The Manufacturing Executive · 9 Aug 2022 · 29m · Episode 114
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.
Where this conversation describes AI being used to build or deliver a product. Part of the AI in practice tracker.
Quality & testFactory QA
The software uses predictive analytics on inspection data to identify trends toward nonconformance, allowing manufacturers to prevent defects before they occur.
“this is where we're starting to get into some predictive analytics where with your inspection sheets … we will be able to tell you when something is starting to trend towards a nonconformance, which will allow you to prevent issues from even occurring in the 1st place.”
Speaker 1 · Hear it at 18:19
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Larry Mager, Founder of MGMT-CTRL, explains why fewer than 20% of companies have started Quality 4.0 despite 63% believing it will transform operations. He introduces his Quantum Quality Management (QQM) framework, a five-phase roadmap that prioritizes people, process, and technology to move beyond compliance. Mager argues that legacy Electronic Quality Management Systems (EQMS) fail because they are pre-programmed, whereas modern solutions use 'digital twins' to model workflows and ensure digital continuity. He emphasizes that successful implementation requires a strategic roadmap, cultural change, and management control rather than just installing software.
Larry Mager, Principal at Mgmt-Ctrl and founder of PQMCoach.com, discusses his evolution from a Fortune 500 quality engineer to a startup operator who built a Quality Management System (QMS) from scratch for a cardiovascular device. He explains the shift from 'Big Q' compliance to 'Little Q' operational excellence, detailing how he navigated an FDA consent decree at a large manufacturer and later moved into consulting to address communication barriers in quality management. Mager advocates for Predictive Quality Management (PQM) and the Plan-Do-Check-Act (PDCA) cycle as universal tools for improving business performance across pharma, medical devices, and CROs.
Sara Adams, a quality engineering expert with extensive experience in FDA inspections, explains why Quality Management Systems (QMS) cannot be bought off-the-shelf, using a sourdough bread analogy to illustrate the need for customization. She details the layers of a QMS, from procedural documents to electronic storage, emphasizing that while tools like Greenlight Guru provide 'guardrails,' the specific procedures must be tailored to the company's risk profile and regulatory requirements. Adams highlights common pitfalls, such as using non-compliant signatures in SharePoint or paper-based systems, and stresses that the ultimate goal of any QMS decision is patient safety, not just passing an audit.
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.
Maryann Mitchell, a Solutions Engineer at Greenlight Guru with 15 years of medical device experience, explains the role of a Compliance Manager and the cultural barriers between engineering and quality teams. She details challenges in managing multi-site quality systems, such as right-sizing procedures for sites ranging from 11 to 1,000 employees, and the pain of losing traceability when engineers iterate without documentation. Mitchell contrasts paper-based systems with electronic Quality Management Systems (eQMS), highlighting how eQMS improves audit defense and reduces administrative bottlenecks like lost physical documents.
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