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JUL-AUG 2017

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Global program leader Deployment teams/ task forces: Definition of standard solution Divisions/ sites* Implementation on sites Vendor IS deployment Valid and qualif. Purchasing Tamper evidence Distrib. Manuf. IS build Mfg. division A Mfg. division B Mfg. division C Mfg. division D Mfg. division E Mfg. division F Site 1 Site 1 Site 1 Site 1 Site 1 Site 1 Site 1 Site 2 Site 2 Site 2 Site 2 Site 2 Site 2 Site 3 Site 3 Site 3 Site 3 Site 3 ... ... ... ... ... Distribution division 18 INTECH JULY/AUGUST 2017 WWW.ISA.ORG PROCESS AUTOMATION Serial number generation l Standard: Generation at lowest possible level based on a corporate specification. l Duplicate handling: Must be at lowest level, i.e., the camera checks and monitors (compares to last number printed). Why? Numbers generated at this level. RISK: Failure may cause duplicate serial numbers. Data matrix location l Standard: Print on the flap; preprint as much as possible, includ- ing the GS1 application identifiers (global standards for business communication), recognizing there will be some exceptions. l Artwork and label position standardization should accommo- date multiple countries. RISK: Dual sourcing Camera l Standard: For item-level printing, the camera should be as far as possible from the print head to ensure ink is dry and to minimize the reflection of the modules in the area of the wet data matrix. l Functions: All printed text must be optical character verifica- tion (OCV) checked, duplicate checked on the printed serial number, and grade equivalence checked. Bundle l Aggregate the bundle only if required by law. l Change the bundle wrapping to uncover the DM for ease of scanning. l If pack codes are not readable downstream of bundling, the bundle must be labeled for aggregation (no virtual ag- gregation is permitted). Case l Apply the label on the case in the case packer machine. l Identify the case with a unique ID, where the unique ID equals the serial shipping container code (SSCC), unless there is another market requirement or law. Pallet l Apply SSCC pallet label immediately upon closing the pallet. Incomplete case/pallet: o Palletizer: Case ID on label > check label > aggregate case to pallet o Pallet should be able to move to the warehouse before the end of the batch. Logistic unit labels: Harmonize to one global standard for all sites (bundle, case, and pallet). l Other special considerations Artwork l Serialization will have an effect (tamper evidence implemen- tation, additional or new space for data matrix). As most art- work will have to be modified, develop artwork templates. l Designations for cost, material scrap, engineering, instal- lation, tests, quality validation Program organization Corporate (coordination team) • Global project coordination • Global contract and costs negotiation with suppliers • Ensure implementation on all the sites of the division • Implementation on site of the corporate solution • Preparation of deployment standard process (line mapping and IS environmental analysis) • Support of deployment teams on key topics • Update on regulatory evolutions (countries, regions) and changes to project timeline • Arbitrate or facilitate decision making • Provide implementation priorities according to regulations • Provide central project teams with implementation status (reporting) • Support vendor on line mapping and implementation • Prepare CAPEX requests • Prepare and follow solution deployment according to standard and best practices • Define schedules and action plans • Capitalize on experiences (Turkey . . . ) • Focus on OEE impact reduction, validation • Define best practices and recommendations • Follow-up on solution implementation Deployment teams (IS core model, manu- facturing, distribution, procurement), additional task forces as needed Division Site Level Responsibilites Actions Technical and economic analysis of a panel of solution providers (10) Serialization and aggregation implementation in 9 months on 26 lines and one distribution center Study/output from pilot to industrialize a global solution and reassess vendors and providers IS optimization of the core model solution and costs negotiation for global worldwide deployment Global deployment according to regulations and integration of lessons learned 2009–2010 2011 2012 2013 2014 onward Maturity of the solution Analysis of all providers Turkish pilot implementation Refinement of the core model Provider reassessment 1 2 3 4 5 Progressive implementation Common tracking and tracing for all sites Manufacturing center Packaging line Packing station Workstation Case Pallet Case Pallet Distribution center Track and trace solution at site and line levels Central Sanofi repository to manage all traceability events 1 2 External manufacturer database MOH 1 Sanofi Database Site Database ERP Site WMS 1 Site Database 1 Site Database Bundle Folding box Program responsibilities Solution: "core model" Global IT standard

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