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.  They simply were not going to let bad product go out the door.

These quality control inspectors (QC’s) moved up and down their assigned assembly lines.  They were tasked with confirming proper line clearance and performing random sample testing**.  They verified assemblers were trained to perform the operations where they were stationed and that the training was up-to-date.  They confirmed the correct work instructions were in place and at the most current revision.  They checked entries on the device history record (DHR) for accuracy and completeness.

This model served the company extremely well in that non-conformities were discovered oftentimes early in the manufacturing process and generally before product was packaged and subsequently sterilized.  On the other hand, nobody likes it when someone else discovers their mistakes, and as anyone who has spent any time working within quality assurance will attest it can give rise to an “us against them” sentiment when the true role of quality assurance is poorly understood.

I once had a production manager suggest to me that we allow him to “deputize” assemblers as quality control inspectors (QC’s)—tell me again, how does that go about the “fox guarding the hen house…”?  At another time and one of the most “interesting” things I have ever witnessed was the proposal by a production manager to elevate select assemblers to the role of “super assembler” (my words).  These folks were to be tasked with doing all those things we paid QC’s to do before the QC’s began their work.

Huh?  What?  I know what you’re thinking…that makes absolutely no sense what-so-ever!  Yet it is indicative of a movement that has taken hold over the past decade or so to remove (or at least greatly reduce) the presence of quality assurance from the production floor.  It is a perpetuation of that “us against them” sentiment and more about power and control than efficiency or productivity, a deliberate refusal to recognize the value this important work brings.  Please…convince me otherwise.

I have seen multiple companies go down this path only to fail spectacularly.  Invariably, there is some series of quality problems leading to substantial complaint rates, multiple recalls, and a good deal of customer ill will.  Without fail, the tangible as well as intangible costs at the back end outweigh any perceived savings on the front end during manufacture.  In a sense, it is a robbing of Peter to pay Paul, and customers know and deeply resent when they become a company’s quality assurance function.


**   You’ll notice I did not say 100% inspection…you cannot inspect quality into a product…it must be designed in from the start.