Matrix Requirements’ Post

I’ll be speaking as part of Q1 Productions‘ “QMSR Implementation & Quality Management Enhancement Professional Education Course” 17-18 June 2024. The hosts are now offering a 50% discount with code QMSR50. With the FDA’s QMSR ruling of 02 Feb this year, greater emphasis has been placed upon the needs of Risk Management for Medical Devices. This being one of my favourite topics for the importance within Medical Device development, Risk Management (alongside the Design Controls process) are often being treated and regarded as, ”those painful document deliverables we need to have…” rather than the tools they can and should be to drive the development process. But when to start them? ISO 14971:2019 (and ISO 13485:2016) define the life cycle (that the standards are applicable to) as “..from the initial conception…”, yet the FDA’s QS Reg wording from 1996 defined in the preamble a period of research, “creativity and innovation” that the FDA would not expect design control requirements. With the QMSR, “…the FDA does not expect manufacturers to maintain records of all changes proposed during the very early stages of the design process…”. Although many manufacturers appreciate this caveat, I’ll be describing the risks (pun absolutely intended) of missing important design knowledge during those early design iterations and using the analogy of Agile Project Management processes to show. With an emphasis on Risk Management and the Design Control Processes as tools for development, rather than the perceived documentation need, I believe that focus on the activity and effort for the two will aid to deliver safe, effective and high-quality Medical Devices. I’ll walk through a detailed (and colourful!) flow-diagram for how this all comes together.

Integrating QMS into Product Lifecycle: A Strategic Quality Approach In product development, the seamless integration of a Quality Management System (QMS) is paramount. Explore how QMS terminology aligns with product lifecycle stages, emphasizing a systematic approach to quality. Quality Policy and Objectives in Design: The QMS foundation is a clear quality policy and objectives. In design, adherence ensures product specifications align with defined quality standards. QMS terms like Design Inputs and Outputs shape a comprehensive design process prioritizing quality. Risk-Based Thinking in Design and Prototyping: QMS emphasizes risk-based thinking for proactive quality management, aligning with risk identification and mitigation. Terms like Risk Analysis and Mitigation Plans guide robust designs resilient to real-world challenges. Control of Documents and Records in Manufacturing: As the product transitions to manufacturing, QMS terminology on document control is crucial. Consistency in processes is achieved through meticulous document management, maintaining manufacturing phase integrity. Inspection and Testing in Manufacturing: Quality control in manufacturing involves rigorous inspection and testing. QMS terms like Acceptance Criteria and Inspection Records provide a structured framework for validating each unit, safeguarding against defects and ensuring production uniformity. Training and Competence in User Training: QMS extends to user training by emphasizing personnel competence. Terms like Competence Records and Training Plans guide comprehensive training programs, ensuring users operate the product safely and efficiently. Nonconformity Management in Maintenance: Despite meticulous planning, nonconformities may arise during product usage. QMS terms like Nonconformity Reports and Corrective Actions address issues promptly, preventing recurrence, and maintaining product performance. Continuous Improvement Across the Lifecycle: A fundamental QMS tenet is continuous improvement. Throughout the product's lifecycle, terms like Corrective Action, Preventive Action, and Key Performance Indicators (KPIs) guide enhancements, fostering an environment of ongoing quality improvement. In essence, integrating QMS terminology into the product lifecycle is a strategic approach to achieving and sustaining high-quality standards. By aligning each phase with QMS principles, developers navigate complexities with a systematic focus on quality, delivering reliable and compliant products to the end-user. If you discover value in my articles, consider following for additional insightful content. #QMS #QualityManagement #ProductLifecycle #ContinuousImprovementCulture

I often talk about taking the ‘lean approach’ to quality management, but what does it actually look like? Below are some functions to look for if you want use a lean document management solution to build your eQMS: 🌀 Automated cycles of planning, execution and testing If you’re building engineering specifications, find an eQMS that ensures you’re planning acceptance criteria for your products at the same time. Your eQMS should help predefine all the testing documentation that your team will need to complete. 🙅♂️ No more overprocessing Choose a digital QMS system that will support testing regimes with clear diagrams, videos and forms to fill out, so mistakes are minimised, evidence recorded, and nothing vital omitted. ✅ Automates triggers for CAPA Automated QC workflows with appropriate logs, notifications and reminders will make sure no issue ever falls through the cracks. These workflows will help you undertake root cause analysis, as well as collectively review and approve corrective and preventive measures to prevent the recurrence of mistakes. 🔏 e-Signatures Make sure your Quality System is integrated with e-signatures so that QA and QC records can show exactly who signed off what, why and when. This is more than a nice to have, it’s a requirement for medical device developers. #lean #leanDMS #documentmanagement #eQMS #QMS #CAPA #QualityControl #QualityAssurance #QualityManagement

