FMEA Intelligent use of FMEA This guideline is

FMEA Intelligent use of FMEA This guideline is for training purposes only; Not ISO controlled

Potential Failure Mode and Effects Analysis (Design FMEA) __ System __ Subsystem __ Component Model Year/Vehicle(s): Core Team: Item Function Potential Failure Mode FMEA Number: Page 1 or 1 Prepared by: Lee Dawson FMEA Date (Orig. ): Design Responsibility Key Date: Potential Effect(s) of Failure Potential O C S L C Cause(s)/ E A Mechanism(s) C U V S Of Failure S R Current Design Controls Prevention Current Design Controls Detection Action Results D Responsibility E R. Recommended & Target S O D R. T P. Completion Actions Action(s) E N. E C E P. Date Taken V C T N. C 2

What Is An FMEA? Opportunity to Defeat Murphy’s Law Focus on Prevention Failure Mode And Effects Analysis is An assessment of Risk MURPHY’S LAW 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 3

RELIABILITY BY DESIGN APQP Tool Linkage Process Development Open Issues / Time Line 4

Requirements Cascade How Fmea fits into Product and Process Development This guideline is for training purposes only; Not ISO controlled

Potential KPC Development Requirements Documents • Regulatory • Dimensional • Cosmetic Req. Spec. Document Drawings Warranty History Robustness Tools Boundary Diagram P-Diagram Interface Matrix Item / Process Step Function Potential Failure Mode Potential Effect(s) of Failure S e v C l a s s Potential Cause(s)/ Mechanism(s) Of Failure O c c u r Current Design Controls Prevent Detect D e t e c R P N Action Results Response & Recommended Target S O D R Actions Complete Action E C E P Taken Date V C T N DFMEA Special Characteristics Matrix Cascade Technical Requirements Into Special Product Characteristics S 10 9 E 8 V R 7 6 5 I 4 T 3 Y 2 1 E POTENTIAL CRITICAL CHARACTERISTICS Safety/Regulatory POTENTIAL SIGNIFICANT CHARACTERISTICS Customer Dissatisfaction ANOYANCE ZONE ALL OTHER CHARACTERISTICS Appropriate actions / controls already in place 1 2 3 4 5 6 7 8 9 10 OCCURRENCE 6

Characteristics Matrix Development Process Flow START OPERATION END YES • DFMEA (Potential KPCs: Significant and Critical Characteristics) Op 535 Que for final assy line Shifter lever to shifter tube Op 530 Wave washer to shifter lever Op 520 Assemble shifter lever Op 20 Clamp to shifter tube Op 510 Shifter tube to housing Op 500 O-ring to shifter tube Op 10 Op 430 Lubricate bushing & seal Op 445 Move or stage for final assy Op 420 Chain adj sub assy to housing Reserved Op 410 Op 400 Housing to table Re-load fixture #2 and mandrel Op 350 Operate press OP 340 Retaining ring to top groove Op 320 Mandrel to main shaft bore I. D. Op 330 Operate press Op 310 Housing to fixture #2 Op 300 Op 230 Reload fixture #1 Op 220 Retaining ring to top groove Operate press Op 210 Op 200 Housing to fixture #1 mandrel Pre-load main shaft oil seal to Op 120 Op 110 Pre-load bearing to fixture #2 Op 100 Step 3 PRE-LOAD PRIMARY FIXTURE HOUSING BUSHING TO SEAL TO FIXTURE PRE-LOAD JACK SHAFT Op 100 Step 2 PRE-LOAD DOWEL PINS TO Op 100 Step 1 Vehicle Assembly 5 Component Manufacture SERATION DAMAGE Receive Material 9 Material handling PRIMARY GASKET SEAL SURFACE FINISH F 9 Potential Critical and Significant 0 0 0 0 9 9 0 45 0 27 0 0 3 81 3 0 54 54 261 0 27 0 9 41 0 72 81 0 81 Weighted Importance H G F G H H F F SEAL COMPRESSION HEIGHT G G H H H F H Y H H G 3 F F BEARING FLUSH TO SNAP RING FACE H F 9 G 3 JACK SHAFT SEAL AGAINST SHOULDER H 5 DOWEL PINS 0. 260 TO 0. 270 " TO FACE H BUSHING TO FACE OF JACK SHAFT SEAL Shipping Damage Matrix Severity Special Characteristics Customer Process Steps Assessment Primary Drive Manufacturing Process Steps • Regulations NO IF Special Characteristics Sources • Drawings 1. 090 TO 1. 110 " FACE OF PRIMARY HOUSING Direction of Improvement Relative Importance 7

