Enterprise batch records: Understanding basic concepts
Everybody knows the idea of electronic batch records. Instead of keeping lots of paper about a batch, you keep everything electronically. That makes pretty much everything about the batch much easier to manage and allows you to do other cool things like batch historical analyses, batch-to-batch comparisons, and electronic COAs (certificates of analysis), just to name a few.
Building on the base of electronic batch records is the idea of enterprise batch records where we take those concepts to a whole new level.
The idea is that we are 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 reasons why we want to do this. One of the most important is handling a potential product retrieval or product recall. 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 was the only thing that might trigger a product retrieval.
But, the biggest part of manufacturing is the transformation of materials into the finished product. And, that transformation requires equipment, labor, processes (both automatic and manual), and a whole lot of other stuff that is all required to transform the raw materials in a finished product.
Product retrievals can be triggered by many different problems – problems with equipment, with labor, processes, and so on. That means that to determine what really needs to be retrieved you need to know everything about the equipment, labor, processes, and such.
For example, if foreign objects like metal, wood, or plastic, were found in a manufacturing area, you need to know all the batches that were processed in that area before the objects were found. You need lot tracking going forward but lot tracing back through the raw materials doesn’t help. But, you need to know everything about that manufacturing area and what was processed there.
As another example, suppose there had been a problem with a piece of equipment. Maybe it seemed to be working correctly but really wasn’t. You need to know what was going on, and merely having the lot genealogy doesn’t get you what you need. You need the details on that piece of equipment.
As one last example, maybe there was a problem with a particular person working in the manufacturing area. Maybe that person was not certified, not properly trained, or may have potentially been contaminated with something. In these cases you need to know all the labor information – who worked on what, when, and where. Merely having the lot genealogy doesn’t help much there either. You need the labor information.
So, that’s part of the idea of enterprise batch records. Everything that goes on in the four walls of the manufacturing plant – from the receiving dock to shipping – goes into the enterprise batch records. Not just the material genealogy, but everything that happened. It’s taking electronic batch records to a whole new level.
Next week, more reasons to think about enterprise batch records. Until then, 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.