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Failure mode-and-effects-analysis

The document provides information on Failure Mode and Effects Analysis (FMEA). It begins with an overview of what an FMEA is and its purpose in identifying potential failures, effects, and causes. It then discusses how FMEAs fit within the product and process development process. The document provides examples of tools that can be used as part of an FMEA, such as boundary diagrams, P-diagrams, and a characteristics matrix. It also discusses approaches for effectively preparing and deploying FMEAs.

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FMEA • Intelligent use of FMEA
Potential Failure Mode and Effects Analysis (Design FMEA) __ System __ Subsystem __ Component Model Year/Vehicle(s): Core Team: Design Responsibility Key Date: FMEA Number: Page 1 or 1 Prepared by: Lee Dawson FMEA Date (Orig.): Item Function Potential Failure Mode Potential Effect(s) of Failure Potential Cause(s)/ Mechanism(s) Of Failure Current Design Controls Prevention Current Design Controls Detection Recommended Action(s) Responsibility & Target Completion Date Actions Taken Action Results S E V C L A S S O C C U R D E T E C R. P. N. S E V O C C D E T R. P. N.
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 MURPHY’S LAW
DFMEA Design & Development - Section II GD & T - Drawings - Math Data DFMEA Design Actions Test Plans - Design Verification Design Change IF Design OK Special Characteristics Design Risk Assessment - Open Issues - Spec. Agreements - Materials - Budget - Manufacturing - Program Risks Kick Off Tools / Equipment Gages No Yes Prototype Control Plan Plan & Define Section 1 IDEA Opportunity Defined Form Team - Timing - Resources Collect Market Research Customer Wants/Needs/Desires - QFD Priorities Wants/Needs/ Desires Develop Product Specifications - Linked to Customers Develop Concepts - Product - Process Input From 5 - Failure Mode Analysis - History - Past Performance - Lessons Learned IF Feasible No Yes Initial Process Feasibility - Team Process Design & Development - Section III Process Flow Finalized Characteristic Matrix PFMEA - Manufacturing - Assembly Process Validation Plan - Gage Plan - Capability Plan Packaging Designs IF Process Risk Assessment - Equipment - Gages - Controls - Instructions - Plans - Status of Open Issues - Equipment Installation - Tooling Progress - Gage Design & Progress Special Controls Instructions - Initial YES NO MistakeProof? Pre - Launch Control Plan - Risk/Action - Special Characteristics - Current Controls Process Validation - Section IV Process Trial Run Min 300 pcs/Hits/shots GR & R - Gage Plan Repeatability Reproducibility Statistics - Via Control Plans - Capability Plan Validation Testing Plan Sample The Process - Source Warrants - Supporting Documentation - Level of PPAP Design Change Back to II YES NO - Reduced (n) - Reduced (f) - Optimizing Characteristics IF IF Can we change process to contain? IF YES STABLE? CAPABLE? IF OK? YES NO NO Revisit III PFMEA For Additional Potential Failures NO YES Create Production Control Plan PLANNING Concept Initiation/Approval Program Approval Prototype Pilot Launch PLANNING CONTROL PLANS PRODUCT DESIGN AND DEV. PROCESS DESIGN AND DEVELOPMENT. PRODUCT AND PROCESS VALIDATION. FEEDBACK ASSESSMENT AND CORRECTIVE ACTION PRODUCTION Open Issues / Time Line RELIABILITY BY DESIGN APQP Tool Linkage Process Development
Requirements Cascade • How Fmea fits into Product and Process Development
Potential KPC Development 6 DetectPrevent R P N D E T O C C S E V Action Taken Action Results Response & Target Complete Date Recommended Actions R P N D e t e c Current Controls O c c u r Potential Cause(s)/ Mechanism(s) Of Failure C l a s s S e v Potential Effect(s) of Failure Potential Failure Mode Item / Process Step DetectPrevent R P N D E T O C C S E V Action Taken Action Results Response & Target Complete Date Recommended Actions R P N D e t e c Current Design Controls O c c u r Potential Cause(s)/ Mechanism(s) Of Failure C l a s s S e v Potential Effect(s) of Failure Potential Failure Mode Item / Process Step Function DFMEA Requirements Documents •Regulatory •Dimensional •Cosmetic Req. Spec. Document Drawings Warranty History Robustness Tools Boundary Diagram P-Diagram Interface Matrix 10 9 8 7 6 5 4 3 2 1 1 2 3 4 5 6 7 8 9 10 S E V E R I T Y O C C U R R E N C E POTENTIAL CRITICAL CHARACTERISTICS Safety/Regulatory POTENTIAL SIGNIFICANT CHARACTERISTICS Customer Dissatisfaction Special Characteristics Matrix ANOYANCE ZONE ALL OTHER CHARACTERISTICS Appropriate actions / controls already in place Cascade Technical Requirements Into Special Product Characteristics
Characteristics Matrix Development Severity Process Steps ReceiveMaterial Materialhandling ShippingDamage ComponentManufacture VehicleAssembly Primary Drive Manufacturing Process Steps Op100Step1 PRE-LOADDOWELPINSTO FIXTURE Op100Step2 PRE-LOADJACKSHAFT SEALTOFIXTURE Op100Step3 PRE-LOADPRIMARY HOUSINGBUSHINGTO FIXTURE Op110 Pre-loadbearingtofixture#2 Op120 Pre-loadmainshaftoilsealto mandrel Op200 Housingtofixture#1 Op210 Operatepress Op220 Retainingringtotopgroove Op230 Reloadfixture#1 Op300 Housingtofixture#2 Op310 Operatepress Op320 Retainingringtotopgroove Op330 MandreltomainshaftboreI.D. OP340 Operatepress Op350 Re-loadfixture#2andmandrel Op400 Housingtotable Op410 Reserved Op420 Chainadjsubassytohousing Op430 Lubricatebushing&seal Op445 Moveorstageforfinalassy Op10 O-ringtoshiftertube Op500 Shiftertubetohousing Op510 Clamptoshiftertube Op20 Assembleshifterlever Op520 Wavewashertoshifterlever Op530 Shifterlevertoshiftertube Op535 Queforfinalassyline Customer Assessment Direction of Improvement PotentialCriticalandSignificant 1.090 TO 1.110 " FACE OF PRIMARY HOUSING BUSHING TO FACE OF JACK SHAFT SEAL DOWEL PINS 0.260 TO 0.270 " TO FACE JACK SHAFT SEAL AGAINST SHOULDER BEARING FLUSH TO SNAP RING FACE SEAL COMPRESSION HEIGHT PRIMARY GASKET SEAL SURFACE FINISH SERATION DAMAGE Weighted Importance Relative Importance G F H F H F G F G H G H H F H H F F Y H H H H H G G F 5 3 9 3 9 9 5 0 81 81 72 0 9 41 0 0 27 54 261 3 0 54 81 3 0 0 0 27 0 45 9 9 0 0 0 0 0 0 0 Special Characteristics Matrix START OPERATION OPERATION IF END YES NO Process Flow Special Characteristics Sources •DFMEA (Potential KPCs: Significant and Critical Characteristics) •Drawings •Regulations
