Everyone knows about electronic batch records. They’re generated by batch execution software when a batch is made. Instead of keeping lots and lots of paper about the batch, you keep all the information electronically.
Despite all the good things about electronic batch records, they have some limitations. First, they’re only for a single batch. That’s OK if it only takes one batch to make the product. But in a lot of manufacturing operations it takes more than one batch. There are often several batches and a variety of work-in-progress materials that are produced along the way. That means that it takes many batch records to get from raw materials to finished products and no one batch record has all the information in it you need.
Second, electronic batch records don’t usually record certain classes of information that might be vital to the manufacturing process. For example, most batch records don’t record much, if any, information on labor, not even who or how much. Electronic batch records don’t usually record information on cleaning cycles or maintenance activities before the batch started, or even while the batch was going on. And batch records don’t usually record much in the way of quality, inspection or test result data unless the tests or inspections were performed as part of the processes executed by the batch software. As you probably know, the quality and test data is absolutely vital when dealing with almost any type of problem with a batch or a finished product.
The answer to these shortcomings of electronic batch records is the idea of enterprise batch records. Enterprise batch records expand the idea of electronic batch records to the entire manufacturing operation. The fundamental 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 manufacturing plant goes into the enterprise batch records.
There’s just a lot of different things that happen in the manufacturing plant that are extremely important to the finished product that aren’t necessarily captured in an electronic batch record. That’s where the enterprise batch records come in. The idea is to capture all of the batches that were executed to get from raw materials to finished product and capture all the other important information from within manufacturing that contributed to the production of the finished product.
If done right, the enterprise batch records provide a complete end-to-end story of everything that happened so that you can completely reconstruct what actually happened in manufacturing process right down to the last, significant detail.
The litmus test that I use for enterprise batch records to determine whether or not something should be in there is to ask whether or not the information is needed to deal with a customer complaint. If a customer calls and says there’s something wrong with your product for some reason, do you have everything you need to track down what, when, where, why and how in the manufacturing plant to determine whatever happened actually caused the problem the customer is complaining about?
Think of all things that customers complain about and all the things that can and do go wrong in the manufacturing plant. All these things that go wrong cause problems with the product and cause the customer to complain. So do you have enough information to determine exactly what caused the problem that the customer is complaining about? That’s what enterprise batch records are all about – making sure you have all of the information needed to really understand the root cause of a problem.
Another business reason behind enterprise batch records is product retrievals. Not all industries have to necessarily deal with this issue. But if you’re in an industry where product retrievals are a major liability then you know how important it is to have the information necessary to quickly and accurately retrieve the product in question.
Everyone seems to emphasize the idea of lot tracking and lot genealogy in the context of product retrievals; as if the genealogy of the materials were the only thing that might trigger a product retrieval. But when you think about it, product retrievals can be triggered by different problems, including issues with equipment, labor, maintenance and cleaning. To really determine what needs to be retrieved you need to know everything about the equipment, labor, processes, cleaning and maintenance. That means you really need enterprise batch records to support accurate and fast product retrievals.
So, that’s the idea of enterprise batch records. Everything that goes on between the four walls of the manufacturing plant – from the receiving dock to shipping – goes into the enterprise batch records. It’s taking electronic batch records to a whole new level.