Medical Device Manufacturer RFID WIP Tracking for Regulatory Compliance and Efficiencies
Background
A multinational medical device manufacturer produces precision surgical instruments, implantable medical devices, and other critical healthcare products. With multiple production sites worldwide, maintaining strict quality control and regulatory compliance was essential. As demand for their products grew, the company faced challenges in tracking components through various stages of production, ensuring proper documentation, and reducing inefficiencies in their Work in Process (WIP) tracking system.
Historically, the company relied on manual tracking methods, such as barcodes and handwritten logs, to document component movement and ensure regulatory compliance. However, as demand and production increased, these methods became error-prone, leading to delays, misplacements, and increased risks of non-compliance with FDA and ISO standards.
Challenges
Inaccurate tracking of WIP
Inaccurate tracking of WIP inventory led to lost or misplaced components due to manual logging, causing production slowdowns and the need for rework.
Regulatory and plural risks
Regulatory compliance risks became more pronounced as the lack of a real-time tracking system made it difficult to produce complete and auditable records for regulatory bodies.
Increasing production inefficiencies
Production inefficiencies increased because operators spent excessive time manually recording transactions, reducing overall speed and efficiency.
The lack of real-time visibility
The lack of real-time visibility limited the company's insight into the location of specific components within the production process, making it harder to identify bottlenecks and optimize workflows.
Solution
To address these issues, the company partnered with FactorySense to implement an RFID-based WIP tracking system. FactorySense’s all-in-one solution, covering hardware, software, and consulting, allowed for a rapid and risk-free pilot deployment at the company’s primary production facility.
The solution included these applications
- RFID-tagged components and subassemblies
Each item was tagged at the beginning of production, enabling automated tracking through each stage of manufacturing. - Fixed RFID readers at key production checkpoints
As components moved through different workstations, fixed RFID readers automatically updated their location in real time. - Handheld RFID scanners for spot-checking and compliance audits
Quality control personnel used handheld scanners to verify component history and perform compliance audits without interrupting production. - Cloud-based dashboard integration with the company’s ERP system
This provided real-time visibility into WIP inventory, streamlined compliance reporting, and enhanced production scheduling. - Custom dashboards displayed on large TV screens
Visual dashboards were developed and installed in various production areas, allowing real-time tracking of WIP inventory, cycle times, and bottlenecks. - RFID fencing system for sterile and non-sterile area monitoring and movement
The company expanded the system to create real-time alerting when materials moved between controlled sterile areas (white space) and general production areas (gray space), reducing contamination risks and ensuring compliance with strict manufacturing regulations.
“FactorySense also helped the company focus on lean manufacturing and just-in-time (JIT) production. The implementation enabled daily standups where teams could review visualizations of factory dynamics, including areas that were ‘heating up’ due to bottlenecks and areas that were ‘cooling down’ with excess capacity.”
Having real-time visualizations of cycle times, WIP limits, and production flow allowed teams to react immediately as problems started to develop—rather than waiting until issues had escalated into major disruptions. FactorySense’s ability to rapidly scale ensured that the pilot system was fully operational within weeks, and factory personnel quickly adapted to the new workflow.
Crucially, FactorySense added the dimension of work center-based measurements in addition to work order-based measurements. This enhancement allowed production teams to monitor and adjust workflow at a more granular level, improving efficiency and responsiveness.
Implementation & Results
Following the RFID system’s deployment at the initial facility, the company observed significant improvements:
- Real-time WIP tracking
Real-time WIP tracking accuracy increased by 95%, eliminating lost or misplaced components. - Accuracy and audit
Accuracy and audit readiness improved, with automated digital records replacing error-prone manual logs. - Reduction in downtime
Reduction in production downtime, as real-time tracking enabled faster identification of workflow bottlenecks. - Greater agility
Greater agility in responding to production constraints, as real-time data allowed teams to shift priorities dynamically.
With clear efficiency gains and compliance improvements, company leadership approved a broader rollout across multiple facilities.
Expansion to Additional Locations
The success of the initial pilot led to a phased expansion of the RFID system across two additional manufacturing sites. FactorySense’s cloud-based infrastructure eliminated the need for local servers and database management, allowing for a seamless company-wide rollout.
Key benefits of the expansion included:
- Standardized WIP
Standardized WIP tracking across all facilities, ensuring a unified approach to compliance and operational efficiency. - Improved cross-site coordination
Improved cross-site coordination, allowing different plants to share real-time WIP data for better resource allocation. - Faster audits
Faster response to regulatory inquiries, as digital traceability records were instantly accessible across sites. - Enhanced visibility
Enhanced visibility into cycle times and bottlenecks, leading to better production scheduling and optimized work order distribution. - Increased CGMP controls
Increased CGMP 21 CFR 211 Safeguards. Real-time alerts for material movement between white space and gray space, ensuring strict compliance with cleanliness protocols and minimizing contamination risks.
“FactorySense’s expertise in scaling enterprise-wide RFID solutions ensured that the implementation was completed without disrupting ongoing production.”
Key takeaways for decisionmakers
For operations managers and production supervisors, RFID-based WIP tracking eliminated guesswork, ensuring that each component was accounted for at every stage of production. This resulted in fewer disruptions, less rework, and faster production cycles. The addition of work center-based performance measurements provided an even more precise level of control over workflows, allowing for proactive problem resolution.
For executives and compliance officers, the system provided a clear pathway to improved regulatory compliance and audit readiness. By automating tracking and documentation, the company significantly reduced its risk of non-compliance, avoiding potential fines and production shutdowns. Additionally, the custom dashboards and real-time visualizations allowed leadership to monitor factory health at a glance, ensuring greater efficiency and long-term cost reduction.
Conclusion
By implementing FactorySense’s RFID-based Work in Process tracking system, this global medical device manufacturer significantly improved production efficiency, regulatory compliance, and traceability. The successful pilot program led to a company-wide rollout, demonstrating how RFID technology can seamlessly scale to enhance visibility, reduce waste, and ensure compliance in highly regulated industries. With FactorySense’s expertise in delivering a complete end-to-end solution, the company now benefits from real-time insights, improved workflow efficiency, and enhanced production agility.