Data-driven decisions have long been critical to achieving quality improvements, yet many medical device manufacturers struggle to make informed and timely decisions due to a lack of visibility across the extended supply chain. As supplier networks become more complex and as vendor partnerships expand, complete supply chain visibility has grown as a strategic priority.
Among manufacturers, recent LNS Research
surveys found that supply chain visibility is a top challenge across industries and is a leading roadblock to achieving quality objectives. Manufacturers with poor visibility into supplier performance have a median supplier defect rate more than double the remainder of the population, LNS Research found.
The findings highlight a clear and significant need for automation tools to achieve end-to-end visibility, according to MasterControl's Terrance Holbrook, a senior product manager with 20 years of industry experience in manufacturing fields.
Leveraging a centralized electronic quality management system (EQMS) can help medical device manufacturers bring together all quality data, leading to greater visibility and solutions to at least four key quality challenges across the extended supply chain, Holbrook explained in a recent article for Medical Design Technology
#1 Improve qualification workflow.
As an organization procures new goods and services, and as vendors’ approval statuses change, tracking these activities often becomes more difficult. Information shared across multiple sites or divisions can slip through the cracks, and qualification efforts are often duplicated. Centralizing all supplier qualification activities in a secure, connected EQMS will enable manufacturers to better manage all qualification documents and processes with data controls and qualification audits, make it easier to manage initial lot inspections for supplier certification, and let authorized personnel in different locations access and share qualification data.
#2 Streamline audits.
Supplier audits can be an important tool that gives your organization greater visibility into suppliers’ quality-related activities, yet inefficiencies often make this vital tool work insufficiently. An EQMS can integrate the audit process with the rest of the quality system, connecting all audit data and actions. You can automatically track and store all information related to supplier audits, including audit responses, reports and approval statuses. Maintaining all audit information in a centralized repository enables better visibility into the current state of the supply chain, and makes it easier to find and manage suppliers that meet quality requirements.
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#3 Simplify scorecards.
Ensuring that suppliers maintain an acceptable level of quality, delivery and regulatory compliance is made more challenging by difficulties in collecting supplier performance data and inconsistencies in handling issues. With an EQMS, you can identify and monitor metrics for measuring suppliers’ performance, rate them consistently with objective metrics, and maintain accurate records of deviations, non-conformances, etc. Automation enables you to improve data collection and tracking throughout the supplier scorecard process, convert supplier-performance metrics into a single score that will serve as the basis for action, and create permanent records around all supplier-related quality events.
#4 Ensure accuracy of AVLs.
Tracking and managing the approved vendor list (AVL) can be a complex, often error-prone, process. Further complexities arise when supplier quality information is maintained in separate systems or tracked manually. An EQMS will enable you to automatically track and store each supplier’s approval status and quality information, and ensure that AVL documentation is current and available via a single, centralized system. As suppliers, parts, designs and processes change, automation will help track and add the information to the AVL on a continuous basis to ensure every AVL is accurate and up to date.
To learn more about how an EQMS can be used to improve supplier visibility, read Terrance Holbrook’s full article “Manufacturing Medical Devices: Using Automation to Improve Supplier Quality” published in the September/October 2017 issue of Medical Design Technology magazine.
David Butcher has been writing about business and technology trends in the industrial B2B space for more than a decade. Currently a marketing communications specialist at MasterControl, he previously served as editor of ThomasNet News’ Industry Market Trends and as assistant editor for Technology Marketing Corp.’s Customer Interaction Solutions. He holds a bachelor’s degree in journalism from the State University of New York, Purchase.