Data Management

We began this week with a post about the compatibility of the OPC Express Interface (Xi) standard with the existing OPC classic real-time, alarm & events, and historical data access servers to provide interoperability of process automation software and systems.

The OPC Foundation recently held a webinar highlighting this interoperability. Supplier participants included Advosol, Cogent Real-Time Systems, Emerson, Iconics, InduSoft, Kepware, MatrikonOPC, MobiForm Software, OSIsoft, Smar, Software Toolbox, Transpara.

The full OPC Xi Technology Demonstration hour-long webinar recording is available on the OPC Foundation website if you have an OPC Foundation account.

One of the demonstrations I'd like to highlight from this webinar is InduSoft's Web Studio software connected with Emerson's DeltaV system. I've embedded this 9:17 video from the InduSoft YouTube channel with permission from the InduSoft team.

The first two minutes gives some background on InduSoft and Web Studio and the following minute how the OPC Xi server is part of the DeltaV system. At 3:00, an architecture diagram show the information flow of real-time process, alarm, event, and historical data flow to OPC Xi clients, even through firewalls and across the internet.

This is possible as described in the post earlier this week since OPC Xi is built on top of the secure Windows Communication Foundation (WCF), part of the Microsoft .Net framework.

At 3:30, the demonstration shows how a connection is made from Web Studio across the internet to a DeltaV OPC Xi server. The content inside the OPC Xi server is fully browseable (shown at 5:40). At 7:15, the selected real-time temperature coming from a wireless temperature transmitter [actually located on top of the parking garage at the Emerson Austin facility] is configured and displayed on the Web Studio graphics screen.

This demonstration and all of the others from the webinar show how OPC Xi extends interoperability to address and connect through the complexities of today's highly secure networks. The result is to get the information into the hands of the right people, no matter where on the planet they happen to be.

I've heard that the other videos will soon be available on the OPC Foundation YouTube channel and will update this post when I see them out there.

Update: The videos are now available on the OPC Foundation YouTube channel. There are three: OPC MobiForm, MatrikonOPC, and this same InduSoft one.

Emerson's Christie Deitz and Bristol-Meyers Squibb's Joe Maguire are presenting, Electronic Workflow for a Bioreactor, at the 2010 WBF North American Conference this week in Austin. Their abstract:

Automating workflow and eliminating paper batch records can provide many benefits, including reducing deviations, expediting batch review and release, improving real-time inventory management, and utilizing industry and corporate standards. BMS is currently in the commissioning stage of its new state-of-the-art facility in Devens, Massachusetts. BMS' objective was to create a paperless manufacturing environment. To meet this objective, automation for the facility includes a process control system (PCS) and a manufacturing execution system (MES) system. The project is unique because, to date, it is BMS' most extensive automation of workflow; that is, the manual instructions that might be traditionally done using paper.

The project team learned some valuable lessons with regard to team organization and approach to testing. They also made some key technical decisions around prompting, phase boundaries and recipe design. This paper will explain many of the lessons learned using the bioreactor area of the project as an example.

Joe described the vision to implement a fully automated, paperless solution that supports release by exception utilizing S95/S88 integrated recipe. The systems included a DeltaV control system, Syncade manufacturing execution software (MES), SAP, SmartLab, and Maximo software for enterprise, lab management, and maintenance planning.

To BMS, release by exception means that all exceptions dealt with in real-time and that the batch release needs to verify all exceptions investigated and signed off. Accomplishing this means the process operations are compliant, more efficient, and more visible.

Joe showed workflows around equipment qualification & facilities, materials verification, batch execution, operations review, QA review, and batch disposition. Moving away from manual, paper-based workflows to electronic workflows removed time and mistakes throughout the workflow.

Christie described the how project team executed this electronic workflow effort. She showed the interaction of the MES workflows with the automatic operations driven from the automation system.

On lessons learned for such a large project, overall it went smoothly, considering the large scope of manual workflows. The team took a bottom up approach. For future projects, the team would do electronic workflow and traditional automation more integrally in design and project execution.

On future projects, the team would finalize vision and requirements early and bring in plant operations and manufacturing personnel early.

WBF is holding their annual North American conference this week in Austin, Texas. For those not here, you can get a flavor for what's happening through the WBF Twitter account and the search hash tag, #WBFna.

Two Emerson presenters are on the agenda today. First, Dawn Marruchella is teaming up with Lubrizol's Robert Wojewodka to present, Benefits Achieved Using Online Analytics in a Batch Manufacturing Facility. Their abstract:

Batch operations present manufacturers with a unique setting where operators must work in a highly complex, highly correlated and dynamic environment each day. They must also manage a large amount of data and information on a running unit - all of this making it easy for batches to end up with undesirable processing events and/or less than desirable end of batch quality. Lubrizol wanted to improve their operations by providing their operators with the ability to detect upset conditions before they have a negative impact on their batches. In order to do so, they are collaborating to develop and deploy the use of online data analytics, based on multivariate analysis, initially at their facility in Rouen, France.

Here are some of my live-blog notes from their presentation. Operators and engineers work in a highly complex, highly correlated and dynamic environment and need to manage a large amount of data and information on a running unit. They need to avoid undesirable operating conditions and reduce variation, improve throughput and improve quality yet maintain safety. Data is everywhere and needs to be understood to achieve these plant objectives.

Lubrizol and Emerson jointly worked to develop viable on-line multivariate batch process data analytics to predict product quality on-line and on-line process fault detection and identification. Through a field trial, they wanted to document the benefits of this approach and learn about improvement opportunities.

Batch processes have challenges around process holdups, variations in feedstocks, access to lab data, and varying operating conditions. There is variability between batches, which makes analysis difficult. Borrowing from voice recognition technology, the team used Dynamic Time Warping (DTW) to characterize and align batch-to-batch comparisons.

By looking at the multivariate relationships, these questions can be asked about the running batch:

• Is it in multivariate statistical control?
• Is it within acceptable variation?
• Are any relationships atypical?
• Is end-of-batch quality still predicted within specification?
• Is there something I should be looking at regarding the health of the batch?
• Is there a way to get at what I need to look at very quickly?

