 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.

Summary
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.