Characteristics Matrix 8 Severity Process Steps ReceiveMaterial Materialhandling ShippingDamage ComponentManufacture VehicleAssembly Primary Drive Manufacturing Process Steps Op100Step1 PRE-LOADDOWELPINSTO FIXTURE Op100Step2 PRE-LOADJACKSHAFT SEALTOFIXTURE Op100Step3 PRE-LOADPRIMARY HOUSINGBUSHINGTO FIXTURE Op110 Pre-loadbearingtofixture#2 Op120 Pre-loadmainshaftoilsealto mandrel Op200 Housingtofixture#1 Op210 Operatepress Op220 Retainingringtotopgroove Op230 Reloadfixture#1 Op300 Housingtofixture#2 Op310 Operatepress Op320 Retainingringtotopgroove Op330 MandreltomainshaftboreI.D. OP340 Operatepress Op350 Re-loadfixture#2andmandrel Op400 Housingtotable Op410 Reserved Op420 Chainadjsubassytohousing Op430 Lubricatebushing&seal Op445 Moveorstageforfinalassy Op10 O-ringtoshiftertube Op500 Shiftertubetohousing Op510 Clamptoshiftertube Op20 Assembleshifterlever Op520 Wavewashertoshifterlever Op530 Shifterlevertoshiftertube Op535 Queforfinalassyline Customer Assessment Direction of Improvement PotentialCriticalandSignificant 1.090 TO 1.110 " FACE OF PRIMARY HOUSING BUSHING TO FACE OF JACK SHAFT SEAL DOWEL PINS 0.260 TO 0.270 " TO FACE JACK SHAFT SEAL AGAINST SHOULDER BEARING FLUSH TO SNAP RING FACE SEAL COMPRESSION HEIGHT PRIMARY GASKET SEAL SURFACE FINISH SERATION DAMAGE Weighted Importance Relative Importance G F H F H F G F G H G H H F H H F F Y H H H H H G G F 5 3 9 3 9 9 5 0 81 81 72 0 9 41 0 0 27 54 261 3 0 54 81 3 0 0 0 27 0 45 9 9 0 0 0 0 0 0 0 Special Characteristics Matrix Process Operation from Process Flow Potential Significant and Critical Characteristics from DFMEA & Other Sources High/Medium Interactions are causes/failure modes in PFMEA Characteristics Ranked in order of Importance Prioritized ranking of process steps relative to risk
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 Lifter Assembly •Body •Insert •Roller •Pin •Clip •wire CAM Shaft Pushrod •Rod •Cup •Ball Intake Rocker Assembly Exhaust Rocker Assembly •Body •Insert •Roller •Pin •Clip Arm Group Assembly •Intake rocker assembly •Exhaust rocker assembly •Stand(s) W & W/o oil supply •Shaft Assembly •Mounting Bolt •Spring/Spacer Bridge Spring Group •Inner & Outer Springs •Spring Base •Retainer/Rotator •Valve Keeper Valve Group •Intake Valve •Exhaust Valve •Intake Seat •Exhaust Seat •Valve Guide •Valve Guide Seal CAM Bearings Thrust Plate Cylinder Block Oscillating Lifter •Pressure Lube OR Bore in Block •Pressure Lube Lube Oil Cylinder Head Vibration Valve CoverClearance Shaft Assembly •Shaft •Cup •Pin Valve •Injector oil Floating Cylinder Head Load Valve Stem Seal Clear at full stroke Lube Oil Cylinder Head Cylinder Head Seat Insert Valve Seat Additional Clearances •Injector & Spring •Injector & Spring Base •Injector & retainer •Injector & Bridge •Injector & injector clamp Compression Brake Vibration
P-Diagram 11 1. Piece to piece variation 2. Other systems 3. Customer usage/duty cycle Heat shields Foot peg location After market changes Pipe maufacturing variation Engine mount -mufflers, foot pegs, decorative covers Frame variation Change calibrations, runs hotter, componet discoloring, over drive system, excesive lean angle Supension changes, lowers bike Improper storage practices 4. Deterioration/degredagtion over time 4. Environment Gasket wear Ocean sea side (salt) Motor mount wear Sand, dust Corrosion Gravel Loss of torque on fasteners Parade duty (low speed) Input Ideal function Exhaust gases from engine Exhaust Pipes, Front & Rear Engine vibration Road vibration Meet Styling Requirements Transfer of exhaust gas Adequate clearance to other components Control factors Meet Durability Requirements Regulatory Error states Lean Angle (SAE) Difficult to service Durability Requirements (GES) Does not meet styling review Difficult to assemble High warranty Poor lean angle Noise Factors
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 12
System/Subsystem/ Design FMEA – Failure Mode: Pure anti-function 13 FUNCTION (ANTI)
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 14
Severity Column 15 DetectPrevent R P N D E T O C C S E V Action Taken Action Results Response & Traget Complete Date Recommended Actions R P N D e t e c Current Process Controls O c c u r Potential Cause(s)/ Mechanism(s) Of Failure C l a s s S e v Potential Effect(s) of Failure Potential Failure Mode Item / Process Step DetectPrevent R P N D E T O C C S E V Action Taken Action Results Response & Traget Complete Date Recommended Actions R P N D e t e c Current Process Controls O c c u r Potential Cause(s)/ Mechanism(s) Of Failure C l a s s S e v Potential Effect(s) of Failure Potential Failure Mode Item / Process Step Function Severity Column Severity Column
