FMEA

1. FMEA Potential Failure Mode and Effects Analysis Design and Process FMEA

2. Reference Material • Potential Failure Mode and Effect Analysis Reference-Manual (Third Edition, Juli 2001) • VDA 4.2 (1996) • APQP & CP Reference Manual (1994) • APQP Status Reporting Process (Ford, Checklist) • PPAP Third Edition (09 1999)

3. FMEA Definition (QS-9000) A systemized sequence of activities intended to: 1. recognize and evaluate the potential failure of a product/ process and its effects. 2. identify actions which could eliminate or reduce the chance of the potential failure occuring, and 3. document the process.

4. Types of FMEAs(DaimlerChrysler/ QZ 5/2002) • Hybrid FMEA • Product and Process or Process and Product • integrate compatible data during Design- and Process planning phase • assure systematic feedback between both planning phases • achieve better elimination of failures using design approach

5. Types of FMEAsPPAP: Third Edition Sept. 1999 • FMEA for Bulk Material • Design and Process FMEA • note: special ratings (S,O,D) • significant impact of bulk product characteristic and final product attributes • products: paint, oil, plastics...

6. Types of FMEAsFord Motor Company (03.2001) • Machinery FMEA • Evaluation criteria (selection) • affects operator, plant or maintenance personnel • non-compliance with government regulation • downtime • defective parts • process parameter variability • MTBF: Mean Time between Failure

7. Types of FMEAsFord Motor Company (03.2001) • Environment FMEA • Evaluation criteria (selection) • non-compliance with customer standards • non-compliance with legal regulations • fuel economy and recycling • vehicle interior air quality • allergenic materials • light weight material (energy consumption)

8. Types of FMEAsFord Motor Company (APQP) • Logistik-FMEA • Evaluation criteria (selection) • non-compliance with legal regulations • long lead time and transportation routes • loading and unloading of dangerous goods • packaging

9. Types of FMEAsConcept FMEA Definition (Ford): • Concept FMEAs analyze systems and subsystems and their interrelationships during early phases of the development process • potential failure modes are evaluated in correlation with planned functions and design intentions

10. Evaluation Criteria for Design FMEA Failure Rate (VDA) Failure Rate(Ford/ AIAG) Likelyhood (VDA) Severity (S) Occurrence (O) Detection (D) Factor Very high severity ranking when a potential failure mode affects safe vehicle operation and/ or involves non-compliance with government regulation without warning. Very high:Persistent failures 500.000 ppm ³ 100 per 1.000 100.000 ppm AbsoluteUncertainty 90% 10 Very high severity ranking when a potential failure mode affects safe vehicle operation and/ or involves non-compliance with government regulation with warning. 100.000 ppm 50 per 1.000 50.000 ppm Very remote 90% 9 Very high, vehicle/ item is inoperable (loss of primaryfunction). High:Frequent failures 50.000 ppm 20 per 1.000 20.000 ppm Remote 98% 8 High, vehicle/ item is operable but at reduced level of performance. Customer is very dissatisfied. 10.000 ppm 10 per 1.000 10.000 ppm Very Low 98% 7 Moderate, vehicle/ item is operable, but Comfort/ Convenience item(s) are inoperable. Customer is dissatisfied. Moderate:Occasional failures 5.000 ppm 5 per 1.000 5.000 ppm Low 99,7% 6 Low, vehicle/ item is operable, but Comfort/ Convenience item(s) are operable at a reduced level of performance. Customer is somewhat dissatisfied. Moderate 2 per 1.000 2.000 ppm 1.000 ppm 99,7% 5 Very low, Fit & Finish/ Squeak & Rattle item does not conform. Defect is noticed by most customers (greater than 75%). 500 ppm Moderately High 99,7% 4 1 per 1.000 1.000 ppm Minor, Fit & Finish/ Squeak & Rattle item does not conform. Defect is noticed by 50% of customers. Low:Relatively few failures 100 ppm 0,5 per 1.000 500 ppm High 99,9% 3 Very minor, Fit & Finish/ Squeak & Rattle item does not conform. Defect is noticed by discriminating customers (less than 25%). 50 ppm 0,1 per 1.000 100 ppm Very High 99,9% 2 None, no discernible effect. Remote: Failure unlikely 1 ppm Almost Certain 99,99% 1 £ 10 ppm HNUHN_QMS

