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Most companies we see that struggle with audits aren’t struggling because their quality systems are “bad.” They’re struggling because they confuse being compliant with being audit-ready, and they underestimate how much the outcome depends on logistics, preparation, and understanding how auditors actually think.
A great auditor isn’t looking to catch you doing something wrong. They want to verify that what you’re doing is safe. But they’re also trained in specific psychological techniques (open-ended questions designed to get you talking, strategic silence to make you fill the gaps, deliberate friendliness to lower your guard) and if your team isn’t prepared for those dynamics, even a compliant organization can create problems for itself in the room.
Nick Capman recently sat down with Sneha Saggurthi, Quality Compliance Manager and Lead Auditor at Cartesian Therapeutics, to dig into how understanding auditor psychology, common inspection patterns, and smart logistics can transform audit readiness from last-minute panic into an everyday operational mindset.
Sneha works in cell therapy quality and compliance, holding her ASQ Certified Quality Auditor (CQA) credential and managing supplier quality and inspection readiness at Cartesian. She conducts supplier and vendor audits regularly and brings a practical, dual perspective — she knows what it’s like on both sides of the audit table.
Before Cartesian, she held quality and training roles at Catalent, Precision For Medicine, and Charles River Laboratories. She’s also a Lean Six Sigma Green Belt, an adjunct instructor at Frederick Community College where she teaches a biotech bootcamp, and serves as Vice Chair of Young Women In Bio within the Women In Bio organization.
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Sneha’s key insights and practical takeaways
If you’re short on time, here are the most important lessons from the discussion.
The biggest reason audits trigger panic isn’t weak quality systems. It’s how people view the auditor. Many teams see regulators the same way they see QA: as the police, someone coming to investigate. That adversarial framing creates anxiety even when the company is fully compliant. Sneha’s recommendation is to shift toward a partnership mindset. The auditor and the company share a common goal: protecting the patient. When you treat an auditor like a partner (the way you’d treat a key vendor or supplier), the dynamic changes. Engage professionally and see observations as opportunities to improve your system rather than as attacks.
Being compliant and being audit-ready are not the same thing! Compliance means your documentation is in order and you’re following your regulations. Audit readiness is about logistics: if the FDA showed up tomorrow, do you have a plan? Do you know who’s leading the back room? Do you know the tour route? Do you know how to defend the choices you’ve made? Regulations are often vague — they don’t tell you exactly how to be compliant. Being audit-ready means you can articulate why you did it your way and explain why that approach meets the regulatory intent.
Auditors think in terms of SISPQ: safety, identity, strength, purity, quality. Everything an auditor is looking for rolls up to whether the product has those attributes. The mindset going in isn’t to target the company. It’s trust but verify. You can tell an auditor anything, but they need to see documentation that confirms it’s actually happening. Companies that understand this frame their preparation around demonstrating that their systems reliably produce those outcomes, not around hiding gaps.
First impressions matter, and stalling on document requests is an immediate red flag. Auditors notice when companies acknowledge a request and then quietly hope it gets lost in the volume of requests coming in. That tactic backfires. It signals either disorganization or evasion, and auditors track their requests. Similarly, answering an observation with something like “we’ve never seen a bug” instead of having a documented pest control program is the kind of response that immediately erodes confidence. What builds confidence: fast document retrieval, prepared subject matter experts, and transparency about what happened and what you did about it.
Logistics are the make-or-break, not the compliance itself. This was one of Sneha’s strongest points. The speed at which documents arrive tells the auditor whether information is readily accessible (a core ALCOA principle). If one person is running the entire audit and responses are delayed, it can signal insufficient quality support even if the underlying systems are solid. Sneha recommends clearly defined roles: a back room lead, a front room host, a scribe, a runner — each knowing their responsibilities. A well-coordinated team with fast turnaround creates far more auditor confidence than a scrambling team with perfect documentation buried somewhere in an archive room.