AUTOMOTIVE EXAMPLE SEVERITY EVALUATION CRITERIA Hazardous- with warning Very High High Very high severity ranking when a potential failure mode affects safe vehicle operation and/or involves noncompliance with government regulation without warning Low Very Low Minor Very Minor None Very high severity ranking when a potential failure mode affects safe vehicle operation and/or involves noncompliance with government regulation with warning Vehicle/item inoperable (loss of primary function). Vehicle/item operable but at a reduced level of performance. Customer very dissatisfied. Vehicle/item operable but Comfort/Convenience item(s) inoperable. Customer dissatisfied. Vehicle/item operable but Comfort/Convenience item(s) operable at a reduced level of performance. Customer somewhat dissatisfied. Fit & Finish/Squeak & Rattle item does not conform. Defect noticed by most customers (greater than 75%). Fit & Finish/Squeak & Rattle item does not conform. Defect noticed by 50% of customers. Fit & Finish/Squeak & Rattle item does not conform. Defect noticed by discriminating customers (less than 25%). No discernable effect. 10 8 7 6 3 2 1 Hazardous- without warning Moderate 4 5 EFFECT CRITERIA: Severity of Effect RNK. SEVERITY EVALUATION CRITERIA 9
FMEA General • For High Severity 9/10
Failure Mode/Cause Relationship In Different FMEA Levels Inadequate Electrical Connection Inadequate Electrical Connection Motor Stops Causes Cause Failure Mode Failure Mode Inadequate Locking Feature Harness Too Short
Causes – Causes from P-Diagram • Noise factors – Continue through all failure modes. – Note that many causes are recurring. 19
Occurrence Column 20 DetectPrevent R P N D E T O C C S E V Action Taken Action Results Response & Traget Complete Date Recommended Actions R P N D e t e c Current Process Controls O c c u r Potential Cause(s)/ Mechanism(s) Of Failure C l a s s S e v Potential Effect(s) of Failure Potential Failure Mode Item / Process Step DetectPrevent R P N D E T O C C S E V Action Taken Action Results Response & Traget Complete Date Recommended Actions R P N D e t e c Current Process Controls O c c u r Potential Cause(s)/ Mechanism(s) Of Failure C l a s s S e v Potential Effect(s) of Failure Potential Failure Mode Item / Process Step Function Occurrence Column Occurrence Column
Occurrence Evaluation Criteria 21 *Note: Zero (0) rankings for Severity, Occurrence or Detection are not allowed Probability of Likely Failure Rates Over Design Life Ranking Failure SUGGESTED OCCURRENCE EVALUATION CRITERIA Very High: Persistent failures High: Frequent failures Moderate: Occasional failures Low: Relatively few failures Remote: Failure is unlikely ≥ 100 per thousand vehicles/items 50 per thousand vehicles/items 20 per thousand vehicles/items 10 per thousand vehicles/items 5 per thousand vehicles/items 2 per thousand vehicles/items 1 per thousand vehicles/items 0.5 per thousand vehicles/items 0.1 per thousand vehicles/items ≤ 0.01 per thousand vehicles/items 10 9 8 7 6 5 4 3 2 1
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. 22 DATA HARD FACTS
Example of Significant/ Critical Threshold 23 10 9 8 7 6 5 4 3 2 1 1 2 3 4 5 6 7 8 9 10 S E V E R I T Y O C C U R R E N C E POTENTIAL CRITICAL CHARACTERISTICS Safety/Regulatory POTENTIAL SIGNIFICANT CHARACTERISTICS Customer Dissatisfaction ALL OTHER CHARACTERISTICS Appropriate actions / controls already in place Special Characteristics Matrix ANOYANCE ZONE
Classification And Definition Column 24 S e v R. P. N. Item Function Potential Failure Mode Potential Effect(s) of Failure C l a s s Potential Cause(s) / Mechanism(s) of Failure O c c u r Current Design Controls D e t e c Recommended Actions Response & Target Complete Date Actions Taken Classification and Definition Column Action Results O c c S e v D e t R. P. N.
Design Verification (Current Design Controls) – Think of Design Control in two ways; Prevention and Detection. List them separately. – To save time, add any new (untried) prevention/detection ideas to the document under Recommended Actions column. • Prevention is specifically related to reduction or elimination of a cause. • Detection is how well the test or series of tests may find the design flaw – Causes – Failure Mode 25
Detection Rating Absolute Uncertainty Very Remote Remote Very Low Low Moderate Moderately High High Very High Almost Certain 10 9 8 7 6 5 4 3 2 1 Design Control will not and/or cannot detect a potential cause/ mechanism and subsequent failure mode; or there is no Design Control. Very Remote chance the Design Control will detect a potential cause/mechanism and subsequent failure mode. Remote chance the Design Control will detect a potential cause/ mechanism and subsequent failure mode. Very Low chance the Design Control will detect a potential cause/mechanism and subsequent failure mode. Low chance the Design Control will detect a potential cause/mechanism and subsequent failure mode. Moderate chance the Design Control will detect a potential cause/ mechanism and subsequent failure mode. Moderately High chance the Design Control will detect a potential cause/mechanism and subsequent failure mode. Very High chance the Design Control will detect a potential cause/ mechanism and subsequent failure mode. High chance the Design Control will detect a potential cause/ mechanism and subsequent failure mode. Design Controls will almost certainly detect a potential cause/ mechanism and subsequent failure mode. DETECTION SUGGESTED DETECTION EVALATION CRITERIA CRITERIA RNK.
Analysis Of Risk – RPN / RISK PRIORITY NUMBER – What Is Risk? – Probability of danger – Severity/Occurrence/Cause 27
RPN / Risk Priority Number Top 20% of Failure Modes by RPN R P N Failure Modes
Evaluation by RPN Only – Case 1 • S=5 O=5 D=2 RPN = 50 – Case 2 • S=3 O=3 D=6 RPN = 54 – Case 3 • S=2 O=10, D=10 = 200 – Case 4 • S=9 O=2 D=3 = 54 29 WHICH ONE IS WORSE?
