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Properly Using A Recipe Lifecycle Management System

*This blog has been re-published from Automation World! You can see the original published work here.


Protecting the sanctity of a product is an important aspect of recipe lifecycle management, but the flexibility of your system may not be fully utilized. See how a system can easily be extended to a new product without much change when properly installed.

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.



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Documenting Your Manufacturing Ecosystem

*This blog is a repost from a March 9, 2020 blog post that ECS President wrote for AutomationWorld.com

Understanding your manufacturing ecosystem is one thing, but documenting it is just as important. Having extensive documentation of the manufacturing ecosystem, helps those who aren’t involved in daily, plant-floor operations make informed decisions.

Your manufacturing ecosystem is the system you use for making your product(s), and fully documenting and understanding this ecosystem will help the decision-making process of your organization.

It is very common to think about how a plant or process cell goes about making its product(s) in terms of component offerings. I hear, “We use blank for our historian, blank for reporting, a spreadsheet to schedule labor, another spreadsheet to schedule production, and we get orders from our ERP [enterprise resource planning] on paper.” Vendors in, what is sometimes called, the manufacturing execution system and manufacturing operations management space offer separate software packages or modules for various pieces in this space.

As an integrator, we think of this space as a vibrant, agile ecosystem full of people using tools to accomplish and measure production, where the various pieces are software packages, spreadsheets, or paper, is less material than the interaction of the whole system.

By documenting your plant’s manufacturing ecosystem, you can understand how decisions in one part of the plant affect other parts of the plant process. As I wrote previously, standards, such as ISA-95, only guide you on a journey to more deeply comprehend the workings of your unique process for manufacturing your products. Each plant or process cell needs to document its own ecosystem, because each is different. An experienced integrator can help you with this process by asking, “How do you do this and how does it interact with that?”

Documenting your ecosystem allows you to quickly understand, at a higher level, how the plant operates. You will be able to more easily “connect the dots” of data being received from the plant floor, and utilize basic equipment resources, personnel, instructions, and materials to manufacture the final product.

One way to use this new understanding is to make better decisions is optimization. The documented ecosystem helps understand how improving one aspect will affect another. Though there may be additional cost or additional benefit or both, you will reduce risk of unforeseen consequences of a change.

We often show clients higher payback from improving how they manage their manufacturing process than from how they control it. A food product manufacturer was able to add 20% capacity by improved scheduling. Another added nearly 20% through improved equipment utilization. A third set production records a week after implementing an overall equipment effectiveness and “paper on glass” quality data collection system.

Documenting your ecosystem will help you get the capital funds for an improvement by helping you explain to the business managers how what you propose will affect the plant, not just the process. Information, derived from data, is the lifeblood of good management decision making. Your ecosystem document will help you explain to management how the improvements you are making can be measured and reported.

Documenting your ecosystem takes work, as do other worthwhile endeavors. Perhaps it is 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.

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Digitalizing Your Manufacturing Ecosystem

Making digitalization work for you requires understanding your manufacturing ecosystem. Standards, such as ISA-95, only guide you on a journey to more deeply comprehend the workings of your unique process for manufacturing your products.

A batch manufacturing ecosystem often includes campaign management. Campaign management is not mentioned in ISA-95 which only speaks generally of “order processing.” Campaign management is an example of applying the general concepts of ISA-95 to the specific needs of a batch manufacturing process.

Campaigns are groups of full and partial batches corresponding to the number of sellable units prescribed by the “order processing” function. Campaign management starts with determining, within maximum and minimum size constraints, the minimum number of batches to manufacture to satisfy the order. Digitalizing campaign management is often a quasi-custom effort, dependent on how orders are received from the Enterprise Resource Planning (ERP) package.

The next step is to schedule the required batches. Production scheduling, as it is called in ISA-95, is constrained by availability of required inputs, such as raw materials, minor ingredient kits, labor, energy, and, of course, equipment. Digitalizing batch scheduling can be complex, dependent on how many constraints are applied. However, efficient scheduling can add significantly to a process cell’s capacity. ECS helped a sauce manufacturer optimize scheduling to reduce cleaning time, adding almost 20% to the process cell capacity without additional equipment or labor cost.

When it is time to run a batch, the appropriate control recipe is created and delivered to the sequencing engine. The sequencing engine steps through the ordered recipe steps, commanding the control system to perform appropriate actions. As it works, the control system creates data, documenting what happens.

Quantities of both event-based and time-series data are valuable benefits of digitalizing your ecosystem. Data is used for many purposes such as quality control, meeting regulatory requirements, supporting raw and finished goods inventory management and driving process improvements.