The statistical methods used include Principal Components Analysis (PCA), Projections to Latent Structures (PLS), and PLS with Discriminant Analysis (PLS-DA). Dawn shared how the operators can see multivariable relationships trending in real time and flagging anything trending outside the norm.

The goal is not to have close loop control, but rather to provide process relationships for the engineers and operators to better understand how their process really operates. They do not want it to be a black box with the answers. Instead, it provides multivariable data relationships that cannot be seen. Here's an article, Data Analytics in Batch Operations that describes this project and its results in more detail.

Last week, we cautioned about the use of obsolescence in developing an automation modernization project justification. Sticking on the theme of justification, I received a copy of a presentation, Tank Farm and Terminal Automation: Developing a Business Case. Emerson's Patrick Truesdale gave this presentation at the 2008 NPRA Annual Meeting.

For those not familiar with tank farms and terminals, they are known as Offsites operations in the industry vernacular. These Offsites operations provide receiving, shipping, and storage facilities for hydrocarbon liquids and gases processed or produced by refineries and petrochemical complexes.

Typical units include tank farms, blenders, and terminals. The terminals handle truck, rail, marine, and/or pipeline-based transport. For a consumer product like gasoline, the terminals are the spot where the gasoline tankers fill up before delivering the gasoline to the gas stations where you fill up your automobile.

Historically, these Offsites have had a piecemeal approach to automation with disparate controls for custody transfer, loading and unloading, blending, and vapor recovery to name a few processes. Making decisions requires tracking down information from many places. Also, for these Offsites facilities in mature markets, operations personnel with this knowledge are approaching retirement age.

Other challenges are the increasing regulatory compliance reporting such as Sarbanes-Oxley in the U.S. and greenhouse emissions regulations in many countries. These regulations have also increased the number of fuel additives and alternative fuel mixes such as ethanol and biodiesel.

Patrick sees the justification opportunity for taking an integrated Offsites operations in increased revenues, reduced working capital, increased capacity, and reduced direct and variable costs. The integrated approach streamlines the business process from production planning where the production orders occur to the work preparation phase where these production orders are prepared. The work details that come out feed the work execution phase where the production orders are executed, followed by the production accounting phase where the production order is completed and performance monitoring steps taken.

These business processes can be integrated based on the ISA95 enterprise-control system integration model, which helps eliminate many of the manual operations including manual data collection and reporting. This integrated approach adds movement control and gentry control on top of the automation system performing the regulatory control across all the processing units. Hydrocarbon movement scheduling is performed above the movement control level. It connects with the order management and production accounting systems. Likewise, slot-blocking operations are performed above the gentry control. They also connect with the order and accounting applications.

The justification process begins by benchmarking current performance in the areas of process unit, tankage, and loading/unloading asset utilization rates. Revenues can be improved by integrating the flow of information on process units such as crude units, cokers, FCCs, HCUs, and Reformers as well as tankage and loading/unloading areas.

Margins can be improved by increasing yields especially on high-value products. Reducing losses in better custody transfer measurement, unaccounted losses, quality giveaway, and lower contamination also improves margins. Improved schedules also reduces demurrage costs.

Soft costs to aid in the justification can be found in reduced fuel and hydrogen consumption, increased staff productivity, and improved supplier/customer relations through more efficient and effective scheduling. Once the benchmarking and expected benefits are tabulated, they should be broken into distinct project phases and prioritized base on projected return on investment. This helps manage the scope and execution of these modernization efforts.

For Offsites operations with piecemeal regulatory controls and manual work processes, Patrick has seen terminal handling efficiency increase 20%, truck turnaround times reduced 33%, annual maintenance costs reduced 60% compared to industry average, and equipment availability exceed 99.7%.

MP3 | iTunes

I caught up the other day with Emerson's Shenling Yang, who is a senior project execution engineer in the Life Sciences and Food & Beverage (LSFB) industry group. You may recall Shenling from earlier posts.

She shared two pieces of news with me. The first is that the Critical Data Backup application developed by the LSFB team, and used for protection of DeltaV automation system configuration and critical process data, has been extended to the Syncade operations management software. Shenling has been working on a project with a pharmaceutical manufacturer implementing this application.

In one of the earlier posts with Shenling, Backing Up and Recovering Critical Control System Data, the goal of a biotech manufacturer was total recovery from a system failure in hours instead of weeks. For highly regulated industries, the scenario described was:

...the dreaded 3 am phone call from the plant with the news that production has stopped, people standing around and it's up to you to do something. Choice one is to go to the plant, to rebuild the automation system configuration, to revalidate the process, to lose a bioreactor batch that may have been running for up to 100 days, and then to hopefully resume production within a few weeks.

The Critical Data Backup application was the solution:

...to meet the 21CFR Part 11 compliance for backup, recovery and preservation of electronic records. It's a part of the overall disaster recovery plan, which includes files, spare on-site server hardware, physical separation of equipment and networks, and always-available support personnel on-site.

With the ISA95 Enterprise-Control System Integration standard, this critical backup need extends to level 3. The Critical Data Backup covers some of the Syncade Suite modules including: Document Control & Archiving, Security & Audit, Equipment Tracking, Batch Production Record, Recipe Authoring, Training and Development, and Manufacturing Information Portal. The backup extends beyond the operational and configuration data to include backup reports, style sheets, and behaviors.

I did mention there were two pieces of news. The second is that Shenling is moving to Shanghai to work with the Emerson Asia Pacific marketing team. She's promised to help me discover and tell stories of all the great work being done by our experts in China. I look forward to being able to broaden out the view of these Emerson experts around the world.

Safe travels and best of success in your new assignment, Shenling! And, make sure to show this post around to everyone that we've promised our readers some good stories.

MP3 | iTunes

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.

MP3 | iTunes

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.

MP3 | iTunes

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

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!

