FMEA or Failure Mode Effects Analysis has been in use since the 1940s. It was primarily used in the aerospace industry to start with and then slowly made its way into the automotive sector where it gained popularity. In 2019 a change was made to the FMEA methodology used and AIAG (The US Automotive Group) and VDA (the German counterpart) issued a new FMEA handbook that changed the methodology of how this process was carried out. For companies this does not mean that an immediate changeover is required. The need for use of the new methodology will be driven by the customer as part of their requirements.
What is FMEA? FMEA is a tool used to assess risk. There are two types of FMEA. Process FMEA and design FMEA. Using the tool organizations can identify potential threats within their process and design and take actions to address them before they develop into a non-conformity. In essence therefore it is a preventive tool. While there are differences between the traditional and new methodologies, they both use the same process to identify and mitigate risks.
They both still requires three axes for calculation of the risk to the organization. The first is the probability or likelihood of detection, the next is the severity or consequences and the last factor taken into consideration is the ease of detection before the error or risks occurs. If less likely to detect the risk is greater and is easy to detect then the risk overall is considered to be less. FMEAs must be done by teams and the overall risk is based on a criteria set by the organization and not by one individual. Therefore, it is also always better to use teams to conduct an FMEA opposed to one individual doing it.
FMEA’s are not static documents that once created do not require a change. They are living documents that are updated and reviewed at periodic intervals to ensure no changes that may change the overall risk. In the traditional FMEA an RPN or Risk Priority Number was calculated. A number or people over the years have critiqued the RPN approach as the threshold at which a risk is considered not acceptable is often arbitrary. In the AIAG-VDA approach they have changed this to an Action Number and the handbook provides a table for guidance with what each Action Number means. The new methodology is also broken down into seven steps.
To learn more about FMEA and how to conduct either a Design FMEA or a process FMEA join QMII’s training offered in both an onsite and virtual instructor led format.

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