Adventures in Auditing: A Witty Guide to Probing Without the Pain

Introduction: Where Fun Meets Form 483

Picture this: you’re an auditor stepping into the high‑stakes world of FDA, ISO 13485 and

MDSAP audits, where one undocumented deviation can send a medical device company into regulatory orbit. Audits have a reputation for being tense, awkward, and about as fun as a surprise root canal—but they don’t have to be.

Think of this article as your witty roadmap to surviving (and even enjoying) the human side of audits. We’ll cover understanding auditees, asking better questions, listening like a pro, and spotting fraud—all without sucking the joy out of the room. Imagine Sherlock Holmes auditing a cleanroom: observant, direct, professional… minus the hat, plus sarcasm.

Understanding the Auditee: Professional Stalking, But Make It Ethical

In FDA and ISO 13485 audits, auditees aren’t just people—they’re guardians of information that can make or break market approval. Your golden rule? Do your homework.

Review quality manuals, previous audit reports, and yes, maybe even that LinkedIn post

about “surviving FDA scrutiny.” Be direct when asking about CAPAs, sprinkle in light small talk, read body language, and always stay professional. Arms crossed during a

manufacturing tour? That’s not cold—it’s a red flag wearing a jacket.

Handling Difficult Auditees Without Causing a Spill

When tensions rise, avoid escalation like you’d avoid a biohazard spill. Stay calm, shift

perspective, and remember: they may be stressed about an upcoming MDSAP audit or last year’s findings.

Use positive body language, let them talk through options, and build rapport. Witty rule of thumb: treat difficult auditees like tricky ISO clauses—interpret generously, but verify

relentlessly.

Interview Techniques: Oprah, But With a Checklist

Interviews are the heart of audits, yet most auditors weren’t hired for their talk‑show

skills. We’re often improvising like actors in a boardroom.

Start strong: hold an opening meeting, define objectives, review known issues, and prep

your questions. Smile (yes, even behind a mask), be polite, and don’t be

intimidated—regardless of job titles.

Silence is golden. Let people talk. Ask open‑ended questions like, “Tell me how that risk

assessment works,” and watch the story unfold. And always read the room before

attempting humor—no one wants a joke that lands like a non‑conformance.

Listening: Hearing Is Free, Listening Takes Effort

Hearing is passive. Listening is active. Hearing is ‘yada yada yada.’ Listening is realizing the building is on fire.

Great auditors don’t interrupt, don’t rush, and don’t assume. They summarize, paraphrase, and confirm understanding. Listening uncovers nuance—and nuance is where risk hides.

Witty wisdom: good listeners become great auditors. Bad listeners become case studies.

Spotting Fraud: The F‑Word

Fraud—aka the F‑word—isn’t an honest mistake. It’s intent. And it loves patterns.

Red flags include photocopied records, missing originals, rehearsed answers, lightning‑fast tours, and managers who answer for everyone else. If it feels scripted, it probably is.

Fraudsters believe photocopiers are magical cloaking devices. Auditors know better—we’ve seen every trick, including the ones that make you question humanity.

Lessons Learned: Audit Like a Human, Not a Robot

Auditors are a special breed. Embrace it.

Don’t intimidate. Ease nerves. Prepare for surprises (including the occasional overshare).

Remember that compliance lives in shades of gray, much like FDA guidance.

Audit with patience, humanity, and wit—and you’ll not only find issues, you’ll help prevent them.

A Final Note (No Clipboard Required)

If audits feel stressful, reactive, or harder than they should be, M.E. Dorat Consulting helps organizations build audit-ready systems through targeted training, effective internal audits, and executive advisory. Our goal is simple: fewer surprises, stronger quality systems, and audits that actually add value.

Whether you’re preparing for your next inspection, strengthening your quality system, or

just want audits that feel more human, we’re here to help—no magnifying glass

intimidation tactics required. Book a consultation – Let’s talk

© 2025 M.E. Dorat Consulting, LLC

Marie E. Dorat is a regulatory and quality consultant helping FDA- ISO, 13485 and MDSAP–regulated organizations prepare for audits with confidence, clarity, and far less stress.