Optimal alignment between Processes, Organisation & Technology. Senior Specialist Leif Poulsen, MSc, PhD, Automation & IT, NNE Pharmaplan A/S

Transcription

1 Optimal alignment between Processes, Organisation Technology Senior Specialist Leif Poulsen, MSc, PhD, Automation IT, NNE Pharmaplan A/S

2 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 2

3 Business Objectives Means Customer Service Quality Compliance Costs Link between business Objectives and means Business Processes Organization Automation/IT Technology Processes Objectives Means 3

4 Process understanding is key to success Good Good understanding understanding of of the the requirements requirements including including how how the the technology technology shall shall support support the the business business manufacturing manufacturing processes processes is is key key to to success success Business Processes: MRP Planning Inventory Specification Execution Reporting Optimization Quality Control Assurance Maintenance Engineering Building Environment Energy Utility 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 4

5 Roles responsibilities must be known It It is is important important to to understand understand who who are are going going to to use use the the system, system, what what are are their their roles roles and and responsibilities responsibilities and and what what level level of of education education training training can can be be anticipated anticipated Overall targets purpose for organisation Define equipment, manufacture business processes Define project organisation tasks Define production organisation job positions Recruitment Define execute training Execute project Ramp up to production 5

6 Use proven technology recognized standards Good Good reliable reliable Automation Automation IT IT solutions solutions can can be be ensured ensured by by choosing choosing proven proven technologies technologies and and recognized recognized standards: 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 Manufacturing IT PCS DCS + SCADA/PLC Instrumentation Field Busses Recognized Standards Guidelines: Computer Validation (GAMP5) Systems Compliance (e.g. 21CFR11) Plant Integration (ISA S ) Batch Control (S ) Interfaces (OPC, B2MML) Control System Security (ISA S99) Fieldbus (IEC 61158) Barcodes (GS1) 6

7 Approach to understanding of the processes 7

8 Pharma Business Processes Purchasing Purchasing Supply Supply Equipment Equipment Maintenance Maintenance Engineering Engineering Building Building Environment Environment Human Human Resource Resource Inventory Inventory Material Material Energy Energy Utility Utility Finance, Finance, Accounting Accounting IT IT MRP MRP Planning Planning Scheduling Scheduling Execution Execution Process Process Supervision Supervision Control Control Research Research Development Development Specification Specification Optimisation Optimisation Reporting Reporting Marketing, Marketing, Sales Sales Distribution Distribution Quality Quality Assurance Assurance Quality Quality Control Control 1. Finance, Accounting IT 2. Human Resource 3. Research Development 4. Marketing, Sales Distribution 5. MRP Planning 6. Purchasing Supply 7. Inventory 8. Specification 9. Scheduling 10. Execution 11. Process Supervision Control 12. Optimisation 13. Reporting 14. Material 15. Quality Assurance 16. Quality Control 17. Maintenance Engineering 18. Building Environment 19. Energy Utility 8

9 Work Flow Cartoon Example 9

10 Work Flow Diagram Example 10

11 Work Flow Chart - Example 11

12 Work Flow List Example 12

13 ERP Example (Process Flow) 13

14 ERP Example (Organisation) Manager Team Leader Operator Specialist Engineer Technician Analyst Assistant 14

15 ERP Example (Technology) 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 (MM) Quality (QM) Maintenance (PM)* Adapted to shop floor requirements for labelling SAP System Supplier Quality (QM) Purchasing Supply (MM) RM Finance Accounting (FI, CO, AM) Planning Scheduling (PP-PI) Process Execution Purchasing Purchasing Supply Supply Equipment Equipment Maintenance Maintenance Engineering Engineering Building Building Environment Environment Plant Maintenance (PM) Sales Distribution (SD) FG Human Human Resource Resource Inventory Inventory Material Material Handling Handling Energy Energy Utility Utility Finance, Finance, Accounting Accounting IT IT Supply Supply Chain Chain Planning Planning Scheduling Scheduling Execution Execution Reporting Reporting Customer Research Research Development Development Specification Specification Quality Quality Control Control Optimisation Optimisation Marketing, Marketing, Sales Sales Distribution Distribution Quality Quality Quality Quality Assurance Assurance 15

16 MES Example (Process Flow) PAS-X Order Operations SAP 16

17 MES Example (Organisation) 17

18 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 18

19 SCADA/PLC Example (Process Flow) 19

20 SCADA/PLC Example (Organisation) Manager Team leader Operator Technician Chemist Administrative 20

21 SCADA/PLC Example (Technology) 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 Trend Curving Access Control Reporting PLC PLC scope PLC PLC-Switch Standard Monitor SCADA Server PLC Report Printer Touch Screen SCADA Client Backbone Ethernet SCADA scope Touch Screen SCADA Client Touch Screen SCADA Client Touch Screen SCADA Client Server room 21

22 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 Business Processes Organization Automation/IT Technology Processes 22