249 - The Best Audit Advice Nobody Told Me

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.

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:

1) Audit the system, not the person: The goal is to understand how the system operates, not to catch an individual making a mistake.

2) Look for patterns, not isolated errors: One typo is different from a recurring or systemic problem, unless the individual event is critical.

3) Scope the audit before you start: The objective, criteria, time, resources, and agenda need to align before the audit begins.

4) Technical expertise is not the same as audit skill: Auditing requires its own tools, tactics, strategies, interviewing skills, and qualification.

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.

Chapters

00:00 Audits Aren’t Gotchas

00:38 Audit the System, Not the Person

03:16 Look for Patterns, Not Isolated Mistakes

05:27 Set a Clear Audit Scope

08:21 Auditing Is Its Own Skill and Being Technical Helps

11:11 Lower the Temperature and Be a Human

About Subhi

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.

Learn more:

https://letscombinate.com/

subhi@letscombinate.com

Connect with Subhi on LinkedIn:

https://www.linkedin.com/in/subhi-saadeh-1169aa21