11/13/2015 The Future of Manufacturing in a Connected World Rockwell Automation Joe Whyte Global Serialization Lead Ph: 973-768-3617 jwhyte@ra.rockwell.com PUBLIC PUBLIC - 5058-CO900H Copyright © 2015 Rockwell Automation, Inc. All Rights Reserved. 11/13/2015 Manufacturing Control Disciplines Command and Control Data / Information Energy Management Visualization Condition Monitoring Drive Systems Batch Systems Process Control PUBLIC Discrete Control Safety Systems Servo Systems Robot Systems Copyright © 2015 Rockwell Automation, Inc. All Rights Reserved. 11/13/2015 Multiple Control Disciplines Condition Monitoring PUBLIC Drive System Servo Systems Safety Systems Discrete Control Robot System Process Control Energy Management Batch Systems Copyright © 2015 Rockwell Automation, Inc. All Rights Reserved. 11/13/2015 Control System Evolution Safety System Controller / I/O HMI Switch ENET SERCOS / IRT Freq Drive DNET / RT Motion Control Distributed I/O Power Monitoring Integrated Condition Monitoring Distributed I/O Safety Relay Safety Relay PUBLIC Copyright © 2015 Rockwell Automation, Inc. All Rights Reserved. 11/13/2015 Control System Evolution – ENET IP Safety System Controller / I/O HMI Switch ENET Freq Drive Motion Control Distributed I/O Power Monitoring Integrated Condition Monitoring Distributed I/O Safety Relay Safety Relay PUBLIC Copyright © 2015 Rockwell Automation, Inc. All Rights Reserved. 11/13/2015 Control System Evolution – Ring Integrated Safety Safety System Controller / I/O HMI ENET Freq Drivs Motion Control Distributed I/O Power Monitoring Integrated Condition Monitoring Distributed I/O Safety Relay Safety Relay PUBLIC Copyright © 2015 Rockwell Automation, Inc. All Rights Reserved. 11/13/2015 Control System Evolution – Embedded Historian Historian / Trending Controller / I/O Secure Access HMI ENET Freq Drive Motion Control Distributed I/O Power Monitoring PUBLIC Integrated Condition Monitoring Distributed I/O Copyright © 2015 Rockwell Automation, Inc. All Rights Reserved. 11/13/2015 Purdue Reference Model Level 4 - ERP Business Planning & Logistics Executive Finance Production Scheduling, Operational Management, Resource Planning, etc. Level 3 - MES WAN Manufacturing Operation & Control Operations Quality IT Dispatch Production, Detail Production, Scheduling, Asset Management, etc. Level 2,1,0 – Control, I/O, Batch Devices Control LAN Continuous Control Discrete Control Engineering Maintenance Purchasing Control Networks PUBLIC Copyright © 2015 Rockwell Automation, Inc. All Rights Reserved. 8 11/13/2015 IIoT for Manufacturing Systems Level 5 - Cloud Cloud Level 4 - ERP Consumer, Social, Serialization, Mobility, Analytics,…….. Business Planning & Logistics Production Scheduling, Operational Management, Resource Planning, etc. Level 3 - MES Manufacturing Operation & Control Level 2 - Control Dispatch Production, Detail Production, Scheduling, Asset Management, etc. Manufacturing Control Systems Level 1 – Smart Devices Batch, Continuous, Discrete HMI, Alarming, Trending, Asset Mgmt I/O & Devices Sensors, Power, Instrumentation, Controls Level 0 – Physical Physical Plant Equipment PUBLIC Copyright © 2015 Rockwell Automation, Inc. All Rights Reserved. 9 11/13/2015 <14% 21% 2 Exabytes 75% $20B $65B Machines tied to Enterprise Networks Manufacturers who have suffered IP loss in past year Big data generated by manufacturing More than any other sector US Plants more than 20 years old Risk in the cost of unplanned downtime Global installed base if legacy automation systems nearing end of life SOURCE: Industry Week SOURCE: Kapersky (2014) SOURCE: McKinsey SOURCE: ARC SOURCE: Industry Week SOURCE: ARC IoT - $19T Value at Stake in the Private sector over next 10 years IIoT - $3.9T in Manufacturing 7 Copyright © 2014 Rockwell Automation, Inc. All Rights Reserved. 10 11/13/2015 v Data Materials Time People Resources MANUFACTURING PROCESS Product Energy Waste PUBLIC Copyright © 2015 Rockwell Automation, Inc.11 All Rights Reserved. 11 11/13/2015 THE GOAL: Optimizing Manufacturing Performance 43% of industrial companies make management decisions without the support of relevant data and information Source: ARC Insights Report, Global survey of CIOs, Gartner, Inc.’s Executive Programs PUBLIC Copyright © 2015 Rockwell Automation, Inc. All Rights Reserved. 1212 11/13/2015 What’s stopping you? PUBLIC Standards - Everyone should have them Security - Interconnectivity and access vs IP and Risk Data Privacy and IP - Internal Silos and transparency Legacy Systems - If it isn’t broken don’t fix it Role Models - Who can I copy? Who will let me copy C-Suite Champions - What get’s you up in the morning? Silo vs. Matrix - One or the other? New Working Cultures - Dichotomies of epic proportion Copyright © 2015 Rockwell Automation, Inc. All Rights Reserved. 