Batch Manufacturers Require More Robust, Dock-to-Dock Control Systems

By John Blanchard

ARC STRATEGIES

MAY 2003

Batch Manufacturers Require More Robust, Dock-to-Dock Control Systems

Executive Overview ......................................................................3

The Batch Manufacturing Landscape ...............................................4

Standards & Regulatory Compliance Are Key to Success in

Batch Manufacturing.....................................................................7

Key Batch Control Standards and Guidelines....................................7

US FDA Ruling 21 CFR Part 11 .......................................................9

Product Genealogy Requirements ................................................. 11

Change Control Requirements...................................................... 13

Enterprise Optimization for Batch Manufacturers ............................ 14

User Survey: Batch Control System Requirements......................... 16

User Prioritized Functional Requirements ............................................ 17

Recommendations...................................................................... 21

THOUGHT LEADERS FOR MANUFACTURING & SUPPLY CHAIN

ARC Strategies • May 2003

2 • Copyright © ARC Advisory Group • ARCweb.com

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Prioritization of User Requirements for Batch Control Systems

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Standards Enable Enterprise Asset Optimization


Copyright © ARC Advisory Group • ARCweb.com • 3

Although batch control systems still

lack some required functionality,

users can now develop an

automation strategy that meets

current and future business needs

using standards-based products that

are not limited by technology.

Executive Overview

Aware of the many choices in products and services, the consumer is con-scious of product price to value and demanding increased product quality, safety, variety, and convenience. Most industries with batch manufactur-ing processes are consolidating, requiring fewer plants to produce an increased variety of products.

To survive, businesses that employ batch control processes must maximize return on their assets while satisfying constantly changing consumer de-mands. New government regulations continue to increase business costs. Business and manufacturing process automation and integration have be-come critical to business success.

While the functionality and standardization of com-mercial off-the-shelf batch control systems has increased dramatically in the last few years, they still lack functionality needed to meet current and future business requirements in the fine chemical, pharma-ceutical, food, and beverage industries. Standards have been rapidly evolving and suppliers continue to increase functionality needed to meet user business

requirements. Manufacturers in these industries can now develop an automation strategy to meet current and future business needs using stan-dard products based on standards and not limited by technology.

Key success strategies for batch manufacturing enterprises to achieve and maintain competitive advantage include:

• Develop and deploy global standards • Deploy commercial off-the-shelf batch control systems and products • Evaluate and prepare to meet dramatically increased regulatory re-

quirements • Develop an automation strategy that does not limit future options or

alternatives • Make business to manufacturing systems integration a collaborative

decision process that ensures the needs of all organizations are met



The Batch Manufacturing Landscape

It is estimated that over seventy-five percent of all manufacturing plants have some batch manufacturing processes. Most of these batch processes are not as automated as the traditional continuous and discrete process segments. There are several major reasons for this lack of automation. Traditional PLC suppliers saw economic benefit in fulfilling the needs of discrete industries such as automotive and heavy machinery. Traditional DCS suppliers saw economic benefit in fulfilling the needs of the continu-ous process industries such as refining and petrochemical. The needs of enterprises with batch processes, such as those found in the chemical,

pharmaceutical, food, and beverage industries, were largely ignored because batch processes were more difficult to automate, required a mixture of both manual and automatic proce-dures, and generally provided less economic incentive to users and suppliers.

Today, there are tremendous economic incen-tives and regulatory pressures driving automation of batch process operations. New technology and standards are emerging to ad-dress the needs of batch manufacturing. Automation suppliers are responding with new products, services, and restructured organiza-

tions to support this market segment. Today, manufacturers with batch processes have significant opportunity to influence automation suppliers.

Characteristics of Enterprises with Batch Processes

A significant amount of manufacturing in the chemical, pharmaceutical, food, and beverage industries is composed of batch process operations. These industries and manufacturing processes are sometimes called “hy-brid.” They represent the largest segment of the batch control market, followed by paper, personal health care, mining, and metals industries. In fact, there are batch process operations in almost every industry.

A typical batch manufacturing operation has a process section as well as a discrete section. The processing section usually contains some mixing or filling, weighing, blending, cooking, reacting, or other similar operations.

Batch Manufacturing Processes Are Typically Associated with the Hybrid Industries

Discrete

Continuous

AutomotiveAerospaceElectronicsMachinery

TextilesFine ChemicalsPharmaceuticalFood & Beverage

Soaps & CosmeticsMining & Metals

Pulp & PaperWater & WastePetrochemicals

PowerRefiningOil & Gas

Discrete

Hybrid

Continuous



The manufacturing process also contains a significant amount of packaging equipment for applications such as bottling, flow wrapping, cartoning, la-beling, palletizing, weighing, inspection, robotics, bagging, and materials handling. Packaging is usually a significant part of the “product,” a part of product safety and convenience delivered to the customer, and a part of the product marketing appeal.

