软件控制的电子机械系统可靠性-ASQ.pdf

/site/resiliencereliability/ Software controlled Electro- Mechanical Systems Reliability by David Tu      AGENDA •  Introduction •  Government agencies •  Standards and Guidelines •  Reliability model and function •  Case Study •  Conclusion Discussing INTRODUCTION Goal Develop reliable software controlled electronic mechanical systems. Approach , Utilize agencies and regulations as supportive guidelines instead of obstacles. Procedures 1) Identify government agencies 2)Understand regulations and standards 3) Identify activities and develop procedures 4) Develop Reliability Program, MTBF analysis and test plan 5) Collaborate analysis and test 6) Review results 7) Perform root cause analysis for findings 8) Collaborate and implement corrective actions 9) Write reports 10) Monitor and improve reliability during product life cycle GOVERNMENT AGENCIES •  Food and Drug Administration FDA / Develop and enforce compliance for safety, effectiveness and reliability. FDA does not develop engineering specifications and standards for Medical Devices. FDA regulations are free for reference. •  International Electrotechnical Commission http://www.iec.ch/ Develop regulatory and engineering safety specifications and standards for medical device safety. Medical devices at European market requires CE marking. It is a self declaration process wit