1. Does Anyone Remember Lawn Darts?

2. Yet Another Picture of Lawn Darts

3. If a Design FMEA had Been Performed…. If a Design FMEA had been performed on Lawn Darts, David Snow’s Seven Year old Daughter would be alive today.

4. Why We Do an FMEA *Prioritizes possible catastrophic failure *Corrects major defects before product reaches the customer

5. Two Types of Failure Mode Effect Analysis *Design *Process

6. Design FMEA  Takes technical/physical limits of a manufacturing/assembly into consideration  Some examples of Design FMEA Tasks  1. Necessary mold drafts  2. Limited surface finish  3. Assembling space/access for tooling  4. Limited Harden ability of Steels  5. Tolerance/process capability/performance

7. Who Creates the Design FMEA *The Design Responsible Engineer *Quality Function Deployment Manager

8. Process Failure Mode Effect Analysis *Identifies the process functions and requirements *Identifies potential product and process related failure modes *Identifies the potential manufacturing or assembly process causes and identifies process variable on which to focus controls for occurrence reduction or detection of the failure conditions *Identifies process variables on which to focus process controls

9. PFMEA Continued *Develops a ranked list of potential failure modes, thus establishing a priority system for preventive/corrective actions considerations *Documents the results of the manufacturing or assembly process

10. Make-up of Team Performing Process Failure Mode Effect Analysis *Design Engineer *Assembly Engineer *Manufacturing Engineer *Quality, Service, and Supply Personnel *Area responsible for the Next Assembly *End User

11. Development of a PFMEA Box 9: Process Function Requirements- *Simple Description of the Process or Operation being Analyzed *Keeping in mind the environment, materials, applicable performance records, and information about design metrics

12. Potential Failure Mode: Box 10 This is how the process fails to meet process requirements-and/or design intent described in the requirement column List Each Failure Mode Associated with the Particular Item and Function Typical Failure Modes: 1. Cracked 2. Loosened

13. Potential Failure Modes Continued 3. Sticking 4. Fractured 5. Slips or does not hold torque 6. Inadequate support 7. Disengages to fast 8. Intermittent signal 9. Deformed/Leaking/Oxidized

14. Potential Effects of Failure: Box 11 Potential Effects of failure are defined as effects of the failure mode on the function, as perceived by the Customer. Typical Failure Effects: 1. Noise 2. Erratic Operation 3. Effort 4. Scrap

15. Typical Failures Continued 5. Leaks 6. Rough 7. Inoperative 8. Unpleasant Odor 9. Operation Impaired 10. Vehicle Control Impaired 11. Customer Dissatisfaction

16. Severity: Box 12 Severity is the Rank Associated with the most serious effect for a given failure mode and is a Relative Ranking within the scope of the individual FMEA. Reduction of this ranking can only effected through the scope of a design change to the system 1-10 ranking system- one being no issue 10 being certain failure

17. Classification: Box 13 This Section is used to classify any special product or process characteristics such as critical, key, major, significant for subsystems or systems that may require additional process controls

18. Potential Cause(s)/Mechanisms of Failure: Box 14 Potential cause of failure is defined as how the failure could occur, described in terms of something that can be corrected or controlled For Example: 1. Improper torque-over,under 2. Improper weld- current, time, pressure 3. Inaccurate gauging

19. Potential Causes of Failure Continued 4. Improper heat treat-time, temperature 5. Inadequate gating/venting 6. Part missing or mis-located 7. Worn Locater 8. Worn tool 9. Improper machine set-up 10. Improper Programming

20. Occurrence: Box 15 Occurrence is the likelihood that a specific cause/mechanism of failure will occur. Again this scale has a relative scale to this Process FMEA Scale runs from one to ten-one is unlikely to fail-ten is for imminent death!

21. Current Process Controls: Box 16 Current Process Controls are descriptions of the controls that either prevent the failure mode or cause/mechanism of failure from occurring, or detect the failure mode should it occur Two Categories 1. Prevention 2. Detection

22. Current Process Controls: Two Categories Continued Prevention: Prevent the cause of failure or failure mode from occurring and or reduce their rate of occurrence Detection: Detect the cause of failure and lead to corrective actions

23. Detection: Box 17 Detection is the rank associated with the best detection control listed in the process control column. To achieve a lower ranking the planned process control has to be improved

24. Risk Priority Number: Box 18 Severity X Occurrence X Detection Within the scope of a Failure Mode Effect Analysis, dictates what has the most concern Number can be between 1 and 1000 The lower the number-the more ebullience!

25. Recommended Actions: Box 19 Look for the High or Severe Risk Priority numbers-(Numbers near 1000) Generally when your severity is a nine or ten, regardless of what the RPN is, special attention needs to be given to this category To Reduce the probably of occurrence, process and/or design revisions are required

26. Recommended Actions: Continued Only the a design and/or process revision can bring about the reduction in the severity ranking Preferred method in the reduction of the detection ranking is the use of error/mistake proofing methods

27. Responsibility for the Recommended Actions: Box 20 Entering who is responsible for the recommended action and the target date

28. Actions Taken: Box 21 After the action has been implemented, enter a brief description of the actual action and effective date.

29. Action Results: Box 22 After the Preventive/corrective action has been identified, estimate and record the resulting, severity, occurrence, and detection rankings If no action is taken, leave the related ranking columns blank

30. Follow Up Actions for TQM Process engineer needs to ensure: 1. Process/product requirements are achieved 2. Reviewing engineering drawing, process/product specifications, and process flow 3. Confirm the incorporation of changes in assembly, manufacturing, documentation 4. Review control plans and operation instructions