In this diverse mixture of batch, continuous, and discrete operations, manu-facturing automation is still not well integrated. This has limited the visibility of data between operating departments and prevented enterprise–wide optimization.

Changing Business Environment

Internet technology, e-commerce, and product globalization are changing the way business must be conducted. Power has shifted from manufactur-ers and their mass marketing of a limited number of products to consumers

and mass merchandisers. The modern consumer expects more consistent product, while demanding increased qual-ity, variety, and convenience. The consumer is value and safety conscious. It takes more effort for manufacturers to maintain brand value and minimize brand risk. Sales and marketing are no longer the bottleneck to growth. Manu-facturing and its responsiveness, or lack thereof, is now the bottleneck to growth and business performance.

As industry consolidation continues, fewer plants exist. These remaining plants are required to produce an increas-ingly complex mix of products while continuing to reduce costs. This requires maximizing the utilization of limited financial, physical, and human assets. The ability of com-panies to utilize innovative technology and maximize manufacturing flexibility will be a strategic advantage. Suppliers are increasingly becoming an integral part of a company’s internal organization and are expected to con-

tribute to improvement rather than just execute on an order or project specification.

Consumer demands for increased product quality, safety, variety, and

convenience

Less brand loyalty and increasing brand risk

Fewer plants manufacturing a more complex mix of products

Increasing margin pressure from business globalization

Growing lack of technical resources

Increased use of third party services

More alliances with a limited number of technology suppliers

Increased government or regulatory requirements

Industry Trends Impact Batch Manufacturing



The Batch Control Systems Market

The chemical, pharmaceutical, food, and beverage industries represent over 75 percent of the current batch control systems market. Batch control sys-tems represent almost a third of all process automation systems sold annually to the chemical industry, but the percentage of batch processes in this industry is much higher. Batch control systems represent 57 percent of all process automation systems sold annually to the pharmaceutical indus-try. This higher percentage is to be expected in an industry with a significant amount of batch processing.

Most manufacturing operations are made up of both batch and continuous operations. All industries have non-batch process automation in areas such as power and steam generation and waste treatment. The statistics for the pharmaceutical industry might lead to the conclusion that this market has limited additional potential. While the bulk active ingredients plants are usually highly automated, the intermediates plants are not as well auto-mated. In addition, the impact of US FDA ruling 21 CFR Part 11 will fuel

further growth of newer, more capable batch control systems. With limited in-house technical resources and limited supplier resources, manufacturers in these industries have a growing need for more ro-bust, easy to use and maintain, commercial off-the-shelf (COTS) batch control systems. Users in these industries are also adopting standards such as Ethernet, ANSI/ISA-88/IEC 61512, and ANSI/ISA-95/IEC 62264 as well as the OMAC PackML State Model and intelligent fieldbus technologies.

Batch control systems represent only 10 percent of all process automation systems sold annually to the food & beverage industry, even though this industry is dominated by batch processing. Users in this industry indicate that they are aware of the ANSI/ISA-88 (IEC 61512) batch control standard and have evaluated currently available batch control systems. Their con-clusions are that current systems require increased functionality and ease of use to be justified and to fulfill the needs of their manufacturing operations. They have further indicated that users and suppliers need more collabora-tion so that enhancements to batch control systems can be determined and prioritized based on user business needs. It is therefore no surprise that users are forming key global alliances with a more limited number of sup-pliers.

Industry

S88 Percentage of Total Systems

Purchased

Chemical 28.8

Pharmaceutical 57.0

Food & Beverage 10.0

ISA S88-Based Batch Control Systems Account for Differing Shares

of Total Purchases by Industry



Manufacturers with batch process

operations are adopting standards

such as industrial Ethernet,

ANSI/ISA-88/IEC 61512, ANSI/ISA-

95/IEC 62264, OMAC PackML, and

intelligent fieldbus technologies.

Standards & Regulatory Compliance Are Key to Success in Batch Manufacturing

Standards have been in existence for many years. At one time they were considered of limited importance to the enterprise and full of tedious tech-nical jargon. In today’s world of global commerce and Internet technology, standards are considered essential to improving business performance and achieving competitive advantage. Interest in standardization has expanded from the engineering offices to the executive offices.

Standards can help reduce costs, increase efficiency, increase manufacturing flexibility, ensure more consis-tent product quality, reduce time to market, and provide improved response to consumer demands. In a recent ARC survey, users indicated that the most im-portant business benefit to applying ISA S88/IEC 61512 standard methodologies is increased manufacturing

flexibility. This was reinforced by additional user comments on its impor-tance in reducing the time to market of a new product launch. This was followed by more consistent product quality, reduced engineering costs, increased manufacturing efficiency, and reduced maintenance and operat-ing costs. Another important benefit noted by pharmaceutical industry users was a consistent applications engineering approach from plant-to-plant to facilitate audits by regulatory inspectors.