MP3 | iTunes

This is a great time of year to be a blogger for Emerson with the Emerson Exchange happening next week. It's that time when process manufacturing professionals, Emerson and local business partner professionals, and alliance members gather to exchange their expertise with one another.

It's also a target rich environment for me to find great things to discuss in blog posts. Emerson's Dave Rehbein, a senior data management solutions consultant, will be presenting a workshop, Plant Floor Security Assessments - Key Findings. I've known Dave for a long time. We represented Fisher-Rosemount in the original OPC standards effort back in the mid 1990s. Dave served as the master editor for the original OPC specification released in 1996.

If your responsibilities include the cyber-security efforts around your automation systems, and you'll be at the Exchange next week, this is a presentation you'll not want to miss (Wed 10/1, 2:15pm Chesapeake 7, Thurs 10/2 9am Chesapeake 7.)

Dave will present aggregate findings from three different process manufacturers where he performed plant-floor security assessments. He'll discuss risks found in the areas of: patch management, isolation of plant control network from the office network, following existing security procedures, use of unsecure legacy operating systems, security log auditing, and hardening of PCs and servers.

Dave describes the security assessment process as one that typically takes two weeks and involves reviewing existing plant floor security processes, reviewing network and device security, developing a risk matrix of the plant floor systems and application, and developing the risk mitigation plan based upon the findings from these earlier steps.

It's critical that the process manufacturers have participation throughout the organization for the plans to be executed and the work processes put in place for ongoing security. He recommends participants include an executive sponsor, a plant area engineer, plant IT director, security officer, chief network architect, network/telco architect and an operations manager. Dave presents an overview of the flow of activities over the two weeks.

Microsoft provides some excellent assessment tools that can gather information on the current state of security. Dave mentioned the Microsoft Baseline Security Analyzer (MBSA) and the Microsoft Security Assessment Tool (MSAT) as important assessment tools for things like identifying patch levels and to conduct interviews with key plant personnel to assess the maturity of the existing security programs.

The risk matrix that is developed as part of this security assessment process takes each recommendation developed and looks at its urgency, impact and investment required. Each of these parameters is graded on a low, medium, high scale. This helps establish the priority, justification and roadmap for cyber security improvements.

As I had mentioned in an earlier post, commercial off the shelf technologies (COTS) have allowed all automation suppliers to rapidly improve their platforms by taking advantage of the price/performance curve described by Moore's Law. The downside is that security is a much greater concern since parts of the technology development are outside the control of the supplier. Security consultants help suppliers to rigorously test their equipment to identify and fix areas of security concern.

Process manufacturers must also do establish security practices for the lifecycle of the automation equipment on which they rely to operate their plants. The process Dave describes in his talk is a great way to compare with what you're currently doing today.

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.

One of my Google blog search RSS feeds on batch processes alerted me to an article, The New Recipe for Pharma Success. It describes how many Life Sciences manufacturers use low-tech tools like spreadsheets, flow charts, and other unstructured documents to create and maintain the process definitions. It concludes:

Bottom line, unstructured documents needlessly increase expenses and prolong time to market. Bad data may be introduced--or good data may be overlooked--at any stage of the product lifecycle, requiring companies to repeat one or more stages.

I ran this post by Joanne Salazar (perspective21 for you Twitterers out there.) Joanne has many years of experience with Emerson and is extremely knowledgeable of the regulatory compliance challenges pharmaceutical and biotech manufacturers face. She is currently focusing her efforts on the Compliance Suite manufacturing operations software, which joined the Emerson family last summer.

Joanne wrote back such a great reply, I thought it best to include in its entirety:

Pharma companies spend lots of money and lose valuable time bringing drugs to market as the patent expiration dates move ever closer. The data involved in defining the "recipe" for the drug is voluminous and needs to be managed throughout its lifecycle. Companies are gaining efficiencies to quickly startup production facilities in several ways:

• integrating change control between development and operations as a drug facility is brought online
• creating reusable libraries of process operations using S88 and S95 standards as a basis
• integrating commissioning and qualification efforts
• using .NET framework to minimize validation efforts, by ensuring functionality of applications once then deploying to various clients

In regards to managing the information and documentation, several additional practices are evolving:

• more structured documents upstream in the drug development cycle enable pertinent data to be easily imported into manufacturing systems - resulting in faster time to market
• the technology and ability to easily interface various systems in a manner that is maintainable is becoming a reality due to S95 and other standards; therefore, pharma manufacturers can readily produce a complete electronic batch records that include recipe, formulas, manual, and automated actions, comments, required data to be gathered during processing, prompts, alarms, deviations, signatures, approvals, etc.
• easily accessing current and approved reference documents (SOP, MSDS) for plant floor work instructions to ensure proper actions are taken
• verifying the training certification of operators at point of action
• managing documents throughout their life cycle: document check-in and check-out, version management, automatic routing, storage, single- and multi-document change control, archived records management, and printing

Helping process manufacturers solve these documentation, maintainability, training and change management challenges is simplified with software like Compliance Suite and project teams who can automate these manual processes.

Twice here at Emerson Process Experts, I've featured the work of Shenling Yang. The first was in her role as member of the DeltaV technology team and the second as an integration specialist in the Life Sciences industry center. Shenling shared with me a presentation she is developing with a biotech manufacturer for the Emerson Exchange on backing up and recovering critical process data. This is a huge requirement for regulated industries like pharmaceutical and biotech manufacturers.

The scenario they will present is the dreaded 3 am phone call from the plant with the news that production has stopped, people standing around and it's up to you to do something. Choice one is to go to the plant, to rebuild the automation system configuration, to revalidate the process, to lose a bioreactor batch that may have been running for up to 100 days, and then to hopefully resume production within a few weeks. To give you a sense of the value of saving a batch, it's important to note that the medications being produced in these bioreactors save lives and any loss of a batch means a delay for a patient who needs this medication.