The constraints of a blog article allow only a cursory overview of a typical batch manufacturing ecosystem. Standards are generalizations. Every ecosystem is uniquely complex. Comprehending your ecosystem is the first step to realizing the benefits of digitalization. Let’s go!

*This blog was written for and is published on AutomationWorld.com– check it out on their site!

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Manufacturing Digitalization That Works

Though digitalization is a process that is often seen as great, the benefits are not the same for everyone. Asking how digitalization is going to benefit your organization may be important to your digital future.

Industry 4.0, Industrial Internet of Things (IIoT), connected enterprise, and smart manufacturing, among others, are all descriptive of applying digital technologies to manufacturing. Often, digitalization is presented as so powerfully good that it just needs to be done, but most are generally skeptical, asking, “Exactly how is this going to help me perform better?”

ISA-95 describes an ecosystem common to manufacturing enterprises and plants. Part one— adopted in 2000—will officially be ancient in a few months. Yet, amazingly, it remains relevant, particularly to applying digitalization to manufacturing.

Certainly, the entire standard is worthy of comprehension, but the famous, functional enterprise-control model—identified as figure five in clause six with its associated descriptions in the remainder of that clause—provides a great place to gain some immediate value. Reviewing the described functions—and their relationships—while asking the questions, “How do we do this?” and “How might we do this better/faster/cheaper/digitally?” can bring a wealth of improvement ideas to life.

After a recent implementation of digital manufacturing technology “from one end of the plant to the other” in a food manufacturing plant, our client commented:

“With everyone seeing the same information and analyzing the same data; communication, productivity, and efficiency has been improved significantly. Supervisors are helping R&D with new formulations, material managers are helping schedulers understand order and inventory, and everyone is helping solve problems. In just a few months of production, [we have] created, controlled, and tracked hundreds of batches and dozens of products. The new system accelerates our speed to market for new products and improvements to existent ones, troubleshooting issues for quick resolutions, and supporting data for nutritional label declarations.”

This is digitalization that works, not just the ever-bigger data. This is making manufacturing more consistent, safer, and produce more profitably.

While you can purchase a copy of ISA-95 from the International Society of Automation (isa.org) and perform this simple exercise yourself, but you shouldn’t have to. World-class integrators can serve you as a trusted advisor in asking these questions and implementing offerings that make sense for you.

How might you get started? What parts of your manufacturing ecosystem make your life difficult? Is your organization using your manufacturing data for problem-solving? Seeking out answers to these questions from trusted advisors is how manufacturing digitalization can begin to work for you!

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.


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The Advantages of an Agile Cleaning System
There are many benefits to investing in an agile cleaning system. And though manufacturers may have to make an initial financial investment, the advantages that come along with it are as many as they are profitable.

ECS President, Tim Matheny, recently lent his expertise to AutomationWorld on the subject. Check out the full piece HERE!

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The Benefits of Batch Recipe Lifecycle Management
ECS President Tim Matheny is back and talking about the benefits of batch recipe lifecycle management on the AutomationWorld blog. Read to learn how a batch management package can reduce risk and help get products to market much quicker. #blog #automationworld #batchexperts #batchmanufacturing

Click here to read more!

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Tim Matheny Talks “Cooking to Kill” on AutomationWorld.com

In a recent article on AutomationWorld.com, ECS Solutions’ President & CSIA guest blogger, Tim Matheny shared his insights into the best manufacturing process for cooking.

Here is an excerpt from the piece:

Many of the ready-to-eat products that we consume today are cooked. Cooking kills pathogenic bacteria in food products. Cooking properly makes food safer to consume. The best manufacturing process for cooking a certain ingredient or product is the process that produces lethality as quickly as possible without adverse effect to the product.

Check out the full article HERE!

Nice work, Tim!

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Options for Dosing Genealogy

The following, written by ECS Solutions President Tim Matheny, was published in Automation World in April of 2019. The article can be seen HERE.

Batch manufacturing in Food and Pharmaceuticals requires knowing the genealogy, or history, of any ingredient materials. When the source container or vessel contains several lots of the ingredient material, the Control System Engineer must make some assumptions and do some math.

One choice, often referred to as plug flow, is to assume that there is no mixing between the lots—that they are stacked on top of each other in the vessel as if there were an invisible membrane between each consecutive lot. The control system assumes that until the volume or weight of lot “a” is dosed out, that lot, and only lot “a”, is being dosed. When lot “a” is gone, the control system assumes only lot “b” is being dosed. At most there will be one product batch with some of lot “a” and some of lot “b”. Risked recall cost, when this assumption is used, is very high because a significant number of batches/lots of product must be included due to the ridiculous underlying assumption. Generally, a plug flow assumption should not be used today.