Key Batch Control Standards and Guidelines

Several types of standards exist. De facto standards such as the Microsoft Windows operating system make users dependent upon a supplier. Formal standards developed through standards agencies such as ISA and IEC are supplier independent and intended for use by all suppliers to promote an interoperable multi-supplier environment.



ANSI/ISA S88 (IEC 61512)

The ANSI/ISA-88 (IEC 61512) batch control standard contains three sec-tions. Part 1 defines standard terminology and a number of models for batch control. Most major suppliers have adopted standard terminology and are designing batch control systems with a modular set of functions

and hierarchy based on the Control Activity Model. Part 2 is in three parts: data models, information exchange ta-bles, and procedure function charts. Procedure Function Chart (PFC) notation addresses procedural control and execution. Part 3 defines General and Site Recipes. This recipe structure provides a common way to identify pro-duction capability and ensure more consistent product quality.

ANSI/ISA S95 (IEC 62264)

ANSI/ISA S95 (IEC 62264) is the enterprise to control system integration standard, which contains three sections. Part 1 provides standard termi-nology and a consistent set of concepts and models for integrating control systems with enterprise systems. Part 2 further defines the object models described in the Part 1 of the standard by adding attribute definitions and examples. Part 3 defines models for the disparate collection of activities that must occur in manufacturing operations for effective and efficient manufacturing. The goal is to provide manufacturing companies with a common language to describe requirements to vendors and let companies compare alternate architectures and solutions.

OMAC Packaging Workgroup PackML

PackML (Packaging Machinery Language) is an initiative sponsored by the Open Modular Architecture Controls (OMAC) Packaging Workgroup to develop common conventions and definitions for common terminology in the packaging industry. Currently only a guidance, PackML has developed a state model that is similar to the one specified in Part 1 of the S88 batch control standard. It will help provide greater visibility regarding the state of packaging machinery in plant operations.

ANSI/ISA-S88 (IEC 61512)

ANSI/ISA-S95 (IEC 62264)

WBF B2MML Schema

OMAC PackML

IEC 61131-3

Key Batch Control Standards and Guidelines



World Batch Forum B2MML

B2MML, or Business to Manufacturing Markup Language, is a set of sche-mas developed by World Batch Forum (WBF) based on ANSI/ISA-95.00.02–2001 Enterprise/Control System Integration standard. B2MML schemas are organized to align with the ISA-95 standard’s data models. These include common personnel, equipment, maintenance, material, proc-ess capability, process segment, product definition, production schedule, and production performance. ARC believes that standard schemas devel-oped by WBF will be of significant benefit to batch manufacturers because they will make integration of disparate business and control systems easier.

IEC 61131-3

The IEC 61131-3 standard is intended to provide general programming compatibility between different brands of PLCs. The standard can also be applied in the DCS environment to similar advantage. It defines four lan-guages - Instruction List, Structured Text, Ladder Diagram, and Function Block Diagrams. However, common user requirements specifications (URS) must still be developed.

US FDA Ruling 21 CFR Part 11

Maintaining product genealogy records has been a major business and regulatory requirement in the food, beverage, and pharmaceutical industry for many years. This is in part because their products have a dramatic ef-fect on the health and safety of a vast number of people; and product recalls are common in these industries. Such records minimize the economic im-pact of a recall and help ensure that safe product is delivered to the consumer. The movement to electronic government needed to meet the challenges of the 21st century is producing dramatic new regulatory re-quirements and enforcement actions regarding electronic records and electronic signatures. The cost of meeting regulatory requirements contin-ues to increase, while new regulatory enforcement actions and fines are creating additional business risk.

US FDA 21 CFR Part 11 is becoming the criteria upon which product qual-ity or genealogy records functional requirements are being defined. Enacted in 1997, it stipulates requirements for creating, maintaining, archiv-



Change control has become one

of the most complex and difficult

aspects of regulatory compliance

in the pharmaceutical industry.

With the June 2002 enactment of

the US Public Health Security and

Bio-terrorism Response Act, Part 11

will likely impact most segments of

the food and beverage industry

sooner than anticipated.

ing retrieving, and transmitting electronic documents and includes criteria for consideration of electronic signatures to be the equivalent of full hand-written signatures. These genealogy or traceability records also include requirements for determining and documenting any corrective and

preventative actions (CAPA). It applies to all indus-tries regulated by the FDA under the US Food, Drug, and Cosmetic Act.

