Ekaterina Potemkina

✍🏽 Do you know there are 5 important laws in Lean Six Sigma for Process Optimization? 🤗 No worries! I've explained these 5 important laws in simple terms in the video. 💎 For more details about the most effective and practical Lean Six Sigma programs with lifetime access and mentoring support visit the following link: https://lnkd.in/d7W2zUip #leansixsigma #sixsigma #successfulcareerhub #learnandapply #lawsinleansixsigma #5lawsforprocess #lawsforprocessoptimization #processimprovement

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🔄 5. Common Challenges in Change Management: 🔸 Lack of Communication: Poor cross-department collaboration. 🔸 Inadequate Risk Assessment: Superficial evaluation of potential risks. 🔸 Delayed Approvals: Bottlenecks in the review and authorization process. 🔸 Poor Documentation: Missing or incomplete records. ✅ Solutions: Adopt Digital Change Control Systems (e.g., QMS platforms). Regular training sessions for teams. Clear escalation protocols for urgent changes. 💡 6. Best Practices for Effective Change Management: ✅ Follow a structured and documented process. ✅ Perform thorough impact assessments. ✅ Keep stakeholders informed throughout the process. ✅ Use Change Control Software for tracking and approvals. ✅ Conduct regular audits to evaluate change effectiveness. 🚀 7. The Role of Technology in Change Management: ✅ Use Quality Management Systems (QMS) to streamline workflows. ✅ Digital tools enable: Real-time tracking of changes Automated approval workflows Audit trail for traceability 📣 Key Takeaway: A robust change management system ensures that any modification in processes, systems, or materials is controlled, evaluated, and documented properly, safeguarding product quality, regulatory compliance, and patient safety. 👉 How does your organization manage changes? Are you leveraging any digital tools for change control? Share your thoughts below! #ChangeManagement #PharmaceuticalIndustry #QualityManagement #RegulatoryCompliance #RiskAssessment #PatientSafety #Pharma

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Is your organization ready for the future of quality? The ISO 9001:2015 standard is the international benchmark for quality management systems (QMS). By implementing a robust QMS, organizations can demonstrate their commitment to consistently delivering high-quality products and services. Here's what ISO 9001:2015 can do for your business: Increase customer satisfaction: A focus on meeting and exceeding customer expectations is at the core of the standard. Boost efficiency and productivity: Streamlined processes and continuous improvement lead to smoother operations. Minimize errors and waste: Preventive measures help to identify and address potential issues before they occur. Enhance employee engagement: A strong quality culture empowers employees and fosters a sense of ownership. Gain a competitive edge: ISO 9001 certification is a globally recognized symbol of quality, opening doors to new markets. Feeling inspired? Let's discuss how ISO 9001:2015 can help your organization achieve its quality goals. #ISO9001 #QMS #QualityManagementSystem

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Quality Control Cycle in Process Improvement Explained ... https://lnkd.in/d_AYSDsX In today's competitive business environment, continuous process improvement has become essential for maintaining high-quality standards and achieving operational efficiency. At the heart of this improvement lies the Quality Control Cycle (QCC), which is a structured approach to identifying and eliminating issues that affect product or service quality. By systematically applying quality control, organizations can reduce errors, improve customer satisfaction, and enhance productivity. This article will dive into the key stages of the Quality Control Cycle, its significance, and how it ties into broader process improvement efforts. 👇 https://lnkd.in/d_AYSDsX

