Enterprise batch records: Understanding basic concepts

If you liked moving to electronic batch records from keeping them all on paper, here’s the next step where everything that happens is kept in the data. First of three parts.


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.

No comments
The Top Plant program honors outstanding manufacturing facilities in North America. View the 2015 Top Plant.
The Product of the Year program recognizes products newly released in the manufacturing industries.
The Engineering Leaders Under 40 program identifies and gives recognition to young engineers who...
Safety for 18 years, warehouse maintenance tips, Ethernet and the IIoT, GAMS 2016 recap
2016 Engineering Leaders Under 40; Future vision: Where is manufacturing headed?; Electrical distribution, redefined
Strategic outsourcing delivers efficiency; Sleeve bearing clearance; Causes of water hammer; Improve air quality; Maintenance safety; GAMS preview
SCADA at the junction, Managing risk through maintenance, Moving at the speed of data
Safety at every angle, Big Data's impact on operations, bridging the skills gap
The digital oilfield: Utilizing Big Data can yield big savings; Virtualization a real solution; Tracking SIS performance
Applying network redundancy; Overcoming loop tuning challenges; PID control and networks
Driving motor efficiency; Preventing arc flash in mission critical facilities; Integrating alternative power and existing electrical systems
Package boilers; Natural gas infrared heating; Thermal treasure; Standby generation; Natural gas supports green efforts

Annual Salary Survey

Before the calendar turned, 2016 already had the makings of a pivotal year for manufacturing, and for the world.

There were the big events for the year, including the United States as Partner Country at Hannover Messe in April and the 2016 International Manufacturing Technology Show in Chicago in September. There's also the matter of the U.S. presidential elections in November, which promise to shape policy in manufacturing for years to come.

But the year started with global economic turmoil, as a slowdown in Chinese manufacturing triggered a worldwide stock hiccup that sent values plummeting. The continued plunge in world oil prices has resulted in a slowdown in exploration and, by extension, the manufacture of exploration equipment.

Read more: 2015 Salary Survey

Maintenance and reliability tips and best practices from the maintenance and reliability coaches at Allied Reliability Group.
The One Voice for Manufacturing blog reports on federal public policy issues impacting the manufacturing sector. One Voice is a joint effort by the National Tooling and Machining...
The Society for Maintenance and Reliability Professionals an organization devoted...
Join this ongoing discussion of machine guarding topics, including solutions assessments, regulatory compliance, gap analysis...
IMS Research, recently acquired by IHS Inc., is a leading independent supplier of market research and consultancy to the global electronics industry.
Maintenance is not optional in manufacturing. It’s a profit center, driving productivity and uptime while reducing overall repair costs.
The Lachance on CMMS blog is about current maintenance topics. Blogger Paul Lachance is president and chief technology officer for Smartware Group.
This article collection contains several articles on the vital role of plant safety and offers advice on best practices.
This article collection contains several articles on the Industrial Internet of Things (IIoT) and how it is transforming manufacturing.
This article collection contains several articles on strategic maintenance and understanding all the parts of your plant.
click me