FMEA

Intelligent use of FMEA

This guideline is for training purposes only; Not ISO controlled

__ System __ Subsystem __ Component Model Year/Vehicle(s): Core Team:

Potential Failure Mode and Effects Analysis (Design FMEA)
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 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

D Action Results 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 MURPHY’S  Focus on Prevention  Failure Mode And Effects Analysis is An assessment of Risk
Safety Regulatory Customer Satisfaction Program

LAW

Coordinated/Documented team effort
To determine what can go wrong

A method to determine the need and priority of actions

3

Plan & D efine Section 1
ID E A

RELIABILITY BY DESIGN APQP Tool Linkage
GD & T - D rawings - M ath D ata

D esign & D evelopment - Section I I
O pportunity D efined

Process D esign & D evelopment - Section I I I
Process F low F inalized

Mi sta ke Pro of

F orm T eam - T iming - Resources C ustomer C ollect Wants/ N eeds/ D esires M arket R esearch - Q FD

DFME A DFME A

Special Characteristics

Prototype C ontrol C haracteristic Plan M atrix PF M E A - M anufacturing - Assembly

Pre - L aunch C ontrol Plan - R isk/ Action YES - Special C haracteristics IF - C urrent C ontrols
NO

?

Process Validation - Sectio
Process T rial R un M in 300 / H its/ shots pcs

I nput F rom 5 - F ailure M ode A nalysis - H istory - P ast P erformance - L essons L earned

Priorities Wants/ N eeds/ D esires

D esign D esign A ctions hange D evelopCC oncepts

T est Plans - D esign Verification
No

Packaging D esigns

- Product - Process

Special C ontrols Process V alidation Plan - G age P lan - C apability Plan I nstructions - I nitial Revisit III PF M E A For Additional Potential Failures Process R isk A ssessment
- E quipment YES - Gages Can w e chang e - Controls p ro ce ss to I F - I nstructions co n t a in ? - Plans NO - Status of O pen I ssues

V alidation T esting Plan
OK?

IF D esign OK
Yes

GR & R - G age Plan Repeatability Reproducibility
NO

D evelop Product Feasibility Specifications - T eam - L inked to C ustomers

IF
YES

Process Development
IF N o Feasible

Concept Initiation/Approval Program Approval Prototype
I nitial Process

Yes

D esign R isk A ssessment - O pen I ssues - Spec. A greements - M aterials - Budget - M anufacturing - Program R isks

Statistics - Via C ontrol Plans - Capability Plan
STA BLE ? NO

IF
YES

Pilot Launch
K ick O ff T ools / E quipment G ages

PLANNING

PLANNING

- E quipment I nstallation - T ooling Progress - G age D esign & P rogress

NO

C A PA BL E?

IF
YES

PRODUCT DESIGN AND DEV. PROCESS DESIGN AND DEVELOPMENT. PRODUCT AND PROCESS VALIDATION. PRODUCTION FEEDBACK ASSESSMENT AND CORRECTIVE ACTION

D esign C hange B ack to II

Sample T he C reate Production C ontrol Plan
- R ed u c e d (n ) - R ed u c e d (f) - O p t im izin g C h ar a c t e ris tic s

- Source Wa - Supportin - L evel of P

Open Issues / Time Line

CONTROL PLANS

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

Spec.Potential KPC Development Requirements Documents •Regulatory •Dimensional •Cosmetic Req. 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 Action Actions Complete Taken E C E P Date V C T N DFMEA 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 Cascade Technical Requirements Into Special Product Characteristics POTENTIAL SIGNIFICANT CHARACTERISTICS Customer Dissatisfaction ALL OTHER CHARACTERISTICS Appropriate actions / controls already in place ANOYANCE ZONE 1 2 3 4 5 6 7 8 9 10 OCCURRENCE 6 .

110 " FACE OF PRIMARY HOUSING Weighted Importance Relative Importance Special Characteristics 5 9 9 3 9 3 5 Severity Receive Material Material handling Shipping Damage Component Manufacture Vehicle Assembly 0 81 F 81 F 72 H Y 0 9 H Op 100 Step 1 PRE-LOAD DOWEL PINS TO FIXTURE 41 H G G 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 IF END START YES 0 OPERATION OPERATION NO 0 27 H Op 120 Pre-load main shaft oil seal to mandrel Op 200 Housing to fixture #1 F F F Process Flow 54 H H 261 F H Op 210 Operate press Op 220 G 3 0 54 81 Retaining ring to top groove Op 230 Reload fixture #1 Process Steps H H H F H Op 300 Housing to fixture #2 Op 310 Operate press 3 G Op 320 Retaining ring to top groove 0 0 0 27 0 45 Op 330 Mandrel to main shaft bore I.270 " TO FACE BUSHING TO FACE OF JACK SHAFT SEAL Direction of Improvement BEARING FLUSH TO SNAP RING FACE PRIMARY GASKET SEAL SURFACE FINISH 1.090 TO 1.260 TO 0. OP 340 Operate press Op 350 Re-load fixture #2 and mandrel Op 400 H F Primary Drive Manufacturing Process Steps Housing to table Op 410 Reserved Op 420 Chain adj sub assy to housing 9 9 0 0 0 0 0 0 0 Op 430 G G 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 Characteristics Matrix Development 7 .D.•Drawings Special Characteristics Sources •Regulations •DFMEA (Potential KPCs: Significant and Critical Characteristics) Potential Critical and Significant JACK SHAFT SEAL AGAINST SHOULDER SEAL COMPRESSION HEIGHT SERATION DAMAGE Matrix DOWEL PINS 0.

