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Fmea design la Fmea design la Presentation Transcript

  • Potential Failure Mode &Effects Analysis FMEADESIGN FMEAISO TS 16949:2002 Lead Auditor Course
  • 2Course Objectives• By the end of the course theparticipant should be able to;• Understand how to audit DFMEA’s• Understand link between DFMEA andother ISO TS 16949 documentation• identify the two types of FMEA’s• complete a Design FMEA for a project• understand how to determine the RPNand its implication
  • 3Failure Mode and Effects Analysis• ISO TS 16949 requires FMEA’s to begenerated and revised during the followingstages;– Advanced Product Quality Planning - before or atdesign concept finalisation/prior to tooling forproduction– Design reviews– As a result of customer complaints– As as result of customer/field returns• FMEA’s are LIVING DOCUMENTS
  • 4Failure Mode and Effects Analysis• What is an FMEA?– An FMEA is a structured process used toanalyse design and/or process activities andto assure that potential failure modes havebeen addressed and effects analysed.
  • 5Failure Mode and Effects Analysis• An FMEA is ateam process not asingle personprocess
  • 6Failure Mode and Effects Analysis• Benefits of FMEA’s– 1. Utilises previous history andassociated failure modes toassist in developing qualityproducts during design - betterunderstanding of the product
  • 7Failure Mode and Effects Analysis• Benefits of FMEA’s– 2. An objective evaluation of thedesign or process - not subjective.It forces an organisation toquantify
  • 8Failure Mode and Effects Analysis• Benefits of FMEA’s– 3. Cost & time savings - Theprocess identifies potentialcauses/mechanisms of failurebefore they occur
  • 9Failure Mode and Effects Analysis• Benefits of FMEA’s– 4. Provides a system forestablishing design andprocess improvements andfor identifying SpecialCharacteristics
  • 10Failure Mode and Effects Analysis• Benefits of FMEA’s• 5. A structured proactive system thataims to provide for CustomerSatisfaction
  • 11Failure Mode and Effects Analysis• There are two types of FMEA’s• 1. Design FMEA– Cooling system for vehicle, spoiler assembly,wiring harness etc..• 2. Process FMEA– Injection moulding, welding, assembling etc...
  • 12Failure Mode and Effects Analysis• Definition of a Design FMEA– A design FMEA is a structured processused by Design Responsible companies toensure, to the extent possible, that possiblefailure modes and their associated causesand mechanisms have been consideredduring the design process.
  • 13Failure Mode and Effects Analysis• Examples of when Design FMEA’s may be used;– A company may be responsible for the completedesign of the cooling system of a vehicle.– A company may be responsible for designing acomplete trimmed seat assembly– A company may be responsible for developing anddesigning a material to reduce Noise and Vibration in avehicle
  • 14Failure Mode and Effects Analysis• Definition of a Process FMEA– A process FMEA is a structured processused by a manufacturing company toidentify potential failure modes and theirassociated causes and mechanisms for themanufacture and assembly of product.
  • 15Failure Mode and Effects Analysis• Examples of when Process FMEA’smay be used;– A company has been provided with all ofthe technical information to manufacture;• An injection moulded interior door handle• A metal pressed bracket• A family of fasteners
  • How to Complete aDesign FMEA
  • 17Design Failure Mode and EffectsAnalysis• How to complete a Design FMEA1. FMEA number• A number used for tracking and identifying theDesign FMEA
  • 18Design Failure Mode and EffectsAnalysis– How to complete a Design FMEA2. System, Sub-system or Component name &number• Indicate the type of analysis and enter the name andnumber of the system, sub-system or component
  • 19Design Failure Mode and EffectsAnalysis– How to complete a Design FMEA3. Design Responsibility• Indicate the OEM, department and/or groupwhich is responsible for the design of theproduct
  • 20Design Failure Mode and EffectsAnalysis– How to complete a Design FMEA4. Prepared by:• Enter the contact details of the personresponsible for preparing the Design FMEA.This is typically the Design Engineer
  • 21Design Failure Mode and EffectsAnalysis– How to complete a Design FMEA5. Model Year(s)/Vehicle(s)• Enter the intended model year(s) and vehiclelines that will utilise and/or be affected by thedesign being analysed, if known
  • 22Design Failure Mode and EffectsAnalysis– How to complete a Design FMEA6. Key Date• The key date is defined as the due date for thedesign FMEA. This date should not exceed thescheduled design release date.• Typically this is the Design freeze date
  • 23Design Failure Mode and EffectsAnalysis– How to complete a Design FMEA7. FMEA Date• This date is defined as the original date theDesign FMEA was compiled and the latestrevision date.
