Dallas Harris

Its easier to understand than ever before.

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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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Vincent F. Cafiso so these are my 5 cent contribution to the subject at hand, compliants. As a former FDAer, I was the biggest peeping Tom into the window of compliants as soon as I issued the FDA-482. I considered compliants along with CAPAs usually the other symbiotic system the windows to the soul of the firm’s investment in true QMS if done correctly. There we will see if the firm truely is invested in listening to and investigating the feedback from their products once the product leaves the confines of their quality control. As a private consultant the first part is also true, but in addition it reveals the weakness the QMS has, at minimum the areas targeted for improvement to advise the client. As soon as I arrive at your firm I dive into these two systems, I can tell if you are faking it or you are raking the trending the data from these systems to improve. A form that fakes its compliant system or has untrained staff taking compliants and more importantly processing them is subject to risk creep that will eventually lead to serious ramifications such as recalls. That said the compliant system is facing the facts, the evidence of quality and compliance.

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📊 Audit Schedules and Audit Plans 📊 Maintaining a robust Quality Management System (QMS) is crucial. ISO 13485 emphasizes the significance of systematic audits to ensure ongoing compliance and continuous improvement. Audit Schedule: An audit schedule is a strategic tool that outlines when and how often audits will be conducted. It ensures that all areas of the QMS are regularly reviewed. Key elements include: Frequency: Establishing regular intervals for audits based on the complexity and criticality of processes. Scope: Covering all aspects of the QMS, including design, production, and post-market activities. Resources: Allocating sufficient resources, including qualified auditors, to conduct thorough reviews. Audit Plan: The audit plan provides detailed guidelines on how each audit will be conducted. It ensures a structured approach and consistent application of audit principles. Key components include: Objectives: Clearly defined objectives that align with the overall goals of the QMS. Criteria and Scope: Specific criteria and scope for each audit, including relevant standards and regulatory requirements. Methodology: A detailed methodology outlining the audit process, from planning and execution to reporting and follow-up. Timeline: A well-defined timeline to ensure the audit is completed efficiently and effectively. Benefits of a Well-Structured Audit Schedule and Plan: Enhanced Compliance: Regular audits help ensure compliance with ISO 13485 and other regulatory requirements. Continuous Improvement: Identifying areas for improvement and implementing corrective actions to enhance the QMS. Risk Management: Proactively identifying and mitigating risks associated with medical device production and quality. Operational Efficiency: Streamlining processes and improving overall operational efficiency through systematic reviews. #MedicalDevices #ISO13485 #QualityManagement #AuditSchedule #AuditPlan #RegulatoryCompliance #ContinuousImprovement #Healthcare #PatientSafety

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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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https://lnkd.in/g2DWUiYN An FMEA helps identify Risks within your organization. Based on the FMEA data you can create a plan to prevent possible issues.

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https://lnkd.in/g2DWUiYN An FMEA helps identify Risks within your organization. Based on the FMEA data you can create a plan to prevent possible issues.

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For my second post for my SCLT 4380 class, I decided to look deeper into TQM and the importance of it. TQM(Total Quality Management) is crucial because it can aid in cost reduction, efficiency improvement, and increase customer satisfaction. The principles that this article covers are not theoretical but are actively used by leading organizations like Toyota to drive success and sustainability. Utilizing TQM can lead to stronger, more resilient operations and give companies a competitive edge. https://lnkd.in/ggiNcyBA Gulshan Singh, PhD #SCLT4380 Margaret A. Kidd, CMILT, CPE™

