In-process Inspection Services
Manufacturing medical devices and high-precision components requires strict adherence to dimensional tolerances and quality specifications throughout the production process. Defects that go undetected can lead to costly rework, regulatory compliance failures, and potential product recalls, ultimately damaging a company’s reputation and profitability.
GD&T provides comprehensive in-process inspection services and other inspection services that prevent quality issues before they become expensive downstream problems. Our metrology solutions offer objective, third-party verification with predictable, project-based pricing and access to specialized measurement expertise. Read on to learn more about our specialized inspection services, how these services have been optimized for medical devices, and how GD&T inspection capabilities address the needs of other high-precision manufacturing applications.
What is In-Process Inspection?
An in-process inspection is a quality control methodology that involves measuring and evaluating parts during various stages of the manufacturing process, rather than waiting until completion. This proactive approach utilizes coordinate measuring machines (CMM) and other precision measurement tools to verify dimensional accuracy, geometric tolerances, and surface finish requirements while parts are still in production.
These high-precision manufacturing inspection services typically involve two main types of quality checks: dimensional and visual inspections. Dimensional inspections measure parts against specifications to ensure proper fit and assembly compatibility, while visual inspections detect surface defects, marks, or damage that could affect product performance.
The general workflow of performing in-process inspection includes:
- Part Setup and Fixturing: Secure the workpiece for the appropriate inspection system using appropriate fixtures and clamps to ensure stability during measurement while maintaining access to critical features and datums.
- Program Selection and Calibration: Load the appropriate inspection program for the specific part geometry and perform probe calibration to ensure measurement accuracy and repeatability.
- Dimensional Measurement: Execute measurement routines to capture critical dimensions, geometric tolerances, and surface profiles according to engineering specifications and quality requirements.
- Data Analysis and Comparison: Compare measured values against design specifications and tolerance limits, identifying any deviations that may require process adjustments or part rejection.
- Documentation and Reporting: Generate comprehensive inspection reports with measurement data, statistical analysis, along with charts, graphs, and image captures to fully illustrate dimensional findings.
When Should In-Process Inspections Be Conducted?
In-process dimensional inspection services for medical devices are typically conducted based on three primary intervals: time-based schedules, quantity-based intervals, or observation-driven assessments. Time-based inspections occur at predetermined intervals, such as every few hours or days, while quantity-based inspections are performed after producing a specific number of parts to maintain acceptable quality levels (i.e., C=0 AQL Sampling Plan). Some inspections are conducted on a random basis when technicians observe potential issues or rely on their experience to identify when additional quality checks are needed.
These inspections should also be strategically timed at critical production stages to prevent defects from advancing through the manufacturing process. The primary inspection points include:
FAI: First article inspections verify the initial part produced to confirm that setup, tooling, and materials are correct before beginning full production runs.
Critical Process Transitions: Conduct inspections after major manufacturing operations such as machining/molding, welding/assembly, heat treatment, surface finishing, or post-processing to verify quality before proceeding to subsequent steps.
Process Adjustments: Perform immediate inspections following any equipment changes, tool replacements, material substitutions, or machine calibrations to ensure continued compliance with specifications.
Pre-Assembly Checkpoints: Execute final component inspections before assembly or packaging operations to confirm all parts meet requirements and proper fit-up will be achieved.
Case Study: Inspecting Parts for Critical Life-Sustaining Medical Devices
We recently performed comprehensive in-process inspection services for a medical device manufacturer who produces critical components for life-saving devices. The customer required multi-stage quality verification throughout their complex manufacturing process to ensure all parts meet strict design specifications and struggled to find a quality inspection process that met all the necessary demands. Our role involved in-process dimensional inspection and part sorting at four distinct production stages before final assembly and distribution.
The high-precision manufacturing inspection began with inspecting molded components for several key critical dimensions and features immediately after initial production. We separated any parts that did not meet tight specifications and returned conforming parts to the customer for overmolding operations. This cycle repeated after overmolding, followed by additional inspections after assembly operations and final inspection of pad printing, ensuring quality control at every critical manufacturing step.
Other Inspection Services for Medical Device Manufacturers
GD&T specializes in high-precision inspections and a diverse array of other inspection capabilities routinely demanded by medical device manufacturers that require intense analysis to address tolerances and dimensional accuracy. By embedding certified metrologists directly into your facility, we integrate with your quality team to eliminate bottlenecks and avoid operational disruptions.
Every project includes comprehensive inspection reports with clear data interpretation and technical support. This hands-on approach ensures project timelines are accelerated by delivering accurate data precisely where it matters most.
We offer the following inspection services for clients involved in high-precision manufacturing sectors:
First Article Inspection (FAI): GD&T metrologists conduct exhaustive FAI inspections to verify that your products meet all engineering and design requirements outlined in detailed specifications. Our comprehensive FAI reports detail whether manufacturing processes meet design specifications and provide recommendations to achieve 100% compliance with applicable industry standards.
Custom Fixtures & Gauges: Advanced 3D printing technology enables us to design and build customized inspection fixtures for faster prototyping and lower costs than traditional machining methods. Our fixtures integrate seamlessly with your quality control processes to make independent dimensional inspections more efficient and accurate.
Reverse Engineering & Complete Dimensional Representation: We provide complete dimensional representation through part digitization, CAD solid models, and detailed technical drawings of your existing products. Our modern equipment delivers exceptionally accurate digitized models with fast turnaround times to support your engineering and quality control objectives.
Manufacturing Quality Consulting & Training: Our experienced metrologists integrate seamlessly with your team to analyze manufacturing process results and provide targeted recommendations for improved dimensional inspection and operational efficiency. We offer on-site employee training for custom fixtures and gauges, and equipment programs, ensuring your staff can replicate our dimensional inspection results independently.
High-Precision In-Process Inspection Services for Critical Components
In-process inspection services are essential for medical device manufacturers and high-precision manufacturing operations that cannot afford quality failures. Strategic quality verification at critical production stages prevents costly rework while ensuring consistent compliance with engineering specifications and regulatory standards.
At GD&T, we bring decades of dimensional metrology expertise and state-of-the-art measurement equipment. Our comprehensive inspection services and experienced staff eliminate inspection bottlenecks while providing the quality assurance your business needs to maintain a competitive advantage.
Click below for a quote and to learn more about how our in-process inspection services can improve your manufacturing quality, production efficiency, and overall costs.