Operations Management

I saw a tweet yesterday, which pointed to a great BioProcess International article, Biopharmaceutical Information Infrastructure 2.0 (Part 1 of 2). I sent the link to Emerson's Jonathan Lustri, who manages the Syncade smart operations management brand for his thoughts. I thought they were great and needed no further elaboration from me. Here's what he wrote back:

Regarding information management within a Biopharmaceutical operation, this article does a nice job of laying out information about data collection and visualization for postproduction analysis. Systems that do this may generally be categorized as manufacturing intelligence (MI) systems.

This is all well and good for applications where engineers and quality assurance (QA) people want to perform analysis on how to improve the process or investigate what went wrong. It misses all together the opportunity to use information to prevent errors and assure manufacturing efficiently. In order to truly gain benefits to eliminate human error and speed QA review and approval, information has to be applied within the context of performing manufacturing procedures.

So in addition to all of the points made in this article, biopharm processing should consider software systems that electronically dispatch work procedures to operating personnel and bring to them the information they need to correctly perform the procedure. In most Biopharm facilities, work procedures are coordinated with paper standard operating procedure (SOP) documents and Batch Production Records.

Depending on personnel to read paper instruction, correctly follow these instructions, and then manually record key information by hand in paper batch production records affords huge opportunity for error. Furthermore, even if a site has a well-developed manufacturing intelligence system, all the information recorded on paper either never makes it into the MI database, or requires the information to be transcribed at a later point.

There are software systems now available, such as Emerson's Syncade Smart Operations Management suite that include workflow engines that dispatch step-by-step work procedure guidance to operators to direct them how to perform the procedure. And, through integration with other systems, information can be brought to the operator within the context of the procedure to assure efficiently performing the procedure.

For example, a sampling operation may require a sample ID from the laboratory information management system (LIMS). By using a workflow software system to guide the operator on the steps to take the sample, we can increase the likelihood the procedure will be performed correctly and we can automatically provide the technician the sample ID if the workflow is integrated to the Lab information system and even automatically print out the sample bar code label.

Another value workflow execution systems can bring is in the coordination of work activities. If quality manufacturing requires two operators to perform different tasks which need to be coordinated, using paper-based batch records, such coordination can only occur by two technicians talking together to verify things are coordinated.

The result is that they may not talk and the activities may occur uncoordinated. Using a workflow execution system, the workflow engine performs the coordination and only dispatches work activities at the point in time they should be performed.

To summarize, data collection and visualization information systems for manufacturing intelligence provide significant value in postproduction analysis for investigations and process understanding. The biopharm industry should also look to workflow software systems to apply information within the context in process procedure execution.

The primary benefits of this are that it enables truly paperless operations, eliminates human error and increases productivity by eliminating many manual information look up steps.

It makes sense to reduce errors by automating the workflows where possible and practical.

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In an earlier post I mentioned how Emerson's Shenling Yang had taken an assignment in Shanghai, China. She's bringing her expertise in operations management and the Syncade software gained while executing projects as a member of the Life Sciences industry team. Shenling had some thoughts on the FDA Globalization Act of 2009 and its impact on pharmaceutical and biotech manufacturers across the globe.

The Formulary web site sums up the act:

The Globalization Act expands FDA's authority to inspect foreign plants, to block questionable imports, and to crack down on those who fail to comply. Regulatory "parity" is sought to ensure that lax oversight is not luring manufacturers from the United States to Asia. All registered manufacturers and importers--including generic drugmakers--will have to pay new user fees to support the broader oversight program, and manufacturers will ensure the integrity of product supply chains through electronic pedigrees. FDA also would gain the power to detain, recall, or destroy unsafe, adulterated, or misbranded goods. The act gives the agency added authority to subpoena records and to impose criminal penalties for drug counterfeiting.

The web site continues:

Ironically, legislation that increases FDA inspections of foreign drugmakers may reopen the door to drug importing. A group of leading senators is sponsoring a bill to allow nationwide reimportation of prescription drugs, claiming that the program would save $50 billion over 10 years. All of the imports would have to come from FDA-approved manufacturing plants in Canada, Europe, Australia, New Zealand, and Japan--a policy that assumes more frequent inspections and a viable pedigree system.

