T03 - Serialization. Best Practices in Reducing Risk and Achieving Business Agility PUBLIC



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T03 - Serialization Best Practices in Reducing Risk and Achieving Business Agility PUBLIC PUBLIC - 5058-CO900G

PUBLIC 2 Agenda What is Serialization Why Serialize The Future of Serialization - Connected Enterprise Serialization Implementation Challenges & Solutions Why Rockwell Automation

PUBLIC What is Serialization? Serialization is the application of unique serial numbers to packages Aggregation is linking all the package level serial numbers in Parent/Child data relationships Unit Dose Carton Case Pallet 8305254961 4693602591-8305254961 1112131415-4693602591 - 8305254961 6016768-1112131415 - 4693602591-8305254961

Supply Chain PUBLIC 4 Holistic Serialization Solution Level 5 Consumer Authentication (Brand Loyalty) Mobile APP Covectra EPCIS Cloud Repository EPCIS Supply Chain

PUBLIC 5 Agenda What is Serialization Why Serialize The Future of Serialization - Connected Enterprise Serialization Implementation Challenges & Solutions Why Rockwell Automation

PUBLIC Why Serialize?

PUBLIC Why Serialize?

Why Serialize? PUBLIC 8

PUBLIC 9 Serialization of Infant Formula for China A $32B global business with Asia representing 53% of the market 2008 contamination of Chinese infant formula results: Increased government regulation of the industry Sharp increase in demand of western product Series of draft guidelines and regulations published in 2014 on infant formula production, including traceability requirements Unofficial reports that Chinese government will require each primary package of infant formula to be serialized starting in Jan 2015 Chinese supply chain partners willing to support track & trace implementation

PUBLIC Why Serialize? Business Category Consumer Safety/Brand Protection Customer Service & Returns Processing Supply Chain Recalls Supply Chain Optimization Brand Loyalty Programs Business Optimization Connected Enterprise Business Benefit Regulatory compliance Product adulteration & diversion control Authenticate transactions Improve chargeback payment accuracy Increase recall accuracy Reduce product recall size Improve forecasting Optimize inventory Improve supply chain planning Drive customer specific target marketing programs Share data across departments Sales, Marketing, Finance, Operations, Supply Chain, etc.

PUBLIC 11 Agenda What is Serialization Why Serialize The Future of Serialization - Connected Enterprise Serialization Implementation Challenges & Solutions Why Rockwell Automation

PUBLIC 12 All manufacturers will serialize their products within 10 years Business benefits - a common data source for: Real time product consumption & demographic data Customer buying behavior information Brand protection, brand loyalty, compliance Big Data from manufactured products will optimize businesses by serving as a common thread across their connected enterprise Various departments will use the common data for their specific needs In the Internet of Everything world, a company s serialization data, when used to optimize the way a business operates, will become one of its most valuable assets

PUBLIC 13 Agenda What is Serialization Why Serialize The Future of Serialization - Connected Enterprise Serialization Implementation Challenges & Solutions Why Rockwell Automation

PUBLIC 14 Level 0 and Level 1 Challenges: Serialized Packaging Lines With Aggregation Serialization Level 1 Aggregation Workstations Blister Packing Cartoning Bundling Case Packing Palletizing Print & Verify Print & Verify Inspect, Confirm Print & Verify Inspect Print & Verify Inspect Print & Verify Insp P&

PUBLIC Printing Expertise Required Thermal Ink Jet HP Laser Drop on Demand Thermal Transfer Continuous Ink Jet Hybrid Flexo / Digital Inks Solvent, UV, Water-based, Security Substrates Paper, Foil, PVC, Tyvek Metal, Direct part marking

PUBLIC Vision Expertise Required Tablet Inspection Gray Scale & Color 3D Imaging, Line Scanners OCR / OCV Part Features Barcode Grading (ANSI Standards) Laser Engraved Metal Integration into HMI Packages High Speed Applications High Speed Web Inspection 2D Matrix Code Grading @ 400 PPM TIJ Printed Carton with Serialized Data

PUBLIC 17 The Solution: Commercial Off-The Shelf Technology Open Serialization platform to interface with existing packaging equipment PLC/PAC controllers for data management at Level 0 & Level 1 Open Network & Communication Standards (EtherNet/IP) PLC/PAC Software in standard IEC 61131-3 programming languages Modular, Reusable & Scalable Solution

PUBLIC Level 2 Level 4 Challenges: Data Integration & Data Management EPCIS: Electronic Product Code Information Services to enable disparate applications to leverage EPC data via EPC-related data sharing, both within and across enterprises. EPCIS ERP Wholesaler External Supply Chain Internal Order Supply number (Enterprise) Order Order endchain status Pharmacist AlarmsPlant A Plant B Contractor Site OEE data Serialization-relevant Shop Floor A1data is A2 widely distributed B1 B2 over different C1 Shop Floor GTIN SSCC Batch number Expiry Prod. date date Line A1-1 Cartoner Print data DM data Bundler Verification data Label Layout Serial Serial range number EPC data EPC event Order number Order status GTIN SSCC SSCC Batch number Order end Alarms Order start Produced quantity Serial number OEE data Expiry date EPC data EPC event Prod. date Line configuration Unit configuration Case Packer Order start Packaging size Palletizer Level 4 Produced quantity Automation and Information Systems at different ISA-95 levels. Level 3 Level 2 Level 0,1

PUBLIC 19 Serialization Data Management Challenges Data exchange? Data consistency? Data redundancy? Data ownership? Who is the master? Scalability? How to manage additional lines? Additional countries? Additional formats? Additional regulations Additional?

