Post on 08-Sep-2018
JORNADA TECNICAMES* EN INDUSTRIA FARMACEUTICA 14/05/2010
*MANUFACTURING ENTERPRISE SYSTEMS AADECA ISPE
Preventing Errors with a Mobile MESPreventing Errors with a Mobile MES
DISERTANTE: Daniel Marin EMPRESA: Honeywell
Agenda
• Manufacturing Challenges - MES Benefits
• MES Systems Purpose and Functionality– Integration to other systems– Material Control– Equipment Control
• New technological advances in MES– Web Based– Mobile Apps– Virtualization
• Specification Standard S88
DISERTANTE: Daniel Marin EMPRESA: Honeywell
Pharmaceutical Manufacturing
• Processes in Pharma typically involve people
ProcessInput Output
Human factor
• Human factors are unavoidable and when they cause errors it translate to:– Wasted time– Poor quality– Higher cost
DISERTANTE: Daniel Marin EMPRESA: Honeywell
What can we do?
Root Cause: Human errorCAPA (Corrective and Prevention Action): Re-train
“The problem is seldom the fault of an individual; it is the fault of the system. Change the people without changing the system and the problems continue.”
Don Norman
Prevention: Poka-Yoke: Fail-safing, mistake proofing…MES
DISERTANTE: Daniel Marin EMPRESA: Honeywell
Pharma Examples
• Pharma manufacturing is a combination of automated and manual procedures– Automated processes are usually handled by Automation
Systems with limits, alarms, etc….– Manual procedures is where MES plays a key role
• Regulatory Agencies have required fail-safe procedures for a long time (e.g. double signatures)
• MES Systems enforce that the procedures are followed and provides mistake proofing by:– Sequential electronic work instructions step-by-step– Material Management: Correct material, correct quantity…– Equipment Management: Correct equipment, correct status..
DISERTANTE: Daniel Marin EMPRESA: Honeywell
Manufacturing Challenges
Costs of GMP ComplianceMaintaining Paper RecordsOperator Errors and
OmissionsReview of Records Investigating Exceptions
Production EfficiencyMaximizing Equipment UsageMaintenance and CleaningReworkOperator Training
InventoryRaw Materials – Stock Levels, WasteWIP TrackingHolds on Finished GoodsAccurate Inventory & Quality Tracking
Manufacturing FlexibilityNew ProductsExpansionCustomer Demand
DISERTANTE: Daniel Marin EMPRESA: Honeywell
Manufacturing Errors are Costly
Costs of Compliance are High
Production Efficiencynot Optimal
• Enforce Best Practices • Reduction and Avoidance of Manufacturing
Errors
• Right Information - Right Time • Drive Production• Integrated Systems
• Reduced Paperwork• Release by Exception• Electronic Compliance Records
Issues Why MES?
DISERTANTE: Daniel Marin EMPRESA: Honeywell
What is MES?
A Manufacturing Execution System (MES) is a system that companies can use to measure and control critical production activities. Some of the benefits with regards to MES solutions are increased traceability, productivity, and quality. Other functions served by MES solutions may include equipmenttracking, product genealogy, labor tracking, inventory management, costing, electronic signature capture, defect and resolution monitoring, Key Performance Indicator monitoring and alarming, Executive Dashboards and other various reporting solutions.
DISERTANTE: Daniel Marin EMPRESA: Honeywell
traceability, productivity, and quality. equipmenttracking, product genealogy, labor tracking, inventory management, costing, electronic signature capture, defect and resolution monitoring, Key Performance Indicator monitoring and alarming, Executive Dashboards and other various reporting solutions.
Manufacturing Execution System (MES)
ReportReport
Completed Completed Batch RecordBatch Record
MaterialsMaterials
EquipmentEquipment
PeoplePeople
ExecuteExecute
SpecifySpecify
Master Batch RecordMaster Batch Record
DISERTANTE: Daniel Marin EMPRESA: Honeywell
Process Integration
SPECS
Execution
MES Functionality
Business Integration
Materials Procedures Equipment
REPORTS
DISERTANTE: Daniel Marin EMPRESA: Honeywell
Planning and Supply Chain( ERP)
Order, material consumed, produced
Device
Work Order Management
Material Management
Batch Record / Genealogy Records
Automated
Quality Management
Equipment Management
Batch Procedure
Manual
Process Historian
Instruments, Pumps, Valves Scales, Bar Code, Handheld
EnterpriseRecipe andSpecifications
S88
SchedulingLab System (LIMS)
CAPA/DMSSamples, Assay Data
Training
TrainingRecords
Activity Schedule
QC &Support Data
Device
Fieldbus Serial / Wireless
InteroperableAutomation
Honeywell Application Architecture
External Systems
Automated Unit Unit Procedure
Automated Operation Operation
Phase Phase Phase Instruction
Batch Analysis
DISERTANTE: Daniel Marin EMPRESA: Honeywell
Integrated Manufacturing Control
• Combining manufacturing process control and procedural control
Experion PKSDCS
Other DCS PLC
Control System Interface
Scale Instrument
POMSnetProcedure
Direct Connect Device
ERPMaster Recipe
DocumentManagement
LIMS
Data Historian
Other
DISERTANTE: Daniel Marin EMPRESA: Honeywell
Interfaced Data
ERP
Inventory Management
Purchasing Management
Planned OrderProduct
Data Mgmt
DistributionMgmt
Resource andCapacity Planning
Receiving
Material andQuality DataManagement
Order/BatchManagement
Recipe
Mat Receiving
DispensingBatch Execution
Mat Management Production Recipe
21 34
5
67
3
4
5
6 9
Item/Material Master Material IssueReport Waste Adjust for SampleAdjust ContainerLot StatusLocation Change
PO DownloadVendor List
Production/Batch Order
Production/Batch StatusMaterial Receipt
AssetMgmt
7
Equipment Status
Recipe / BOM / Routing
Ship Approval /Execution
Report ProductionReport Consumption
Shipping
Shipping
Sales Order Mgmt
8 9
8 Ship Request
ManufacturingProcurement Demand Management
1
2
DISERTANTE: Daniel Marin EMPRESA: Honeywell
Do It Right EVERY TIME!
