Lead Auditors: You Need Them, but Can You Guarantee They Really Add Value? скачать в хорошем качестве

Lead Auditors: You Need Them, but Can You Guarantee They Really Add Value?

Most MedTech companies know they need auditors. Far fewer know how to tell whether their lead auditors are actually improving the quality system—or just creating paperwork and stress. In this Friday In-Focus replay, Rob Packard (President, Medical Device Academy) shares how he went from reluctantly inheriting quality and regulatory to building a career as a full-time auditor and trainer of notified body auditors. He explains what separates a checkbox auditor from a genuinely value-adding lead auditor, and how to build an audit program that strengthens your QMS instead of draining resources. Through real stories—from fully automated plants with robot-controlled traceability to painful third-party audits where the client says “please don’t ever send that auditor again”—Rob shows what good and bad auditing look like in practice. You’ll also hear his candid perspective on fees, career paths, and continuing education for auditors, including how he thinks about rates, how he trains new consultants, and why he still has to defend his credentials—even to auditors he once trained. 💡 You’ll Learn • How Rob became a full-time auditor (and why he now loves it). • The difference between an auditor and a lead auditor: planning, agenda, opening/closing meetings, and final decisions on nonconformities. • Why checklist audits are “just going through the motions” and how value-adding auditors ask smarter questions instead. • How internal and supplier audits can simulate FDA / certification body audits so your team knows what’s coming. • Why third-party certification audits are often “almost useless” from a value-add standpoint—and when you should fire an auditor who doesn’t add value. • What auditors actually charge, how Rob sets his rate, and how he grows new consultants from $200/hr upwards. • How to add value ethically as a third-party auditor by pointing clients to guidance documents instead of “consulting” directly. • Why continuing education, documentation, and an up-to-date resume matter—and how Rob uses every webinar, course, and audit to keep his credentials current. 🎙️ Speaker Rob Packard President, Medical Device Academy Auditor, consultant, and trainer for notified bodies and MedTech companies worldwide. ⏱️ Chapters (00:00) – Welcome & housekeeping (generic intro slot) (04:32) – How Rob fell into quality & regulatory (and nearly quit) (05:28) – From “paperwork punishment” to seeing auditing as a consulting business & thoughts on AI replacing paperwork (06:21) – Quitting his job to become a full-time BSI auditor – and learning to love auditing (08:09) – What qualifies someone to be an auditor? Sean asks, Rob answers (09:55) – Checklist audits vs real auditing: why “anyone can tick boxes” (10:44) – “The dumbest question I ever heard”: tampon factory, robots & traceability (11:32) – Understanding digital traceability: when auditors “don’t read robot” (12:25) – What is a lead auditor? Responsibilities, decisions, and running the audit (13:20) – Simulating certification & FDA audits in internal audits (two-auditor drills) (14:40) – Preparing small teams to support multi-auditor certification and MDSAP audits (16:22) – Why certification audits rarely add value—and why internal/supplier audits should be different (18:06) – What auditors can earn: Rob’s rate, new consultant rates, and aiming to be “the best, not the cheapest” (19:59) – Adding value as a third-party auditor by pointing clients to guidance documents (21:27) – Teaching clients to look things up: audits as learning, not spoon-feeding (36:54) – Continuing education & using webinars as part of your training record (38:27) – Defending your credentials—even to the auditors you once trained (39:41) – Audience question: how to justify regulatory knowledge (Canada, US, Japan, Australia) as part of auditor competence ℹ️ About Friday In-Focus Friday In-Focus is MLVx’s weekly webinar series—always free, always interactive—spotlighting MedTech’s most experienced thinkers and doers. 👉 Join the MLVx community: https://members.mlvexchange.com 🎟️ Use code SEAN20 to save 20% on membership.