11/13/2015 Today’s Food Safety Programs This isn’t new HASIP invented 30 years ago Paper based / spreadsheet Snap-shots in time Difficult to track or trace products – can you link process parameters to track product track & traceability Not responsive to the demands that will come in the future REFERENCE: Food Engineering Study statistics PUBLIC Copyright © 2015 Rockwell Automation, Inc. All Rights Reserved. 11/13/2015 LIKE AUTHENTIC POST SHARE Amplified by social media. Rockwell Automation TechED 2015 @ROKTechED #ROKTechED Copyright © 2015 Rockwell Automation, Inc. All Rights Reserved. 15 11/13/2015 Tomorrow’s Food Safety Programs Increase consumer confidence / meet regulatory demands / improve operational efficiency Move from reactive to proactive approach Ease record keep and traceability – improve product tracking Labelling issues – especially for allergens Avoid costly product recalls Maintain brand loyalty. ACCESS TO REAL TIME INFORMATION PUBLIC Copyright © 2015 Rockwell Automation, Inc. All Rights Reserved. 11/13/2015 IMPROVE YOUR FOOD SAFETY PROGRAM 1 Get connected PUBLIC 2 3 Secure your Employ a riskbased preventative networks program 4 Implement product traceability 5 Improve operational efficiency Copyright © 2015 Rockwell Automation, Inc. All Rights Reserved. 11/13/2015 The Connected Enterprise EXECUTION MODEL Assessment Secure, Upgrade Working Data Capital Analytics Collaboration PUBLIC Copyright © 2015 Rockwell Automation, Inc. All Rights Reserved. 11/13/2015 Serialization & Product Traceability Rockwell Automation Joe Whyte Global Serialization Lead jwhyte@ra.rockwell.com PUBLIC PUBLIC - 5058-CO900H Copyright © 2015 Rockwell Automation, Inc. All Rights Reserved. 11/13/2015 Agenda What is Serialization Why Serialize Serialization Implementation Challenges & Solutions The Future of Serialization – Connected Enterprise Why Rockwell Automation PUBLIC Copyright © 2015 Rockwell Automation, Inc. All Rights Reserved. 20 11/13/2015 Serialization Requirements Blister Pack (Unit) Bundle 8305254961 4693602591 8305254961 Human readable unique serial number On each package (USA) On primary package (EU) PUBLIC Case 1112131415 4693602591 8305254961 Pallet 1452267440 1112131415 4693602591 8305254961 Aggregation of all primary package serial numbers to their lower level sub-package serial numbers in parent/child relationships Copyright © 2015 Rockwell Automation, Inc. All Rights Reserved. 21 11/13/2015 Serialization Requirements Track & Trace Track & trace raw materials Generate Acquire, Manage UID for each saleable item Aggregate Package level serial numbers in Parent/Child Data relationships Store Code information in a secure database Associate Code information when dispatching products PUBLIC Scan Codes to verify authenticity of product Validate Serialization data matches the physical product received Raw Materials Track Status of dispensed items to prevent re-use of serial numbers Confirm That products have complete and accurate documentation Warehouse Supplier Central Database (What? When? Where? Why?) Manufacturer Finished Goods Pharmacy Distribution Center Real world goods EPC / Barcode data Copyright © 2015 Rockwell Automation, Inc. All Rights Reserved. 11/13/2015 PUBLIC Copyright © 2015 Rockwell Automation, Inc. All Rights Reserved. 11/13/2015 Agenda What is Serialization Why Serialize Serialization Implementation Challenges & Solutions The Future of Serialization – Connected Enterprise Why Rockwell Automation PUBLIC Copyright © 2015 Rockwell Automation, Inc. All Rights Reserved. 24 11/13/2015 Market Trends: Global Medicinal & Food Product Safety The World Health Organization estimates counterfeit drug sales to range between $35 and 40 billion per year. Between 8 and 10% of the worldwide drug supply is estimated to be counterfeit. Growing health and safety risk with counterfeited drugs Growing involvement in the drug supply chain of under-regulated wholesalers and re-packagers Proliferation of Internet pharmacies, advancements in technology that make it easier to produce counterfeit drugs Increased importation of gray market medicines Ex: the 2008 contamination of Chinese infant formula PUBLIC Copyright © 2015 Rockwell Automation, Inc. All Rights Reserved. 11/13/2015 Regulations & Requirements Regulations and industry standards specify what but not how to implement Serialization. EU Falsified Medicines Directive Drug Supply Chain Security Act (U.S.) China Food & Drug Administration Brazilian Health Surveillance Agency Directive 2001/83/EC- prevention of the entry of falsified medicinal products Identification of suspect product and notification Electronic Drug Supervision Code (EDSC) Resolution RDC 54 Published Dec 10th, 2013 Other countries have begun instituting increased government regulations. PUBLIC Copyright © 2015 Rockwell Automation, Inc. All Rights Reserved. 