Example – Extreme Safety/Regulatory Risk • =9 & 10 Severity – High Risk to Customer Satisfaction • Sev. > or = to 5 and Occ > or = 4 – Consider Detection only as a measure of Test Capability. 30
Example of Significant/ Critical Threshold 31 10 9 8 7 6 5 4 3 2 1 1 2 3 4 5 6 7 8 9 10 S E V E R I T Y O C C U R R E N C E POTENTIAL CRITICAL CHARACTERISTICS Safety/Regulatory POTENTIAL SIGNIFICANT CHARACTERISTICS Customer Dissatisfaction ALL OTHER CHARACTERISTICS Appropriate actions / controls already in place Special Characteristics Matrix ANOYANCE ZONE
Actions 32 Item Function System Subsystem Component: Model Year/Vehicle (s): Core Team: Your Company Name Here Potential Failure Mode and Effects Analysis (Design FMEA) Design Responsibility: Key Date: FMEA Number: Page of Prepared by: FMEA Date (Orig.): (Rev.): Potential Failure Mode Potential Effect (s) of Failure s e v c l a s s Potential Cause (s)/ Mechanism (s) Failure o c c u r Current Design Controls D e t e c R. P. N. Recommended Action(s) Responsibility & Target Completion Date Actions Taken s e v o c c D e t R. P. N. A c t i o n R e s u l t s
Actions 33 EXAMPLE: Project: Date Of Meeting: Issue Number Issue Status/ Open Date Issue Champion Action Number Action Date Action Person Resp. Team Completion Date 143
Re-rating RPN After Actions Have Occurred 34 Item Function System Subsystem Component: Model Year/Vehicle (s): Core Team: Your Company Name Here Potential Failure Mode and Effects Analysis (Design FMEA) Design Responsibility: Key Date: FMEA Number: Page of Prepared by: FMEA Date (Orig.): (Rev.): Potential Failure Mode Potential Effect (s) of Failure S e v C l a s s Potential Cause (s)/ Mechanism (s) Failure O c c u r Current Design Controls D e t e c R. P. N. Recommended Action(s) Responsibility & Target Completion Date Actions Taken S e v O c c D e t R. P. N. A c t i o n R e s u l t s
Re-rating RPN After Actions Have Occurred – Severity typically stays the same. – Occurrence is the primary item to reduce / focus on. – Detection is reduced only as a last resort. – Do not plan to REDUCE RPN with detection actions!!! • 100% inspection is only 80% effective! • Reducing RPN with detection does not eliminate failure mode, or reduce probability of causes • Detection of 10 is not bad if occurrence is 1 35
FMEA in a continuous flow process • Steel Making example: – Design FMEA was performed on a Crankshaft to determine the best material for the product being considered. This was a critical application. – Key features such as Geometry, Strength, Duty Cycle, were described to the Steel producer. 36
– The key product requirements were mapped against the required customer features. E.g. chemistry and microstructure, Internal stress at ingot level, – Product Grade and requirements documents created. – Key characteristics mapped against processes – Process FMEA was performed on processes that affected customer wants based on priority. 37
Phase I QFD Phase II QFD Product Specifications Customer Wants (Marketing Information) Product Specifications Systems / Sub- Systems / Components Phase Progressio n System DFMEA Sub-System DFMEA Component DFMEA DFMEA Failure Modes QFD Phase Progression Inputs •Boundary Diagram •P-Diagram •Interface Matrix •Drawings •Warranty •FMA
The Completed Characteristics Matrix 39 Severity Process StepsReceiveMaterial Materialhandling ShippingDamage ComponentManufacture VehicleAssembly Primary Drive Manufacturing Process Steps Op100Step1 PRE-LOADDOWELPINSTO FIXTURE Op100Step2 PRE-LOADJACKSHAFT SEALTOFIXTURE Op100Step3 PRE-LOADPRIMARY HOUSINGBUSHINGTO FIXTURE Op110 Pre-loadbearingtofixture#2 Op120 Pre-loadmainshaftoilsealto mandrel Op200 Housingtofixture#1 Op210 Operatepress Op220 Retainingringtotopgroove Op230 Reloadfixture#1 Op300 Housingtofixture#2 Op310 Operatepress Op320 Retainingringtotopgroove Op330 MandreltomainshaftboreI.D. OP340 Operatepress Op350 Re-loadfixture#2andmandrel Op400 Housingtotable Op410 Reserved Op420 Chainadjsubassytohousing Op430 Lubricatebushing&seal Op445 Moveorstageforfinalassy Op10 O-ringtoshiftertube Op500 Shiftertubetohousing Op510 Clamptoshiftertube Op20 Assembleshifterlever Op520 Wavewashertoshifterlever Op530 Shifterlevertoshiftertube Op535 Queforfinalassyline Customer Assessment Direction of Improvement PotentialCriticalandSignificant 1.090 TO 1.110 " FACE OF PRIMARY HOUSING BUSHING TO FACE OF JACK SHAFT SEAL DOWEL PINS 0.260 TO 0.270 " TO FACE JACK SHAFT SEAL AGAINST SHOULDER BEARING FLUSH TO SNAP RING FACE SEAL COMPRESSION HEIGHT PRIMARY GASKET SEAL SURFACE FINISH SERATION DAMAGE Weighted Importance Relative Importance G F H F H F G F G H G H H F H H F F Y H H H H H G G F 5 3 9 3 9 9 5 0 81 81 72 0 9 41 0 0 27 54 261 3 0 54 81 3 0 0 0 27 0 45 9 9 0 0 0 0 0 0 0 Special Characteristics Matrix Process Operation from Process Flow Potential Significant and Critical Characteristics from DFMEA High/Medium Interactions are causes/failure modes in PFMEA Characteristics Ranked in order of Importance Prioritized ranking of process steps relative to risk
40 System DFMEA Sub-System DFMEA Component DFMEA Classification of Characteristic s SC’s & CC’s Process Operations Process Related SC’s & CC’s From all DFMEA’s Process FMEA SC’s & CC’s Phase III QFD Phase IV QFD Process Parameters / Variables High Priority Process Operations Causes on PFMEA Failure Modes on PFMEA Causes from DFMEA’s Control Plan Key Control Characteristics Inputs •Process Flow •Line Layout •MFMEA •Failure Data •Process Capability 10 9 8 7 6 5 4 3 2 1 1 2 3 4 5 6 7 8 9 10 S E V E R I T Y O C C U R R E N C E CRITICAL CHARACTERISTICS Safety/Regulatory SIGNIFICANT CHARACTERISTICS Customer Dissatisfaction ALL OTHER CHARACTERISTICS Appropriate actions / controls already in place Special Characteristics Matrix ANNOYANCE ZONE
Summary – FMEA can be used creatively in continuous processing. – Linking key customer requirements to process outputs instead of standard product grade is valuable. – Future customer requirements will drive new and modified processes to achieve specialty results as a normal practice 41
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Failure mode-and-effects-analysis

  • 1.
  • 2.
    Potential Failure Mode andEffects Analysis (Design FMEA) __ System __ Subsystem __ Component Model Year/Vehicle(s): Core Team: Design Responsibility Key Date: FMEA Number: Page 1 or 1 Prepared by: Lee Dawson FMEA Date (Orig.): Item Function Potential Failure Mode Potential Effect(s) of Failure Potential Cause(s)/ Mechanism(s) Of Failure Current Design Controls Prevention Current Design Controls Detection Recommended Action(s) Responsibility & Target Completion Date Actions Taken Action Results S E V C L A S S O C C U R D E T E C R. P. N. S E V O C C D E T R. P. N.
