Potential Failure Mode &Effects Analysis FMEAPROCESS FMEAISO TS 16949:2002 Lead Auditor Course
2Course Objectives• By the end of the course theparticipant should be able to;– Understand how to audit FMEA’sprocessident...
3Failure Mode and Effects Analysis• ISO TS requires FMEA’s to be generated andrevised during the following stages;– Advanc...
4Failure Mode and Effects Analysis• What is an FMEA?– An FMEA is a structured process used toanalyse design and/or process...
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 ...
7Failure Mode and Effects Analysis• Benefits of FMEA’s–2. An objective evaluation of thedesign or process - not subjective...
8Failure Mode and Effects Analysis• Benefits of FMEA’s–3. Cost & time savings - Theprocess identifies potentialcauses/mech...
9Failure Mode and Effects Analysis• Benefits of FMEA’s– 4. Provides a system forestablishing design andprocess improvement...
10Failure Mode and Effects Analysis• Benefits of FMEA’s• 5. A structured proactive system thataims to provide for Customer...
11Failure Mode and Effects Analysis• There are two types of FMEA’s• 1. Design FMEA– Cooling system for vehicle, spoiler as...
12Failure Mode and Effects Analysis• Definition of a Design FMEA– A design FMEA is a structured processused by Design Resp...
13Failure Mode and Effects Analysis• Examples of when Design FMEA’s may be used;– A company may be responsible for the com...
14Failure Mode and Effects Analysis• Definition of a Process FMEA– A process FMEA is a structured processused by a manufac...
15Failure Mode and Effects Analysis• Examples of when Process FMEA’smay be used;– A company has been provided with all oft...
How to Complete aProcess FMEA
17Process Failure Mode and EffectsAnalysis• How to complete a Process FMEA1. FMEA number• A number used for tracking and i...
18Process Failure Mode and EffectsAnalysis– How to complete a Process FMEA2. Item• Enter the name and number of the system...
19Process Failure Mode and EffectsAnalysis– How to complete a Process FMEA3. Process Responsibility• Indicate the OEM, dep...
20Process Failure Mode and EffectsAnalysis– How to complete a Process FMEA4. Prepared by:• Enter the contact details of th...
21Process Failure Mode and EffectsAnalysis– How to complete a Process FMEA5. Model Year(s)/Vehicle(s)• Enter the intended ...
22Process Failure Mode and EffectsAnalysis– How to complete a Process FMEA6. Key Date• The key date is defined as the due ...
23Process Failure Mode and EffectsAnalysis– How to complete a Process FMEA7. FMEA Date• This date is defined as the origin...
24Process Failure Mode and EffectsAnalysis– How to complete a Process FMEA8. Core Team• List the names of the responsible ...
25Process Failure Mode and EffectsAnalysis– How to complete a Process FMEA9. Process/Function Requirements• Enter the name...
26Process Failure Mode and EffectsAnalysis– How to complete a Process FMEA10. Potential Failure Mode• Enter the potential ...
27Process Failure Mode and EffectsAnalysis– How to complete a Process FMEA11. Potential Effects of Failure• What if the fa...
28Process Failure Mode and EffectsAnalysis– How to complete a Process FMEA12. Severity• Enter the severity rating as descr...
29Process Failure Mode and EffectsAnalysis– How to complete a Process FMEA13. Classification• Enter the special characteri...
30Process Failure Mode and EffectsAnalysis– How to complete a Process FMEA14. Potential Cause(s)/Mechanism(s) ofFailure• E...
31Process Failure Mode and EffectsAnalysis– How to complete a Process FMEA15. Occurrence– Enter the Occurrence as per Appe...
32Process Failure Mode and EffectsAnalysis– How to complete a Process FMEA16. Current Process Controls• Enter the current ...
33Process Failure Mode and EffectsAnalysis– How to complete a Process FMEA17. Detection• Enter the detection probability a...
34Process Failure Mode and EffectsAnalysis– How to complete a Process FMEA18. Risk Priority Number (RPN)• The Risk Priorit...
35Process Failure Mode and EffectsAnalysis– How to complete a Process FMEA19. Recommended Action(s)• When high RPN’s are e...
36Process Failure Mode and EffectsAnalysis– How to complete a Process FMEA20. Responsibility• Enter the name of the person...
37Process Failure Mode and EffectsAnalysis– How to complete a Process FMEA21. Actions taken• Enter the effectiveness and t...