260 TO 0.110 " FACE OF PRIMARY HOUSING BUSHING TO FACE OF JACK SHAFT 5 SEAL DOWEL PINS 0. OP 340 Operate press Op 350 Re-load fixture #2 and mandrel Op 400 Housing to table Op 410 Reserved Process Operation from Process Flow 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 Primary Drive Manufacturing Process Steps High/Medium Interactions are causes/failure modes in PFMEA 8 Characteristics Matrix Customer Assessment .Potential Critical and Significant SEAL COMPRESSION HEIGHT SERATION DAMAGE Direction of Improvement BEARING FLUSH TO SNAP RING FACE PRIMARY GASKET SEAL SURFACE FINISH Potential Significant and Critical Characteristics from DFMEA & Other Sources 1.090 TO 1.D.270 " TO 3 FACE JACK SHAFT SEAL AGAINST 9 SHOULDER 0 Receive Material Material handling Shipping Damage Component Manufacture Vehicle Assembly 81 81 72 0 9 Weighted Importance Special Characteristics Matrix Relative Importance 5 9 9 3 Severity F F H H Y Prioritized ranking of process steps relative to risk 41 H G G 0 0 27 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 H Characteristics Ranked in order of Importance 54 H F F F F H H 261 3 0 54 81 3 0 0 0 27 0 45 9 9 0 0 0 0 0 0 0 Op 120 Pre-load main shaft oil seal to mandrel Op 200 Housing to fixture #1 Op 210 Operate press G H H H F G G H F G H 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 Process Steps Op 330 Mandrel to main shaft bore I.

FMEA Deployment  A layered approach is highly recommended as FMEAs can get complex. 9 .  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 Cylinder Head Vi br Additional Clearances •Injector & Spring •Injector & Spring Base •Injector & retainer •Injector & Bridge •Injector & injector clamp Valve •Injector oil Floating at ion on rati Vib Compression Brake Shaft Assembly •Shaft Intake Rocker Assembly •Cup Exhaust Rocker Assembly •Pin •Body •Insert •Roller •Pin •Clip Pushrod •Rod •Cup •Ball Arm Group Assembly •Intake rocker assembly •Exhaust rocker assembly •Stand(s) W & W/o oil supply •Shaft Assembly •Mounting Bolt •Spring/Spacer Bridge Clearance Valve Cover Lube Oil Spring Group •Inner & Outer Springs Load •Spring Base Cylinder Head •Retainer/Rotator •Valve Keeper oke str Valve Stem Seal at full Clear Valve Group •Intake Valve •Exhaust Valve •Intake Seat Lube Oil •Exhaust Seat •Valve Guide •Valve Guide Seal Cylinder Head Valve Seat Seat Insert Cylinder Head CAM Bearings Lifter Assembly •Body •Insert •Roller •Pin •Clip •wire CAM Shaft Oscillating Lifter •Pressure Lube OR Bore in Block •Pressure Lube Thrust Plate Cylinder Block .

Other systems Foot peg location Engine mount 3. Deterioration/degredagtion over time Gasket wear Motor mount wear Corrosion Loss of torque on fasteners 4. Front & Rear Meet Styling Requirements Transfer of exhaust gas Adequate clearance to other components Control factors Regulatory Lean Angle (SAE) Durability Requirements (GES) Meet Durability Requirements Error states Difficult to service Does not meet styling review Difficult to assemble High warranty Poor lean angle 11 . decorative covers Change calibrations. runs hotter. lowers bike Improper storage practices 4.P-Diagram Noise Factors 1. Environment Ocean sea side (salt) Sand. Customer usage/duty cycle After market changes -mufflers. componet discoloring. excesive lean angle Supension changes. foot pegs. Piece to piece variation Heat shields Pipe maufacturing variation Frame variation 2. over drive system. dust Gravel Parade duty (low speed) Input Exhaust gases from engine Engine vibration Road vibration Ideal function Exhaust Pipes.

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 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 Process Controls Prevent Detect D e t e c R P N Response & Recommended Traget Actions Complete Date Action Results Action Taken S E V O C C D E T R P N Severity Column 15 .

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

FMEA General For High Severity 9/10 17 .

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

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

Occurrence Column 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 Process Controls Prevent Detect D e t e c R P N Response & Recommended Traget Actions Complete Date Action Results Action Taken S E V O C C D E T R P N Occurrence Column 20 .

