John Clemons, director of manufacturing IT for system integrator Maverick Technologies (www.maverickglobal.com), says everyone understands electronic batch records. They’re typically generated by batch execution software as part of the process of making a batch and they usually include information on the ingredients that went into the batch, the recipe used to make the batch, the details on the actual parameters of the batch—like time, temperature, pressure and so on—and information on the materials produced by the batch. But, he says, there is a better way.

“Electronic batch records have some limitations in the way they’re usually implemented,” says Clemons. First, they’re only for a single batch. That’s OK if it only takes one batch to get from raw materials to finished products. But, in a lot of manufacturing operations, there are several batches and a variety of intermediate or work-in-process materials produced along the way. That means it takes many electronic batch records to get from raw materials to finished product, and no one electronic batch record has all the information in it.

Secondly, Clemons says, electronic batch records don’t usually record certain classes of information that might be vital to the manufacturing process. For example, most don’t record much, if any, information on labor—not even who or how much. They don’t usually record information on cleaning cycles or maintenance activities before the batch started —or even while the batch was going on.

“They don’t usually record much in the way of quality, inspection or test result data unless the tests or inspections were performed right there, as part of the processes executed by the batch software,” says Clemons. “And, as you probably know, quality and test data is absolutely vital to have when dealing with almost any type of problem with a batch or a finished product.”

The solution is to take the idea of electronic batch records to a whole new level, with Enterprise Batch Records.

The fundamental idea of Enterprise Batch Records is 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 should go into the Enterprise Batch Records. Capture all of the batches that were executed to get from raw materials to finished product, and all the other important information from within manufacturing that contributed to the production of the finished product,” says Clemons.

“If done right, the Enterprise Batch Records provide a complete end-to-end story of everything that occurred, so you can completely reconstruct what actually happened in manufacturing process right down to the last, significant detail,” says Clemons.

The litmus test Clemons uses to determine whether or not something should be in an Enterprise Batch Record is to ask whether the information is needed to deal with a customer complaint. Another business reason for Enterprise Batch Records is dealing with product retrievals.

“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 recall. But product recalls can be triggered by a lot of different problems—problems with equipment, labor, processes, maintenance, cleaning and so on. To really determine what needs to be retrieved, you need to know everything about all of these factors,” says Clemons.