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ISO 9001:2015 QMS Standard in Brief ===== Clause One, the Scope—a standard map to lead, For every organization, no matter the creed. Requirements are flexible, built for all, To boost quality in organizations, whether big or small. Clause Two brings Normative Reference notes, ISO 9000:2015 vocabulary, fundamentals in its quotes. Definitions to guide the standard with clarity true, So all we understand what we need to do. Clause Three deals with Terms and Definitions with care, It references ISO 9000, precise and fair. Each term and definition in ISO 9000, laid out right, To keep our understanding clear and bright. Clause Four, Organization Context, broad and wide, Interested parties' expectations the standard won’t let slide. Scope and processes we must determine and define, To align organization's QMS with business design. Clause Five, Leadership, leads the way, Top management’s active role here to stay. Roles, guidance, and values that they share, The team of the organization remains inspired and prepared. Clause Six, Planning, addresses risks and targets, Objectives and changes are planned well to get. Risk-based thinking strengthens the foundation, To foster success, growth, and innovation. Clause Seven, Support, for all we need, Resources, skills, to help succeed. From documents to system knowledge shared, A solid quality management system, well prepared. Clause Eight, Operation, brings it alive, Design and production, in which we thrive. Services or products delivered, outputs controlled, Standards we met and many processes rolled. Clause Nine, Performance evaluation checks all the way, Data analysis, internal audits, and management review say. To measure, to analyze, to see what’s best and true, So, our systems stay strong, achieve all goals in view. Clause Ten, Improvement, a call to always rise, Nonconformity and corrective action, learning wise. Continual improvement and growth, in steps we tread, Quality’s journey progress, always QMS remains ahead. Annex A informative adds a guiding light, Concepts and terms clarified to sight. Annex B informative provides other standards near, Thus, ISO makes the broader quality sphere. At the end, a Bibliography is given, wise and deep, To reference the Quality that we sow and reap. ISO 9001:2015 QMS standard, in harmony rings, A popular QMS standard for excellence ISO brings. - Keshav Ram Singhal https://lnkd.in/d-THhWv7  

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Learn the 5 most common mistakes made when organizations are auditing their FMEAs. Avoid these common pitfalls when auditing your FMEA, and learn how they interact with another. Utilize this information to avoid wasting time and money during your FMEA audits: Mistake # 1: Putting Ritual Ahead of Result There are times where individuals go out with a really good plan but at the end of the day what the audit actually produced was no result. There was a lot of paperwork that was done there was a lot of time that was wasted, but there were no results and it was more focused on ritual. Mistake # 2: Not Having an Objective (Applies to Design and Process) Imagine that you go to the grocery store, you have an objective. You plan out what you are going to purchase so that you know what you are going to buy there so that you are not just showing up and wandering around hoping to stumble upon what you need. If you are from a six-sigma background the question to ask is “What is the needle we are trying to move?”   Mistake # 3: Not Having the Correct Team When you place an auditor in the position of an audit you are entrusting them to deliver the result from Mistake # 1 to meet the objective from Mistake # 2 and get the job done. Mistake # 4: Identifying Irrelevant Items The fourth major mistake that people engage in when doing an FMEA they write up things, that do not actually matter. Think of it this way: You spend two hours auditing and the line sees an impact because you’re out there on the line, or you’re in there with the designers at the end of the day. They are paying you for information. Now if you come with information that is either just busy -work or information that they already know. They are going to look at you and ask why would I pay you to do that again, when in reality you didn’t tell me anything that was useful, and anything that I didn’t already know? So, this is the fourth major mistake that we see because if you put the wrong person in from Mistake # 3, and they are writing up things that, don’t drive performance from Mistake # 4 you will never get support for your auditing program. Mistake # 5: Making the Scope too Large Process parts are very complex. One of the things that we want to keep in mind is how do we work through and keep the scope myopic, you have a better than average chance of succeeding in your objective, because you are able to go deeper into the material while not dealing with too much information.