Characteristics Matrix Que for final assy line Op 535 Shifter lever to shifter tube Op 530 Wave washer to shifter lever Op 520 Assemble shifter lever Op 20 Clamp to shifter tube Op 510 Shifter tube to housing Op 500 O-ring to shifter tube Op 10 Move or stage for final assy Op 445 Lubricate bushing & seal Op 430 Chain adj sub assy to housing Op 420 H Reserved Op 410 Housing to table Op 400 Re-load fixture #2 and mandrel Op 350 Operate press OP 340 Mandrel to main shaft bore I. D. Op 330 H Retaining ring to top groove Op 320 Operate press Op 310 Housing to fixture #2 Op 300 Reload fixture #1 Op 230 Retaining ring to top groove Op 220 Operate press Op 210 Housing to fixture #1 Op 200 mandrel Pre-load main shaft oil seal to Op 120 Pre-load bearing to fixture #2 Op 110 FIXTURE HOUSING BUSHING TO PRE-LOAD PRIMARY Op 100 Step 3 SEAL TO FIXTURE PRE-LOAD JACK SHAFT Op 100 Step 2 FIXTURE PRE-LOAD DOWEL PINS TO Op 100 Step 1 Vehicle Assembly H 0 0 0 0 9 9 0 45 0 27 0 0 3 81 0 54 3 54 261 27 0 0 41 9 0 72 81 0 81 High/Medium Interactions are causes/failure modes in PFMEA Prioritized ranking of process steps relative to risk H F G F Customer Assessment Primary Drive Manufacturing Process Steps Component Manufacture Shipping Damage Receive Material handling Direction of Improvement Potential Critical and Significant Weighted Importance H F F H G G H 9 F H H F Y H PRIMARY GASKET SEAL SURFACE FINISH F G 1. 090 TO 1. 110 " FACE OF PRIMARY HOUSING 5 BUSHING TO FACE OF JACK SHAFT SEAL DOWEL PINS 0. 260 TO 0. 270 " TO 3 FACE JACK SHAFT SEAL AGAINST 9 SHOULDER H G H 9 SEAL COMPRESSION HEIGHT G 3 BEARING FLUSH TO SNAP RING FACE F 5 SERATION DAMAGE Severity Special Characteristics Matrix Process Operation from Process Flow Characteristics Ranked in order of Importance Potential Significant and Critical Characteristics from DFMEA & Other Sources Process Steps Relative Importance 8

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. 9

System Boundary Diagram Cylinder Head Compression Brake n Vi tio ra Vib br Additional Clearances at ion • Injector & Spring Base • Injector & retainer • Injector & Bridge • Injector & injector clamp Floating Valve Arm Group Assembly • Intake rocker assembly • Exhaust rocker assembly • Stand(s) W & W/o oil supply • Shaft Assembly • Mounting Bolt • Spring/Spacer Shaft Assembly • Shaft Intake Rocker Assembly • Cup Exhaust Rocker Assembly • Pin • Body • Insert • Roller • Pin • Clip Bridge Pushrod • Rod • Cup • Ball • Injector oil Spring Group • Inner & Outer Springs Load Cylinder Head • Spring Base • Retainer/Rotator • Valve Keeper roke t s ll Valve Stem Seal u f at Clear Valve Group • Intake Valve • Exhaust Valve • Intake Seat Lube Oil • Exhaust Seat • Valve Guide Cylinder Head • Valve Guide Seal Lifter Assembly • Body • Insert • Roller • Pin • Clip • wire CAM Shaft Clearance Valve Cover Lube Oil Oscillating Lifter • Pressure Lube OR Bore in Block Valve Seat Insert Cylinder Head CAM Bearings • Pressure Lube Thrust Plate Cylinder Block 10

P-Diagram 11

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 FUNCTION (ANTI) 13

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

SEVERITY EVALUATION CRITERIA EFFECT CRITERIA: Severity of Effect RNK. Hazardouswithout warning Very high severity ranking when a potential failure mode affects safe vehicle operation and/or involves noncompliance with government regulation without warning Hazardouswith warning Very high severity ranking when a potential failure mode affects safe vehicle operation and/or involves noncompliance with government regulation with warning Very High Vehicle/item inoperable (loss of primary function). 8 High Vehicle/item operable but at a reduced level of performance. Customer very dissatisfied. 7 Moderate Vehicle/item operable but Comfort/Convenience item(s) inoperable. Customer dissatisfied. 6 Low Vehicle/item operable but Comfort/Convenience item(s) operable at a reduced level of performance. Customer somewhat dissatisfied. 5 Very Low Fit & Finish/Squeak & Rattle item does not conform. Defect noticed by most customers (greater than 75%). 4 Minor Fit & Finish/Squeak & Rattle item does not conform. Defect noticed by 50% of customers. 3 Very Minor Fit & Finish/Squeak & Rattle item does not conform. Defect noticed by discriminating customers (less than 25%). 2 None No discernable effect. 1 10 9 16

