# 238 - 6 Audit Strategies Every Auditor Should Know

- Show: [Let's Combinate](https://hardwarepodcasts.com/podcast/lets-combinate)
- Published: 2026-05-13
- Length: 10m
- Page: https://hardwarepodcasts.com/podcast/lets-combinate/2026-05-13-238-6-audit-strategies-every-auditor-should-know
- Listen: https://podcasters.spotify.com/pod/show/letscombinate/episodes/238---6-Audit-Strategies-Every-Auditor-Should-Know-e3j9ttg

## Summary

Subhi Saadeh, founder of Let’s Combinate and a veteran auditor with experience at Pfizer, Gilead, and Baxter, explains six major auditing strategies for quality systems in drug-device combination products. He details the tracing method, process approach, department method, element method, process-based management, and discovery method, outlining the specific use cases, strengths, and limitations of each. Saadeh emphasizes that effective auditors must combine these strategies based on limited time and specific audit objectives rather than relying on a single checklist.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/lets-combinate/2026-05-13-238-6-audit-strategies-every-auditor-should-know#t=0) Introduction and Course Context

## Topics

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

## Most relevant to

established companies

## Mentioned

- Pfizer (company)
- Gilead (company)
- Baxter (company)
- ISO 9001 (other)
- CQA book (other)

## Related episodes from other shows

- [For the Love of Internal Auditing](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-04-26-for-the-love-of-internal-auditing) (Global Medical Device Podcast)
- [Auditing the Auditor](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-01-07-auditing-the-auditor) (Global Medical Device Podcast)
- [#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)
- [#467: Combination Product Compliance: PMOA, 21 CFR Part 4 & QMS Alignment](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-08-03-467-combination-product-compliance-pmoa-21-cfr-part-4-qms-alignment) (Global Medical Device Podcast)
- [#323 The Combination Products Handbook](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-06-16-323-the-combination-products-handbook) (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/2026-05-13-238-6-audit-strategies-every-auditor-should-know. 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.