本文发表于2016年7月的《质量文摘》。作者乔恩·施佩尔是Greenlight.Guru公司的联合创始人以及负责质量保证和法规事务的副总裁。该公司主要为医疗器械公司生产质量管理软件和提供服务。美国食品药品管理局要求医疗器械生产企业实施风险管理流程,通过全产品生命周期,来分析、评价、评估以及控制风险。本文通过对2015年F DA数据的分析,探讨了设计控制和风险管理流程可能会失败的8个原因和应对措施。 This article was published in the July 2016 Quality Digest. Jon Speer is co-founder of Greenlight.Guru and vice president of Quality Assurance and Regulatory Affairs. The company mainly produces quality management software and services for medical device companies. The FDA requires medical device manufacturers to implement a risk management process that analyzes, assesses, assesses and controls risk through the full product life cycle. This article examines F DA data for 2015 and explores eight reasons why design control and risk management processes may fail and how to deal with them.