30mar, 2023

Food and Drug Safety Finally Steps Up

This may come as a shock to you, but when you pick that product off the shelf in the grocery store, you are the only one that knows the lot number and expiration date of the inventory in your hand. With the simple twist of a wrist, you can see the lot number and when the product is going to expire printed on the side of the box.

The manufacturer that created the product cannot tell you which lot was shipped to which customer. They cannot determine which lots are still in their possession or which lots they received from which vendors. The same lack of awareness afflicts the wholesaler and retailer that touched the product to get it on the shelf for you to select.

The supply chain of our healthcare is not any better. If there is a problem with a manufactured lot and it must be recalled, the only way anyone can identify if the lot impacted is in their possession is by walking out and checking each box.

Do the food and drug manufacturers, wholesalers and retailers not think their customers health or their own product liability risks are not important? No. They fully understand the business they are in and that quality and customer confidence are key to their business. The problem is that their existing systems and processes do not capture or store lot/expiration date as a characteristic of the inventory in their possession.

To comply with US FDA Food Safety Modernization Act (FSMA) requires that lots must be tracked from the vendor that shipped you the inventory to the customer receiving your lot-controlled inventory. And since your existing systems do not have the data or process to accommodate US FDA Compliance, it is essential that you augment your supply chain and existing systems with an In Transit Inventory Control System.

From the moment your vendor creates a lot-controlled product your supply chain needs to track the lot, expiration date, order number, SKU, and quantity every time it hits your receiving dock. Then as that lot is consumed making another lot-controlled product, you need to track the lot consumed and the new lot created. Finally, when the customer orders the product, you must track the lot number which you shipped to them.

You can achieve regulatory compliance, avoid fines, and continue to be able to sell your products to your customers by augmenting your existing systems and processes with an In Transit Inventory Control System. From Booking an inbound shipment from your vendor, each trackable unit of inventory gets a serial label created, printed, and applied at the source. Then as this box moves through your supply chain and into your company, validated each step of the way, you have the provenance to prove where it came from, where it was consumed and to which customer you shipped the box.

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