[英语学习]qualityoneASQ_presentation.pptVIP

FMEA Intelligent use of FMEA What Is An FMEA? Opportunity to Defeat Murphy’s Law Focus on Prevention Failure Mode And Effects Analysis is An assessment of Risk Safety Regulatory Customer Satisfaction Program Coordinated/Documented team effort To determine what can go wrong A method to determine the need and priority of actions Requirements Cascade How Fmea fits into Product and Process Development Potential KPC Development Characteristics Matrix Development Characteristics Matrix FMEA Deployment A layered approach is highly recommended as FMEAs can get complex. FMEAs are like ONIONS/LAYERS. Each layer is closer to the root cause Each layer is more detailed The closer to core the more detail Core gets to the root cause Do too many and you will cry. System Boundary Diagram P-Diagram FMEA Preparation Vertical Approach Key Elements of Efficient Development Identify all functions/process steps Boundary Diagram P Diagram Identify all failure modes via brainstorming/data/warranty/COQ Identify all effects via brainstorming/data Customer focus Develop data pools for Failure Modes, Effects and Causes for future/ faster FMEA development System/Subsystem/ Design FMEA Failure Mode: Pure anti-function System/Subsystem/ Design FMEA Effect Customer view/customers words Regulation violation Level of dissatisfaction Consider All Customers End User Engineering Community Manufacturing Community (Operators/Employees) Regulatory Body Severity Column FMEA General Failure Mode/Cause Relationship In Different FMEA Levels Causes Causes from P-Diagram Noise factors Continue through all failure modes. Note that many causes are recurring. Occurrence Column Occurrence Evaluation Criteria Occurrence Rating If an action would effectively eliminate the possibility of the cause occurring, the action is listed as described earlier. Occurrence of 1 or 2 require proof using a surrogate product or mistake proofing. Example of Significant/ Critical Threshold C