6 Ways to Stay Ready for FDA Inspections
Readiness depends less on last-minute preparation and more on whether your quality system is clear, defensible, and easy to execute every day.
Inspection readiness has always been a moving target. But for many drug and device manufacturers, the target feels a little less predictable right now.
We’re seeing (and hearing from teams we help with auditing and readiness) that inspection timing has sometimes become less routine than it was a few years ago. There also seems to be a more “varied” group of investigators running inspections. On top of that, we’re seeing relatively minor 483 observations that might previously have been handled as discussion items addressed while an investigator was on-site.
More uncertainty and inconsistency here mean that inspection readiness has to be built into your quality system, which operates every day, rather than being a discrete exercise it sometimes becomes (whether intentional or not).
In a recent episode of The Life Science Rundown, we spoke with Jeff Brenneman, Vice President of Global Operations Quality at Alora Pharmaceuticals, about how manufacturers can sustain high-performing teams and robust quality systems in this kind of environment. We wanted to return to it because Jeff packs quite a bit of great advice into it.
Much of that conversation came back to a simple point: when inspections are harder to predict, quality systems need to be easier to understand, defend, and execute. And that posture has to exist at all times.
Here are six practical ways to do that that Jeff touched on. We fold these into our readiness philosophy all the time. Talk to us if you need audit or inspection readiness support.
1. Write investigations for someone outside your organization
One of the most useful inspection-readiness tests is also one of the simplest: Could someone who does not work at your company understand this investigation?
That matters because companies often write documents from inside their own bubble, so to speak. They use internal acronyms and assume the reader understands their product, equipment, process, deviation history, and organizational shorthand. That may work for people who live inside the system every day, but it often does not work for an investigator coming in cold. They shouldn’t have to ask for constant definitions and clarity.
This is especially important for deviations, investigations, risk assessments, and other documents that are likely to become focal points during inspections.
A strong investigation should orient the reader before it gets technical.
What product was involved?
What happened?
When did it happen?
Where in the process did it occur?
What equipment, batch, lot, or system was implicated?
Why did the event matter?
The technical details still need to be there, of course. But they should come after the basic story is clear. If an investigator has to work too hard to understand what happened, they are naturally more likely to keep digging. If the document lays out the event plainly and logically, the discussion starts from a better place, and often ends faster.
A few suggestions here and in the other sections below:
Run a simple “cold reader” test. Give a closed investigation to someone qualified but outside the process (QA from another site, Regulatory, Validation, etc.) and ask them to summarize what happened in a few sentences. If they can’t explain the event, impact, root cause, and rationale without a walkthrough, the investigation probably assumes too much internal knowledge.
Add a required orientation paragraph. At the top of deviations, investigations, and risk assessments, require a short plain-language paragraph that explains the product, process step, equipment/system involved, what went wrong, and why it matters. Treat it like the executive summary an investigator would need before reading the technical details.
2. Make risk-based decisions easier to defend
Risk assessment is often where quality systems move from black-and-white compliance into gray space. That’s not a problem by itself, but the rationale behind a risk-based decision has to be clear enough that someone outside the company can follow it. In that way, it relates to our first tip.
This becomes especially important if the investigator doesn’t have the same background or product-specific experience your team is used to seeing (which is happening more these days). A decision that seems obvious internally may look unsupported externally if the record does not show how you actually got there.
The practical fix is to treat every risk-based decision as something you may need to explain later. That means documenting:
The question being evaluated
The applicable requirement or expectation
The data used to support the decision
The assumptions made
The rationale for the path chosen
Any controls or follow-up actions used to manage the remaining risk
The idea here is to make your reasoning super visible wherever you might be asked about it. If the decision is defensible, the documentation should support it rather than relying on memory or other less tangible sources.
We often suggest having someone argue the other side before approval. For higher-risk assessments, assign one reviewer to play the investigator: “What would make this rationale look weak?” They’re trying to identify missing evidence, unsupported assumptions, or language that sounds more like opinion than a defensible conclusion.
3. Simplify the quality system before complexity becomes the finding
“Robust” is one of those empty adjectives we often hear used to describe a quality system. But in practice, it’s very often a nicer way to say “big and complicated.”
In reality, most genuinely “robust: quality systems we see are simple, efficient, and compliant. Problems actually tend to emerge when the system becomes too complex for people to follow consistently. We see that complexity show up as a few common symptoms:
Procedures that contradict themselves
Procedures that conflict with other procedures
Unclear roles and responsibilities
Process handoffs that are not defined
Training assigned too broadly
Electronic systems governed by procedures that do not match how the system is actually used
These issues create risk because they make failure easier. If following one SOP causes someone to deviate from another, the problem is way worse than user error. It’s a real system design problem.
The same is true when responsibilities are vague. If a procedure says QA is responsible for a step, but doesn’t specify which QA role, when the step occurs, what evidence is required, or who owns the final decision, the organization has left too much to interpretation and is quietly asking for trouble.
When we come into a firm for inspection-readiness support, one thing we do is look for friction points in the system. Where do people hesitate? Where do handoffs break down? Where does the procedure require more effort than the risk justifies? Where are teams creating workarounds because the official process is too hard to use? Those are all places where complexity is already weakening compliance.
Two really helpful tips here:
Map your SOP collisions, not just SOP ownership. Instead of reviewing procedures one at a time, pick a process like and map every other SOP it touches. Look specifically for places where one procedure hands off to another, uses different terminology, assigns responsibility differently, or creates conflicting timing expectations.
Track “workarounds” as quality signals to pursue. Ask teams to identify the unofficial spreadsheets, side trackers, email approvals, duplicate logs, and manual reminders they use to make the official process work. Those workarounds often point directly to the parts of the quality system that are too slow, unclear, or poorly designed to survive inspection pressure.