  • 3.
    What Is AnFMEA? – 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 MURPHY’S LAW
  • 4.
    DFMEA Design & Development- Section II GD & T - Drawings - Math Data DFMEA Design Actions Test Plans - Design Verification Design Change IF Design OK Special Characteristics Design Risk Assessment - Open Issues - Spec. Agreements - Materials - Budget - Manufacturing - Program Risks Kick Off Tools / Equipment Gages No Yes Prototype Control Plan Plan & Define Section 1 IDEA Opportunity Defined Form Team - Timing - Resources Collect Market Research Customer Wants/Needs/Desires - QFD Priorities Wants/Needs/ Desires Develop Product Specifications - Linked to Customers Develop Concepts - Product - Process Input From 5 - Failure Mode Analysis - History - Past Performance - Lessons Learned IF Feasible No Yes Initial Process Feasibility - Team Process Design & Development - Section III Process Flow Finalized Characteristic Matrix PFMEA - Manufacturing - Assembly Process Validation Plan - Gage Plan - Capability Plan Packaging Designs IF Process Risk Assessment - Equipment - Gages - Controls - Instructions - Plans - Status of Open Issues - Equipment Installation - Tooling Progress - Gage Design & Progress Special Controls Instructions - Initial YES NO MistakeProof? Pre - Launch Control Plan - Risk/Action - Special Characteristics - Current Controls Process Validation - Section IV Process Trial Run Min 300 pcs/Hits/shots GR & R - Gage Plan Repeatability Reproducibility Statistics - Via Control Plans - Capability Plan Validation Testing Plan Sample The Process - Source Warrants - Supporting Documentation - Level of PPAP Design Change Back to II YES NO - Reduced (n) - Reduced (f) - Optimizing Characteristics IF IF Can we change process to contain? IF YES STABLE? CAPABLE? IF OK? YES NO NO Revisit III PFMEA For Additional Potential Failures NO YES Create Production Control Plan PLANNING Concept Initiation/Approval Program Approval Prototype Pilot Launch PLANNING CONTROL PLANS PRODUCT DESIGN AND DEV. PROCESS DESIGN AND DEVELOPMENT. PRODUCT AND PROCESS VALIDATION. FEEDBACK ASSESSMENT AND CORRECTIVE ACTION PRODUCTION Open Issues / Time Line RELIABILITY BY DESIGN APQP Tool Linkage Process Development
  • 5.
    Requirements Cascade • How Fmeafits into Product and Process Development
  • 6.
    Potential KPC Development 6 DetectPrevent R P N D E T O C C S E V Action Taken ActionResults Response & Target Complete Date Recommended Actions R P N D e t e c Current Controls O c c u r Potential Cause(s)/ Mechanism(s) Of Failure C l a s s S e v Potential Effect(s) of Failure Potential Failure Mode Item / Process Step DetectPrevent R P N D E T O C C S E V Action Taken Action Results Response & Target Complete Date Recommended Actions R P N D e t e c Current Design Controls O c c u r Potential Cause(s)/ Mechanism(s) Of Failure C l a s s S e v Potential Effect(s) of Failure Potential Failure Mode Item / Process Step Function DFMEA Requirements Documents •Regulatory •Dimensional •Cosmetic Req. Spec. Document Drawings Warranty History Robustness Tools Boundary Diagram P-Diagram Interface Matrix 10 9 8 7 6 5 4 3 2 1 1 2 3 4 5 6 7 8 9 10 S E V E R I T Y O C C U R R E N C E POTENTIAL CRITICAL CHARACTERISTICS Safety/Regulatory POTENTIAL SIGNIFICANT CHARACTERISTICS Customer Dissatisfaction Special Characteristics Matrix ANOYANCE ZONE ALL OTHER CHARACTERISTICS Appropriate actions / controls already in place Cascade Technical Requirements Into Special Product Characteristics
  • 7.
    Characteristics Matrix Development Severity ProcessSteps ReceiveMaterial Materialhandling ShippingDamage ComponentManufacture VehicleAssembly Primary Drive Manufacturing Process Steps Op100Step1 PRE-LOADDOWELPINSTO FIXTURE Op100Step2 PRE-LOADJACKSHAFT SEALTOFIXTURE Op100Step3 PRE-LOADPRIMARY HOUSINGBUSHINGTO FIXTURE Op110 Pre-loadbearingtofixture#2 Op120 Pre-loadmainshaftoilsealto mandrel Op200 Housingtofixture#1 Op210 Operatepress Op220 Retainingringtotopgroove Op230 Reloadfixture#1 Op300 Housingtofixture#2 Op310 Operatepress Op320 Retainingringtotopgroove Op330 MandreltomainshaftboreI.D. OP340 Operatepress Op350 Re-loadfixture#2andmandrel Op400 Housingtotable Op410 Reserved Op420 Chainadjsubassytohousing Op430 Lubricatebushing&seal Op445 Moveorstageforfinalassy Op10 O-ringtoshiftertube Op500 Shiftertubetohousing Op510 Clamptoshiftertube Op20 Assembleshifterlever Op520 Wavewashertoshifterlever Op530 Shifterlevertoshiftertube Op535 Queforfinalassyline Customer Assessment Direction of Improvement PotentialCriticalandSignificant 1.090 TO 1.110 " FACE OF PRIMARY HOUSING BUSHING TO FACE OF JACK SHAFT SEAL DOWEL PINS 0.260 TO 0.270 " TO FACE JACK SHAFT SEAL AGAINST SHOULDER BEARING FLUSH TO SNAP RING FACE SEAL COMPRESSION HEIGHT PRIMARY GASKET SEAL SURFACE FINISH SERATION DAMAGE Weighted Importance Relative Importance G F H F H F G F G H G H H F H H F F Y H H H H H G G F 5 3 9 3 9 9 5 0 81 81 72 0 9 41 0 0 27 54 261 3 0 54 81 3 0 0 0 27 0 45 9 9 0 0 0 0 0 0 0 Special Characteristics Matrix START OPERATION OPERATION IF END YES NO Process Flow Special Characteristics Sources •DFMEA (Potential KPCs: Significant and Critical Characteristics) •Drawings •Regulations
  • 8.
