A failure modes and effects analysis (FMEA) is a systematic process for evaluating potential failure modes within a system or design and assessing the relative impact of those failures. By conducting a thorough FMEA, engineers can gain valuable insights into ways the system may fail and assess how to minimize risk and the effects of any potential failures that do occur. Some key findings that could emerge from a comprehensive FMEA may include:
The FMEA would carefully examine each component, subsystem and interface within the overall system or design. Engineers would evaluate potential ways that each part could fail to perform its intended function, considering factors such as material defects, wear and tear, excessive stresses, improper assembly, incorrect operational parameters, etc. Through this process, certain components may be identified as having higher failure potential due to their complexity, number of failure modes, operating stresses or other risk factors. For example, some parts that interface with users or are exposed to harsh environmental conditions could emerge as particular risk areas based on potential failure modes.
Upon determining all potential failure modes, the team would then assess the impact or severity of each failure on system performance, safety and other critical attributes. Some failure modes, even if relatively unlikely, may carry catastrophic or critical consequences like injury, system damage or inability to complete a primary function. Other failures may only cause minor quality issues or inconveniences. This severity analysis helps identify where design or process changes could help minimize overall risk. Certain component failures or failure combinations ranked with high severity may warrant immediate design focus or additional controls.
An important consideration would be the likelihood or probability of each specific failure mode occurring. Factors like history of similar parts, design maturity, manufacturing processes and component stresses are evaluated. Failures seen as very likely due to high risks require special attention versus others seen as only remotely possible. Combining severity and occurrence evaluations into an overall risk priority number, the FMEA can objectively pinpoint the highest priority issues to address proactively through design or process improvements.
Patterns may emerge implicating certain suppliers, manufacturing steps, environmental conditions or other root causes as contributing factors in multiple failure modes. For example, if many failures can be traced to variations in a critical material property, material certification and testing processes may need review. Such systematic insights help prioritize the most valuable corrective and preventive actions to take.
Recommended actions are formulated to reduce occurrence and/or minimize impact of the highest risk failures. These may include design changes like adding features to reinforce weaknesses, improve inspection points, or adding redundancies. Process recommendations could involve tightening controls, adding process validation checks, supplying staff training and so on. An effective FMEA drives continuous improvement by prioritizing actions supported by objective analysis.
Once improvements are made, the FMEA should be recalculated or revisited periodically over the system’s life cycle to verify effectiveness and consider additional learning from field data. New potential failure modes may emerge as designs or usage profiles evolve too. Periodic review ensures the analysis stays aligned with current conditions.
A robust FMEA process involves cross-functional perspectives in the analysis and uses its findings to help develop comprehensive reliability test plans as well as maintenance and inspection protocols. The end goal is achieving an optimal balance of high reliability, safety and cost-effectiveness throughout the system’s lifecycle. When consistently applied and maintained, FMEA can significantly reduce development and operational risks.
A thorough failure modes and effects analysis provides a rigorous, evidence-based process for identifying and prioritizing reliability and safety concerns within a system or design. Its key findings light the path for targeted improvements to minimize overall risks and their impacts on performance, schedule and budgets. Used effectively, FMEA drives powerful gains that resonate throughout the development, production and field support phases of any product or operation.