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

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Text version: https://stenobird.com/podcast/let-s-combinate-drugs-devices-4474248/231-audit-findings-explained-nonconformity-vs-observation-cqa.md
Podcast: [Let's Combinate - Drugs + Devices](https://stenobird.com/podcast/let-s-combinate-drugs-devices-4474248)
Published: 2026-03-25T10:00:00+00:00
Episode link: https://podcasters.spotify.com/pod/show/letscombinate/episodes/231---Audit-Findings-Explained-Nonconformity-vs-Observation-CQA-e3gu8jk
Audio file: https://anchor.fm/s/6770b9a0/podcast/play/117432372/https%3A%2F%2Fd3ctxlq1ktw2nl.cloudfront.net%2Fstaging%2F2026-2-24%2F420706371-44100-2-6e98b45aff0cb.mp3
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JSON: https://stenobird.com/v1/public/podcasts/let-s-combinate-drugs-devices-4474248/episodes/231-audit-findings-explained-nonconformity-vs-observation-cqa
Duration seconds: 718

## Resource

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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## Transcript

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