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JUL-AUG 2017

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PROCESS AUTOMATION INTECH JULY/AUGUST 2017 19 Shared packs l Some countries request a specific national product code. This means that several data matrix codes have to be print - ed on the pack, which causes technical complexity and con- fusion at dispensing. l Most shared packs will not be possible anymore. Only shared artwork can be used, but with late DM marking (late differentia- tion) or specific stock-keeping units (with batch size reduction). Special considerations Zero defect acceptance criteria If there is a zero-defect acceptance criteria for knowing which serial numbers are shipped, all lines will need aggregation. Lessons learned There is great value in having a standardized global approach when deploying serialization. Extra time is required for global alignment and coordination, but advantages include: l Many resources from multiple sites to tackle a common objective l Centralized knowledge and testing l Tests can be executed once and leveraged across many lines l Reduced capital cost and better cost control (through buying power) l Reduced vendor documentation l Continuous improvement lessons from one site can be implemented on the next n ABOUT THE AUTHOR Bill Lydon (blydon@isa.org) is chief editor of InTech. Lydon has been active in manufacturing automation for more than 25 years. He started his career as a designer of computer-based machine tool controls; in other positions, he applied programmable logic con- trollers and process control technology. In addition to experience at various large companies, he cofounded and was president of a venture-capital-funded industrial automation software company. View the online version at www.isa.org/intech/20170802. One common approach for all sites based on lean principles • One program, one team, one way of working for all sites • Standard templates for all qualification documentation • No unnecessary redundant tests • Leverage tests based on capitalization in compliance with corporate quality guidelines and principles Reduce business impact • Reduce or limit the shutdown period to implement serialization on a line Increase industrial performance • Optimize Sanofi resources allocated to the Q&V process • Optimize vendor resources and consequently costs associated with Q&V activities Share a common compliance vision • Provide one common view to regulatory requirements and inspections • Q&V documentation is similar at all sites (e.g., URS and test protocols) Validation strategy WEFTEC is the one event for professionals, industry experts, and the most innovative companies from around the world. Learn from the very best thought-leaders in water quality. REGISTER NOW www.weftec.org MCCORMICK PLACE CHICAGO CONFERENCE SEP 30 – OCT 4 EXHIBITION OCT 2 – 4

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