26 11/13/2015 Aggregation India Country Nigeria Tamper Evident Other Regulations Serialization China Status Codification Regulatory Timelines Denmark Scope December 2015 2012/13 EDL list* July 2014 All Rx drugs - Exports October 2014 Anti-Infective drugs January 2014 All Pharmaceutical Products Algeria January 2015 All Pharmaceutical Products Korea January 2015 All Rx drugs January 2015 All Rx drugs U.S. (Phase 1) Slovenia January 2015 All Rx drugs Saudi Arabia (Phase 1) May 2015 All Rx drugs July 2015 All Rx drugs December 2015 All Pharmaceutical Drugs Japan Brazil (Phase 1) - Final Regulation PUBLIC Deadline - Pending final approval *EDL: Essential Drug List Copyright © 2015 Rockwell Automation, Inc. All Rights Reserved. 27 11/13/2015 Serialization Brazil (Phase 2) Canada Jordan January 2017 All Rx Drugs Ukraine January 2017 All Rx Drugs Saudi Arabia (Phase 2) March 2017 All Rx Drugs U.S. (Phase 2) November 2017 All Rx Drugs UK Q4 2017 All Rx Drugs EU Q4 2018 All Pharmaceutical Products Taiwan January 2018 All Rx Drugs U.S. (Phase 3) November 2023 All Rx Drugs Tamper Evident Other Regulations Codification Status Mexico Country - Final Regulation PUBLIC Aggregation Regulatory Timelines Deadline Scope January 2016 All Rx Drugs December 2016 All Rx Drugs January 2017 All Rx Drugs - Pending final approval Copyright © 2015 Rockwell Automation, Inc. All Rights Reserved. 28 11/13/2015 Albania Cameroon Chile Columbia Libya Singapore Tamper Evident Other Regulations Aggregation Serialization Country Codification Status Regulatory Timelines TBD All Pharmaceutical Products TBD All Pharmaceutical Products TBD All Pharmaceutical Products TBD All Pharmaceutical Products TBD All Rx Drugs TBD All Rx Drugs TBD All Pharmaceutical Products - Pending final approval Country PUBLIC Scope Malaysia - Final Regulation Deadline Regulation Deadline Scope U.S. UDI Varies All Med Devices UK UDI TBD All Med Devices Copyright © 2015 Rockwell Automation, Inc. All Rights Reserved. 29 11/13/2015 Why Serialize? - Business ROI Reasons Business Category Business Benefit • CONSUMER SAFETY/ BRAND PROTECTION • • CUSTOMER SERVICE & RETURNS PROCESSING SUPPLY CHAIN INTEGRITY • • • • • SUPPLY CHAIN OPTIMIZATION • • • MARKETING & BRAND LOYALTY PROGRAMS • • • BUSINESS OPTIMIZATION – CONNECTED ENTERPRISE PUBLIC • Regulatory compliance Product adulteration control Diversion source & location control Authenticate transactions Improve chargeback payment accuracy Complete Supply Chain Traceability Increase recall accuracy & efficiency Direct to customer notifications Improve forecasting Optimize inventory Improve supply chain planning Real time consumer & product market data Customer specific target marketing programs Consumer authentication via mobile device Share data across departments: Sales, Marketing, Finance, Operations, Supply Chain, etc. Copyright © 2015 Rockwell Automation, Inc. All Rights Reserved. 30 11/13/2015 Agenda What is Serialization Why Serialize Serialization Implementation Challenges & Solutions The Future of Serialization – Connected Enterprise Why Rockwell Automation PUBLIC Copyright © 2015 Rockwell Automation, Inc. All Rights Reserved. 31 PUBLIC LEVEL 5 Scalability in Supply Chain • Scalable serialization solution to support distributed operations: manufacturing, distribution, warehouse, pharmacy • EPCIS - How to manage additional lines? Countries? Formats? Regulations? LEVEL 4 Data Integration & Data Management • High amount of data • Printing and verification in a high speed environment LEVEL 3 Data Accessibility & Management (Level 3) LEVEL 2 • Data security • Data exchange with external partners and interfaces between systems • Data consistency, Data redundancy, Data Ownership, Master data LEVEL 1 OEM IMPLEMENTATION CHALLENGES 11/13/2015 LEVEL 0 Operational Challenges for Data Generation & Acquisition • • • • • • Uniqueness of applied numbers (preferred randomized) Product handling, product rejection, product rework, line modifications Physical product package limitations (space, materials, environment, etc.) Application & Inspection of printed codes Wide range of products, data formats, packaging line types Data Sequencing & Coordination of Material Handling, Printing & Inspection Copyright © 2015 Rockwell Automation, Inc. All Rights Reserved. 32 11/13/2015 Operational Challenges IMPLEMENTATION CHALLENGES (LEVEL 0 – LEVEL 1) PUBLIC Copyright © 2015 Rockwell Automation, Inc. All Rights Reserved. 