  • 24Design Failure Mode and EffectsAnalysis– How to complete a Design FMEA8. Core Team• List the names of the responsible individualsand departments who have participated in thegeneration of the design FMEA.
  • 25Design Failure Mode and EffectsAnalysis– How to complete a Design FMEA9. Item/Product Function• Enter the name of the item and the productfunction. It is important to be as concise aspossible. Use the same terminology as per anyreference documents.Be sure to use allintended functions and unintended functions
  • 26Design Failure Mode and EffectsAnalysis– How to complete a Design FMEA10. Potential Failure Mode• Enter the potential failure mode(s) for thatitem. Examples of failure modes might be, butnot limited to;– Fracturing, Leaking, Cracking, Fading,Peeling, Breaking, Deformed, Oxidised,Slips, sticks etc…
  • 27Design Failure Mode and EffectsAnalysis– How to complete a Design FMEA11. Potential Effects of Failure• What if the failure occurs, what are the potentialeffects? These need to be written from the customersperspective• Examples• inoperable, unsatisfactory appearance, noisy becauseof vibration, uncomfortable, regulatorynoncompliance, erratic operation etc..
  • 28Design Failure Mode and EffectsAnalysis– How to complete a Design FMEA12. Severity• Enter the severity rating as described inAppendix 1. The severity is an assessment ofthe seriousness of the problem
  • 29Design Failure Mode and EffectsAnalysis– How to complete a Design FMEA13. Classification• Enter the special characteristic symbol as percustomer requirements for any critical,significant, major, safety or Key characteristic.ISO TS Section II should define the type ofsymbol required.ISO TS requires that all special characteristicsare addressed during the FMEA stage.
  • 30Design Failure Mode and EffectsAnalysis– How to complete a Design FMEA14. Potential Cause(s)/Mechanism(s) of Failure• Enter any potential reasons for these failures• Examples are:• Specification incorrect ie. formulation, material etc.• Insufficient testing• Inadequate product design• Over stressing• Incorrect assumptions, Fatigue, creep, wear etc..
  • 31Design Failure Mode and EffectsAnalysis– How to complete a Design FMEA15. Occurrence– Enter the Occurrence as per Appendix 2.The Occurrence is defined is theprobability or the likelihood that thespecific cause or mechanism will occur.This may be based on previous fieldhistory, similar products and experience
  • 32Design Failure Mode and EffectsAnalysis– How to complete a Design FMEA16. Current Design Controls• Enter the current design verification/validationactivities that will assure the adequacy of thedesign• Typical examples may be, environmentaltesting, Engineering test, reliability studies,design reviews, FEA etc..
  • 33Design Failure Mode and EffectsAnalysis– How to complete a Design FMEA16. Current Design Controls• There are two type of controls to considerPreventionA pro-active methodto reduce rate ofoccurrenceDetectionDetecting the failureusing analytical orphysical testing
  • 34Design Failure Mode and EffectsAnalysis– How to complete a Design FMEA17. Detection• Enter the detection probability as per Appendix3. Detection is defined as the ability of theproposed design controls to detect any designweakness or potential failure.
  • 35Design Failure Mode and EffectsAnalysis– How to complete a Design FMEA18. Risk Priority Number (RPN)• The Risk Priority Number is defined as theSeverity multiplied by the Occurrencemultiplied by the Detection. The RPN is ameasure of the design risk. The RPN will bebetween 1 and 1000. It is the responsibility ofthe group to define what a high RPN is andtake the appropriate actions.
  • 36Design Failure Mode and EffectsAnalysis– How to complete a Design FMEA19. Recommended Action(s)• When high RPN’s are established correctiveaction should be incorporated with a focus onreducing the design risk
  • 37Design Failure Mode and EffectsAnalysis– How to complete a Design FMEA20. Responsibility• Enter the name of the person(s) or organisationwho has the responsibility for implementingthe corrective action(s). This should alsoinclude a target date for completion.