Part 11 is currently having dramatic impact on the global pharmaceutical industry and its automation and services suppliers. With the June 2002 enactment of the

US Public Health Security and Bio-terrorism Response Act, Part 11 will likely impact most segments of the food and beverage industry sooner than had been anticipated even as interpretation and enforcement policies con-tinue to evolve. This includes the recent change in interpretation of the number of records which fall under Part 11 requirements as well as the new FDA enforcement discretion policy. It should be recognized that traceabil-ity includes change control procedures and documentation and that change control, as defined by the FDA, is not designed into the core functionality of current batch control systems.

Standards-Based Project Engineering Tools

Implementation and maintenance are increasingly becoming the major part of a batch control system’s total expenses. The tasks involved in a control system implementation include writing functional specifications, generat-ing control code, configuring HMI, simulating control code for testing and operator training, and managing changes after implementation. In fact,

change control has become one of the most complex and difficult aspects of regulatory compliance in the pharma-ceutical industry.

With the increased acceptance of standards such as IEC 61131-3 for PLC programming and ANSI/ISA-88 Part 1

and 2 (IEC 61512) for batch, control and software architectures are becom-ing similar from project to project. This has given impetus to third party suppliers to develop packages that help configure and maintain control software. There are now a number of independent suppliers in this market, including SPEC-Soft, Neumaflo, and ControlDraw.



Product Genealogy Requirements

Most enterprises today are dependent on a few major product brands. A key business strategy is to extend the product line under these brand names. While maximizing brand value has always been a key business strategy, minimizing brand risk has now become just as important. Risk is now a major part of the financial equation. Product genealogy records play an important part in assuring the delivery of quality, safe product to the consumer. With global procurement, manufacturing, and product delivery, the effort required to ensure delivery of quality, safe product to the con-sumer has increased dramatically.

FDA ruling 21 CFR Part 11 was promulgated to help ensure the authentic-ity, integrity, and in some cases the confidentiality of regulated electronic records to ensure public health and safety. Its immediate impact is on the pharmaceutical industry, but it is becoming the criteria upon which prod-uct quality records or genealogy records functional requirements are being

defined globally. Such strict standards are required to meet the challenges of business globalization and world-wide trade and communications in the 21st century.

Disease, corruption, and terrorism have global impact. They cannot be isolated to small geographic areas as they had been in the last century. As a result, the general population now recognizes need for im-proved and more secure electronic traceability records as well as the additional

cost associated with them. The June 2002 US Public Health Security and Bio-terrorism Response Act will have significant impact on e-records re-quirements in the food and beverage industry. It requires every business involved in the production and distribution of food products and ingredi-ents to maintain upstream, in-process, and downstream product traceability records by the end of 2003, regardless of whether the FDA has issued any additional regulations or guidelines. It also shows how fast regulatory requirements change, since such decisions are based on public health and safety risk evaluations.

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Global Procurement and Distribution Are Increasing the Need for Traceability Records



ARC believes that the Batch

Record Specification currently

being drafted by the ISA-SP88

committee will provide the model

for a rigorous set of electronic

product traceability records.

Ensuring the quality and safety of products is a top priority of manufactur-ers in the pharmaceutical, food, and beverage industries. Most of these industries are also highly regulated because their products have such an impact on public health and safety. Product recalls are common and often go unnoticed, as most do not pose a serious threat to public health. How-ever, unsafe products do occasionally reach consumers, requiring tremendous efforts in identification and recall. That includes detection of the source of the problem and identification of additional products that might be tainted. Manufacturers expend great efforts to protect product brand value and reduce brand risks because a single product recall has the potential to destroy a brand. Coca Cola’s share price dropped dramatically after it recalled 2.5 million bottles in Europe. More recently, Cargill joined the list of meat packers battered by food-safety mistakes, sharply expand-ing its recall of ground beef from 416,000 pounds to 2.8 million pounds.

Rigorous product genealogy or traceability records help ensure delivery of safe products to the consumer, identify unsafe products as quickly as pos-sible, minimize the threat to public health, and reduce the financial impact on the manufacturer. However, developing and maintaining electronic product traceability records in today’s world of global sourcing and prod-uct distribution requires information from many sources and systems.

Traceability requires rigorous data collection, maintenance, and retrieval functionality, as well as integration between different control systems. User requirements for batch control systems identified improved traceability re-cords as a top user priority, coupled with improved data collection and

material tracking. These functions should also be able to ensure the integrity, security, and confidentiality of such records in order to meet regulatory requirements.

ARC believes that the Batch Record Specification cur-rently being drafted by ISA-SP88 committee will provide the model for a rigorous set of electronic product trace-

ability records. ARC also believes that batch control system suppliers must enhance the functionality of their systems to support multi-supplier archi-tecture for electronic records systems.



Batch control system suppliers

must add rigorous change control

functionality with object level audit

trails to meet the requirements of

US FDA 21 CFR Part 11.