Manage your CAPAs and respond efficiently to Non-Conformancies with the agile BPAQuality365®, https://lnkd.in/djrk2w6x ⭐ CAPA Effectiveness Checks 101: How To Verify That Your Actions Plans Are Successful, https://lnkd.in/dwQBRKTm #capa #8d #continuousimprovement #sixsigma #qualitymanagement #eQMS

Struggling to keep up with your Quality Management System (QMS)? You're not alone! Here are four key strategies to help you get ahead of the game: 1. Automate your QMS: Embrace technology to streamline your QMS processes. Implementing QMS software can automate tasks such as document control, corrective and preventive actions (CAPAs), and audit management, saving time and reducing the risk of errors. Automation also allows for real-time monitoring of quality metrics, facilitating data-driven decision-making and continuous improvement. 2. Train your staff: Invest in comprehensive training programs to equip your staff with the knowledge and skills needed to effectively manage the QMS. Training should cover QMS procedures, compliance requirements, and the use of QMS tools and software. By empowering your team with the necessary training, you ensure that they are equipped to uphold quality standards and contribute to the success of the QMS. 3. Review your QMS: Regularly review and assess your QMS to identify areas for improvement and ensure its effectiveness. Conduct internal audits and performance evaluations to evaluate adherence to procedures and compliance with regulatory requirements. Solicit feedback from stakeholders and employees to gather insights into potential pain points and opportunities for enhancement. Continuously refining and optimizing your QMS ensures its alignment with organizational goals and enhances overall performance. 4.Involve your stakeholders: Foster a culture of collaboration and engagement by involving stakeholders in the QMS process. Seek input from employees, customers, suppliers, and other relevant parties to gain diverse perspectives and identify areas for improvement. By involving stakeholders in decision-making and problem-solving, you create a sense of ownership and accountability, driving collective efforts towards QMS success. Incorporating these strategies into your QMS approach can help you overcome challenges, enhance efficiency, and achieve sustainable success in quality management. Remember, continuous improvement is key to staying ahead of the game and maintaining excellence in your QMS practices. Have more strategies to share? We'd love to hear from you in the comments below! Let's collaborate to strengthen our QMS and drive quality excellence together. #QualityManagement #QMS #ContinuousImprovement #QualityExcellence #Collaboration

Designing and implementing a Quality Management System (QMS) can be challenging (sometimes feels like you are in a war against the whole team of process owners), Lets see which are 4 major blocks and what can be done to overcome them: 1. Resistance to Change: Block 1: Employees may resist adopting new processes or technology; The answer: try to provide comprehensive training and clear communication about the benefits of the QMS. 2. Lack of Resources: Block 2: Insufficient time, money, or personnel can hinder QMS implementation; The answer: secure executive support, prioritize tasks, and allocate resources effectively. 3. Complexity: Block 3: QMS can be complex, especially in larger organizations; The answer: simplify the process by breaking it down into manageable steps, and use available software tools to automate tasks and ensure consistency. 4. Maintaining Momentum: Block 4: After initial implementation, maintaining enthusiasm and adherence to the QMS can wane; The answer: foster a culture of continuous improvement by celebrating successes, providing regular training, and soliciting feedback from employees. By addressing these blocks with proactive strategies, organizations can successfully design and implement a QMS that drives quality, efficiency, and customer satisfaction. Have a Happy QMS Journey !!

Great article! ensuring that quality is just as much a part of your programs development is imperative to repeatable successes!