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To All Colleagues interested in Quality, QMS & ISO 9001:2015. ISO 9001 Updated summary of emerging themes document issue 2022. Emerging themes relating to quality management – summary Introduction This document contains a brief summary of themes considered to increasingly affect quality management, quality management systems (QMS), quality management system standards and/or the documents developed by ISO/TC 176. This exploration has been undertaken by ISO/TC 176 members as an information-gathering exercise, utilizing existing materials written, developed and published by experts in the respective subjects, both within ISO committees and in the wider world. * Prepare yourself to be ready for 6th. new edition of ISO 9001. *How can you implement these concepts in QMS ? 1. SDGs :17 Sustainable Development Goals of UN. 2.customer Experience 3. People Aspects 4. Relationship Management 5. Demographic Change 6.change Management 7.Integration 8. Agility 9. Knowledge Management 10. Innovation 11. Information Aspects 12. Circular Economy 13. Emerging Technology 14. Ethics & Integrity 15. Organization Culture ملخص محدث لسنة 2022 لإصدار وثيقة الموضوعات الناشئة وفقا لمواصفة الأيزو 9001 لسنة 2015 و نظام إدارة الجودة. 1. أهداف التنمية المستدامة: 17 هدفًا للتنمية المستدامة للأمم المتحدة. 2. تجربة العملاء 3. جوانب و مظاهر العاملين بالشركة : (الكفاءة، الدافع، التفضيلات، مستوى المشاركة، الفروق الفردية، السلوكيات الاجتماعية) 4. إدارة العلاقات 5. التغيير الديموغرافي 6.إدارة التغيير 7. التكامل 8. الرشاقة المؤسسية = Agility 9. إدارة المعرفة 10. الابتكار 11. جوانب المعلومات 12. الاقتصاد الدائري 13. التكنولوجيا الناشئة 14. الأخلاق والنزاهة 15. ثقافة المنظمة قراءة مفيدة إن شاء الله تعالي للجميع بالتوفيق والسداد إن شاء الله تعالي للجميع تحياتي المدرب و الإستشاري : / أسامة إسماعيل

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The potential impact of outsourcing on an organization’s Occupational Health and Safety (OH&S) performance. ISO 45001:2018 Clause 8.1.4.2 states that an organization shall ensure that the requirements of its OH&S management system are met by external providers and their workers. Outsourcing can introduce several risks to OH&S, such as differing safety standards, reduced control over work practices, and challenges in monitoring compliance.   Effective coordination can assist in addressing OH&S impacts in several ways: Aligning Safety Standards and Expectations By working closely with external providers, an organization can ensure that the provider’s safety standards align with its own which would establish consistent safety expectations across all parties. Regular Monitoring and Auditing Coordinating with external providers to schedule regular safety audits and inspections can help identify any safety issues or discrepancies between the provider’s practices and the organization's OH&S standards. Training and Awareness Offering joint training programs for both the organization’s staff and external provider employees ensures that all workers are familiar with the organization’s OH&S culture, emergency protocols, and safety procedures. Incident Reporting and Communication Establishing strong communication channels for reporting safety concerns, incidents, and near misses between the organization and its external providers ensures that OH&S issues are quickly addressed, and corrective actions are implemented. Risk Assessment and Hazard Identification Working together to conduct risk assessments that consider both the organization's and the external provider's operations helps to identify potential hazards before they result in incidents.   Emergency Preparedness and Response Ensuring that both the organization and its external providers have coordinated emergency plans help streamline responses in case of incidents.    Regularly conducting joint safety drills (e.g., fire drills, emergency evacuation simulations) with external providers ensures that all parties are prepared to respond effectively in the event of a crisis. Ensuring Legal Compliance External providers may operate in different jurisdictions with different OH&S regulations. Coordinating with them ensures that the provider complies with local safety laws. Cultural and Safety Leadership Organizations can help external providers develop a safety culture by offering mentorship, guidance, and resources.   Senior leaders from both the organization and the external provider can collaborate to set a strong tone at the top regarding safety priorities, which can then cascade down through the ranks. By fostering a collaborative relationship with external providers, organizations can not only minimize the potential negative impact of outsourcing on OH&S performance but also ensure that safety remains a top priority across all operations, thus enhancing the overall safety culture.

