Is your FMEA performing for you?

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. 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. 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. Why Assess the Effectiveness of your FMEA process? • Stay Competitive! • Reassure Management the investment really does pay off!

5. What work goes into the FMEA? • 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?

6. 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. 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. 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. 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. 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. 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. Maintaining the System • We often overlook variables that could have an impact on product, process, and quality. • Typical FMEA Process: Planning stage, Performing FMEA stage, review stage, implementation stage. The process is missing the Maintenance stage. • The FMEA must be mapped, analyzed, and controlled

14. 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. 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. Just Say No • Why is the RPN not and effective measure of the FMEA System? • We should assess Severity, Severity x Occurrence = Criticality, and Risk = Severity x Occurrence x Detection = RPN separately. • 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. 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. 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. Measure FMEA Effectiveness • Use Internal nonconformance data • 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. Measure FMEA Effectiveness • 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

21. Measure FMEA Effectiveness • 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%

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