Risk analysis is an essential component of your quality management system. A mandatory task for every new medical device about to hit the market is creating an appropriate Risk Management Plan as required by ISO 14971, the international standard for applying risk management to the design and manufacture of medical devices.
Read More →Reduce Supplier Risk, Reduce Organizational Risk
Risk is a major focus in most businesses today, regardless of industry. In the past few years, the Life Sciences have seen a steady rise in supply chain issues resulting in lost market caps, recalls, regulatory fines, and other financial impacts valued in the billions of dollars. The Medical Device Industry is no exception to this reality; if the industry wants to improve patient outcomes, then it has to manage risk. According to Pilgrim Quality Solutions, one of the largest sources of organizational risk is dependence on third-party suppliers. Today’s global economy has added complexity to supply chains, and longer supply chains are making it increasingly difficult to manage suppliers, and in many cases, suppliers’ suppliers, thereby increasing overall risk. The plethora of regulatory requirements placed on Medical Device organizations, including the updates to ISO 13485:2016, reflect this new reality.
Read More →EQMS and Quality 4.0: Build a Successful Quality Strategy for a Life Science Company
Quality is a critical concern in life science manufacturing industries, and leaders across life science companies have many quality and compliance considerations. However, few of those concerns have the strategic impact that Quality 4.0 does. Quality 4.0 is the digitalization of quality management through the application of traditional and Industry 4.0 technologies to improve quality monitoring and outcomes. At its core, Quality 4.0 is the digital continuum of quality data combined with other data from sources such as manufacturing, machine sensors, supplier management, and in-service across a product’s life, new analytical insights derived from that data, and the organization-wide transparent consumption of insights.
Read More →Why You Need a New Quality Management System
With technology rapidly changing, a global market, and competition around every corner, quality is one of the most important factors in manufacturing. Quality in products and process will ultimately keep any organization relevant in today’s marketplace. Additionally, having an efficient, paperless, and compliant QMS System can give an organization a competitive advantage.
Read More →Leadership Strategies for Enabling Supplier Quality Management
When it comes to quality management, life sciences organizations all face a similar set of challenges derived from both the significant industry competition necessitating improved quality performance and reduced costs, and from ever-tightening regulatory compliance measures. Quality leaders in life sciences need to contend with these pressures while also meeting goals around innovation, and improving efficiency across the product development lifecycle in an industry that is relying more and more on a growing global network of suppliers, contract manufacturers, and other partnerships. The growing network of suppliers in life sciences means that visibility into supplier quality and across the value chain are more important than ever before, as an adverse event could quickly lead to recalls, fines, and irreparable brand damage.
Read More →How to Avoid Data Integrity Disasters in Your Manufacturing Network
Lachman Consultants says that pharmaceutical manufacturers can establish a competitive advantage by preventing questions about their product quality data from disrupting current and future revenue. In recent years, data integrity shortcomings identified during GMP inspections have cost firms dearly. In some cases, the financial impact has run into the hundreds of millions of dollars. Despite the risk, many manufacturers do not seek help with data integrity compliance until there is a problem. By then, it may be too late to avoid an impact on profitability. For this reason, Lachman Consultants urges pharmaceutical companies to establish a competitive advantage by taking a proactive approach to data integrity assurance.
Read More →The Quality 4.0 Impact and Strategy Handbook
The most recent decade has seen rapid advances in connectivity, mobility, analytics, scalability, and data, spawning what has been called the fourth industrial revolution, or Industry 4.0. This fourth industrial revolution has digitalized operations and resulted in transformations in manufacturing efficiency, supply chain performance, product innovation, and in some cases enabled entirely new business models. This transformation should be top of mind for quality leaders, as quality improvement and monitoring are among the top use cases for Industry 4.0. Quality 4.0 is closely aligning quality management with Industry 4.0 to enable enterprise efficiencies, performance, innovation and business models. However, much of the market isn’t focusing on Quality 4.0, since many quality teams are still trying to solve yesterday’s problems: inefficiency caused by fragmented systems, manual metrics calculations, quality teams independently performing quality work with minimal cross-functional ownership, and ineffective supplier communication, among others.
Read More →Lean Implementation throughout the Supply Chain
So you’ve been successful at implementing your own lean initiative, but now you’re being squeezed by your customers, who want lower prices and higher quality, and your shareholders who want higher profits. How do you satisfy both stakeholders? Generis thought leaders from Navistar, Under Armour, Toyota, the Lean Enterprise Institute, and Wabash Corporation share how they have worked with their suppliers to implement lean throughout the supply chain to decrease cost and improve product quality.
Read More →Creating a Culture of Continuous Improvement: The Case for Change
A lot has been written about how to truly implement continuous improvement processes and lean initiatives, you need to embed it in the culture of the organization. “Every company in manufacturing has to develop an operating philosophy, a standard methodology, and a language that creates a culture that focuses on continuous improvement,” Byron Greene, former VP & Head of Vehicle Assembly at FCA, explains. But how does an organization go about doing this? Michele Calbi, former VP, Lean Transformation at Navistar, told the audience at the 2016 American Manufacturing Summit, “You have to create a case for change. It is extremely powerful. If you can drive that passion into the employees, you will see amazing things.” She shared a few stories of companies that have pulled themselves out of dire situations by creating a powerful case for change.
Read More →Automation Today
As manufacturers struggle to fill highly skilled production positions—according to NAM (National Association of Manufacturers), “80 percent of manufacturers report a moderate or serious shortage of qualified applicants for skilled and highly skilled production positions”—technology may need to step in to fill the gap. As the article “Automation Today” by FARO Technologies states: “It’s no secret that manufacturing continues to become more automated, and manufacturing output per worker is on the rise.” Smart factories are sought after because they are quickly becoming the “factories of the future,” while growing changes in automation become difficult to ignore. Find out more about the latest advancements in optical 3D measurement and automation technology in the article below including: Advanced Manufacturing; Automated Metrology; and Cobalt.
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