11/13/2015 Printing Expertise Required IMPLEMENTATION CHALLENGES (LEVEL 0 – LEVEL 1) Selecting the right technology for the application is critical to success • Thermal Ink Jet HP • Laser • Preprinted Label • Drop on Demand • Thermal Transfer • Continuous Ink Jet • Hybrid – Flexo / Digital • Inks – Solvent, UV, Waterbased, Security • Substrates – Paper, Foil, PVC, Tyvek Metal, Direct part marking PUBLIC Copyright © 2015 Rockwell Automation, Inc. All Rights Reserved. 11/13/2015 Vision Expertise Required IMPLEMENTATION CHALLENGES (LEVEL 0 – LEVEL 1) Tablet Inspection Selecting the right technology for the application is critical to success • Gray Scale & Color • 3D Imaging, Line Scanners • OCR / OCV Laser Engraved Metal • Part Features • Barcode Grading (ANSI Standards) • Integration into HMI Packages • High Speed Applications TIJ Printed Carton w/ Serialized Data PUBLIC • High Speed Web Inspection • 2D Matrix Code Grading @ 400 PPM Copyright © 2015 Rockwell Automation, Inc. All Rights Reserved. 35 11/13/2015 Commercial Off-The Shelf Technology IMPLEMENTATION SOLUTION (LEVEL 0 – LEVEL 1) • 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 Copyright © 2015 Rockwell Automation, Inc. All Rights Reserved. 36 11/13/2015 Data Management Challenges Serial range SITE SHOP FLOOR GTIN Order(ENTERPRISE) number Order INTERNAL CHAIN SSCC Order end status Order start Batch number SUPPLY Expiry Prod.date date Produced quantity LEVEL 4 LEVEL 3 Alarms Plant AOEE data Serialization-relevant data isPlant widely distributed over different B Contractor Automation and Information Systems at different ISA-95 levels! SHOP FLOOR A1 A2 B2 B1 C1 SSCC OrderOrder statusstart Produced quantity number Line A1-1GTIN Order end SSCC BatchOrder number Alarms Serial number Expiry date Prod. date Print data CARTONER PUBLIC Serial number EPCIS EVENT REPOSITORY EPC data EPC event PHARMACIST EXTERNAL SUPPLY CHAIN WHOLESALER ERP EPCIS IMPLEMENTATION CHALLENGES (LEVEL 2 – LEVEL 4) OEE data DM data Verification data BUNDLER Line configuration Label Layout EPC data EPC event Unit configuration Packaging size CASE PACKER LEVEL 2 LEVEL 0,1 PALLETIZER Copyright © 2015 Rockwell Automation, Inc. All Rights Reserved. 37 11/13/2015 Data Accessibility & Data Management IMPLEMENTATION CHALLENGES (LEVEL 2 – LEVEL 4) 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 server cope with the diversity of products, formats, country requirement, packaging line types? Is your site server CFR 21 Part 11-compliant? Code of Federal Regulations Part 11 of Title 21: electronic records, electronic signatures Is your site server pre-validated according to GAMP 5? A risk-based approach to compliant good automated manufacturing practice computerized systems PUBLIC Copyright © 2015 Rockwell Automation, Inc. All Rights Reserved. 38 11/13/2015 Data Convergence (ISA-88 aligned data model) EPCIS EVENT REPOSITORY WHOLESALER PHARMACIST EXTERNAL SUPPLY CHAIN LEVEL 4 ERP EPCIS IMPLEMENTATION SOLUTION (LEVEL 2 – LEVEL 4) INTERNAL SUPPLY (ENTERPRISE) CHAIN SHOP FLOOR SITE ERP INTEGRATION GATEWAY Delivering the right data to the right place at the right time! GTINSSCC Batch number Unit configuration Packaging size EPC event EPC SerialSerial rangeExpiry Label Layout Verification Line data configuration Order start number DM data OEEOrder data EPC data Order status OrderProduced end number quantity Prod. datePrint datedata Alarms SHOP FLOOR A1 A2 B1 B2 C1 Line A1-1 LEVEL 2 LEVEL 0,1 CARTONER PUBLIC LEVEL 3 SITE SERVER BUNDLER CASE PACKER PALLETIZER Copyright © 2015 Rockwell Automation, Inc. All Rights Reserved. 39 11/13/2015 ISA-88 aligned data model IMPLEMENTATION SOLUTION (LEVEL 2 – LEVEL 4) Serialization Master Data Master Recipe SSCC Serial range level Randomizer →GTIN Per packaging Site Model Line configuration Unit configuration → Per packaging line Print and Camera Format → Per packaging level Print DM data Verification data data → Per product Label Layout Packaging size Graphical workbench ISA-88 Approval recipe workflow structure Version control User Management Re-usable Real-time Mass Import/Export change building blocks verification Packaging Order Batch number Serial number →Expiry Per order date / Prod. date batch Alarms OEE data Order number Order status Order start Order end Produced quantity Well structured data, ISA-88 and -95 aligned: PUBLIC Consistent Reusable Scalable No redundancies EPC data EPC data EPC event Copyright © 2015 Rockwell Automation, Inc. All Rights Reserved. 40 11/13/2015 Open Architecture IMPLEMENTATION SOLUTION (LEVEL 2 – LEVEL 4) J2EE – proven technology for missioncritical enterprise applications High data volumes, high throughput Many users accessing data concurrently Security and stability Complex business logic Scalability without limits Scalability 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 PUBLIC Copyright © 2015 Rockwell Automation, Inc. All Rights Reserved. 