Choice two is to load the data backed up from the critical data backup application, have the operator restart the plant, verify normal operations and save the running batch in the bioreactor. Obviously, choice two was the way to go. It is vital to protect and recover control system data because human error or system failure can wipe out years of work, experience, plant operations information and process records.

The U.S. Food and Drug Administration (FDA) regulates and requires fully validated backup and restoration solutions for critical data. With the FDA's 21CFR Part 11 electronic record provisions include the accurate and ready retrieval of control system information through the record retention period. The FDA's 21CFR Part 210 & 211 good manufacturing practices (GMP) require this retention period be at least one year after the expiration date of the batch.

The goal established by this biotech manufacturer was to be able to recover and be back up and running 100% with minimal loss in three hours or less. They were looking for something with minimal customization that would automatically back up the configuration and version control databases without any operator intervention. The solution was to use the Critical Data Backup application (CDBA) developed by the data management services team to meet the 21CFR Part 11 compliance for backup, recovery and preservation of electronic records. It's a part of the overall disaster recovery plan, which includes files, spare on-site server hardware, physical separation of equipment and networks, and always-available support personnel on-site and at their Emerson local business partner location.

The backup system includes a server, tape carousel and gigabit network to link multiple DeltaV systems and transfer large files quickly, safely and efficiently. This application help formalize the backup process which was not as diligent or documented as it should have been.

Like anyone who administers a server or even backs up the family PCs can attest, you don't know how good it will work until you have to use it. The day came when this site lost two hard drives in a RAID array. They were able to put a new server in the rack, transfer data using CDBA, do a warm batch restart and be back up in an hour with no loss to the batch.

This sounds like a great presentation to catch if you need a way to formalize your system backup and recovery effort.

While in Asia last week, I had the opportunity to catch a presentation by Bob Lenich, Director of Emerson's Data Management Services. With the announcement last year of Emerson's acquisition of Decision Management International and the Compliance Suite manufacturing execution system software, Bob has been busy integrating the organizations.

The Compliance Suite software is being used by many process manufacturers, especially in highly regulated industries such as Life Sciences--Pharmaceutical and Biotech manufacturers. The starting point for applying manufacturing execution system software is the data model defined by the ISA-95 (S95) standard. The S95 standard describes the architecture of information flow between the plant floor, the automation system, the manufacturing execution level and the enterprise resource planning levels. Getting these workflow activities and the flow of information between them right is what defines highly efficient, customer-responsive manufacturers.

Bob described the place to start as understand the challenges of improving quality, improving throughput and/or increasing process availability/uptime as a few examples of what can drive process manufacturers to look at improving the flow of information around the organization. You have to understand the problems and needs in order to improve things.

As an example, in the area of quality, typical issues are to reduce deviations. These can be caused by ensuring the right material is available to add at the right time or eliminating manual error in calculations. Also, much time and effort currently spent just doing all the paperwork and paper work tracking required to meet today's regulatory needs. Converting from paper to paperless systems can eliminate all of these problems

In addition to eliminating problems, reducing these deviations also improves throughput by reducing batch variability, reducing batch cycle time and reducing the overall batch release time as there aren't as many problems to address.

Solving these problems requires addressing a mixture of automated and manual processes. Bob noted that the best way to address these issues should begin with a look at the current workflow, to understand where efficiencies can be gained.

The workflow should look at equipment, people, materials, documents and existing information to develop the business justifications and information architecture to address the areas of inefficiencies. Once a good benchmark is established, improvements can be made and the results quantified.

There many opportunities to do this and Compliance Suite is a great tool to use for enforcing these changes. Bob stressed that these changes are typically strategic in nature for the process manufacturer and require the upfront planning and design work to focus the efforts to the areas of greatest efficiency gains and continuing to prioritize the areas of improved data management and flow over time.

In the process of moving hydrocarbon through the supply chain from producer to consumer, terminals play an important role. They receive liquids and gases from many sources including ship, rail and pipeline. These gas and liquid hydrocarbons are stored in tanks or vessels until required to move via other methods of transportation including barge, truck and pipeline.

I had the chance to view an upcoming article featuring Emerson's Cor Vermeijs. He's based in the Netherlands. The article explored ways for terminal operators to use automation to optimize the inventory management and operational efficiency of their terminals. The goal is to improve the quality, productivity and availability of the terminal and help the owner of the terminal lower the costs of operations and maintenance, improve environmental and safety compliance, and reduce energy usage.

He notes that many terminals today are manually operated from planning all the way to manually operated valves and pumps. This limits the availability of real-time information to make the most efficient schedules. These delays affect the throughput of the terminal, which directly affects its profitability.

In the article, Cor stresses the starting point should be to study the current operational processes. The key is to look for areas of inefficiency that can be automated. The study typically includes a cross-section of the organization from operations, sales and management. The output of this study is:

...a plan to optimize these processes, to automate them, and to implement them wherever necessary. The results of this site audit are issued in a report that gives the solution for the concept, a cost-benefit analysis, the payback period and a performance guarantee. It's all based on the best possible use of the storage tanks, the pumps, the pipelines and the jetties. The objective is as many product movements as possible without running the risk of product contamination or tank overfills.

Architecturally, when manual processes are automated, the information is collected in a single system. This information becomes the basis for a route planner. The system takes the recommended route with the corresponding pipeline segments, valves and pumps and links it to the data from the work order. This information can include the time when the route/transfer can be started, how long it will take, which ship or train will deliver the volume, and who is the owner. Cor sums this up:

...all information is available not only to the operator in the control room, but also to the man on the jetty, the planner and perhaps even to the captain of the unloading or receiving vessel. And it all takes place in real time, with immediate feedback of events such as a delay along the line, so that you can adjust your planning while the work goes on without interruption, thus increasing your terminal's efficiency.

Terminal management includes a number of processes including custody transfer accounting, inventory tracking, security management, loader or driver verification, load requests and initiation, permissives management, ticket generation, custom reports, remote dock monitoring, event logging, and system integrity management.

Standards play an important role in fostering technological progress--both in the willingness of consumers to adopt the technologies and suppliers in developing products to meet the standards.

