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.

Serial/Lot Tracking Ease of Use Factors

As I’ve discussed in previous posts, manufacturing software that performs real serial/lot tracking is more difficult to use and more labor intensive to maintain than software that “fakes it” by just providing a text field in the item master to record serial/lot numbers. Therefore it is incumbent on the designers of the software to make it as easy as possible to use while maintaining the integrity of the data being collected.

For example, when serialized or lot-tracked raw material items are being received, their serial/lot numbers may have been assigned by the supplier -- or that may be job of the customer (the manufacturing company). If the serial/lot assignment is done by the manufacturer, then it is likely that the serial/lot numbers can be assigned in sequence. Good manufacturing software will ease the burden of assigning serial/lot numbers by letting you create a sequence of, say 100 serial/lot numbers starting from XYZ001. Poorly designed software would require you to enter 100 serial/lot numbers.

On the other hand, if the serial/lot assignment is done by the supplier, then good manufacturing software will allow you to enter 100 unique serial/lot numbers (even though doing so is more time-consuming) because there is a good chance the parts will come to you that way.

Then there is the matter of when serial/lot assignments are most conveniently done. If your receiver can open a box and readily read the numbers printed on serial/lot-tracked items, then it may be most convenient (and efficient) to assign the serial/lot numbers right then and there.

However, if serial/lot tracked items are being used in the production process, then you may not wish to hold up production while you update the computer with the serial-lot numbers of the items being used. Deferred entry of serial/lot numbers may be the best (or only) entry method you would consider at this phase of the manufacturing process.

You will rarely find manufacturing software that gives you the option of entering serial/lot numbers in real time, or deferring the entry process to a more convenient time. The MISys Manufacturing System is among the few systems that give you the flexibility of both methods.

For more information about MISys go to www.misysinc.com.

Serial Number Tracking for Manufacturing Companies

In my previous postings about lot tracking in a manufacturing environment, I tried to differentiate between manufacturing business management systems that take a shortcut to lot tracking and those that perform what I call “cradle-to-grave” lot tracking. I feel it is important to make this distinction because the latter will satisfy regulatory agencies such as FDA and FAA (as well as meeting ISO 9000 standards) while the former will not.

The characteristic that makes cradle-to-grave lot tracking so important lies in its ability to track the lot number(s) of any raw material component through multiple levels of sub-assembly, to the lot number(s) of the finished goods being produced.

I also pointed out that any software you select to assist with lot tracking in a manufacturing environment must deal with partial (split) lots. In other words, if there isn’t a sufficient quantity of a required material in one lot, then you need to get the balance for a different lot. The rub is that once you split lots, the software has to track all those lots through the entire production process.

Tracking serial numbers isn’t all that different from tracking lot numbers. While there can be many members of a lot, there can be only one member of a serial number. The MISys Manufacturing System allows you to identify a tracked item as either lot-tracked or serialized.

If raw materials are serialized, the serial number can be pre-assigned by the supplier, or assigned by the manufacturer at the time they are received. Some manufacturing software simply provides a field in the item master in which you can record the serial numbers of the items you have received. Bad choice.

As we have seen with lot-tracking, professional-grade manufacturing software (such as MISys) keeps a transaction log of the serial numbers received, then follows each individual serial numbered item through the manufacturing process. Ultimately, the software can tell you where a serialized item was used – and what serialized item(s) were used as components in a tracked finished good.

Without a doubt, using software that performs “cradle-to-grave” serial or lot tracking like MISys requires a degree of overhead that is not needed when running simple (arguably inadequate) manufacturing software. In my next post I’ll take a closer look at the work required to adequately track serial and lot numbers and discuss what MISys does to ease the burden.

For more information about the MISys Manufacturing System visit www.misysinc.com.

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.

More About Lot Tracking In A Manufacturing Company

Manufacturers often need to track lot numbers for one of two reasons (sometimes both):

1. They need to uniquely identify the source of raw materials.
2. They need to identify the destination of a group of finished goods.

Many inventory management systems offer lot tracking capabilities and have provisions for capturing the lot number of raw materials you receive as well as the lot number of customer shipments. In a manufacturing environment, the task of lot tracking gets more complicated because a manufacturing company typically uses the lot-tracked raw materials to create lot-tracked finished goods.

Imagine a raw material Item A being used in a sub-assembly Item B, Item B used in sub-assembly Item C, and Item C used in finished good Item D. If Item A is lot-tracked, the software needs to be able to record the lot number whenever Item A is received. Likewise, if finished-good Item D is lot-tracked, the software needs to be able to record the lot number whenever Item D is produced.

Whether Item B or Item C are lot-tracked themselves is not so important (they may or may not be), except that these sub-assemblies perform a role in consuming the lot-tracked raw material, Item A. This is to say that, in a manufacturing environment, it is important to be able to track the “use” of a lot-tracked component step by step through the manufacturing process to the finished good.

There are two views of the manufacturing process that regulatory agencies require you to meet:

1. A view of where a lot-tracked item was used (the lot-tracked component item looking forward).
2. A view of the lot-tracked item(s) used in a finished good (the lot-tracked finished good item looking back).

If your manufacturing process requires lot-tracking, be certain that the software you are evaluating delivers both views. Be careful because some software (and some software vendors) try to fake it.

If the job of tracing lot-numbers through the entire manufacturing process wasn’t difficult enough, there’s another complexity of lot tracking that many manufacturing software products gloss over.

Going back to the example of raw material Item A being baked into finished good Item D, consider this: the production of sub-assembly Item B may require more of Item A that exists in a single lot. So, to build Item B, multiple lots of Item A are consumed. The manufacturing software needs to know how many of Item A was used from each lot. Then when sub-assembly Item C is produced, the manufacturing software cannot lose track of the various lots of Item A included in Item C. Likewise, the production of the finished good Item D, includes various lots of Item A. But which lots? Regulatory agencies require you to know. Make sure the manufacturing software you are evaluating can tell you accurately.

The lot tracking capabilities of the MISys Manufacturing are specially designed to be able to trace a lot-numbered raw material throughout the entire production process, regardless of how many levels of sub-assembly are involved, and deal accurately with the consumption of multiple lots. As you might imagine, this is a massively complex process, management of which few MISys competitors can match. If you are required to accurately trace lot numbers through the entire multi-level manufacturing process, by choice or necessity, MISys Manufacturing is up to the task. See www.misysinc.com/ for more details.

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.