Fmea - What Is Its Meaning?

FMEA - Failure Mode and Effect Analysis is a system - a systematic technique - for finding and preventing product and process failures. In ISO9001 terminology it is an accurate 'Prevention' tool, it is a Risk Assessment.

As might be expected, FMEAs were first introduced into the obvious high risk industries of aero-space and military ordnance, followed eventually by the automobile industry. The objective of safety FMEA activities is clearly to prevent failures that lead to incidents and accidents. Note that with this system the focus is on complete prevention, it is not Corrective Action following the event. The performance standard is Defect Free, and practitioners of FMEA do not generally talk in terms of minimizing risk, as though some level of risk is acceptable, but in risk elimination. That is the purpose of this process.

It might be thought that a standard Corrective Action process has within it an FMEA activity, and while that could be true in a specific case, the reality of life is that the reverse is true. Corrective actions are about discovering solutions for currently identified failures - usually at minimum cost and inconvenience, while FMEAs are concerned with the identification and prevention of Potential failures. Corrective actions are concerned with the inconvenient present, FMEAs focus on not having an inconvenient future.

Where FMEA's are a usual feature of a business organisation they regularly form part of a product design technique, and quite often also a feature of the associated production process also. These analyses are invariably conducted by a multi-disciplined team, and are integrated into the product design-review system. FMEA teams usually exist only for a particular purpose or project, and are individually free to pursue work elsewhere when their task is complete.

To talk of FMEA teams suggests a marked increase in the cost of a product development, and while some cost escalation may be incurred a successful analysis will invariably impact favourably on total life cycle costs simply due to the reduction in re-design in the light of past failings. The same situation applies to FMEA activity around production processes. For both it is true that it is always less costly to do the job right-first-time, than to get it wrong and do it over again. Within the design and manufacturing environment this is clearly true. When the product weakness is identified post-delivery the consequential costs can become prohibitive.

Conducting a FMEA is not an especially difficult task, but requires the establishment of a team with appropriate skills, including interpersonal skills. In many situations the analysis process will challenge some earlier judgment of one or more team members, and this cannot be avoided since their expertise is essential to the effectiveness of the process. Similarly this analysis process must be robust and the decisions auditable. The records of FMEA could well be needed to demonstrate the organisation's execution of their duty of care to their employees or the wider community.

An FMEA is therefore a thorough assessment of the potential for failure of a product, along with an estimate of the percentage chance of each failure happening, and a decision on the actions to come from the aquisition of that information.

FMEA processes, once established within an organisation's working culture, are seldom abandoned, but to establish FMEAs requires a commitment to the necessary training and up-front costs of implementation.