FMEA – Effective or Not?

headerAnother issue has been reported with your design.  The repercussions often range from irate customer calls, to rework in the field, to recalls, to lost sales, and litigation.

Product development managers know that their design staff needs to be extremely diligent about the details of the product design. Companies often turn to tools like Failure Mode Effects Analysis (FMEA) to drive this discipline.

FMEA is essentially a form (or spreadsheet) with lots of boxes that helps organize ‘What could go wrong with the design?’, ‘How big of a deal is it?’ and ‘What are we going to do about it?’

But, does FMEA really prevent or minimize design issues?

Insisting that design teams conduct FMEA may help a company identify and address a few potential design flaws, but it will not instill the rigor required to dramatically improve designs.

To be successful FMEA needs to be a part of a bigger departmental system and culture that includes:

  • Leadership that believes in and challenges the content of the FMEAs.  FMEA teams need exposure to fresh, experienced perspectives to help them consider the many conditions, environments and variables their design may see.  When leadership is involved, it communicates that, “FMEAs matter” and it drives quality of content.
  • A resident FMEA expert and/or clear definitions on how to fill out the form. Users of the FMEA form often struggle.  For instance, a common argument design teams have is, ‘Is that a Failure Mode or a Cause?’  Let’s say, for instance, we are analyzing a paper cup with an insulated sleeve (as shown in the photo above). Which of the following are Failure Modes? A) The design won’t pass the company’s Thermal Conductivity Test. B) The dimensional tolerances between lid and the cup are too tight/loose. C) The machine that cuts the paper (prior to folding it into a cup) won’t cut consistently. They all sound pretty legitimate, but what if I told you that noneof these would meet one particular consumer good company’s definition of a failure mode. They expect failure modes to reflect a customer’s negative experience. For instance: The cup leaks. The lid won’t stay on securely. The ink on the cup comes off on your hand. Having a resident FMEA expert available to coach design teams and/or providing clear instruction will keep teams on track and provide consistency.
  • Historic FMEAs. Companies that take the time to build FMEAs from field data and then insist new design teams leverage the historic FMEAs reduce the likelihood of repeat failures.

 The author, Bobbie Gilman, has a B.S. in Mechanical Engineering. She has designed and implemented 100’s of high volume components. She led the efforts of nearly 50 product development professionals globally to standardize on a FMEA method for a Fortune 500 company.  The team’s work, along with that of Donald J. Wheeler was published in the Automotive Industry Action Group’s (AIAG) FMEA Manual – 4th Edition.  

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