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The Importance of Material Tracing

Traceability on a processing or production line is incredibly important, especially when it comes to food products, where having the ability to track every ingredient down to the source is crucial to the health and safety of the consumers.

As parts of the country begin to move out of COVID-19 shutdowns, we have been hearing about “contact tracing” as a tool for containing a secondary spread of the disease. Material, lot tracing, or traceability has been part of producing safe food products for a long time. The concepts behind contact tracing and material tracing are similar.

The US food industry should be rightfully proud and the US consumer properly thankful that behind the scenes, out of sight and out of mind, tremendous efforts are being made to ensure food safety.

The Food and Drug Administration (FDA) Good Manufacturing Practices (GMPs) require “traceability to the source.” Establishing traceability to the source for all intended and unintended ingredients of a product in a consumer’s grocery cart relies on each producer or manufacturer that contributed to that product to have and be able to rapidly retrieve traceability data for its products.

To enable tracing, food ingredients and final products are produced and packaged in “lots.” For example, a lot may be the amount of product produced by a certain producer on a certain line during a certain day. Each producer tracks the lot numbers of any ingredients that are used in the production of any final product lots.

Confused? Let’s investigate that bottle of salad dressing you picked up the other day. That bottle has a lot code on the label. The dressing manufacturer can use that lot code to pull up a list of the ingredients, the producer of the ingredients and the producer’s lot codes for the exact ingredients that went into that bottle. A bottle of salad dressing may have 10-15 ingredients. Those ingredients may have ingredients. Each producer down the line—all the way back to the source—can do the same. That is “traceability to the source.”

If you are thinking, “Wow, that’s a lot of data unlocked by one number on my dressing bottle label that I never noticed before,” you are exactly right. If you are thinking, “Wow, how would we ever collect and manage data for contact tracing and who would responsibly manage that data,” you are also right. But try, if you can, to refocus on food material tracing.

The data each producer must collect, store, and be able to retrieve can be gathered manually, semi-automatically, or automatically. It can be stored in boxes of paper or in a relational database. Incomplete or inaccurate data can create tremendous liability. Activities required to collect, store, and retrieve data add to cost-of-production, so it needs to be performed efficiently. Across the industry, there are a myriad of tools and methods for collecting, storing, and retrieving traceability data accurately and efficiently.

When building new or performing a significant upgrade to an existing production line or process cell, collection and storage activities can be tightly integrated into the operating controls for maximum accuracy, minimal cost, and minimal operator interference. The system can integrate fully with the plant’s ecosystem including inventory databases that contain manufacturer and lot information. Collected information is stored with batch records to be easily retrieved with off-the-shelf reporting tools. Operator interaction might involve some barcode scanning and/or verification. Automated weighing and dispensing increase the level of integration possible.

Often older systems utilize paper forms or forms on a computer screen. Essentially manual systems are prone to human inaccuracy and consume valuable operator time. Such systems were or are less expensive to implement but are often not less expensive over the project lifecycle.

When a targeted upgrade is done to a line or process cell, collection activities are often semi-automatic. A semi-automated system interacts with the operators by providing clear instructions for activities that need to be performed, such as specifying where to locate containers from the appropriate ingredient lot. All activities are electronically journaled, including amounts of ingredients consumed, either automatically or by operator entry. Instructions can be provided for intermediate materials, such as kits, as well as for finished products. Semi-automated systems can also interact with the plant ecosystem, such as the enterprise resource planning system, to receive work orders, execute them and report material consumed and finished goods produced.

Traceability, whether food ingredient tracing or contact tracing, is incredibly important for the health of people living in our communities and nation. Tracing food product ingredients to the source requires detailed collection, storage, and retrieval of accurate and complete data. Producers that accomplish this accurately and efficiently have a competitive advantage. How are you handling traceability? How can you reduce costs and increase accuracy?

This is a re-post of a July 2020 Automation World blog. To see the original piece, click HERE.

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Securing Your Intellectual Property

Protecting intellectual property is very important for many organizations, it is also the main target for hackers. Steps need to be taken in practically every part of the organization to make sure the intellectual property is secure.

As U.S. manufacturers once again grapple with outsourcing production to foreign facilities, issues with intellectual property protection begin to arise. Intellectual properties provide companies with a competitive advantage, making them incredibly valuable. Not only does it include patentable property but also the know-how involved in making the products.

The intellectual property for making your product goes beyond the components or ingredients used to make it, setpoints, durations, tolerances, and the best order for performing all steps are also included. When these are strewn about as printed work instructions, they become easier to steal. Conversely, when automated, steps may be hidden from the operator making theft more difficult. However, an electronic-encoded intellectual property can still be hacked. So, using multi-layer security can be used to thwart such attacks. Multi-layer security should include all—or most—of network security, device security, application security, and encryption.

