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Poka-Yoke: An Essential Tool for Error Prevention in Manufacturing Poka-Yoke, a Japanese term meaning "mistake-proofing" or "error-proofing," The concept is : implement mechanisms that either prevent mistakes from occurring or immediately correct them if they do happen. History📑of Poka-Yoke The term Poka-Yoke was developed by Shigeo Shingo, an industrial engineer at Toyota, in the 1960s. Initially, the concept was known as "Baka-Yoke," which means "fool-proofing," but it was later changed to Poka-Yoke. Shingo's realized that many defects were caused by simple human errors, such as missing parts or incorrect assembly. By designing processes and tools that made it impossible to make these errors, he significantly improved the quality and reliability of the products. Poka-Yoke devices and systems can be categorized into three types: contact methods, fixed-value methods, and motion-step methods. 1️⃣ Contact Methods These methods use physical attributes to detect errors. For example, a machine might be designed with a specific shape or size that only allows the correct part to fit. Example ▶ A jig with a specific shape that only allows correctly shaped components to be inserted. 2️⃣ Fixed-Value Methods These methods monitor fixed values, such as the number of parts or operations, to ensure accuracy. Example ▶ A counter that tracks the number of screws used in an assembly. If the correct number is not reached, the process cannot proceed. 3️⃣ Motion-Step Methods These methods ensure that the correct sequence of operations is followed. If a step is skipped or performed out of order, the process stops. Example ▶ An assembly line that requires specific actions in a sequence, with sensors that detect if a step is missed. Levels of Poka-Yoke 1️⃣ Error Prevention The highest level of Poka-Yoke, where mechanisms are in place to make it impossible for errors to occur. Example ▶ A connector that only fits in one orientation, preventing incorrect assembly. 2️⃣ Error Detection This level focuses on detecting errors as they occur and immediately signaling the problem so it can be corrected before moving on to the next step. Example ▶ A light sensor that detects if a part is missing and stops the production line. 3️⃣ Error Mitigation The lowest level, where the system allows errors to occur but provides means to easily identify and correct them later. Example ▶ A checklist used by workers to verify steps after the process is completed.

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Internal Quality audits can help you identify gaps, weaknesses, risks, and opportunities for improvement in your quality performance. Furthermore, it can reduce costs and risks by preventing or minimizing waste, rework, complaints, recalls, and penalties. Finally, quality audits can drive innovation and learning by identifying best practices, gaps, and opportunities for improvement while fostering a culture of quality and excellence.

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ISO 9001:2015 QMS Clause 9 | Performance Evaluation | Quality Management System | Total Quality Management | Shakehand with Life https://lnkd.in/dHaC9wsm Watch this video till the end and learn the clause 9 of ISO 9001:2015 QMS. Clause 9 includes ►Monitoring, Measurement, Analysis and Evaluation ►Internal Audit ►Management Review #ISO9001_2015 #QMS #qmstraining #quality #qualitymanagementsystem #ISOStandards #iso9001 #ISO #performance #evaluation #monitoring #measurement #Analysis #InternalAudit #management #review #leanmanufacturing #leansixsigma#TQM #TotalQualityManagement

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Dear Quality Professionals: in your Quality System, do you differentiate between "Reviewers" and "Approvers"? ⚕ 21CFR 820.40 requires an individual *or* individuals to approve documents, meaning one is enough. There are numerous other references in the Guidances about having appropriate *reviewers*, especially for Design Controls, and that's where "reviewers" and "approvers" seem to be defined by different requirements. 📄 ISO 13485 4.2.4 requires approval either by the original approving function or another designated function - again implying that one *approver* is enough. ✔ The upside of multiple approvers is that the contributors explicitly acknowledge their agreement with the document and ensures inclusion of multiple voices, ideally with a good outcome. ✖ However decision-by-consensus can be a ball and chain on any project, and is not necessary for effective accountability (nor does it seem necessary for compliance). ❔How do you treat "approvers" vs "reviewers"?

