The document discusses Failure Mode and Effects Analysis (FMEA), a systematic method for evaluating potential failures in design, manufacturing, and production processes. It was originally developed in the 1940s for the military and is now commonly used in various industries. An FMEA involves analyzing how and how often a process might fail and classifying the failures by severity, occurrence, and detection. The analysis helps prioritize risks and identify actions needed to prevent failures.

1. FAILURE MODE AND EFFECTS ANALYSIS (FMEA)Non-commercial use only without written permission. Any unauthorized use is prohibited.Author – Jason R Bower

2. Knowledge BaseRisk AssessmentWHAT IS FMEA?IT’S CRITICAL!!!!!Quality ControlContinuous Improvement

3. WHAT IS FMEA?Analysis of potential failuresClassification of failures by severity of the effects, how often they occur and how easily can they be detected

4. Definition of controls to prevent failures

5. What do we need to do next?FMEA HISTORYOriginally developed in the 1940’s for the US military

6. Utilized in the Apollo space program to minimize failures of expensive prototypes

7. Ford formally brought it into the automotive industry in the 1970’s after the Pinto “thermal events”FMEA HISTORYNow adopted as part of APQP (Advanced Product Quality Planning)

8. Required elements of PPAP (Production Part Approval Process)

9. Design Element #4

10. Process Element #6

11. Integrated into QS-9000 & ISO/TS 16949BENEFITS OF FMEAReduces costs

12. Field failure

13. Scrap

14. Prioritizes risk

15. Engineering / manufacturing knowledge baseBENEFITS OF FMEAPrevents failures before they happen

16. Identifies critical aspects of designs and processes

17. Identifies controls needed

18. Identifies where to focus

19. Essential to Continuous Improvement

20. Essential to QualityTYPES OF FMEASDesign (DFMEA)

21. Process (PFMEA)

22. Other less common (Concept, System, Service, etc.)Customer RequirementsExperience / KnowledgeWHAT MAKES AN FMEA?Lessons LearnedPlan For Improvement

23. WHERE IT ALL FITS

24. PRODUCT CYCLECustomer RequirementsDesignProductionSatisfied Customer

25. PRODUCT CYCLECustomer RequirementsTHE BIG QUESTIONWhat is important and how are we ensuring it’s right?THE BIG ANSWERCritical Characteristics are output from DFMEA and input to PFMEADesignProductionSatisfied Customer

26. PRODUCT CYCLEDFMEAWhat do they need?

27. What’s critical?

28. What do we know?

29. What can go wrong?

30. What happens?Customer RequirementsDesignProductionSatisfied Customer

31. PRODUCT CYCLECustomer RequirementsDFMEAWhat have we learned?

32. How can we make it better?

33. How can we reduce cost?DesignProductionSatisfied Customer

34. PRODUCT CYCLECustomer RequirementsPFMEAWhat do they need?

35. What’s critical?

36. What do we know?

37. What can go wrong?

38. What happens?DesignProductionSatisfied Customer

39. PRODUCT CYCLECustomer RequirementsDesignProductionPFMEA & DFMEAWhat have we learned?

40. How can we make it better?

41. How can we reduce cost?Satisfied Customer

42. FMEA FORM

43. EXAMPLE FMEAIdentifies the individual functions of components / system / process

44. Drill down

45. Be specificEXAMPLE FMEAIdentifies the individual potential failure modes

46. Be specific

47. Avoid simple ‘anti-function’EXAMPLE FMEAIdentifies what happens if this failure occurs

48. Be specific

49. There can be several effects – list them allEXAMPLE FMEARates the potential effects of failure

50. Rating is 1–10 based on standard rules

51. Rating is based on the most severe effect but all should still be listedEXAMPLE FMEAIdentifies ‘Critical Characteristics’

52. Items critical to function

53. Items flagged here should show up in Control PlanEXAMPLE FMEAIdentifies potential causes

54. Be specific

55. Include outside influences as well as those related to design (DFMEA) / process (PFMEA)EXAMPLE FMEARates the possibility of occurrence

56. Rating is 1–10 based on standard rulesEXAMPLE FMEAIdentifies what controls are currently in place

57. Good place to reference design / process standards and best practices

58. Part of the knowledge baseEXAMPLE FMEARates the likelihood of detection of failure

59. Rating is 1–10 based on standard rulesEXAMPLE FMEARisk Priority Number

60. Severity * Occurrence * Detection

61. Ranks the potential failure modes

62. There are limitations to this numberEXAMPLE FMEAWhat can be done to reduce Severity, Occurrence and Detection ratings

63. Outline for Continuous ImprovementEXAMPLE FMEAReferences Recommended Action

64. Assigns ownership and timingEXAMPLE FMEAWhat was done to reduce Severity, Occurrence and Detection ratings

65. More knowledge base information

66. Continuous Improvement RecordEXAMPLE FMEARerating of Severity, Occurrence and Detection ‘Actions Taken’ have been completed

67. RPN is recalculatedEXAMPLE DFMEA