41 11/13/2015 Integration with ERP Business Systems IMPLMENTATION SOLUTION IMPLEMENTATION SOLUTION (LEVEL (LEVEL 3– 2Level – LEVEL 4) 4) Serialization Module PUBLIC Copyright © 2015 Rockwell Automation, Inc. All Rights Reserved. 42 11/13/2015 Supply Chain Challenges IMPLEMENTATION CHALLENGES (LEVEL 5) EPCIS Certified Event Repository on Microsoft Azure Brazil - Dec 2015 Manufacturing Consumers Consumers Brasilia RDC Product Flow Data Flow CDC – Central Distribution Center RDC – Regional Distribution Center PUBLIC Sao Paulo CDC RDC’s Copyright © 2015 Rockwell Automation, Inc. All Rights Reserved. 43 11/13/2015 Forward/Reverse Logistics IMPLEMENTATION CHALLENGE (LEVEL 5) EPCIS Event Repository Checking Service Checking Service PUBLIC Copyright © 2015 Rockwell Automation, Inc. All Rights Reserved. 44 11/13/2015 GS1, EPCIS & Global Interoperability ALL COUNTRIES WITH THE EXCEPTION OF CHINA ARE FOLLOWING THE GS1 STANDARDS GSI - An International not-for-profit association with over 100 country organizations • Design and implement global standards and solutions that improve efficiency and visibility of supply and demand chains globally across sectors. • Most widely used supply chain standards system in the world. GS1 Standards • • • • • • • • Barcode Standards Data Accuracy Standards eCom Standards Electronic Product Code (EPC) Standards Global Data Synchronization Network (GDSN) Standards Global Data Dictionary Global Product Classification (GPC) Standards Extensible Markup Language (XML) Standards EPCIS: Electronic Product Code Information Services • Enables disparate applications to leverage EPC data via EPCrelated data sharing, both within and across enterprises. © RC Partners 2015 PUBLIC Copyright © 2015 Rockwell Automation, Inc. All Rights Reserved. 45 11/13/2015 IDENTIFY: GS1 identification numbers GS1 Standards begin with GS1 Identification Numbers used to uniquely distinguish all products (trade items), logistic units, locations, assets, and relationships across the supply chain from manufacturer to consumer. © RC Partners 2015 PUBLIC Copyright © 2015 Rockwell Automation, Inc. All Rights Reserved. 46 11/13/2015 Capture: GS1 Data carriers GS1 Data Carriers are capable of holding varying amounts of data to accommodate different needs for different products. The appearance of the EPCglobal Seal is to inform that an EPC-Enabled RFID tag is present on or within the packaging of the product(s). 47 © RC Partners 2015 PUBLIC Copyright © 2015 Rockwell Automation, Inc. All Rights Reserved. 11/13/2015 SHARE: GS1 Data EXCHANGE Interoperability, made possible by identification standards, data capture standards, and data exchange standards, allows product information to flow through the supply chain. 48 © RC Partners 2015 PUBLIC Copyright © 2015 Rockwell Automation, Inc. All Rights Reserved. 11/13/2015 FDA Draft Guidance on data exchange Transaction Statement, Transaction Information, Transaction History 2015: 1. 2. 3. Transaction Statement Transaction Information Transaction History 2023: 1. 2. 3. Transaction Statement Transaction Information “facilitate gathering the information necessary to produce the transaction information for each transaction going back to the manufacturer” … (TIn) © RC Partners 2015 PUBLIC 49 Copyright © 2015 Rockwell Automation, Inc. All Rights Reserved. 11/13/2015 FDA Draft Guidance on data exchange Transaction Statement, Transaction Information, Transaction History © RC Partners 2015 PUBLIC 50 Copyright © 2015 Rockwell Automation, Inc. All Rights Reserved. 11/13/2015 FDA Draft Guidance on data exchange EPCIS Basics + 1. 2. 3. 4. PUBLIC Purpose Built for T&T Extensible Includes Query Capability Global + 1. 2. Application Identifiers (things we want to track) Global (National Health Reimbursement Numbers) 51 1. 2. 3. 4. 5. Business Steps Product Dispositions Standard Vocabularies Extensible Global © RC Partners 2015 Copyright © 2015 Rockwell Automation, Inc. All Rights Reserved. 11/13/2015 What is EPCIS? Purpose built for T&T – Flexible – Extensible - Global Manufacturer Distributor(s) Dispenser Dispense 1 Commission < Pack < Ship < Rcv < Unpack < Pack < Ship < Rcv < Unpack Destroy < Decommission 2 DSCSA Data DSCSA Data EPCIS was purpose built for Track & Trace 3 EPCIS includes the ability to query or ask for information: All events for Item “00312345325671”? • • • PUBLIC Commissioning Event Packing Event Shipping Event 52 1. Extensible “events” and “Dispositions” 2. May Extend Information for: 3. Geographies Industries Trading Partners Includes Query functionality © RC Partners 2015 Copyright © 2015 Rockwell Automation, Inc. All Rights Reserved. 