Harold Brown

Built in quality is critical if you want to reduce value chain cost and lead-time. The key components of built in quality: 1) Building in critical to quality processes into standardized work 2) Embedding a quality check into the standardized work as well. (In this picture, the standardized work did not include an embedded test, and would have created quality defect if it wasn't caught by a subsequent phase gate check.) #TPS #toyotaproductionsystem #toyotaway #TnTkaizen #continuousimprovement #processimprovement #peopledevelopment #leadershipdevelopment #kaizen #PDCA #quality #problemsolving

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❓Curious about how JMT Compliance Consulting can support your business needs❓ 🌐 Whether you need to design or optimize your quality management system, strengthen your QA/RA leadership team, refine regulatory strategies, or drive operational excellence, let's connect! 🤝Let's work together to achieve your organizational goals and deliver exceptional results! Please feel free to reach out to learn more: 📩 [email protected] 🌐 www.jmtcompliance.com Or schedule some time: 📅 https://lnkd.in/gbJF65pW If you found this post interesting, please: ♻️ Like, Comment and/or Reshare with your network ➡️ Follow JMT Compliance Consulting for news and updates

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🔍🔧 Understanding the differences between Quality Assurance (QA) and Quality Control (QC) is essential for effective quality management. This article covers the basics of QA and QC, key practices, examples of integration, and their key differences. Learn more here: https://lnkd.in/dZjnsVGi #QualityAssurance #QA #QualityControl #QC #QualityManagement #ProcessImprovement #ProductTesting

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Quality Management System Regulation (#QMSR) for #MedicalDevice: Final Rule Amending the Quality System Regulation Update: August 7, 2024 The revised #part820 is now titled the Quality Management System Regulation (#QMSR). When referring to the rule that is currently effective, the FDA uses the term "Quality System (QS) Regulation" or "#QSregulation." On January 31, 2024, the #FDA issued a final rule amending the device current good manufacturing practice (#CGMP) requirements of the Quality System (QS) Regulation under 21 CFR 820 to align more closely with the international consensus standard for Quality Management Systems for medical devices used by many other regulatory authorities around the world. This rule amends 21 CFR 820 by incorporating by reference the quality management system requirements of the international standard specific for medical device quality management systems set by the International Organization for Standardization (ISO), #ISO13485:2016. Find out more 👇 https://lnkd.in/e_chz2w7

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Are you confident in your quality management system (QMS)? Understanding how to identify potential pitfalls is crucial. In this free whitepaper, we break down the core building blocks of a solid QMS so you can be confident in your system. Download here: https://azzur.co/43ZYMum #CAPA #QualityManagementSystem #LifeScience #ISOStandards #GMP

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ISO 9001 states the requirements for your Quality Management System (QMS). There are 10 sections (clauses) in ISO 9001, with additional subclauses related to the Plan-Do-Check-Act system. However, only sections 4-10 contain requirements that are auditable. To successfully implement ISO 9001:2015 within your organizsation, you must satisfy the requirements within clauses 4-10 along with meeting customer and applicable statutory and regulatory requirements.

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Quality auditing is essential for organizations to ensure compliance with industry standards and to deliver products or services that meet customer expectations. This article examines the fundamental aspects of quality auditing, the importance of a certified quality auditor (CQA), and the certification process involved. #AuditCriteria #auditmethod #BestPractices #InternalAudit #qualitycontrol #RiskManagement #StandardOperatingProcedures

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Quality control (QC) is the misunderstood essential for improvement. When effectively used, quality control methods can help internally monitor performance, assess progress, and help systems to direct improvement resources to where they are needed most. Many industries successfully use QC methods, but in health care, QC is often unfortunately misunderstood as synonymous with quality assurance (QA). Read more in this blog: https://lnkd.in/ePEUrrTJ Are you interested in joining IHI's Leading Quality Improvement Program (LQI)? The program uses innovative teaching methods to enhance engagement and deepen understanding of quality improvement to improve organizational efficiency. Learn more about the LQI program and download the full agenda here: https://lnkd.in/eCTrGXn8

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When your Quality Management System (QMS) becomes top heavy with CAPAs and deviations focused on implementation, correcting, "shoring up", and rebuilding the QMS, it has lost its effectiveness as an "operational control" intended to produce safe and effective medical products. #QMS #QualityManagement #operationalcontrol #medicaldevices

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One of my fav topics! I 💕 statistical analysis.

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Is your company quality systems up to scratch❓❓❓ Does your company or team use the QMS core systems as they should be, so that your regulatory compliance is under control? I often find that clients do not understand what system to use when something happens or goes wrong, and one system, usually the CAPA, gets used for most things. This is a problem because it buries in formation, making it hard to track and trend. And can make it hard to diagnose issues before they become raging compliance problems. So check out my newest online course - Implementing Core Quality Systems. And don't forget, there is 20% off if you sign up or book a call for team training before 6th August... tomorrow! Use the coupon code 𝗤𝗦𝗡𝟮𝟶𝗢𝗙𝗙. Learn more about the course here, and what quality systems are included 👉 https://lnkd.in/gUUvkzFr #GMP #QMS #pharmaceuticals #medicaldevice #training

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5 blind spots to check in your CAPA process: 1️⃣ Complaints, including reportable adverse events, are not considered for CAPA decision 2️⃣ Failing to conduct a health hazard evaluation (HHE) when required by CAPA procedure 3️⃣ Missing out on potential safety signals and not taking timely action through CAPA 4️⃣ Failing to escalate manufacturing nonconformances to CAPA for corrective actions 5️⃣ Failing to check CAPA effectiveness and to ensure there is no adverse effect on the device 👇Check out this Let's Talk Risk! special feature article to learn more. See link in comments below. ============================= 👍Like this post? ♻️Repost and share. #letstalkrisk #riskmanagement #medicaldevices

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Question: What are the duties of a quality assurance manager? See my answer below. Commenters: In your experience, have you seen QA manager duties that differ from what is shown? If so, what were their duties? See more questions and answers like the one below in my book "Year of Quality: 365 Questions and Answers About Business Performance", available at https://lnkd.in/eQccWjuZ #tqm #qualitymanagementsystem #iso9001 #dmaic #operationalexcellence #leansixsigma #leanmanufacturing

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