Optimal alignment between Processes, Organisation & Technology

Senior Specialist Leif Poulsen, MSc, PhD, Automation & IT, NNE Pharmaplan A/S

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Agenda• Business Objectives & Means• Process Understanding is Key• Roles & Responsibilities is Key• Proven Technology is Key• Systematic Automation Approach• ERP Example (SAP, China)• MES Example (PAS-X, France)• SCADA/PLC Example (iFix, Brazil)• Conclusion

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Business Objectives & Means

Customer Service

Costs

ComplianceQualityOrganization

Production Processes

Automation/IT Technology

Business Processes

Objectives Means

Link between business Objectives and means

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Process understanding is key to success

Manufacturing Processes:• Fermentation & Synthesis• Recovery & Purification• Granulation & Powder Handling• Process utilities & Waste water treatment• Formulation & Component Preparation• Aseptic Filling & Inspection• Freeze Drying & Solids Dose Manufacturing• Plastic Molding & Device assembly• Labeling & Packaging• Materials Handling & Warehousing

Business Processes:• MRP Planning• Inventory Management• Production Specification• Production Execution • Production Reporting• Production Optimization• Quality Control & Assurance• Maintenance & Engineering• Building & Environment Management• Energy & Utility Management

Good understanding of the requirements including how the technology shall support the business & manufacturing processes is key to success

Good understanding of the requirements including how the technology shall support the business & manufacturing processes is key to success

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Roles & responsibilities must be known

Define project organisation & tasks

Overall targets & purpose for organisation

Define equipment, manufacture & business processes

Define production organisation & job positions

Recruitment

Define & execute training Execute projectRamp up to productionProduction

It is important to understand who are going to use the system, what are their roles and responsibilities and what level of education & training can be anticipated

It is important to understand who are going to use the system, what are their roles and responsibilities and what level of education & training can be anticipated

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Use proven technology & recognized standards

Recognized Standards & Guidelines:• Computer Validation (GAMP5)• Systems Compliance (e.g. 21CFR11) • Plant Integration (ISA S95.01 & 02)• Batch Control (S88.01 & 02)• Interfaces (OPC, B2MML)• Control System Security (ISA S99)• Fieldbus (IEC 61158)• Barcodes (GS1)

Good & reliable Automation & IT solutions can be ensured by choosing proven technologies and recognized standards:

Good & reliable Automation & IT solutions can be ensured by choosing proven technologies and recognized standards:

• ERP-interfaces: SAP ERP, Oracle Application, Microsoft Dynamics

• Manufacturing-IT: OSI: PI, AspenTech: IP21, Werum: PAS-X, Rockwell Automation: PMX/Pharma Suite, Emerson: Syncade, GE Intelligent Platforms: iBatch, Wonderware: InBatch

• DCS: ABB: SattLine, System800xA, Emerson: DeltaV, Siemens: PCS7, Logica: Procos

• SCADA/PLC: GE Intelligent Platforms : iFix, iHistorian, Siemens: WinCC, S7, Rockwell Automation: Allen Bradley PLC, RSView, Wonderware: InTouch

• Field busses: Foundation Fieldbus, ControlNet, Profibus

• Instrumentation: Sensors, Actuators, Drives, Data Loggers etc.

ERP

PCS + SCADA/PLC

Instrumentation & Field Busses

ERP

DCS + SCADA/PLC

Manufacturing IT

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Approach to understanding of the processes

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Pharma Business Processes1. Finance, Accounting & IT2. Human Resource Management3. Research & Development4. Marketing, Sales & Distribution5. MRP Planning6. Purchasing & Supply7. Inventory Management8. Production Specification9. Production Scheduling10.Production Execution 11.Process Supervision & Control12.Production Optimisation13.Production Reporting14.Material Management15.Quality Assurance16.Quality Control17.Maintenance & Engineering18.Building & Environment Management19.Energy & Utility Management

