FMEA

What is an FMEA?

A failure mode and effects analysis (FMEA) is a systematic method of identifying and preventing product, service, or process failures before they occur. FMEAs focus on prevention (i.e., “fix it before it breaks”). The objective of an FMEA is to look at all of the ways a product or process can fail, analyze risks, and take action where warranted. Typical applications include preventing defects, improving processes, identifying potential safety issues, and increasing customer satisfaction. FMEAs should be conducted by organizations from initial product or process design through the life of the product. There are both design FMEAs and process FMEAs. Organizations can also benefit from conducting FMEAs on existing products or processes.

The FMEA process includes forms and customized evaluation criteria that provide a standardized, comprehensive approach, greatly reducing the variation of this preventive action process. The process allows an organization’s cross-functional teams to share and understand information in a common language. Both technical and non-technical people can easily use the FMEA process.

What are the benefits of FMEAs?

Implementation of an FMEA can help

• identify potential failures and warranty problems.
• identify cost reductions and quality improvement opportunities.
• reduce the cost of making changes by identifying issues early in the development-to-market cycle.
• demonstrate an organization’s commitment to a comprehensive quality system.
• provide an excellent preventive action tool for ISO 9001 and a typical component of a supplier PPAP provided to a customer.

What can CIRAS do for my company?

CIRAS can provide expert assistance in FMEAs for both automotive and non-automotive applications, including:

• Development of a DFMEA or PFMEA for specific applications
• Education of staff on creating FMEAs on paper and using simple software
• Assistance in establishing severity, occurrence and detection criteria
• Review of developed FMEAs for adequacy

What is my next step?