242 - Pharma/MedTech Audits: 6 Strategies for Choosing Where to Start

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?

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https://letscombinate.com

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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 speaker with experience across pharma, biotech, medical devices, and combination products.

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