I have seen organisations where the documentation was in place, procedures were approved, people were trained, and equipment had been qualified. From a compliance perspective, things appeared to be under control.
And yet, when you looked at how the operation actually worked, a different picture emerged.
An experienced colleague knew which sequence worked best, even though it was not obvious from the procedure. Someone in Quality knew exactly whom to call to prevent a problem from escalating. Planning relied on informal conversations to resolve conflicts before they became visible. And whenever something unexpected happened, a few very capable people somehow managed to keep everything moving.
At first glance, that might even look like a strength. People were experienced, committed and willing to help each other.
And of course, those are strengths.
But I started wondering whether we sometimes confuse the resilience of people with the resilience of the system.
Because what happens when one of those people is absent? When production increases? When a new colleague takes over? Or when two things go wrong at the same time?
We often talk about how a system performs under pressure, as though pressure is an exceptional situation.
But in radiopharmaceutical manufacturing, working under pressure is simply another day.
The product is decaying. Production windows are narrow. Materials, equipment, people and patients are connected through time-critical dependencies. A delay of a few minutes can have consequences far beyond those few minutes.
Pressure is not necessarily a deviation from normal operations. It is part of the environment for which the operation must be designed.
And that brings me to something I consider fundamental: simplicity and efficiency are not merely performance objectives. They are also important contributors to quality and compliance.
Every unnecessary step creates another opportunity for something to go wrong. Every redundant entry, unclear responsibility or avoidable handover adds workload and creates another possibility for misunderstanding.
And when things do go wrong, we need investigations, corrections, documentation and sometimes additional controls. All of which consume time and resources that were already limited.
A complicated system can therefore create additional work simply by being complicated.
Of course, simplicity does not mean removing necessary controls or compromising GMP requirements. Quite the opposite. It means understanding why a control exists, what risk it addresses and how to integrate it into the actual operation in the most effective way.
A good process should make doing the right thing the easiest practical option.
We need professional judgement, experience and flexibility. We cannot, and should not, try to write a procedure for every possible situation.
But there is an important difference between a system that supports professional judgement and one that depends on people continually compensating for weaknesses nobody has addressed.
We can demonstrate that equipment is qualified, training has been completed and procedures have been approved. Those are necessary elements of GMP compliance. But they do not, individually or collectively, demonstrate that the entire operation will remain reliable under its normal working conditions.
Perhaps we should spend more time asking not only whether the required controls are in place, but also whether they are practical, understandable and efficient enough to be followed consistently.
Where does the process depend on individual knowledge? Which problems are repeatedly solved through informal intervention? Which steps add complexity without meaningfully reducing risk? And which deviations might never occur if we designed the process differently in the first place?
Because preventing an avoidable error is better than becoming exceptionally good at investigating it.
And perhaps the most uncomfortable question of all:
Are we looking at a robust system, or at very capable people making a complicated, fragile system work?
I do not think the answer is always obvious. But I do think we should stop treating operational simplicity as something that comes after compliance.
Sometimes, simplicity is precisely what makes compliance sustainable.
What am I missing?
Do we sometimes create more compliance work than necessary because we have made the underlying processes too complicated?
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