01 per thousand vehicles/items *Note: Zero (0) rankings for Severity.5 per thousand vehicles/items 0.1 per thousand vehicles/items ≤ 0. Occurrence or Detection are not allowed 21 .Occurrence Evaluation Criteria SUGGESTED OCCURRENCE EVALUATION CRITERIA Probability of Failure Likely Failure Rates Over Design Life Ranking Very High: Persistent failures ≥ 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 10 9 8 7 6 5 4 3 2 1 High: Frequent failures Moderate: Occasional failures 2 per thousand vehicles/items 1 per thousand vehicles/items Low: Relatively few failures Remote: Failure is unlikely 0.

the action is listed as described earlier.Occurrence Rating  If an action would effectively eliminate the possibility of the cause occurring. DATA HARD FACTS 22 . Occurrence of 1 or 2 require proof using a surrogate product or mistake proofing.

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 3 4 5 6 7 8 9 10 OCCURRENCE 23 *Used by permission of Ford Motor Company .

Classification and Definition Column 24 . Recommended Target t P.Classification And Definition Column Item Potential Potential S Failure Effect(s) of e Mode Failure v Function C O Potential l c Cause(s) / a c Mechanism(s) s u of Failure s r Current Design Controls D Response & e R. Actions Complete e N. c t N. Date c Action Results Actions Taken S e v O D R. c e P.

List them separately. Detection is how well the test or series of tests may find the design flaw Causes Failure Mode 25 .Design Verification (Current Design Controls)  Think of Design Control in two ways. Prevention is specifically related to reduction or elimination of a cause. add any new (untried) prevention/detection ideas to the document under Recommended Actions column. Prevention and Detection.  To save time.

or there is no Design Control. 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. High chance the Design Control will detect a potential cause/ mechanism and subsequent failure mode.Detection Rating SUGGESTED DETECTION EVALATION CRITERIA DETECTION CRITERIA Design Control will not and/or cannot detect a potential cause/ mechanism and subsequent failure mode. Low 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. 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. RNK. Very High 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. 10 Absolute Uncertainty Very Remote Remote Very Low Low Moderate Moderately High High Very High Almost Certain 9 8 7 6 5 4 3 2 1 26 .

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

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.

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 3 4 5 6 7 8 9 10 OCCURRENCE 31 *Used by permission of Ford Motor Company .

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

Actions EXAMPLE: Project: Issue Number 143 Issue Status/ Open Date Date Of Meeting: Issue Champion Action Number Action Date Action Person Resp. Team Completion Date 33 .

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

 Occurrence is the primary item to reduce / focus on.Re-rating RPN After Actions Have Occurred  Severity typically stays the same.  Detection is reduced only as a last resort. or reduce probability of causes Detection of 10 is not bad if occurrence is 1 35 .  Do not plan to REDUCE RPN with detection actions!!! 100% inspection is only 80% effective! Reducing RPN with detection does not eliminate failure mode.

Key features such as Geometry. were described to the Steel producer. Strength.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. 36 . Duty Cycle. This was a critical application.

E.g. 37 . Internal stress at ingot level. Key characteristics mapped against processes Process FMEA was performed on processes that affected customer wants based on priority. Product Grade and requirements documents created. chemistry and microstructure.The key product requirements were mapped against the required customer features.

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

090 TO 1.270 " TO 3 FACE JACK SHAFT SEAL AGAINST 9 SHOULDER 0 Receive Material Material handling Shipping Damage 81 81 72 0 9 Weighted Importance Special Characteristics Matrix Relative Importance Potential Significant and Critical Characteristics from DFMEA 5 9 9 3 Severity F F H H Y Component Manufacture Vehicle Assembly Prioritized ranking of process steps relative to risk 41 H G G 0 0 27 54 261 3 0 54 81 3 0 0 0 27 0 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 H H H H H H H F F G H F G H F F F Characteristics Ranked in order of Importance 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 Process Steps Op 330 Mandrel to main shaft bore I. OP 340 Operate press Op 350 Re-load fixture #2 and mandrel Op 400 Housing to table Op 410 Reserved Primary Drive Manufacturing Process Steps 45 9 9 0 0 0 0 0 0 0 Op 420 Chain adj sub assy to housing Process Operation from Process Flow G G High/Medium Interactions are causes/failure modes in PFMEA 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 The Completed Characteristics Matrix 39 .D.260 TO 0.110 " FACE OF PRIMARY HOUSING BUSHING TO FACE OF JACK SHAFT 5 SEAL DOWEL PINS 0.Potential Critical and Significant SEAL COMPRESSION HEIGHT SERATION DAMAGE Direction of Improvement BEARING FLUSH TO SNAP RING FACE PRIMARY GASKET SEAL SURFACE FINISH 1.

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

Future customer requirements will drive new and modified processes to achieve specialty results as a normal practice 41 . Linking key customer requirements to process outputs instead of standard product grade is valuable.Summary FMEA can be used creatively in continuous processing.

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

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