In a medical device manufacturing setting, striving for zero defects is always an important goal, and one that many manufacturers do their best to reach. They have regular human inspectors who receive special training, and use the latest machines and monitoring systems to check for defects. But automated visual inspections can help companies get so much closer in reaching that zero-defects threshold that this process is worth a look. Automated visual inspection is one of the latest error-reducing solutions and it promises to be a real game-changer. For one, automated inspections can help reduce costs, especially by preventing defects, and they can help ensure that all parts and processes are made consistently. Variability and minute differences can have a serious effect on the acceptance and performance of medical devices, and human inspections can be a major factor in these different variations. A human inspection doesn't always catch all the very minor defects that can cause problems. Even if the defective parts are caught at the final inspection before they ever leave the plant, the fact that the products were finished means money has been needlessly wasted in producing something that has to be scrapped.
How are automated visual inspection systems used?
An automated visual inspection is basically the eyes of an automated manufacturing system. Rather than relying solely on humans — who are prone to tired eyes, fatigue, and distractions — to perform inspections, an automated inspection can provide a broad range of options, including the presence or absence of certain elements, read barcodes and QR codes, manage sorting and assembly, pick items from warehouse shelves, help with calibration, and determine positioning and status of robotic arms and fingers. By constantly feeding visual data into a machine learning system, the inspection system grows and improves. This can help companies automate their quality control, especially in conditions where it's difficult to place humans; provide testing for leaks, flaws, and deformities; monitor a system's performance, including output and consistency; collect data for monitoring systems; and give visual feedback for robotic systems, such as an item's location, condition, and quantity.
What are some problems visual inspections solve?
In the medical and pharmaceutical industries, automated visual inspections can help with something as seemingly mundane (but still critical) as label inspections. Since even the labels are regulated and require certain information, an automated visual inspection system can ensure that every field of every label has been properly filled in and affixed. This ensures 100% consistency and compliance. Because visual inspections are repetitive, using an automated system can also help companies reduce their hiring needs. Since it's becoming harder to fill some manufacturing positions, companies can free up the human inspectors, and assign them to more sophisticated tasks, which reduces their need to fill certain positions.
What is the FDA’s view of automation and inspections?
(the) FDA supports and encourages the use of automation and that it has the potential to help with better product knowledge, tracking and trending, plus a host of other applications. Manufacturers can gain advantages from automation throughout the entire product lifecycle. They can reduce or eliminate errors, optimize resources and reduce patient risk. FDA’s position is that using these sorts of software products can be an excellent way to enhance product quality and safety, which in the end, is the overarching goal.
Automated visual inspections are proving eminently useful in the medical device industry: they reduce errors and rejection rates, create more consistent quality and specs, and let manufacturers reallocate their human labor to more sophisticated tasks within the operation. NuTec specializes in designing, building, and integrating assembly automation solutions such as automated visual inspection systems. If you would like to learn more about how you can upgrade your manufacturing facility, improve your productivity, all while reducing your error rates and waste, you can contact us for more information.