Whether you work in the automotive and aerospace industries or the medical device industry, you understand the importance of part identification. For each division of manufacturing, there are laws and regulations put in place regarding identification to reduce error and ensure part safety.
In the medical device industry, the Food and Drug Administration released a final rule in 2013 requiring all manufacturers to include a unique device identifier (UDI) on device labels and packages, except where the rule provides for an exception or alternative; but as of September 2018, the FDA ruled that there must be visible dates on the labels of all devices, regardless if they are excepted from the 2013 rule.
The notion of part traceability is similar to that utilized by automotive and aerospace part manufacturers.
In the aerospace industry, engines, propellers and other replacement and modification parts are required to include certain registration and identification marking. The Federal Aviation Administration (FAA) determines which information is appropriate to include, such as the builder’s name, model designation and certification – if any – among other things. These markings are required to be on a fireproof dataplate or a similarly approved fireproof method.
Regulations for the medical device industry and the aerospace industry, as well as those in place for the automotive industry, are designed to help increase safety for all types of parts.
For example, automotive companies utilize part traceability to increase safety and reliability in their vehicles. If a component fails, the manufacturer can quickly and easily determine when and where the part was produced, allowing for critical recalls and warranty decisions to be made sooner.