11/13/2015 EPCIS Vs. EDI for DSCSA EDI … ASNs: EPCIS: • For 2015 requirements: • For 2015 requirements: • Extended version is working. • • For 2023 requirements: • • • • • • • • We’re asking a lot from a message format that wasn’t created for this purpose. It’s not global (Format: ANSII in US, GS1 elsewhere) It’s not extensible without Standards action (multi-year process) Carries more data than needed No Exception Processes No query mechanism Needs Checking/Discovery process Needs Certification process Extended version is working. • For 2023 requirements: • • • • • • • • Purpose built for T&T It’s global It’s extensible without Standards action (multi-year process) Carries minimum data Exception Processes Query mechanism Needs Checking/Discovery process Needs Certification Process © RC Partners 2015 PUBLIC 53 Copyright © 2015 Rockwell Automation, Inc. All Rights Reserved. 11/13/2015 Serialization Event Repository Database IMPLEMENTATION SOLUTION (LEVEL 5) Database is EPCIS certified by GS1 to support global exchange of data with supply chain partners Generation of random or sequential serial numbers in GS1 format - prevents duplication across enterprise (multiple sites) Hosted in Microsoft Azure Cloud Data centers located in 89 countries Compliance with SOC2 / SOC3 and ISO/IEC27001:2005 for security, routine backup, and disaster recovery Includes event repository, which captures every event (e.g. commissioning, decommissioning, rework, authentication) of each package barcode. Event file is maintained for the life of the product. Provisions serial numbers and downloads to the Level 3 site server at client’s facility. Receives serial numbers after completion of batch. PUBLIC Copyright © 2015 Rockwell Automation, Inc. All Rights Reserved. 54 11/13/2015 Supply Chain Applications IMPLEMENTATION SOLUTION (LEVEL 5) Configuration of supply chain partners to enable rework of pallets and cases while maintaining aggregation integrity Authentication by supply chain partners using smart scanners Track & Trace through downstream supply chain Detection of gray market diversion More efficient recall management More accurate returns management, including returns price verification Consumer authentication, communications and loyalty programs using mobile devices PUBLIC Copyright © 2015 Rockwell Automation, Inc. All Rights Reserved. 55 11/13/2015 Multi-function Dashboards IMPLEMENTATION SOLUTION (LEVEL 5) PUBLIC Copyright © 2015 Rockwell Automation, Inc. All Rights Reserved. 56 11/13/2015 © Microsoft 2015 11/13/2015 Huge infrastructure scale is the enabler 19 Regions ONLINE…huge datacenter capacity around the world…and we’re growing North Europe Central US North Central US Iowa Illinois Ireland West Europe Netherlands China North * US Gov Beijing East US Iowa West US Virginia South Central US Texas India West US Gov India East Japan West TBD Osaka TBD Virginia Saitama Shanghai East US 2 California Japan East China South * Virginia East Asia Hong Kong SE Asia Singapore Australia East Sydney Brazil South Sao Paulo 100+ datacenters One of the top 3 networks in the world (coverage, speed, connections) 2 x AWS and 6x Google number of offered regions G Series – Largest VM available in the market – 32 cores, 448GB Ram, SSD… Australia West Melbourne Announced Operational * Operated by 21Vianet © Microsoft 2015 11/13/2015 Virtual Machines Cloud Services App Services Windows Store iOS Android HTML5/JS Windows Phone iOS Android Nokia X GALLERY DEPLOY YOUR CODE Load Balancer Gallery Load Balancer Windows VIRTUAL MACHINES WEB ROLE INSTANCES Load Balancer APP INSTANCES Linux QUEUE VIRTUAL NETWORK SQL CACHE TYPE X TYPE Y APP TYPES … API APP Blobs/Files Database STORAGE BLOBS / FILES (Virtual Disks) Get full control over a server in the cloud and maintain it as your business requires. Managed Virtual Machines with specific web and worker roles that are stateless Batch For running large scale parallel and high performance computing (HPC) applications Scheduler Create jobs that run reliably on simple or complex schedules to invoke any type of service. Access Windows apps that run within the Service on VM’s from any device and any location. Express Route Provision and manage VPNs in Azure and securely link to your onpremises IT infrastructure. Connect on-premises and cloud data centers directly through dedicated, non-internet lines. Store binary application data and web content – store for dedicated and shared virtual disks for VM’s Add backend capabilities to mobile apps, with native client support on most device platforms. API Apps Create and surface your app logic as APIs for other services and apps to consume. Logic Apps Build/execute business processes by linking your own custom API’s with an API Gallery/Marketplace Simple message queue for application de-coupling architecture for scale out. Load-balance incoming global traffic across multiple services running in multiple data centers. Active Directory Identity and access management for cloud