Monday, April 30, 2012

Confirming Serial/Lot Numbers in MISys Manufacturing

There is little chance that you’ll decide to track serial/lot numbers for the sheer fun of it. Most manufacturing companies take on the added burden of tracking raw materials and finished good because some regulatory agency demands it. One of the other things that regulatory agencies demand is the assurance that, once you have assigned a serial number of lot number to an item in a stock transaction, it is impossible for someone to change that assignment. It’s understandable. If, as a regulator, you were concerned about maintaining the integrity of the data created by a computer system, you would certainly want to build in barriers against unscrupulous users who felt the need to change the data.

When we were first designing the Serial/Lot Tracking module for the MISys Manufacturing System, we considered long and hard the implications of this security rule. What bothered us most was the knowledge that tracking serial/lot numbers through multiple levels of assembly requires no small amount of data entry. Human beings, imperfect machines that they are, can be depended on to make data entry errors when assigning serial/lot numbers to item transactions.

Just about everywhere else in the MISys Manufacturing System, it is possible to fix a data entry error by editing a form, or making an adjusting entry. But, to satisfy the regulators, there should be no way to change the assignment of a serial/lot number after the fact. Obviously, a compromise was needed.

Ultimately, the compromise came in the form of an “Undo” function for the serial/lot number assignment process. That is to say, if you make a mistake when assigning a serial number or lot number to an item transaction, you have a certain fixed period of time during which you can undo the assignment and try again before the “ink” as it were sets.

So, in the MISys Manufacturing System, every serial/lot assignment transaction that you enter gets stored in a temporary register. If you have an “Oh sh…” moment and want to undo the transaction you’ve just entered, you can go to the Assignment Register, select the transaction you wish to undo, then click the Undo button.

Recognize that the process of undoing a serial/lot transaction is just as complex as doing it in the first place. The MISys software not only undoes that item assignment transaction itself, but necessarily, it also undoes all the ancillary assignments that were made automatically.

The regulatory consultants we contacted weren’t crazy about the transactions being left in the Assignment Register for all time. We agreed that doing so would open (and keep open) a large security hole that could easily be breached. For this reason, MISys requires that you confirm serial/lot tracking assignments with 30 days of making them.

MISys Manufacturing periodically checks to make sure there are no un-confirmed serial/lot number assignments older than 30 days. If it finds any, the program will remind you of the need to confirm the outstanding serial/lot assignments by triggering a dashboard alert.

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