Enterprise batch records and supply chain traceability
I’ve talked before a little bit about electronic batch records and enterprise batch records. Electronic batch records are all about keeping everything about a batch electronically instead of on lots of paper. That makes everything about the batch easier to manage and supports other things like batch historical analyses, batch-to-batch comparisons, and electronic certificates of analysis (COAs).
Building on the idea of electronic batch records is the idea of enterprise batch records. Enterprise batch records take the idea of electronic batch records to a whole new level. The idea of enterprise batch records is that we’re trying to capture everything that happened to the finished product from the receiving dock to the shipping dock. Everything that goes on in the four walls of the manufacturing plant goes into the enterprise batch records.
There are several significant business reasons for enterprise batch records. At the core, enterprise batch records support:
A. The handling of a product retrieval or product recall,
B. Dealing with a problem with a piece of equipment, and
C. Solving a problem with a particular person working in the manufacturing area.
But, there’s more than just that. Enterprise batch records also connect upstream to suppliers and downstream to customers, taking traceability to the next level and linking to the supply network and the distribution network, supporting supply chain traceability.
Most people know the importance of traceability upstream and downstream throughout the supply chain. Many industries have somewhat different requirements for that traceability but almost every industry has some kind of initiative in place to provide complete end-to-end traceability. (The farm-to-fork concept in the food, beverage, dairy, meat, and poultry industries comes readily to mind, as an example.)
On the supplier side, there is already a lot of information that should be coming in from every supplier. Lot genealogy information is a minimum along with a COA and/or a certificate of compliance (COC). These should all be coming in electronically and should all be linked into the enterprise batch records. This allows for interested personnel to take a look at what’s going on the shop floor and see the supplier information.
For example, if someone is checking up on a potential quality issue, they might immediately look at the quality test results, look at the manufacturing processes, and then want to take a look at the raw materials used. Without the supplier information they won’t really know much about the raw materials and might have to go find a paper copy of a COA.
With enterprise batch records and the supplier information linked, they would be able to look at the test results, the manufacturing processes, and then look at the supplier information all at once. This allows them to see the complete picture and to better diagnose any potential quality problem. It also allows them to get to the heart of the matter a lot quicker and is especially important in situations where time is of the essence.
So, from the supplier side, at a minimum you need the lot traceability and the quality information in the form of COAs or COCs. There is probably more information that you need, including details on the shipments and links to the purchase orders, specifications, and so on. But, on the supplier side, this is definitely the place to start. Linking all this to the enterprise batch records provides a complete picture and really supports the analysis of any and all types of problems when they occur.
On the distribution side, the story is much the same. The first thing that’s needed is complete distribution traceability linked into the enterprise batch records. Just like on the supplier side, this will allow someone to take lot genealogy information and trace it through the distribution network. This allows them to quickly and easily deal with a product retrieval situation. And by linking the enterprise batch records to the distribution traceability this allows any problems that are detected in manufacturing to quickly be traced seamlessly through manufacturing and seamlessly into distribution.
The other thing that’s needed on the distribution side is the information on the finished goods composition. This is where you might be providing your customers with COAs and/or COCs. Many customers require a significant amount of information about the products even if they don’t necessarily require a COA or COC.
Using the enterprise batch records is the natural way to provide this information, avoids the duplication of information, and again allows the seamless integration of the information from manufacturing into the distribution network. This allows for very quick and very easy analysis and diagnosis of problems by having all of the information readily available, and being able to trace forward or backward seamlessly through manufacturing and the distribution network.
Enterprise batch records are very powerful in and of themselves, but expanding them so that they connect upstream to suppliers and downstream to customers, takes traceability to the next level. It links manufacturing to the supply network and manufacturing to the distribution network, supporting end-to-end supply chain traceability.
So, the basic idea of enterprise batch records is simple. Everything that goes on in the four walls of the manufacturing plant—from the receiving dock to the shipping—goes into the enterprise batch records. Not just the material genealogy, but everything that happened.
Then, the next level of enterprise batch records is connecting them to the supplier network and the distribution network providing end-to-end supply chain traceability from the supply network to manufacturing and from manufacturing to the distribution network.
It’s taking enterprise batch records to a whole new level.
Thanks for letting me tell you about enterprise batch records. Until next time, good luck and have fun.
This post was written by John Clemons. John is the Director of Manufacturing IT at MAVERICK Technologies, a leading automation solutions provider offering industrial automation, strategic manufacturing, and enterprise integration services for the process industries. MAVERICK delivers expertise and consulting in a wide variety of areas including industrial automation controls, distributed control systems, manufacturing execution systems, operational strategy, business process optimization and more.