What 100% Inspection Really Is

Louis Roy, President

I don’t know about you, but over the years, I have certainly heard the term 100% inspection loosely thrown around on more than one occasion. According to the FDA’s requirements for label inspection, 100% inspection refers to single run product inspections that are carried out by machines vs. 200% inspection, which refers to double run product inspections carried out by humans.

However, to fully understand the significance and benefits that 100% inspection delivers to packaging lines, we first need to define exactly what it is comprised of. Specifically, 100% inspection, from the standpoint of the output of a packaging line, involves 100% inspection of a specific component(s) of a product, 100% inspection of that component(s) on all products all of the time and finally, 100% detection and rejection of all products containing a flaw in this component(s) from the line.

The reason for introducing machines onto packaging lines seems obvious. As pharmaceutical companies strive to increase packaging line efficiency and reduce overall production costs through the implementation of high speed packaging lines, it is not surprising to learn that human visual inspection of products is simply no longer financially feasible. However, all machines are not created equal, and for the pharmaceutical industry’s inspection requirements, only highly-accurate, robust vision inspection systems are capable of providing a ‘true’ 100% product inspection, 100% of the time.

For example, within the pharmaceutical industry, inspection of product labels and other product components, such as inserts and cartons require detailed pixel resolution to ensure a constant 100% component inspection. Inspection of one component is a straightforward process; however, inspection of more than one component is a complex endeavor since the inspection results from each component must be linked together to form a complete 100% inspection profile of a product. This further limits the use of certain vision inspection systems since not all systems are able to provide the pixel resolution necessary for carrying out these functions.

Furthermore, vision inspection systems must have fail-safe design features and controls during the inspection processes to ensure 100% detection of all random and nonrandom flawed products. And finally, vision inspection systems must have feedback data capabilities and be able to securely store the inspection data in accordance to the FDA 21 CFR Part 11 requirements. Presently, there is only a handful of vision inspection systems on the market that are capable of providing these necessary features.

As the trend from 200% human inspection to 100% machine inspection continues, advertising of vision inspection solutions that are the next ‘best thing’ for providing 100% inspection is sure to increase. However, providing a ‘true’ 100% inspection is and will remain a challenge that is far easier said than done; a challenge that Optel Vision will continue to meet.