FMEA General For High Severity 9/10 17

Failure Mode/Cause Relationship In Different FMEA Levels Inadequate Electrical Connection Cause Failure Mode Motor Stops Inadequate Electrical Connection Inadequate Causes Harness Locking Too Short Feature 18

Causes from P-Diagram Noise factors Continue through all failure modes. Note that many causes are recurring. 19

Occurrence Column 20

Occurrence Evaluation Criteria SUGGESTED OCCURRENCE EVALUATION CRITERIA Probability of Failure Very High: Persistent failures High: Frequent failures Moderate: Occasional failures Low: Relatively few failures Remote: Failure is unlikely Likely Failure Rates Over Design Life Ranking 100 per thousand vehicles/items 10 50 per thousand vehicles/items 9 20 per thousand vehicles/items 8 10 per thousand vehicles/items 7 5 per thousand vehicles/items 6 2 per thousand vehicles/items 5 1 per thousand vehicles/items 4 0. 5 per thousand vehicles/items 3 0. 1 per thousand vehicles/items 2 0. 01 per thousand vehicles/items 1 *Note: Zero (0) rankings for Severity, Occurrence or Detection are not allowed 21

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. DATA HARD FACTS 22

Example of Significant/ Critical Threshold Special Characteristics Matrix S E V E R I T Y 10 9 8 7 6 5 4 3 2 1 POTENTIAL CRITICAL CHARACTERISTICS Safety/Regulatory POTENTIAL SIGNIFICANT CHARACTERISTICS Customer Dissatisfaction ANOYANCE ZONE ALL OTHER CHARACTERISTICS Appropriate actions / controls already in place 1 2 *Used by permission of Ford Motor Company 3 4 5 6 7 8 9 10 OCCURRENCE 23

Classification And Definition Column Item Function Potential Failure Mode Potential Effect(s) of Failure S e v C l a s s Potential Cause(s) / Mechanism(s) of Failure O c c u r Current Design Controls D Response & e R. Recommended Target Actions t P. Complete e N. Date c Action Results Actions Taken S e v O c c D e t Classification and Definition Column 24 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 SUGGESTED DETECTION EVALATION CRITERIA DETECTION CRITERIA RNK. Absolute Uncertainty 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. 9 Remote chance the Design Control will detect a potential cause/ mechanism and subsequent failure mode. 8 Very Low chance the Design Control will detect a potential cause/mechanism and subsequent failure mode. 7 Low chance the Design Control will detect a potential cause/mechanism and subsequent failure mode. 6 Moderate chance the Design Control will detect a potential cause/ mechanism and subsequent failure mode. 5 Moderately High chance the Design Control will detect a potential cause/mechanism and subsequent failure mode. 4 High chance the Design Control will detect a potential cause/ mechanism and subsequent failure mode. 3 Very High chance the Design Control will detect a potential cause/ mechanism and subsequent failure mode. 2 Almost Certain Design Controls will almost certainly detect a potential cause/ mechanism and subsequent failure mode. 1 Low 10 26

Analysis Of Risk RPN / RISK PRIORITY NUMBER What Is Risk? Probability of danger Severity/Occurrence/Cause 27

RPN / Risk Priority Number 28

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 WHICH ONE IS WORSE? Case 4 S=9 O=2 D=3 = 54 29

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 Special Characteristics Matrix S E V E R I T Y 10 9 8 7 6 5 4 3 2 1 POTENTIAL CRITICAL CHARACTERISTICS Safety/Regulatory POTENTIAL SIGNIFICANT CHARACTERISTICS Customer Dissatisfaction ANOYANCE ZONE ALL OTHER CHARACTERISTICS Appropriate actions / controls already in place 1 2 *Used by permission of Ford Motor Company 3 4 5 6 7 8 9 10 OCCURRENCE 31

Actions Potential Failure Mode and Effects Analysis (Design FMEA) Your Company Name Here System Subsystem Component: FMEA Number: Page of Prepared by: FMEA Date (Orig. ): Design Responsibility: Key Date: Model Year/Vehicle (s): (Rev. ): Core Team: Item Potential Failure Mode Function Potential Effect (s) of Failure s e v c l a s s Action Results 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 32 R. P. N.