In our world of process automation, standards have continued to advance from base-level digital communications protocols to higher-level data communications standards for process manufacturers. The ISA-95 (S95) or IEC/ISO 62264 family of standards as they are globally known are an example of a set of data standards for the interface between enterprise planning systems and automation systems.

I had a chance to get a preview of a whitepaper that Emerson's Shenling Yang is developing around S95 and the XML-based implementation of this standard called Business To Manufacturing Markup Language (B2MML). You may recall Shenling from an earlier post on project timelines. She is now a data integration specialist in the Life Sciences industry center.

As stated in an ISA press release this past January on B2MML improvements:

B2MML was developed by the WBF's XML Working Group to provide manufacturing companies with a freely available XML Schema implementation of the ISA-95 Enterprise - Control System Integration Standard.

You can get a sense for just how detailed and comprehensive these standards are by viewing some of the schema documents available on the World Batch Forum's B2MML web page. Beyond the common schema organized around the S95 data model, other schemas exist for equipment, extensions, maintenance, materials, personnel, process segments, product definitions, production capabilities, production performance, and production schedules. Warning, these schema documents are not light reading!

On projects requiring workflow improvements and/or paperless operations, Shenling and the team follow B2MML data definitions to be consistent with the S95 standard. Because leading enterprise resource planning (ERP) systems like SAP support B2MML, Shenling finds that it simplifies connectivity and reduces the overall engineering effort for integration between the ERP and manufacturing execution systems like Compliance Suite. Ongoing maintenance is also reduced since the information exchanged between applications follows well-defined data definitions.

An example is an order coming down from SAP in an XML-formatted document complying with the B2MML Production Performance schema. The project team used transaction templates, along with the Compliance Suite support component and the process order XML from SAP to generate the actual transaction documents to be passed from the ERP to Compliance Suite. The automated parts are handled by the DeltaV Batch system and other parts of the process like materials management, laboratory information, and proof of personnel training are sent to their respective workflow processes.

The results of these workflows and batch data from the automation system are consolidated in an electronic batch record, which is a critical piece in reducing the overall cycle time on the way to releasing the product for sale.

Update: Gary Mintchell reports on his Feed Forward blog today that the World Batch Forum has announced version 4 of the B2MML standard and some of the additions to this standard. Here's the announcement from the WBF.

I caught up the other day with Michael Barrett who manages some of Emerson's relationships with providers of production management software like OSIsoft.

Michael strongly believes that production management is a key success factors for process manufacturers competing in a global market. He defines production management as the area of management information systems that work with the planning and scheduling applications that drive the manufacturing operations in a Continuous Improvement Loop. This supports a company's Supply Chain Management by insuring the availability of right product at right time at the lowest cost.

As an example, Michael cites a refiner who imports heavy crudes. They may have several locations to decide where to process it. The refinery ultimately receiving this heavy crude must ensure that they have available tankage to receive the crude, processing capacity to run it and logistics capability to handle the products. They must also make sure they are receiving precisely the quantity for which they are being invoiced. One of the challenges is accurate measurement of water in the crude receipt. If a refinery needs to wait on a 2MM Barrel parcel to let it settle in a tank to accurately measure water--that takes time and at the current price of crude is huge investment tied up ($50/Bbl times 2MM = $100,000,000).

They also may have to consider the hydrogen and fuel requirements to keep the refinery in hydrogen and fuel balance. Doing monthly or even weekly mass balance on the refinery and the internal units does not generate enough visibility to maximize the operational efficiency for the refiner in a global market. To accomplish these objectives many sites are facing a measurement shortfall. An obvious example is the water in crude measurement. Typical errors here can translate into millions of dollars paid for water. Many refineries also have issues with high levels of unaccounted losses in the loss control reports. Top tier refineries maintain unaccounted losses to less than 0.5% on crude. That kind of performance is not possible if you only measure the loss once per month.

Companies are engineering new refineries today coming on-line in 5-7 years in parts of the world where the owners will own the crude feed. They are being designed with digital communications technologies in the processing equipment and systems to interact more tightly with the scheduling and planning systems to maximize and optimize these assets and the added value products coming from the crude.

Michael believes the challenge for existing refineries is to improve and integrate the production management systems to account accurately on a daily basis actual verses planned production. This allows the planning and scheduling departments to improve asset utilization and squeeze more efficiency from existing equipment. Production Management systems should provide key metrics for operations management to make decisions that maximize response to market demands, spot opportunities and operating flexibility to better differentiate themselves from their competitors. This agility coupled with improved asset utilization will help existing refiners better compete as the modern, high-tech refineries begin to come on-line.

Michael recommends beginning with a thorough analysis of the production management system as a first step. This can be the basis of building a business case for change to more agile production. Developing and providing decision alternatives with their business impact is an important part of this improvement plan. There is no one thing, but rather a combination of tools, work flow changes and operational discipline which can reveal the scale of performance improvements possible.

As reported in my DeltaV News RSS feed, Emerson's Michalle Adkins and Dawn Marruchella have written a great piece in the AIChE's Chemical Engineering Progress Magazine entitled, Ask the Experts - Avoiding the Pains of Systems Integration.

In it, they recognize some of the issues process manufacturers have faced with manufacturing execution system (MES) integration projects and they share their expertise about how to reduce concerns about integrating existing batch process and achievable business benefits.

Their initial guidance is to analyze the integration needs and current business processes and develop a solution weighing the costs and risks against the sought benefits.

Functionality can overlap in both the MES and control system. If your control system has well integrated batch capabilities, Michalle and Dawn recommend using it to manage recipe execution and historical data collection around the batch. This reduces the complexity of the integration between the MES and control system and helps simplify the requirements for the MES. Then ease of MES and DCS integration and specifically capturing the information required for the electronic batch record would be the focus of the integration efforts.

Also, as mentioned in prior posts, they recommend that the solution have:

Support for web services, a service-oriented architecture, and the use of XML schemas, such as ISA-S95's business-to-manufacturing markup language (B2MML)...

