Beispiel einer I&A Analyse mit ISA-95 - HGP AG

Beispiel einer I&A Analyse mit ISA-95
Integriertes Informations- und Automatisierungssysteme in
der pharmazeutischen Produktion
GMP- und Technologiekongress am 20.-21.10.2011
© Halfmann Goetsch Peither AG

Overview
This presentation provides an overview on
● What is ISA 95
● What are the benefits of ISA 95
● How does the ISA 95 model support the integration of
information from manufacturing to ERP
● How can ISA 95 be used as an analysis tool
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Why ISA 95?
ISA 95 – Enterprise Control System Integration
● Heavy investments have been made in ERP systems
and automation of the processes control layer (PCS)
● In many production sites we are facing a gap between
those two layers, i.e. between business automation and
process automation
● ERP systems need data! However most of the data is
provided manually
● Although integration of ERP systems and control
systems provides important strategic advantages, many
companies do not maintain a centralized information
and automation integration strategy
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Why ISA 95?
● IT and automation departments must handle a
heterogeneous landscape of systems, different
technology, user interfaces, data models, etc.
● Even worse: often automation engineers and IT staff do
not have a sound understanding of each others’ field of
work è� Babylonian confusion begins…
● Many stakeholders are usually involved in production
automation projects (e.g. MES implementation) which
requires good communication between the various
stakeholders, but also between systems
● ISA 95 helps to speak the same language!
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What is ISA 95?
● ISA 95 is not a language!
● ISA 95 is not an automation system!
● ISA 95 is a method, a way of working, thinking, and
communicating
● ISA 95 contains models and terminology that can be used to
analyze a manufacturing organization
● ISA 95 compromises of the following publications:
• Part 1: Models and Terminology
• Part 2: Object Model Attributes
• Part 3: Activity Models of Manufacturing Operations Management
• Part 4: Object models and attributes of manufacturing operations
management activities (not published yet)
• Part 5: Business-to-Manufacturing Transactions
• Part 6: Manufacturing operations transactions (not published yet)
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ISA 95 - Functional Hierarchy Model
Level 4
Level 3
Level 2
Level 1
Level 0
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Batch
Control
Business Planning
& Logistics
Plant Production
Scheduling, Operational
Management, etc
Manufacturing
Operations Mgmt.
Dispatching Prod.,
Detailed Production
Scheduling, ...
Continuous
Control
Discrete
Control
Establishing the basic plant schedule -
production, material use, delivery, and
shipping. Determining inventory levels.
ERP (SAP)
Work flow control to produce the desired
end products. Maintaining records and
optimizing the production process.
MES, LIMS, WMS
Monitoring, supervisory control and
automated control of the production
process
SCADA, DCS
Sensing the production process,
manipulating the production process
The actual production process
Months,
weeks,
days
Days,
shifts,
hours,
minutes,
seconds
Hours,
minutes,
seconds
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Equipment Hierarchy Model
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Process
Cell
Production
Unit
Enterprise
Site
Area
Production
Line
Unit Unit Work Cell
Unit Unit Work Cell
Storage
Zone
Storage
Storage
Unit
Unit
Work
Centers
Work
Units
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Function Enterprise – Control Model
Long Long Term Term Material Material
and and energy energy
requirements
requirements
Material and
Energy Control
(4.0)
Material Material and and
Energy Energy Order Order
Requirements
Requirements
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Incoming Incoming material material and and energy energy receipt receipt
Production
Scheduling
(2.0)
Incoming Incoming
Order Order
Confirmation
Confirmation
Source: ANSI/ISA 95
Procurement
(5.0)
Production Production Orders Orders
Availability Availability
Pack Out Schedule
Short Term Material and
Energy Requirements
Material and Energy Inventory
Finished Goods Inventory
Production capability
P roduction from pl an
Production capability
P roduction from pl an
Schedule Schedule
Maintenance
Maintenance
Purchase Purchase Order Order
Requirements
Requirements
Level 4 / Level 3 Interface
Order
Processing
(1.0)
Production
Control
(3.0)
Maintenance Standards
and Methods
Maintenance Maintenance Requests Requests
Maintenance Technical
Feedback
Maintenance Responses
Maintenance
Management
(10.0)
and and Costs Costs
Production Production Performance
Performance
Production Production Cost Cost Objectives Objectives
Product Product and and Process Process Information Information request request
Process Process Data Data
Process Process Data Data
Product Product and and Process Process Technical Technical Feedback Feedback
QA QA Results Results
Product Product and and Process Process Know Know How How
Product Cost
Accounting
(8.0)
Finished Finished Goods Goods
Waiver Waiver
Standards Standards and and Customer Customer
Requirements
Requirements
In In Process Process
Waiver Waiver Request Request
Research
Development
and Engineering
Quality
Assurance
(6.0)
Product Product
and and Process Process
Requirements
Requirements
Standards Standards and and
Customer Customer
Requirements
Requirements
Product
Shipping Admin
(9.0)
Product
Inventory Control
(7.0)
QA QA Results Results
Confirm to ship
Release to ship
Marketing &
Sales
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Information Exchange Model
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Product
definition
information
(What must be
defined to
make a
product)
Business Planning & Logistics Information
Plant Production Scheduling, Operational Management, etc.
Production
capability
information
(What
resources are
available)
Production
schedule
information
(What actual
Production will
be executed)
Manufacturing Operations & Control Information
Production Operations, Maintenance Operations, Quality
Operations, etc.
