How can R&D quality assurance speed up technology development projects?

R&D quality assurance can be achieved by - 1. Introduce APQP in development 2. There will be distributed work along with different functions like desig, development & Proto, DoEs, Validation, VP and PP builds, SOP. 3. Development time line should have clear goal with Gateway clearances at every stage of project to ensure that right quality achieved. 4. Followup through organized meeting along with dedicated program and project managers.

Definir objetivos e critérios claros na área de Garantia de Qualidade dentro da área de P&D é crucial para assegurar a seguran?a, eficácia e conformidade dos produtos e alguns pontos devem ser seguidos, tais como: 01-Seguran?a do Paciente: garantir que os medicamentos desenvolvidos sejam seguros para uso, minimizando riscos adversos. 02-Eficácia Terapêutica: assegurar que os medicamentos atendam aos padr?es de eficácia pretendidos para tratar as condi??es médicas alvo. 03-Conformidade Regulatória: garantir que todos os processos e produtos estejam em conformidade com as regulamenta??es locais e internacionais. Lembrando que esses objetivos e critérios podem ser adaptados conforme a natureza específica do projeto de P&D.

R&D QE! There is always room for innovation - turning idea into product easier when R&D and QE are working together. R&D and QE is to answer the whys of every step of their thinking and process. Eliminating risk is an innovation in itself! With product design and manufacturing contributing to substantial amount of adverse event reports it is crucial that R&D and QE have a comprehensive understanding of each other. If R&D and QE feel comfortable/free to communicate/constructively question one another the result will be better product quality. R&D people; reach out to your QEs early and often! QE people; be curious to understanding product development/R&D tasks!

The QA must analyze and validate the business requirements to technology features mapping. If any of the customer needs are not trackable to any solution features, it may recommend for solution augmentation immediately or in subsequent phase depending on its importance. The second most important aspect is to study the possible scenarios in which customers will use the technology and ensure different test cases cover them well. In present AI-era, the QA tests must include rich data sets for the problem area.

Early QA Integration Incorporate QA from Inception Comprehensive Requirements Analysis Thorough Documentation Agile Methodologies Agile QA Practices Automated Testing Test Automation Tools Continuous Integration (CI) and Continuous Deployment (CD) CI/CD Pipelines Risk-Based Testing Prioritize Testing Based on Risk Collaborative Approach Cross-Functional Collaboration Performance Testing Early Performance Testing DevOps Integration DevOps Practices Real-time Monitoring Monitoring Systems Knowledge Transfer QA Training for Development Teams Regulatory Compliance Concurrent Regulatory Compliance Checks Continuous Improvement Feedback Loops Resource Optimization Flexible Resource Allocation

Planejar e documentar o processo de P&D é crucial para garantir a qualidade, transparência e conformidade com as regulamenta??es a que se destina o novo produto e alguns pontos devem ser considerados, vou citar apenas 2 dos mais relevantes: 01-ICH Guidelines: ele fornece diretrizes globais para o desenvolvimento de medicamentos e recomendo particularmente o documento ICH E6 (R2) para orienta??es sobre Boas Práticas Clínicas (BPC) e ICH Q9 para gerenciamento de riscos. 02-Protocolo de Desenvolvimento de Medicamentos: sugiro que desenvolva um protocolo abrangente que detalhe os objetivos, métodos, cronograma e critérios de avalia??o do seu estudo. Lembre-se que os requisitos podem variar com base na natureza do produto/legisla??o local.

This is a critical step of R&D. Without process and documentation, there is no way of knowing if the results of different experiments are comparable. In the case of long tail R&D, documentation will ensure new team members can run further tests to compare results.

Efficient R&D QA hinges on meticulous planning and comprehensive documentation. By mapping out the end-point, encompassing methods, data sources, design tools, testing protocols, and evaluation metrics, teams establish a foundation for consistency and accuracy. This not only fortifies the robustness of results but helps to discover potential issues in future. Furthermore, it serves as a repository of knowledge and transfer of best practices. In R&D, a well-orchestrated plan and meticulous documentation are not mere formalities but the keystones to success. Including SOPs and technical reports aid in tech-transfers in future. Also, for industries which come under strict regulatory control (like Pharma)should consider the requirements ahead.

Furthermore, R&D brings new concepts and/or new processes to the companies, so documentation is important for future queries.

Documenting the R&D project results and finidings is critical even the project is a failure to support the future r&d development. This will improve the quality of research outcomes.

Regular reviews and feedback help build team collaboration and connection to stakeholders. R&D teams can feel like a service instead of partners in the innovative growth and development of future products.

In any circumstance where R& is being performed to improve a product or experience for a customer, regular review and feedback with ensure the R&D is still aligned to the customer's requirements. This is particularly important in a dynamic environment where customers are seeking opportunities for improvements or change.

Uma coisa que achei muito útil é um check list semanal de 15 minutos com a equipe para verificar andamento das tarefas de cada área. Isso traz seguran?a e envolvimento de todos.

