Tuesday, April 10, 2012

Cradle To Grave Lot Tracking

In my last post about lot tracking in a manufacturing environment, I tried to differentiate between software that allows you to record the lot number of materials you receive and complete -- and software that maintains an auditable connection between received raw materials and completed finished goods.

The cheap way to implement lot tracking in a software product is to maintain a table of lot numbers for raw materials received. If the software you are evaluating records lot numbers on the PO receiving side, there’s a good chance it also records lot numbers of the MO production side of the house. That may be as far as it goes, but that may not be far enough for your needs, or the needs of a regulatory agency that keeps tabs on your operations.

If the software you are evaluating is advertised as being “integrated with a core accounting system” then you should look for the ability to pass the lot number of the items just assembled to the sales order invoicing system. If the core accounting system has lot tracking capability, look for the ability to see which lots were delivered to which customers -- or which customers received which lots.

The MISys Manufacturing System provides what we call “cradle-to-grave” lot tracking – the complete path of lot numbered items as they move through the production process. It’s a system that meets the audit requirements of most regulatory agencies.

Imagine that you are notified by the FDA of a product recall of some raw material Item XYZ. You immediately need to be in touch with customers who purchased a finished good you produced that used the affected lot. You find yourself in a very precarious position if your manufacturing software cannot trace the affected lot number from the time it was received as a raw material, through every level of sub-assembly, to the finished good, and eventually to the customer.

Similarly, imagine that within a few hours of one another, three customers all complain of the same failure in a finished good you produce. You suspect some particular lot of a raw material item used in the product, but which lot? If you could determine that the same lot numbered raw material was used in each of their products then you’d have fingered the culprit. You need help from your manufacturing software.

As you can see, the real value of a lot tracking system is lies in its ability to connect the vendor’s raw material item to the customer’s finished good item. Software that does this will cost more and require more data entry on your part, but when a regulatory agency comes calling, you’ll be glad you made the right choice.

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