Change Control Requirements

Already one of the most highly regulated industries in the world, US FDA ruling 21 CFR Part 11 has placed additional burden on the pharmaceutical industry in terms of electronic records requirements for currently installed systems and all future systems. This ruling and similar rulings are affecting other regulated industries such as food, beverage, and fine chemicals.

In the pharmaceutical industry, applications and infrastructures of systems that affect product quality as defined by predicate rules and particularly the Good Manufacturing Practices (GMPs) must be validated to achieve regula-tory compliance. This validation process includes installation qualification (IQ), operational qualification (OQ), process qualification (PQ), and a life cycle change control process. In terms of batch control systems, both appli-cation software and the standard hardware-software infrastructure that supports it must have a life cycle change control process.

Change control is also a good business and engineering practice. It has well-defined protocols for paper-based record systems. Whether in regu-lated or non-regulated industries, it is designed to ensure product safety and quality, data integrity, authenticity, and confidentiality. In the phar-maceutical industry, this also includes product efficacy. The financial services industries are some of the leading adopters of electronic records systems with change control and object level audit trails. This functionality is relatively easy to accomplish in these systems because they are single dimension transactional systems, although improvements in security and confidentiality are still needed. In addition, such functionality does not

usually extend to transactions that originate outside a single company’s system.

Change control in manufacturing process control sys-tems is more difficult to accomplish because it is a complex multi-dimensional process, and suppliers are

just beginning to develop needed functionality. To meet the needs of the pharmaceutical industry, batch control system suppliers must add rigorous change control functionality with object level audit trails to controller and HMI configuration records. It will be more difficult to achieve this with the HMI than with the controller configuration records. Currently it is not pos-sible to segregate quality objects from other objects within each of these databases, which makes the entire database subject to electronic records



requirements for change control and audit trails. Such audit trails must also ensure prompt notification of any authorized or unauthorized change to the appropriate authority. This requires continuous real-time change monitoring. There are several approaches, either a mixture of manual and automated procedures or fully automated functions. Suppliers should evaluate which approaches best meet their users’ requirements. Finally, it must also be determined if such changes require any level of process re-validation.

System infrastructure requires change control, but replacing “like with like” IQ and OQ qualified equipment requires a very simple audit trail. These changes should not require any re-validation or review to determine if re-validation is needed.

Enterprise Optimization for Batch Manufacturers

To maximize return on assets (ROA), manufacturing companies will be op-timizing not only their production plants but also their enterprise and supply chain domains. It is no longer sufficient for an enterprise to have islands of automation along with isolated supply chains. To maximize the potential of batch production, manufacturing plants and supply chains need to work together in an optimized fashion. In this new environment,

manufacturing will continue to maintain its central role, but en-terprise-wide optimization of production facilities and supply chains are going to be increas-ingly important for maintaining the bottom line.

Process Plant Optimization

Facilities for optimization of continuous processes based on rigorous mathematical and empirical models have been in use in chemical industries for quite some time. However, these techniques are somewhat limited in their applicability to batch production. Suppliers should provide more fa-cilities to optimize batch production processes using rule-based techniques.

Benefits Challenges

Lower business cost Flexible production facility

Extended global reach Transaction security

Faster customer response Facilities for faster shipments

Made-to-order manufacturing Change in corporate culture

Benefits and Challenges of Batch Optimization



In a typical manufacturing company, different models are used for produc-tion design, optimization, operator training, and batch execution. Significant effort is required to build these models. Batch control system suppliers should provide facilities for generating a single model or facilities for transformation from one model to another without significant effort

Enterprise-Wide Optimization

Manufacturing enterprises are beginning to understand their manufactur-ing requirements, their business needs, and the relationships between them to create viable integration strategies. Suppliers can help manufacturers by offering viable facilities for information exchange between business and process automation systems, which may range from simple production schedules to elaborate quality, inventory, and production management in-structions.

Effective integration of these two worlds re-quires significant technical, educational, and planning efforts. The General and Site Recipe concepts in the batch control standards and the ISA-95 standard are conceptually helping the integration, while XML and component technol-ogy are the main enablers. Today, integration of process automation and business systems are mostly done on a custom basis to solve specific problems. Suppliers should start offering stan-dards-based integration products.

Supply Chain Optimization

Understanding supply chain types is an important step in supply chain op-timization. Some industries are procurement intensive. Others are manufacturing or distribution intensive.

Specialty chemical, pharmaceutical, food & beverage, and consumer prod-ucts constitute a majority of the batch processes. Specialty chemical and pharmaceutical industries fall between the manufacturing-intensive and distribution-intensive areas, whereas food & beverage and consumer prod-ucts are mostly distribution-intensive. Therefore, batch control system

Batch Manufacturing and the Supply Chain

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ARC recently conducted a user

survey to identify and

prioritize user functional

requirements for a more

robust batch control system.

suppliers need to provide facilities for optimization of supply chain in both the manufacturing and distribution areas.

