mes overview
TRANSCRIPT
Manufacturing Execution System (MES) Overview
t: 1890 924 155 / +353 21 4536121
f: +353 1 6335872
w: www.esp.ie
What is MESWhat is MES MES is an electronic interface between personnel, equipment automation, orders, logistics, equipment and processing instructions (batch records). MES is located between the company-wide Enterprise Resource Planning system (ERP) and the process control systems. MES mediates between business administration (covering core functions such as sales and production planning or controlling) and the automation of the production process.
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Foundation for MES
Return
The REPAC model (Ready, Execute, Process Control, Analyze, Coordinate) laid the foundations for an MES (source: AMR).
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Vision of an MES SystemSome paper? No Paper
Lights Out, Continuous Batch
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Benefits of MES Labour avoided and quality enhanced Data Validation No Blanks (Fields need to be completed to allow process to continue) Value Limits (warning/enforced) Automatic Calculations (eliminate double signature) Eliminate generation, verification and mgt of paper batch record Check the batches by exception
Increased Compliance (inc. 21 CFR Part 11) Reporting across batches or work centres Data Security Archiving and Retrieval Enhanced audit trail Improved traceability Improved Product Information Increased Efficient Information Improved Quality Information Ease of use of Product Information Reporting Reduce/ Remove Paper
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System LayersCorporate Business Layer Provides direction to the Company (Outside the scope of this training course) Manages the business supply chain (i.e. demand forecasting, planning and strategic supply organisational planning)
Manufacturing Layer
Sends manufacturing plans from ERP to the plant floor. Sends plant Information operations backup to ERP
Equipment/Process Automation Layer
Minute by minute real time operation of the floor, a combination of hardware and software that control all equipment in the plant
Pharmaceutical manufacturing operations are inefficient and costly. The cost of low efficiencies Is generally not understood or appreciated (e.g. manufacturing costs far exceed those for research And development operations). Low efficiency is predominately due to self imposed constraints in the system (e.g. static manufacturing processes, focus on testing as opposed to quality by design, Approach to specifications based on discrete or this so-called zero tolerance). These 6 constraints keep the system in a corrective action mode
Physical & Decisional HierarchicalEnterprise
Financial ManagementSite
Area
Planning
Work Center
SchedulingWork Unit
Equipment Module
Operations
Control Module
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System InterfacesLevel 4ERP
Business Planning & Logistics
Plant Production Scheduling, Operational Management, etc
MES
Level 3
Dispatching Production, Detailed Production Scheduling, Reliability Assurance, ...
Manufacturing Operations & Control
Information is to be exchanged accurately, Modularise manufacturing operations Batch Control
Levels 2,1,0Automation
Batch Control
Continuous Control
Discrete Control
Equipment Control Intelligent Devices
ISA Standards8
Key Systems Supporting Manufacturing and Quality Business Systems ERP MRP
Collectively involved in the planning, sales, purchase of raw materials
Manufacturing Systems
MES CAPA Laboratory Systems Chromatography Historian SDMS (Scientific Data Mgt. System) EQM (Equipment and Container Mgt) Weigh and Dispense Document Mgt.
Collectively involved in the production of the end product.
Automation Systems
PLC (Programmable Logic Controller) DCS (Distributed Control System) SCADA (Supervisory Control and Data Acquisition)
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Different Points of View of Key SystemsBusiness Systems Time Horizons Long-term view
Manufacturing & Automation Systems Time Horizons Real-time view
Model detail Linear route structures
Model detail Complex routes with rework paths
Control emphasis Product cost and overall profitability
Control emphasis Physical movement & accountability
Modeling Criteria material movement reference points
Modeling criteria Accounting reference points
View from the work center
View from the boardroomHow Much is the stuff worth Where is my stuff
All of these systems are integrated together to allow the transition of data from ERP down to the Automation layer and the results from the Automation layer is sent back up to the ERP layer, providing full control of all activities in the manufacture of end product.
