Managing Automation - December 2008 - (Page 41)

you make — even if it is just a component for a device — and understand how it works and its potential failures so that you can build a manufacturing process that consistently gives you good parts that don’t fail in a critical way and harm a patient,” Moll’s Jobson says. To that end, Moll, which works with about a dozen medical device OEMs, created a quality planning process that doesn’t just take a customer’s information at face value, but applies a risk analysis that looks at design for manufacturability. “The solution is all about identification, measurement, and mitigation of risk.” — Dyadem’s North “If it comes down to having a product with a design that could yield a defect, we go back to the customer and make suggestions and proposals that may eliminate it,” Jobson says. Dyadem’s risk assessment software, together with its Stature QLM hub, helps close the loop with product design, build, and delivery, whereby information on failures, effects, and causes can be transferred back to the design process to influence product specifications. “At the end of the day, the solution is all about identification, measurement, and mitigation of risk,” says Kevin North, Dyadem’s president and CEO. That means looking at a product from the component level, identifying what could potentially fail, measuring the impact of the potential failures, and ultimately instigating changes in design or manufacturing processes to pre-empt a problem, he says. While vendors such as Dyadem, CIMTEK, Sparta Systems Inc., and MetricStream Inc. offer products geared toward quality workflow, there is still no substitute for the statistical analysis and detailed data tracking for regulatory compliance that DataNet Quality Systems, IBM, and others offer. QUALITY COSTS The medical device industry has been influenced more by regulatory mandates than by efficiency gains. “They are getting killed on the cost of compliance, so [QM] is the low-hanging fruit for them,” DataNet’s Arnett says. The DataNet WinSPC software performs statistical analysis on production processes to detect and correct non-conformances. The goal is data integrity. “If you look at traceability or design changes that impact production, you want to know every bit of context so that when you look at the needle in the haystack, you are looking at the smallest haystack possible,” Arnett says. To that end, WinSPC groups statistical methods into classifications defined by variables that will have bearing on the outcome. “You don’t want to collect 100 variables that are not relevant to the decision you are trying to make,” Arnett says. In this case, you are not measuring output efficiency, but variables related to quality. Similarly, IBM’s Telelogic DOORS software offers product requirements management via traceability from conception to implementation. Since documentation is a critical requirement in the medical manufacturing world, each team — engineering, manufacturing, and quality — is responsible for describing the steps in the process. Correlating that cross-functional information is difficult to do without a change management repositor y that captures the relationships among the systems, which is what DOORS does. “The business driver here is it helps you demonstrate back to auditors that you did what you said you were going to do and that you can validate that,” says Kathi Lafser, senior application engineer at IBM. Prior to joining Telelogic, which IBM acquired earlier this year, Lafser worked as a quality manager at a U.S.-based pharmaceutical company. “We always said, ‘If it’s not documented and not demonstrated, then you didn’t do it,’ ” she says. “Having an audit trail is key in a regulated environment, and DOORS captures all changes.” Indeed, the ability to show compliance, as Moll’s Jobson had to do a year ago during the recall, is managingautomation.com a critical measure of success. The ultimate RELATED ARTICLES: Managing Outsourcing: Ensuring Quality Across goal, however, is to Oceans catch potential failures www.managingautomation.com/managingoutsourcing before they happen. Giving Up the Paper Chase Today, Jobson says, www.managingautomation.com/paperchase Moll is fairly close to PLM’s Vertical Challenge guaranteeing that what www.managingautomation.com/plmchallenge it pushes out of its own Quality Lifecycle Management Goes Enterprise manufacturing faciliwww.managingautomation.com/qlm ties would not be a contributing factor if COMPANIES MENTIONED: there were to be a CIMTEK www.managingautomation.com/cimtek product recall. “We can design a DataNet Quality Systems www.managingautomation.com/datanet process that gives you zero defects on any Dyadem International www.managingautomation.com/dyadem critical quality attributes,” Jobson says. IBM www.managingautomation.com/ibm That’s quality control at its best. ■ maonline Photo courtesy: Dyadem 41 December 2008 http://www.managingautomation.com http://www.managingautomation.com/managingoutsourcing http://www.managingautomation.com/paperchase http://www.managingautomation.com/plmchallenge http://www.managingautomation.com/qlm http://www.managingautomation.com/cimtek http://www.managingautomation.com/datanet http://www.managingautomation.com/dyadem http://www.managingautomation.com/ibm

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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