Managing Automation - December 2008 - (Page 39)

[DECEMBER 2008] Transformation Integration TechWatch Industries [ INDUSTRIES ] FINDING FLAWS before they spread Medical device manufacturers, contending with FDA-mandated traceability, as well as the need to manage suppliers and reduce recalls, are turning to quality lifecycle management as the killer app. BY STEPHANIE NEIL ndy Jobson has been working in the medical manufacturing industry for 15 years, and every year he sees stricter FDA regulations and higher risk associated with product recalls. As quality director of Moll Industries, a contract manufacturer specializing in drug delivery and surgical instruments and devices, he says defects due to a manufacturing glitch are unacceptable to him as well as to his customers, their patients, and, of course, the FDA. “If there is ever a defect in a manufacturing device and it causes harm to a patient, there is an FDA sequence of events that will happen, up to and including a recall,” Jobson says. “And if it gets to the stage that they find a particular manufacturing process was at fault, ignorance is not an excuse.” Jobson knows firsthand what it feels like to be caught up in an FDA probe. Last year, one of his customers recalled a product for a defect that, in the course of an FDA investigation, was found to have resulted from a weakness within Moll’s manufacturing process. After finding the root cause and correcting the problem using failure mode and effect analysis (FMEA) software from Dyadem International, Moll implemented a comprehensive quality planning and management system that enables the company to make process changes in order to avoid producing a similar defect in the future. As a result of that incident, the company not only tracks quality processes along the production line, but also has built a risk analysis template that includes a provisional flow diagram illustrating the manufacturing process design. Now, the company builds quality into its early manufacturing design and can flag anything that might cause a product defect down the line — even before it hits production. Photo: iStockphoto.com 39 December 2008 http://www.iStockphoto.com

Table of Contents Feed for the Digital Edition of Managing Automation - December 2008

Managing Automation - December 2008 Contents Take 1 Business Objects Chief Says Union with SAP Meets Objectives After One Year Yes, Emerson, Too, Is in the MES Market Infor Chief Puts Off IPO, Restarts Buying Plans Kronos Now Tracks Shop Floor Machines IQMS Rolls Out User Interace, Other Upgrades Notes Five Ideas for Demand Planning Building on the SOA Blueprint Innovation Now A Team Effort Lean %2B Technology = LEAN^2 Finding Flaws Before They Spread Product Scan Advertiser Index Next

Managing Automation - December 2008

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