1. This guideline is for training purposes only; Not ISO controlled FMEA Intelligent use of FMEA Presented by Quality Associates International Visit us at: www.quality-one.com

2. 2 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 SEVSEV CLASSCLASS OCCUROCCUR DETECDETEC R. P. N. SEVSEV OCCOCC DETDET R. P. N.

3. 3 www.quality-one.com 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 It is not designed to record previously designed elements MURPHY’S LAW

4. 4 www.quality-one.com 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.

5. 5 www.quality-one.com FMEA Strategy Strategic Deployment of FMEA to support DFSS (Design for Six Sigma) The requirements cascade to achieve success

6. Process CPPDM Overview Business Phase 0 Phase 4 Phase 3Phase 2Phase 1 Concept Developed / Business Rationale Definition Complete & Design Feasibility Demonstrated Design, Development, Vehicle Integration and Parts Authorized PPAP/IPPAP, Equipment, Tooling and Processes Ready, FPE Vehicles Built, Approved to Launch Project Close Out and Make Good Business Rationale Developed Base E.O. Assigned Initial Service Life Cycle Costs Visual or Physical Rep. of Concept Full Vehicle Requirements Defined Research of existing knowledge Business Case Confirmation After Action Reviews Business Case Developed Resources Assigned Project Plan Complete Design Risk Assessment (FMEAs) System, Sub- System, & Vehicle Specs. Developed Make vs. Buy decisions & sources selected Styling Inputs Manufacturing Process Definition Containers, Crating, Material Handling Reqmnts. Process Risk Assessment (PFMEA) Process Control Plan Training Plans Process Verification Product Validation Systems, Sub- systems, and Components are Qualified After Action Reviews Make Good Reports Business Case Confirmation Production System Validation PPAP/IPPAP Plant Training FPE Vehicles Built Motorcycle Support Information Regulatory Req’s Complete & Documented Project Records / Documentation Collected Project Reviews / Technical Reviews Ongoing Operation Instructions Make Good Reports Design Prelim. Mfg Assessment Life Cycle Plan Approved & Project Started

7. Process CPPDM Summary (Verification vs. Validation) Business Phase 0 Phase 4 Phase 3Phase 2Phase 1 Concept Developed / Business Rationale Definition Complete & Design Feasibility Demonstrated Design, Development, Vehicle Integration and Parts Authorized PPAP/IPPAP, Equipment, Tooling and Processes Ready, FPE Vehicles Built, Approved to Launch Project Close Out and Make Good Product Design ConceptVerificationValidation ConceptVerificationValidation Process

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

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

10. 10 www.quality-one.com Phase I QFD Phase II QFD Product Specifications Customer Wants (Marketing Information) Product Specifications Systems / Sub-Systems / Components Phase Progression System DFMEA Sub-System DFMEA Component DFMEA DFMEA Failure Modes QFD Phase Progression Inputs Boundary Diagram P-Diagram Interface Matrix Drawings Warranty FMA

11. 11 www.quality-one.com The Completed Characteristics Matrix Severity Process Steps Receive Material Material handling Shipping Damage Component Manufacture Vehicle Assembly Primary Drive Manufacturing Process Steps Op 100 Step 1 PRE-LOAD DOWEL PINS TO FIXTURE Op 100 Step 2 PRE-LOAD JACK SHAFT SEAL TO FIXTURE Op 100 Step 3 PRE-LOAD PRIMARY HOUSING BUSHING TO FIXTURE Op 110 Pre-load bearing to fixture #2 Op 120 Pre-load main shaft oil seal to mandrel Op 200 Housing to fixture #1 Op 210 Operate press Op 220 Retaining ring to top groove Op 230 Reload fixture #1 Op 300 Housing to fixture #2 Op 310 Operate press Op 320 Retaining ring to top groove Op 330 Mandrel to main shaft bore I.D. OP 340 Operate press Op 350 Re-load fixture #2 and mandrel Op 400 Housing to table Op 410 Reserved Op 420 Chain adj sub assy to housing Op 430 Lubricate bushing & seal Op 445 Move or stage for final assy Op 10 O-ring to shifter tube Op 500 Shifter tube to housing Op 510 Clamp to shifter tube Op 20 Assemble shifter lever Op 520 Wave washer to shifter lever Op 530 Shifter lever to shifter tube Op 535 Que for final assy line Customer Assessment Direction of Improvement Potential Critical and Significant 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 GF HF HF GFG HGHHFHH FFYHHHHHGG F 5 3 9 3 9 9 5 0 81 72 0 9 41 0 0 2754 261 3 0 54 81 30 0 0 27 0 45 9 900000 00 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