    Characteristics Matrix 8 Severity Process Steps ReceiveMaterial Materialhandling ShippingDamage ComponentManufacture VehicleAssembly PrimaryDrive Manufacturing Process Steps Op100Step1 PRE-LOADDOWELPINSTO FIXTURE Op100Step2 PRE-LOADJACKSHAFT SEALTOFIXTURE Op100Step3 PRE-LOADPRIMARY HOUSINGBUSHINGTO FIXTURE Op110 Pre-loadbearingtofixture#2 Op120 Pre-loadmainshaftoilsealto mandrel Op200 Housingtofixture#1 Op210 Operatepress Op220 Retainingringtotopgroove Op230 Reloadfixture#1 Op300 Housingtofixture#2 Op310 Operatepress Op320 Retainingringtotopgroove Op330 MandreltomainshaftboreI.D. OP340 Operatepress Op350 Re-loadfixture#2andmandrel Op400 Housingtotable Op410 Reserved Op420 Chainadjsubassytohousing Op430 Lubricatebushing&seal Op445 Moveorstageforfinalassy Op10 O-ringtoshiftertube Op500 Shiftertubetohousing Op510 Clamptoshiftertube Op20 Assembleshifterlever Op520 Wavewashertoshifterlever Op530 Shifterlevertoshiftertube Op535 Queforfinalassyline Customer Assessment Direction of Improvement PotentialCriticalandSignificant 1.090 TO 1.110 " FACE OF PRIMARY HOUSING BUSHING TO FACE OF JACK SHAFT SEAL DOWEL PINS 0.260 TO 0.270 " TO FACE JACK SHAFT SEAL AGAINST SHOULDER BEARING FLUSH TO SNAP RING FACE SEAL COMPRESSION HEIGHT PRIMARY GASKET SEAL SURFACE FINISH SERATION DAMAGE Weighted Importance Relative Importance G F H F H F G F G H G H H F H H F F Y H H H H H G G F 5 3 9 3 9 9 5 0 81 81 72 0 9 41 0 0 27 54 261 3 0 54 81 3 0 0 0 27 0 45 9 9 0 0 0 0 0 0 0 Special Characteristics Matrix Process Operation from Process Flow Potential Significant and Critical Characteristics from DFMEA & Other Sources High/Medium Interactions are causes/failure modes in PFMEA Characteristics Ranked in order of Importance Prioritized ranking of process steps relative to risk
  • 9.
    FMEA Deployment – Alayered 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.
  • 10.
    System Boundary Diagram LifterAssembly •Body •Insert •Roller •Pin •Clip •wire CAM Shaft Pushrod •Rod •Cup •Ball Intake Rocker Assembly Exhaust Rocker Assembly •Body •Insert •Roller •Pin •Clip Arm Group Assembly •Intake rocker assembly •Exhaust rocker assembly •Stand(s) W & W/o oil supply •Shaft Assembly •Mounting Bolt •Spring/Spacer Bridge Spring Group •Inner & Outer Springs •Spring Base •Retainer/Rotator •Valve Keeper Valve Group •Intake Valve •Exhaust Valve •Intake Seat •Exhaust Seat •Valve Guide •Valve Guide Seal CAM Bearings Thrust Plate Cylinder Block Oscillating Lifter •Pressure Lube OR Bore in Block •Pressure Lube Lube Oil Cylinder Head Vibration Valve CoverClearance Shaft Assembly •Shaft •Cup •Pin Valve •Injector oil Floating Cylinder Head Load Valve Stem Seal Clear at full stroke Lube Oil Cylinder Head Cylinder Head Seat Insert Valve Seat Additional Clearances •Injector & Spring •Injector & Spring Base •Injector & retainer •Injector & Bridge •Injector & injector clamp Compression Brake Vibration
  • 11.
    P-Diagram 11 1. Piece topiece variation 2. Other systems 3. Customer usage/duty cycle Heat shields Foot peg location After market changes Pipe maufacturing variation Engine mount -mufflers, foot pegs, decorative covers Frame variation Change calibrations, runs hotter, componet discoloring, over drive system, excesive lean angle Supension changes, lowers bike Improper storage practices 4. Deterioration/degredagtion over time 4. Environment Gasket wear Ocean sea side (salt) Motor mount wear Sand, dust Corrosion Gravel Loss of torque on fasteners Parade duty (low speed) Input Ideal function Exhaust gases from engine Exhaust Pipes, Front & Rear Engine vibration Road vibration Meet Styling Requirements Transfer of exhaust gas Adequate clearance to other components Control factors Meet Durability Requirements Regulatory Error states Lean Angle (SAE) Difficult to service Durability Requirements (GES) Does not meet styling review Difficult to assemble High warranty Poor lean angle Noise Factors
  • 12.
    FMEA Preparation VerticalApproach – 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 12
  • 13.
    System/Subsystem/ Design FMEA –Failure Mode: Pure anti-function 13 FUNCTION (ANTI)
  • 14.
    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 14
  • 15.
    Severity Column 15 DetectPrevent R P N D E T O C C S E V Action Taken Action Results Response& Traget Complete Date Recommended Actions R P N D e t e c Current Process Controls O c c u r Potential Cause(s)/ Mechanism(s) Of Failure C l a s s S e v Potential Effect(s) of Failure Potential Failure Mode Item / Process Step DetectPrevent R P N D E T O C C S E V Action Taken Action Results Response & Traget Complete Date Recommended Actions R P N D e t e c Current Process Controls O c c u r Potential Cause(s)/ Mechanism(s) Of Failure C l a s s S e v Potential Effect(s) of Failure Potential Failure Mode Item / Process Step Function Severity Column Severity Column
  • 16.
    AUTOMOTIVE EXAMPLE SEVERITYEVALUATION CRITERIA Hazardous- with warning Very High High Very high severity ranking when a potential failure mode affects safe vehicle operation and/or involves noncompliance with government regulation without warning Low Very Low Minor Very Minor None Very high severity ranking when a potential failure mode affects safe vehicle operation and/or involves noncompliance with government regulation with warning Vehicle/item inoperable (loss of primary function). Vehicle/item operable but at a reduced level of performance. Customer very dissatisfied. Vehicle/item operable but Comfort/Convenience item(s) inoperable. Customer dissatisfied. Vehicle/item operable but Comfort/Convenience item(s) operable at a reduced level of performance. Customer somewhat dissatisfied. Fit & Finish/Squeak & Rattle item does not conform. Defect noticed by most customers (greater than 75%). Fit & Finish/Squeak & Rattle item does not conform. Defect noticed by 50% of customers. Fit & Finish/Squeak & Rattle item does not conform. Defect noticed by discriminating customers (less than 25%). No discernable effect. 10 8 7 6 3 2 1 Hazardous- without warning Moderate 4 5 EFFECT CRITERIA: Severity of Effect RNK. SEVERITY EVALUATION CRITERIA 9
  • 17.
