As companies move to implement serialization, much of the energy is focused on line execution. Getting the packaging lines fitted or installed enables the imprinting of serial numbers. Line execution is essential, but it has to be done with good quality process. Without implementing sound quality controls, your company could face serious compliance risks. Serialization brings many existing and new suppliers into the scope. Contract manufactures and contract packaging companies play a significant and important role in your project. They need to understand your requirements and comply with your quality standards. The same for the serialized label and carton providers.
In the past, these suppliers may be qualified as a lower risk category, which means less stringent quality agreements and longer audit cycles. With serialization, their risk level should be re-evaluated and the quality agreement and the audit cycles should be re-assessed. Serialization also calls for new equipment and new systems. The new equipment manages the packaging lines and the new business systems manage the serialization data. This means dealing with equipment suppliers, solution providers and service providers. Unfortunately, many of these providers have under-performed and under delivered. It is critical that you chose the right provider to partner with and manage the relationship under sound quality agreement, so if issues arise they can be addressed quickly and painlessly.