Shenling provided her views on the legislation's impact on Asia:

It will impose higher costs on the Asia Pharma industry, because of its stringent quality compliance requirements, particularly the new requirements to secure entire supply chains. On the other hand, it might also help raise Asia Pharma industry's competitiveness on the global stage.

The Act may encourage Asia exporters to follow a more structured approach towards securing supply chain and higher quality standards. Hence, it might reduce the cases of non-compliance. Considering the growing export markets, maintaining the quality standards required for these exports might help Asia Pharma companies grow revenues to offset the costs of this legislation.

Shenling described how the ISA95 information model with automation like the DeltaV system and Syncade operations management can help with compliance.

One of the important aspects of the operations management is quality and compliance. By using the latest technology and adhering to the ISA95 standard, Syncade smart operations management suite integrates smart real-time, plant-floor data with your business processes. Through data and workflow management, Syncade suite reduces non-value added activities and variability. By identifying and correcting problems during the manufacturing process instead of post-process, this streamlined workflow improves the product quality and regulatory compliance.

DeltaV Batch uses the ISA88 standard, which helps batch process manufacturers to define a single recipe in a single engineering environment. It reduces time and cost during the documentation, implementation, and validation phases of a project, and enables manufacturers to quickly produce a quality end product.

Thanks for your perspectives on this legislation and its impact on pharmaceutical and biotech manufacturers, Shenling.

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I'd like to welcome a new voice, Emerson's Alan Babbitt, to the blogosphere. Alan and team's purpose with this new blog, The Emerson Global Life Sciences Blog, is:

...to provide insight into the Life Sciences Industry from a number of perspectives. We will provide periodic updates on industry trends that include commentary on the state of the Life Sciences marketplace. Of particular interest is the current state of the economy and how we are all affected by change that is in our midst. Our blog will also speak to the value and importance of how the Emerson Team solves business problems at the automation and operations layers of the S95 context model. Readers will benefit from the many years of hands-on experience our team has realized, working with some of the largest pharmaceutical and biotechnology firms in our industry.

Beyond the initial welcome post, his second post looks at the Capital Contraction occurring and its impact on the Life Sciences industry. Alan writes:

Only 1 Biotech firm went public in 2008 and predictions are the Initial Public Offering (IPO) space will continue to be a tough year in 2009. The guess is there will be very few IPOs completed in 2009 and they will be the companies that have proven revenue growth coupled with limited risk. Gone are the IPOs with large technology or regulatory risk. Additionally, venture backed companies looking for more rounds of development capital will be questioning their outlook.

Much like the ModelingAndControl.com blog, I have subscribed to Alan and the Life Sciences team's blog and look forward to sharing some of their thoughts here at Emerson Process Experts.

If you have interests in the Life Sciences industry, the ISA88 and ISA95 models of information management, or industry perspectives of current global economic conditions, you'll want to subscribe too.

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Last week, Syncade smart operations management suite software was officially unveiled at ARC Advisory Group's Orlando Forum--Winning Strategies and Best Practices for Sustainable Manufacturing. The Syncade suite of software provides resource management, operations optimization, integrated information, quality and compliance at level 3 of the ISA95 Enterprise-Control System Integration information framework standard.

Of course, those of you highly connected Twitterers already knew this because you followed the real-time coverage of the event by those Twitterers tagging their posts with #ARC. For those not as steeped in Twitter geekdom as me, there are several great summaries:

• ARC Advisory Group - Emerson's New Syncade Smart Operations Management Suite to Help Plants Improve Performance
• Automation.com - Emerson announces Syncade Smart Operations Management Suite
• ControlGlobal.com - Freaky Fast-- Emerson gets first Syncade project
• Control Engineering - Emerson Syncade Smart Operations Management Suite integrates data
• Gary Mintchell's Feed Forward - ARC Forum 2009 press conferences
• Intech - New Year means new products
• Manufacturing Business Technology - Smart operations management: Emerson touts new software as MES replacement
• Plant Automation - Emerson Announces New Syncade Smart Operations Management Suite To Help Plants Improve Performance

Emerson's Bob Lenich and Joanne Salazar were there to present and answer questions about Syncade to the trade press and attendees of this ARC conference. You may recall Bob and Joanne from an operations management decisions interview (post/podcast) we did a while back.

