# 248 - What Is a Quality Unit? QA vs. QC Explained

- Show: [Let's Combinate](https://hardwarepodcasts.com/podcast/lets-combinate)
- Published: 2026-07-29
- Length: 8m
- Page: https://hardwarepodcasts.com/podcast/lets-combinate/2026-07-29-248-what-is-a-quality-unit-qa-vs-qc-explained
- Listen: https://podcasters.spotify.com/pod/show/letscombinate/episodes/248---What-Is-a-Quality-Unit--QA-vs--QC-Explained-e3mm6oe

## Summary

Subhi Saadeh, a quality consultant specializing in drug-device combination products, explains the regulatory and practical distinctions between the Quality Unit, Quality Assurance (QA), and Quality Control (QC). He defines the Quality Unit as the overarching function responsible for establishing, operating, and releasing products within a quality management system. Saadeh details how QA focuses on system processes like audits and change control, while QC focuses on tangible testing and inspection, noting that organizational structures vary significantly between pharmaceutical and medical device companies.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/lets-combinate/2026-07-29-248-what-is-a-quality-unit-qa-vs-qc-explained#t=0) Introduction: Subhi Saadeh and the Quality Unit Concept
- [0:00](https://hardwarepodcasts.com/podcast/lets-combinate/2026-07-29-248-what-is-a-quality-unit-qa-vs-qc-explained#t=0) The Three Major Responsibilities of the Quality Unit
- [0:00](https://hardwarepodcasts.com/podcast/lets-combinate/2026-07-29-248-what-is-a-quality-unit-qa-vs-qc-explained#t=0) Functions Within Quality: QA, QC, Validation, and Supplier Quality
- [4:32](https://hardwarepodcasts.com/podcast/lets-combinate/2026-07-29-248-what-is-a-quality-unit-qa-vs-qc-explained#t=272) QA vs. QC: Process Focus vs. Product Focus

## Topics

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

## Most relevant to

established companies

## Mentioned

- 21 CFR 211 (other)
- ICH Q10 (other)

## Related episodes from other shows

- [#380: Navigating the Complex World of Combination Products with Subhi Saadeh](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-08-30-380-navigating-the-complex-world-of-combination-products-with-subhi-saadeh) (Global Medical Device Podcast)
- [#329 The Right Way to Start a QMS: When, How, & What](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-07-27-329-the-right-way-to-start-a-qms-when-how-what) (Global Medical Device Podcast)
- [#420: MedTech Synergy: The Project Manager and Quality Professional Relationship](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2025-08-18-420-medtech-synergy-the-project-manager-and-quality-professional-relationship) (Global Medical Device Podcast)
- [Meet a Guru: Erica Loring](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-10-28-meet-a-guru-erica-loring) (Global Medical Device Podcast)
- [What are the Opportunities for Improvement (OFI) for Quality?](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-02-23-what-are-the-opportunities-for-improvement-ofi-for-quality) (Global Medical Device Podcast)

## Citing this page

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