applications and ability to link to on-premises Server AD. Multi-Factor Authentication Safeguard access to data and apps with additional physical layer of security control. API Management Publish and Manage APIs to developers, partners and employees securely and at scale. Notification Hubs Deliver millions of cross platform push notifications from any application backend, anywhere. HDInsight Big Data (based on Apache Hadoop) analytics that integrate easily with Microsoft Office. Machine Learning Stream Analytics Data Factory Mine historical data with compute power to predict future trends or behavior. Process data streams in real-time to discover and react to trends. Ingest data from multiple sources to combine into a cloud based Data Warehouse. Media Services Range of services that support video on-demand and live streaming workflows. Content Delivery Network (CDN) Cache content for your apps at 100’s of edge locations to improve user experiences. Managed service that handles backup/restore of Windows Server machines/backup agent. Import/Export For massive data transfer – ship encrypted disks to move data in/out of blob storage. Site Recovery Coordinate replication and recovery of System Center private clouds StorSimple Automated, policy driven solution to extend on-premises primary storage for backup / DR. SQL Database DocumentDB Managed relational database service with high availability and selectable performance levels. Store/retrieve millions of JSON objects from a highly scalable NoSQL document database. Portal Key Vault Redis Cache Make applications scale and be more responsive under load by keeping data closer to app logic. MANAGEMENT Biztalk Services Build EDI and Enterprise App Integration (EAI) solutions in the cloud. Hybrid Connections Connect apps in Azure with onpremises resources without a VPN or dedicated line. Service Bus Messaging capabilities (pub/sub, queues) and on-premises to cloud connectivity solution. Automation Run durable PowerShell scripts to automate frequent, long running, complex Azure tasks. Event Hubs Ingest, persist, process millions of events per second from millions of devices. Mobile Engagement Ingest, persist, process millions of events per second from millions of devices. DEVELOPER SERVICES DATA Backup HYBRID INTEGRATION Storage Queues Traffic Manager ANALYTICS Mobile Apps STORAGE & BACKUP Storage Blobs & Files MEDIA & CDN IDENTITY & ACCESS Virtual Network Remote App WEB & MOBILE Managed web platform, get started for free and scale as you go using many tools/ languages. API MARKETPLACE… NETWORKING Cloud Services Web Apps Tables/NoSQL MOBILE APP WEB APP STORAGE SOLUTIONS COMPUTE Virtual Machines LOGIC APP Search Managed, scalable search service for your apps, create tunable search results and ranking models. Tables Massive scale for semi-structured key/value type data in this schema-less NoSQL store. Visual Studio Online Store code, plan and track projects, build, deploy and test apps in the cloud collaboratively. Application Insights Analyze app usage, availability and performance to detect issues and solve problems proactively. COMMERCE Web based experience to provision, control and monitor all Azure services. Safeguard and control keys and secrets in cloud scale hardware security modules. Operational Insights Analyze and troubleshoot onpremises IT infrastructure without using instrumented code. Store / Marketplace Find and manage other services provided by third parties. VM Depot Find free open source VM images that you can download and run in Azure Virtual Machines. © Microsoft 2015 11/13/2015 Support & Maintainability Challenges When serializing for regulatory compliance reasons Serialization system failures in production sites = No Production Network infrastructure Site Server Unit & line controllers Equipment data interfaces Operator interfaces Printers & Vision systems PUBLIC Mission critical production assets require immediate attention Single point of contact for the entire Level 0 – Level 3 system Real-time Serialization Application-level support Periodic performance analysis and reviews Remote monitoring & diagnostics Emergency dispatch Copyright © 2015 Rockwell Automation, Inc. All Rights Reserved. 60 11/13/2015 Remote Serialization Application & Monitoring Support Internet Process Firewall Industrial Security Zone VSE- Remote Access Cell/Area Zone PUBLIC Copyright © 2015 Rockwell Automation, Inc. All Rights Reserved. 61 11/13/2015 Scalable Supply Chain Connectivity Model IMPLEMENTATION SOLUTION (LEVEL 5) Scalable Distribution Center Site Server Solution – Servers, Switches, Storage, Memory & Software Standard Solution for Long Term Support Tested, validated reference design Inclusive of all hardware, software and services Best choice of server, network & storage Lower total lifecycle cost – Reduced IT administration and support – Reduced server footprint – Enhanced security – Simplified backup – Simplified restore PUBLIC Copyright © 2015 Rockwell Automation, Inc. All Rights Reserved. 