Quality has a reputation for saying no.
Sometimes that’s exactly the right call. Other times, “no” is just the easiest answer.
In this episode, Subhi breaks down four situations where Quality should absolutely stop the train, and a few where it’s worth stepping back and asking what’s really driving the no in the first place.
Subhi covers:
when there is real patient or product risk
when the evidence doesn’t support the decision
when moving forward would clearly violate requirements or SOPs
when schedule or business pressure is pushing a team to close something that isn’t actually closed
He also talks through some weaker reasons Quality says no, including:
personal preference or “this is how we’ve always done it”
uncertainty from lack of technical familiarity
applying more GMP rigor than the stage of development actually requires
If you work in quality, combination products, development, manufacturing, or technical leadership, this is a practical look at how to think about “no” in a more risk-based way.
Timestamps
00:00 Why Quality Says No
00:45 Channel Intro and Setup
02:02 No When Risk Is Real
03:06 No When Evidence Fails
05:02 No When Requirements Break
05:44 No to Schedule Pressure
07:48 Bad No From Preference
08:33 Bad No From Uncertainty
09:20 Overkill and Phase GMPs
10:08 Build Flexible Quality Culture
12:16 Wrap Up and Takeaways
Subhi Saadeh is a consultant, trainer, auditor, and the Founder and Principal of Let’s Combinate. He has spent his career across medical devices and pharmaceuticals, with experience spanning research and development, industrialization, quality systems, and combination products. Through Let’s Combinate, he helps professionals and organizations better understand and navigate the intersection of drugs, devices, quality, and regulatory requirements.
Connect with Subhi Saadeh
LinkedIn: https://www.linkedin.com/in/subhi-saadeh-1169aa21/
Website: http://letscombinate.com/
Book a quick chat: https://calendly.com/letscombinate/quick-chat
Email: subhi@letscombinate.com
Listen / Follow Let’s Combinate
YouTube: https://www.youtube.com/@LetsCombinate
Spotify: https://open.spotify.com/show/71wYadhCrfLsdYTVachpD2
Apple Podcasts: https://podcasts.apple.com/us/podcast/lets-combinate-drugs-devices/id1589285792
#Quality #CombinationProducts #Pharma #MedTech #RiskManagement #GMP #DesignControls #SupplierQuality #QualitySystems #LetsCombinate
