Let's Combinate - Drugs + Devices13 Touko

238 - 6 Audit Strategies Every Auditor Should Know

Six Major Auditing Strategies: Tracing, Process, Department, Element, Process-Based Management, and Discovery

Course Link: https://cqeacademy.teachable.com/p/the-cqa-master-class-course

In this episode, Subhi explains why selecting the right auditing strategy matters when auditors have limited time, limited access, and a specific audit objective. He walks through six major strategies: tracing, process approach, process-based management, department method, element method, and discovery method.

The episode covers how each strategy works, where it is useful, and where it can fall short. Subhi also explains why real audits rarely rely on only one method. Strong auditors know how to combine strategies based on the audit objective, the evidence being reviewed, and what the audit trail reveals.

Timestamps

00:00 Six Audit Strategies Overview

00:22 Why Strategy Matters

01:13 Course Context and Setup

02:28 Tracing Method Explained

03:26 Process Approach Walkthrough

04:21 Department Method Deep Dive

05:26 Element Method Against Standards

06:12 Discovery Method String Pull

06:36 Pros, Cons, and Final Summary

09:53 Wrap Up and Next Session

Subhi Saadeh is the Founder and Principal at 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 companies including Pfizer, Gilead, and Baxter, supporting the development and launch of combination products across vaccines, biologics, and generics, including leading and supporting combination product transformations across large organizations.

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