Episode
242 - Pharma/MedTech Audits: 6 Strategies for Choosing Where to Start
- Published
- Jun 17, 2026
- Duration seconds
- 730
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Summary
One of the hardest parts of auditing is not knowing what to look for.It is deciding where to start. Do you trace a deviation? Walk the process? Focus on one department? Audit CAPA across the organization? Or pull on a thread that does not quite make sense? In this video, Subhi walks through six audit strategies from the ASQ Certified Quality Auditor Body of Knowledge and explains how they apply in real-world pharma, biotech, and combination product audits. The six strategies covered are: 1. Tracing 2. Process Approach 3. Process-Based Management 4. Department Method 5. Element Method 6. Discovery Method These approaches are useful whether you are auditing a supplier, a manufacturing site, a testing laboratory, or a quality system that spans drug, device, and combination product responsibilities. Need support with combination product quality, auditing, supplier quality, or quality system strategy? Schedule a Let’s Combinate intro call: https://calendly.com/letscombinate/let-s-combinate-intro-session Learn more about Let’s Combinate: https://letscombinate.com Preparing for the CQA exam? Check out the CQA Master Class here: https://cqeacademy.teachable.com/p/the-cqa-master-class-course Chapters: 00:00 Six Audit Strategies Overview 01:12 Tracing Method Explained 02:59 Process Approach Workflow 04:27 Process-Based Management 05:46 Department Method Deep Dive 06:27 Element Method Across the QMS 07:12 Discovery Method: Pull the Thread 08:55 Summary: Pros and Cons 11:31 Final Tips and Next Steps Subhi Saadeh is the Founder and Principal of Let’s Combinate, where he helps teams develop and control drug-device combination products by aligning quality systems, development, and regulatory expectations across drug and device domains. He is a consultant, auditor, trainer, and speake…