Their final recommendation is to review successful implementations to understand not only the software and integration, but also the experience of the project team who implemented the solution.

The benefits for these efforts must accomplish the highly sought after business objectives. If these objectives are to reduce the cycle time for product release, you can incorporate much of the current after-the-fact documentation into the running batch process. Examples cited include:

• Manual setup, cleaning, and maintenance activities
• Review and approval processes for master and batch documents
• On-line data validity checks, electronic signatures, and completed calculations
• Exception-based reporting tailored for intended audience

By executing these tasks during the production of the batch, process manufacturers can increase their right-first-time metrics and shorten the post-batch approval cycle time. The article cites other achievable benefits based on the identified business objectives such as reducing deviations, significantly decreasing manual data entries, and eliminating paper log books.

Manufacturers increasingly look to optimize their businesses by integrating their business processes with their manufacturing processes. ANSI/ISA-95 (S95) is an international standard for developing an automated interface between enterprise and control systems.

Over the last several years our Life Sciences Industry Center has been working with pharmaceutical and biotech manufacturers on this optimization process in pursuit of operational excellence. I caught up with integration consultant, Dick Seemann, who discussed some commonalities he sees in integration transactions between enterprise planning systems like SAP business software, manufacturing execution system (MES) software and control systems like the DeltaV system.

A key transaction is the process order download which comes from the planning and scheduling software to the manufacturing system in the form of a request for a campaign of process orders or a single process order. The transaction contains a process order number, material components, equipment requirements, and specific parameters that are exchanged through standard web services. The team typically uses Compliance Suite as the MES software between the SAP software and the DeltaV system.

The MES software combines this information from the production, material management, and quality management software and then manages the order execution, performs weigh and dispense, and executes the manual work instructions in conjunction with the automated control system tasks. A complete electronic batch record is maintained at MES level, since it combines recorded manual processes and procedures with electronic information at the control system and enterprise planning system levels. Alarms, events, operation actions, and batch history are passed as transactions from the control system to the MES.

The process orders as the campaigns are being executed provide status transactions back to the planning systems on status changes during execution and upon completion of the process order. Materials consumed during the production and recorded by the manufacturing execution system are passed back as transactions to the material management module to accurately reflect what is available for planning future production.

Start and end times for each of the steps in the batch are also passed back as transactions to the planning systems to provide and accurate picture of equipment utilization and how long production steps take compared to standard times.

Dick notes that all process manufacturers have different business processes and that there are many more transactions that can occur between the three levels. As these paper-based processes are moved into an integrated, transactional world, end-to-end cycle times are reduced resulting in greater manufacturing efficiency.

Transcription errors are also reduced when all communications is electronic-based versus the paper batch sheets. Also, troubleshooting problems becomes easier when a history of electronic batch records is available to review to analyze where inefficiencies have begun to occur.

When modernizing your automation systems to take advantage of the digital technologies today's systems offer, you need to also take a look at the historical data you may have been collecting over the life of the system.

Recently Emerson's Clarence Presha presented a paper with a customer who looked at how to take 10 years of historical data collected by the Biles AIM historian and move it to OSIsoft PI System. The driver was that this data is the foundation for production reporting, process troubleshooting, and process improvement. Over this period of time, quite a bit of reporting and visualization tools have been built including using Excel spreadsheets for basic graphics, and Excel macros for reporting functions. This solution built over the years had limited capacity, slow frequency data (60 sec scan rate), and had custom code that was difficult to maintain and improve.

Clarence and the team identified more than 10,000 tags that needed to be converted. The agreed upon approach was to take a thin slice to demonstrate the proposed data management modernization solution. For this thin slice phase, sample PI tags were created with simulated history. Performance equations were added replacing the existing AIMcalcs. PI ProcessBook displays with a proposed graphics standard were created to improve visualization. Some existing production reports with custom Excel macros were updated standard PI functions. Finally, RtPortal was used to show plant information which could be made available to engineering, operations, and management via web browser.

Clarence and the Emerson data management experts provided design, configuration, data migration, testing, training of the operations, technical, maintenance, and engineering staff, and on-site deployment services for this project.

Some of the key results cited in this presentation were better visualization tools for real-time and historical information for the operators to analyze what was going on in the process. Also some newer equipment that had not been added to the legacy data management solution could now be added extending the operators' view. The web-based view into the key process parameters opened up more parts of the organization to what was occurring in the process. This view was combined with information from other business systems including the MRP, scheduling, and plant maintenance systems.

Anyone who has been a project engineer knows that there are some areas of a project with more inherent risk to schedule and cost more than others. Areas like data integration between hardware, software and systems need early attention so that they can be resolved before the pressures of the critical path are felt.

One of the Emerson Exchange papers being presented in the Project Work Processes track is Data Flow Requirements for Main Automation Contractor (MAC) projects. Emerson's Mike Simpson and Jim Davis from our West Coast Business Partner, Caltrol, convey processes, procedures, and tools for the information formats, milestones, sequences, and timing for smoother project execution.

Mike notes that many of the decisions for standards and responsibilities are made during Front End Engineering Design (FEED) phase. These have major impact on the data exchange processes during project execution. Their recommendation is to set the communications rules during this phase of the project and confirm all the data sources and predecessors.

The key is to designate a single coordinator for all data exchange. This person establishes the data exchange standards including: data types, formats, media, due date, supplied by, supplied to, risks. A database application with milestone alerts can help to issue project controls for completion and near term due exchange alerts and all long term milestones.

When on a project with a new process or process technologies, Mike and Jim recommend testing to avoid surprises. Split this work into two phases with the first phase, a thin slice phase and the latter, the main phase. The thin slice phase lets you test new hardware, control strategies, and/or communications to discover surprises. This testing helps avoid committing your entire project to the new technology and avoid assumed methods of engineering and implementation without assessing how it will work.

Mike and Jim show examples of how this applies in integrating process units and process skids using serial and digital bus-based communications and taking advantage of software tools like Intergraph's SmartPlant Instrumentation to manage this project data flow.