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ISO standards, particularly ISO 9001 for Quality Management Systems (QMS), are structured into a series of clauses that outline the requirements an organization must meet to achieve certification. Here is an overview of the key clauses in ISO 9001:2015: 1. **Scope**: - Defines the scope and boundaries of the standard. - Describes what the standard covers and the intended outcomes. 2. **Normative References**: - Lists the reference documents that are indispensable for the application of the standard. - Provides context and additional details relevant to the standard. 3. **Terms and Definitions**: - Provides definitions for key terms used in the standard to ensure a common understanding. 4. **Context of the Organization**: - Understand the organization and its context (internal and external issues). - Understand the needs and expectations of interested parties (stakeholders). - Determine the scope of the QMS. - Establish the QMS and its processes. 5. **Leadership**: - Demonstrate leadership and commitment by top management. - Establish a quality policy that aligns with the organization's purpose and context. - Define organizational roles, responsibilities, and authorities. 6. **Planning**: - Address risks and opportunities to ensure the QMS achieves its intended outcomes. - Establish quality objectives and plan actions to achieve them. - Plan changes to the QMS. 7. **Support**: - Provide resources (people, infrastructure, environment, etc.) necessary for the QMS. - Ensure competence and awareness of employees. - Maintain documented information (documents and records) to support the QMS. 8. **Operation**: - Plan, implement, and control processes to meet requirements. - Establish criteria for processes and ensure conformity of products and services. - Control externally provided processes, products, and services. - Implement actions to address nonconforming outputs. 9. **Performance Evaluation**: - Monitor, measure, analyze, and evaluate QMS performance. - Conduct internal audits to ensure the QMS is effectively implemented. - Review QMS performance and make improvements. 10. **Improvement**: - Identify opportunities for improvement and implement necessary actions. - Address nonconformities and take corrective actions to prevent recurrence. - Continually improve the QMS to enhance performance and achieve quality objectives. These clauses form the structure of ISO 9001:2015 and guide organizations in establishing, implementing, maintaining, and continually improving their QMS. By adhering to these requirements, organizations can ensure consistent quality in their products and services, enhance customer satisfaction, and achieve continual improvement.

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📚 Training 📚 Ensuring that all personnel are adequately trained is critical for maintaining high standards of quality and compliance. ISO 13485 emphasizes the importance of competency and continuous improvement through comprehensive training programs. Key Elements of Training as per ISO 13485: Competency Requirements: ISO 13485 requires that all personnel performing work affecting product quality are competent based on education, training, skills, and experience. Organizations must define the necessary competencies for each role. Structured Training Programs: Develop structured training programs that address the specific needs of different roles within the organization. This includes initial training for new hires and ongoing training to keep staff updated on the latest regulations, technologies, and best practices. Documentation and Records: Maintain thorough documentation of all training activities, including training plans, attendance records, and assessment results. This ensures traceability and demonstrates compliance during audits and inspections. Evaluation of Training Effectiveness: Regularly evaluate the effectiveness of training programs through assessments, feedback, and performance reviews. Adjust training content and methods based on these evaluations to ensure continuous improvement. Continuous Improvement: Foster a culture of continuous improvement by encouraging employees to seek further education and training opportunities. Keep training materials updated to reflect changes in standards, regulations, and industry advancements. Benefits of Effective Training: Enhanced Compliance: Well-trained employees are better equipped to comply with regulatory requirements, reducing the risk of non-compliance. Improved Product Quality: Training ensures that employees have the necessary skills and knowledge to perform their tasks accurately and efficiently, leading to higher product quality. Operational Efficiency: A competent workforce can operate more efficiently, reducing errors and increasing productivity. Employee Engagement: Investing in training demonstrates a commitment to employee development, boosting morale and engagement. #MedicalDevices #ISO13485 #Training #QualityManagement #RegulatoryCompliance #ContinuousImprovement #EmployeeDevelopment #Healthcare

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Failure Mode Effects Analysis (FMEA) vs. ISO 14971 Risk Management... are you clear on the differences between them? 🤔 While FMEA can and should be used as a helpful tool for design and development teams evaluating materials, components, and sub assemblies comprising medical devices, it is NOT a substitute for the Risk Management standard. FMEA is different in both its scope and purpose. The basis of FMEA is identifying failure modes. However, the risks inherent in medical devices are not solely a function of failure. A medical device might never exhibit a failure mode, yet it may still have risks. We go more in-depth on these distinctions in this article: https://hubs.ly/Q02ZtQ5_0. #FMEA #iso14971 #riskmanagement #medicaldevices #medtech #regulatorycompliance #greenlightguru #premarket

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https://lnkd.in/dfF7Eefd (website) For a selection of free eBooks on planning and implementing an ISO 13485:2016 quality management system, as well as a selection of other eBooks go to this link: https://lnkd.in/gx5cywTn There are many challenges for start-up medical device companies when implementing a quality management system. This can also be true for established businesses that need to make major changes to their current QMS. One good example is for those US-based MedTech firms that must transition to the QMSR and ISO 13485:2016 requirements. Here I discuss just 3 of those potential challenges. If you are looking for help with your QMSR Transition you can message me and we can start a discussion. For our 41-page QMSR Gap Analysis Checklist go to this link: https://lnkd.in/gSbjhEnN. Also available are document templates for ISO 13485:2016 quality manual and procedure templates https://lnkd.in/gYXi8Xn6 #iso13485 #fdaqmsr #qualitymanagementsystem #qualityprocedures #gapanalysischecklist #isocertification