    FMEA General • ForHigh Severity 9/10
  • 18.
    Failure Mode/Cause Relationship InDifferent FMEA Levels Inadequate Electrical Connection Inadequate Electrical Connection Motor Stops Causes Cause Failure Mode Failure Mode Inadequate Locking Feature Harness Too Short
  • 19.
    Causes – Causes fromP-Diagram • Noise factors – Continue through all failure modes. – Note that many causes are recurring. 19
  • 20.
    Occurrence Column 20 DetectPrevent R P N D E T O C C S E V Action Taken Action Results Response& Traget Complete Date Recommended Actions R P N D e t e c Current Process Controls O c c u r Potential Cause(s)/ Mechanism(s) Of Failure C l a s s S e v Potential Effect(s) of Failure Potential Failure Mode Item / Process Step DetectPrevent R P N D E T O C C S E V Action Taken Action Results Response & Traget Complete Date Recommended Actions R P N D e t e c Current Process Controls O c c u r Potential Cause(s)/ Mechanism(s) Of Failure C l a s s S e v Potential Effect(s) of Failure Potential Failure Mode Item / Process Step Function Occurrence Column Occurrence Column
  • 21.
    Occurrence Evaluation Criteria 21 *Note:Zero (0) rankings for Severity, Occurrence or Detection are not allowed Probability of Likely Failure Rates Over Design Life Ranking Failure SUGGESTED OCCURRENCE EVALUATION CRITERIA Very High: Persistent failures High: Frequent failures Moderate: Occasional failures Low: Relatively few failures Remote: Failure is unlikely ≥ 100 per thousand vehicles/items 50 per thousand vehicles/items 20 per thousand vehicles/items 10 per thousand vehicles/items 5 per thousand vehicles/items 2 per thousand vehicles/items 1 per thousand vehicles/items 0.5 per thousand vehicles/items 0.1 per thousand vehicles/items ≤ 0.01 per thousand vehicles/items 10 9 8 7 6 5 4 3 2 1
  • 22.
    Occurrence Rating – Ifan 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. 22 DATA HARD FACTS
  • 23.
    Example of Significant/Critical Threshold 23 10 9 8 7 6 5 4 3 2 1 1 2 3 4 5 6 7 8 9 10 S E V E R I T Y O C C U R R E N C E POTENTIAL CRITICAL CHARACTERISTICS Safety/Regulatory POTENTIAL SIGNIFICANT CHARACTERISTICS Customer Dissatisfaction ALL OTHER CHARACTERISTICS Appropriate actions / controls already in place Special Characteristics Matrix ANOYANCE ZONE
  • 24.
    Classification And DefinitionColumn 24 S e v R. P. N. Item Function Potential Failure Mode Potential Effect(s) of Failure C l a s s Potential Cause(s) / Mechanism(s) of Failure O c c u r Current Design Controls D e t e c Recommended Actions Response & Target Complete Date Actions Taken Classification and Definition Column Action Results O c c S e v D e t R. P. N.
  • 25.
    Design Verification (CurrentDesign Controls) – Think of Design Control in two ways; Prevention and Detection. List them separately. – To save time, add any new (untried) prevention/detection ideas to the document under Recommended Actions column. • Prevention is specifically related to reduction or elimination of a cause. • Detection is how well the test or series of tests may find the design flaw – Causes – Failure Mode 25
  • 26.
    Detection Rating Absolute Uncertainty Very Remote Remote VeryLow Low Moderate Moderately High High Very High Almost Certain 10 9 8 7 6 5 4 3 2 1 Design Control will not and/or cannot detect a potential cause/ mechanism and subsequent failure mode; or there is no Design Control. Very Remote chance the Design Control will detect a potential cause/mechanism and subsequent failure mode. Remote chance the Design Control will detect a potential cause/ mechanism and subsequent failure mode. Very Low chance the Design Control will detect a potential cause/mechanism and subsequent failure mode. Low chance the Design Control will detect a potential cause/mechanism and subsequent failure mode. Moderate chance the Design Control will detect a potential cause/ mechanism and subsequent failure mode. Moderately High chance the Design Control will detect a potential cause/mechanism and subsequent failure mode. Very High chance the Design Control will detect a potential cause/ mechanism and subsequent failure mode. High chance the Design Control will detect a potential cause/ mechanism and subsequent failure mode. Design Controls will almost certainly detect a potential cause/ mechanism and subsequent failure mode. DETECTION SUGGESTED DETECTION EVALATION CRITERIA CRITERIA RNK.
  • 27.
    Analysis Of Risk –RPN / RISK PRIORITY NUMBER – What Is Risk? – Probability of danger – Severity/Occurrence/Cause 27
  • 28.
    RPN / RiskPriority Number Top 20% of Failure Modes by RPN R P N Failure Modes
  • 29.
    Evaluation by RPNOnly – Case 1 • S=5 O=5 D=2 RPN = 50 – Case 2 • S=3 O=3 D=6 RPN = 54 – Case 3 • S=2 O=10, D=10 = 200 – Case 4 • S=9 O=2 D=3 = 54 29 WHICH ONE IS WORSE?
  • 30.
    Example – Extreme Safety/RegulatoryRisk • =9 & 10 Severity – High Risk to Customer Satisfaction • Sev. > or = to 5 and Occ > or = 4 – Consider Detection only as a measure of Test Capability. 30
  • 31.
    Example of Significant/Critical Threshold 31 10 9 8 7 6 5 4 3 2 1 1 2 3 4 5 6 7 8 9 10 S E V E R I T Y O C C U R R E N C E POTENTIAL CRITICAL CHARACTERISTICS Safety/Regulatory POTENTIAL SIGNIFICANT CHARACTERISTICS Customer Dissatisfaction ALL OTHER CHARACTERISTICS Appropriate actions / controls already in place Special Characteristics Matrix ANOYANCE ZONE
  • 32.
    Actions 32 Item Function System Subsystem Component: Model Year/Vehicle (s): CoreTeam: Your Company Name Here Potential Failure Mode and Effects Analysis (Design FMEA) Design Responsibility: Key Date: FMEA Number: Page of Prepared by: FMEA Date (Orig.): (Rev.): Potential Failure Mode Potential Effect (s) of Failure s e v c l a s s Potential Cause (s)/ Mechanism (s) Failure o c c u r Current Design Controls D e t e c R. P. N. Recommended Action(s) Responsibility & Target Completion Date Actions Taken s e v o c c D e t R. P. N. A c t i o n R e s u l t s
  • 33.
