1. Failure Mode Effects Analysis Effects Analysis Risk Identification FMEA Risk Identification FMEA

2. Failure at 30,000 feet Jeff PrahstQuality Solutions2

3. Bottle Top Failure Jeff PrahstQuality Solutions3

4. Cause of Failure Jeff PrahstQuality Solutions4

5. Different Design Removes Risk Jeff PrahstQuality Solutions5

6. Happy Customer Jeff PrahstQuality Solutions6

7.  Risks of Failure in both Design and Process Identified risks for customers, the business, our personnel and the environment, etc.  Tool to help identify and prioritize risks  Types of FMEA: Design FMEA – DFMEA Process FMEA - PFMEA Implementation FMEAs (for starting new processes) Special PFMEA (used as a specific problem solving tool) FMEA Tool Identifies Risks Quality Solutions7

8. n What in the process can go wrong? –Potential Failure Modes n When failure happens what is the effect on the customer and how bad is ailure? – Effect and Severity n Why does it happen and how often? –Causes and Occurrence n How will failure be detected and corrected before it leaves the process? –Controls and Detection PFMEA - Critical Questions Jeff PrahstQuality Solutions8

9. Risk Identification Process Failure Mode and Effect Analysis Function: Process Step Failure Mode Effects Severity (1-10) Causes Occurrence (1-10) Controls Detectability (1-10) RPN =Risk Priority Number RPN = S x O x D = 1 to 1000 RPN =Risk Priority Number RPN = S x O x D = 1 to 1000 Quality Solutions9

10. PFMEA Form 10

11. Quality by Design DFMEA Design Failure Mode Design Failure Mode and Effects Analysis Jeff PrahstQuality Solutions11

12. Design - DFMEA Format Jeff PrahstQuality Solutions12

13. Benefits -Design FMEA n Aids in design to reduce risks. n Evaluates design requirements / alternatives. n Identifies how a product may fail to meet its intended function. n Examines potential consequences of failure. n Prioritizes corrective actions needed. Jeff PrahstQuality Solutions13

14. Information Source n Boundaries for Customer change notification n Identifies special characteristics for PFMEA n Ranks potential failure modes according to their effect on the custome n Prioritizes risks & improvement opportunities n Problem Solving Tool when analyzing customer product concerns Jeff PrahstQuality Solutions14

15. Team Requirement ? n Team Activity Team Leader / FacilitatorTeam Leader / Facilitator Design and Development EngineersDesign and Development Engineers Process EngineersProcess Engineers Manufacturing Supervisors and OperatorsManufacturing Supervisors and Operators n Others Participate as Needed Quality AssuranceQuality Assurance Quality EngineersQuality Engineers Customers of ProductCustomers of Product Suppliers of Raw Materials and EquipmentSuppliers of Raw Materials and Equipment Jeff PrahstQuality Solutions15

16. Function, Expectation, Failure 1. List Product Functions Appearance, Performance, Processability,...Appearance, Performance, Processability,... 2. List Customer Expectations Appearance – Looks Good; Clean; Shiny; No defects...Appearance – Looks Good; Clean; Shiny; No defects... Performance – Resistant to damage; Starts and runs...Performance – Resistant to damage; Starts and runs... Processability – Easy to use & Easy to make...Processability – Easy to use & Easy to make... 3. Translate into Failure Modes Looks Good – Not shiny; Dirty; Not at expectations...Looks Good – Not shiny; Dirty; Not at expectations... No Defects – Scratches; Dents; Broken parts...No Defects – Scratches; Dents; Broken parts... Starts Easy – Will not start; Hard to start...Starts Easy – Will not start; Hard to start... Jeff PrahstQuality Solutions16

17. Functions & Failure Modes Jeff PrahstQuality Solutions17

18. Effects or Consequences n Identify Effects as perceived by Customer. n What could be the result of failure mode? n Describe in terms of what the customer might experience or notice. –Customer Dissatisfaction –Warranty Costs and Production Line Rework n Consider “Customer” to also be “internal customers” as well as final or ultimate end users. Jeff PrahstQuality Solutions18

