Managing Automation - January 2008 - (Page 38) [ TRANSFORMATION ] Transformation Integration TechWatch Industries ond-ranked top business strategy for 2007, with a healthy 17% making it a priority by 2012 (see chart, p. 37). “While compliance is an important motivator, we’re seeing some evidence of a shift from implementing automated systems just from a compliance perspective to a realization that you need a systematic approach to improving manufacturing processes in order to obtain a competitive advantage,” says Ron Rubenstein, director of product marketing for Spar ta Systems Inc., which sells an enterprise compliance and quality system called TrackWise. THE PAPER JUNGLE For Ultra Machining Co., a contract manufacturer for medical device companies, automating manual and paper-based processes was as much about gearing up for compliance as it was pushing quality to gain a competitive edge. The company for years had entrusted its quality procedures to a veteran employee. But it faced huge gaps in late 2004 when that 35-year employee retired, along with a document control person and a QA manager. That scenario, coupled with the heightened complexity of achieving compliance on more sophisticated engineered components, prompted UMC to install the IQS integrated system in 2005 to automate its quality processes. Since implementing the system for document control and data collection, UMC has cut audit times with customers in half while exhibiting the kind of consistent controls that give it an advantage over competitors, according to Don Tomann, UMC president. “Before, the lead auditor would have managingautomation.com to run around to find the proper documents, which could be in RELATED ARTICLES: multiple locations,” he says. Rx for the FDA Jitters www.managingautomation.com/FDA “With IQS, everything is linked or embedded in the program, Pharma’s Track & Trace Challenge www.managingautomation.com/industries24 and auditors don’t have to leave their chairs.” Every Step of the Way www.managingautomation.com/industries26 Navigating a paper jungle was also an issue for Gaymar IndusIf It Ain’t Broke, Fix It? www.managingautomation.com/warranty tries Inc., which makes temperature and pressure management devices. The company in 2006 COMPANIES MENTIONED: IBS America Inc. went live with a MasterControl www.managingautomation.com/IBS document control system and IQS has seen significant improvewww.managingautomation.com/IQS ments in its quality processes, Siemens PLM Software says Pat Burandt, Gaymar’s www.managingautomation.com/Siemens MasterControl project manager. Sparta Systems Inc. Specifically, Gaymar now manwww.managingautomation.com/Sparta ages its training records more efficiently, a key requirement of maonline compliance, and has a better handle on its CAPA procedures. In addition, having documents easily accessible online reduces meeting requirements and approval processes, contributing to its ability to move products to market faster. “Management now has a snapshot view of everything happening in this company as far as CAPA goes and what its status is,” Burandt says. “Before, everything was far more ambiguous. Since there’s now a focus on these quality issues, everything comes to closure much more quickly and [the problem of] lost documents is something that doesn’t happen any more.” While eliminating the paper chase was one factor in Wright Medical Technology’s decision to automate, the bigger incentive was to establish an integrated system that could provide a complete picture of a product’s development and compliance standing throughout its lifecycle. The company, which makes or thopedic devices, was already using Siemens PLM Software’s Teamcenter PLM platform as the system of record for its prints and design process. In 2006, it added Teamcenter for Medical Devices to trace all activities — from concept to retirement — by automatically linking compliance requirements with engineering and specification data. Having an integrated system that can track information about a product at any point in the lifecycle is critical when you’re talking about the human body. “One inside the body, the lifecycle of that product is the life of the patient, and that could be 20 to 50 years, depending on what’s going on,” says Amy Cooper, quality documentation super visor for Wright Medical. “Being able to track everything, from how it was supposed to be made to how it was made, and look at that 20 to 30 years down the line in some sort of legible format was the goal.” Meanwhile, back at Optos, Booth’s goal was to have a more efficient quality process — and keep her job. After Optos went public in February 2006, Booth knew the FDA audit would come sooner or later, so she pushed upper management to greenlight the purchase of the IBS CompliantPro software to get Optos’ house in order. Her boss supported the implementation, but told Booth that her job was on the line if the rollout wasn’t a success. Less than one year and an FDA audit later, Booth and the rest of the company stand by that decision. In fact, Optos’ headquarters in the United Kingdom is now trading in another quality management platform for CompliantPro in preparation for its compliance audit. “The integrated platform makes life a lot easier,” Booth says. “There’s no question here now that it is a tremendous asset.” s ma January 38 2008 http://managingautomation.com http://www.managingautomation.com/FDA http://www.managingautomation.com/industries24 http://www.managingautomation.com/industries26 http://www.managingautomation.com/warranty http://www.managingautomation.com/IBS http://www.managingautomation.com/IQS http://www.managingautomation.com/Siemens http://www.managingautomation.com/Sparta
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