【正文】 ? PROCESS FMEA Focus on the process. ? Process Flow/Process Sequence/Process Steps/Operators ? Order entry/Invoice payment/On time Delivery ? APPLICATION FMEA ? Suppliers Side Upstream ? Customers Side Downstream ? SERVICE FMEA Focus on Field Service after Sales ? Reliability/Maintainability/Warranty/Spare Parts 3/12/2023 ? APPLICATION FMEA ? SERVICE FMEA ? PRODUCT FMEA ? PROCESS FMEA Our area of focus today! 3/12/2023 What is a FMEA? FMEA is a disciplined procedure that allows an individual to anticipate failures and prevent their occurrence. Identify ways the product or process can fail. Then plan to prevent those failures. Concept 3/12/2023 Role of Process FMEA ? Key tool of a team to improve the process in a preemptive manner (before failures occur) ? Used to prioritize resources to ensure attention to process improvement efforts that are beneficial to customer ? Used to document pletion of projects and resultant improvements to risk calculations ? Should be a dynamic document, continually reviewed, amended, updated Used With Permission ?? AlliedSignal 1995 Dr. Steve Zinkgraf 3/12/2023 Purposes of Process FMEA ? Assists in the analysis of new processes ? Identifies deficiencies in the Process Control Plan so that actions can be taken to improve ? Establishes the priority of actions ? Helps evaluate the risk of process change ? Identifies potential variables to consider in Multivari and DOE studies ? Guides the development of new processes by helping teams understand weaknesses of current processes ? Helps set the stage for breakthrough strategy Used With Permission ?? AlliedSignal 1995 Dr. Steve Zinkgraf 3/12/2023 ? Prevention (Proactive): ? Prevent a Failure Mode from occurring ? Emphasis on avoiding causes, detecting Failure Modes earlier or reducing impacts of failure consequences ? Detection (Reactive): — Emphasis on identifying techniques or detecting methods to pinpoint an occurred failure — The effectiveness of the detection bees the focal point How Does It Work ? Identifies two areas for Improvement Actions 3/12/2023 Controls Controls FMEA Model Effect Effect External customer or downstream process step Cause Cause Failure Mode (Defect) Failure Mode (Defect) Key Process Input Material or Process Input Prevention Detection Detection 3/12/2023 Cause Effect Failure Mode (Defect) Controls Process Step Material or process input External customer or downstream process step FMEA Model 3/12/2023 Definition of Terms ? Failure Mode the way in which a specific key process input fails if not detected and either corrected or removed, will cause Effect to occur. Example: Controls Controls FMEA Model Effect Effect External customer or downstream process step Cause Cause Failure Mode (Defect) Failure Mode (Defect) Key Process Input Material or Process Input Prevention Detection Detection 3/12/2023 Definition of Terms ? Effect impact on customer requirements. Generally external customer focus, but can also include local effect or downstream processes. Example: Controls Controls FMEA Model Effect Effect External customer or downstream process step Cause Cause Failure Mode (Defect) Failure Mode (Defect) Key Process Input Material or Process Input Prevention Detection Detection 3/12/2023 Definition of Terms ? Cause ? Sources of variation that causes the Failure Mode to occur. Example: Prevention Controls Controls FMEA Model Effect Effect External customer or downstream process step Cause Cause Failure Mode (Defect) Failure Mode (Defect) Key Process Input Material or Process Input Detection Detection 3/12/2023 Definition of Terms ? Controls ? Systematized methods/devices in place to prevent or detect failure modes or causes (before causing effects). ? Prevention and Detection consists of foolproofing, automated control, setup verifications, audits, checklists, Inspection, laboratory testing, training, SOP’s, preventive maintenance, etc. Example: Controls Controls FMEA Model Effect Effect External customer or downstream process step Cause Cause Failure Mode (Defect) Failure Mode (Defect) Key Process Input Material or Process Input Prevention Detection Detection 3/12/2023 Failure Mode 1 Failure Mode 2 Effect 1 Failure Mode 1 Effect 1 Effect 2 Linking Failure Modes to Effects The relationship between the Failure Mode and the Effect is not always 1to1 Failure Mode 1 Failure Mode 2 Effect 1 3/12/2023 Which One Is Right ? Poor Raw Steel Stock Corroded Contacts Dead Battery Bulb Doesn’t Shine Flashlight Doesn’t Work Cause Failure Mode Effect Poor Raw Steel Stock Corroded Contacts Dead Battery Bulb Doesn’t Shine Flashlight Doesn’t Work Cause Failure Mode Effect Poor Raw Steel Stock Corroded Contacts Dead Battery Bulb Doesn’t Shine Flashlight Doesn’t Work Cause Failure Mode Effect 3/12/2023 Risk Priority Number (RPN) ? The output of a FMEA is the “Risk Priority Number” The RPN is a calculated number based on information you provide regarding: ? the severity of the effect to the customer ? how often the Cause occurs ? the current ability of the process to detect the failures before reaching the customer ? It is the product of three quantitative ratings: RPN = Severity * Occurrence * Detection Used With Permission ?? AlliedSignal 1995 Dr. Steve Zinkgraf 3/12/2023 Risk Priority Number ? Risk Priority Number is not sacred 。 Go back Review It ? Scaling for Severity, Occurrence and Detection can b