MRPPlanning

MRPPlanning

Finance,Accounting

& IT

Finance,Accounting

& IT

ProductionScheduling

ProductionScheduling

ProductionExecution

ProductionExecution

ProcessSupervision& Control

ProcessSupervision& Control

Research &Development

Research &Development

QualityAssurance

QualityAssurance

QualityControl

QualityControl

InventoryManagement

InventoryManagement

HumanResource

Management

HumanResource

Management

MaterialManagement

MaterialManagement

Energy & Utility

Management

Energy & Utility

Management

Purchasing&

Supply

Purchasing&

Supply

EquipmentMaintenance &

Engineering

EquipmentMaintenance &

Engineering

Building &EnvironmentManagement

Building &EnvironmentManagement

Marketing,Sales &

Distribution

Marketing,Sales &

Distribution

ProductionSpecification

ProductionSpecification

ProductionOptimisation

ProductionOptimisation

ProductionReporting

ProductionReporting

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Work Flow Cartoon – Example

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Work Flow Diagram – Example

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Work Flow Chart - Example

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Work Flow List – Example

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ERP Example (Process Flow)

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ERP Example (Organisation)

• Manager• Team Leader• Operator• Specialist• Engineer• Technician• Analyst• Assistant

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ERP Example (Technology)

Finance &Accounting

(FI, CO, AM)

Planning & Scheduling

(PP-PI)

Purchasing& Supply

(MM)

Sales & Distribution

(SD)

RM ProcessExecution CustomerSupplier

FG

Plant Maintenance

(PM)

QualityManagement

(QM)

SAP System

Supply ChainPlanning

Supply ChainPlanning

Finance,Accounting

& IT

Finance,Accounting

& IT

ProductionScheduling

ProductionScheduling

ProductionExecution

ProductionExecution

ProductionReporting

ProductionReporting

Research &DevelopmentResearch &

Development

QualityManagement

QualityManagement

QualityAssurance

QualityAssurance

InventoryManagementInventory

Management

HumanResource

Management

HumanResource

Management

MaterialHandlingMaterialHandling

Energy & Utility

Management

Energy & Utility

Management

Purchasing&

Supply

Purchasing&

Supply

EquipmentMaintenance &

Engineering

EquipmentMaintenance &

Engineering

Building &EnvironmentManagement

Building &EnvironmentManagement

Marketing,Sales &

Distribution

Marketing,Sales &

Distribution

ProductionSpecificationProduction

Specification

QualityControl

QualityControl

ProductionOptimisationProduction

Optimisation

• Standard ERP system, pre-configured pharma solution

• Mainly used at administrative level

• Finance & Accounting (FI, CO, AM)

• Sales & Distribution (SD)• Planning & Scheduling

(PP/PP-PI)• Purchasing & Supply

(MM)• Inventory & Material

Management (MM)• Quality Management

(QM)• Maintenance

Management (PM)* • Adapted to shop floor

requirements for labelling

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MES Example (Process Flow)P

AS

-X O

rder

Ope

ratio

nsS

AP

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MES Example (Organisation)

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MES Example (Technology)• PAS-X is a standard Manufacturing

Execution System (MES) for the pharmaceutical industry

• Based on configured production recipes, PAS-X guides operators through all steps of production (preparation, material scanning, line clearance, sampling, reconciliation, etc.)

• During production execution, PAS-X automatically collects all relevant information and generates Electronic Batch Records (EBR)

• The electronic batch records are released based on “review by exception”

• Core solution is rolled out to enforce process harmonisation across sites and to improve efficiency and transparency in general

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SCADA/PLC Example (Process Flow)

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SCADA/PLC Example (Organisation)• Manager• Team leader• Operator• Technician• Chemist• Administrative

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SCADA/PLC Example (Technology)

Report Printer

Touch Screen

SCADAClient

Touch Screen

SCADAClient

Touch Screen

SCADAClient

Standard Monitor

SCADAServer

Touch Screen

SCADAClient

PLCPLC PLC

PLC-Switch

BackboneEthernet

SCADA scopePLC scope

Server room

• Standard SCADA/PLC system widely used in pharma industry

• Based on pre-configured soft ware libraries

• Used at shop floor to monitor & control manufacturing processes including:

• Human Machine Interface• Data collection and distribution• Process Control in PLC• Alarming & Event Management• Trend Curving• Access Control• Reporting

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Conclusions• Automation & IT solutions must support your

business objectives• Understanding the processes, both production &

business processes, is key to success• Use graphical tools to capture and verify the

process understanding• It is very important also to understand roles &

responsibilities (organisation)• Remember to consider cultural differences• Use proven technologies & recognised standards

to ensure flexibility and to optimise life cycle costs• Consider technology as a leaver for enforcement

of standardisation of manufacturing & business processes

Organization

Production Processes

Automation/IT Technology

Business Processes