Jason McGlynn, commercial manager for Ireland at industrial metrology specialist The Sempre Group, explores how the latest metrology software can streamline the FAI reporting process.
Human errors and complex offline data capturing can have dangerous consequences in the medical device industry. Take an insulin pen as an example — if any dimensions are slightly incorrect it could lead to false deployment, overdosing or underdosing — putting the user at risk. First article inspection (FAI) ensures that all measurements are verified before production begins. However, if it’s documented on an isolated file, can manufacturers be sure that every part is compliant to the original design?
During the early stages of product development, medical device developers must find the best way to convert a concept and 2D drawing into a 3D, functioning product. An FAI report is a design verification and historic file that provides a reported measurement for each manufactured part. The report consists of a ballooned drawing that points to the individual dimensions and requirements of the part. Developers can use this data to ensure that the final product meets specifications and manufacturers can use the report to ensure that measurement data of final products correlates with the original dimensions in the design.
Completing the report requires engineers to collect and validate all dimensions of the product. This can include distances between edges, positions of holes, diameters or shapes of holes, weight, density or surface finish. The report will also identify the critical to quality (CTQ) dimensions that will be regularly measured during production to monitor quality.
Inspecting these parameters confirms that everything meets expectations before the production run starts. The FAI report gives the developer a pass/fail criteria for the part that they can link back to the balloon drawing and then use for critical to quality dimensions in future quality checks.
No more spreadsheets
Manually ballooning a design, gathering data and inputting results into a report is a time-consuming process prone to human error. Consider this example, an engineer takes notes of measurements from metrology equipment and inputs the dimensions into an Excel file. While these spreadsheets can be a valuable tool, if users do not input the information correctly, it can have costly consequences later in production.
When working with spreadsheets, there is no guarantee that data will be accurately moved from measurement equipment to the report file. Using an isolated document also creates gaps in traceability, which can have a negative impact on production. For example, manufacturers often carry out an FAI report when a part design changes or there has been a lapse in production of that product. If they cannot easily connect the original drawing, product and each report, the process will never be fully traceable and there is no guarantee that any future products are identical to the original drawing.
Automatic reporting
Automating the FAI reporting process enables developers to improve traceability and avoid wasting time and money on manual ballooning and isolated documents. High QA Inspection Manager, for example, allows developers to automatically identify geometric dimensioning and tolerancing (GD&T) from models, identify critical dimensions and input all the data from the ballooned drawing. The software then automatically extracts all of this data to populate reports, such as the FAI report, to comply with industry standards including ISO 17025 and 21 CFR.
Automated quality management system (QMS) tools offer manufacturers an all-in-one solution for quality management, collecting and storing data at every point, from drawing to final product. They eradicate the need for time consuming paperwork and filing, so engineers can easily communicate important quality information across the supply chain.
Medical device manufacturing teams can also benefit from automated reports later in production, for example when producing reports to reflect a change in a design, process or material. Manufacturers can automatically compare the original ballooned drawing with the new report, offering full visibility to the entire team.
While medical device developers can successfully complete a FAI report on an Excel document, it will not offer both the precision and accuracy required in the medical industry to keep patients safe. Automating a FAI report automatically links data from drawings, models and production to ensure that all products are developed and inspected correctly, improving traceability.