• Integrated Recipes for Manual processes
• Rich Operator Instruction Capability– Enforcement– Verification
• Point-of-Use Verification – Material Management– Equipment Management
• Online SOP’s• Online MSDS
DISERTANTE: Daniel Marin EMPRESA: Honeywell
Materials and Quality Control
• Receiving to FG Warehouse Including Intermediates
• Enforce Correct Material Use- Barcoding & Point of Use Verification
• Raw Material Quality, Expiration and Retest• Lot Level and Container Level Inventory• Full Forward and Backward Genealogy• Easily Customized Material Dispensing• Material Reconciliation• LIMS Data (assays, hardness, …)• Standard Transactions for ERP
Receiving ProductionWarehouse Staging Shipping
DISERTANTE: Daniel Marin EMPRESA: Honeywell
Equipment Control
• Enforces Correct Equipment– Recipe Requirements– Cleaning– Calibration
• Routings and Connections• Line Clearance• Configurable Status types• Electronic Logs• Status Expiration
– Cleaning and Calibration Expiration
– Use Horizon
DISERTANTE: Daniel Marin EMPRESA: Honeywell
Standard Product - Phase Library / Building Blocks
EquipmentEquipment
MaterialMaterial PersonnelPersonnel
DISERTANTE: Daniel Marin EMPRESA: Honeywell
Reporting: Electronic Batch Record• EBR
– Release By Exception– Material Consumption– Material Production– Equipment Usage– Operator Actions, Calculations, Comments, E-Signatures– Automated equipment parameters -Temperatures, Weights, pH and Alarms
DISERTANTE: Daniel Marin EMPRESA: Honeywell
Why do we need an EBR?
• Reduce batch review and release time– Typical results show 20 – 30% reduction– Release by Exception
• Reduce Errors than need to be Investigated– “Paper on Glass” or “MES”?– 40% of common GMP errors are removed if the EBR
does point of use verification
• Make the EBR electronically available to all stakeholders simultaneously and in real time
• Enhanced Regulatory Compliance
DISERTANTE: Daniel Marin EMPRESA: Honeywell
Web Based Benefits
Zero Foot Print Client• Reduced Qualification/Validation
• Reduced Maintenance – no application maintenance
• Increased Accessibility via Intranet/VPN
• No Local Data stored on Client
DISERTANTE: Daniel Marin EMPRESA: Honeywell
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Web Browser (No Code)
Web Browser (No Code)
Wireless
• Mobile System Access and Control• Simplified Installation• Flexible Use, Configuration and Maintenance
DISERTANTE: Daniel Marin EMPRESA: Honeywell
Virtualization
Platform Virtualization The decoupling of the Operating System from the underlying hardware upon
which it resides.
• Hardware independence
• Hardware consolidation – fewer servers
• Improved manageability, availability and disaster recovery
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DISERTANTE: Daniel Marin EMPRESA: Honeywell
Virtualization
Application VirtualizationThe decoupling of an application from the underlying operating system.
• Application isolation
• Improved compatibility
• Reduced upgrade and installation times
Overall Benefits• Reduce Hardware and OS Change impact
• Improve Resource Utilization (combine apps on common hardware)
• Reduced Energy Costs
DISERTANTE: Daniel Marin EMPRESA: Honeywell
POMSnet Specification – S88 Standard
– Product RecipeDefines All Processes, Material- and Resource-Requirements for an End-Product
– RecipeDefines the Process, Materials and Resources to Make a Batch of Intermediate- or End-Product
– Unit ProcedureA Re-usable Strategy for Carrying Out a Contiguous Process Within a Production Unit.
– OperationAn Independent Group of Processing Activities
– PhaseSmallest Reusable Process Activity
Can C
onsist Of
Can C
onsist Of
Can be U
sed By
Can be U
sed By
DISERTANTE: Daniel Marin EMPRESA: Honeywell
Bulk Tablets Pack
Setup Mix CIP
Record start time
….. Record end time
e-sign
…..
Dispense Blend GranulateUnit Procedures
Operations
Phases
POMSnet Specification – S88 Standard
MES Executive Summary
• MES systems improve your processes by:• Reducing errors• Reducing Waste• Saving time
• MES systems enable Plant Performance Goals
• Simplified IT infrastructure through Wireless Technology and Virtualization
• Flexibility: Mobile Application
DISERTANTE: Daniel Marin EMPRESA: Honeywell
EfficiencyReliabilityRisk
Honeywell’s Mission
Reduce project risk
Improve compliance position
Reliability solutionsto improve your
production profile
Integrated solutions for faster decision making
and reduced production costs
Improving Your Business Performance
DISERTANTE: Daniel Marin EMPRESA: Honeywell