Quality: The art of keeping everyone alive, albeit moderately unhappy from time to time.

I’m a scientist, through and through. But practicing Quality well, I’ve learned, is just as much an art as it is a science.

Don’t picture me standing at an easel waving around a giant paintbrush. Picture me knitting with eight needles simultaneously on four different patterns while I accidentally inhale a moth and the cat knocks my tomato juice onto the carpet. Somehow, at the end of this movie, I deliver a brilliant tapestry (and the tomato juice gets cleaned up per our hazmat procedures). That’s a quality metaphor (ba-dum-tiss).

The scenario

Your sterile manufacturing suite identifies elevated particle counts. Not enough to trigger a deviation, but clearly trending upward over the past week. Business executives are breathing down your neck because you’re already two weeks behind on a batch release that three major hospitals are waiting for. The team says they can troubleshoot the issue overnight, but that means shutting down a critical manufacturing process. Your quality director demands root cause be identified yesterday. Your site head is calculating the reputational damage of missing delivery commitments. All the while, someone’s in the corner whispering that the trend, while not yet out of specification, establishes a pattern that auditors will definitely ask about during the inspection next week.

The reality

You’re not optimizing for patient safety and product quality, that’s such a quaint idea. You’re actually optimizing for patient safety and product quality within myriad constraints of budget, schedule, resource availability, regulatory interpretation, supplier and client relationships, employee morale, management pressure, lack of sleep, and about forty other conflicting and competing variables that don’t show up in risk assessments.

To navigate these conflicts well, you can’t pretend they don’t exist, though many try! You need to be brutally honest about the trade-offs. You need to ask the uncomfortable questions: What are we really optimizing for here? Who bears the impact if we’re wrong? What precedent does this decision set? Quality demands bravery in the face of daunting political pressures. Many professionals don’t possess this trait.

My hard-won wisdom tells me that Quality is shades of gray, as far as the eye can see. The right decision is often not obvious, and almost always imperfect. It’s the one that best balances competing priorities while maintaining non-negotiable boundaries around patient safety (and quality culture, if you’re protective like me). Some stakeholders will be unhappy. C’est la vie.

The art is in the judgment. And yes, sometimes you will spill tomato juice on the carpet, but if you’re a good Quality artist, that tapestry will kick ass in spite of it.