249 - The Best Audit Advice Nobody Told Me

<p>Audits are not supposed to be gotchas, and they are not meant to evaluate one person’s work in isolation. A good audit looks at whether a system is suitable, effective, and adequate and where it may need to improve.</p><p><br></p><p>In this video, I share the lessons I learned as I moved from being audited and supporting audit rooms to conducting audits as a certified lead auditor:</p><p><br></p><p>1) Audit the system, not the person: The goal is to understand how the system operates, not to catch an individual making a mistake.</p><p>2) Look for patterns, not isolated errors: One typo is different from a recurring or systemic problem, unless the individual event is critical.</p><p>3) Scope the audit before you start: The objective, criteria, time, resources, and agenda need to align before the audit begins.</p><p>4) Technical expertise is not the same as audit skill: Auditing requires its own tools, tactics, strategies, interviewing skills, and qualification.</p><p>5) Lower the temperature to get better evidence: People communicate more clearly when the auditor reduces unnecessary anxiety, although assertiveness is sometimes necessary when information is being withheld.</p><p><br></p><p>Chapters</p><p>00:00 Audits Aren’t Gotchas</p><p>00:38 Audit the System, Not the Person</p><p>03:16 Look for Patterns, Not Isolated Mistakes</p><p>05:27 Set a Clear Audit Scope</p><p>08:21 Auditing Is Its Own Skill and Being Technical Helps</p><p>11:11 Lower the Temperature and Be a Human</p><p><br></p><p>About Subhi</p><p>Subhi Saadeh is a quality professional, consultant, auditor, and trainer who specializes in drug-device combination products, medical devices, pharmaceutical quality systems, supplier quality, and lifecycle management. Through Let’s Combinate, he helps pharmaceutical and medical-device teams bridge the gap between drug and device quality, regulatory expectations, and practical execution.</p><p><br></p><p>Learn more:</p><p>https://letscombinate.com/</p><p>subhi@letscombinate.com</p><p><br></p><p>Connect with Subhi on LinkedIn:</p><p>https://www.linkedin.com/in/subhi-saadeh-1169aa21</p>