  • 38Design Failure Mode and EffectsAnalysis– How to complete a Design FMEA21. Actions taken• Enter the effectiveness and the results of theactions taken
  • 39Design Failure Mode and EffectsAnalysis– How to complete a Design FMEA22. Severity• Re-enter the severity rating as described inAppendix 1. The severity is an assessment ofthe seriousness of the problem.
  • 40Design Failure Mode and EffectsAnalysis– How to complete a Design FMEA23. Occurrence• Re-enter the Occurrence as per Appendix 2.The Occurrence is defined as the probability orthe likelihood that the specific cause ormechanism of failure will occur. This may bebased on previous field history, similarproducts and/or experience.
  • 41Design Failure Mode and EffectsAnalysis– How to complete a Design FMEA24. Detection• Re-enter the Detection probability as perAppendix 3. Detection is defined as the abilityof the proposed design controls to detect anydesign weakness or potential failure.
  • 42Design Failure Mode and EffectsAnalysis– How to complete a Design FMEA25. Resulting RPN• Based on the corrective action, calculate theRPN and record this result. If further action isrequired repeat the corrective action steps inorder to reduce the RPN.
  • 43Appendix 1Severity rating for Design FMEAEffect Criteria: Severity of Effect RankingHazardous-withoutwarningVery high severity ranking when a potential failure mode affects safe vechicleoperation and/or involves noncompliance with government regulation without warning10HazardouswithwarningVery high severity ranking when a potential failure mode affects safe vechicleoperation and/or involves noncompliance with government regulation with warning9Very High Vechicle/item inoperable, with loss of primary function 8High Vechicle/Item operable, but at reduced level of performance. Customer verydissatisfied7Moderate Vechicle/item operable, but comfort/convenience items inoperable. Customerdissatisfied6Low Vehiclle/item operable, but comfort/conveinience items operable at reduced level ofperformance. Customer somewhat dissatisfied5Very low Fit and Finish/squeak and rattle item does not conform. Defect noticed by mostcustomers, greater then 75%4Minor Fit and Finish/squeak and rattle item does not conform. Defect noticed by 50% ofcustomers3VeryMinorFit and Finish/squeak and rattle item does not conform. Defect noticed bydiscriminating customer, less then 25%2None No discernable effect 1
  • 44Appendix 2Occurrence rating for Design FMEAProbabilit y of failure Possible failure rat es RankingVery High - Persistent Failures ≥ 100/thousand vehicles/items 1050/thousand vehicles/items 9High - Repeated Failures 20/thousand vehicles/items 810/thousand vehicles/items 7Moderate - Occasional failures 5/thousand vehicles/items 62/thousand vehicles/items 51/thousand vehicles/items 4Low - Relatively Few Failures 0.5/thousand vehicles/items 30.1/thousand vehicles/items 2Remote - Failure is unlikely ≤ 0.01/thousand vehicles/items 1
  • 45Appendix 3Detection rating for Design FMEADetection Criteria: Likelihood of detection by designcontrolRankingAbsoluteuncertaintyDesign control will not and/or cannot detect a potentialcause/mechanism and subsequent failure mode; or there isno design control10Very remote Very remote chance that the design control will detect apotential cause mechanism and subsequent failure mode9Remote Remote chance that the design control will detect a potentialcause mechanism and subsequent failure mode8Very Low Very Low chance that the design control will detect apotential cause mechanism and subsequent failure mode7Low Low chance that the design control will detect a potentialcause mechanism and subsequent failure mode6Moderate Moderate chance that the design control will detect apotential cause mechanism and subsequent failure mode5Moderately High Moderately High chance that the design control will detect apotential cause mechanism and subsequent failure mode4High High chance that the design control will detect a potentialcause mechanism and subsequent failure mode3Very High Very high chance that the design control will detect apotential cause mechanism and subsequent failure mode2Almost certain Design control will almost certainly detect a potentialcause/mechanism and subsequent failure mode1
  • 46Auditing DFMEA’s1. Is the DFMEA conducted by a cross functionalteam?2. Has the Key date been defined3. Is it consistent with the customer’s design freezedate?4. Does the organisation consider the intended andunintended functions?5. Has the organisation defined what constitutes ahigh RPN6. Does the organisation follow the definition of ahigh RPN
  • 47Auditing DFMEA’s7. Are recommended actions completed prior to theKey date8. Do the sequence of dates make sense?9. How are revisions recorded?10. Does the organisation ensure the DFMEA is aliving document?11. Verify the occurrence rankings are based onobjective evidence