19. Severity Ratings Jeff PrahstQuality Solutions19

20. Design Matrix n Materials and Parts Select Materials, Parts and Quantity Levels Select Materials, Parts and Quantity Levels – Material - Failure under 47% to over 58% by Weight –Part - Failure under X % to over Z % n Material and Part Characteristics Establish Material and Part Specifications Identify significant properties which have a major impact on final product performance – Material: Failure under or over amounts used –Part : Failure to meet specification (under/over ) Jeff PrahstQuality Solutions20

21. Design Matrix n Product Characteristics Select tests and specifications which determine the ultimate performance of the product. –Time to Temp.: Failure under or over specification –Solids - Failure under 65% to over 73% by weight –Pressure Test: Failure @ 5 psi n Process Constraints Identify significant manufacturing constraints –Equipment Required: Stainless, special tools –Space and Line Requirements: Sq Footage; height Jeff PrahstQuality Solutions21

22. Design Matrix n Conditions for Use Identify significant constraints in the conditions involved when the Customer uses of the product. involved when the Customer uses of the product. –Film Build - Failure under 2.0 mils. –Bake Time @ 350°F - Failure under 20 minutes. –Bake Temperature @ 20 min. - Failure under 350°F. –Shelf Life - Failure after Six Month –Storage Temperature - Failure over 70°F. –Humidity - Failure over 60% relative humidity –Temperature (paint): Failure under 50°F to over 120°F Jeff PrahstQuality Solutions22

23. Design Matrix - Jeff PrahstQuality Solutions23

24. Occurrence Table Jeff PrahstQuality Solutions24

25. DFMEA Form Jeff PrahstQuality Solutions25

26. Design Controls n Identify Design Controls  Designed Experiments (DOE)  Customer Validation Tests, Trial Runs  Test Protocols, Test Methods  Subcontractor Third Party Testing  Engineering General Practice Ranges Jeff PrahstQuality Solutions26

27. Detection - Chance of Escape n How likely will design failures escape through our controls to customer? High likelihood = High numberHigh likelihood = High number Low likelihood = Low numberLow likelihood = Low number n Will current Design Controls detect and stop the causes of failure. Designed Experiments (DOE)Designed Experiments (DOE) MSA and Gage R&R resultsMSA and Gage R&R results Jeff PrahstQuality Solutions27

28. Design - Detection Table Jeff PrahstQuality Solutions28

29. Improvement Action Plan n Recommended Action(s) n Responsibility & Target Dates n Actions Taken n Resulting Risk Analysis SeveritySeverity OccurrenceOccurrence DetectionDetection RPNRPN Jeff PrahstQuality Solutions29

30. DFMEA Form Jeff PrahstQuality Solutions30

31. “Living Document” n Select Areas for Improvement. (high risk) Formulate plans for corrective actions.Formulate plans for corrective actions. Implement additional corrective actions.Implement additional corrective actions. Re-compute the risk assessment (RPN).Re-compute the risk assessment (RPN). n Up-Date and Maintain Update as new information is available.Update as new information is available. Record all changes made to Product or Process.Record all changes made to Product or Process. Revise as experience grows.Revise as experience grows. Jeff PrahstQuality Solutions31

32. Importance of Prioritization Jeff PrahstQuality Solutions32

33. Priority and Practicality Jeff PrahstQuality Solutions33

34. DFMEA – Cup of Coffee Jeff PrahstQuality Solutions34

35. DFMEA for Making Coffee Jeff PrahstQuality Solutions35

36. Functions & Failure Modes Jeff PrahstQuality Solutions36

37. Design Matrix - Jeff PrahstQuality Solutions37

38. DFMEA Form Jeff PrahstQuality Solutions38

39. Design FMEA Design FMEA Jeff PrahstQuality Solutions39