How to Ensure Supplier Quality in Medical Devices July 26, 2021 Outsourcing is on the rise, with more manufacturers using third parties than ever before. This helps boost the bottom line, but it also introduces certain risks. Supplier quality management systems can help manufacturers ensure high-quality processes across an increasingly complex supply chain. These systems help address supplier selection and evaluation, nonconformances, risk and product deviations. It’s up to the manufacturer to maintain quality procedures as it is the one that will be held accountable by the FDA and the consumer if there is an issue with the product. Manufacturers must not only find partners that can provide the materials and components necessary for production; they must also find partners who are trustworthy and pose as little risk as possible to the final product. Here’s why managing risk, quality, safety, and compliance begins with an effective supplier quality management system. The Rise of Outsourcing Medical device companies are becoming more global, sourcing more and more in raw materials and components from countries all over the world. The need to manage the complex supply chain is a crucial component to a company’s business strategy. A major challenge is not the lack of supply, delivery, inventory or critical supply data, but rather the visibility of critical information to perform proactive tasks or to make impactful decisions. Companies use multiple suppliers that are “out-of-the-four walls” of their own IT environment, so it is imperative to provide near real-time access to a common system so there is no delay when using data to make both minor and major product decisions. Managing Supply Chain Risk With many suppliers both in the U.S. and abroad working under different regulatory bodies or requirements, having access to the same set of real-time data can be very challenging. In many cases, recalls are caused by supplier-related issues. Considering the cost and resources it takes to remediate, replace, repair and recall a product, it is critical that proactive measures of supplier quality metrics are in place to mitigate as much risk as possible. Learn How to Improve Supplier Quality Ultimately, manufacturers will have to keep accurate records of every aspect of its relationships with suppliers, including transactions and communications. It must also implement best practices. These include a comprehensive selection and evaluation process, supplier audits, supplier scorecards and supplier risk files. More Resources About Supplier Quality Management DEMO: TrackWise Digital Supplier Quality Management (SQM) – Hear about Sparta’s Supplier Quality Management process. We introduce the supplier portal concept that will enable real-time collaboration, data capture and we will also touch on the various reporting that we have seen be very effective in helping streamline the process. CASE STUDY: Orion Corporation Transforms Quality Operations and Supply Chain Traceability with TrackWise Digital – “We needed to simplify the process and make it more transparent.” BLOG: Protect Your Product From the Risks of Supply Chain Complexity – When it comes to the supply chain complexity, visibility and collaboration are an integral part of a proactive quality management approach. BLOG: Managing Quality Within the Medical Device Supply Chain – For medical device manufacturers, supplier quality management can give crucial confidence in the quality of supplier components or raw materials. BLOG: How Technology Simplifies Supplier Audits – The benefits of remote audits include lower costs, no travel restrictions, no logistical constraints, better use of resources and the ability to continuously monitor suppliers. EVENT RECAP: Q&A from Sparta’s “How to Establish Supplier Qualifications” Session – At the 11th Annual Medical Device Supplier Quality Assurance Conference, Sparta’s Zillery Fortner presented her topic “How to Establish Supplier Qualifications.” EVENT RECAP: Sparta Experts Present Their Insights on Digital Quality Transformation and Supplier Management – Sparta Systems, A Honeywell company, was a proud platinum sponsor of the 5th Annual European Medical Device and Diagnostic Supplier Quality Management (SQM) conference in Brussels, Belgium. Share via: Twitter LinkedIn Facebook Email
WEBINAR AI-Driven Innovation: Redefining Quality Management in Life Sciences Take a deep dive into the confluence of AI and life sciences, exploring how artificial intelligence is poised to revolutionize the realm of quality management in the sector. Learn more
EVENT Honeywell Life Sciences Innovation Days Honeywell invites you to join us for one of our Life Sciences Innovation Days, a series offered throughout the globe in 2024. We will present a variety of process innovations to support the digital transformation of life sciences manufacturing. Themes will include orchestrating systems and data, preventing and containing cyber incidents, quality control and management, modular automation, and the Honeywell life sciences roadmap. Discussion will address streamlining manufacturing, creating batch records, and fulfilling regulatory reporting requirements. Learn more
EVENT TUG Europe Join industry peers at one of these FREE events for TrackWise and TrackWise Digital customers, with two dates and locations to choose from. Enjoy a networking at our pre-event receptions, as we celebrate 30 years of TrackWise! Take advantage of a FREE TrackWise Digital pre-event training workshop. Learn more
EBOOK 5 Things to Know About EUDAMED EUDAMED (European database for medical devices) is a centralized database that aims to enhance the transparency and traceability of medical devices in the EU. Learn more
WEBINAR EUDAMED 2024 and Beyond: Preparing for the Future of Medical Device Oversight Watch our on-demand webinar and gain valuable insights into the transformative impact of EUDAMED on the Medical Device industry. Learn more
ON-DEMAND TrackWise Digital®: Managing Complaints with AI QualityWise.ai: Auto-Categorization Product Demo Video Learn more
WEBINAR Transforming Quality Operations in the Digital Age Learn how Orion is using TrackWise Digital® to transform quality operations and enhance traceability among suppliers to continuously improve quality and patient safety. Learn more
WEBINAR Seamless Collaboration with a Digital Supplier Quality Management Solution Join Darrius Kilpatrick for this insightful 30-minute webinar as we showcase TrackWise Digital® for Supplier Quality Management (SQM). Learn more
WEBINAR Risk Management: An Antidote to Managing Supply Chain Uncertainty In this session, we will delve into the complexity of risk management and provide a comprehensive framework for effectively managing risks. Learn more
ON-DEMAND Partnering on the Future of Patient-Centric Health Care Discover how the vision of Salesforce Health Cloud and TrackWise Digital enables connected patient experiences, bringing together manufacturers and customers for real-time visibility into product quality and ultimately improve patient outcomes. Learn more
WEBINAR Next Generation Digital Non-conformance (NC) Management Transform the way your organization manages non-conformances and unlock new operational efficiencies that impact the bottom-line. Learn more