12. 12 www.quality-one.com System DFMEA Sub-System DFMEA Component DFMEA Classification of Characteristics 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 QFD Phase Progression Inputs Process Flow Line Layout MFMEA Failure Data Process Capability 10 9 8 7 6 5 4 3 2 1 123456789 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

13. 13 www.quality-one.com Potential Key Characteristic Development 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 123456789 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

14. 14 www.quality-one.com Characteristics Matrix Development Severity Process Steps Receive Material Material handling Shipping Damage Component Manufacture Vehicle Assembly Primary Drive Manufacturing Process Steps Op 100 Step 1 PRE-LOAD DOWEL PINS TO FIXTURE Op 100 Step 2 PRE-LOAD JACK SHAFT SEAL TO FIXTURE Op 100 Step 3 PRE-LOAD PRIMARY HOUSING BUSHING TO FIXTURE Op 110 Pre-load bearing to fixture #2 Op 120 Pre-load main shaft oil seal to mandrel Op 200 Housing to fixture #1 Op 210 Operate press Op 220 Retaining ring to top groove Op 230 Reload fixture #1 Op 300 Housing to fixture #2 Op 310 Operate press Op 320 Retaining ring to top groove Op 330 Mandrel to main shaft bore I.D. OP 340 Operate press Op 350 Re-load fixture #2 and mandrel Op 400 Housing to table Op 410 ReservedOp 420 Chain adj sub assy to housing Op 430 Lubricate bushing & seal Op 445 Move or stage for final assy Op 10 O-ring to shifter tube Op 500 Shifter tube to housing Op 510 Clamp to shifter tube Op 20 Assemble shifter lever Op 520 Wave washer to shifter lever Op 530 Shifter lever to shifter tube Op 535 Que for final assy line Customer Assessment Direction of Improvement Potential Critical and Significant 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 GF HF HF GFG HGHHFHH F FYHHHHHGG F 5 3 9 3 9 9 5 0 81 72 09 41 00 27 54 261 3 0 54 81 30 00 27 0 45 9 90 00000 0 Special Characteristics Matrix START OPERATION IF END YES NO Process Flow Special Characteristics Sources DFMEA (Potential KPCs: Significant and Critical Characteristics) Drawings Regulations

15. 15 www.quality-one.com Characteristics Matrix Severity Process Steps Receive Material Material handling Shipping Damage Component Manufacture Vehicle Assembly Primary Drive Manufacturing Process Steps Op 100 Step 1 PRE-LOAD DOWEL PINS TO FIXTURE Op 100 Step 2 PRE-LOAD JACK SHAFT SEAL TO FIXTURE Op 100 Step 3 PRE-LOAD PRIMARY HOUSING BUSHING TO FIXTURE Op 110 Pre-load bearing to fixture #2 Op 120 Pre-load main shaft oil seal to mandrel Op 200 Housing to fixture #1 Op 210 Operate press Op 220 Retaining ring to top groove Op 230 Reload fixture #1 Op 300 Housing to fixture #2 Op 310 Operate press Op 320 Retaining ring to top groove Op 330 Mandrel to main shaft bore I.D. OP 340 Operate press Op 350 Re-load fixture #2 and mandrel Op 400 Housing to table Op 410 Reserved Op 420 Chain adj sub assy to housing Op 430 Lubricate bushing & seal Op 445 Move or stage for final assy Op 10 O-ring to shifter tube Op 500 Shifter tube to housing Op 510 Clamp to shifter tube Op 20 Assemble shifter lever Op 520 Wave washer to shifter lever Op 530 Shifter lever to shifter tube Op 535 Que for final assy line Customer Assessment Direction of Improvement Potential Critical and Significant 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 GF HF HF GFG HGHHFHH FFYHHHHHGG F 5 3 9 3 9 9 5 0 81 72 0 9 41 0 0 2754 261 3 0 54 81 30 0 0 27 0 45 9 900000 00 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