38Process Failure Mode and EffectsAnalysis– How to complete a Process FMEA22. Severity• Re-enter the severity rating as de...
39Process Failure Mode and EffectsAnalysis– How to complete a Process FMEA23. Occurrence• Re-enter the Occurrence as per A...
40Process Failure Mode and EffectsAnalysis– How to complete a Process FMEA24. Detection• Re-enter the Detection probabilit...
41Process Failure Mode and EffectsAnalysis– How to complete a Process FMEA25. Resulting RPN• Based on the corrective actio...
42Appendix 1 Severity rating for Process FMEAEffect Customer Effect Manufacturing/Assembly Effect RankingHazardous-without...
43Appendix 2Occurrence rating for Process FMEAProbability of failure Possible failure rates Ppk RankingVery High - Persist...
44Appendix 3Detectionrating forProcessFMEADetection Criteria Suggested Range ofDetection MethodsRankingA B CAlmostimpossib...
45Auditing PFMEA’s1. Is the PFMEA conducted by a cross functionalteam?2. Has the Key date been defined3. Is it consistent ...
46Auditing PFMEA’s7. Are recommended actions completed prior to theKey date8. Do the sequence of dates make sense?9. How a...
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Fmea process la

  1. 1. Potential Failure Mode &Effects Analysis FMEAPROCESS FMEAISO TS 16949:2002 Lead Auditor Course
  2. 2. 2Course Objectives• By the end of the course theparticipant should be able to;– Understand how to audit FMEA’sprocessidentify the two types of FMEA’scomplete a Process FMEA for a projectunderstand how to determine the RPNand its implication
  3. 3. 3Failure Mode and Effects Analysis• ISO TS requires FMEA’s to be generated andrevised during the following stages;– 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
  4. 4. 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.
  5. 5. 5Failure Mode and Effects Analysis• An FMEA is ateam process not asingle personprocess
  6. 6. 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
  7. 7. 7Failure Mode and Effects Analysis• Benefits of FMEA’s–2. An objective evaluation of thedesign or process - not subjective.It forces an organisation toquantify
  8. 8. 8Failure Mode and Effects Analysis• Benefits of FMEA’s–3. Cost & time savings - Theprocess identifies potentialcauses/mechanisms of failurebefore they occur
  9. 9. 9Failure Mode and Effects Analysis• Benefits of FMEA’s– 4. Provides a system forestablishing design andprocess improvements andfor identifying SpecialCharacteristics
  10. 10. 10Failure Mode and Effects Analysis• Benefits of FMEA’s• 5. A structured proactive system thataims to provide for CustomerSatisfaction
  11. 11. 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...
  12. 12. 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.
  13. 13. 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
  14. 14. 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.
  15. 15. 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
  16. 16. How to Complete aProcess FMEA
  17. 17. 17Process Failure Mode and EffectsAnalysis• How to complete a Process FMEA1. FMEA number• A number used for tracking and identifying theProcess FMEA– GM -001A
  18. 18. 18Process Failure Mode and EffectsAnalysis– How to complete a Process FMEA2. Item• Enter the name and number of the system, sub-systemor component for which the process is being analysed– Rear Decklid Spoiler 92078645
  19. 19. 19Process Failure Mode and EffectsAnalysis– How to complete a Process FMEA3. Process Responsibility• Indicate the OEM, department and/or groupwhich is responsible for the Process– Spoiler Design Team
  20. 20. 20Process Failure Mode and EffectsAnalysis– How to complete a Process FMEA4. Prepared by:• Enter the contact details of the personresponsible for preparing the Process FMEA.This is typically the Process/Product Engineer– Max Smart
  21. 21. 21Process Failure Mode and EffectsAnalysis– How to complete a Process FMEA5. Model Year(s)/Vehicle(s)• Enter the intended model year(s) and vehiclelines that will utilise and/or be affected by theProcess being analysed, if known– WH 1999
  22. 22. 22Process Failure Mode and EffectsAnalysis– How to complete a Process FMEA6. Key Date• The key date is defined as the due date for theProcess FMEA. This date should not exceedthe scheduled start of production.– July 1999
  23. 23. 23Process Failure Mode and EffectsAnalysis– How to complete a Process FMEA7. FMEA Date• This date is defined as the original date theProcess FMEA was compiled and the latestrevision date.– June 5, 1998, August 10, 1999 Rev 8
  24. 24. 24Process Failure Mode and EffectsAnalysis– How to complete a Process FMEA8. Core Team• List the names of the responsible individualsand departments who have participated in thegeneration of the Process FMEA.– AW, PS, JA, RK, MH
  25. 25. 25Process Failure Mode and EffectsAnalysis– How to complete a Process FMEA9. Process/Function Requirements• Enter the name of the process being analysed.It is important to be as concise as possible. Usethe same terminology as per any referencedocuments.• Examples are;trimming, vacuum forming, welding etc..
