Radhika Devi’s Post

Quality—risk management is essential to safeguard trust, safety, and reliability. These tools are vital not only to identify and mitigate risks but also to empower innovation. #LovePartnership Perizer #MedTech #RiskManagement #QualityManagement #PatientSafety #FMEA #RootCauseAnalysis #FaultTreeAnalysis #IshikawaDiagram #BowtieAnalysis #HAZOP #MedicalDevices #HealthcareInnovation #Compliance #TrustAndReliability

Curious about the Importance of Medical Device Risk Management?   Dive into our blog where we explore its pivotal role in product development. Discover how ISO 14971 standards and regulatory requirements shape risk management practices. Plus, uncover essential strategies for safeguarding your medical device business against unforeseen challenges. Explore risk, safeguard your success. Read now! https://lnkd.in/errCaMgd Get connected:  Mail ID: [email protected]                             Phone no: +91 9370283428   .   .   .  #MedicalDevice #RiskManagement #ISO14971 #RegulatoryCompliance #HealthcareInnovation #HealthTech #MedicalDevices #QualityManagement #ProductDevelopment #BusinessRisk #IPProtection #medicaldevicemanufacturing #medicaldeviceindustry #healthcare #healthcareinnovations #government #medicalequipment #operonstrategist #consultation #consulting 

🚀 Risk Management in MDR Technical Documentation! 🚀 Our whitepaper dives deep into the essentials of risk management for medical devices under the EU Medical Devices Regulation (MDR). Discover: 📋 The key components of a robust risk management system 🌍 The role of ISO 14971:2019 in ensuring compliance and safety 🔍 Best practices for identifying, analyzing, and controlling risks 💡 How to leverage real-world data and clinical evaluation in risk management Ensure your products meet global regulatory standards and maintain safety throughout their lifecycle. 👉 https://lnkd.in/eUcVY2Wt #RiskManagement #EUMDR #ISO14971 #RegulatoryCompliance #HealthcareInnovation #medtech #medicaldevice #riskmanagement #managementsystem #bestpractices #realworlddata

👀‼️Training Weekend on PROCESS VALIDATION ‼️ Part V 💠Process validation enabling systems and technology💠 👉The application of risk management principles and approaches is instrumental to effective decision- making in the #processvalidationlifecycle. 👉Management of variability is one example of applying risk management in the validation lifecycle. 👉The use of risk management to address variability requires understanding of: ƒ ✅The origin of the variability. ƒ ✅The potential range of the variability. ƒ ✅The impact of the variability on the process, product, and ultimately, the patient. ‼️Risk assessment should occur early in the lifecycle, be controlled appropriately, and effectively communicated. ‼️Risk Management increases product and #processknowledge, which translates into greater control of product and process variability, and a lower residual risk to patients. 👉The #processvalidationlifecycle provides continued assurance that processes will manufacture product in a predictable and consistent manner. ‼️ #QualityRiskManagement applications throughout the process validation #lifecycle include the following 👉Stage 1 — process design The risk assessments during Stage 1 begins with a criticality analysis: an initial definition of #productqualityattributes and an assessment of their relative importance. 👉 Stage 1-2 — transition 👉Stage 2 — process qualification ƒ Risk Management in Stage 2, is used to fine-tune the control strategies drafted in the #ProcessDesign stage. 👉Stage 3 — continued process verification The statistical capability of the process is directly tied to the occurrence rating in the risk assessments. 🌺Statistical analysis tools🌺 Successful process validation depends on sound, scientific data and information. The most commonly used statistical methods are: ✅design of experiments, ✅statistical process control, ✅ process capability 🌺 Process Analytical Technology (PAT)🌺 #PAT is a method of #processcontrol, where the product or in-process material quality attributes are monitored and measured, and the process parameters and conditions are altered to maintain those quality attributes. 🌺 Technology transfer🌺 #Technologytransfer can occur at different stages of the process validation lifecycle. If a new process is being transferred from research and development to commercial manufacturing, the technology transfer may occur between Stages 1 and 2. However, if it occurs after a product has been launched and it is in the commercial manufacturing phase, then transfer will occur during Stages 2 and 3. 🌺 Knowledge Management🌺 The effective and efficient capture and analysis of process-related information is essential to #processunderstanding and #validation. Information that supports process validation should be identified, analyzed, communicated, maintained, and available. If you like this post follow me on LinkedIn👇 https://lnkd.in/dSUvn86V

