Lot or serial numbers can be programmed into the device at the time of manufacture or shortly thereafter. Although the use of lot or serial numbers is mandatory for some products, they are generally used voluntarily for other products. It is also possible to make products look like they contain lot or serial numbers by printing them with ink. This solution is usually both detectable and readable by the user.
The principal benefit of using lot or serial numbers is to ease the burden of failure investigations, repairs, modifications, or recalls. The problem is that a lot or serial number must be programmed into the device at the time of manufacture. This is typically done by using batch codes that are recorded in a batch-reading device or by using a readable bar code. This information is programmed onto the device in a way that it will be readable by the user, usually at the time of manufacture or shortly thereafter. Use of read-only control numbers for the same purpose is less common. Control numbers have the following four advantages:
Manufacturers are responsible for maintaining their records of lot or serial numbers of devices produced, for all purposes under the Quality System, for the period of time for which their devices are manufactured. Record keeping is as specified by the FDA as follows:
Manufacturer's files and records must include records of every lot or serial number issued to a device. The records must be readily available during inspection of the site and may include:
Documentation of the lot number assigned to the label for each device; and
Documentation of the lot or serial number assigned to each device.
The following is a list of some common device controls that are commonly used:
Lot - Lot Number used to control the manufacturing process.
Serial - Serial Number used to identify the part number of the component.
Batch - Batch Number used to control the manufacturing process.
Pass/Fail - Testing or Quality Control label used to indicate whether a device or component has passed or failed a test or inspection. 827ec27edc