Protect Your Product From the Risks of Supply Chain Complexity January 21, 2020 Proactive quality management requires complete visibility into quality—which includes your entire supply chain If reducing the risk of recalls is one of your top priorities in 2020, then proactive quality management is a natural fit. Visibility and collaboration are an integral part of a proactive approach, which is challenging when it comes to the supply chain. Outsourcing, multiple sites and other issues add a level of complexity that can hinder your quality management efforts and increase recall risks. What can you do? The High Cost of Quality Events Recalls are a potentially disastrous—and increasingly common—outcome of quality events. From 2004 to 2013, FDA drug recalls increased 600 percent. Stericycle Expert Solutions reported that more than one million Class 1 medical device units were recalled in Q1 of 2019 alone. The report cited quality issues as cause of the recall in more than half those units.A single recall can easily cost your company tens of millions of dollars, not to mention long-term detrimental effects on sales, brand image, and company value. Major quality events can cost hundreds of thousands of dollars per day and can take weeks-to-months to resolve. Even a spike in temperature or humidity in a controlled manufacturing environment can shut down manufacturing at the site of the event until the problem is resolved.Increasing the number of hand-offs from raw material to finished product increases your risk of a quality event. But regulations are clear that the product owner is ultimately responsible for any quality issues, even those that originate with suppliers. In ICH Q10 (Pharmaceutical Quality System), the FDA states that pharmaceutical companies are “ultimately responsible to ensure processes are in place to assure the control of outsourced activities and quality of purchased materials.” Manufacturers must find ways to manage supplier risk if they hope to control their own. Increased Complexity = Increased Risk Current Good Manufacturing Practice (CGMP) requires robust quality management systems that can keep up with today’s exacting quality standards. Yet the quality systems in place at suppliers and smaller contract manufacturing organizations often fail to meet these standards.A 2018 report in BMJ Global Health noted that inadequate quality systems play a primary role in quality issues across pharmaceutical supply systems in low-income and middle-income countries. The report stated that “the variability of the quality systems across distributors in a country implies a variable level of QA, and a real risk of exposure to poor-quality or degraded medicines.”Even under the best circumstances, the use of separate quality systems at suppliers or contract manufacturers increases complexity and can limit your visibility into end-to-end quality. Issues that stem from supply chain complexity typically involve five factors: The number of variables that must be monitored and controlled The volume of required transactions, especially if they are manual and involve multiple individuals The variability of each interaction, including the levels of interaction that are required for problem resolution The extent of visibility into interactions Mechanisms for managing and communicating change Key steps for mitigating these risks, then, are gaining visibility into supply chain and partner quality data and integrating quality management as much as possible. Expand Visibility to Integrate Supply Chain Quality Cloud technology, as part of a mature digital quality management ecosystem, can lead to innovation and an integrated quality network across your suppliers. Internal quality management processes connect with ecosystem partners, delivering comprehensive visibility into issues from raw material through manufacturing to customer experience. The Benefits Can Be Transformative Increased visibility and instant awareness of quality issues, from both upstream and downstream partners Enhanced accountability for each partner in the supply chain Operational efficiencies that make it easy to track and trend quality issues in real time Product safety and compliance— ultimately, a healthy, quality supply chain enables production of safe products 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: 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 to Ensure Supplier Quality in Medical Devices – Supplier quality management systems can help medical device manufacturers ensure high-quality processes across an increasingly complex supply chain. 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
EVENT 7th Annual European Medical Device QA & SQM Conference 2024 The 7th Annual European Medical Device and Diagnostic Supplier Quality Management Conference aims to bring together the industry’s top-performing Supplier Quality Management (SQM) & QA QC professionals under one roof. We are Bronze Sponsors of the 2024 Medical Device QA & SQM Conference in Belgium. Learn more
EVENT TUG Americas Join industry peers at one of these FREE events for TrackWise and TrackWise Digital customers, with two dates and locations to choose from. Learn more
EVENT Building a Winning Life Science Eco-system – Leveraging the Quality Link between Platform, Processes and Patients Watch this unique webinar to discover how Life Science organizations can a combine a best-in-class platform with freedom of solution choice to improve product quality, productivity, and supply chain continuity. Learn more
CASE STUDY Empowering Innovation: Revelle Aesthetics Transforms Document Management and Training with TrackWise Digital Revelle Aesthetics selected TrackWise Digital to manage its key quality management processes—document management and training management. Learn more
BLOG The Impact of Digital QMS Solutions on the Life Sciences Industry The evolution of cloud-based quality management systems is transforming expectations and changing realities in the life sciences industry. Find out how in our latest newsletter edition. Learn more
BLOG Integrated Risk Management: Go Beyond Compliance To ensure patient safety, proactively detect signals and trends and continuously improve device quality and safety, integrating quality risk management with the quality management system (QMS) is essential. In our latest article, we consider the benefits of this integration and address the growing complexity of risk management. Learn more
BLOG Cultivate a Culture of Quality: 3 Steps to Getting Started Cultivating a quality culture is critical for any organization's long-term success, regardless of industry or size. Learn more
BLOG How Pharmaceutical Quality Drives Performance While many pharmaceutical and biotech companies have begun investing in their quality systems, it’s not uncommon to still find mid-size or emerging manufacturers manually entering data into spreadsheets or using siloed systems that are unable to share information electronically. Learn more
BLOG CAPA Management: Technology to the Rescue If you have been struggling with corrective and preventive action (CAPA) management, it’s possible there is a tech solution that will lift the burden. Learn more
BLOG The Power of Integration: A Holistic Approach to Quality and Document Management One of the key components for Life Sciences companies is to have their documents and data in order.... Learn more
BLOG It’s Time For The Life Sciences Industry To Embrace Quality 4.0 Sparta’s President and CEO, Oxana Karpenko Pickeral, explores how the Life Sciences industry can address core challenges and connect the “data dots” by embracing Quality 4.0. Learn more
WHITE PAPER A Guide to Supply Chain 4.0 and Building Resiliency Now is the time to leverage technology to achieve and maintain a resilient supplier chain. This white paper provides an overview of a strategic, tactical, risk-based approach to Supply Chain 4.0. Learn more
WHITE PAPER How Digital Technology Accelerates Your Move to Proactive Quality Leading manufacturers are embracing digitization initiatives to stay competitive in the global economy. Are you one of them? Learn more
BLOG Document Management: A Tale of Two Manufacturers Experiences from two TrackWise Digital customers, Arbor Pharmaceuticals and Mikart, Inc., highlight the challenges that companies can face... Learn more
EVENT 2023 PDA Quality & Regulations Conference Sparta Systems, a Honeywell Company are Elite sponsors of this event. Learn more