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‘Template’ ISO 13485 Quality Management Systems look great on paper, that’s where it ends, and that’s the problem. The processes that organisations use to make and sell their products need to integrate with their business in the real world. If documented procedures are not implemented properly or do not follow the practices of the business then they won’t be followed leading to non-conformities during certification audits. There is no ‘one size fits all’ QMS, every organisation is different, they have different staff with different levels of skill and experience, different products, different management and different sizes. Kinesys have experience in implementing effective QMS, based on the nature of the organisation (micro, small, medium, large) using a 4 step method. 1)       Gap analysis and training 2)       Implementation (for new systems) or transition support (if you have an existing QMS) 3)       Internal audit 4)       Certification audit assistance

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Having a Corrective and Preventive Action (CAPA) system effectively reacts to quality issues is okay but what if it helps you predict and prevent them before they even occur. That's where an AI-driven CAPA system for manufacturing makes all the difference.    With AI assistant, you get:  ➡ Predictive Insights - Identify potential risks timely and implement effective action plans before issues escalate.   ➡Accelerated Root Cause Analysis - Smart algorithms to analyze collected data and quickly detect the root causes of issues.   ➡Improved Production Quality - Reduce downtime, ensure consistent quality, and maintain compliance without fail.    AI-powered CAPA system transforms reactive problem-solving into a proactive, efficient, and strategic approach that keeps your manufacturing processes running smoothly.    Would you like to take your CAPA strategy to the next level?    💡 Discover how AI can help your manufacturing business achieve quality excellence by requesting a free demo. [https://lnkd.in/eCAg-4s4]    #Manufacturing #QualityManagement #CAPA #AIinManufacturing #AIpoweredQMS #USA #QualityWeeek

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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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Part Submission Warrant (PSW): Understand How This Document Fits Into PPAP #OperationalExcellence #OpEx #SixSigma

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𝐌𝐄𝐃𝐕𝐀𝐂𝐎𝐍 𝐇𝐚𝐬 𝐚 𝐍𝐞𝐰 𝐁𝐥𝐨𝐠 𝐏𝐨𝐬𝐭 Streamline Your QMS with Lean Documentation and Configuration Adopt a lean documentation approach for your QSDR by prioritizing essential information, simplifying data entry forms, and using standardized templates. Engage all stakeholders in the design process to ensure usability. Maintain version control to ensure consistency and accuracy, and configure your QSDR database with only the necessary fields to create intuitive and user-friendly interfaces. Implement automated workflows to streamline record management and ensure data integrity and accuracy. By applying these lean principles, you can enhance compliance, efficiency, and user satisfaction. 𝐓𝐨𝐝𝐚𝐲’𝐬 𝐏𝐨𝐬𝐭: 𝐏𝐚𝐫𝐭 𝟒 𝐨𝐟 𝟖 – 𝐋𝐞𝐚𝐧 𝐃𝐨𝐜𝐮𝐦𝐞𝐧𝐭𝐬 𝐚𝐧𝐝 𝐂𝐨𝐧𝐟𝐢𝐠𝐮𝐫𝐚𝐭𝐢𝐨𝐧 𝐀𝐩𝐩𝐫𝐨𝐚𝐜𝐡𝐞𝐬   “Design data entry forms with simplicity and usability in mind. Keep in mind these two terms are in the eye of the beholder. Therefore, form design should be a collaborative process between Quality, Document Control, the User (operator, technician), the User’s Supervisor and as many of the users/recipients of the executed form/data as possible...” https://lnkd.in/eJyGmR5S #discovery #lifescience #pharma #pharmaceutical #pharmaceuticals #biopharma #biopharmaceuticals #biopharmaceutical #biotech #biotechnology #biotechnologies #biotechindustry #biotechnologyindustry #pharmaceuticalindustry #pharmaceuticalmanufacturing #pharmaceuticalcompanies #pharmaceuticalresearch #pharmaceuticaltechnology #pharmaceuticalpackaging #pharmaceuticalsales #pharmaceuticaljobs #pharmaceuticalinnovation #pharmaceuticalsciences #biotechnologist #compliance #qualitycontrol #computersystemvalidation #cleaningvalidation #processvalidation #dataintegrity #technologytransfer #meddevice #medicaldevice #medicaldevicemanufacturing #medicaldeviceindustry #medicaldeviceregulation #medicaldevicemanufacturing #medicaldevicesales #medicaldevicedevelopment #medicaldevicedesign #medicaldeviceresearch #laboratoryequipment #laboratories #laboratorymedicine #laboratoryservices #laboratoryprofessionals #capa #qualification #validationengineer #engineering #engineeringservices #engineeringsolutions #processengineering #processengineer #engineeringdesign #heretohelp #gettingthejobdone #gettingthingsdone 

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