16. 16 www.quality-one.com 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

17. 17 www.quality-one.com System/Subsystem/ Design FMEA Failure Mode: Pure anti-function FUNCTION (ANTI)

18. 18 www.quality-one.com 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

19. 19 www.quality-one.com Severity Column Severity Column Severity Column

20. 20 www.quality-one.com 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

21. 21 www.quality-one.com FMEA General For High Severity 9/10

22. 22 www.quality-one.com Inadequate Electrical Connection Inadequate Electrical Connection Motor Stops Causes Cause Failure Mode/Cause Relationship In Different FMEA Levels Failure Mode Failure Mode Inadequate Locking Feature Harness Too Short

23. 23 www.quality-one.com Causes Causes from P-Diagram Noise factors Continue through all failure modes. Note that many causes are recurring.

24. 24 www.quality-one.com Occurrence Column Occurrence Column Occurrence Column

25. 25 www.quality-one.com Occurrence Evaluation Criteria *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

26. 26 www.quality-one.com 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. DATAHARD FACTS

27. 27 www.quality-one.com Example of Significant/ Critical Threshold *Used by permission of Ford Motor Company 10 9 8 7 6 5 4 3 2 1 123456789 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

28. 28 www.quality-one.com Classification And Definition Column SevSev R. P. N. Item Function Potential Failure Mode Potential Effect(s) of Failure ClassClass Potential Cause(s) / Mechanism(s) of Failure OccurOccur Current Design Controls DetecDetec Recommended Actions Response & Target Complete Date Actions Taken Classification and Definition Column Action Results OccOcc SevSev DetDet R. P. N.

29. 29 www.quality-one.com 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

30. 30 www.quality-one.com Detection Rating Absolute Uncertainty Very Remote Remote Very Low Low Moderate Moderately 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 CRITERIAR NK.

31. 31 www.quality-one.com Analysis Of Risk RPN / RISK PRIORITY NUMBER What Is Risk? Probability of danger Severity/Occurrence/Cause

32. 32 www.quality-one.com RPN / Risk Priority Number

33. 33 www.quality-one.com 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 WHICH ONE IS WORSE?

34. 34 www.quality-one.com 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.

35. 35 www.quality-one.com Example of Significant/ Critical Threshold *Used by permission of Ford Motor Company 10 9 8 7 6 5 4 3 2 1 123456789 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

36. 36 www.quality-one.com Actions 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 sevsev classclass Potential Cause (s)/ Mechanism (s) Failure occuroccur Current Design Controls DetecDetec R. P. N. Recommended Action(s) Responsibility & Target Completion Date Actions Taken sevsev occocc DetDet R. P. N. A c t i o n R e s u l t s

37. 37 www.quality-one.com Actions

38. 38 www.quality-one.com Re-rating RPN After Actions Have Occurred 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 SevSev ClassClass Potential Cause (s)/ Mechanism (s) Failure OccurOccur Current Design Controls DetecDetec R. P. N. Recommended Action(s) Responsibility & Target Completion Date Actions Taken SevSev OccOcc DetDet R. P. N. A c t i o n R e s u l t s

39. 39 www.quality-one.com 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

40. This guideline is for training purposes only; Not ISO controlled FMEA & Requirement/Specification Cascades for CPPDM

41. 41 www.quality-one.com V Model

42. 42 www.quality-one.com V Model The V Model shows the path a product follows from concept to completion specific to FMEA integration It follows the path of the CPPDM It provides a natural way to cascade critical items through the entire design FMEA process from Concept System Sub-System Component