A key idea they stressed was that the Syncade software builds upon the traditional ISA95 level 1 and 2 spaces occupied by well-known brands like AMS Suite, DeltaV, Fisher, Micro Motion, and Rosemount. The level 3 data management layer is the space between the event-based process manufacturing area we know and the transaction world of the enterprise. It's important that the data coming up from levels 1 and 2 be known good or flagged otherwise, so that the transactional decisions the business makes are based upon sound data. For example, a transaction, such as committing to a delivery date, requires an accurate view of inventory levels.

During the presentation, Bob also stressed the modularity of the Syncade suite of software. Changes in operations management typically involve changes in workflow. It's important to tackle these changes in modular chunks so that the work processes and information flows can be optimized for the business to generate the required results.

An example might be a work process that requires a number of signatures on paper, well after the product has been manufactured. A real-time permissive check that requires on-line signatures for materials and equipment while production is ongoing can avoid rework and waste by identifying problems as they occur. This can significantly reduce product release time.

This flexibility and focus means that process manufacturing personnel and Emerson data management specialists can analyze operations and then prioritize improvement projects, choose the appropriate standards-based modules, and begin implementation. Taking a modular approach also helps to support a limited number of users with additional users being added over time, as more areas are included.

I look forward to telling stories of how the Syncade software is being applied to increase overall manufacturing efficiency.

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Update: I wanted to add the Automation Gear blog and it's post, Emerson Enters MES as another great account of the Syncade launch.

A popular TV drama series here in the U.S. recently dramatized a cyber-attack on a chemical plant, raising awareness of process manufacturing cyber-security risks outside our niche of process automation. Within our industry, this has been an area of concern for many years and is being addressed in many different ways.

I mention this because Emerson's Bob Huba recently spoke at the 63rd Annual Instrumentation Symposium for the Process Industries at Texas A&M University. His presentation was on Control System Cyber-Security.

As a senior product manager for the DeltaV control system, Bob has developed a best practices whitepaper, as well as a philosophies/guidelines whitepaper.

His key message to the symposium participants was that the technologies alone are not enough. Security must be looked at holistically, much the way process-manufacturing plants take a holistic view for safety.

Bob starts by defining SCADA Cyber Security as protection from intentional computer misuse that would cause inability for you to properly control the process. IT security protects information, while SCADA security protects physical assets and production. It also encompasses the protection of your control system, which is required to manage your process.

Threats can come from undirected, automatic sources including worms, viruses, and malware. They can also come from deliberate attacks, which disrupt the system or even take over the system. The concern for these deliberate attacks continues to grow.

To combat these threats the automation industry is developing a standard for control system security, ISA SP99. This standard's charter is to address:

...manufacturing and control systems whose compromise could result in any or all of the following situations:

• endangerment of public or employee safety
• loss of public confidence
• violation of regulatory requirements
• loss of proprietary or confidential information
• economic loss
• impact on national security

Bob reviewed the technology side of the equation that he shares in the whitepapers based on the philosophies of rings of protection and defense in depth.

His big message was that the technology alone is not sufficient. Process manufacturers must develop a culture of security. He suggested that the program could be modeled after the plant safety program. Most plants proudly display their days without a lost-time accident. Everyone in the plant has a role in keeping each other safe. Safety milestones are typically commemorated with high-level management participation to continue to reinforce its importance.

Bob shared that to be successful security must also become a "way of life." It should include all people who come into the plant. The reason to follow the safety model is that the model is easily understood by operations. It is implemented at the right levels of the organization and helps reinforce everyone's behavior in promoting security. The processes and procedures are localized, as they need to be to the site, department, or process unit. Also, control systems are different so some elements of the security enforcement procedures must be specific to the system.

Key to this approach is that you must have an owner or security champion in operations just like most facilities do with an operations safety person. As SCADA security has unique aspects that are different from classic information security, a major role of this "champion" will be to interface with IT to make security work in the control system. Their role is to "make security happen." They are not the security expert, but are knowledgeable and passionate about the need for vigilance in security. Bob defined important roles for this champion including security policy development, system access go-to person, risk assessment team member, control system vendor focal point, and vulnerability reporting and mitigation.

Better security comes from establishing a security-minded culture where everyone plays a role. This approach fosters paying closer attention to the details of technology maintenance, patching, virus management, ongoing assessments and improvements.