An intellectual property can also be stolen or compromised when plant operations modify product methods and procedures. Products of inferior quality or products unsafe for consumer use steal value from the intellectual property by devaluing the product brand. Automation is combined with logging all system activities to guard against this form of intellectual property theft. Some systems allow playback of system operations through the human-machine interface. Some implement automated notification when an operator varies a procedure in any manner. Both are powerful tools to protect the intellectual property value and train operators to take appropriate actions.

Another form of intellectual property theft involves modification by unauthorized individuals. Owners can protect the source files from which work instructions are printed with file level security although, they cannot, as described above, ensure that the procedures are fastidiously followed. Individuals authorized to modify a programmable logic controller, programmable automation controller, or distributed control system programming may or may not comprehend how a programming “fix” can affect intellectual property.

The effects of a change may not be immediately noticed, but during this time hundreds of thousands of dollars of inferior or unsafe product contaminates downstream equipment and inventory or is packaged and warehoused or shipped. Best-in-class systems not only provide access security, they implement version management and roll-back for quick recovery. When an intellectual property is programmed into the control system, such rollback is not possible without additional software and may be cumbersome to use in that it restores an entire program, not just the specific procedure.

Should a plant be ravaged by disease, as we see happening these days, highly automated systems can continue to produce quality products even when staffed with less skilled, temporary, operators. Intellectual properties managed by a secure procedure manager could save millions in lost production and bad publicity as recently experienced by several meat packaging facilities. Obviously, certain products and procedures lend themselves better to automation, but disaster is indiscriminate.

Best-in-class automation—including best in class procedure management—combats all these threats to intellectual property, the value of the intellectual property, and use of it. Capable control systems integrators can help you secure your intellectual property from theft, damage, and more.

This is a re-post of a June 2020 Automation World blog. To see the original piece, click HERE.

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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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The Benefits of Off-The-Shelf SOP Management Software

Being able to keep track of every step and every bit of data is a major necessity for every organization. An off-the-shelf standard operating procedure software is one way to implement new processes and keep track of business operating standards.

Tracking manual operations in discrete, batch, and continuous manufacturing processes can greatly benefit from off-the-shelf products. Clearly specifying your procedures, enforcing their execution, and capturing pertinent data are all major benefits that can be quickly and easily be obtained by implementing off-the-shelf, procedure management software.

To ensure consistency, manufacturers use Standard Operating Procedures (SOPs) to specify how operations are to be done. SOPs may be developed for product operations, safety, periodic maintenance, startup or shutdown operations.

Often, discrete manufacturing processes require a high level of manual operator activities that rely on paper-based SOPs to specify how to manufacture their products.

It is the responsibility of employees to perform the tasks specified in the SOP and to capture any required data. Even in relatively automated process control systems, it is not uncommon to find SOPs that require an operator to input the setpoints or record readings before initiating the required tasks. Sometimes data is recorded on the SOP or a related paper form, but, oftentimes the date and employee identification is required.

As the volume of amount of data and the value of accuracy increases, as does the justification for automating the SOP and data collection.

Standard, off-the-shelf products can be used to replace the paper-based SOPs and electronically interface with the operators via portable devices such as phones, iPads, industrial portable terminals, etc. One such product is Rockwell Automation’s FactoryTalk Batch.

The unfortunate name of the product implies that it is only helpful with batch manufacturing processes, but, in fact, it is very helpful automating any operation where following an ordered set of steps and collecting data is required. FactoryTalk Batch is really a sequencing engine that follows the steps of an operating procedure or recipe.

The operating procedures are clearly specified electronically. A sequencing engine is responsible for prompting the operator to perform the tasks in the order specified by the electronic SOP. Off-the-shelf sequencing engines contain features that streamline the process of following the SOP and recording required data. Many sequencing engines, including FactoryTalk Batch, can transfer required set points to the process control system as well as directly capture process information without relying on the operators. In partially automated processes, data collected from operators via electronic forms can be merged with automatically collected data.

The sequencing engine is now the orchestrator of the process activities and is responsible for interacting with the operator, to instruct them to perform manual tasks and capturing information not available electronically; at the same time, it coordinates all activities with the equipment it can interact with.

This off-the-shelf sequencing engine can be interfaced with the enterprise-resource planning system in order to receive production orders, it clearly specifies and maintains SOPs and their versioning, it coordinates all manual and automated procedural activities, and it captures all pertinent information to recall how a product was made including material traceability.

Fixed industrial human-machine interface products or mobile devices can be used for operator interaction.

Clients see return through increased product yields and improved overall equipment effectiveness. An ISO-9001 certified client realized tremendous benefit in reduced labor costs. Being able to use an off-the-shelf package, significantly reduces implementation cost and schedule. Perhaps you can benefit too.

This is a re-post from a March 2020 Automation World blog. To see the original post, click HERE.

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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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