Fmea process la

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Fmea process la

  1. 1. Potential Failure Mode & Effects Analysis FMEA PROCESS FMEA ISO TS 16949:2002 Auditor Course Supplement Robere & Associates (Thailand) Ltd. 1
  2. 2. Course Objectives• By the end of the course the participant should be able to; – Understand how to audit FMEA’s process • identify the two types of FMEA’s • complete a Process FMEA for a project • understand how to determine the RPN and its implication Robere & Associates (Thailand) Ltd. 2
  3. 3. Failure Mode and Effects Analysis• ISO TS requires FMEA’s to be generated and revised during the following stages; – Advanced Product Quality Planning - before or at design concept finalisation/prior to tooling for production – Design reviews – As a result of customer complaints – As as result of customer/field returns• FMEA’s are LIVING DOCUMENTS Robere & Associates (Thailand) Ltd. 3
  4. 4. Failure Mode and Effects Analysis• What is an FMEA? – An FMEA is a structured process used to analyse design and/or process activities and to assure that potential failure modes have been addressed and effects analysed. Robere & Associates (Thailand) Ltd. 4
  5. 5. Failure Mode and Effects Analysis• An FMEA is a team process not a single person process Robere & Associates (Thailand) Ltd. 5
  6. 6. Failure Mode and Effects Analysis • Benefits of FMEA’s – 1. Utilises previous history and associated failure modes to assist in developing quality products during design - better understanding of the product Robere & Associates (Thailand) Ltd. 6
  7. 7. Failure Mode and Effects Analysis • Benefits of FMEA’s – 2. An objective evaluation of the design or process - not subjective. It forces an organisation to quantify Robere & Associates (Thailand) Ltd. 7
  8. 8. Failure Mode and Effects Analysis • Benefits of FMEA’s – 3. Cost & time savings - The process identifies potential causes/mechanisms of failure before they occur Robere & Associates (Thailand) Ltd. 8
  9. 9. Failure Mode and Effects Analysis • Benefits of FMEA’s – 4. Provides a system for establishing design and process improvements and for identifying Special Characteristics Robere & Associates (Thailand) Ltd. 9
  10. 10. Failure Mode and Effects Analysis • Benefits of FMEA’s• 5. A structured proactive system that aims to provide for Customer Satisfaction Robere & Associates (Thailand) Ltd. 10
  11. 11. Failure 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... Robere & Associates (Thailand) Ltd. 11
  12. 12. Failure Mode and Effects Analysis• Definition of a Design FMEA – A design FMEA is a structured process used by Design Responsible companies to ensure, to the extent possible, that possible failure modes and their associated causes and mechanisms have been considered during the design process. Robere & Associates (Thailand) Ltd. 12
  13. 13. Failure Mode and Effects Analysis• Examples of when Design FMEA’s may be used; – A company may be responsible for the complete design of the cooling system of a vehicle. – A company may be responsible for designing a complete trimmed seat assembly – A company may be responsible for developing and designing a material to reduce Noise and Vibration in a vehicle Robere & Associates (Thailand) Ltd. 13
  14. 14. Failure Mode and Effects Analysis• Definition of a Process FMEA – A process FMEA is a structured process used by a manufacturing company to identify potential failure modes and their associated causes and mechanisms for the manufacture and assembly of product. Robere & Associates (Thailand) Ltd. 14
  15. 15. Failure Mode and Effects Analysis• Examples of when Process FMEA’s may be used; – A company has been provided with all of the technical information to manufacture; • An injection moulded interior door handle • A metal pressed bracket • A family of fasteners Robere & Associates (Thailand) Ltd. 15
  16. 16. How to Complete a Process FMEA Robere & Associates (Thailand) Ltd. 16
  17. 17. Process Failure Mode and Effects Analysis• How to complete a Process FMEA 1. FMEA number • A number used for tracking and identifying the Process FMEA – GM -001A Robere & Associates (Thailand) Ltd. 17