Are you looking for a powerful QMS which offers: 📝 Centralize all documentation & life cycle management 📈 Create & improve your reporting culture 📨 Provide defined & consistent process workflows 📋 Training management & testing Then you need to look at Ideagen Quality Management! IQM can fit any business looking to strive to digitalize quality, improve transparency & have data at you fingertips☝ Take a look at the video below to find out more 👀 If you want to speak further & have a personal demonstration, please reach out directly🎯 #qualitymanagement #Ideagen #DocumentManagement #Training #Compliance #Reporting

There are a lot of myths surrounding quality management.    Let’s debunk a few of them right now.    💰 Myth 1: Quality management is a cost centre     This is simply not true. Quality management is and should be viewed as a profit centre, because you can create value through quality. In fact, it should be seen as an opportunity to improve output.    The truth is, investing in a strong quality system upfront and building your organization on quality principles and QbD from the get-go will lead to better outcomes such as fewer roadblocks in the development process as well as fewer deviations.   🚔 Myth 2: Quality management is a policing centre    Try reframing the narrative: quality management is an innovation centre. They’re doing a service and should be seen as enablers who make things easier for everyone.    We need to leave room for creativity within quality management; it doesn’t always need to be so dry and to the letter.    🛣️ Myth 3: QA belongs at the end of the process     This one really irks me, and it might be the simplest one to apply right out of the gate. Quality should be considered from the beginning when designing processes, helping identify how to ensure QbD.    Quality tools should also take a seat at the table here. Technology makes quality easier, resulting in less friction, easing the documentation burden, and driving processes. All of this will also help to improve inspection readiness.    🚀 To the biopharma startups focused on raising your next round of capital, you need to be able to show that you’re in control.    With a good quality system and the shifting your mindset around the myths I just mentioned, these smaller organizations have every opportunity to achieve what they're after:    ✅ Regulatory approval and market entry     ✅ Operational efficiency    ✅ The highest standards of product quality and safety to build trust with regulators    ✅And so much more    I’m passionate about quality, which is why my team at Montrium has distilled our collective knowledge into our free QMS Bootcamp.    This series is dedicated to empowering biopharma startups to implement a lean-yet-effective QMS for their organization.    Here's what you can expect:    👉 6 actionable modules    👉 Led by 4 passionate QMS industry leaders    👉 All the building blocks you need to develop a robust, right-sized QMS (without the quality headaches)    To sign up for our FREE QMS Bootcamp and get a deeper understanding of our unique approach toward QMS in a modern clinical landscape, visit the link in the comments below. 

What is automated QMS? An automated End-to-end Quality Management System (QMS) is a comprehensive software solution that integrates and automates the entire spectrum of quality-related processes within an organization. This includes document management, change control, incident and non-conformance management, risk assessment, and training management. By leveraging automation, it ensures a seamless and efficient approach to maintaining and enhancing product or service quality while facilitating compliance with industry regulations. Take a stand, book your complimentary demo on our Next-Gen End-to-end eQMS/QEHS now - https://lnkd.in/guQ2DWXS Let's navigate the journey to enhanced quality management together! Benefits of having an E2E QMS solutions in any Organization are: •Efficiency Boost: Automated QMS streamlines processes, reducing manual effort and increasing operational efficiency. Single process may have multiple interactions and these interactions can be in-built in the solution itself. •Consistency in Compliance: Ensures consistent adherence to industry standards and regulatory requirements, minimizing the risk of non-compliance. •Real-time Visibility: Provides instant access to data, enabling quick decision-making and a proactive response to quality issues. •Reduced Errors: Automation reduces the likelihood of human errors in tasks such as documentation, minimizing the risk of quality issues. •Enhanced Collaboration: Facilitates seamless collaboration among teams by centralizing information and communication within the QMS. •Faster Response to Changes: Enables swift adaptation to changes in processes, regulations, or products through automated change control mechanisms. •Continuous Improvement: Supports a culture of continuous improvement by tracking and analyzing data for informed decision-making and optimization. •Cost Savings: Reduces costs associated with manual processes, errors, and compliance issues, contributing to overall financial efficiency ✍️ Discover more valuable content on QMS, EHS, QA, QC, Problem Solving, and Next Gen QMS by connecting with me, Suryakant Bhavikatty, and let's embark on this journey together! 🚀 Aditya Chaudhary Palash Chatterjee Ved Prakash Saini Ashwini Bobale Hexagon Manufacturing Intelligence - K A I #qms #eqms #qualitymanagement #digitalsolutions #qualitymanagementsystem #iatf16949 #iso9001 #etq