Gastonia North Blog

Medical Device Recruiters

INSIGHT: Are you after Improvement or simply trying to Solve a Problem?

Whether the subject is Lean or Six Sigma, what I’ve seen in my manufacturing career is that too often we seek out continuous improvement expertise for all the wrong reasons.  I just read an excellent article on Lean that should be required reading for everyone in manufacturing from the shop floor to the executive level.

Turns out that the great challenge in many western (European and North American) manufacturing environments to a Lean/Continuous Improvement approach is that pesky little word CONTINUOUS.  Targeted improvement is fine and it’s necessary.  Think in terms of a CAPA; the acronym stands for Corrective and Preventative Action.  Even the acronym sounds immediate and that’s because it is!  If you have a component in a device assembly that is constantly at the UCL of the tolerance range, sooner or later you’re going to be looking for this component and doing a CAPA.  The problem is that too many Quality Departments have file cabinets full of CAPA’s.

Change the mentality though and get your people thinking in terms of CONTINUOUSLY looking at their process and its results with an eye toward IMPROVING the condition and the difference is astounding.

I once listened to a VP of Quality at one of the big three device makers talking about a particular device that involved approximately 40 different components supplied by almost 20 different suppliers.  This device was used in a minimally invasive, albeit very unpleasant procedure.  I don’t remember the exact data but his point was simple; if every supplier hit a 1.33 Cpk on every component that went into the device – a minimally invasive procedure would turn into major surgery 1,000 times a year!

Put another way – How many people would die if the air traffic controllers at O’Hare airport were accurate 99% of the time?

Give the article a read [I’m sorry if your offended by the author’s strong reference to an expletive] and if you get to the end of it, you’ll see that even the author isn’t sure about either his assumptions or the solution.  It’s a complex problem but one that you need to face with an eye toward more than that pesky little problem right in front of you.

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My Biggest Lean F**k-Up. Ever.