Preventing Errors with a Mobile MES

Transcription

1 AADECA JORNADA TECNICA MES* EN INDUSTRIA FARMACEUTICA 14/05/2010 *MANUFACTURING ENTERPRISE SYSTEMS ISPE Preventing Errors with a Mobile MES

2 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

3 Pharmaceutical Manufacturing Human factor Input Process Output Processes in Pharma typically involve people Human factors are unavoidable and when they cause errors it translate to: Wasted time Poor quality Higher cost

4 What can we do? Root Cause: Human error CAPA (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

5 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..

6 Manufacturing Challenges Costs of GMP Compliance Maintaining Paper Records Operator Errors and Omissions Review of Records Investigating Exceptions Production Efficiency Maximizing Equipment Usage Maintenance and Cleaning Rework Operator Training Inventory Raw Materials Stock Levels, Waste WIP Tracking Holds on Finished Goods Accurate Inventory & Quality Tracking Manufacturing Flexibility New Products Expansion Customer Demand

7 Issues Why MES? Manufacturing Errors are Costly Enforce Best Practices Reduction and Avoidance of Manufacturing Errors Costs of Compliance are High Reduced Paperwork Release by Exception Electronic Compliance Records Production Efficiency not Optimal Right Information - Right Time Drive Production Integrated Systems

8 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 equipment tracking, 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.

9 Manufacturing Execution System (MES) Master Batch Record Specify Materials Report Report Execute People Completed Batch Record Equipment

10 MES Functionality S P E C S Business Integration Execution Materials Procedures Equipment Process Integration R E P O R T S

11 Honeywell Application Architecture Training Training Records Planning and Supply Chain( ERP) Lab System (LIMS) Scheduling Order, material consumed, produced Samples, Assay Data Activity Schedule Work Order Management Quality Management Batch Record / Genealogy Records CAPA/DMS QC & Support Data Material Management Equipment Management Enterprise Recipe and Specifications External Systems Interoperable Automation Automated Unit Device Batch Procedure Automated Operation Fieldbus Device Unit Procedure Operation Phase Phase Phase Instruction Serial / Wireless S88 Process Historian Batch Analysis Manual Automated Instruments, Pumps, Valves Scales, Bar Code, Handheld

12 Integrated Manufacturing Control Combining manufacturing process control and procedural control Master Recipe ERP Other Document Management POMSnet Procedure LIMS Direct Connect Device Control System Interface Data Historian Scale Instrument Experion PKS DCS Other DCS PLC

13 Interfaced Data ERP Procurement Demand Management Resource and Capacity Planning Manufacturing Distribution Mgmt Purchasing Management Inventory Management Planned Order Product Data Mgmt Sales Order Mgmt 1 2 Receiving Mat Receiving 3 Material and Quality Data Management 4 Order/Batch Management Dispensing Recipe Batch Execution 5 Asset Mgmt Mat Management Production Recipe Shipping Shipping 1 PO Download Vendor List 4 Production/Batch Order 2 Material Receipt 3 Item/Material Master Material Issue Report Waste Adjust for Sample Adjust Container Lot Status Location Change 5 Production/Batch Status Report Production Report Consumption 6 Equipment Status 9 7 Recipe / BOM / Routing 8 Ship Request Ship Approval /Execution

14 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

15 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 Warehouse Staging Production Shipping

16 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

17 Standard Product - Phase Library / Building Blocks Material Personnel Equipment

18 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

19 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

20 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 FOUNDRY NETWORKS FastIron-II Web Browser (No Code) Web Browser (No Code)

21 Wireless Mobile System Access and Control Simplified Installation Flexible Use, Configuration and Maintenance

22 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 FOUNDRY NETWORKS FastIron-II

23 Virtualization Application Virtualization The 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

24 POMSnet Specification S88 Standard Product Recipe Defines All Processes, Material- and Resource- Requirements for an End-Product Recipe Defines the Process, Materials and Resources to Make a Batch of Intermediate- or End-Product Unit Procedure A Re-usable Strategy for Carrying Out a Contiguous Process Within a Production Unit. Can Consist Of Can be Used By Operation An Independent Group of Processing Activities Phase Smallest Reusable Process Activity

25 POMSnet Specification S88 Standard Bulk Tablets Pack Unit Procedures Dispense Blend Granulate Operations Setup Mix CIP Phases Record start time.. e-sign Record end time..

26 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

27 Honeywell s Mission Improving Your Business Performance Risk Reliability Efficiency Reduce project risk Improve compliance position Reliability solutions to improve your production profile Integrated solutions for faster decision making and reduced production costs

28 Questions? Thank you! Daniel Marin