Mike notes that it really boils down to early involvement in the FEED phase of these MAC projects where it is critical to plan these well-executed data hand-offs.

At the recent conference, Implementing Manufacturing Execution Systems in the Pharmaceutical and Biotech Industry, Emerson Senior Vice President John Gardner presented with DMI International's Bob Schiros a paper on Integrated Recipe Authoring on the first day of the conference. John is the general manager for the Life Sciences, Food and Beverage, Pulp & Paper, Energy, Metals and Mining industry organizations.

The thrust of their presentation is that manufacturers need to integrate their existing "functional islands". Today people want to get information easier, but that's just the tip of the iceberg. Integrating and simplifying the management of documents, personnel qualifications, equipment and material, work activity, automation, various plant floor systems, etc. is where the real operational benefits occur.

John stresses the place to begin is to analyze the causes of deviations in these areas. Eliminating these deviations provides the potential operational improvements at the heart of your business case for change. These areas of opportunities should be broken into manageable phases.

Gaining executive sponsorship for the changes is critical since people and processes are likely impacted, and organizational inertia tends to resist changes.

For pharmaceutical and biotech manufacturers, the opportunity comes in reducing the cost of goods manufactured. John stresses the place to begin is to analyze your current functional operations and the causes of deviations in these areas. This will lead to better inventory and yield management, lower regulatory compliance costs, and reduced product release times. John stresses the place to begin is to analyze your current functional operations and the causes of deviations in these areas. Focusing on eliminating these deviations is the most immediate potential improvement and that's at the heart of your business case for change. These areas should then be broken into manageable phases.

John believes the key is to start with the low hanging fruit which is to have a structured integrated recipe authoring process. The process starts by disassembling the recipe into its components: personnel, materials, equipment, data, and documents. These components are optimized and a database of reusable objects is created. Now the recipe can be reassembled with the optimized components and made available for execution of the batch with its associated electronic batch record.

The Emerson Life Sciences industry experts use the manufacturing execution system (MES) software product, Compliance Suite, as a platform to help manufacturers achieve this structured approach.

The presentation highlights measurable results which have been achieved including 40-70% reduction in batch record complexity, 30-50% reduction in product release cycle times, 20-40% reduction in documentation authoring and approval cycle times, and up to 40% reduction in errors, omissions and deviations of operational data.

An interesting paper was presented recently at the Honeywell User Group (HUG) meeting as captured by Pharmaceutical Manufacturing magazine's On Pharma blog. The post, Abbott dispels MES myths (Notes from HUG II) is interesting for the $1.3 Million USD estimated annual savings from applying Manufacturing Execution System (MES) software.

Why I make particular note of this project is that it was accomplished with the help of Emerson Life Sciences expertise in deliverying ANSI/ISA-95 (S95) solutions.

I caught up with Principal Engineer, Josh Gangl in our Life Sciences / Food and Beverage industry organization who was involved in this project. The selected MES software, POMSnet, was integrated by Josh and the team with the plant's DeltaV Batch system.

As the On Pharma post notes:

For Abbott, the MES was a critical aspect of its pursuit of an integrated and paperless environment.

As Abbott's David Kircher noted in the On Pharma post:

The customizations we did were related to integrations and custom reports, but everything else was out of the box.

Highly regulated industries like those in which Life Sciences manufacturers operate need efficient solutions manage and properly document their production and use of materials in the manufacturing process.

The production process usually includes both manual and automated operations. The automated part is typically controlled with process control systems with batch software like the DeltaV system.

I spoke with Principal Engineer Todd Ham who coauthored a paper with Senior Technologist Dick Seemann, both in our Life Sciences industry organization. The paper, A Model for Integrating Material Management in a Production Environment, was presented at a past ISA Automation West Conference.

The paper generically describes a solution that Todd and our Life Sciences industry experts implemented at a biotech manufacturing facility. A manufacturing execution system managed the materials for manual parts of the operation.

Todd said the key to the solution was defining an integrated material management model which included support for the processes: batch campaign creation, raw material weigh-and-dispense, manual material charges, and automated material charges.

In their solution, the first step is campaign and batch creation. A unique campaign ID is established which all material information related to the campaign will connect. Also the batch report manager in the process control system can access this campaign ID, to bring in all the material information into a complete electronic batch record, needed for the release of final product. This information is included with the batch history, alarms, events, operator actions, and other data collected by the process control system.

Todd describes a manual weigh-and-dispense operation. An operator logs into a handheld personal data terminal/barcode reader. The system checks and verifies that he has authority and the up-to-date training to perform the weigh-and-dispense procedure. The operator selects the campaign, is presented with the appropriate and available weigh booths, and scans a weigh booth ID barcode. Next the operator selects an intermediate batch container which has been verified by the system as being the correct size, being clean, etc.

With everything properly validated the operator selects from a list of materials presented on the handheld device connected to the warehouse inventory system. Once the material has been retrieved and barcode scanned it is validated for expiration dates, lot numbers, and any other required quality measures. The operator dispenses and confirms the measured weight within the allowed tolerances.

A label containing all this information, as well as an electronic copy for the electronic batch record is available for the production environment. Similar integrated material management processes are available for manual material charging, automated material charging, and the creation of the batch report.

These integrated manufacturing procedures provide enforced compliance for the manual production activities. And overall cycle times can be reduced since the records captured from these procedures are available in the overall batch record instead of collecting and signing off papers after the fact.

I've shared in earlier posts in the data management category, how process manufacturers are looking at their work processes including the information flows to become more responsive their customers. Although my earlier examples were North American, the need is global.

I caught up with Bas Mutsaers in our Rijswijk office in the Netherlands. Bas leads a team of 10 MES/Integration engineers for projects in Europe, the Middle East, and Africa. The folks on his team average five years of industry and application experience.

As a result of their project work, they have expertise in applying the ISA S95 and S88 standards, as well industry guidelines and regulations like GAMP, the U.S. FDA's 21CFR Part 11 and MESA.