11. Evaluation Criteria for Prozeß FMEA Handout Detection (D) Failure Rate (VDA) Failure Rate (Ford/ AIAG) Likelyhood (VDA) Severity (S), final customer Occurence (O) Cpk Factor Very high severity ranking when a potential failure mode affects safe vehicle operation and/ or involves non-compliance with government regulation without warning. Very high:Persistent failures 100.000 ppm ³ 100 von 1.000 100.000 ppm < 0,33 Almost impossible 90% 10 Very high severity ranking when a potential failure mode affects safe vehicle operation and/ or involves non-compliance with government regulation with warning. 50.000 ppm 50 von 1.000 50.000 ppm ³ 0,33 Very remote 90% 9 Very high, vehicle/ item is inoperable (loss of primaryfunction). High:Frequent failures 20.000 ppm 20 von 1.000 20.000 ppm ³ 0,51 Remote 98% 8 High, vehicle/ item is operable but at reduced level of performance. Customer is very dissatisfied. 10.000 ppm 10 von 1.000 10.000 ppm ³ 0,67 Very low 98% 7 Moderate, vehicle/ item is operable, but Comfort/ Convenience item(s) are inoperable. Customer is dissatisfied. Moderate:Occasional failures 5.000 ppm 5 von 1.000 5.000 ppm ³ 0,83 Low 99,7% 6 Low, vehicle/ item is operable, but Comfort/ Convenience item(s) are operable at a reduced level of performance. Moderate 2 von 1.000 2.000 ppm 2.000 ppm ³ 1,00 99,7% 5 Very low, Fit & Finish/ Squeak & Rattle item does not conform. Defect is noticed by most customers (greater than 75%). 1.000 ppm 99,7% 4 1 von 1.000 1.000 ppm ³ 1,17 Modeartely high Minor, Fit & Finish/ Squeak & Rattle item does not conform. Defect is noticed by 50% of customers. Low:Relatively few failures 100 ppm 0,5 von 1.000 500 ppm ³ 1,33 High 99,9% 3 Very minor, Fit & Finish/ Squeak & Rattle item does not conform. Defect is noticed by discriminating customers (less than 25%). 50 ppm 0,1 von 1.000 100 ppm ³ 1,50 Very high 99,9% 2 £ 10 ppm None, no discernible effect. Remote: Failure unlikely 1 ppm ³ 1,67 Almost certain 99,99% 1 HNUHN_QMS

12. Evaluation Criteria for Prozeß FMEA Handout Detection (D) Inspection Types Failure Rate (Ford/ AIAG) Severity (S), Manufacturing/ Assy Occurence (O) Cpk Factor Error-prfd. Gauging Man.-Insp. Very high severity ranking when a potential failure mode may endanger operator (machine or assembly)without warning. Very high:Persistent failures ³ 100 von 1.000 100.000 ppm < 0,33 Almost impossible can/ is not checked 10 Very high severity ranking when a potential failure mode may endanger operator (machine or assembly)with warning. 50 von 1.000 50.000 ppm ³ 0,33 Very remote indirect or random checks 9 Very high, 100% of product may have to be scrapped, or vehicle/ item repaired in repair department with a repair time > 1 hour. High:Frequent failures 20 von 1.000 20.000 ppm ³ 0,51 Remote 8 visual inspection High, product may have to be sorted and portion < 100% scrapped, or vehicle/ item repaired in repair department witha repair time greater 30 min and less than 1 hour. 10 von 1.000 10.000 ppm ³ 0,67 Very low double visual inspection 7 Moderate, a portion (less than 100% )of product may have to be scrapped with no sorting, or vehicle/ item repaired in repair department with a repair time less than 30 min. Moderate:Occasional failures 5 von 1.000 5.000 ppm ³ 0,83 Low 6 charting (SPC) charting (SPC) Low, 100% of product may have to be reworked, or vehicle/ item repaired off-line but does not go to repair department. Moderate 2 von 1.000 2.000 ppm ³ 1,00 100% Go/ No go gauging 5 detection in subse- quent stat. set-up or first-piece check Very low, product may have to be sorted, with no scrap, and a portion (less than 100%) reworked. 4 1 von 1.000 1.000 ppm ³ 1,17 Modeartely high Minor, a portion (less than 100%) of product may have to be reworked, with no scrap, on-line but out-of-station. Low:Relatively few failures 0,5 von 1.000 500 ppm ³ 1,33 High detection in station multiple select install verify 3 autom. gauging, stop feature cannot pass discrepant part Very minor, a portion (less than 100%) of product may have to be reworked, with no scrap, on-line but in-station. 0,1 von 1.000 100 ppm ³ 1,50 Very high 2 error-prfd design £ 10 ppm No effect, or slight inconvenience to operation or operator. Remote: Failure unlikely ³ 1,67 Almost certain 1 HNUHN_QMS