Dosing genealogy might be determined by modifying the plug flow approach, assuming a band of mixing between consecutive ingredient material. Factors that affect the thickness of the mixing band include: how material is loaded into the vessel, the viscosity of the material, the shape of the vessel, time the lots have resided in the vessel, etc. Recall costs are appropriate because, in the case of a recall on ingredient lot “b”, only batches dosed from bands “a-b”, “b” and “b-c” need be recalled. This approach can be appropriate when ingredient mixing tendencies are well known.

A third approach assumes that the ingredient materials are fully mixed. Until the vessel is drained and cleaned, any dosing genealogy is assumed to include some of all ingredient material lots introduced into the vessel. When there is a long duration between drain-clean cycles, ingredient lot “a” is assumed to be in many product batches/lots, risking very high recall costs. Maintaining a short duration between drain-clean cycles is also expensive. Producers can be driven to designing a system utilizing single-ingredient-lot vessels or containers. This is a very safe approach that is often dictated.

A combination approach to determining dosing genealogy also assumes complete mixing of all ingredient lots in the source vessel. The dosing genealogy is assumed to be the percentage of each ingredient lot remaining in the vessel. Volumes removed for each ingredient lot are accumulated, much as with plug flow. At some small remaining amount, the ingredient lot is assumed to be completely removed from the vessel. This approach offers reasonable recall cost risk without necessitating drain-clean cycles, making it an attractive approach when the extremely safe third approach, above, is not dictated.

With only slightly more math, the Control System Engineer can determine dosing genealogy with any of these approaches while a new ingredient lot is being added to the vessel. Allowing material to enter and leave the vessel concurrently increases equipment availability and, often, overall system OEE.

A risk analysis process is used to choose how dosing genealogy should be determined in a specific situation. Factors mentioned above, and others, must be carefully considered. Producers who determine dosing genealogy appropriately balance risk and cost using engineering analysis to make the right assumptions and do the right math.


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Collaboration and Ratio Control

Mixing and blending of materials is a frequent, important process in the food industry and other industries, often with the final mixture required to contain a critical specific ratio of the components. The approach most often adopted is to control the flow rate of each component into the mixing tank to realize the specified ratio, a pre-defined flow rate ratio (i.e. 5:1)

In our experience, The Batch Brothers have noticed this approach can lead to problems, in that inevitable variations in the established flowrates will result in a ratio of the components in the final blend other than that specified.  By only implementing the flow rate ratios the system may reach the end of the blending process and end up with material that was not blended in.

The Batch Brother’s solution is to monitor the weight of each component remaining and provide a homogeneous blend based on the remaining weight ratios, this way the system is constantly correcting for ratio errors based on materials remaining and not just instantaneous flow rate. The flowrates Ratio setpoints are constantly calculated to maintain a ratio based on the ratio of materials remaining. This approach is particularly beneficial if the individual materials are not homogeneous, perhaps containing particles clumped together which may lead to instant flow errors.

The Batch Brothers also advocate a collaborative work culture so that information is available to all stakeholders. This collaboration implies that opportunities for improvement identified by any employees or provider should be expressed to the team and evaluated.

Batching Across America,
-The Batch Brothers


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CIP Made Simple

The Batch Brothers wondered…can you simplify the automation of Clean In Place (CIP) sequences…yep!

The automation of a manufacturing process today necessarily includes automation of CIP sequences.  The latter is often found to be more complex than making the products and final CIP sequences are frequently defined after the process equipment is built and cleaning tests completed.

The complexity of the CIP sequence arises from the availability of a wide variety of both cleaning equipment and cleaning solutions, such as water, caustic and acid.  In addition, it is found advantageous to recover water used in the final rinse step to reduce overall costs.

The Batch Brothers have developed an approach to make CIP automation straightforward while still providing ample modularity and flexibility. This approach relies upon the use of S88 concepts allowing the separation of the Equipment and Procedure models.  It is then possible to create procedures (Products and Cleaning recipes) after the process has been automated without requiring changes to the control system, all of which can be handled by non-programmers.  The approach easily allows optimization of the CIP recipes which results in both cost reduction and shorter times for the CIP process.  Furthermore, an equipment module is used to expose all parameters on the CIP skid side as well as the parameters required at the destinations.

The key to simplifying the CIP process is to set up equipment using an Equipment Module, this module being able to define all possible configurations in a simple modular matter. Application of the procedural role of S88 enables the specification of the sequence necessary to perform the required procedures.

Batching Across America,
-The Batch Brothers

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