231 - Audit Findings Explained: Nonconformity vs Observation (CQA)
Let's Combinate - Drugs + Devices25 Mar

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

This is a lesson out of my ASQ CQA course with Andy Robertson, on how to write and classify audit findings.


Access the full CQA course here: https://cqeacademy.teachable.com/p/the-cqa-master-class-course


I break down key terms like finding, nonconformity, observation, and noncompliance, and explains that everything must tie back to requirements and objective evidence. The episode covers when to write a nonconformity vs an observation, common severity levels (critical, major, minor), and how to structure clear findings. I also cover how to sequence audit results and where auditors often go wrong, especially when they insert opinion or recommend solutions.


Timestamps

00:00 Course preview

00:42 Key audit terms

01:56 What makes findings reportable

04:16 Severity classification

06:42 Writing findings

07:57 Structuring reports

10:38 Auditor boundaries


Subhi Saadeh is a certified ISO 13485 Lead Auditor, CQE, and CQA with experience leading audits and building quality systems across medical devices and combination products at companies like Baxter, Pfizer, and Gilead Sciences. Through Let’s ComBinate, he focuses on bridging the gap between pharma and devices through educational content, industry collaboration, and consulting.

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