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

- Show: [Let's Combinate](https://hardwarepodcasts.com/podcast/lets-combinate)
- Published: 2026-03-25
- Length: 11m
- Page: https://hardwarepodcasts.com/podcast/lets-combinate/2026-03-25-231-audit-findings-explained-nonconformity-vs-observation-cqa
- Listen: https://podcasters.spotify.com/pod/show/letscombinate/episodes/231---Audit-Findings-Explained-Nonconformity-vs-Observation-CQA-e3gu8jk

## Summary

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.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/lets-combinate/2026-03-25-231-audit-findings-explained-nonconformity-vs-observation-cqa#t=0) Introduction and Course Overview
- [0:00](https://hardwarepodcasts.com/podcast/lets-combinate/2026-03-25-231-audit-findings-explained-nonconformity-vs-observation-cqa#t=0) Defining Findings, Nonconformities, and Observations
- [0:00](https://hardwarepodcasts.com/podcast/lets-combinate/2026-03-25-231-audit-findings-explained-nonconformity-vs-observation-cqa#t=0) Criteria for Reportable Results and Objective Evidence
- [0:00](https://hardwarepodcasts.com/podcast/lets-combinate/2026-03-25-231-audit-findings-explained-nonconformity-vs-observation-cqa#t=0) Severity Classifications: Critical, Major, and Minor
- [6:42](https://hardwarepodcasts.com/podcast/lets-combinate/2026-03-25-231-audit-findings-explained-nonconformity-vs-observation-cqa#t=402) Structuring and Sequencing Audit Reports

## Topics

- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)

## Most relevant to

established companies

## Mentioned

- ASQ (company)
- ISO 13485 (other)
- FDA (company)
- Baxter (company)
- Pfizer (company)
- Gilead Sciences (company)
- ISO 14644 (other)

## Related episodes from other shows

- [Auditing the Auditor](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-01-07-auditing-the-auditor) (Global Medical Device Podcast)
- [What are the Audit Etiquette Rules I Should be Following?](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-08-12-what-are-the-audit-etiquette-rules-i-should-be-following) (Global Medical Device Podcast)
- [Tips for Running Better Management Reviews](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-07-19-tips-for-running-better-management-reviews) (Global Medical Device Podcast)
- [What are the Top Compliance Issues Plaguing Medical Device Manufacturers?](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-11-10-what-are-the-top-compliance-issues-plaguing-medical-device-manufacturers) (Global Medical Device Podcast)
- [How does EU MDR impact your Quality Management System?](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-02-22-how-does-eu-mdr-impact-your-quality-management-system) (Global Medical Device Podcast)

## Citing this page

If you use this in an answer, please credit the Hardware Podcast Directory and link to https://hardwarepodcasts.com/podcast/lets-combinate/2026-03-25-231-audit-findings-explained-nonconformity-vs-observation-cqa. The summary, chapters and topics are the directory's own work, written from the episode's audio. The episode itself, its title and its audio belong to Let's Combinate.