  18. 18. Process Failure Mode and EffectsAnalysis– How to complete a Process FMEA2. Item • Enter the name and number of the system, sub-system or component for which the process is being analysed – Rear Decklid Spoiler 92078645 Robere & Associates (Thailand) Ltd. 18
  19. 19. Process Failure Mode and EffectsAnalysis – How to complete a Process FMEA 3. Process Responsibility • Indicate the OEM, department and/or group which is responsible for the Process – Spoiler Design Team Robere & Associates (Thailand) Ltd. 19
  20. 20. Process Failure Mode and EffectsAnalysis – How to complete a Process FMEA 4. Prepared by: • Enter the contact details of the person responsible for preparing the Process FMEA. This is typically the Process/Product Engineer – Max Smart Robere & Associates (Thailand) Ltd. 20
  21. 21. Process Failure Mode and EffectsAnalysis – How to complete a Process FMEA 5. Model Year(s)/Vehicle(s) • Enter the intended model year(s) and vehicle lines that will utilise and/or be affected by the Process being analysed, if known – WH 1999 Robere & Associates (Thailand) Ltd. 21
  22. 22. Process Failure Mode and EffectsAnalysis – How to complete a Process FMEA 6. Key Date • The key date is defined as the due date for the Process FMEA. This date should not exceed the scheduled start of production. – July 1999 Robere & Associates (Thailand) Ltd. 22
  23. 23. Process Failure Mode and EffectsAnalysis – How to complete a Process FMEA 7. FMEA Date • This date is defined as the original date the Process FMEA was compiled and the latest revision date. – June 5, 1998, August 10, 1999 Rev 8 Robere & Associates (Thailand) Ltd. 23
  24. 24. Process Failure Mode and EffectsAnalysis – How to complete a Process FMEA 8. Core Team • List the names of the responsible individuals and departments who have participated in the generation of the Process FMEA. – AW, PS, JA, RK, MH Robere & Associates (Thailand) Ltd. 24
  25. 25. Process Failure Mode and EffectsAnalysis – How to complete a Process FMEA 9. Process/Function Requirements • Enter the name of the process being analysed. It is important to be as concise as possible. Use the same terminology as per any reference documents. • Examples are; trimming, vacuum forming, welding etc.. Robere & Associates (Thailand) Ltd. 25
  26. 26. Process Failure Mode and EffectsAnalysis – How to complete a Process FMEA 10. Potential Failure Mode • Enter the potential failure mode(s) for that process. 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... Robere & Associates (Thailand) Ltd. 26
  27. 27. Process Failure Mode and EffectsAnalysis – How to complete a Process FMEA 11. Potential Effects of Failure• What if the failure occurs, what are the potential effects? These need to be written from the customers perspective. This can mean the next operation or machine, not just end customer.• Examples• inoperable, unsatisfactory appearance, noisy because of vibration, uncomfortable, erratic operation, unable to fit or locate etc... Robere & Associates (Thailand) Ltd. 27
  28. 28. Process Failure Mode and EffectsAnalysis – How to complete a Process FMEA 12. Severity • Enter the severity rating as described in Appendix 1. The severity is an assessment of the seriousness of the problem Robere & Associates (Thailand) Ltd. 28
  29. 29. Process Failure Mode and EffectsAnalysis – How to complete a Process FMEA 13. Classification • Enter the special characteristic symbol as per customer requirements for any critical, significant, major, safety or Key characteristic. ISO TS Section II should define the type of symbol required. ISO TS requires that all special characteristics are addressed during the FMEA stage. Robere & Associates (Thailand) Ltd. 29
  30. 30. Process Failure Mode and EffectsAnalysis – How to complete a Process FMEA 14. Potential Cause(s)/Mechanism(s) of Failure • 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 Robere & Associates (Thailand) Ltd. 30
  31. 31. Process Failure Mode and EffectsAnalysis – How to complete a Process FMEA 15. Occurrence – Enter the Occurrence as per Appendix 2. The Occurrence is defined is the probability or the likelihood that the specific cause or mechanism will occur. This may be based on previous field history, similar products and experience Robere & Associates (Thailand) Ltd. 31
