# 249 - The Best Audit Advice Nobody Told Me

Page: https://stenobird.com/podcast/let-s-combinate-drugs-devices-4474248/249-the-best-audit-advice-nobody-told-me
Text version: https://stenobird.com/podcast/let-s-combinate-drugs-devices-4474248/249-the-best-audit-advice-nobody-told-me.md
Podcast: [Let's Combinate - Drugs + Devices](https://stenobird.com/podcast/let-s-combinate-drugs-devices-4474248)
Published: 2026-08-05T10:00:00+00:00
Episode link: https://podcasters.spotify.com/pod/show/letscombinate/episodes/249---The-Best-Audit-Advice-Nobody-Told-Me-e3mvrbf
Audio file: https://anchor.fm/s/6770b9a0/podcast/play/123775791/https%3A%2F%2Fd3ctxlq1ktw2nl.cloudfront.net%2Fstaging%2F2026-7-4%2F429230947-44100-2-71ded49cdbd7f.mp3
Processing state: not_requested
JSON: https://stenobird.com/v1/public/podcasts/let-s-combinate-drugs-devices-4474248/episodes/249-the-best-audit-advice-nobody-told-me
Duration seconds: 869

## Resource

Audits are not supposed to be gotchas, and they are not meant to evaluate one person’s work in isolation. A good audit looks at whether a system is suitable, effective, and adequate and where it may need to improve. In this video, I share the lessons I learned as I moved from being audited and supporting audit rooms to conducting audits as a certified lead auditor: 1) Audit the system, not the person: The goal is to understand how the system operates, not to catch an individual making a mistake. 2) Look for patterns, not isolated errors: One typo is different from a recurring or systemic problem, unless the individual event is critical. 3) Scope the audit before you start: The objective, criteria, time, resources, and agenda need to align before the audit begins. 4) Technical expertise is not the same as audit skill: Auditing requires its own tools, tactics, strategies, interviewing skills, and qualification. 5) Lower the temperature to get better evidence: People communicate more clearly when the auditor reduces unnecessary anxiety, although assertiveness is sometimes necessary when information is being withheld. Chapters 00:00 Audits Aren’t Gotchas 00:38 Audit the System, Not the Person 03:16 Look for Patterns, Not Isolated Mistakes 05:27 Set a Clear Audit Scope 08:21 Auditing Is Its Own Skill and Being Technical Helps 11:11 Lower the Temperature and Be a Human About Subhi Subhi Saadeh is a quality professional, consultant, auditor, and trainer who specializes in drug-device combination products, medical devices, pharmaceutical quality systems, supplier quality, and lifecycle management. Through Let’s Combinate, he helps pharmaceutical and medical-device teams bridge the gap between drug and device quality, regulatory expectations, and practical execution. Learn more…

## Actions

- request_transcript: `POST https://stenobird.com/v1/public/podcasts/let-s-combinate-drugs-devices-4474248/episodes/249-the-best-audit-advice-nobody-told-me/transcription-requests` — Idempotently request low-priority transcript generation for this episode.
- read_markdown: `GET https://stenobird.com/podcast/let-s-combinate-drugs-devices-4474248/249-the-best-audit-advice-nobody-told-me.md` — Read the agent-friendly Markdown representation of this episode resource.

A page view does not enqueue transcription. Agents should invoke `request_transcript` explicitly when they need this episode processed.

## Transcript

Full transcripts are not published on public pages unless there is a clear rights basis.