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Overview Functionality of ERP, MES, AutomationERPSupply Chain
Enterprise Resource PlanningInventory Management MRP Asset Management Financial Management
Warehouse Management Equipment/ Container Management Central Recipe & Configuration Management
Scheduling & Planning LIMS /SPC Weighing & Dispensing (Electronic) Batch Record Data Historian Equipment ControlConsole Controller Corrective And Preventive Action Tracking
Personnel Qualification & Training
MES
Document Management CAPA
Material Tracking (Genealogy)
Reporting/ Information
AutomationPLC/Intelligent Device
SCADA
DCSConsole Controller
PLC/Intelligent Device
including system integration
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IT View of System LandscapeERP
Level 4Business Process Information Network
ERP, APO, Logistics Systems
MES
Level 3Operations Information Network
MES, LIMS, WMS, CMM Systems
Level 2Automation
HMI, SCADA, Batch SystemsAutomation Network
PLC, DCS, Packaged SystemsDiscrete & Process Device Communication Networks
Level 1
I/O, Devices, Sensors
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Typical MES Architecture
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Modules/Benefits of MESTypical Modules of an MES System EBR/MBR Weigh & Dispense Warehouse Mgt Material Flow Control Equipment & container Mgt Finite Scheduling
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Standard MES FunctionalityManufacturing Order (ERP)
Work Order (MES)
SFO1
SFO2
SFO3
SFO4
SFO5
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Material Mgt Within Production Controlled by MES
Blending Compression Coating
Electronic control of all materials in production (Order and Stock)
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Visual Production Status/TrackingSign off clean sheet
Line clearance
Tablet filler set-up
labeller
Checkweigher
Vision system
Take first retain sample
production
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Automatic Recording of Daily balance checks in EQMPaper Log Book Paperless EQM
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Automatic Complete Check of Room and Setup PartsPaper BMR Paperless EBR
Plausibility Check Electronic Signature Check by System
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Packaging Line Batch DetailsProduct: Tablet 800mg Market; IE/ UK Batch No: 123 Exp date: SEP 2006
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Barcode Identification and ScanningRoom and equipment Pack room 1 Checkweigher Bottle unscrambler Auto cartoner Vision system GMP No.F-05 CW-001 BUS-001 CRT-001 PVS-003
Verified By
Room F-05
BUS-001CW-001
CRT-001
PVS-003
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Barcode Identification and ScanningScannedRoom and equipment Pack room 1 Checkweigher Bottle unscrambler Auto cartoner Vision system Set-up checks GMP No.F05 CW-001 BUS-001 CRT-001 PVS-003
Verified By
Not Necessary
variables
John Smith 30 Sep 05 Verified by:______________________________Date:___________________________________22
th
Automatic Calculation of water to add for GranulationPaper BMR Paperless EBR
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Automatic Downloading of setpoints to control equipment (e.g. Granulator PLC)Paper BMR Paperless EBR
MESControl Network
Granulator
Blender
Coaters
Presses24
Execute EBR for Electronic Batch Recording
Steering of RSBatch execution by using EBR and monitor batch execution. Real-time process and data presentation using RSVIEW and process control using RSBatch.
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Execute EBR for Electronic Batch RecordingReturn
Create Batch Report
Analyse, review and approve batch report for real-time Release
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Standards & Best Practises(and FDA Current Initiatives)
Regulation/Compliance 21 CFR Part 11 (Electronic Records & Signature) Validation of Systems Copies of records Protection of records Limitations on access Computer Time stamped records Operational system checks (permission of sequencing) Authority checks Use of devices for determination of checks Qualified personnel Adherence to written policies Use of appropriate control Control for open systems EBRs (unique and attached to the executed record) Periodic testing of controls
Standards/ Best Practises PAT Reduction of cycle times Less batch failures Faster batch release time Improved management change control Reduced start-up time Improved speed of deployment
GAMP4 EMEA (European Medicines Agency) ISPE (International Society ofPharmaceutical Engineers)
Lean Manufacturing S95 standard S88 standard
FDA (Food and Drug Administration) IMB (Irish Medicine Board) Annex (11 & 15)27
Future Requirements & Standards Competitive markets is forcing the need to have accurate,timely information on which to make business decisions. The data already exists on the manufacturing floor. The issue is accessing the data and turning that into useful information. The need is to leverage standards to help move forward.
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Any Questions?
t: 1890 924 155 / +353 21 4536121
f: +353 1 6335872
w: www.esp.ie