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At the request of one of Emerson Process Experts blog readers who has long commute to and from his office, I started to add podcast recordings at the end of each post to provide an audio version of each post, beginning this past October.

Today, I thought we'd push the envelope a little further by conducting an interview with data management specialists, Bob Lenich and Joanne Salazar. We're discussing the decisions you might consider as you define your operations management strategy and architected solution.

Here's a rough transcript of the podcast interview:

Jim: Where should operations management (also commonly known by the MES acronym) functionality reside within your system architecture?

Joanne: The ISA95 Enterprise-Control System Integration standard defines data models, work activity, and information exchange of operations management activities. ISA has defined a functional hierarchy model within a manufacturing operation that helps companies optimize functions, processes, and data. The activities defined in Levels 3, 2, or 1 are critical to plant safety, reliability, efficiency, product quality, and maintaining regulatory compliance. ISA95 Level 3 functions coordinate the resources (people, equipment, and materials) needed through all process steps to produce the end product. These solutions integrate across plant functions to enable optimized operations.

Bob: Many people correlate MES with ISA Level 3 functionality. These functions are distinctive, yet it can be challenging to determine where MES functionality resides within the system architecture components, especially if the end user is integrating to an Enterprise Resource Planning (ERP) system. Functions need to be evaluated based on organizational structure to determine the best fit for each activity into either the enterprise domain or the real-time plant floor arena. In a practical sense, this analysis defines who owns the function. Technology is then applied to achieve this functional structure. Using solutions from various suppliers can result in product overlaps and gaps in functionality. Each gap or overlap needs to be analyzed to determine how best to address the function.

Jim: Does the selected technology play a role in these decisions?

Joanne: In a way, it is a "Catch 22"; functional alignment activity is independent of the platform; however, in reality, some alignment decisions are dependent on the applications selected. How does an end user determine the best solution?

Bob: The best result is achieved by optimizing the functional organizational structure; then identifying the technology solutions that best meet these needs. It is important to select a long-term solution partner with both experience and a committed technology investment program to help make these alignment decisions. For example, material management from a warehouse and purchasing perspective may best reside in an ERP system; however, materials management within the process (such as tracking lots and adjusting for potency) may best be performed by the MES solution.

Jim: Are there other considerations in this decision process?

Joanne: Yes, the required response time can help determine where the function should reside within the system architecture. Control systems provide response times in subseconds, seconds, minutes, and hours. MES systems typically provide response times of seconds, minutes, hours, shifts, and days. ERP systems respond in days, weeks, and months.

Bob: That is right. However, the ease of integration between the systems can also be a defining factor in determining where functions should reside. Bottom line, each end user needs to evaluate their specific needs and organizational structure, and then work with a committed partner to determine the best solution.

Jim: Joanne, Bob, I really appreciate your time, sharing your insights about operations management with the Emerson Process Experts readers and listeners.

If you have thoughts on this approach or suggestions for future podcasts, I'd love to read or hear them!

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Emerson's DeltaV team announced news of new smart switches for the DeltaV control network. The topic of cyber-security is on the minds of a lot of process manufacturers right now. In fact, the November 2008 issue of Control magazine is devoted to security-related issues for process manufacturers.

I discussed in an earlier post how commercial off-the-shelf (COTS) technologies rapidly advanced the capabilities and performance for all of the process automation systems. Since these technologies are no longer totally proprietary and within the total control of the automation suppliers, security is a fundamental issue that must be addressed by both suppliers and process manufacturers.

The use of COTS technologies, like Ethernet-based control networks, has caused a collision in the worlds of IT and plant automation teams. Much has been written about the competing objectives and methods between these teams. DeltaV product manager, Bob Huba, has been in these discussions for several years, ferreting out requirements in his role managing security for the DeltaV system.

Bob notes that the fundamental premise behind the smart switch is to make it easy for automation engineers to secure their control networks and give them a way to help their IT organization help themselves. They can do this without having to involve the IT group in the setup and ongoing support of the Ethernet-based networks used for process control.

These switches, used to connect workstations, controllers, WirelessHART gateways, and other Ethernet-based devices are built-for-purpose and fully accessible from inside the DeltaV system. The switches are designed to work with the DeltaV control network with no configuration nor network specialization required.