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🌟 Passion for Empowering Organizations with Quality Excellence! 🌟 This week, I’m thrilled to lead impactful training sessions for my clients on the following essential quality management topics: 1️⃣ IATF 16949 (for 2 esteemed clients) 2️⃣ Measurement Systems Analysis (MSA) 3️⃣ Statistical Process Control (SPC) 4️⃣ Environmental & Occupational Health & Safety IQA 5️⃣ 10-Step Problem Solving Helping teams understand and implement these principles is not just a job, but a passion. Each of these areas plays a crucial role in driving efficiency, sustainability, and safety within organizations. Let’s unlock the potential for excellence, boost productivity, and ensure the highest standards across all functions. 🚀 💡 Ready to elevate your team’s capabilities? Let’s connect and discuss how we can bring world-class training to your organization! #IATF16949 #MSA #SPC #EnvironmentalHealthSafety #QualityManagement #Training #ProblemSolving #ContinuousImprovement #SohaumQualitymanagementservices

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Ineffective HSQE Strategy Approaches: What NOT to Do    Many organisations approach HSQE with the wrong mindset, which leads to underwhelming results, wasted time and money down the drain.    Here’s what doesn’t work:    ❌ Treating HSQE as a vague idea of what it should look like.  ❌ Viewing it as just a plan—without follow-through or integration.  ❌ Focusing on short-term goals that are detached from your business operations.  ❌ Copying what everyone else is doing without tailoring it to your organisation.    Effective HSQE is more than checklists and plans. It’s about creating a strategy that’s tailored, integrated, and forward-looking.    If you’re serious about transforming HSQE in your business, this is where it starts.    What’s been your biggest challenge in aligning HSQE with business goals?    P.S. If you found this helpful, feel free to share it with your network! #strategy #WHS #Consulting #WorkHealthandSafety #WHSStrategy #Leadership #ContinualImprovement #SafetyConsulting #ConstructionSafety #MiningSafety

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🚀 ISO 9001:2026 – The Evolution of Quality Management is Near! 🌟 The upcoming revision of the ISO 9001 standard, published in 2026, marks a significant shift in quality management practices. The ISO Technical Committee TC 176/SC2 is developing this new edition, addressing modern challenges and emerging opportunities. 🔧 Key Highlights of ISO 9001:2026: 🔹 Integration of Emerging Technologies: - The revised standard will emphasize digitization and the use of artificial intelligence in automated decision-making processes. This change reflects the increasing importance of technology in enhancing the efficiency and accuracy of quality management. 🔹 Focus on Ethics and Integrity: - New guidelines will align business decisions with ethical principles and stakeholder expectations. This aims to strengthen transparency and trust within organizations and with their stakeholders. 🔹 Expansion of Customer Experience: - Customer satisfaction will be broadened to encompass the entire customer experience. This holistic approach ensures that every interaction positively impacts the customer's perception of the organization. 🔹 Enhanced Flexibility in Implementation: - The new ISO 9001 will offer greater flexibility, allowing organizations to tailor the standard to their specific needs and operational contexts. This customization will enable more effective and targeted application of the requirements. 📅 Timeline and Transition Impact The new ISO 9001 standard is expected to be published in 2026, with a three-year transition period for organizations to comply with the new requirements. The standard's current and new versions will coexist during this period, providing organizations ample time to adjust their quality management systems. 🛠 Preparing for the Transition To successfully navigate the transition, organizations should: - Stay Informed: Follow updates from ISO and other reliable sources. - Conduct a Gap Analysis: Identify discrepancies between the current quality management system and the expected new requirements. - Develop a Transition Plan: Outline necessary steps to comply with the revised standard. - Allocate Resources: Ensure sufficient financial and human resources to support the transition process. - Engage Your Team: Communicate upcoming changes to employees and encourage their active participation in the transition. Stay updated on the latest developments and prepare to lead your organization to new levels of excellence with ISO 9001:2026! How is your organization preparing for the upcoming ISO 9001 changes? Share your strategies and insights below. #ISO9001 #QualityManagement #Innovation #Technology #Ethics #CustomerExperience #Leadership #ISOTransition

