
256 - The New FDA Inspection Playbook: Where to Start with QMSR
QMSR became effective on February 2, 2026. Alongside that change, FDA retired the Quality System Inspection Technique (QSIT) and began using the inspection process described in Compliance Program 7382...
28 Sep 9min

255 - Audit Interview Techniques: How Good Auditors Get Better Evidence
A huge part of the job is knowing how to interview people, understand how work is actually performed, and corroborate what you hear against records, observations, and other objective evidence.In this ...
21 Sep 11min

254 - Saying No Is the Easy Part of Quality
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 abs...
13 Sep 12min

253 - FDA Is Making Big Changes to Its Inspection Approach
FDA is changing how it organizes and deploys its investigators but it isn’t simply returning to the old generalist model.Eric Pittman spent more than 20 years at FDA, conducted approximately 800+ insp...
7 Sep 45min

252 - Acceptance Sampling Fundamentals: AQL, Attributes vs Variables, and Risk (OC Curves)
Acceptance sampling is one of the most commonly used and commonly misunderstood tools in quality.In this video, I break down the fundamentals of acceptance sampling: what it is, what an AQL actually m...
31 Aug 13min

I'm Changing The Podcast
After 250 straight weeks of publishing Let’s Combinate every Wednesday, I’m making a change.Starting now, new episodes will go live Mondays at 5:00 AM CT.To everyone who watches, listens, shares, or h...
18 Aug 2min

250 - PIC/S PI 006-4 (2026): What Changed in Qualification & Validation?
PIC/S has issued its first major update to its qualification and validation recommendations in nearly 20 years. PI 006-4 replaces PI 006-3 from 2007 and brings the document much closer to how qualific...
12 Aug 11min


