Production
performance
information
(What actual
production
was
achieved)
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Application Examples of ISA 95
● Using ISA 95 (part 2) as a basis for developing software
with MES functionality
● Using ISA 95 (parts 1, 2 and 5) for standardized
information exchange between enterprise and control
systems
● Using ISA 95 (parts 1 and 3) as an analysis tool
• Part 1: Reference model for evaluation of requirements and
assessment which solution best fits
• Part 3: Reference model for data flow of manufacturing
information that enables enterprise-control system integration
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ISA 95 as Analysis Tool – Objectives
● Providing a reference model for integration of enterprise
and process control information
● Closing the gap between business automation and
process automation
● Providing transparency of data and information
requirements and flows
● Basis for definition of a corporate information and
automation integration strategy
● Evaluation of requirements for implementation of a new
Manufacturing Execution System
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Steps of an ISA 95 Analysis
1. Start with a plant tour
2. Define scope and business drivers
Conduct workshops and interviews based upon:
3. Functional Hierarchy Model
4. Equipment Hierarchy Model
5. Functional Enterprise - Control Model
6. Production Operations Management Activities Model
7. Maintenance Operations Management Activities Model
8. Quality Test Operations Management Activities Model
9. Inventory Operations Management Activities Model
10. Other activities
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Functional Enterprise - Control Model
Source: ANSI/ISA 95
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1. Production Plant Tour
● Familiarize yourself with actual production processes
● Depending on the scope of the analysis, the plant tour
includes
• Manufacturing
• Warehouse
• Quality control laboratory
• Maintenance department
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2. Define Scope and Business Drivers
● Conduct Scope & Business Drivers workshop with members of the
management team
• Accurately determination of the ISA 95 analysis scope
• Sound understanding of the company’s business drivers
● Business drivers generate the need for information to flow between the
executive offices and the process or manufacturing floor
● Examples for business drivers
• Available to promise
• Reduced cycle time
• Asset efficiency
• Agile manufacturing
• Supply chain optimization
• Quality and traceability
• Improved planning
● Annex C of ISA 95 Part 1 provides an overview about business drivers
and key performance indicators
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3. Functional Hierarchy Model
● Assign ISA 95 to department
responsibilities
● Activities fall within a control domain
if the department is directly involved
or if one of the following conditions
applies:
• Activity is critical to plant safety
• Activity is critical to plant reliability
• Activity is critical to plant efficiency
• Activity is critical to product quality
• Activity is critical to maintaining regulatory
compliance
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4. Equipment Hierarchy Model (Example)
Enterprise Site Area Work Center Work Unit
HGP
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Basel
Singapore
Solid Dosage Production
Liquid Production
Bulk processing
Packaging
Distribution Warehouse
…
Mixer
Granulator
Tablet Press
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4. Equipment Hierarchy Model (simplified)
ERP
MES
Out of scope
Source: ANSI/ISA 95
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ISA 95 Workshops & Interviews
● Facilitate workshops and / or conduct interviews with all
departments, that have been identified during the
preparation phase of the ISA 95 Analysis with the
following objectives:
• Gather all relevant information for the subsequent steps 5 to 10
• Structure and document all relevant information
● Use a standard reference model for recurring analyses,
e.g. for multi-site MES implementation programs
● Safeguard the scope of the analysis
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ISA 95 Workshops & Interviews
● Example for structuring the workshop and interview
results:
Process Segment
Description of the current process
Information Flow
Points of Concern
Current Automation Systems
Requirements
Nice-to-have
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5. Functional Enterprise-Control Model
● Start with Level 4 functions and go into more depth on
Level 3 functions and activities using the operations
management models for
• Production
• Maintenance
• Quality Assurance
• Inventory
● All subsequent workshops and interviews are based on
the models in Part 3 of ISA 95
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Functional Enterprise - Control Model
Source: ANSI/ISA 95
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6. Production Operations Mgmt. Model
Source: ANSI/ISA 95
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6. Production Operations Mgmt. Model
Example:
Detailed activity
“Resource Management”
Source: ANSI/ISA 95
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7. Maintenance Operations Mgmt. Model
Source: ANSI/ISA 95
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8. Quality Test Operations Mgmt. Model
Source: ANSI/ISA 95
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9. Inventory Operations Mgmt. Model
Source: ANSI/ISA 95
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10. Other Activities
In addition to the major activities already described, there are
other activities that are used within manufacturing operations,
e.g.:
● Management of security within manufacturing operations
● Management of information within manufacturing operations
● Management of configurations within manufacturing
operations
● Management of documents within manufacturing operations
● Management of regulatory compliance within manufacturing
operations
● Management of incidents and deviations within
manufacturing operations
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10. Other Activities
Source: ANSI/ISA 95
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Lessons Learnt
● Explain the method and background to all participants
● Plan enough time for the workshops and interview sessions –
especially for processing of information and follow up
● Never skip the Business Drivers step and ensure that
management provides their input
● Stay within and safeguard the scope
● Determine the level of detail that is required
● Conclude a final review of the analysis results and conclusion
● Inform all participants about the results
● Beware of politics
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Conclusion
An ISA 95 Analysis can be a very powerful and efficient tool
to
● Determine and / or adjust your information and
automation integration strategy
● Assess the need for manufacturing automation, e.g.
MES, LIMS, WMS
● Evaluate the scope and system for Electronic Batch
Records implementation
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Contact
Halfmann Goetsch Peither AG
St. Alban Vorstadt 94
CH-4052 Basel
Switzerland
W www.hgp.ag
E info@hgp.ag
T +41 61 544 0000
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