Failure Mode and Effects Analysis (FMEA)

1. Failure Mode and Effects Analysis (FMEA) XONITEK Corporation

2. FMEA… XONITEK Corporation • A way to conduct a “reliability analysis” of a product or service • A systematic look for: • Function • Failure causes • Failure modes • Failure consequences

3. Types of FMEA activities… XONITEK Corporation • DFMEA – Design analysis of: • Components • Subsystems • Main systems • PFMEA – Process analysis of: • Equipment • Scheduling • Workstations • Gages • Procurement • Employee training • Tests

4. FMEA Core Criteria… XONITEK Corporation • Relies on valid data on either the output or process for assessments to be valid • Documented procedures that can be validated as part of the process help identify the source of variability… • Random approaches to a process by employees can inject variability and create the different outcomes. • Most effective when operating within the framework of a sound quality system

5. FMEA Benefits… XONITEK Corporation Improved Service Quality and Robustness… Reduced Customer Service Costs… Reduced Delivery Problems… Improved Service Implementation… Improved Safety…

6. Creating the FMEA Team… XONITEK Corporation • Keep the team small so contribution and focus are most important in the ultimate success of the project. • Both the “process experts” and those “unfamiliar” with the process will drive insight. • Don’t forget to “walk the walk” when possible to get first hand knowledge for each member of the team.

7. FMEA Reference Form… Sample FMEA form… XONITEK Corporation

8. FMEA Header Data… XONITEK Corporation • FMEA Title – Name of the System, Subsystem, Component or Process… • FMEA Type – Circle or otherwise highlight if this is a Design or Process project. • Project Leader – Person responsible for the FMEA overall… • Prepared By – Individual maintaining updates on the project. • Project Description – Concise and easy to understand description of the function… • Include any additional technical parameters to help define the failure modes…

9. FMEA Header Data… XONITEK Corporation • Dates: • Original Date – the date the FMEA was created. • Revised Date – this is the date the input from various persons was added to the file. • Key Date – the targeted completion date of the project. • Core Team – Members of the team responsible for the development of the FMEA and various aspects of its completion.

10. Current State Section… XONITEK Corporation • Item or Function – Identifies the various parts, processes or subsystems that may fail. • Use Brainstorming to begin to identify these elements of the FMEA. • Man, materials, design, process, environment. • Fishbone Diagrams may be useful to “get to” the root causes. • Potential Failure Mode – Describes how the process or design may fail to perform with regard to design or process parameters… • Can be a list of separate failure modes for the same functions • May reference the upper or lower assembly impacts… • Potential Effects Mode – Describes the impact of the failure with regards to the customer (internal or external)… • “If – Then” consequential statements. • Classification – Optional information, used when Govt. Regs., Safety Considerations or Engr. Specs exist for the product or process… • Use a key for this field and add to the FMEA form to clarify symbols.

11. Severity Rating Scale.. • Severity Rating – Scale of 1 to 10 created by the team… with 10 as the most severe. XONITEK Corporation

12. Current State Section… XONITEK Corporation • Potential Causes of Failure – Descriptive and comprehensive list of all “root” causes of failure… • Reference “Fishbone” diagram as one of the tools to find this cause… • Each “potential failure mode” may have more than one cause of failure. • OccurrenceRating – An estimate of the frequency of the failure… derived from a team created table… • Occurrence ranking shown on next slide…

13. Occurrence Rating Scale… XONITEK Corporation

14. Current State Section… XONITEK Corporation • Current Controls Prevention – Identify the methods and testing parameters that exist to find this failure... • Current ControlsDetection – Defines the manner that the defect is identified… • Preference is detection by use of SPC or other testing methods. • Discovery by failure is NOT preferred… • DetectionRating – User defined table with assigned probabilities and associated rankings… • Ranking table guide in next slide…

15. Detection Ranking… XONITEK Corporation

16. Current State Section… XONITEK Corporation • Risk Priority Number(RPN) – A value to rank the concerns calculated from the multiplication of the other rankings … • RPN = Severity x Occurrence x Detection (the product of these three values) • Use this value to prioritize the actions and resources of the organization. • Do not overstep your resource capabilities… set a threshold of items for action and focus on those items first. • Items with lower numbers but still have high severity must be addressed… • Recommended Actions – Actions taken to lower the RPN… includes Cause and Effect diagrams, control charts or other actions necessary to reduce the risk tied to the RPN…

17. Actions to RPN… XONITEK Corporation • Develop a strategy of what items to address in what order… • Look for “synergy” of activities, where multiple problems may overlap. • If you can’t eliminate the issue find ways to make it easily detectable when it occurs. • Reduction of “severity” or “occurrence” is preferred over making the failure more detectable. • Document all process or design changes and their impacts as part of the report out methodology. • Recalculate the RPN as improvements are made to re-establish priorities.

18. Details of filling out the FMEA… XONITEK Corporation Person Responsible and Due Date – Enter the name of the person who has the lead action and target date of completion… Actions Taken – Describe the action and implementation date… Severity/Occurrence/Detection – The revised values based on actions taken… RPN – Revised RPN recalculated (multiply the three values: Severity, Detection and Occurrence) from the values above…

19. Sample Completed FMEA… XONITEK Corporation

20. FMEA – Interactive Example XONITEK Corporation