QA/RA Consulting, Auditing & Training
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QA/RA Consulting, Auditing & Training
If you’ve worked in pharma long enough, you’ve seen this play out.
A deviation gets raised, maybe a parameter drifts during a batch, or an environmental monitoring trend doesn’t look quite right, or a result comes back out of specification.
An investigation starts. People ask the right questions. The paperwork gets filled out. A root cause is assigned. CAPAs are put in place.
The deviation is closed.
This is exactly what should happen on paper. Pharmaceutical quality systems depend on timely investigations, sound documentation, and appropriate follow up. The challenge is that a closed investigation and an effective investigation are not the same thing. The true measure of success isn’t whether a record reached closure, it’s whether the underlying problem was understood, addressed, and prevented from recurring.
But that isn’t always what happens.
And a few weeks—or a few months—later, something very similar shows up again.
At that point, it’s hard not to wonder:
Did we actually solve anything, or did we just move the process along?
Pharma organizations are incredibly good at moving investigations to closure.
We know how to:
That’s not a criticism—that’s the system working the way it’s designed.
But over time, something subtle can happen. The goal shifts.
Instead of asking, “Do we understand this?”
We start asking, “Are we done with this?”
And those are not the same questions.
If you look at enough investigations, you start to see patterns.
Certain root causes show up repeatedly:
Sometimes those are valid.
But sometimes… they’re just where the conversation stopped.
Because “operator error” doesn’t really explain much on its own.
Consider a deviation involving an incorrect process setting. It’s easy to conclude that the operator made a mistake. But what if the setting wasn’t clearly visible? What if similar settings were positioned side by side on the interface? What if multiple operators had previously made the same error, but the trend was never identified? In those situations, the operator may have triggered the event, but the system created the opportunity.
That distinction matters. “Operator error” may identify where the event occurred, but it rarely explains why it occurred. It just tells you where to look.
If you don’t answer those questions, the system hasn’t really changed.
You’ve just labeled the event.
This comes up a lot with OOS and deviation investigations.
The natural instinct is to focus on the immediate issue:
That’s where the urgency is, especially when timelines are tight.
But in practice, the issue is often a little bigger than the event itself.
Maybe the process has more variability than expected.
Maybe the equipment behaves differently under certain conditions.
Maybe there are decisions being made on the floor that don’t quite match what the procedure assumes.
Those things don’t always show up if you stay tightly focused on the event.
And if you miss them, the underlying risk is still there, you’ve just explained how it manifested this time.
When something happens again, it’s easy to treat it as a new problem.
But most of the time, it isn’t.
It’s the same problem—just showing up in a slightly different way.
And that’s usually a sign that:
None of that means the team didn’t do a good job.
It just means the investigation didn’t go quite far enough.
Recurrence is often one of the clearest signals that the original understanding of the problem was incomplete.
One of the most useful shifts I’ve seen in investigations is small, but powerful.
Instead of asking only, “What happened?”
Ask: “What did the system allow to happen?”
That changes the conversation.
You start looking at:
And that’s where things start to click.
Because now you’re not just explaining the event—you’re understanding how the system behaves under real conditions.
Some teams handle this better than others. You can usually tell pretty quickly.
They don’t rush to lock in a root cause.
They’re a little uncomfortable with quick answers.
They’ll go back and ask one more question, even when the report is almost done.
And when something happens again, they don’t just fix it; they revisit what they thought they knew.
It’s not that they have fewer deviations.
It’s that their investigations help identify what needs to change in the process.
Closing a deviation is part of the job.
But if the same issue comes back, in some form, the system is telling you something didn’t stick.
And in pharma—where consistency matters, and small issues don’t always stay small—that’s a signal worth paying attention to.
If your organization is struggling with recurring deviations, repeat OOS results, or investigations that produce corrective actions without lasting improvement, ELIQUENT Life Sciences offers training and consulting support focused on investigation effectiveness, root cause analysis, CAPA, and pharmaceutical quality system performance. Our goal is simple: help teams move beyond documenting problems to preventing them.
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