In industries like manufacturing, engineering, and quality control, the Risk Priority Number (RPN) is a crucial numerical assessment tool for risk analysis and management. It helps in identifying, prioritizing, and addressing potential risks associated with processes or products. **Key Factors in RPN Calculation:** 1. **Severity**: Assesses the potential impact or seriousness of the risk. Rated on a scale from 1 to 10, higher numbers indicate greater severity. 2. **Occurrence**: Refers to the likelihood or frequency of the risk event happening. Rated from 1 to 10, with higher values representing a higher likelihood. 3. **Detection**: Signifies the probability of identifying the risk before it causes harm. Rated from 1 to 10, higher ratings indicate a lower probability of detection. **RPN Formula:** = Severity × Occurrence × Detection A higher RPN indicates a more critical risk that requires immediate attention and mitigation efforts. By breaking down risks into these components, teams can focus on reducing severity, lowering occurrence likelihood, or improving detection methods. The RPN isn't just an indicator of risk; it’s a powerful decision-making tool that helps organizations prioritize and effectively manage risks, ensuring the safety and reliability of their systems and processes. #ExcellenceWithMohan

Beyond Compliance: Why 14971 is Your Product's Best Friend 🤝 ISO 14971, the gold standard for medical device risk management, often gets a bad rap for being bureaucratic and cumbersome 😫. But this standard, when embraced effectively, can be a powerful ally in building safer, more reliable products. Here's why 14971 is your product's best friend: 1️⃣ Proactive Approach 🚀: It encourages thinking about risks from the beginning, not just as an afterthought. This proactive approach minimizes design flaws, reduces costly recalls, and—most importantly—protects patients from harm. 2️⃣ Structured Framework 🏗️: The standard offers a clear, step-by-step process for identifying, evaluating, and controlling risks. This structure helps ensure comprehensiveness, reduces ambiguity, and facilitates consistent documentation. 3️⃣ Risk-Based Decisions 🎯: It promotes making risk-based decisions throughout the product lifecycle. This means prioritizing efforts on the most critical risks and avoiding wasted resources on trivial issues. 4️⃣ Traceability is Key 🔗: The standard emphasizes traceability between hazards, risks, mitigations, and verification activities. This traceability ensures that all risks are addressed and provides a clear audit trail for regulatory reviews. 5️⃣ Continuous Improvement 📈: 14971 advocates for ongoing risk management throughout the product's lifecycle, incorporating post-market surveillance data to identify and mitigate new risks. This continuous improvement cycle ensures that devices remain safe and effective over time. Remember, 14971 isn't just about checking boxes ✅. It's a philosophy that should permeate your entire development process, helping you create products that are safe, reliable, and can make a positive impact on patients' lives. ❤️

 I'm excited to share my insights on navigating modern business challenges and staying ahead with White Arrow Technology! We specialize in ISO certification, risk management, internal auditing, AI regulation, cost reduction, and more. If you're interested in learning more or have any questions, feel free to reach out. Let's start the conversation today! 🚀💼 #ModernBusinessChallenges #StayAhead #Innovation