    Actions 33 EXAMPLE: Project: Date Of Meeting: Issue Number IssueStatus/ Open Date Issue Champion Action Number Action Date Action Person Resp. Team Completion Date 143
  • 34.
    Re-rating RPN AfterActions Have Occurred 34 Item Function System Subsystem Component: Model Year/Vehicle (s): Core Team: Your Company Name Here Potential Failure Mode and Effects Analysis (Design FMEA) Design Responsibility: Key Date: FMEA Number: Page of Prepared by: FMEA Date (Orig.): (Rev.): Potential Failure Mode Potential Effect (s) of Failure S e v C l a s s Potential Cause (s)/ Mechanism (s) Failure O c c u r Current Design Controls D e t e c R. P. N. Recommended Action(s) Responsibility & Target Completion Date Actions Taken S e v O c c D e t R. P. N. A c t i o n R e s u l t s
  • 35.
    Re-rating RPN AfterActions Have Occurred – Severity typically stays the same. – Occurrence is the primary item to reduce / focus on. – Detection is reduced only as a last resort. – Do not plan to REDUCE RPN with detection actions!!! • 100% inspection is only 80% effective! • Reducing RPN with detection does not eliminate failure mode, or reduce probability of causes • Detection of 10 is not bad if occurrence is 1 35
  • 36.
    FMEA in acontinuous flow process • Steel Making example: – Design FMEA was performed on a Crankshaft to determine the best material for the product being considered. This was a critical application. – Key features such as Geometry, Strength, Duty Cycle, were described to the Steel producer. 36
  • 37.
    – The keyproduct requirements were mapped against the required customer features. E.g. chemistry and microstructure, Internal stress at ingot level, – Product Grade and requirements documents created. – Key characteristics mapped against processes – Process FMEA was performed on processes that affected customer wants based on priority. 37
  • 38.
    Phase I QFD PhaseII QFD Product Specifications Customer Wants (Marketing Information) Product Specifications Systems / Sub- Systems / Components Phase Progressio n System DFMEA Sub-System DFMEA Component DFMEA DFMEA Failure Modes QFD Phase Progression Inputs •Boundary Diagram •P-Diagram •Interface Matrix •Drawings •Warranty •FMA
  • 39.
    The Completed CharacteristicsMatrix 39 Severity Process StepsReceiveMaterial Materialhandling ShippingDamage ComponentManufacture VehicleAssembly Primary Drive Manufacturing Process Steps Op100Step1 PRE-LOADDOWELPINSTO FIXTURE Op100Step2 PRE-LOADJACKSHAFT SEALTOFIXTURE Op100Step3 PRE-LOADPRIMARY HOUSINGBUSHINGTO FIXTURE Op110 Pre-loadbearingtofixture#2 Op120 Pre-loadmainshaftoilsealto mandrel Op200 Housingtofixture#1 Op210 Operatepress Op220 Retainingringtotopgroove Op230 Reloadfixture#1 Op300 Housingtofixture#2 Op310 Operatepress Op320 Retainingringtotopgroove Op330 MandreltomainshaftboreI.D. OP340 Operatepress Op350 Re-loadfixture#2andmandrel Op400 Housingtotable Op410 Reserved Op420 Chainadjsubassytohousing Op430 Lubricatebushing&seal Op445 Moveorstageforfinalassy Op10 O-ringtoshiftertube Op500 Shiftertubetohousing Op510 Clamptoshiftertube Op20 Assembleshifterlever Op520 Wavewashertoshifterlever Op530 Shifterlevertoshiftertube Op535 Queforfinalassyline Customer Assessment Direction of Improvement PotentialCriticalandSignificant 1.090 TO 1.110 " FACE OF PRIMARY HOUSING BUSHING TO FACE OF JACK SHAFT SEAL DOWEL PINS 0.260 TO 0.270 " TO FACE JACK SHAFT SEAL AGAINST SHOULDER BEARING FLUSH TO SNAP RING FACE SEAL COMPRESSION HEIGHT PRIMARY GASKET SEAL SURFACE FINISH SERATION DAMAGE Weighted Importance Relative Importance G F H F H F G F G H G H H F H H F F Y H H H H H G G F 5 3 9 3 9 9 5 0 81 81 72 0 9 41 0 0 27 54 261 3 0 54 81 3 0 0 0 27 0 45 9 9 0 0 0 0 0 0 0 Special Characteristics Matrix Process Operation from Process Flow Potential Significant and Critical Characteristics from DFMEA High/Medium Interactions are causes/failure modes in PFMEA Characteristics Ranked in order of Importance Prioritized ranking of process steps relative to risk
  • 40.
    40 System DFMEA Sub-System DFMEA ComponentDFMEA Classification of Characteristic s SC’s & CC’s Process Operations Process Related SC’s & CC’s From all DFMEA’s Process FMEA SC’s & CC’s Phase III QFD Phase IV QFD Process Parameters / Variables High Priority Process Operations Causes on PFMEA Failure Modes on PFMEA Causes from DFMEA’s Control Plan Key Control Characteristics Inputs •Process Flow •Line Layout •MFMEA •Failure Data •Process Capability 10 9 8 7 6 5 4 3 2 1 1 2 3 4 5 6 7 8 9 10 S E V E R I T Y O C C U R R E N C E CRITICAL CHARACTERISTICS Safety/Regulatory SIGNIFICANT CHARACTERISTICS Customer Dissatisfaction ALL OTHER CHARACTERISTICS Appropriate actions / controls already in place Special Characteristics Matrix ANNOYANCE ZONE
  • 41.
    Summary – FMEA canbe used creatively in continuous processing. – Linking key customer requirements to process outputs instead of standard product grade is valuable. – Future customer requirements will drive new and modified processes to achieve specialty results as a normal practice 41
  • 42.

Editor's Notes

  • #2 DESIGN FMEA - GENERAL MODULE 2 Notes:
  • #5 Notes:
  • #10 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 Notes:
  • #13 Key Elements of Efficient Development Identify all functions/process steps 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 Notes:
  • #15 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) Notes:
  • #22 Notes:
  • #31 Example Extreme Safety/Regulatory Risk =9 & 10 Severity High Risk to Customer Satisfaction Sev. > or = to 5 and Occ > or = 4 Consider Detection only as a measure of Test Capability.