Instead of COTS, the DeltaV team has coined the acronym, POTS--purpose-built, off-the-shelf to describe this class of device.

Bob described how it helps the IT team by saying that they are fully simple network management protocol (SNMP) version 3 capable, which provides three valuable services: authentication, privacy and access control.

With the proper authentication, IT staff members can get view-only access to these switches and incorporate the information into their network management processes. Bob threw a new term I hadn't heard, MIB-II. Google, always my trusty friend, told me it meant Management Information Base, and Wikipedia defined it:

A management information base (MIB) stems from the OSI/ISO Network management model and is a type of database used to manage the devices in a communications network. It comprises a collection of objects in a (virtual) database used to manage entities (such as routers and switches) in a network.

From the automation team's viewpoint, knowing that it's view-only access helps them all sleep better at night. They don't have to know a thing about SNMPs, MIBs, OSIs, ISOs and other IT stuff, which is of great comfort to them.

In addition, for local access to switch information, each switch has a built-in read-only, web browser interface. Process maintenance folk can browse any switch and get the diagnostic information they need.

What automation folks care about is that their automation systems are secure. The smart switches address one of the largest concerns--open Ethernet ports that people can plug into, or add wireless access points to--and open up the control network to all sorts of security risks. The release describes an easy way to prevent this--one-button lockdown:

The one-click lockdown application automatically scans the DeltaV network to find the DeltaV switches and then allows the user the choice to automatically unlock or lock the switches. Unlocking also enables an auto-relock of the switches in 60 minutes if the user does not perform a manual relock before then.

If you can have a way to bring peace between the automation and IT groups, have the level of security you need, and have the ease-of-use so it is in fact used, then Bob just may have ferreted out something good in all those conversations.

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Update: ARC Advisory Group has a nice summary of these smart switches.

When it comes to level 3 of the ANSI/ISA95 model, the production/operations management level, Emerson's Joanne Salazar and Bob Lenich are two very knowledgeable folks. I caught up with them recently in a discussion around this standard.

For those not steeped in the ISA95 standard, Enterprise-Control System Integration, it is the industry standard for information exchange between enterprise and manufacturing control activities and their supporting IT systems. This standard is oriented toward the definition of data models, work activity, and information exchange. ISA has defined four levels within a manufacturing operation that help companies optimize functions, processes, and data. These levels are based on the Purdue Reference Model for Computer Integrated Manufacturing (CIM). The levels include:

• Level 0: physical equipment and facilities
• Level 1: instrumentation, measurements, and equipment health
• Level 2: automation, asset management, and process data collection
• Level 3: operations management, workflow execution, and document management (MES)
• Level 4: transaction-based enterprise management (ERP)

Joanne noted that the level 3 functions are important because they include key work processes: workflow management, recipe control, maintaining records, and optimizing the production process. By addressing these functions, process manufacturers can reduce costs, increase efficiencies, and optimize resource utilization. Manufacturers face price pressure and increasing global competition, and seek ways to squeeze efficiencies from their manufacturing operations. Joanne also commented that process manufacturers have struggled to implement successful solutions that link the real-time plant floor activities with the transactional-based business planning functions.

Bob responded that level 3 functionality can be addressed in a comprehensive manner-including a single recipe for batch-based processes that address both manual and automated activities, life cycle documentation management, and integration of data that is not real-time-but impacts the product (such as lab results.) These level 3 solutions provide "closed loop" control for operations beyond the automated processes, which enables the manufacturer to make better and faster business decisions and optimize their resources.

While Joanne supported this vision, the practical implementation of these solutions has been difficult. Software integration interfaces have historically been time consuming and require extensive testing-not to mention the difficulties that can arise when the support staff must maintain and upgrade the software.

Bob believed this is where standards, such as ISA95 Enterprise Integration, play a big role. By defining data models, common terminology, and information exchange definitions, the integration of various software packages becomes practical in a working plant. Level 3 manufacturing operations software suppliers who adopt these standards make it easier for the process manufacturer to connect solutions from different companies.

By sitting on the ISA95 committee, Bob has had the opportunity to help define this standard. The collaborative effort of suppliers and users in this standard has helped provide a framework for software suppliers that can help to achieve some of the operational efficiencies sought. Bob pointed to Emerson's automation and operations management solutions that communicate--using the ISA88 recipe model--so that the batch process manufacturer can define a single recipe in a single engineering environment. This recipe spans all functions of an operation, both manual and automated, and enables comprehensive data collection. This single recipe approach may streamline change control and reduce the engineering effort.

