April 22, 2021

Medical Device Manufacturing: Achieving Top Quality

Building a reputation as a top-quality medical device manufacturer takes time, and a lot of persistence and effort, between compliance tracking and reporting for the U.S. Food & Drug Administration, keeping up to date with Federal Regulations, and meeting the standards for International Standards Organization certification. At the same time, manufacturers are relying more on their supply chains than ever before to meet strict product quality and compliance standards. Supplier quality management and compliance is non-negotiable in medical device manufacturing.

The highest performing medical device manufacturers rely on key metrics obtained from their systems to define strategic plans to achieve compliance and quality goals. Key performance indicators (KPI) provide data and manufacturing intelligence needed to make more informed decisions for the shop floor. Data captured at the machine level, aggregated into metrics and KPIs, and displayed on dashboards guide manufacturing managers to collaborate with senior management to reach key company goals.  

When production management, product engineering and senior management are all using the same KPIs, potential issues are diagnosed, and recommended solutions are implemented quicker. This close collaboration from the plant to the executive team enables greater insights into key areas including production efficiency, quality, and cost. Production delays are minimized, and product quality is realized consistently with collaboration based on common metrics across multiple departments. This type of data is indispensable in medical device manufacturing as it enables production centers to attain new levels of scale, accuracy, and production.

Five Metrics for Quality Management

  1. Complaints: Metrics to monitor include the number of complaints open, the average time they spend open, and the number of overdue complaints. This data needs to be shared in real-time to improve product quality.

  2. Non-conformance: Metrics include the number and percentage of non-conformance instances closed within 60 days and patterns in recurring non-conformance instances by type. QMS software can be used to automatically detect and communicate all out-of-specification conditions, providing real-time visibility into quality levels and compliance. A common metric for tracking this aspect of quality is non-conformance/correction action (NC/CA). Auditors check NC/CA levels and closed case rates during quality audits for FDA compliance.

  3. Corrective action: Automated corrective and preventive action (CAPA) management streamlines traditionally manual, paper-based processes, such as approvals and escalation. Quality management system (QMS) software helps to identify root causes faster and communicate them to the organization. This is critical for realizing continuous improvements in processes.

  4. Medical device reporting (MDR): Automated MDR reporting, and tracking product quality are essential for compliance. Typical issues tracked are the percentage of MDRs being submitted to the FDA on time versus late and the total number of MDRs. 

  5. Audit findings: Many leading indicators can be developed from external and internal audits. These include on-time completion rates for scheduled audits, number of major non-compliances, percentage of high-risk non-compliance instances, recurring problems, and time to closure for corrective action requests.

Analyzing why there are variations in performance is invaluable in determining how quality and compliance can be improved. Medical device contract manufacturers that understand and make this a key component of their overall business strategy will be the ones most successful.

An experienced manufacturer, like Sanbor Medical, that specializes in contract manufacturing exclusively for the electronic medical device industry can be a valuable partner in order to achieve the quality you are looking for.

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