© Halfmann Goetsch Peither AG

ISA�95: Analyse-Tool für die MES-Einführung

Vision Pharma 2012, Karlsruhe Thomas Halfmann www.hgp.ag Besuchen Sie uns auch 2013 vom 5. bis 7. Februar wieder auf der Vision Pharma!

© Halfmann Goetsch Peither AG

Disclaimer

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●  Eine Genehmigung kann unter den am Ende angegebenen Kontaktadressen eingeholt werden.

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Overview

This presentation provides an overview on

●  What is ISA-95

●  What are the benefits of ISA-95

●  How can ISA-95 be used as an analysis tool for MES projects

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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 ! 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

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Level 4 Business Planning

& Logistics Plant Production

Scheduling, Operational Management, etc

Establishing the basic plant schedule - production, material use, delivery, and shipping. Determining inventory levels.

Months, weeks, days

ERP (SAP)

Level 3 Manufacturing

Operations Mgmt. Dispatching Prod.,

Detailed Production Scheduling, ...

Work flow control to produce the desired end products. Maintaining records and optimizing the production process.

Days, shifts, hours, minutes, seconds MES, LIMS, WMS

Level 1

Level 2

Bat

ch

Con

trol

Monitoring, supervisory control and automated control of the production process

Hours, minutes, seconds SCADA, DCS

Con

tinuo

us

Con

trol

Dis

cret

e C

ontro

l

Sensing the production process, manipulating the production process

Level 0 The actual production process

Equipment Hierarchy Model

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Enterprise

Site

Area

Process Cell

Production Unit

Production Line

Storage Zone

Unit Unit Work Cell Storage Unit Unit Unit Work Cell Storage Unit

Work Centers

Work Units

Information Exchange Model

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Business Planning & Logistics Information Plant Production Scheduling, Operational Management, etc.

Manufacturing Operations & Control Information Production Operations, Maintenance Operations, Quality

Operations, etc.

Product definition

information

(What must be defined to

make a product)

Production capability

information

(What resources are

available)

Production schedule

information

(What actual Production will be executed)

Production performance information

(What actual production

was achieved)

ERP (SAP)

MES

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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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

●  Focus on such things as •  Material flow, material transport, user / machinery interactions,

department interfaces, process flow, information flow, information handling, storage locations, order processing time, …

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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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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 3 to 10

•  Structure and document all relevant information

●  Use a standardized reference model for recurring analyses, e.g. for multi-site MES implementation programs and brown-field implementation projects

●  Safeguard the scope of the analysis

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ISA-95 Workshops & Interviews

●  Example for structuring the workshop and interview results:

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Process Segment:

Description of the current process •  E.g.: use cases

Information Flow •  E.g.: workflow diagrams

Points of Concern •  E.g.: implementation risks

Current Automation Systems •  E.g.: available systems and architecture

Requirements •  E.g.: required features and processes

Nice-to-have •  E.g.: wish list, to be decided for future steps

Fit-Gap Assessment •  As-is vs. to-be status

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 Basel

Solid Dosage Production Bulk processing

Mixer Granulator Tablet Press

Packaging Liquid Production

Singapore Distribution Warehouse

…

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4. Equipment Hierarchy Model (simplified)

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ERP

MES

Out of scope

Source: ANSI/ISA-95

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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6. Production Operations Mgmt. Model

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Source: ANSI/ISA-95

6. Production Operations Mgmt. Model

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Example: Detailed activity “Resource Management”

Source: ANSI/ISA-95

7. Maintenance Operations Mgmt. Model

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Source: ANSI/ISA-95

8. Quality Test Operations Mgmt. Model

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Source: ANSI/ISA-95

9. Inventory Operations Mgmt. Model

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Source: ANSI/ISA-95

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

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Source: ANSI/ISA-95

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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HGP Group

HGP Headquarter Basel, Switzerland

HGP Deutschland GmbH Schopfheim, Germany

HGP Asia Pte Ltd. Singapore

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HGP Service Portfolio

●  Improvement of Production Processes (LEAN)

●  Implementation of Paperless Manufacturing (MES)

●  GMP Consulting (Good Manufacturing Practice)

●  Computer System Validation (GAMP)

●  GLP Consulting (Good Laboratory Practice)

●  IT Quality and Compliance Management (COBIT)

●  Internal Control Systems and Risk Management (COSO, SOX)

●  Retrofit of Pharmaceutical Machinery

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HGP Skills Profile

●  HGP consultants have multiple years healthcare industry experience

●  Skills and education cover all domains of the healthcare industry •  Marketing, Manufacturing, Quality Assurance, Finance, IT,

Automation, Engineering, Risk Management, Auditing, …

•  Pharmacists, Engineers, Economists, …

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HGP Tools

RiColution – the HGP application to manage risks and compliance effectively and efficiently!

ISA 95 Analysis – the powerful and efficient tool to determine information and automation integration strategy, evaluate the scope and system for EBR implementation!

Reality Check – an analysis that helps to show weaknesses quickly and accurately and identify the potential for optimization! As easy as playing a game!

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HGP Training Curriculum (1)

How to Survive in the Jungle of GMP •  The World of GMP •  GMP in Practice •  Critical GMP Aspects Validation of Computerized Systems •  What is CSV? •  Introduction into GAMP 5 •  How Much Validation Is Enough? The Mystic 11 – Annex 11 and 21CFR11 •  The New Annex 11 to the EU / PIC/S Guidelines of GMP •  21CFR11 – Electronic Records & Electronic Signatures •  Implementation and Validation Aspects ISA 95 Analysis – A Powerful Analysis Tool for Process and Automation Design •  What is ISA 95? •  Hands-on ISA 95 Analysis Training

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HGP Training Curriculum (2)

IT Risk Management •  Risk & Compliance Management •  IT Frameworks & IT Controls •  How to Implement IT Risk Management Effectively Implementation of Electronic Batch Records •  Fundamentals •  Technical Solutions (Overview) •  Implementation Strategy and Methods How to Prepare for an Audit •  Audit Preparation Activities •  Auditee Briefing •  The Audit Process

Visit out website www.hgp.ag or ask your HGP consultant for the actual training curriculum, upcoming events or a tailored training course There is more to come!

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Vision Pharma 2013

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Besuchen Sie und auch im nächsten Jahr wieder auf der Vision Pharma 2013!

5. bis 7. Februar 2013