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Enhancing Quality Through Supplier Corrective Action Requests (SCARs) When aiming to elevate quality standards within an organization, the role of quality audits cannot be overstated. These audits are crucial for uncovering non-conformances that may arise internally, ensuring that processes and outputs meet stringent quality benchmarks. However, it's equally vital to extend this vigilance to external stakeholders, particularly suppliers. Securing raw materials of optimal quality is paramount, as the old adage goes, "garbage in, garbage out." This underscores the importance of implementing Supplier Corrective Action Requests (SCARs) as a formal mechanism to address and rectify issues related to products or services supplied by external partners. SCARs play a pivotal role in several key aspects: Issue Resolution: They serve as a structured approach to report and resolve issues concerning the quality, performance, or compliance of supplied goods or services. By promptly addressing non-conformances and defects, organizations uphold product integrity and service excellence. Quality Improvement: Through systematic documentation and corrective actions, SCARs facilitate continuous improvement in the quality of received products. This fosters reliability, consistency, and heightened customer satisfaction. Supplier Performance Management: SCARs are integral to evaluating supplier performance over time. They provide valuable insights into supplier responsiveness, quality standards adherence, and overall reliability in meeting organizational expectations. Prevention of Recurrence: Beyond addressing immediate issues, SCARs focus on root cause analysis and preventive measures. By identifying underlying causes and implementing robust corrective actions, organizations mitigate the risk of recurring issues. Communication and Documentation: SCARs serve as formal records of communication between organizations and their suppliers. They detail issue specifics, investigative findings, corrective actions taken, and outcomes, providing a transparent audit trail.  Continuous Improvement: Embracing SCARs fosters a culture of continuous improvement across the supply chain. By proactively addressing challenges and fostering collaborative problem-solving with suppliers, organizations drive sustained enhancements in product quality and supplier relationships. In summary, SCARs represent a cornerstone in maintaining high-quality standards, effective supplier management, regulatory compliance, and fostering a culture of continual improvement. By leveraging SCARs diligently, organizations not only safeguard their reputation but also enhance operational excellence and customer satisfaction. Kereen R. McPherson, CEO/Founder, KRMcPherson Quality Management (KQM) [email protected] https://lnkd.in/ebcaFnif https://lnkd.in/emY3k6Zw LI: Ms Kereen McPherson 1-868-761-8206 #SupplierRelationships #ContinuousImprovement #SCARs #SupplyChainExcellence

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While most medical device manufacturers prioritize quality control within their processes, the approach is often insufficient and delayed. Quality control and assurance activities that occur too late in the production process or rely excessively on a designated team of inspectors can lead to significant waste, rework, and increased labor costs. It’s essential for manufacturers to integrate quality from the very start of the design phase, writes Nero Haralalka of TBM Consulting Group in this new Med Device Online article. https://lnkd.in/eurvtFyB #medicaldevices #qualitymanagement #medicaldevicemanufacturing

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Quality community, help us grow together. I have recently been sending out invites to as many quality directors and regulatory managers as I could. My goal is to have a network of people that have the same goals and passions I have in my professional career. I know there are hundreds of groups you can join here but not everyone in our community is aware of, or active in these groups. Find these people and bring them into the fold, show them that others are here to support them and make sure that everyone is aware that we can help each other professionally even if we don't work at the same company. General quality questions can be asked and answered easily enough on this platform, encourage people to do that and if you have productive feedback share it here so we can grow as a quality community.

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❓ How would FDA's approach to CAPA change under QMSR? ✅ I asked this question to Darrin Carlson, RAC-Devices, PMP in a recent Let's Talk Risk! podcast. 👇 Listen to his answer in this brief clip. 👉 Full recording coming soon to Let's Talk Risk! =============================== 💕 Love this tip? ♻ Repost to share with others in your network. #letstalkrisk #qmsr #medicaldevices #livideo

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The 𝟱𝗦 𝗺𝗲𝘁𝗵𝗼𝗱𝗼𝗹𝗼𝗴𝘆 has always been one of my favorite elements of lean management. I especially appreciate the way its implementation impacts employee morale. 😊 👀 Our actions are always closely observed by the people we employ. I would say they are 𝘁𝗵𝗲 𝘀𝗼𝘂𝗹 𝗼𝗳 𝘁𝗵𝗲 𝗰𝗼𝗺𝗽𝗮𝗻𝘆. If something starts to go wrong, their negative reaction is usually the first sign of it. Combating chaos and organizing everything within the framework of 5S can work wonders in this area. That's why I believe teaching this method is extremely important! #5SMethodology #LeanCulture #EmployeeMorale

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