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. Implementation of an FMEA can help an organization to identify potential failures, warranty problems, cost reductions, quality improvement opportunities. FMEA also helps to reduce the cost of making changes by identifying issues early in the development-to-market cycle. FMEA demonstrates an organization’s commitment to a comprehensive quality system and provides an excellent preventive action tool for ISO 9001
Significant Characteristics: | Significant Characteristics are Special Characteristics defined by Ford Motor Company as characteristics that significantly affect customer satisfaction and require quality planning to ensure acceptable levels of capability. | Special Process Characteristics: | Special Process Characteristics are process characteristics for which variation must be controlled to some target value to ensure that variation in a Special Product Characteristic is maintained to its target value during manufacturing and assembly. | Special Product Characteristics: | Special Product Characteristics are product characteristics for which reasonably anticipated variation could significantly affect a product’s safety or compliance with governmental standards or regulations, or is likely to significantly affect customer satisfaction with a product. | | | | | | | | | |