  32. 32. Process Failure Mode and EffectsAnalysis – How to complete a Process FMEA 16. Current Process Controls • Enter the current Process verification/validation activities that will assure the adequacy of the Process • Typical examples may be, SPC, gauging error proofing etc... Robere & Associates (Thailand) Ltd. 32
  33. 33. Process Failure Mode and EffectsAnalysis – How to complete a Process FMEA 17. Detection • Enter the detection probability as per Appendix 3. Detection is defined as the ability of the proposed Process controls to detect any Process weakness or potential failure. Robere & Associates (Thailand) Ltd. 33
  34. 34. Process Failure Mode and EffectsAnalysis – How to complete a Process FMEA 18. Risk Priority Number (RPN) • The Risk Priority Number is defined as the Severity multiplied by the Occurrence multiplied by the Detection. The RPN is a measure of the Process risk. The RPN will be between 1 and 1000. It is the responsibility of the group to define what a high RPN is and take the appropriate actions. Robere & Associates (Thailand) Ltd. 34
  35. 35. Process Failure Mode and EffectsAnalysis – How to complete a Process FMEA 19. Recommended Action(s) • When high RPN’s are established corrective action should be incorporated with a focus on reducing the Process risk Robere & Associates (Thailand) Ltd. 35
  36. 36. Process Failure Mode and EffectsAnalysis – How to complete a Process FMEA 20. Responsibility • Enter the name of the person(s) or organisation who has the responsibility for implementing the corrective action(s). This should also include a target date for completion. Robere & Associates (Thailand) Ltd. 36
  37. 37. Process Failure Mode and EffectsAnalysis – How to complete a Process FMEA 21. Actions taken • Enter the effectiveness and the results of the actions taken Robere & Associates (Thailand) Ltd. 37
  38. 38. Process Failure Mode and EffectsAnalysis – How to complete a Process FMEA 22. Severity • Re-enter the severity rating as described in Appendix 1. The severity is an assessment of the seriousness of the problem. Robere & Associates (Thailand) Ltd. 38
  39. 39. Process Failure Mode and EffectsAnalysis – How to complete a Process FMEA 23. Occurrence • Re-enter the Occurrence as per Appendix 2. The Occurrence is defined as the probability or the likelihood that the specific cause or mechanism of failure will occur. This may be based on previous field history, similar products and/or experience. Robere & Associates (Thailand) Ltd. 39
  40. 40. Process Failure Mode and EffectsAnalysis – How to complete a Process FMEA 24. Detection • Re-enter the Detection probability as per Appendix 3. Detection is defined as the ability of the proposed Process controls to detect any Process weakness or potential failure. Robere & Associates (Thailand) Ltd. 40
  41. 41. Process Failure Mode and EffectsAnalysis – How to complete a Process FMEA 25. Resulting RPN • Based on the corrective action, calculate the RPN and record this result. If further action is required repeat the corrective action steps in order to reduce the RPN. Robere & Associates (Thailand) Ltd. 41
  42. 42. Appendix 1 Severity rating for Process FMEA Eff ect Cu st o m er Ef fect Ma nu fa ct u r ing/ Asse m bly Effect Ra nk in g Hazardous- Very high severity ranking when a pot ential Or may endanger machine or assembly 10 without failure mode aff ects saf e vehicle operat ion operator, without warning. warning and/or involves nonconpliance wit h government regulat ion without warning. Hazardous Very high severity ranking when a pot ential Or may endanger machine or assembly 9 with failure mode aff ects saf e vehicle operat ion operator, with warning warning and/or involves nonconpliance wit h government regulat ion without warning Very High Vehicle/ item is inoperable, loss of primary Or 100% of product may have t o be 8 function scrapped, or vehicle/it em repaired in repair dept wit h a repair time greater then 1 hr High Vehicle/ item is operable, but at a reduced Or product may have to be sorted and a 7 level of perf ormance. Customer very port ion (less than 100% ) scrapped, oer dissatisf ied. vehicle/item repaired in the repair department with a repair t ime between a half hour t o one hour. Moderate Vehicle/ item is operable, but Or a portion (less than 100% ) of the 6 comfort /convenience items inoperbale. product may have