User Survey: Batch Control System Requirements

ARC recently conducted a survey to identify and prioritize functional re-quirements for batch control systems. This included functionality not currently provided by batch control systems and enhancements to current

functionality. To qualify responses, respondents were asked how familiar they were with ANSI/ISA-88/IEC 61512 (S88) and ANSI/ISA-95 (S95) standards. ARC asked additional questions such as the number of current standards-based systems deployed and the importance of such functions as change control, enhancement of the batch historian, stan-

dard library of control modules, and library of common phases. User re-sponses were segregated from supplier responses for evaluation. The survey also compared the differences between user and supplier responses.

The largest number of user responses came from the chemical industry, fol-lowed closely by pharmaceutical, food & non-alcoholic beverage, and alcoholic beverages. All those in the “other” category identified their in-dustry as consumer products. User company size ranged from those with a few plants to companies with over one hundred plants. User deployment of S88-based batch control systems ranged from few to over 75 percent of their applicable processes.

Summary Results

Results of the survey indicate that users require more robust commercial, off-the-shelf batch control systems to meet their business requirements. Further, many larger companies cannot justify replacing home grown sys-tems because off-the-shelf batch control systems lack some required functionality, such as robust change control and integration with other en-terprise applications such as materials handling, order management, and warehouse management.



Users indicated that they require many functional enhancements to cur-rently available systems and that several of these functional requirements were considered critically important in addressing their business require-ments. Users as a whole indicated their top priorities were closely-coupled ease of use tools for engineers and operators. This was followed by the whole issue of complete genealogy or traceability records, system-wide change control, and increased functionality such as batch execution at the controller level.

Every pharmaceutical industry user indicated that change control was their top priority and critically important, followed by data collection and stor-age that could meet the requirements of US FDA 21 CFR Part 11. Some users indicated a need for improved integration among batch software modules and other enterprise applications. Others indicated a need for data to go directly to a relational database rather than to a flat file. Finally, several users indicated a need for better dock-to-dock coordination and equipment utilization optimization.

User Prioritized Functional Requirements

In this ARC survey, users were asked to prioritize twenty batch control sys-tem functions on a scale ranging from 'not important' to 'critically

important'. For further clarification, users were also given the opportunity to comment on any additional functional enhancement they considered important. These functional requirements were later grouped into four categories: loose-coupled engineering tools, close-coupled engineering tools, server level management & control functions, and controller level management & control functions.

Loose-Coupled Engineering Tools

The need for loose-coupled engineering tools includes tools to covert P&IDs to code, tools to convert P&IDs to user re-quirements specifications, and tools to convert General and Site recipes to Master recipes. These types of tools are being offered by third parties like Neumaflo, SPEC-soft, and Con-trolDraw. Although some users are requiring such tools in

• Robust, secure e-signature capability

• Integration with other enterprise applications

• Standard design and system development methodology

• More reliable batch server

• Batch data directly to relational database

• Improved routing and equipment utilization optimization

• Link to safety systems

• Improved operator prompting and ease of use

Users Surveyed Mentioned a Number of Additional

Functional Requirements



their bid specification, users indicated loosely-coupled engineering tools were a low priority compared to the other functional categories. Most users also indicated that the change control functionality in these loosely-coupled engineering tools does not meet the business or regulatory requirements.

Close-Coupled Engineering Tools

The need for closely-coupled engineering tools includes, in order of user priority: a standard library of control modules, a standard library of equipment modules, a better integrated view of batch control for the opera-tor, a set of common phase structures, and a common library of HMI objects. Users indicated a need for a better integrated “operational” view of batch control that would be aligned with the needs of a typical operator on the plant floor. For example, some users do not want operators to see phase execution. Others wanted the operators to observe simultaneously

the state of several batches on a single screen to manage them effectively. Users also indicated a need for a common set of objects, phases, and modules across all suppliers’ systems, not just within a single supplier’s system. A user in the pharmaceutical industry stated that these latter functional requirements were needed for “presen-tation of a somehow accepted standard to inspecting authorities” (FDA).

This category of functionality is more closely asso-ciated with supplier development efforts. It also requires more collaborative effort between users

and suppliers as well as among suppliers themselves. This category and its three highest functional priorities ranked highest in importance to the over-all user respondents.

Server Level Management and Control Functions

Server level management and control function needs include, in order of user priority: improved product genealogy or traceability, enhanced data collection and historian, improved material tracking module, improved change control, distributed batch execution, and increased size of the execu-tion system. Increasing the size of the batch execution system was significantly less important than all the other functions.

