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FMEA  (Failure Mode & Effects Analysis)

FMEA (Failure Mode & Effects Analysis)

The FMEA (Failure Mode & Effects Analysis) aims to bring out the weaknesses of the process with the aim of defining preventive and corrective actions for the drafting of control plans so as to reduce the cases of failure ( waste, production stops, etc.) and / or reduce their impact.

 

The process is analyzed in detail, identifying all the potential critical issues. The FMEA technique is the analysis tool that is used to ensure that every possible anomaly of the process in question is considered and evaluated according to the indicators of gravity (G), probability to occur (P) and its detection (R), assigning a score from 1 to 10 for each indicator.

The product G * P * R of the values attributed to every fault mode returns a priority index of risk called RPN - Risk Priority Number.

When the IPR value exceeds a certain threshold (normally = 100) it needs to identify and implement appropriate preventive actions to reduce the risk in that specific area.

Once the necessary measures have been implemented, the FMEA module is updated by the recalculation of the risk priority index.

Afterward, the Team assesses the effectiveness of the measures adopted by standardizing what has been implemented.

The FMEA is a living document that is updated whenever changes and improvements are made to the process.

VITART applies this tool during the design and analysis phase of the production process (P-FMEA) of all products destined for the Automotive sector.

Furthermore, the P-FMEA analysis is also applied for manufacturing non-automotive products for complex components or where the Team, following a risk assessment, deems it necessary or useful to guarantee the care of qualitative details beyond the standard or where it is evaluated  necessary to further improve a production process.

The main advantages of using analytical tools like the FMEA are:

  • Evaluate the expressed and unexpressed needs of customers.
  • Lower manufacturing and management costs and make production more competitive.
  • Define a conceptual framework for carrying out a process.
  • Have a complete overview of possible errors and actions to prevent them by enhancing and keeping track of "lessons learned".
  • Being able to apply continuous improvement to the process
  • Consolidate the corporate know-how.

The New FMEA is now

The German Association of the Automotive Industry (VDA) and the American Association AIAG (Automotive Industry Action Group) have completed the work of harmonizing the respective "national" FMEA (Failure Mode and Effects Analysis) manuals, creating a single manual " FMEA AIAG & VDA ”, which will become the automotive industry standard for US and German OEMs.

In essence, the bases and concepts remain those of the traditional FMEA, adding some new elements. Particularly, updates have been introduced regarding risk assessments, with the transition from the IPR (risk priority index) to the concept of risk matrix, that considers errors / failures and the severity of their effects till to the customer in order to prevent them.

Davide Calabretti  (VITART Quality Assurance Manager)

Vitart

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