ISA-88 batch recipes are not just simple lists of ingredients, they describe the ordered process for producing a product. Recipes make your system flexible enough to produce multiple products and agile enough to make quick yet safe changes. Recipe lifecycle management is important to batch manufacturers because the recipes represent a significant portion of the system programming.
A proper batch manufacturing system separates the programming that supports the capabilities of the system’s equipment from the programming that defines what the manufacturer wants to do with the equipment. Equipment programming runs a pump after making sure there is a clear flow path. This programming—which is concerned to safely operate the pump independent of what is being pumped—is often in a programmable logic controller or a programmable automation controller. Procedure programming instructs the pump to run at the appropriate point in the manufacturing process, this programming—which is concerned to effectively produce high quality products—is the programming in your batch recipe.
Why this separation? The programming that supports what the equipment is capable of never changes—that is unless the equipment is changed or the programming was incompletely developed in the first place. What a manufacturer does with that equipment can change dramatically.
So, how might a manufacturer today use a line originally designed to make pancake syrup changeover to produce hand sanitizer needed to protect the world from COVID-19? If this fundamental concept was followed, all that would need to be done is to write a new recipe and, of course, put the corresponding ingredients into the supply tanks! And, if done correctly any process-knowledgeable person, capable of manipulating flowcharts, can make these changes without inadvertently modifying or bypassing equipment programming designed to prevent equipment damage or misuse and without engaging outside resources.
Your recipes are valuable! They encapsulate your intellectual property and the best practices for making your products. They are a significant part of your system, orchestrating the steps your equipment needs to make your products. Any change made to your recipes may improve or degrade the quality of your products or the effectiveness with which they are manufactured.
This is but one reason why properly implemented, world-class batch manufacturing systems utilize a proven recipe lifecycle management package with recipe lifecycle management tools—such as security, genealogy tracking, version management, enforced approval requirements and audit trails. One such market-leading package is Rockwell Automation’s FactoryTalk Batch.
Capable recipe lifecycle management should include security controlling which limits who can edit your master recipes. It should support the coexistence of multiple recipe versions, with only one holding the “released to manufacturing” status. Individuals deemed trustworthy to develop and modify recipes need to be able to create separate versions for testing ingredient changes or other process improvements. The genealogy of these derivative recipes—which version of which prior recipe this version was created from—should be tracked as it helps developers keep track of what they have done. Version management also allows a developer to release an improvement for manufacturing, evaluate its effects on the product and on the product’s effective production, then roll back to the previous version if necessary. Enforced approval requirements facilitate communication between developers and production managers, assuring all stakeholders buy into any modifications. Audit trails help teams figure out what happened if something does go wrong.
These may sound familiar if you are familiar with GAMP 5. Originally developed by ISPE for the pharmaceutical industries, GAMP 5 is being adopted by many food and beverage manufacturers seeking a risk-managed approach to more consistent production practices and improved food safety.
Does your manufacturing system include a capable batch management product? Are you using it? Are you using all its capabilities? Is your programming properly divided so that your recipes can manage all your equipment capabilities? Any or all of these might be opportunities to improve your operations. Perhaps now is a good time to get started.
Timothy S. Matheny, P.E., is president of ECS Solutions, a certified member of the Control System Integrators Association (CSIA). He is also author of a paper on model-based control, presented to the ISA Food and Pharmaceutical Industry Division in 2014. To obtain a copy of Matheny’s paper, or for more information about ECS Solutions, visit its profile on the CSIA Industrial Automation Exchange.