Page 177 - DMGT524_TOTAL_QUALITY_MANAGEMENT

Total Quality Management

Notes etc.), the timing of FMEAs (for example, prior to design freeze) and the selection criteria (such as
new technology, new applications, etc.).

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.

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.

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.

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Caution 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.
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.

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).

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.
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

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