NotImportant

CriticallyImportant

2.64

3.00

3.16

3.16

3.24

0.00 0.50 1.00 1.50 2.00 2.50 3.00 3.50 4.00

Common Library ofHMI Objects

Common PhaseStructure

Better Integrated Viewof the Batch

Standard Library ofEquipment Modules

Standard Library ofControl Modules

NotImportant

CriticallyImportant

2.64

3.00

3.16

3.16

3.24

0.00 0.50 1.00 1.50 2.00 2.50 3.00 3.50 4.00

Common Library ofHMI Objects

Common PhaseStructure

Better Integrated Viewof the Batch

Standard Library ofEquipment Modules

Standard Library ofControl Modules

Prioritization of User Needs for Close Coupled Engineering Tools



The challenge in this category is for suppliers to translate these user requirements into product de-velopment requirements, since there are many possible approaches to address these user needs. For example, improved product traceability re-quires enhancement of data collection and historian, an improved material tracking module, and improved integration with other enterprise-wide applications collecting product information. Some of the latter applications include warehouse management systems, logistics management sys-tems, laboratory information management systems, and specifications management systems. This

category ranked second highest in importance to the overall user respon-dents, but highest in importance to users in the pharmaceutical and food & non-alcoholic beverages industries.

Controller Level Management and Control Functions

Controller level management and control function needs include, in order of user priority: controller data buffering and accurate time-stamping, im-proved change control, and batch execution in the controller. The pharmaceutical industry has been requesting controller level data buffering

and accurate time stamping for many years. Pro-viding this functionality increases the reliability of data collection, reducing the possibility of uncol-lected quality data and resultant loss of product. In addition, current BCSs do not provide the re-quired regulatory time resolution for every type of application. Change control includes electronic records for system configuration, controller appli-cation code, and HMI configuration or code.

The controller level functional requirements are closely bound to the server level functions. For example, designing a change management system

requires inclusion of controller level editors and configurators, usage au-thorizations, and server storage & control of controller application code.

NotImportant

CriticallyImportant

2.68

2.72

2.84

0.00 0.50 1.00 1.50 2.00 2.50 3.00 3.50 4.00

Batch Execution in theController

Improved ChangeControl

Controller DataBuffering & Time

Stamping

NotImportant

CriticallyImportant

2.68

2.72

2.84

0.00 0.50 1.00 1.50 2.00 2.50 3.00 3.50 4.00

Batch Execution in theController


Controller DataBuffering & Time

Stamping

Prioritization of User Needs for Controller Level Management and Control Functions

NotImportant

CriticallyImportant

1.96

2.67

2.72

2.73

2.96

3.00

0.00 0.50 1.00 1.50 2.00 2.50 3.00 3.50 4.00

Increasing Size ofExecution System

Distribute BatchExecution Functions


Improved MaterialTracking Module

Enhanced DataCollection/Historian

Improved ProductTraceability

NotImportant

CriticallyImportant

1.96

2.67

2.72

2.73

2.96

3.00

0.00 0.50 1.00 1.50 2.00 2.50 3.00 3.50 4.00

Increasing Size ofExecution System

Distribute BatchExecution Functions


Improved MaterialTracking Module

Enhanced DataCollection/Historian

Improved ProductTraceability

Prioritization of User Needs for Server Level Management and Control Functions



Supplier Selection Criteria and Alignment with User Needs

Users indicated that the most important criterion in supplier selection was the functionality of the software and hardware. This reflects the fact that current batch control systems do not have all of the functionality users re-quire to meet their business needs.

Additional criteria in order of importance were services capability, knowledge of the industry and its processes, local support, and the cost of application services. This reflects the complexity of automating a batch process and that effectively auto-mating such processes requires knowledge of the process operation.

The least important were their current in-stalled base, cost of the hardware, and software compatibility with other control system suppliers. The current installed base is less important because many batch

operations are still manual or because automated operations are using in-house developed batch controls. Hardware and software price is less im-portant because the application engineering costs are significantly higher than hardware and software costs.

The top ten priorities of suppliers were similar to the top ten priorities of users, but not in the same order or level of importance. Users identified many of the top ten functions as critically important while suppliers con-sidered only a few of these functions critically important. Suppliers were least aligned with users on the need for common phase structures and data buffering and accurate time stamping in the controller. In fact, most sup-pliers did not understand the business needs that require controller level data buffering and time stamping functionality.

