Hardware Podcasts

What are the Audit Etiquette Rules I Should be Following?

Global Medical Device Podcast · 12 Aug 2020 · 36m · Episode 159

What this episode covers

Greenlight Guru founder Jon Speer interviews Taylor Brown, a certified ISO 13485 Lead Auditor and medical device guru at Greenlight Guru, on the rules of audit etiquette. Brown explains that maintaining a 'stay ready' culture, where the Quality Management System (QMS) is the daily way of life rather than a panic-driven response, is critical for passing audits. The conversation covers specific behaviors such as controlling information flow, leveraging internal audits, and using the Greenlight Guru software to facilitate efficient, evidence-based audits.

Most relevant to

early-stage companies

Topics

Mentioned

Companies
Greenlight Guru
Products
Greenlight
Also
Taylor Brown, Jon Speer, ISO 13485, FDA

Related episodes from other shows

Other shows on the same ground, closest first.

  • Let's Combinate · 15m

    188 – Certified Quality Auditor(CQA) and Audits in the Future

    Subhi Saadeh, an ISO 13485 certified lead auditor and host of Let's Combinate, discusses the evolving role of auditing in the medical device and pharmaceutical industries. He reflects on his recent acquisition of the Certified Quality Auditor (CQA) credential and outlines the key qualities that distinguish great auditors, such as risk-based decision-making and the ability to trace issues across systems. Saadeh argues that while AI can streamline tasks like trend analysis and traceability, it cannot replace the human judgment, cultural assessment, and adaptability required for effective audits.

    Quality & yieldAI & machine learning
    2 chapters

  • Let's Combinate · 14m

    249 - The Best Audit Advice Nobody Told Me

    Subhi Saadeh, a quality professional and certified lead auditor specializing in drug-device combination products, shares five key lessons learned from transitioning from the auditee to the auditor side. He emphasizes that audits should evaluate the health and adequacy of a system rather than targeting individuals, and that auditors must look for systemic patterns rather than isolated errors. Saadeh also stresses the importance of setting realistic scopes, recognizing auditing as a distinct skill set separate from technical expertise, and lowering anxiety to gather better evidence.

    Quality & yieldCareers & education
    2 chapters

  • Let's Combinate · 13m

    215 - Why Aren’t Technical People Leading Drug-Device Audits?

    Subhi Saadeh, Founder of Let’s Combinate BioWorks, explains why engineers in pharma and medical devices should become auditors, arguing that technical expertise combined with audit methodology creates the most effective auditors. He details how auditing provides a system-level perspective, revealing how design decisions ripple through Quality Management Systems (QMS) and identifying systemic root causes that isolated engineering work often misses. Saadeh addresses common misconceptions, such as the view that auditing is merely bureaucratic paperwork, and reframes it as a critical tool for building regulatory fluency and career versatility across industries like aerospace and medical devices. He concludes with practical steps for engineers to enter the field, including shadowing internal audits, learning audit frameworks like ISO 13485, and seeking mentorship from experienced professionals.

    Quality & yieldCareers & education
    1 chapters

  • Let's Combinate · 13m

    168 - Audits, Audits, Audits: Why They Matter in Pharma, Medical Devices, and Personal Growth

    Subhi Saadeh, host of Let's Combinate and Quality Professional, discusses the parallel between Peter Drucker’s book 'Managing Oneself' and the role of audits in pharma and medical device industries. He explains the three levels of audits—first-party (internal), second-party (supplier), and third-party (regulatory/certification)—and their specific purposes in ensuring compliance with regulations like ISO 13485 and 21 CFR Part 4. Saadeh emphasizes that audits are systematic, evidence-based appraisal activities designed to reveal system weaknesses and build trust with regulators and patients, rather than just catching mistakes.

    Quality & yieldCertification & compliance
    1 chapters

  • Let's Combinate · 11m

    255 - Audit Interview Techniques: How Good Auditors Get Better Evidence

    Subhi Saadeh, founder of Let's Combinate, explains audit interviewing techniques developed with partner Andy Robertson, emphasizing that interviews are the bridge to verifying quality systems beyond desktop reviews. He details how to build rapport, use open-ended questions, and avoid checklist-driven approaches to get accurate evidence from auditees. The episode covers handling special situations like group interviews and translators, and managing challenges such as uncooperative escorts or time constraints during audits.

    Quality & yield
    1 chapters

The summary, chapters and topics are generated from the episode’s audio by this directory, not written by Global Medical Device Podcast. The episode itself belongs to its publisher.