Hardware Podcasts

097 - Predictive Quality, Business Process Capabilities, 3 Lines of Quality Defense, TOC, COSO and Business Risk with Larry Mager

Let's Combinate · 9 Aug 2023 · 43m

What this episode covers

Larry Mager, Principal at Mgmt-Ctrl and founder of PQMcoach.com, explains his Predictive Quality Management (PQM) framework, which applies the PDCA cycle to business processes rather than just product compliance. He argues that quality organizations must move beyond 'Big Q' compliance to facilitate 'Little Q' across all operations, using concepts like the 3 Lines of Defense and COSO risk management to identify and address constraints. Mager emphasizes that companies must define core capabilities, such as commercial product release, and use data analytics to drive systemic improvements rather than relying on siloed quality teams.

Most relevant to

established companies

Topics

Mentioned

Companies
Mgmt-Ctrl
Also
PQMcoach.com, Edwards Deming, COSO, ICH Q10, ISO 13485, ISO 14971

Related episodes from other shows

Other shows on the same ground, closest first.

  • The Manufacturing Executive · 29m

    Digitizing Quality Management

    Andrew Steele, founder of FactoryQA, discusses the critical role of quality management systems (QMS) in manufacturing, emphasizing that quality must be a cultural element driven by engaged employees rather than just a posted policy. He explains how ISO 9001 certification serves as a vital credibility signal for suppliers and outlines the significant risks of poor quality, including high costs of poor quality and reputational damage. Steele highlights the inefficiencies of analog, paper-based systems and introduces FactoryQA as a cloud-based solution that digitizes non-conformance tracking, document control, and inspection sheets to enable real-time analytics and predictive maintenance.

    Quality & yieldAI & machine learning
    5 chapters

  • Global Medical Device Podcast · 45m

    Building a Culture of Quality

    Dan Purvis, CEO and co-founder of Velentium, discusses building a quality-centric culture in medical device engineering that moves beyond mere regulatory compliance. He outlines a 'three-legged stool' model integrating people, business, and quality, emphasizing that true quality aligns with risk and safety rather than just adherence to standards. Purvis shares insights on hiring for teachability, fostering high-performance teams, and the importance of proactive preventive actions in quality management systems.

    Leadership, teams & cultureQuality & yield
    9 chapters

  • The Manufacturing Executive · 38m

    Quality Management in a Changing Manufacturing Environment w/ Naveen Poonian

    Naveen Poonian, President and CEO of iBase-T, discusses the critical state of quality management in aerospace and defense manufacturing, citing Boeing and Starliner delays as examples of risks when speed compromises quality. He argues that manual, paper-based processes and disconnected data systems lead to massive rework costs and quality escapes, urging a shift to digital ecosystems that enforce process control. Poonian highlights the urgent need to capture retiring workforce tribal knowledge into software to prevent quality loss and enable hyper-automation. He outlines iBase-T’s consultative approach to implementing MES and MRO solutions, emphasizing cloud-native agility, IT/OT integration, and phased adoption strategies to ensure user buy-in and successful digital transformation.

    Quality & yieldManufacturing partners & offshoring
    6 chapters

  • Global Medical Device Podcast · 43m

    We Achieved ISO Certification! Now What?

    Mark Alpert, Director of Quality at Greenlight Guru, explains that achieving ISO 9001 and ISO 27001 certification is merely the beginning of the journey, not the destination. He argues that companies must align their Quality Management System (QMS) with their broader business strategy to drive continuous improvement and use quality as a competitive advantage. Alpert highlights the common pitfall of focusing only on reactive Corrective Actions (CAPA) rather than proactive process improvement, urging leaders to create strategic gaps to drive performance. He emphasizes that a mature QMS integrates all functions, from sales to finance, to ensure the entire organization works toward the same high-level goals.

    Quality & yieldCertification & compliance
    7 chapters

  • Global Medical Device Podcast · 39m

    #420: MedTech Synergy: The Project Manager and Quality Professional Relationship

    Beth Waring, a medical device consultant at Greenlight Guru, discusses the critical relationship between project managers and quality professionals, advocating for a shift from a 'police force' mentality to a collaborative partnership. She explains the distinction between 'big Q' (the department) and 'small Q' (a company-wide quality mindset), emphasizing that open communication and explaining the 'why' behind procedures are key to adoption. The conversation highlights how digital EQMS solutions like Greenlight Guru streamline design controls, change orders, and traceability, reducing the manual burden on project managers and ensuring compliance with regulations like 21 CFR Part 820 and ISO 13485.

    Quality & yieldDesign for manufacturing & NPI
    9 chapters

The summary, chapters and topics are generated from the episode’s audio by this directory, not written by Let's Combinate. The episode itself belongs to its publisher.