And that just might squeeze some more efficiency from the manufacturing operations.

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One of the things I'd like to do more in future posts, is to "hand over the keys" to this blog to one of our experts and "let them drive." Today's post is from Joanne Salazar, a member of the Data Management Services team. For those of you who use Twitter, Joanne is @perspective21. Joanne's subject is that area historically defined as manufacturing execution systems (MES). I'll not indent in a quote box for space considerations, but I hope you enjoy Joanne's words below:

The promise of MES has been difficult to achieve over the years, partly due to limited product functionality. MES is broadly defined as an information technology (IT) solution that supports the primary production processes in a production plant. These applications close the gap between ERP systems and production equipment control, distributed control systems (DCS), programmable logic controllers (PLC), and/or supervisory control and data acquisition (SCADA) applications.

MES applications have become essential to support real-time production control, as well as data collection and reporting that is required in order to improve production performance; however, the practical implementation of these systems can be overwhelming and expensive. The challenge of MES solutions lies in the fact that it is broadly defined and impacts virtually every manufacturing function.

Product functionality that enables a batch recipe to span manual workflow and automated processes, provides a consistent operator interface, and generates a comprehensive batch record without custom coding has not been available until now. In this post, I would like to address the benefits of having a SINGLE batch recipe, developed in a SINGLE engineering environment, using ISA S88 and S95 STANDARDS.

SINGLE RECIPE. In all manufacturing facilities, manual and automated processes need to be coordinated. Manual operations may include filter changes, equipment cleaning, and material weigh dispense. Automated processes involve reading instruments and sequencing values, including steps such as heating, agitation, and material transfers.

Manual operations have historically been addressed via SOP's and paper-based procedures. Automation is commonly addressed using a control system. Therefore, a recipe needs to span across both manual and automated systems to be comprehensive. If the manual and automation systems are not addressed by the recipe, coordination and synchronization of activities needs to be forced, requiring additional resources and reducing efficiency.

One comprehensive recipe that spans manual and automated processes can provide:

• links to reference documents (SOPs, MSDS, P&IDs, etc)
• easy, intuitive interface that walks the operator through work instructions
• transparent access to automated activities with easy views of current process status
• ability to capture data from both manual and automated processes
• synchronization of manual and automated steps to ensure right-first-time manufacturing

SINGLE ENGINEERING ENVIRONMENT. To support a single recipe, it is important to have a single engineering environment to create, modify, and maintain the recipes. A single recipe definition reduces development time, minimizes custom interface software, and enables the process experts to define the recipe. This engineering environment can provide:

• ability to write a "library" of modular operations and steps that can be used multiple times within multiple recipes
• ability to initiate sequencing from one system to the other
• authorization and security functions that are defined once and used throughout the manufacturing facility
• easy, intuitive interface that graphically shows the recipe sequence including both manual and automated processes
• seamless, transparent passing of information between the recipe and the automation systems ensuring synchronization of process steps without the need to write custom code
• comprehensive capture of both manual and automated information, including seamless, transparent capture of automation system data to the recipe electronic batch record

ISA S88 and S95 STANDARDS The use of standards to define and implement recipes improves implementation efficiency and reduces the cost to maintain the solution over its life cycle. ISA-95 (S95) Standard, Enterprise-Control System Integration, is the industry standard for information exchange between enterprise and manufacturing control activities and their supporting IT systems. S95 is oriented toward the definition of data models, work activity, and information exchange.

ISA-88 (S88) Standard, Batch Control, provides guidelines for the design and specifications of batch control systems. S88 is oriented toward physical work execution. S88 is based on a well-defined equipment-oriented conceptual structure and a hierarchy of control functions that acknowledge manufacturing management functions and extend all the way to the manufacturing equipment itself.

Products that adhere to these standards provide easier implementation of recipes by using common terminology, providing a structure that allows process experts to define the recipe, enabling software module libraries for common functions, and predefined integration to other software applications. The use of standards also makes it easier to maintain the solution over its life cycle, ensuring that new product software versions will continue to function and communicate properly with other software applications.