While identification and traceability are a requirement of 21 CFR 820, ISO 9001 and ISO 13485, it also makes good business sense to take this approach. Each of the standards have a requirement for manufacturers to have product identified at all stages of its lifecycle (receipt, production, distribution, etc.). The goal of this requirement is to eliminate the risk of mixing products, parts, or materials from different lots or different quality statuses. It is also designed to provide traceability with an historical path throughout the manufacture process.
Identification of documentation, material, components, equipment and operations used in the manufacture, procurement and maintenance of products is required. By assigning a unique number to each batch or lot of material (whether it’s a component or finished product), you have the ability to identify where each item ended up. Traceability through the accurate documentation and retention of records provides the ability to identify and track a product or component through its creation to completion.
A component lot number can be issued to a finished product configuration, with all paperwork noting the components used during production. This is extremely beneficial in the case of quality problems, as it will allow you to identify the manufacturing batch effected along with all component lots used. Should the issue be the result of a component, you would then have the ability to identify any other manufacturing batches that used the same component lot.
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