Tuesday, April 03, 2012

Complexities of Lot Tracking

When you are looking for a right-sized manufacturing software system, lot tracking is another one of the “deal-breaker” features that, if you need to perform this level of tracking, will eliminate a great many prospective manufacturing solutions.
Lot tracking is difficult by any measure.
First, the software required to track lot numbers in a manufacturing environment is difficult to write (we have seen a number of totally unworkable lot tracking systems).
Second, the task of accurately maintaining records detailing the movement of tracked items from raw material receipts to customer shipments is time-consuming and error-prone.
So why do lot tracking? Because regulatory agencies require it.
If you are in the pharmaceuticals manufacturing business, the Food and Drug Administration will require you to track lot numbers and maintain a detailed audit of every production run. FDA won’t ask you if you would like to do lot tracking. It is a requirement – no matter the cost.
Some of the most basic and low-cost manufacturing software products claim to feature lot tracking, but the devil is in the details: beware!
For some manufacturers (well, actually very few manufacturers) lot tracking simply means making a permanent record of the lot number of the finished good they just assembled. Their record-keeping amounts to keeping track of the lot lumber of the products they built, the date they built them, and possibly the customer to whom the material was shipped.
If this is all you need (and we suggest you explore this extensively) then consider yourself lucky. The software to perform this task is relatively easy to write, inexpensive to obtain, and is often included as a “feature” in an inventory control system.
However, if the audit requirement is that copious records be maintained for lot-tracked raw materials, through all levels of sub-assembly to the finished good and beyond, then the job gets a lot tougher. The software gets harder to design, more difficult to use, and more expensive.
A manufacturing-oriented lot tracking system (of the sort required by FDA, FAA, and others) must maintain 2 distinct views:
1) A view showing the lot number of every tracked component, tracking its use throughout the entire product structure. We call this the “Where Did It Go” view.
2) A view showing the lot number of every assembled product, tracking its production back throughout the entire product structure to every tracked component. This is what we call the “Where Did It Come From” view.
If the software you have selected does not allow for such a bi-directional view, do not allow the FDA or FAA auditors in the door. You will most certainly fail the audit and be shut down.
Nobody likes to perform lot tracking. But when a regulatory agency says “jump” you do it.
The good news is that manufacturing software with effective 2-way lot tracking does exist, although it is not cheap. In my next blog post I’ll introduce you to the lot tracking capabilities of the MISys Manufacturing System.

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