to be scrapped with no Customer dissat isfied sort ing, or vehicle/it em repaired in repair department with a repair t ime of less t hen 1 hour Low Vehicle/ item is operable, but Or 100% of product may have t o be 5 comfort /convenience items operbale at a reworked, or vehicle it em repaired off line reduced level of performance but does not fo to repair dept Very low Fit and f inish/squeak and rattle item does Or t he product may have to be sorted, 4 not conform. Defect not iced by most with no scrap, and a portion(less then customers (greater then 75% ) 100% ) scrapped. Minor Fit and f inish/squeak and rattle item does Or a portion (less then 100% ) of the 3 not conform. Defect not iced by 50% product may have to be reworked with no customers. scrap, on line but out of station. Very Minor Fit and f inish/squeak and rattle item does Or a portion (less then 100% ) of the 2 not conform. Defect not iced product may have to be reworked with no bydiscriminating customers (less then 25% ) scrap, on line but in stat ion. None No discernable eff ect. Or slight inconvenience to operation or 1 Robere & Associates (Thailand) Ltd. 42 operator, or no effect
  43. 43. Appendix 2Occurrence rating for Process FMEAProbability of failure Possible failure rates Ppk RankingVery High - Persistent failures ≥ 100 per thousand pieces < 0.55 10 50 per thousand pieces ≥ 0.55 9High - Frequent failures 20 per thousand pieces ≥ 0.78 8 10 per thousand pieces ≥ 0.86 7Moderate - Occasional Failures 5 per thousand pieces ≥ 0.94 6 2 per thousand pieces ≥ 1.00 5 1 per thousand pieces ≥ 1.10 4Low - Isolated failures associated with 0.5 per thousand pieces ≥ 1.20 3similar processesLow - Relatively few failures 0.1 per thousand pieces ≥ 1.30 2Remote - Failure is unlikely. ≤ 0.01 per thousand pieces ≥ 1.67 1 Robere & Associates (Thailand) Ltd. 43
  44. 44. Detection Criteria Inspection Suggested Range of Ranking Types Detection Methods Almostimpossible Absolute certainty of non- A B C X Cannot detect or is not checked 10 Appendix 3 detectionVery remote Controls will probably not X Control is achieved with indirect or random checks only 9 Detection Remote detect Controls have poor chance of X Control is achieved with visual inspection only 8 rating for Process detection Very Low Controls have X Control is achieved with double 7 poor chance of visual inspection only FMEA detection Low Controls may X X Control is achieved with SPC 6 detect charting methods Moderate Controls may X Control is based on variable 5 detect gauging after parts have left the station, or GO/NO GO gauging performed on 100% of the parts after the parts have left the station Inspection typesModerately Controls have a X X Error detection in subsequent 4 High good chance to operations, OR gauging detect performed on setup and first A = Error proofed piece check B = Gauging High Controls have a X X Error detection in station, or 3 good chance to detection in subsequent C = Manual Inspection detect operations by multiple layers of acceptance: supply, inspect, install and verify. Cannot accept discrepant part. Very High Controls X X Error detection in-station 2 almost certain (automatic gauging with to detect automatic stop feature). Cannot pass discrepant part. Very High Controls X Discrepant parts cannot be made 1 certain to because item has been error- detect proofed by process/product Robere & Associates (Thailand) Ltd. design 44
  45. 45. Auditing PFMEA’s1. Is the PFMEA conducted by a cross functional team?2. Has the Key date been defined3. Is it consistent with the customer’s PPAP date?4. Does the organisation consider all of the elements within the process flow chart?5. Has the organisation defined what constitutes a high RPN6. Does the organisation follow the definition of a high RPN Robere & Associates (Thailand) Ltd. 45
  46. 46. Auditing PFMEA’s7. Are recommended actions completed prior to the Key date8. Do the sequence of dates make sense?9. How are revisions recorded?10. Does the organisation ensure the PFMEA is a living document?11. Verify the occurrence rankings are based on objective evidence12. Ensure the organisation is using the correct rankings for Severity, Occurrence and Detection Robere & Associates (Thailand) Ltd. 46

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