Hardware Podcasts

231 - Audit Findings Explained: Nonconformity vs Observation (CQA)

Let's Combinate · 25 Mar 2026 · 11m

What this episode covers

Subhi Saadeh, host of Let's Combinate and a certified ISO 13485 Lead Auditor, explains how to classify and write audit findings for the ASQ CQA certification, drawing on his experience with companies like Baxter and Pfizer. He distinguishes between nonconformities (failures to meet requirements) and observations (notes of concern) and details severity classifications of critical, major, and minor. Saadeh emphasizes that findings must be tied to objective evidence and specific requirements, warning against auditors inserting personal opinions or recommending solutions.

Most relevant to

established companies

Topics

Mentioned

Companies
ASQ, FDA, Baxter, Pfizer, Gilead Sciences
Also
ISO 13485, ISO 14644

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