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ROI CalculatorThe purpose of Failure Mode and Effects Analysis (FMEA) is to provide a structured method for determining potential areas of failure within a product, process, or system. It is also useful for determining where these potential areas of failure may occur before they turn into defects, safety issues, or non-compliance.
FMEA is based on many years of experience in industry, so it incorporates both engineering principles and risk scoring to assist teams in making informed decisions as products progress through their lifecycle. This approach helps teams to proactively strengthen their weakest links so they can embed quality into design, production, and service operations.
FMEA has become integral in assisting the development of robust and resilient operational strategy from the ground up, with respect to quality.
FMEA is a proactive methodology that provides an engineering and quality perspective to the identification of risks due to potential failures in processes, products or systems and that allows for the systematic identification of those risks before they occur in operations or experienced by a customer. It has become a key element of lean manufacturing, Six Sigma and QMS programs across a variety of industries, including automotive, life sciences and industrial manufacturing.
The FMEA process evaluates all known failure modes associated with a particular process and assesses each mode's overall impact, likelihood of occurrence and ability to detect failure. The risk scores associated with these assessments are then used to drive the decision-making processes related to the allocation of resources, control measures, and improvements to the product's lifecycle.
By concentrating on root causes before execution, FMEA minimizes internal failures, fast-tracks time-to-market, and backs first-time-right design philosophy.
Knowing when to perform FMEA can mean big savings if you prevent failures and respond to them properly. In ideal cases, FMEA must be used under the following junctures:
Product design and development
When executing new processes, materials, or suppliers
Before taking corrective measures for customer grievances
When performing process audits or root cause analysis
Standards such as the IATF 16949, ISO 9001 and QSR establishes regulations that require risk-based thinking, so, FMEA will provide an organization with an efficient way to fulfill these requirements.
FMEA has become an essential element within all global quality systems, so aligning the organization’s processes within recognized standards helps maintain Coordination/Traceability/Compliance. There are currently many standards used internationally by FMEA users that apply to different industries and operational types. Among the most prominent are:
AIAG-VDA FMEA: A harmonized standard created for use in the Automotive Industry and combines North American and European Best Practices into one standard. The standard introduces the use of an Action Priority Scale instead of the traditional RPN to determine a risk ranking.
SAE J1739: The North America Automotive Standard is focused on documenting and ranking failure modes using severity, occurrence and detection.
IEC 60812: A generic, internationally recognized standard that is common in high-risk industries, such as electronics and defense.
ISO 14971: Medical device manufacturers require the use of this standard to manage risk. However, FMEA is often combined with other types of FMEA tools to ensure compliance with FDA requirements.
Such forms of standardization ensures consistency in:
Scoring
Risk mitigation measures
Documentation and audit preparedness
The Harmonized AIAG/VDA model introduces an action priority metric to replace the original RPN in determining a risk score, which provides a clearer route to arrive at a decision.
