How to Make Inspection Readiness a Daily Habit

When it comes to inspections, most teams fall into one of two camps: those who panic when someone in a suit shows up at the door, and those who take a breath and calmly get the binder.

It’s not about luck. It’s about habits.

Most FDA inspections are unannounced. That means readiness can’t be a project you start when the calendar says, “audit in 30 days.” True inspection readiness is a way of operating. It’s baked into your daily decisions, your documentation, and your quality culture.

So, how do you make inspection readiness a habit? Let’s break it down.

Shift the Mindset: Inspection Readiness = Operational Readiness

Inspections are not out-of-the-ordinary events. They’re part of doing business in a regulated industry. If your team is operating in a compliant, well-documented way every day, then inspection readiness isn’t something you prepare for. It’s something you live.

This mindset shift starts with leadership. When quality is positioned as everyone’s responsibility, teams start to recognize how their day-to-day work contributes to a compliant, audit-ready system. That includes recording deviations, completing training on time, documenting CAPAs clearly, and maintaining change controls properly.

Ask your team: “Could we explain this process to an inspector tomorrow?” If the answer is no, it’s time to review how that process is being executed and documented.

Focus on Progress not Perfection

Too often, companies stall because they’re waiting for the “perfect” QMS or the “right” moment to overhaul their processes. Here’s a secret: inspectors don’t expect perfection. They expect transparency, traceability, and accountability.

It’s better to show that you identified a gap and took action than to pretend everything is fine. You can begin making progress with small daily actions:

• Review one procedure per week and check for alignment with current practices

• Perform informal documentation checks to verify that forms are being filled out completely and on time

• Track open CAPAs weekly, not just during review meetings

• Encourage teams to escalate issues early rather than waiting

  
  

Making progress visible and actionable builds confidence and keeps your systems innovative and complaint.

Treat Records Like Evidence Because They Are

When the inspector requests to see your last 10 deviations, what they’re really saying is: “Prove to me that your system works.”

That’s why your records matter so much. Every document, log, or form tells a story. Is it complete? Accurate? Signed and dated on time? If not, it’s a risk.

Daily inspection readiness means maintaining records as if someone will ask for them tomorrow. Because one day, someone will.

Pro tip: Whether digital or paper-based, your documentation should be consistent, complete, and easy to retrieve. If you’re scrambling to locate your most recent CAPA summaries, it’s a sign that your documentation systems may need a tune-up.

Create Feedback Loops That Stick

One of the most powerful habits you can build is the routine analysis of your own gaps. Complaints, deviations, and audits aren’t just reactive events, they’re data points.

At ASQ WCQI, I shared how complaint data, when properly categorized and reviewed, becomes a goldmine for risk management and preventive action. The same applies here: use your findings as fuel.

• Incorporate audit observations into monthly quality meetings

• Assign follow-up actions with due dates—and track them

• Ask your team what’s getting in their way of doing things right the first time

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Inspection readiness is never a “set it and forget it” thing. It’s a living loop.

Operate as if the FDA Could Walk in Today Because They Might

It’s easy to think, “We’ll get to that later.” But “later” might be too late.

Every document, every log, every investigation should be accurate, up to date, and ready to hand over. If the FDA showed up tomorrow, could your team explain:

• How is training tracked and updated?

• What happens after a nonconformance is discovered?

• How are CAPAs assigned, documented, and verified?

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You don’t need to panic. You need to be ready.

Get the Logistics Right: Set the Stage Before They Arrive

When the FDA shows up, the first five minutes matter more than you think. Calm, professional logistics signal control. Control is what inspectors are looking for.

Here’s how to prepare:

• Know who greets the inspectors. Whether it’s the QA Manager, site lead, or another designee, assign someone who’s trained to greet FDA personnel, verify credentials, and guide them to the inspection room.

• Designate an inspection room. Choose a quiet, professional space for the FDA to work. This room should have a working printer, enough space for binders, documents, and note-taking, and limited distractions and foot traffic

• Assign an escort. An FDA inspector must be accompanied at all times. Identify and train a group of employees (often from QA or regulatory) to serve as escorts who can manage tours or lab visits calmly and accurately.

• Appoint a scribe/note taker. This person tracks every question asked, document requested, and response given. Their notes are critical to ensuring consistency and preparing responses to any observations.

• Prep a document runner. You’ll need someone responsible for locating and delivering requested documents quickly and accurately. They’ll coordinate with the back-room team to ensure smooth communication.

• Set up a back room. This is where the document team works during the inspection. Keep all files organized, label everything clearly, and maintain good communication with the front room.

  
  

A well-orchestrated inspection setup shows the FDA that you take quality seriously and helps your team stay calm under pressure.

Build a Culture That’s Always Ready

The best inspection-ready companies don’t prepare the night before because they don’t have to. They already live in their quality system. That takes time to build, but it starts with the basics:

• Clean, complete records

• Clear ownership of tasks

• Honest, transparent communication

• A mindset that sees compliance not as a burden but as how we do things here

When the FDA shows up, you don’t want to scramble. You want to hand over the binder, walk through your process, and move on with your day.

Final Thought: Start Small, Stay Consistent

If inspection readiness feels overwhelming, that’s okay. Start with one habit, one daily or weekly practice and build from there. You don’t need to overhaul your whole system in a week. You just need to start acting like someone might knock on your door at any time.

Because in this industry, someone eventually will.

And when they do, you’ll be ready.

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