Know your auditor before they arrive. When you know who’s coming, do a deep dive on their background. If the auditor has a strong QC background, have a QC subject matter expert on hand. That’s where they’ll focus because that’s where their expertise is. For international audits especially, auditors tend to be more scientifically focused. Sneha recommends having extra deep-dive slides prepared beyond the standard opening presentation, with MSAT and QC experts ready to explain the science if the auditor goes deeper than expected.
Batch records are the most common rabbit hole. When auditors review batch records, they see associated deviations, GDP issues, and that leads them to pull the GDP SOP, then the deviation, then the CAPA that came from it. The thread keeps going. Sneha’s advice: for anything you’re going to put in front of an auditor, have a storyboard ready. Know the narrative: what happened, how you investigated, what CAPA you implemented, and why it prevents recurrence. Auditors respond far better to transparency about a deviation with a clear corrective story than to a suspiciously clean batch record or evasive answers.
Train your people to be comfortable with audits, not to hide from them. One of the most counterproductive reflexes Sneha sees is companies moving manufacturing staff upstairs and out of sight when an audit starts. Floor operators know the most about what’s happening on the floor, and they should be comfortable speaking with auditors. Use internal audits as practice runs for external and regulatory inspections. Get operators used to the experience so they’re not rattled when it counts.
The everyday audit readiness mindset is simple: would this hold up two years from now? Sneha pushes this question as a daily operating principle, especially on the manufacturing floor. When you’re writing in a batch record, documenting a deviation, or closing a CAPA — ask yourself: if someone reads this two years from now and I’m not at this company anymore, will they know what happened? That forward-looking habit, applied consistently, is what separates reactive organizations from continuously ready ones.
Three changes in the next 90 days to move from reactive to ready. First, check your document accessibility — if everything is sitting in an archive room in the back of the building, run a fire drill. Ask someone to retrieve a document from two years ago and see how long it takes. Second, build an audit logistics plan: who leads back room, who’s the front room host, who scribes, who runs documents, and what happens if your primary person is out that day. Cross-train for every role. Third, instill the culture shift — make “how would I defend this to an auditor?” a question your team asks themselves every day, not just when a notification arrives.
The psychology tricks auditors use and how to handle them. Sneha shared several specific techniques that auditors are trained to use. Open-ended questions (”walk me through your process if I were a new employee”) are designed to get people talking freely rather than pointing to a specific SOP. Strategic silence (where the auditor asks a question, you answer, and they just sit there looking at you) is designed to make you uncomfortable enough to keep talking and potentially volunteer information you didn’t need to share. And deliberate friendliness and charisma can lower a team’s guard, leading people to rant or overshare. The countermeasures: train your people to be comfortable with silence, to give short and concise answers, to redirect to documentation rather than trusting memory, and to maintain professionalism even when the auditor is being personable. Be friendly, but keep your guard up in a healthy way.
One thing to bring back to your team
Pick one document from around two years ago (a batch record, a deviation, a CAPA) and ask someone who wasn’t involved to pull it and tell you what happened. Then ask yourself:
How long did it take to retrieve?
Could someone outside the company understand what happened and why?
If this were the document an auditor pulled first, would you feel confident in the story it tells?
If the answers make you uncomfortable, you don’t need an eight-month readiness program. You need fire drills, clear logistics roles, and a daily mindset shift. Every company has gaps. No company is perfect. The difference is whether you can show an auditor that when you found the gap, you did something about it.
Sneha Saggurthi is Quality Compliance Manager at Cartesian Therapeutics, a cell therapy company, where she leads inspection readiness, supplier quality, the internal and external audit program, and GxP training. She holds an ASQ Certified Quality Auditor (CQA) credential and a Lean Six Sigma Green Belt. Before Cartesian, Sneha held quality and training roles at Catalent, Precision For Medicine, and Charles River Laboratories. She is an adjunct instructor at Frederick Community College, where she teaches a biotech bootcamp, and serves as Vice Chair of Young Women In Bio within the Women In Bio organization. She holds a BA in Biology and a BS in Psychology from the University of Maryland, Baltimore County.
Connect with Sneha on LinkedIn here.
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