失效模式与影响分析（FMEA）包括关键性分析以及设计、保障、软件和过程 FMEA

FMEA is a systematic approach aimed at identifying and mitigating potential risks in the design, manufacture, and maintenance of a product. Implementing FMEA provides a range of benefits, such as:Preventing potential failures early in the life cycle.Identifying risk - establishing clear linkages ensures that no potential failure mode is overlooked across the life cycle of the product.Improving product safety, reliability, performance, and supportability.Enhancing collaboration - the framework fosters cross-functional communication, enabling design, manufacturing, and maintenance teams to work in harmony.Achieving effectiveness - by integrating analyses and plans, organizations can streamline workflows and reduce redundancies.Reducing costs associated with product failures.Enhancing customer satisfaction through consistent quality and reliability.Improving product quality - comprehensive linkage reduces errors and ensures a robust design and manufacturing process.Providing the basis for developing product support requirements through supportability analysisFMEA is versatile and shall be applied across various dimensions of product and process management. This standard provides terms, definitions, defined data elements, and essential information within each category of FMEA. The are many types of FMEA, but the primary types defined in this standard include:DFMEA: Focuses product design deficiencies during the design phase of a product and is updated based on product design changes throughout the life of the product design.SwFMEA: Addresses risks and issues specific to software during the design phase of a product and is updated based on software changes throughout the life of the product design.SupFMEA: Evaluates factors affecting product support and maintenance during the design phase of a product and is updated throughout the life of the product design.PFMEA: Concentrates on manufacturing and operational processes to identify and mitigate risks during the design phase of a product and is updated based on product or process changes throughout the life of the product design.Quantitative Criticality Analysis: Focuses on determining the risk of failure based on calculated or estimated failure rates.An essential part of the FMEA process is to identify and communicate potential issues that need to be addressed. When significant risks are discovered, it is incumbent on the FMEA team to communicate quickly to key stakeholders so that the project team can address as soon as feasible and not wait until the contracted deliverable is completed. FMEA is a dynamic and living process, the result of which is improved designs, manufacturing processes, and supportability, not forms or databases that are filled out.This standard applies to any product, process, or software in all phases of their life cycle. As a standard, this document contains requirements (“shall”) and recommendations (“should”) to guide the user through FMEA methods.