13. Evaluation Criteria for Prozeß FMEA Detection (D) Occ. (O) (PPM) Severity (S), Manufacturing/ Assy Severity (S), final customer F Error-prfd. Gauging Man.-Insp. Very high severity ranking when a potential failure mode may endanger operator (machine or assembly)without warning. Very high severity ranking when a potential failure mode affects safe vehicle operation and/ or involves non-compliance with government regulation without warning. 100.000 can/ is not checked 10 Very high severity ranking when a potential failure mode may endanger operator (machine or assembly)with warning. Very high severity ranking when a potential failure mode affects safe vehicle operation and/ or involves non-compliance with government regulation with warning. 50.000 indirect or random checks 9 Very high, 100% of product may have to be scrapped, or vehicle/ item repaired in repair department with a repair time > 1 hour. Very high, vehicle/ item is inoperable (loss of primaryfunction). 20.000 8 visual inspection High, product may have to be sorted and portion < 100% scrapped, or vehicle/ item repaired in repair department witha repair time greater 30 min and less than 1 hour. High, vehicle/ item is operable but at reduced level of performance. Customer is very dissatisfied. 10.000 double visual inspection 7 Moderate, a portion (less than 100% )of product may have to be scrapped with no sorting, or vehicle/ item repaired in repair department with a repair time less than 30 min. Moderate, vehicle/ item is operable, but Comfort/ Convenience item(s) are inoperable. Customer is dissatisfied. 5.000 6 charting (SPC) charting (SPC) Low, 100% of product may have to be reworked, or vehicle/ item repaired off-line but does not go to repair department. Low, vehicle/ item is operable, but Comfort/ Convenience item(s) are operable at a reduced level of performance. 2.000 100% Go/ No go gauging 5 Very low, product may have to be sorted, with no scrap, and a portion (less than 100%) reworked. detection in subse- quent stat. set-up or first-piece check Very low, Fit & Finish/ Squeak & Rattle item does not conform. Defect is noticed by most customers (greater than 75%). 4 1.000 Minor, a portion (less than 100%) of product may have to be reworked, with no scrap, on-line but out-of-station. Minor, Fit & Finish/ Squeak & Rattle item does not conform. Defect is noticed by 50% of customers. 500 detection in station multiple select install verify 3 Very minor, a portion (less than 100%) of product may have to be reworked, with no scrap, on-line but in-station. autom. gauging, stop feature cannot pass discrepant part Very minor, Fit & Finish/ Squeak & Rattle item does not conform. Defect is noticed by discriminating customers (less than 25%). 100 2 error-prfd design £ 10 No effect, or slight inconvenience to operation or operator. None, no discernible effect. 1 HNUHN_QMS

14. Special CharacteristicsD FMEA Classi- fication Memo Rating Control YC potential CC in P FMEA S: 9 or 10 n.a. YS potential SC in P FMEA S: 5 - 8 O: 4 - 10 n.a. none CC or SC S: < 5 n.a.

15. Special CharacteristicsP FMEA Classi-fication Memo Rating Control CC critical characteristic S: 9 or 10 Control Plan SC significant characteristic S: 5 - 8; O: 4 - 10 Control Plan HI high impact (capable processes) S: 5 - 8; O: 4 - 10 specialcare

16. Special CharacteristicsP FMEA Classi-fication Memo Rating Control OS operator safety S: 9 or 10 approval by Safety Engineer none not CC or SC HI or OS other n.a.

17. Special Characteristics • Note: • special characteristics are confirmed after completion of D FMEA and P FMEA • include in Design Review with customer(QS-9000, ISO TS 16 949, VDA 6.1, ....) • Control Plan and FMEAs must be signed(Ford: CC, for all Control Item Parts (Ñ))

18. Design FMEA Definition (VDA 4.2): • a Design FMEA (System FMEA Product) evaluates potential failure modes in terms of a potential malfunction of product or systems • potential failure mode is defined as the manner in which a component, subsystem, or system fails to meet design intent

19. Process FMEA Definition (VDA 4.2): • A Process FMEA (System FMEA Process) evaluates potential failure modes of a product in terms of a potential malfunction of processes (production or assembly, logistics).

20. FMEA “Overview” Concept FMEA: • defines functions of design (intent) Design FMEA: • evaluates a product before release to production Process FMEA: • “completed“ before process steps are defined and special characteristics are listed in the Control Plan

21. FMEA “Up-Dates” compare PPAP (examples) • new laws and regulations • engineering change or new and additional field of product usage • new or changed processes • new location for production of product • as part of 8D Problem Solving (escape point) • customer complaints and nonconformities

22. Related APQP Elements • Design Review • Design Verfication Plan • Prototype Build Control Plan • Manufacturing Process Flow Chart • Pre-Launch Control Plan • Production Control Plan • Operator Process Instructions

23. Timing Prepare FMEAs before: • defining systems • prototype phase • selection of material and processes • development of packaging • deciding about logistics

24. Optimization • goal • robust design • capable processes • reduction of severity (C and D FMEA only!) • reduction of occurence rate (Ford: criticality = S x O) • defect prevention • reduction of RPN = S x O x D • mistake proofing, defect detection