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FMEA

FMEA (Failure Mode & Effects Analysis) is one of the core tools in Design for Six Sigma.

Failure Modes and Effects Analysis (FMEA) is a risk assessment and management technique used commonly in the motor industry. It makes use of brainstorming sessions to identify as many potential failure modes as possible and their causes and effects. These are then assessed for likelihood of Occurrence, Severity of effect and likelihood of Detection, usually on a 1-10 basis. Finally an overall ranking is produced leading to an action plan to reduce the risks involved, called a Risk Priority Number, or RPN. The results are recorded in a pre-determined format, either on paper or in an Excel spreadsheet or by using specific software.

The key is to then formulate actions for the most important items that will lead to reducing the RPN and hence a better (i.e. less risky) design or process.

It is best performed as a cross-functional team brainstorming session, starting early in the design of a product or process, as conducting an FMEA may lead to design changes to reduce or eliminate the risk.

Elite Consulting has developed its own general industrial FMEA process based mainly on the Automotive Industry Action Group (AIAG) QS9000 standard, but bringing in other aspects, so that it can be used for most industries. In this model there are 3 different versions of FMEA to be performed, a System FMEA, a Design FMEA and a Process FMEA.

For Service Industries, or for other industries where service is an important aspect, a Service FMEA is also available.

For the medical device and healthcare industries specially adapted versions of the FMEAs are available. These comprise System, Design, Process and Service FMEA’s that take into account medical device regulations and standards, such as the Medical Device Directive (93/42/EEC and related amendments), BS EN 13485, BS EN ISO 14971 and the FDA Regulations (21 CFR 820).

Other versions are also available for general business processes and for the financial industry. 

For more information, click here.

Elite Consulting will come to you to undertake FMEA training, FMEA consultancy, or to be an FMEA facilitator.

Please contact us for more details, or to discuss your requirements.

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