Hardware Podcasts

238 - 6 Audit Strategies Every Auditor Should Know

Let's Combinate · 13 May 2026 · 10m

What this episode covers

Subhi Saadeh, founder of Let’s Combinate and a veteran auditor with experience at Pfizer, Gilead, and Baxter, explains six major auditing strategies for quality systems in drug-device combination products. He details the tracing method, process approach, department method, element method, process-based management, and discovery method, outlining the specific use cases, strengths, and limitations of each. Saadeh emphasizes that effective auditors must combine these strategies based on limited time and specific audit objectives rather than relying on a single checklist.

Most relevant to

established companies

Topics

Mentioned

Companies
Pfizer, Gilead, Baxter
Also
ISO 9001, CQA book

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