Failure Mode Effects Analysis_Meas Eff

Is your FMEA performing for you?

Measuring FMEA Effectiveness

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

25/23/2011 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


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


Why Assess the Effectiveness of your FMEA process? Stay Competitive! Reassure Management the investment

really does pay off!


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?


One Critical Factor of Your Risk Assessment System AN EFFECTIVE FMEA PROCESS HAS

THE FOLLOWING COMPONENTS Implementation of a Good SystemMaintaining that SystemAssessing Your System’s Effectiveness

IMA – I’m a Fool If I Don’t


FMEA Success Factors

Align your success factorsQuality 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?


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)


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


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


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


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


Maintenance of the System

Ensure you update process flow charts, control plans, and FMEA data with the following:Data – internal and externalChanges – systemic, process, productAudit Results


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


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


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


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


Measure FMEA Effectiveness

Use Internal nonconformance datao Internal Nonconformances could impact the

occurrence and/or detection ratingsS = 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


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



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%



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


References1. 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.htm4. http://www.reliasoft.com/rnewsletter/v6i1/fmea/factors.htm5. http://elsmar.com/forums/showthread.php?t=25760&page=2

Failure Mode Effects Analysis_Meas Eff

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