62 11/13/2015 Agenda What is Serialization Why Serialize Serialization Implementation Challenges & Solutions The Future of Serialization – Connected Enterprise Why Rockwell Automation PUBLIC Copyright © 2015 Rockwell Automation, Inc. All Rights Reserved. 63 11/13/2015 The Connected Enterprise Prediction All manufacturers will serialize their products within 10 years BUSINESS BENEFITS • • • PUBLIC Real time product consumption & demographic data Customer buying behavior information Brand protection, brand loyalty, compliance…. BIG DATA • • Serialized products will optimize businesses by serving as a common thread across the connected enterprise Various departments will use the common data for their specific needs “INTERNET OF EVERYTHING” • A company’s serialization data, when used to optimize the way a business operates, will become one of its most valuable assets Copyright © 2015 Rockwell Automation, Inc. All Rights Reserved. 64 11/13/2015 Agenda What is Serialization Why Serialize Serialization Implementation Challenges & Solutions The Future of Serialization – Connected Enterprise Why Rockwell Automation PUBLIC Copyright © 2015 Rockwell Automation, Inc. All Rights Reserved. 65 LEVEL 5 CONSUMER AUTHENTICATION (BRAND LOYALTY) EPCIS CERTIFIED CLOUD BASED EVENT REPOSITORY CONSUMER AUTHENTICATION (BRAND LOYALTY) EPCIS MES ERP Turnkey, holistic solution providing complete serialization LEVEL 4 EIG EIG BACKEND LEVEL 3 SITE SERVER LEVEL 2 LINE CONTROLLER Mobile applications MOBILE CLIENT From controllers to MES to ERP PUBLIC MOBILE APP EIG Holistic Serialization Solution 11/13/2015 Secure Cloud-based central data storage for serialized date connectivity to support consumer product authentication PMC PEC Serial number generation management PLC Central communication hub for supply chain partners OEMS LEVEL 1 PRIMARY PACKAGING CASE PACKAGING PALLETIZER PACKAGING AGGREGATION WORKSTATION AGGREGATION WORKSTATION AGGREGATION WORKSTATION LEVEL 0 Copyright © 2015 Rockwell Automation, Inc. All Rights Reserved. 66 11/13/2015 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 & event repository • Expertize 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 and a potential Return on Investment • Modular, reusable and scalable solutions • Solution built with Commercial-off-the Shelf (COTS) products and software • Proven technology & integration expertize with ERP & MES applications • Capability to provide internal and external supply chain tracking • Stable, global partner with global delivery and global support capabilities PUBLIC Copyright © 2015 Rockwell Automation, Inc. All Rights Reserved. 67 11/13/2015 Why Rockwell Automation: Global Support Centers Global technical telephone support centers Trained resources for deployment in 80 countries Real-time response 24 / 7 /365 Cleveland / United States Vancouver / Canada Backup / Disaster Recovery PUBLIC Sao Paolo / Brazil Milton Keynes / UK Haan-Gruiten / Germany Shanghai / China Singapore Melbourne / Australia Copyright © 2015 Rockwell Automation, Inc. All Rights Reserved. 68 11/13/2015 Why Rockwell Automation: Remote Serialization Application & Monitoring Support Administration Configuration & Change Management Knowledge Management Portal for all reference information Network Design Services Surveillance and Alarming Infrastructure standards and governance Remote Asset & Process Health Monitoring Serialization Application Support TechConnect PUBLIC Copyright © 2015 Rockwell Automation, Inc. All Rights Reserved. 69 11/13/2015 Why Rockwell Automation: Remote Serialization Application & Monitoring Support Serialization Application Support PUBLIC Site Visit Gather documentation, code familiarization Designated support team becomes intimately familiar with your system Real-time Serialization application-level support Dedicated telephone and e-mail Periodic performance reviews Copyright © 2015 Rockwell Automation, Inc. All Rights Reserved. 70 11/13/2015 Why Rockwell Automation: Remote Serialization Application & Monitoring Support Surveillance and Alarming PUBLIC Remote Asset and Process Health Monitoring Network and virtual infrastructure Control process and infrastructure Drive systems Alarm acknowledgement in agreed upon SLA’s Copyright © 2015 Rockwell Automation, Inc. All Rights Reserved. 71 11/13/2015 Upcoming Events Serialization in Action Join us at this upcoming event to learn more about Serialization November 18-19, 2015 Automation Fair PUBLIC Chicago, IL Copyright © 2015 Rockwell Automation, Inc. All Rights Reserved. 72