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:
subhi@letscombinate.com
Connect with Subhi on LinkedIn:
https://www.linkedin.com/in/subhi-saadeh-1169aa21
