Quality management is dead. Change my mind.

Traditional quality management is largely theater. We measure things that don’t much matter. We pray at the altar of prevention. We insist that quality is black and white. We think that conforming to yesterday’s practices assures tomorrow’s success. These lines of thinking are simply not based on first principles and, while useful up to a point, don’t effectively maximize the benefits they purport to seek.

Yes, I still believe that patient protection, continuous improvement, and organizational learning are the worthy endpoints of any quality philosophy; I’m not a monster. But the “industry standard” quality management methods to achieve those aims, however, are fully stagnant and will not elevate quality in any meaningful way going forward.

The measurement mantra

“If you can’t measure it, you can’t manage it.” W. Edwards Deming said that. But did he? The actual quote (from his book “The New Economics”) is “It is wrong to suppose that if you can’t measure it, you can’t manage it – a costly myth.” Deming was actually warning against numerical targets divorced from methodical understanding. Yet somehow this became quality scripture. Quality equals quantification, the numerification of excellence.

The reality is that quality is a spectrum and inherently unquantifiable (just think a second about the root of the word “qualitative”). Our standard indicators and measurements approximate quality (at best), but don’t fundamentally define or predict it. Burying a complicated and nuanced story behind a red/green metric is intellectually silly, and doesn’t equip decision-makers with actionable intelligence. It’s false precision that creates the illusion of control.

I’m not saying don’t measure. I’m saying be real about what you’re measuring (and what you’re not). Develop metrics that predict future outcomes and stop believing that everything that gets measured matters, because it doesn’t.

The variation vestige

From Shewhart we get: reduce variation to zero. This gave rise to statistical process control that dominates continuous improvement methodologies. The relentless pursuit of identical outputs. Maintaining mediocrity.

But variation drives evolution. And innovation. This mindset prioritizes mass production over continuous improvement. Take Toyota, the poster-company of variability reduction. Unbeknowst to many, their processes actually seek out beneficial variation by creating planned experiments within production. Workers introduce deliberate changes. Most fail safely, but some revolutionize manufacturing. Regulators get what they want: ever-improving quality that never compromises safety. Somehow, only half their example stuck in modern quality management philosophy.

Variation is dual-edged. We need to cultivate beneficial variation while preventing catastrophic deviations. Variation provides invaluable learning opportunities: something is different… why?

The prevention prerogative

We are conditioned to believe that zero defects is the best possible scenario. That prevention is more important than detection. That failure is bad. Resilience after the fact is a nice-to-have.

The regulations seek to protect patients from harm, not prevent all failure. A system that learns from small failures can prevent catastrophic ones. Traditional quality management hides failures until they explode when we should instead celebrate small failures that provide valuable organizational learning. Zero defects means zero learning.

Netflix has a tool called Chaos Monkey. It deliberately breaks production systems. Not sandbox or development servers. Production. This seems insane by traditional quality standards, yet Netflix achieves 99.99% availability precisely because they practice failure.

The key here is allowing (or even promoting) controlled, graceful failures that inform protective measures against uncontrolled, catastrophic failures. Failure isn’t the opposite of quality; it is quality’s most impactful teacher.

Embrace the evolution of quality

None of these mindset shifts violate regulatory requirements. In fact, they fully exemplify the spirit of the regulations. If, like me, you consider compliance to be the bare minimum, and quality exists in the ether at least a couple sigma (thanks Shewhart) above compliance, then these thoughts will take you closer to quality excellence than the existing and increasingly archaic dogma we call quality management ever will.