Serialization consultant Michael Marrone shares his experiences over the years as a leading advisor in the life sciences industry on serialization and digital supply chain. 

It’s never an easy call to make late on a Friday afternoon: informing the Senior Vice President of Supply Chain that a new product launch scheduled for Monday must be postponed.  And you don’t know for how long. A deafening silence follows. After which you meekly explain that a required New Product Master Set Up document is still being routed for Approval, and the final e-signature is waiting on the Director of Quality Assurance. Who is on an eco-tourism trek with no cell phone service until Tuesday.

Such are the Tales of Serialization Consulting Horror told in hushed tones over drinks in the hotel bar.

Why is an emergency Product Master Set Up document being routed in the first place? Well, 6 months ago, somebody forgot to include the Serialization Team on the New Product Launch planning call, and now the Contract Packaging Partner has 100,000 doses to pack and label over the weekend, and no idea what GTIN should be encoded in the bar code of each carton. Without that, the packaging line won’t be started.

How Did This Happen?

Too often, the integration of Serialized Product Data with enterprise-level master data processes and systems is under emphasized by the organization, creating multiple points of potential failure.  In a typical scenario, the Serialization Project Team will have completed creation of the required GS1 data values for a serialized finished good early in the project. And then that information – Company Prefix, GLN, GTIN – sits dormant in the standalone serialization L4 system while other launch support initiatives are given higher priority.  The serialized product data is documented, validated, and … forgotten.

Which brings about the phone call above. Which includes an uncomfortable reminder to that SVP that shipping product under the Drug Supply Chain Security Acts (DSCSA) without required data elements is a violation of the Drug Quality and Safety Act (DQSA).  Packaging at risk is not an option.

Can This Scenario Be Avoided?

Of course it can.

With project and operational planning that ensures supply chain leadership understands the critical importance of serialization data to their product flow. With education of those with operational responsibility for finished goods product data integrity and completeness.  With all business area stakeholders represented in any serialization project: IT Master Data Management. Supply Chain Security. Quality. Contract Partner Management. Regulatory.

Fortunately, for all involved, the call above never needed to happen because the Serialization Project Manager made sure that routing of that New Product Master Set Up form was part of the Mock Launch activity executed one month earlier. And that the “GTIN” field was marked as REQUIRED.  And that responsibility for the value in that GTIN field was specified in the “Serialized Product Management” SOP to be the Supply Chain Systems Director. An SOP which also directed each Approving Department to designate at least one delegated backup signer in case, you know, someone was in the jungle 😉

In the next tale from a serialization consultant – how to avoid thinking that the SKU <-> GTIN strategy that worked in the US will cut it in the EU. Spoiler alert: it won’t.