optimal alignment between processes, organisation &...
TRANSCRIPT
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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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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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 (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 (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