Bas said that many of the process manufacturers that have applied Emerson's PlantWeb architecture integrate other components on the plant floor from other automation suppliers. By integrating these in a standard way with their scheduling and planning systems using the standards available, the real benefits start to show for the manufacturer's operations group. By using OSIsoft's RtPM software for their other applications connected to their manual processes, their maintenance and quality systems as well as hundreds of other standard applications can be integrated with this supported software platform.

The new PI Protocol Converter product from OSIsoft connects the embedded DeltaV Continuous Historian with OSIsoft client applications like PI Process Book, PI DataLink, PI ActiveView, and PI RTPortal, making the information from the manufacturing process to various people throughout the organization to improve decision making and work flow. Bas' group has built many reusable tools for the many industries Emerson Process Management serves. These include mass balance calculations, nomination tools, emission tools, and standard production reports.

These connections provide the basis for the flow of information about inventories, continuous processes, batch processes, and packaging areas to the scheduling and planning systems to more quickly and efficiently respond to demand. Bas and his consultants develop solutions based upon work processes the process manufacturer is seeking to improve.

The real benefit begins when planning systems are connected to the plant floor and possible schedules are made based on the information in intelligent devices that are often part of the more critical loops. The protocol converter also can connect to the OSIsoft Enterprise Server which integrates a broader range of applications.

Bas believes a successful data management project includes the following elements:

• The right answers are not always found in the technical tools that are under the hood.
• Success lies in the experience working with the various technologies in the field and by applying the knowledge of working processes together with the manufacturer's vision. Bas calls this the recipe for success.
• Implementing the recipe for success requires a team consisting of at least 4 functions: technical architects, current or future users of the solution, experienced Emerson and manufacturer project managers to keep the team focused on the vision, milestones, and scope changes. A sponsor with a vision knows where the opportunities to generate real business results exist.

The people provide the basis for the flows of information about inventories, continuous processes, batch processes, and packaging areas to the scheduling and planning systems to more quickly and efficiently respond to demand. By automating the critical processes in such a way these efficiencies can be realized.

Emerson has worked for more than a decade with OSIsoft starting first with embedded technologies and then in forming an alliance to provide integration services around the world. The demand for these services has continued to grow, with integration teams now in Canada, Malaysia, the Netherlands, Singapore, the United Kingdom, and the United States.

Process manufacturers are pressed by their shareholders to improve their return on assets. To do this, they must get more out of their plants, people, and systems to respond more quickly to their customer requests than their competitors can respond. This response time can be the difference needed to avoid commodity pricing.

So how are manufacturers integrating their businesses to become more agile and more predictable? It starts by better linking your enterprise resource planning systems to your plants. According to SAP AG's Global Director of the Chemical & Pharmaceutical industries from a 2005 ARC Forum:

If you install SAP for traditional ERP functionality but don't link to your Plants, you leave about 40 to 60% of the benefits on the table.

Gary says first and foremost, companies need to see this process as a journey. It's much more than point-to-point integration between business and automation systems. Since the impact is on people and existing business processes it requires high-level leadership within the manufacturer. Groups that traditionally have been very separate like Information Technology and Engineering must get on the same page for significant business results to be achieved.

Once on the journey, Gary stressed the key areas to get right around the improvement of manufacturing automation is the data model and the process model.

The data model identifies the capabilities and business functions required at each connection point between the ERP system including: inventory management, production control/scheduling, quality management, and plant maintenance with the automation level including: process control systems, OEM/skid-based systems, batch systems, process historians, and the plant floor relational database.

The process model defines the flow from customer order and/or order forecast back through the business process defining the dependent requirement required to meet the packing schedule. The storage locations contain the physical work-in-process inventories from raw materials to the finished product ready for shipment.

Gary summed up what makes a successful project as strong leadership/vision, a well thought out architecture, and picking the right pilot project looking at factors such as availability, capability of resources, and the ability to execute. Once the learning and benefits can be measured versus the critical success factors, the deployment can roll out more broadly to other plants using the same architecture, infrastructure, and data model.

As competitive pressures drive process manufacturers to run their processes more efficiently, a key area of focus is to improve the management of data from various sources. Better, more timely decisions come from better data.

I spoke with one of our Life Sciences/Food & Beverage industry senior manufacturing consultants and data management experts, Gary Silverman about this need to consolidate and migrate data. He cited several reasons for this:

• Updating a historian and/or operating system because it's no longer supported by the original supplier
• Needing to consolidate data from multiple process automation system platforms and other data sources into a single enterprise historian
• Changing business needs requiring broader dissemination of information from the manufacturing process to plant and corporate personnel with web browser-based technologies.

One example Gary cited was a DeltaV system upgrade project where an AIM/Bile Historian with 9 years of process data collected from a PROVOX system needed to move to an OSIsoft PI historian. The finished solution collected data from the new DeltaV system, PROVOX and utilities programmable controllers. Emerson is an OSIsoft Platinum Partner as a provider of data management and integration services.

The data management team had developed automated tools and methods to extract the AIM tag database, create the PI tag database and migrate this vast amount of data. The team also built a Process Module Database to streamline the implementation of the OSIsoft RtPortal/WebParts technology. The Portal allows operators, aupervisors or engineers to quickly spot problems and then use ProcessBook and/or DataLink to drill down for in-depth analysis. The Portal also provides a central repository for Shift Logs, Operator Logs, etc.

Another key need was being able to perform batch-to-batch analysis with data from over 70 reactors and make comparisons of critical process parameters to discover any deviations from the best or "Golden Batch." PI Batch configuration and the PI Batch Client Tools provided the customer with a means to do this. They were also able to monitor and improve cycle times as a result of this analysis. In the end the project achieved its objectives to modernize the existing technology disseminate information more broadly and provide critical data in Batch context for continuous improvement.

Given the high interest in having better information to help plants run more efficiently, I'll be checking back with Gary and other data management experts from time to time.