Failure Mode Effects Analysis Is your FMEA performing for you Measuring FMEA Effectiveness Kathleen

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Failure Mode Effects Analysis Is your FMEA performing for you Measuring FMEA Effectiveness Kathleen Powered By Docstoc
					                            Is your FMEA
                            performing for you?

                             Measuring FMEA

Kathleen Stillings – CPM, CQE, CQA, MBB
Quality is not an act – it is a habit (Aristotle)
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

5/23/2011 Kathleen Stillings                        2
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

5/23/2011 Kathleen Stillings                              3
Why Assess the Effectiveness of
your FMEA process?
 Stay Competitive!
 Reassure Management the investment
  really does pay off!

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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?

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One Critical Factor of Your Risk
Assessment System
       Implementation  of a Good System
       Maintaining that System
       Assessing Your System’s Effectiveness

    IMA – I’m a Fool If I Don’t

5/23/2011 Kathleen Stillings                    6
FMEA Success Factors
 Align your success factors
 Quality starts and ends with training (Kaoru Ishikawa)
              Does your Management team support the
              Do you have adequate resources?

              Does your team understand the basics of the
               FMEA process?

5/23/2011 Kathleen Stillings                                 7
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)

5/23/2011 Kathleen Stillings                                                8
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

5/23/2011 Kathleen Stillings                                     9
Close the Gaps in the System
    Gap 7 – not implementing effective quality tools to
     perform the FMEA assessment with in the team

    Gap 8 – missing links to internal and external quality

    Gap 9 – failure to identify critical characteristics

    Gap 10 – failure to effectively train people on the basics
     of completing a FMEA process

5/23/2011 Kathleen Stillings                                  10
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

5/23/2011 Kathleen Stillings                                 11
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

5/23/2011 Kathleen Stillings                                  12
5/23/2011 Kathleen Stillings   13
Maintenance of the System
    Ensure you update process flow charts,
     control plans, and FMEA data with the
       Data – internal and external
       Changes – systemic, process, product
       Audit Results

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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

5/23/2011 Kathleen Stillings                                      15
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

5/23/2011 Kathleen Stillings                                                                   16
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

5/23/2011 Kathleen Stillings                                        17
How are you looking at your FMEA
    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

5/23/2011 Kathleen Stillings                    18
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

5/23/2011 Kathleen Stillings                                                                   19
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
          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

5/23/2011 Kathleen Stillings                                                      20
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.

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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

5/23/2011 Kathleen Stillings                              22
1.     Steve Pollock, Create a Simple Framework to Validate FMEA
       Performance, Six Sigma Forum Magazine, August 2005.

5/23/2011 Kathleen Stillings                                            23

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