I’ll Bet You Didn’t Know…

I recently had an opportunity to visit with the Vice President of Operations at a small medical device start-up in the San Diego area.  He began our visit by taking me immediately on a tour of his new facility.  You could tell—and rightfully so—that he was proud of the work he and his team had accomplished over the past few years.  The facility was clean, well organized, and the firm clearly had room to grow. 

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The Vanishing QC

I’m a somewhat old fashion kind of guy, and I tend to be somewhat resistant to change.  In other words, if it ain’t broke don’t try to fix it.  I came of age in a manufacturing environment for medical devices where you routinely had a quality assurance presence on the production floor by way of quality control inspectors (QC’s).  Often, they came from the best of the best of your assemblers, and they were hard-wired to do their best work every day. 

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OMG Not Another SOP!

I have been fortunate throughout my career to have worked for some really great companies.  Of course, I’ve worked for some really ugly dogs too.  Amongst the best, I can say was Advanced Cardiovascular Systems (ACS).  It changed my life.  ACS was a wholly owned subsidiary of Eli Lilly a pharmaceutical giant.  ACS then became part of Guidant Corporation when Lilly divested itself of nine medical device companies taking six of the nine to create that entity. 

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What the Heck is a QMS?

Frequently, when I interview either potential clients or candidates—depending on my employment situation at the time, I ask them to tell me what the term quality management system (QMS) means to them.  The typical response I get is “well, you know, the SOP’s…and ah…the test results…and um…the documents?”   I continue to be truly surprised as to how little top management as well as functional areas outside of quality and compliance understand about such an important part of the business.

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