43. 43 www.quality-one.com Voice of the Customer/Market The true customer’s wants, needs, desires, and delights must be represented to assure Excitement Quality, i.e. Customer Satisfaction This is typically captured from surveys, market research, customer feedback, etc. Added to Vehicle Requirements if cost and value are demonstrated

44. 44 www.quality-one.com Vehicle Requirements Vehicle performance and features with measures are listed Developed directly from Voice of the Customer/Market Legacy Engineering and styling inputs

45. 45 www.quality-one.com Concept FMEA The various vehicle concepts are compared by risk of not meeting vehicle or system requirements The Concepts come directly from the Vehicle requirements phase

46. 46 www.quality-one.com System Specifications All specifications are determined for each of the high level vehicle systems cascaded from the vehicle requirements The system specifications will be generated directly from the vehicle requirements

47. 47 www.quality-one.com System FMEA To create effective Design FMEA’s, the design must have between 50-75% design content The System FMEA will highlight sub-system and components that have the most risk, based on safety, regulatory, etc. The system specifications will provide the necessary functions for the System FMEA Part of the FMEA process is the creation of the boundary diagram, the p-diagram, and the interface matrix – these ensure that robustness is achieved

48. 48 www.quality-one.com Transmission Case/Covers/Gaskets Main shaft Bearings/Bushings/Seals Main shaft Gears Countershaft/Bearings/Bushings/Seals Transmission/Gearing Accessories Countershaft Gears Transmission/Gearing Exhaust System & Mounts (All Subsystems) Secondary Drive System (All Subsystems) Instrumentation (Speedometer & Sensor) Engine Management System (ECM) Physical Energy Data Materials Interfaces DFMEA Boundary Vehicle Frame System Crank Case (Big Twin) Starter System Rear Brake Line Primary Drive System Rider Interface (Foot Pegs) Lubrication System -Dyna/FLT; physical interface -Buell; material exchange Engine Mounting System Electrical SystemEvaporative Emissions System Shifter Cam Assembly Shifter Forks/Rails/Drums Synchronizers Shifter Controls/Shafts/Links/Pedals Shift Mechanism Accessories Shift Mechanism Crank Case System (Mid Weight) Clearance Ergonomics Grounding Clearance Carburetor Calibration Example Boundary Diagram Engine Lubrication System -breather External Shift Linkage

49. 49 www.quality-one.com Example P-Diagram Potential Causes Design Function Failure Modes Design Controls Design Function (Detail)

50. 50 www.quality-one.com Example Interface Matrix

51. 51 www.quality-one.com System Verification Testing (DVP&R) The outputs from the System FMEA will drive the DVP&R, which are noise factors which must be considered in the testing strategy

52. 52 www.quality-one.com Risk Strategy The Risk Strategy is generated from the System FMEA It highlights critical characteristics with severities of 9’s and 10’s and significant characteristics with severities from 5 to 8 with probabilities high enough to warrant consideration These characteristics are nominated for KPC’s

53. 53 www.quality-one.com Sub-System FMEA The Sub-System FMEA is similar to the System FMEA It may not be necessary in all instances, as the System FMEA may be cascaded directly to the Component FMEA Example System = Styled surfaces Sub-System Fenders Tour Pack

54. 54 www.quality-one.com Sub-System Verification Testing (DVP&R) The outputs from the Sub-System FMEA will drive the DVP&R and reliability studies Noise factors which must be considered in the testing strategy are potential causes of failure

55. 55 www.quality-one.com Component Specifications All component specifications are cascaded from the System Specifications, the System FMEA, and the Sub-System FMEA The component specifications will be used to determine, in conjunction with the risk strategy from the Sub-System FMEA, which component FMEA’s need to be completed.