Actions 33

Re-rating RPN After Actions Have Occurred Potential Failure Mode and Effects Analysis (Design FMEA) Your Company Name Here System Subsystem Component: FMEA Number: Page of Prepared by: FMEA Date (Orig. ): Design Responsibility: Key Date: Model Year/Vehicle (s): (Rev. ): Core Team: Item Potential Failure Mode Function Potential Effect (s) of Failure S C e l v a s s Potential Cause (s)/ Mechanism (s) Failure O c c u r Current Design Controls D R. e P. t N. e c Recommended Action(s) Responsibility & Target Completion Date Action Results Actions Taken S O D R. e c e P. v c t N. 34

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 Product Specifications Phase Progression Phase II QFD Systems / Sub-Systems / Components Customer Wants (Marketing Information) DFMEA Failure Modes Product Specifications System DFMEA Sub-System DFMEA Inputs Component DFMEA • Drawings • Boundary Diagram • Warranty • P-Diagram • FMA • Interface Matrix QFD Phase Progression 38

The Completed Characteristics Matrix Que for final assy line Op 535 Shifter lever to shifter tube Op 530 Wave washer to shifter lever Op 520 Assemble shifter lever Op 20 Clamp to shifter tube Op 510 Shifter tube to housing Op 500 O-ring to shifter tube Op 10 Move or stage for final assy Op 445 Lubricate bushing & seal Op 430 Chain adj sub assy to housing Op 420 H Reserved Op 410 Housing to table Op 400 Re-load fixture #2 and mandrel Op 350 Operate press OP 340 Mandrel to main shaft bore I. D. Op 330 H Retaining ring to top groove Op 320 Operate press Op 310 Housing to fixture #2 Op 300 Reload fixture #1 Op 230 Retaining ring to top groove Op 220 Operate press Op 210 Housing to fixture #1 Op 200 mandrel Pre-load main shaft oil seal to Op 120 Pre-load bearing to fixture #2 Op 110 FIXTURE HOUSING BUSHING TO PRE-LOAD PRIMARY Op 100 Step 3 SEAL TO FIXTURE PRE-LOAD JACK SHAFT Op 100 Step 2 FIXTURE PRE-LOAD DOWEL PINS TO Op 100 Step 1 Vehicle Assembly H 0 0 0 0 9 9 0 45 0 27 0 0 3 81 0 54 3 54 261 27 0 0 41 9 0 72 81 0 81 High/Medium Interactions are causes/failure modes in PFMEA Prioritized ranking of process steps relative to risk H F G F Customer Assessment Primary Drive Manufacturing Process Steps Component Manufacture Shipping Damage Receive Material handling Direction of Improvement Potential Critical and Significant Weighted Importance H F F H G G H 9 F H H F Y H PRIMARY GASKET SEAL SURFACE FINISH F G 1. 090 TO 1. 110 " FACE OF PRIMARY HOUSING 5 BUSHING TO FACE OF JACK SHAFT SEAL DOWEL PINS 0. 260 TO 0. 270 " TO 3 FACE JACK SHAFT SEAL AGAINST 9 SHOULDER H G H 9 SEAL COMPRESSION HEIGHT G 3 BEARING FLUSH TO SNAP RING FACE F 5 SERATION DAMAGE Severity Special Characteristics Matrix Process Operation from Process Flow Characteristics Ranked in order of Importance Potential Significant and Critical Characteristics from DFMEA Process Steps Relative Importance 39

System DFMEA Sub-System DFMEA Phase III QFD Process Operations Phase IV QFD Component DFMEA High Priority Process Operations Process Parameters / Variables SC’s & CC’s Classification Causes from DFMEA’s of Characteristics Special Characteristics Matrix S E V E R I T Y 10 9 8 7 6 5 4 3 2 1 CRITICAL CHARACTERISTICS Safety/Regulatory SIGNIFICANT CHARACTERISTICS Customer Dissatisfaction ANNOYANCE ZONE ALL OTHER CHARACTERISTICS Appropriate actions / controls already in place 1 2 3 4 5 6 7 8 9 10 OCCURRENCE SC’s & CC’s Process Related SC’s & CC’s From all DFMEA’s Failure Modes on PFMEA Causes on PFMEA Key Control Characteristics Process FMEA Inputs • Failure Data • Process Flow • Line Layout • Process Capability • MFMEA QFD Phase Progression Control Plan 40

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

Q&A This guideline is for training purposes only; Not ISO controlled