Hello, Do you ask questions or enquire as to "WHY", when certain problems and issues happen in your day to day life be it work or otherwise. This "WHY" is extremly important and this allows us to identify the origins of the problems or issues in hand - we call it the "Root Cause". Similarly in internal audit it is extremly important to analyse the root cause of any observation that is being reported. So what is this Root Cause Analysis (RCA) - in simple terms it means getting to the bottom of the issue and identify the underlying reasons which is leading to such failures or observations. without proper root cause analysis the given recommendations may only treat the visible symptoms but not the actual disease. Importance of RCA are: # it may help to improve decision making and provide better recommendations to help solve the issue and get better outcomes # Prevents recurrence of the issue as the problem will be rectified from the root which is causing the problem. it therefore leads to permanent resolution # Improves process efficiency in the systems, process and policies . this helps in better operations, improved resource allocations and or cost savings to the organization # Helps in streghthening internal controls which may reduce future breakdowns # helps in improving risk managenent and avoid similars risk from happening in future and strengthening the overall risk management framework. Incorporating this in Internal Audit and of course in the organization will help the organization maintain lasting improvements. feel free to add anything Happy Implementing Soneel

Risk Management in Medical Laboratory 🧪 🥼 🧫 As per ISO 15189:2022 5.6 :Risk Management 8.5 : Action to addresses risk and opportunities for improvement . ISO 15189:2022 requires laboratories to identify, assess, and mitigate risks, as well as pursue opportunities for improvement. Here are actions to address risks and opportunities for improvement: *Risk Management (5.6 ISO 15189:2022) 1. Identify risks: Determine potential sources of risk to the laboratory's quality management system (QMS). 2. Assess risks: Evaluate the likelihood and impact of identified risks. 3. Mitigate risks: Implement controls to reduce or eliminate risks. 4. Monitor and review risks: Regularly review and update risk assessments. *Opportunities for Improvement (8.5 ISO 15189:2022) 1. Identify opportunities: Recognize areas for improvement through audits, feedback, and performance metrics. 2. Evaluate opportunities: Assess potential benefits and feasibility of improvements. 3. Implement improvements: Develop and implement plans to address opportunities. 4. Monitor and review improvements: Verify effectiveness and make adjustments. Actions to Address Risks and Opportunities 1. Develop and implement procedures to mitigate risks. 2. Provide training and awareness programs for personnel. 3. Conduct regular audits and reviews. 4. Analyze data and performance metrics. 5. Implement corrective actions. 6. Continuously monitor and review the QMS. 7. Document and communicate actions taken. *Tools and Techniques* 1. Risk matrix 2. Failure Mode and Effects Analysis (FMEA) 3. SWOT analysis 4. Fishbone diagrams 5. Root cause analysis 6. Pareto analysis 7. Quality improvement teams *Documentation* 1. Risk register 2. Opportunity for improvement log 3. Corrective action reports 4. Quality improvement plans 5. Management review records By addressing risks and pursuing opportunities for improvement, laboratories demonstrate their commitment to maintaining a robust QMS, ensuring quality services, and continually improving operations.

When you have a high-risk task, how do you start? This is the process I go through when challenged with a new task that has inherent risks. The video is how I break down a scaffold boiler chain. Mapping the Process: Start by thoroughly mapping out the process you’re dealing with. This includes identifying all steps, inputs, outputs, and interactions. A clear process map helps you see where potential risks might arise. Identifying Risks: Once you have a comprehensive view of the process, you can identify where things might go wrong. Depending on the process's nature, risks could be operational, financial, strategic, or compliance-related. Analyzing Risks: Assess the likelihood and potential impact of each identified risk. This helps prioritize which risks need more immediate attention and resources. Implementing Controls: Based on the risk analysis, you can implement controls to mitigate those risks. Controls might include policies, procedures, technologies, or training programs designed to reduce the likelihood or impact of a risk. Monitoring and Reviewing: Regularly monitor the process and the effectiveness of your implemented controls. This helps ensure they’re working as intended and allows for adjustments if new risks emerge or the process changes. Continuous Improvement: The process should be reviewed periodically to identify areas for improvement. This might involve updating risk assessments, refining controls, or adjusting the process to handle risks better. By thoroughly understanding the process and how risks can impact it, you’re better equipped to implement practical and effective controls, ultimately leading to a more resilient and reliable operation.