  26. 26. 26Process Failure Mode and EffectsAnalysis– How to complete a Process FMEA10. Potential Failure Mode• Enter the potential failure mode(s) for thatprocess. Examples of failure modes might be,but are not limited to;– Stressing, Burrs, Cracking, Burning, Flash,Fails to open, Part leaking, bent, brittle,worn, tool mark etc...
  27. 27. 27Process Failure Mode and EffectsAnalysis– How to complete a Process FMEA11. Potential Effects of Failure• What if the failure occurs, what are the potentialeffects? These need to be written from the customersperspective. This can mean the next operation ormachine, not just end customer.• Examples• inoperable, unsatisfactory appearance, noisy becauseof vibration, uncomfortable, erratic operation, unableto fit or locate etc...
  28. 28. 28Process Failure Mode and EffectsAnalysis– How to complete a Process FMEA12. Severity• Enter the severity rating as described inAppendix 1. The severity is an assessment ofthe seriousness of the problem
  29. 29. 29Process Failure Mode and EffectsAnalysis– How to complete a Process 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.
  30. 30. 30Process Failure Mode and EffectsAnalysis– How to complete a Process FMEA14. Potential Cause(s)/Mechanism(s) ofFailure• Enter any potential reasons for these failures– Examples are:– Improper weld– Part not mounted correctly before drilling– Incorrect cycle time– Inadequate gauging– Human error, Fatigue, interaction..– Tool worn
  31. 31. 31Process Failure Mode and EffectsAnalysis– How to complete a Process 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
  32. 32. 32Process Failure Mode and EffectsAnalysis– How to complete a Process FMEA16. Current Process Controls• Enter the current Process verification/validationactivities that will assure the adequacy of theProcess• Typical examples may be, SPC, gaugingerror proofing etc...
  33. 33. 33Process Failure Mode and EffectsAnalysis– How to complete a Process FMEA17. Detection• Enter the detection probability as per Appendix3. Detection is defined as the ability of theproposed Process controls to detect any Processweakness or potential failure.
  34. 34. 34Process Failure Mode and EffectsAnalysis– How to complete a Process 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 Process 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.
  35. 35. 35Process Failure Mode and EffectsAnalysis– How to complete a Process FMEA19. Recommended Action(s)• When high RPN’s are established correctiveaction should be incorporated with a focus onreducing the Process risk
  36. 36. 36Process Failure Mode and EffectsAnalysis– How to complete a Process FMEA20. Responsibility• Enter the name of the person(s) or organisationwho has the responsibility for implementing thecorrective action(s). This should also include atarget date for completion.
  37. 37. 37Process Failure Mode and EffectsAnalysis– How to complete a Process FMEA21. Actions taken• Enter the effectiveness and the results of theactions taken
  38. 38. 38Process Failure Mode and EffectsAnalysis– How to complete a Process FMEA22. Severity• Re-enter the severity rating as described inAppendix 1. The severity is an assessment ofthe seriousness of the problem.
  39. 39. 39Process Failure Mode and EffectsAnalysis– How to complete a Process 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.
  40. 40. 40Process Failure Mode and EffectsAnalysis– How to complete a Process FMEA24. Detection• Re-enter the Detection probability as perAppendix 3. Detection is defined as the abilityof the proposed Process controls to detect anyProcess weakness or potential failure.
  41. 41. 41Process Failure Mode and EffectsAnalysis– How to complete a Process 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.