2.33

2.46

2.52

2.83

2.84

2.88

2.96

3.12

0.00 0.50 1.00 1.50 2.00 2.50 3.00 3.50 4.00

Your Current Installed Base

Cost of Software & Hardware

Software Compatible with Multiple ProcessControl System Suppliers

Cost of Application Services

Local Support

Knowledge of the Industry/Process

Services Capability

Functionality of Software & Hardware

NotImportant

CriticallyImportant

2.33

2.46

2.52

2.83

2.84

2.88

2.96

3.12

0.00 0.50 1.00 1.50 2.00 2.50 3.00 3.50 4.00

Your Current Installed Base

Cost of Software & Hardware

Software Compatible with Multiple ProcessControl System Suppliers

Cost of Application Services

Local Support

Knowledge of the Industry/Process

Services Capability

Functionality of Software & Hardware

NotImportant

CriticallyImportant

User Prioritization Criteria for Supplier Selection



Prioritized User Requirements

Suppliers Aligned

with Users

Suppliers Some-what Aligned

with Users

Suppliers Not Aligned with Users

1. Standard library of control modules X

2. Standard library of equipment modules X

3. Better integrated view of the batch X

4. Common phase structures X

5. Improved product traceability records X

6. Enhanced data collection & historian X

7. Data buffering & time stamping in controller X

8. Improved change control X

9. Improved material tracking modules X

10. Batch execution in the controller X

Supplier Alignment with User Requirements for Batch Control Systems

Recommendations

E-commerce, Internet technology, the globalization of products and compe-tition, and new global regulatory initiatives are changing the way business is conducted. ARC believes the following are key success strategies for batch manufacturing enterprises to maintain competitive advantage:

• Develop and deploy standards. This includes standardization of sup-pliers and products as well as the use of standards such as ANSI/ISA-88/IEC 61512, ANSI/ISA-95/IEC 62264, and XML/B2MML. It is also critical for users to be involvement in standards organizations so that they can continue the development of user requirements specifications (URS). Common URSs will allow suppliers to continue to develop common batch control system functionality to meet user needs.

• Deploy commercial off-the-shelf (COTS) batch control systems and products

• Evaluate and prepare to meet dramatically increased regulatory re-quirements

• Develop an automation strategy that does not limit future options or alternatives.



• Make business and manufacturing systems integration a collaborative decision process to ensure the needs of all organizations are met

Deploying products based on standards will eliminate the high cost of in-house systems and strategically position the enterprise to more easily and rapidly adapt to future business requirements and technology. This can be successfully accomplished only after developing an automation strategy that will be able to meet your current and future business requirements. This architecture should also include functional requirements even if they are not addressed by current technology. Technology will not be the limit-ing factor.

Bu

sin

ess

Op

tim

izati

on

D

eals

wit

h P

lan

nin

g

Business

Capacity and Product OrientedDriven by Market Opportunity

Empowered with a Real-time Supply Chain PerspectiveReal-time Computing

Man

ufa

ctu

rin

g O

pti

miz

ati

on

D

eals

wit

h R

esp

on

se

Accountable for Capable to Promise/Profitable to PromiseEngineering Oriented

Constrained by Physical Processes and Assets

Manufacturing

SupplyChain

AssetManagement

Negotiated Targets

The Integrated Real-time Business and Manufacturing System Model

Power has shifted to retailers and consumers, who are demanding in-creased quality, safety, variety, and convenience. In the old model, sales and marketing were the bottlenecks, but today manufacturing and its sup-ply chain are the bottlenecks and the key to business success. More real time decisions are occurring at the business level, which is becoming capac-ity and product oriented and driven by market opportunity. With manufacturing a key to business success, it is becoming accountable for such things as capability to promise, profitability to promise, and quality assurance. This requires manufacturing operations to become a part of the collaborative decision process that determines the automation and integra-tion strategy.



Analyst: John Blanchard

Editor: Asish Ghosh

Distribution: MAS-P & MAS-H Clients

Acronym Reference: For a complete list of industry acronyms, refer to our web page at www.arcweb.com/Community/terms/terms.htm

ANSI American National Standards

Institute

B2MML Business to Manufacturing

Markup Language

CAPA Corrective and Preventative

Actions

CFR Code of Federal Regulations

cGMPs Current Good Manufacturing

Practices

COTS Commercial Off-The-Shelf

DCS Distributed Control System

FDA Food and Drug Administration

GAMP Good Automated Manufacturing

Practices

GERM Good Electronic Records Man-

agement

GMP Good Manufacturing Practices

HMI Human Machine Interface

IEC International Electrotechnical

Commission

ISA Instrumentation, Systems &

Automation Society

IQ Installation Qualification

OMAC Open Modular Architecture

Controls

OQ Operational Qualification

PackML Packaging Machinery Language

PLC Programmable Logic Controller

PFC Procedure Function Chart

PQ Process Qualification

ROA Return on Assets

SFC Sequential Function Chart

URS User Requirements

Specification

WBF World Batch Forum

XML Extensible Markup Language

Founded in 1986, ARC Advisory Group has grown to become the Thought Leader in Manufacturing and Supply Chain solutions. For even your most complex business issues, our analysts have the expert industry knowledge and firsthand experience to help you find the best answer. We focus on simple, yet critical goals: improving your return on assets, operational performance, total cost of ownership, project time-to-benefit, and shareholder value.

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