In the final installment, consider how customer complaints can inform your decisions about what you include in your record keeping.
When considering what can and should be in the enterprise batch records, the litmus test that I use is to ask whether or not the information is needed to deal with a consumer complaint. So, if a consumer calls up and says that 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 whatever it was that happened to cause the problem the consumer is complaining about?
Let’s consider a few possibilities, starting with materials:
Do you have all information on the materials that you consumed?
On the intermediate or WIP products that you produced?
On the finished products that you produced?
Do you have links to supplier information on the raw materials?
Do you have links into the distribution network?
How about your processes:
Do you know all the manufacturing processes that were performed along the way?
Do you have all the relevant data about those processes that you need?
Can you tell whether or not the processes worked they way there were supposed to?
Do you know all the manufacturing equipment that was used throughout the plant?
Do you have all the relevant data about equipment that you need?
Can you tell whether or not the equipment worked they way it was supposed to?
Do you have the information you need on maintenance activities?
Maintenance that was performed right before the products were produced?
Any breakdowns that occurred during the manufacturing runs?
Any other maintenance activities that may have affected your finished product?
What about cleaning activities?
Do you have information to confirm the equipment was properly cleaned?
Do you know if proper cleaning protocols were performed during the manufacturing runs?
Do you have all the information you need on the labor that was used throughout the plant?
Do you know who worked where and when they worked?
Do you know what jobs they did?
What materials they produced?
What processes they performed?
What equipment they used?
Do you have all of the quality results?
Do you have all the information you need on quality problems that may have occurred?
Any process deviations that may have occurred?
Any quality deviations that may have occurred?
Any rework that happened?
The list could go on, but you get the idea. The litmus test for enterprise batch records is simple: do you have all the information you need to deal appropriately with all consumer complaints that come in?
That’s what the concept behind enterprise batch records is all about—making sure you have all the data you need to know what actually happened in the manufacturing plant when you manufactured that product.
Like the old commercial said, “It’s in there.” It’s all about getting the data you need to know for certain what really happened so you can fix things that don’t work and make good things better. That’s what enterprise batch records is all about. 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.