In the medical device sector, human errors and complicated offline data capture might have disastrous repercussions. Consider an insulin pen: if any of the measurements are slightly off, it could result in erroneous deployment, overdosing, putting the user at risk. Before manufacturing begins, the first article inspection (FAI) confirms that all measurements have been validated. Can manufacturers ensure that every item is compliant with the original design if it’s documented on a separate file?
Before the production run begins, these parameters are checked to ensure that everything is in order. The FAI for as9102 software benefits the developer with pass criteria for this part. They can link back to the balloon drawing and utilize it in future quality checks for necessary quality dimensions.
No More Spreadsheets
Manually creating a design, collecting data, and entering results into a report is time-consuming and error-prone. Consider the following scenario: an engineer records measurements from metrology equipment and documents the dimensions into an Excel spreadsheet. While these spreadsheets can be a helpful tool, incorrect data entry can have costly consequences later in the manufacturing process. There is no guarantee that data will be accurately transferred from measurement equipment to the report file while dealing with spreadsheets.
Using a single document also causes traceability holes, which can negatively affect productivity. When a part design changes or a lapse in production, manufacturers frequently do an FAI report. The process will never be entirely traceable if they can’t connect the original drawing, development, and report. There’s no guarantee that future goods will be equal to the initial drawing.
Automatic Reporting
Developers can increase traceability by automating the FAI reporting process and avoid spending time and money on manual ballooning and isolated papers. For example, High QA Inspection Manager enables developers to automatically detect geometric dimensioning and tolerancing (GD&T) from models, identify essential dimensions, and input all data from the ballooning drawing. The software then takes all of this information and builds reports by industry standards, such as the FAI report. While medical device makers can create an FAI report in Excel, it lacks the precision and accuracy required in the medical business to keep patients safe. Automating an FAI report can link data from drawings, models, and manufacturing to verify that all items are generated and inspected accurately, increasing traceability.
FAI standards demand that all manufacturing procedures, including tooling, all development aspects, material requirements, and testing processes and measurements, be appropriately documented and verified in full. A first-article inspection report acts as the companies and government-mandated documents. The FAI procedure and paperwork are typically more complicated the more sophisticated the production element is. I hope you’ve gained some insight from this article. Thank you for taking the time to read this!
