It ain’t easy…
It ain’t easy, bein’ QA…
As I prepare for a talk at the upcoming PDA Week Conference in Denver, I am tasked with presenting on the role of QA into the future, with the ultimate goal being Quality Management Maturity [better known as “QMM”].
I’m somewhere in the clouds above Indiana (I think) this evening, and just had in interesting thought gazing over the lights of some small town… It’s wild, if you think about it for a moment, that the Qualified Person (QP) is legally bound to certify Quality of a drug product, yet the folks building the product do not report in through them. In theory, the Quality Unit has the ultimate authority to reject a batch for any reason. The real limitation to this theory, however, being this relies on good behavior and self-reporting of potential problems. So….. let’s be honest…. In reality, this is a system built largely on trust, and to a lesser extent on verify. I think we can all agree on that conclusion.
This limitation of trust becomes a real problem when the driver for “Quality” within an organization becomes non-discerning metrics, which often cause shortcuts to become necessary for operations in the quest for the goal.
As only a fraction of operations can be verified, building trust is critical – which means actually empowering production to do what Henry Ford understood more than a hundred years ago: that Quality is doing the right thing when no one is looking… This statement may seem overly simple or cliché, but if you just think a level deeper, it is incredibly meaningful and difficult to achieve.
With Ford’s aim in mind, what is the role of the QA Associate in 2026?
QA as a Coach. This analogy is too right to ignore. QA is on the sidelines and plays zero minutes, while operations win or lose, according to their abilities and game plan (strategy). I don’t mean QA as a Coach in an arrogant or bossy manner, but through empowerment - a bit of research on what makes a great coach (e.g., Dan Lanning, Oregon Football), will demonstrate that the key to success lies with human-centric leadership. We do not own the processes we are tasked with approving. If we push through tasks that operations feel is waste, they will simply not follow them and product quality will suffer - we all lose. This is human nature, we would do the same thing. Operations own their processes, our job is to influence and empower them to do the right thing when no one is looking. When coached in the principles of true ‘old school’ quality [think Lean & Qualitative QRM principles], the right way becomes obvious as critical thinking is no longer discouraged and the “keep your head down and follow the SOP” culture evaporates. But clouded with old school metrics and clunky quantitative QRM tools, the right way becomes lost in the mist and emotion and inter-department conflict steers the ship.
Coaching operations to achieve true quality involves a three step enablement program:
Critical Thinking: From “just follow the SOP” to the objective evaluation of a problem to form a solution
Qualitative Quality Risk Management: From a single quantitative tool to common sense risk management using the nine-box methodology
Quality Management Maturity: From a “reactive” quality system (see recent FDA WLs) to proactive continuous improvement via operator owned stand-alone CAPAs
If you are a young QA Associate, I encourage you to start specialization in the principles of QUALITATIVE Risk Management and what makes a great coach (human-centered leadership): they will serve you well, well into the future.
If you are at the Senior QA level, I encourage you to change the formula for quality in our industry from the top down. Restructure our role from roadblock to roadrunner, accelerating the business to serve patients better with higher quality at lower cost.
Pete
