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What Does It Mean to Operate in a State of Control?

There is nothing here about perfection

The QA Pharm

John Snyder & Co.

Mon, 06/06/2011 - 05:30
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Once upon a time I asked, “What does it mean to operate in a state of control?” at an off-site “strategy” meeting of a senior management group. You know the kind of meeting that I'm talking about—one in which a working breakfast was followed by a day of golf, and I was the one doing the working.

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The question was particularly germane to the purpose of my invitation, because these executives did not want to follow the path of other major industry giants into ruin by taking their eye off the proverbial current good manufacturing practice (CGMP) compliance ball.

After a bit of awkward silence, someone offered a stab at the answer with, “Zero defects.” Another rebuked his colleague, “That’s so passé. It should be ‘right first time.’” The next 10 minutes was the battle of the buzzwords and I was the game show host. Conversation erupted in a murmur across the room.

I responded by saying that perfection was a worthy goal, but statistically impossible. I am highly suspicious of perfection, and firms that punish less than perfection drive bad behavior. In fact, when things are too perfect—I suspect fraud.

That quieted the room.

 …

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