1. Is your FMEA performing for you? Measuring FMEA Effectiveness Kathleen Stillings – CPM, CQE, CQA, MBB Quality is not an act – it is a habit (Aristotle)

2. 2 5/23/2011 Kathleen Stillings Today’s Goals Introduction and Review Understand why we want to assess the process Cover the typical gaps in the FMEA process Review maintaining the FMEA Discuss the reason why the RPN alone is not an effective measure of the process Introduce a published practical FMEA assessment tool

3. 3 5/23/2011 Kathleen Stillings What does the FMEA do for us? Reduces the likelihood of Customer complaints Reduces maintenance and warranty costs Reduces the possibility of safety failures Reduces the possibility of extended life or reliability failures Reduces the likelihood of product liability claims

4. 4 5/23/2011 Kathleen Stillings Why Assess the Effectiveness of your FMEA process? Stay Competitive! Reassure Management the investment really does pay off!

5. 5 5/23/2011 Kathleen Stillings The process can be time consuming – that is why we ask if YOU are working for the process when you prefer the process work for you. Are you getting the expected benefits for all your hard work? What work goes into the FMEA?

6. 6 5/23/2011 Kathleen Stillings One Critical Factor of Your Risk Assessment System AN EFFECTIVE FMEA PROCESS HAS THE FOLLOWING COMPONENTS  Implementation of a Good System  Maintaining that System  Assessing Your System’s Effectiveness IMA – I’m a Fool If I Don’t

7. 7 5/23/2011 Kathleen Stillings FMEA Success Factors Align your success factors Quality starts and ends with training (Kaoru Ishikawa) Does your Management team support the process? Do you have adequate resources? Does your team understand the basics of the FMEA process?

8. 8 5/23/2011 Kathleen Stillings Close the Gaps in the System Gap 1 – stated previously – ineffective evaluation of RPN leading to wasted time and effort Gap 2 - lack of process improvements not effectively implemented because of ignorance of assessing the critical factors with high risks Gap 3 – failure to address ALL high risk failure modes: High Severity, High Criticality, RPN with a value under the “threshold” assigned by the process that could lower Customer satisfaction (internal and external Customers)

9. 9 5/23/2011 Kathleen Stillings Close the Gaps in the System Gap 4 – neglect to include systemic interfaces as part of the FMEA Gap 5 – the dangerous “we don’t know what we don’t know” – not addressing the unknown because we are only as good as the team working on the FMEA – we may not effectively choose the correct resources within the organization to be part of the FMEA team Gap 6 – not including critical voices in the process – Customer, Operator, Quality, Testing or Analysis

10. 10 5/23/2011 Kathleen Stillings Close the Gaps in the System Gap 7 – not implementing effective quality tools to perform the FMEA assessment with in the team environment. Gap 8 – missing links to internal and external quality data Gap 9 – failure to identify critical characteristics Gap 10 – failure to effectively train people on the basics of completing a FMEA process

11. 11 5/23/2011 Kathleen Stillings Close the Gaps in the System Gap 11 – lack of resources assigned to the process – time, people, research, and follow-up Gap 12 – not linking Mistake Proofing with failure modes. Gap 13 – assuming Detection controls are better than they really are or are implemented when they are not. Gap 14 – neglecting to capture all the details Gap 15 – Failure to maintain the system

12. 12 5/23/2011 Kathleen Stillings Maintaining the System We often overlook variables that could have an impact on product, process, and quality. o Typical FMEA Process: Planning stage, Performing FMEA stage, review stage, implementation stage. The process is missing the Maintenance stage. o The FMEA must be mapped, analyzed, and controlled

13. 13 5/23/2011 Kathleen Stillings

14. 14 5/23/2011 Kathleen Stillings Maintenance of the System  Ensure you update process flow charts, control plans, and FMEA data with the following:  Data – internal and external  Changes – systemic, process, product  Audit Results

15. 15 5/23/2011 Kathleen Stillings Assess the System’s Effectiveness  The fundamental value enhancing applications of FMEA are process management and process improvement  One measure of process improvement is the reduction in RPN (Risk Priority Number) FMEA is Process Improvement Process Improvement is the reduction in failures A reduction in failures is a reduction in RPN

16. 16 5/23/2011 Kathleen Stillings Just Say No Why is the RPN not and effective measure of the FMEA System? o We should assess Severity, Severity x Occurrence = Criticality, and Risk = Severity x Occurrence x Detection = RPN separately. o There is not weighting factor used to evaluate the risk S=10 (Hazardous without warning), O=10 (Occurs 10% of the time), D=1 (certain to detect) RPN = 100 S=1 (No effect), O=10 (Occurs 10% of the time), D=10 (not detectable) RPN = 100

17. 17 5/23/2011 Kathleen Stillings Just Say No S=10 (Hazardous without warning), O=10 (Occurs 10% of the time), D=1 (certain to detect) RPN = 100 S=1 (No effect), O=10 (Occurs 10% of the time), D=10 (not detectable) RPN = 100 S=10 (Hazardous without warning), O=10 (Occurs 10% of the time), D=1 (certain to detect) Criticality = 100 S=1 (No effect), O=10 (Occurs 10% of the time), D=10 (not detectable) Criticality = 10

18. 18 5/23/2011 Kathleen Stillings How are you looking at your FMEA effectiveness? Use the process control capability index Compare performance to a target. How well is the process performing to expectations  Use Internal Nonconformance metrics  Use Warranty / Field Failure Metrics

19. 19 5/23/2011 Kathleen Stillings Measure FMEA Effectiveness Use Internal nonconformance data o Internal Nonconformances could impact the occurrence and/or detection ratings S = 1 (no effect), O = 10 (high occurrence rate), D = 1 (always likely to detect) = RPN = 10 S = 1 (no effect), O = 10 (high occurrence rate), D = 8 (difficult to detect) = RPN = 80 How do we do this?  Simply be reviewing the identified failure modes listed in the FMEA as compared to the failure mode identified on the NCR

20. 20 5/23/2011 Kathleen Stillings How does one use warranty / field failure data to assess FMEA effectiveness  Warranty / Field failures impact the Customer’s perception.  The same basic principles apply as with internal NCR methodology  Look at the number of warranty / field failures failure modes reported versus the number of FMEA identified failure modes  Management team should establish a goal for this KPI – the metric would report against that goal Number if identified failure modes for the product / number of warranty failure modes = capability Measure FMEA Effectiveness

21. 21 5/23/2011 Kathleen Stillings 18 Internal NCR issued – analysis shows 5 identified failure modes were not listed on the FMEA. The FMEA had 12 failure modes identified. 5/12 = 0.42 40 missed warranty failure modes of 46 identified FMEA failure modes. 40/46=87% Measure FMEA Effectiveness

22. 22 5/23/2011 Kathleen Stillings Actions Speak louder than Words  Don’t forget the most important function of the FMEA. Actions that are identified and taken are more important than a metric

23. 23 5/23/2011 Kathleen Stillings References 1. Steve Pollock, Create a Simple Framework to Validate FMEA Performance, Six Sigma Forum Magazine, August 2005. 2. http://www.qualitytrainingportal.com/resources/fmea/fmea_pitfalls. htm 3. http://www.reliasoft.com/rnewsletter/v6i2/fmea/factors.htm 4. http://www.reliasoft.com/rnewsletter/v6i1/fmea/factors.htm 5. http://elsmar.com/forums/showthread.php?t=25760&page=2