Cyber-Physical Inspection Systems for High-Accuracy Industrial Operations: Standards-Aligned Architecture and Sensor-Driven Traceability

High-accuracy industrial operations demand inspection systems that are not only precise but also scalable, traceable, and compliant with regulatory standards. This paper presents a pilot cyber-physical inspection architecture developed for regulated manufacturing environments, integrating collaborative robotics, structured-light scanning, and industrial IoT concepts. The validated portion of the system includes robotic surface preparation using an in-house spray setup and dimensional evaluation via Zeiss ScanBox, supported by Gauge R&R studies that demonstrate improved repeatability and reduced cycle time across critical features. These subsystems were physically implemented and tested in a controlled production environment, with performance benchmarks compared against manual inspection workflows. Additional components-including contextualized data streaming, integration with digital electronic device history record (eDHR) systems, and closed-loop analytics—are conceptual and currently under development. These elements are designed to support future scalability, predictive quality control, and regulatory alignment under standards such as ISO 13485 and FDA 21 CFR Part 11. A comparative analysis of traditional and robotic inspection modalities is provided, along with a discussion of system architecture, workflow design, and deployment considerations. The proposed framework offers a replicable model for intelligent inspection systems in high-accuracy manufacturing, with potential for multi-site rollout and enterprise-wide digital transformation.