56. 56 www.quality-one.com Risk Strategy The Risk Strategy is generated from the Sub- System FMEA It highlights critical characteristics with severities of 9’s and 10’s and significant characteristics with severities from 5 to 8 with probabilities high enough to warrant consideration

57. 57 www.quality-one.com Component FMEA The Component FMEA will highlight characteristics that have the most risk, based on safety, regulatory, etc. Component FMEA’s are only necessary for components that contribute to higher level failure system/sub-system New technology Changed product Past failures New environment for use The boundary diagram, the p- diagram, and the interface matrix are also created for components similar to system/sub-systems The Risk Strategy, Sub-System FMEA, and Component Specifications dictate which components need to be addressed

58. 58 www.quality-one.com Component Bench Testing (DVP&R) The outputs from the Component FMEA will drive the component DVP&R Bench tests

59. 59 www.quality-one.com Risk Strategy The Risk Strategy used in the Component FMEA determines which characteristics need to be addressed It highlights critical characteristics with severities of 9’s and 10’s and significant characteristics with severities from 5 to 8 with probabilities high enough to warrant consideration These become KPC/KCC at manufacturing

60. 60 www.quality-one.com Prototype Control Plan The characteristics that are required to be correct for appropriate design verification are listed on the prototype control plan The prototype control plans are used by those producing the prototypes

61. 61 www.quality-one.com Design Review There are vehicle level design reviews which focus on vehicle level indicators, such as cost, timing, weight, etc. There are system level design reviews which focus on timing and systems level issues There are technical design reviews which are related to specifications and performance Action reviews from FMEA’s/test results are addressed in design review

62. 62 www.quality-one.com Phase I QFD Phase II QFD Product Specifications Customer Wants (Marketing Information) Product Specifications Systems / Sub-Systems / Components Phase Progression System DFMEA Sub-System DFMEA Component DFMEA DFMEA Failure Modes QFD Phase Progression Inputs Boundary Diagram P-Diagram Interface Matrix Drawings Warranty FMA

63. 63 www.quality-one.com The Completed Characteristics Matrix Severity Process Steps Receive Material Material handling Shipping Damage Component Manufacture Vehicle Assembly Primary Drive Manufacturing Process Steps Op 100 Step 1 PRE-LOAD DOWEL PINS TO FIXTURE Op 100 Step 2 PRE-LOAD JACK SHAFT SEAL TO FIXTURE Op 100 Step 3 PRE-LOAD PRIMARY HOUSING BUSHING TO FIXTURE Op 110 Pre-load bearing to fixture #2 Op 120 Pre-load main shaft oil seal to mandrel Op 200 Housing to fixture #1 Op 210 Operate press Op 220 Retaining ring to top groove Op 230 Reload fixture #1 Op 300 Housing to fixture #2 Op 310 Operate press Op 320 Retaining ring to top groove Op 330 Mandrel to main shaft bore I.D. OP 340 Operate press Op 350 Re-load fixture #2 and mandrel Op 400 Housing to table Op 410 Reserved Op 420 Chain adj sub assy to housing Op 430 Lubricate bushing & seal Op 445 Move or stage for final assy Op 10 O-ring to shifter tube Op 500 Shifter tube to housing Op 510 Clamp to shifter tube Op 20 Assemble shifter lever Op 520 Wave washer to shifter lever Op 530 Shifter lever to shifter tube Op 535 Que for final assy line Customer Assessment Direction of Improvement Potential Critical and Significant 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 GF HF HF GFG HGHHFHH FFYHHHHHGG F 5 3 9 3 9 9 5 0 81 72 0 9 41 0 0 2754 261 3 0 54 81 30 0 0 27 0 45 9 900000 00 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

64. 64 www.quality-one.com System DFMEA Sub-System DFMEA Component DFMEA Classification of Characteristics 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 QFD Phase Progression Inputs Process Flow Line Layout MFMEA Failure Data Process Capability 10 9 8 7 6 5 4 3 2 1 123456789 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

65. 65 www.quality-one.com 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

66. 66 www.quality-one.com Training and Facilitation Fmea benefits certainly outweigh the obvious difficulty in developing them. To maintain efficiency, FMEA must be deployed with several methods of varying degrees of intensity. Methods to consider Computer based training Pin point Facilitation for Family groups. Database approach to legacy