Joseph Anderson, in a recent webinar, discussed the “Fail Fast/Fix-it Fast” approach and its misapplication in the medical device sector, leading to quality escapes. He emphasized the need for proper design verification and quality checks during development to prevent defects. A more effective approach would be “Detect Fast, Fix-it Fast” to ensure product reliability and consumer safety.
On September 10, 2020, lectures on Configuration Management at Avans University highlighted the “Butterfly Effect,” where minor changes can lead to significant impacts in product development. The presenter emphasizes awareness and collaboration in managing changes effectively, urging professionals to enhance exposure to Configuration Management in educational settings for broader positive outcomes.
On September 10, 2020, I conducted lectures and workshops on Configuration Management for 20 students at Avans University in Eindhoven, Netherlands. Despite COVID-19 restrictions, the CM Game facilitated an engaging learning experience. One team nearly achieved the correct configuration, making only one mistake and winning the day.
The LinkedIn poll explored the compatibility of Configuration Management with a Product Thinking approach, presenting two statements. Most participants favored a product-centric mindset, indicating that change processes should support managing configurations, rather than the reverse. This emphasizes the importance of holistic product management for efficient change processing and reduced risk.
The COVID-19 Impact on Configuration Management Survey garnered 35 responses, revealing that about a third of organizations experienced disruptions in their Configuration Management processes. Most organizations were not paper-based and relied on automation. Change Management and Verification & Audit were the most affected areas, while some reported positive outcomes, particularly with enhanced electronic processes.
The transition to a Model Based Enterprise (MBE) offers benefits for impact analysis and decision-making. However, challenges arise in identifying ownership and efficiently planning for changes within modeled information. To enhance usability and maintainability, it is crucial to clearly define dataset boundaries and facilitate decoupling of various elements to ensure effective planning and execution of tasks.
Joe Barkai’s article “How Many ECOs are Preventable?” discusses the negative impact of Engineering Change Orders (ECOs) on product development, emphasizing that they are often corrective actions stemming from poor requirements, design, or manufacturing. Companies should focus on minimizing ECOs while promoting positive changes that generate value and improve efficiency.
The recent discussions focus on the challenges of demonstrating the ROI of Product Lifecycle Management (PLM). Emphasizing an infinite mindset, the articles argue that aligning PLM initiatives with a just cause enhances understanding and support. Successful implementation requires translating business needs into actionable capabilities while showing both qualitative and quantitative benefits.
Oleg Shilovitsky discusses the complexities of revising Bill of Material (BOM) documents related to assembly changes. He emphasizes using the FFF criteria for assessing interchangeability and traceability, advocating for issuing new part numbers when necessary. Collaborative decision-making involving various engineering and supply chain perspectives is crucial for accurate re-identification processes.
Join the 10x Medical Device Conference in London on February 17, 2020, to experience the Configuration Management Game. This engaging event highlights the importance of configuration management in business operations and showcases key speakers. Don’t miss this opportunity to learn and have fun while understanding critical processes.