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

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 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

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

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

6 Potential KPC Development Requirements Documents Regulatory Dimensional Cosmetic Req. Spec. Document Drawings Warranty History Robustness Tools Boundary Diagram P-Diagram Interface Matrix 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 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 TO " FACE OF PRIMARY HOUSING BUSHING TO FACE OF JACK SHAFT SEAL DOWEL PINS TO " 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 Special Characteristics Matrix START OPERATION IF END YES NO Process Flow Special Characteristics Sources DFMEA (Potential KPCs: Significant and Critical Characteristics) Drawings Regulations

8 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 TO " FACE OF PRIMARY HOUSING BUSHING TO FACE OF JACK SHAFT SEAL DOWEL PINS TO " 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 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 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 Cover Clearance Shaft Assembly Shaft Cup Pin Valve Injector oil Floating Cylinder Head Load Valve Stem Seal Clear at full stroke Lube Oil 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

12 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

13 System/Subsystem/ Design FMEA Failure Mode: Pure anti-function 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

15 Severity Column Severity Column Severity Column

16 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 Hazardous- without warning Moderate 4 5 EFFECT CRITERIA: Severity of Effect RNK. SEVERITY EVALUATION CRITERIA 9

17 FMEA General For High Severity 9/10

18 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

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

20 Occurrence Column Occurrence Column Occurrence Column

21 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

22 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

23 Example of Significant/ Critical Threshold *Used by permission of Ford Motor Company 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 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.

25 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

26 Detection Rating Absolute Uncertainty Very Remote Remote Very Low Low Moderate Moderately High Very High Almost Certain 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.

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

28 RPN / Risk Priority Number

29 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?

30 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.

31 Example of Significant/ Critical Threshold *Used by permission of Ford Motor Company 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 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

33 Actions

34 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

35 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

36 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.

37 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.

38 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

39 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 TO " FACE OF PRIMARY HOUSING BUSHING TO FACE OF JACK SHAFT SEAL DOWEL PINS TO " 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 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 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 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 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

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