The Solution - Data Convergence EPCIS ERP Wholesaler External Supply Chain Internal Supply (Enterprise) Chain Pharmacist Level 4 Site ERP Integration Gateway Site Controller GTIN SSCCBatch Serial Serial number Expiry Prod. range Print number DM date Label data Verification Line Layout Unit Packaging configuration EPC data EPC datasize event Alarms OEE Order data Order number Order status Produced start end quantity Level 3 Shop Floor A1 A2 B1 B2 C1 Line A1-1 Shop Floor Delivering the right data to the right place at the right time! Cartoner Bundler Case Packer Palletizer Level 2 Level 0,1 PUBLIC 20

PUBLIC 21 Site Controller Database Challenges How to integrate different external level 3/4 MES / ERP / EPCIS systems? Do you have to customize for every external system? Are you able to extend and adapt quickly? How to seamlessly integrate with level 0/1/2 Systems and equipment? Can you cope with high speed real-time Serialization systems? Can your site controller cope with the diversity of products, formats, country requirements, pack. line types? Is your site controller CFR 21 Part 11 compliant? Is your site controller pre-validated according to GAMP 5?

PUBLIC 22 Integration with Level 4 (Overview)

PUBLIC 23 The Solution: Open architecture J2EE proven technology for mission-critical enterprise applications Security and stability Scalability without limits Service Oriented Architecture (SOA) Feature rich business layer Supports rich and thin (HTML) clients Variety of supported software Operating Systems Databases Multi-tier data model Application development framework J2EE Strengths High data volumes, high throughput Many users accessing data concurrently Complex business logic Scalability

PUBLIC 24 The Solution: ISA-88 aligned data model Serialization Master Data GTINSSCC Per packaging Serial Randomizer rangelevel Site Model Per Unit packaging configuration line Line configuration Print and Camera Format Print Per DM data packaging Verification data level data Master Recipe Per product Label Layout Packaging size ISA-88 Graphical Approval recipe workbench Version structure Re-usable Mass Real-time change control workflow User Import/Export Management building verification blocks Packaging Order Batch number Serial number Expiry Per order date / Prod. batch date Alarms OEE data Order number Order status Order start Order end Produced quantity Well structured data, ISA-88 and -95 aligned: Consistent Reusable Scalable No redundancies EPC data EPC data EPC event

PUBLIC 25 Level 5 Supply Chain Challenges: Data Accessibility, Management & Security AuthentiTrack Cloud Server Consumers Manufacturing Chicago Los Angeles RDCs Miami Product Flow Data Flow

PUBLIC Forward / Reverse Logistic Challenges

PUBLIC 27 The Solution EPCIS Certified Serial Number Generation & Event Repository (AuthentiTrack Cloud) Layered applications provide a holistic brand integrity solution interfaces to the brand owner, supply chain partners and customers. Central Storage location for serialized data commissioned, decommissioned, event data Serial Number Generation Management - prevent duplication across enterprise (multiple sites) Central communication hub for supply chain partners using EPCIS connector Mobile Applications Connectivity consumer product authentication (iphone, ipad, Droid) Cloud Data Center Services & Security Compliance with SOC2 / SOC3 & ISO/IEC27001:2005 for security, routine backup, disaster recovery Modular & Scalable Distribution Solution Model for Levels 1 3 Scalable Site Server and Network Architecture Modular Supply Chain Rework Stations Disaggregate/Re-aggregate, Decommissioning, etc.

PUBLIC 28 Agenda What is Serialization Why Serialize The Future of Serialization - Connected Enterprise Serialization Implementation Challenges & Solutions Why Rockwell Automation

PUBLIC 29 Why Rockwell Automation? Turnkey Serialization solution unique ability to provide all the key components of a complete serialization solution EPCIS certified Cloud-based serial number generation, management and event repository Expertise in Level 3 4 integration (serialization site server to MES & ERP systems) Packaging line serialization solution for all package types using open architecture Supply chain applications to provide business benefits with a Return on Investment Modular, reusable and scalable solutions Solution built with commercial-off-the-shelf (COTS) products and software Proven technology and integration expertise with ERP & MES applications Capability to provide internal and external supply chain tracking Stable, global partner with global delivery and global support capabilities

PUBLIC 30 Global Support Centers Vancouver Canada (Back-Up/Disaster Recovery) Milton Keynes UK Haan-Gruiten Germany Global Technical Telephone Support Centers Cleveland United States São Paolo Brazil Trained resources for deployment in 80 countries Shanghai, China Singapore Melbourne, Australia Real-time response: 24/7/365

PUBLIC 31 On-site Services with a Local Address North America 280 Field Engineers 206 Tech Support Engineers 780 Project Mgrs./Engineers 390 Additional Tech Resources Europe, Middle East & Africa 165 Field Engineers 40 Tech Support Engineers 930 Project Mgrs./Engineers 277 Additional Tech Resources Asia Pacific 105 Field Engineers 31 Tech Support Engineers 600 Project Mgrs./Engineers 233 Additional Tech Resources Latin America 80 Field Engineers 19 Tech Support Engineers 250 Project Mgrs./Engineers 77 Additional Tech Resources Average 13+ years automation experience operating locally in 80+ countries helping you to install, operate, and maintain