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"𝙎𝙚𝙧𝙫𝙞𝙘𝙚 𝙃𝙤𝙪𝙧𝙨 𝘼𝙧𝙚𝙣’𝙩 𝙁𝙧𝙚𝙚𝙗𝙞𝙚𝙨: 𝘼 𝙍𝙚𝙢𝙞𝙣𝙙𝙚𝙧 𝙛𝙤𝙧 𝙀𝙫𝙚𝙧𝙮 𝘾𝙡𝙞𝙚𝙣𝙩 𝙖𝙣𝙙 𝘾𝙤𝙣𝙨𝙪𝙡𝙩𝙖𝙣𝙩" 💼⏰ There’s a common misconception that consulting hours can be stretched or renegotiated at the last minute. Here’s a story that illustrates why a professional’s time deserves the same respect—and payment—as any other valuable service. Some years back, I worked on an IATF 16949 certification project for a client. Everything was clearly outlined from the start: mandays, scope, and fees, all confirmed in writing 📝 I put my full effort into preparing them, often working late in the evening. The result? They were recommended for certification 🎉—a win for everyone involved. But then came a surprising twist… 💸 During our final payment discussion, a senior representative, who had agreed to all the terms from the beginning, suddenly asked for a discount. I was taken aback. Not only had I delivered exactly what we’d agreed upon, but I’d also gone above and beyond without charging extra. He even mentioned that I’d shared chai and meals with the auditors during the final days as if that somehow diminished my work’s value. To hear this request felt like my commitment was being undervalued 💔. So, I stood my ground. I reminded him that our agreement wasn’t just a casual suggestion—consulting is a professional service that relies on time, expertise, and commitment. I wasn’t charging a rupee more than what we had agreed upon, and it was a matter of respecting the effort I had invested in the project. Here’s what this experience taught me: 1. Service Hours Are Valuable ⏳ - Every hour represents dedication, skill, and expertise. Professional time isn’t free and deserves fair compensation. 2. Document Everything 📝 - A written agreement protects both sides and reinforces the value of the work done. 3. Set Boundaries, Build Trust 🤝 - Delivering value is important, but it should be recognized. Going the extra mile should be appreciated, not taken for granted. 4. Stand by Your Value 💪 - Professional integrity means standing by the worth of your work, even when it’s tough. In the end, he understood, and we closed on good terms. He even reached out later for additional work, this time with a renewed respect for my time and expertise. To every consultant and client out there: Service hours are not freebies. Honor your agreements, value the work, and together, let’s build partnerships that thrive on respect and integrity. #ConsultingLife #ValueYourTime #RespectForProfessionals #StandByYourWorth

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🔸LEAN's Blindspot🔸 LEAN is well known for improving productivity. However, when it comes to compliance and such things as inspections and audits these are seen as waste and something to be eliminated. For LEAN to have a transformational effect on compliance it needed to understand that compliance and production have more in common than most realize. LEAN fundamentally is concerned with removing variation from processes. Compliance is also concerned with this but calls in uncertainty. Instead of defects as the effects of variation, compliance focuses on non-conformance as the effects of uncertainty. Variation and uncertainty are really two sides of the same coin. Instead of only eliminating waste by contending with variation, LEAN Compliance eliminates risk by contending with uncertainty. In fact, we can say, waste is the outcome of ineffective compliance and is indeed something to eliminate. https://lnkd.in/gckhXjee #leancompliance #lean #compliance

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🔍 Exploring the Hierarchy of Quality Requirements in ISO 9001:2015 ✔ During a recent QMS ISO 9001:2015 Foundations Certification Course, a thought-provoking question from Faith Umeaku led to an insightful debate: ⁉ "Which of the quality requirements comes first?" ⁉ This discussion underscored the essential role of statutory and regulatory requirements within quality management. While ISO 9001:2015 doesn't prioritize requirements in strict order, understanding their practical implications reveals a graded hierarchy. Statutory and regulatory compliance are foundational, ensuring legality and operational legitimacy. However, for a QMS to thrive, it must integrate customer-focused, organizational, standard, product and service, and process requirements, forming a robust framework for continuous improvement and excellence. Dive deeper into our analysis and join the conversation about the practical hierarchy within quality management systems. https://lnkd.in/dkfddFyv #QualityManagement #ISO9001 #QualityImprovement #ProfessionalDevelopment

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Hi everyone, Please see my new blog on assessing if risk exists within lean standard work. I decided to assess if this true and if it is, what can be done to mitigate the risk. https://lnkd.in/eRX-NMFU

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