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
1.72
1.88
1.96
1.96
2.04
2.54
2.64
2.67
2.68
2.72
2.73
2.84
2.96
2.96
3.00
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
G eneral to m aster recipe conversion tool
P&IDs to U RS conversion tool
Increasing size of execu tion system
Link procedu re to equ ip. control
Tools to convert P&IDs to code
Com m on S95 data definitions
Com m on library of H M I objects
Distribu te batch execu tion fu nctions
Batch execu tion in the controller
Im proved change control
Im proved m aterial tracking m odu le
Controller data bu ffering & tim e stam p
En hanced data collection/h istorian
Com m on ph ase stru ctu re
Im proved produ ct traceability
Better integrated view of th e batch
Standard library of equ ip. m odu les
Standard library of control m odu les
Not
Important
Critically
Important
1.72
1.88
1.96
1.96
2.04
2.54
2.64
2.67
2.68
2.72
2.73
2.84
2.96
2.96
3.00
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
G eneral to m aster recipe conversion tool
P&IDs to U RS conversion tool
Increasing size of execu tion system
Link procedu re to equ ip. control
Tools to convert P&IDs to code
Com m on library of H M I objects
Distribu te batch execu tion fu nctions
Batch execu tion in the controller
Im proved change control
Im proved m aterial tracking m odu le
Controller data bu ffering & tim e stam p
En hanced data collection/h istorian
Com m on ph ase stru ctu re
Im proved produ ct traceability
Better integrated view of th e batch
Standard library of equ ip. m odu les
Standard library of control m odu les
Not
Important
Critically
Important
Prioritization of User Requirements for Batch Control Systems
Business SystemBusiness
Process
Transactions
Business
Work
Processes
S95.01
Definition
Manufacturing
Work
Processes
Production
Management
Transactions Production Management
BatchContinuous Logic
S88Structures
XML
Sensors, Actuators, and
Logical Devices
T
T
P
F
F
F
L
F
L
L
F
L
L
L
T
T
P
F
F
F
L
F
L
L
F
L
L
L
Production
Definition
Production
Capability
Production
Plan
Production
Performance
Collaborative Process
Automation System
Real-time
Control &
Events
OPC
21 CFR Part 11
GAMP/GERM
OMAC Standards
BusinessOptimizationDealswithPlanning
ManufacturingOptimizationDealswithResponse
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
Automotive
Aerospace
Electronics
Machinery
Textiles
Fine Chemicals
Pharmaceutical
Food & Beverage
Soaps& Cosmetics
Mining & Metals
Pulp & Paper
Water & Waste
Petrochemicals
Power
Refining
Oil & 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.
Ingredient A
Ingredient B
Ingredient C
Manufacturing
Product B
Product A
Brazil
Mexico
USA
Canada
UK
Spain
Ingredient AIngredient A
Ingredient BIngredient B
Ingredient CIngredient C
ManufacturingManufacturing
Product BProduct B
Product AProduct A
Brazil
Mexico
USA
Canada
UK
Spain
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
SOURCING
INTENSIVE
MFG.
INTENSIVE
Process
Discrete
Supplier
Distributor/
Consumer
DISTRIBUTION
INTENSIVE
Batch
Processes
Batch
Processes
SOURCING
INTENSIVE
MFG.
INTENSIVE
Process
Discrete
Supplier
Distributor/
Consumer
DISTRIBUTION
INTENSIVE
Batch
Processes
Batch
Processes

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.
Not
Important
Critically
Important
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 of
HMI Objects
Common Phase
Structure
Better Integrated View
of the Batch
Standard Library of
Equipment Modules
Standard Library of
Control Modules
Not
Important
Critically
Important
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 of
HMI Objects
Common Phase
Structure
Better Integrated View
of the Batch
Standard Library of
Equipment Modules
Standard Library of
Control 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.
Not
Important
Critically
Important
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 the
Controller
Improved Change
Control
Controller Data
Buffering & Time
Stamping
Not
Important
Critically
Important
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 the
Controller
Improved Change
Control
Controller Data
Buffering & Time
Stamping
Prioritization of User Needs for Controller
Level Management and Control Functions
Not
Important
Critically
Important
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 of
Execution System
Distribute Batch
Execution Functions
Improved Change
Control
Improved Material
Tracking Module
Enhanced Data
Collection/Historian
Improved Product
Traceability
Not
Important
Critically
Important
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 of
Execution System
Distribute Batch
Execution Functions
Improved Change
Control
Improved Material
Tracking Module
Enhanced Data
Collection/Historian
Improved Product
Traceability
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 Process
Control System Suppliers
Cost of Application Services
Local Support
Knowledge of the Industry/Process
Services Capability
Functionality of Software & Hardware
Not
Important
Critically
Important
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 Process
Control System Suppliers
Cost of Application Services
Local Support
Knowledge of the Industry/Process
Services Capability
Functionality of Software & Hardware
Not
Important
Critically
Important
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.
BusinessOptimization
DealswithPlanning
Business
Capacity and Product Oriented
Driven by Market Opportunity
Empowered with a Real-time Supply Chain Perspective
Real-time Computing
ManufacturingOptimization
DealswithResponse
Accountable for Capable to Promise/Profitable to Promise
Engineering Oriented
Constrained by Physical Processes and Assets
Manufacturing
Supply
Chain
Asset
Management
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.
ARC Strategies is published monthly by ARC. All information in this report is
proprietary to and copyrighted by ARC. No part of it may be reproduced with-
out prior permission from ARC.
You can take advantage of ARC's extensive ongoing research plus experience
of our staff members through our Advisory Services. ARC’s Advisory Services
are specifically designed for executives responsible for developing strategies
and directions for their organizations. For subscription information, please
call, fax, or write to:
ARC Advisory Group, Three Allied Drive, Dedham, MA 02026 USA
Tel: 781-471-1000, Fax: 781-471-1100, Email: info@ARCweb.com
Visit our web page at ARCweb.com

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

Recommandé

Recommandé

Contenu connexe

Tendances

Tendances (20)

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

Similaire à Batch Manufacturers Require More Robust, Dock-to-Dock Control Systems (20)

Plus de ARC Advisory Group

Plus de ARC Advisory Group (20)

Dernier

Dernier (20)

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