  42. 42. 42Appendix 1 Severity rating for Process FMEAEffect Customer Effect Manufacturing/Assembly Effect RankingHazardous-withoutwarningVery high severity ranking when a potentialfailure mode affects safe vehicle operationand/or involves nonconpliance withgovernment regulation without warning.Or may endanger machine or assemblyoperator, without warning.10HazardouswithwarningVery high severity ranking when a potentialfailure mode affects safe vehicle operationand/or involves nonconpliance withgovernment regulation without warningOr may endanger machine or assemblyoperator, with warning9Very High Vehicle/item is inoperable, loss of primaryfunctionOr 100% of product may have to bescrapped, or vehicle/item repaired inrepair dept with a repair time greaterthen 1 hr8High Vehicle/item is operable, but at a reducedlevel of performance. Customer verydissatisfied.Or product may have to be sorted and aportion (less than 100%) scrapped, oervehicle/item repaired in the repairdepartment with a repair time between ahalf hour to one hour.7Moderate Vehicle/item is operable, butcomfort/convenience items inoperbale.Customer dissatisfiedOr a portion (less than 100%) of theproduct may have to be scrapped with nosorting, or vehicle/item repaired in repairdepartment with a repair time of less then1 hour6Low Vehicle/item is operable, butcomfort/convenience items operbale at areduced level of performanceOr 100% of product may have to bereworked, or vehicle item repaired off linebut does not fo to repair dept5Very low Fit and finish/squeak and rattle item doesnot conform. Defect noticed by mostcustomers (greater then 75%)Or the product may have to be sorted,with no scrap, and a portion(less then100%) scrapped.4Minor Fit and finish/squeak and rattle item doesnot conform. Defect noticed by 50%customers.Or a portion (less then 100%) of theproduct may have to be reworked with noscrap, on line but out of station.3Very Minor Fit and finish/squeak and rattle item doesnot conform. Defect noticedbydiscriminating customers (less then 25%)Or a portion (less then 100%) of theproduct may have to be reworked with noscrap, on line but in station.2None No discernable effect. Or slight inconvenience to operation oroperator, or no effect1
  43. 43. 43Appendix 2Occurrence rating for Process FMEAProbability of failure Possible failure rates Ppk RankingVery High - Persistent failures ≥ 100 per thousand pieces < 0.55 1050 per thousand pieces ≥ 0.55 9High - Frequent failures 20 per thousand pieces ≥ 0.78 810 per thousand pieces ≥ 0.86 7Moderate - Occasional Failures 5 per thousand pieces ≥ 0.94 62 per thousand pieces ≥ 1.00 51 per thousand pieces ≥ 1.10 4Low - Isolated failures associated withsimilar processes0.5 per thousand pieces ≥ 1.20 3Low - Relatively few failures 0.1 per thousand pieces ≥ 1.30 2Remote - Failure is unlikely. ≤ 0.01 per thousand pieces ≥ 1.67 1
  44. 44. 44Appendix 3Detectionrating forProcessFMEADetection Criteria Suggested Range ofDetection MethodsRankingA B CAlmostimpossibleAbsolutecertainty of non-detectionX Cannot detect or is not checked 10Very remote Controls willprobably notdetectX Control is achieved with indirector random checks only9Remote Controls havepoor chance ofdetectionX Control is achieved with visualinspection only8Very Low Controls havepoor chance ofdetectionX Control is achieved with doublevisual inspection only7Low Controls maydetectX X Control is achieved with SPCcharting methods6Moderate Controls maydetectX Control is based on variablegauging after parts have left thestation, or GO/NO GO gaugingperformed on 100% of the partsafter the parts have left thestation5ModeratelyHighControls have agood chance todetectX X Error detection in subsequentoperations, OR gaugingperformed on setup and firstpiece check4High Controls have agood chance todetectX X Error detection in station, ordetection in subsequentoperations by multiple layers ofacceptance: supply, inspect,install and verify. Cannot acceptdiscrepant part.3Very High Controlsalmost certainto detectX X Error detection in-station(automatic gauging withautomatic stop feature). Cannotpass discrepant part.2Very High Controlscertain todetectX Discrepant parts cannot be madebecause item has been error-proofed by process/productdesign1InspectionTypesInspection typesA = Error proofedB = GaugingC = Manual Inspection
  45. 45. 45Auditing PFMEA’s1. Is the PFMEA conducted by a cross functionalteam?2. Has the Key date been defined3. Is it consistent with the customer’s PPAP date?4. Does the organisation consider all of the elementswithin the process flow chart?5. Has the organisation defined what constitutes a highRPN6. Does the organisation follow the definition of ahigh RPN
  46. 46. 46Auditing PFMEA’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 PFMEA is a livingdocument?11. Verify the occurrence rankings are based onobjective evidence12. Ensure the organisation is using the correctrankings for Severity, Occurrence and Detection

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