Los departamentos están conformados por humanos y como humanos siempre hay cosas que mejorar, por lo tanto las auditorías, las revisiones periódicas nos van a permitir detectar áreas de mejora. Adicionalmente, un departamento de Investigación y Desarrollo, aunque no parezca, en un área con mucha carga de trabajo y con objetivos que la alta gerencia quiere y necesita que se cumplan rápido para satisfacer las necesidades de los clientes, y en este corre corre muchos detalles pueden pasar por alto y precisamente en estas revisiones es donde el departamento detecta su debilidades (poco personal???) y con las observaciones encontradas se plantean las estrategias para mejorar.

Regular reviews and feedback in R&D quality assurance are crucial for accelerating technology development. Continuous evaluation ensures adherence to objectives, identifies bottlenecks, and allows for swift adjustments. Engaging the AI and LinkedIn community for diverse insights amplifies the feedback loop, fostering innovation and agility in the project. This collaborative approach enhances efficiency and propels advancements in the ever-evolving landscape of technology.

Using an agile methodology will also keep your project aligned to an outcome that is of value to the customers' needs, this is critical if you want the developments to have commercially positive outcomes.

As customer requirements change and possibly new customer segments get added, product feature evolution needs to be planned by R&D and reflected in validation suite by QA. Sprint duration can be quite different for consumer product process vis-a-vis space, defense projects; but agile process can surely be adopted.

In agile laboratories, ensuring customer needs are addressed is essential, requiring the laboratory to maintain adaptability. Notable examples of methodologies, such as Lean, Kanban, and Scrum, are tailored for quality management systems. Lean focuses on waste elimination and process optimization, Kanban provides a visual approach to workflow management, and Scrum relies on rapid and collaborative development cycles. Concentrating on waste elimination, process optimization, and agile development cycles, these practices effectively transform the laboratory environment, promoting agile and efficient quality management.

Agile approach involves breaking the project into phases and emphasizes continuous collaboration and improvement. Teams follow a cycle of planning, executing, and evaluating. In my experience, the tool which is used is not that crucial; what really matters are the attitude of the team and the approach of the management. A lot of downtime in the later stage of the project can be saved by following agile and iterative approaches.

AI-based automation and digital tools can offer a range of advantages for expediting technology development to the R&D QA. They enable efficient data analysis, predictive analytics for risk management, and automation of repetitive tasks. AI-driven testing tools swiftly detect issues, while digital collaboration tools streamline documentation and resource allocation. Natural language processing aids in communication and categorizing information, and AI ensures continuous quality control. Moreover, AI monitors markets and emerging technologies, promotes a culture of continuous improvement, and facilitates early issue detection. Real-time collaboration fosters seamless teamwork, ultimately accelerating technology development projects.

En una era donde la tecnología domina, los procesos de Investigación y Desarrollo no se pueden quedar atrás en adaptarlas. Ciertamente para peque?as empresas implementar algunas herramientas y avances digitales no se les hace fácil, ya sea por presupuesto o desconocimiento, pero la invitación es a que empiecen por algo, así sea muy peque?o para que disfruten de las ventajas y sea el Clic para seguir avanzando.

During the R&D process, laboratory scale and/ or pilot scale apparatus are often used. Laboratory safety is often not given the right priority or enough importance with a misconception that owing to the relatively lower volume of the components being handled and lower energy being contained, safety risks are minimal. This has been proven wrong time and again. Several instances of laboratory safety incidents have been reported in the literature. Hence, it is imperative that enough time and resources are spent with the process safety experts for understanding the risks and their mitigations before embarking on lab-scale experiments.

Develop smart Key Performance Indicators for your project. Have early approach to the Risk Management Plan and have frequent meetings to monitor the progress and adjust as you go. Have risk mitigation strategies for all risks that were identified and have proper documentation on how you mitigated these risks.

Risk Mitigation needs to be worked through systematically and progressively all through the process flow and the each step needs to be scrutinized carefully. It is never a one-man-job it is total team work. Where each one asks "What can really go wrong?" Being honest at each step and taking the bull by the horns and checking out each risk is the hallmark of a successful project. Creating an environment of positively handling failure and issues goes a long way in facing project risks. Open, non-judgemental, intelligent handling of issues is key. All processess work like magic if team dynamics are great!

By regularly asking "What can go wrong?" on the numerous levels of the intended innovation a first step in QA is taken. These further 3 key questions are worth asking: "What can reduce the risk of failure occurrence?", "What can help in compensating the occurrence of failures?" and "What can support the timely detection of failure occurrence?". These questions are closely related to the Risk Priority Number in Failure Mode and Effects (Criticality) Analysis (FME(C)A) and the answers lead the way to valuable risk mitigation measures.

QA play a crucial role by following compliance and regulation by offering clear guidelines, risk reduction, process efficiency, customer trust, faster approvals, streamlined auditing, and a competitive edge. It's provide a structured framework, reducing uncertainty and facilitating efficient decision-making. Adherence to regulations minimizes legal and safety risks, preventing potential setbacks. It also streamlines approval processes and audits, saving time. Building customer trust through compliance minimizes delays arising from disputes or product recalls. Additionally, compliance enhances competitiveness, attracting investments and partnerships that can accelerate technology development, contributing to a faster time-to-market.