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August 2008 |
Volume 12, Number 8 |
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To Ensure Workable Procedures, Consult Your Workers, FDA Advises
EFFECTIVE QUALITY SYSTEM PROCEDURES begin with listening to employee feedback, FDA quality systems expert Kim Trautman tells device manufacturers. She points out that some firms have too many procedures, while others stuff their SOPs full of extraneous information, which is why it’s important for companies to ask workers to sound the alarm when they become overwhelmed. Managers "need to go to the people who are doing the processes and determine what procedures they’re utilizing, how they’re utilizing them, and whether [the SOPs] are confusing or bouncing them around to too many different places," Trautman says. Also, officials at Welch Allyn, Thoratec and Philips Consumer Healthcare Solutions discuss their approaches to building strong SOPs...
REFORMS AT BOSTON SCIENTIFIC have allowed the company to manufacture products based on a "new foundation of quality and a new way of doing things," the firm’s recently appointed quality chief, Fred Colen, says in an interview...
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| July 2008 |
Volume 12, Number 7 |
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QSR May Eventually Direct Firms To Gather, Use Customer Feedback
COLLECTING CUSTOMER FEEDBACK isn’t necessarily required of device manufacturers, but it one day could be if FDA brings the Quality System Regulation more in line with ISO 13485, CDRH’s compliance chief says. "One difference between the Quality System Regulation and ISO 13485 is the idea of continuous improvement and customer satisfaction," says Tim Ulatowski, director of the Office of Compliance. Meanwhile, it is possible the agency may modify the QSR to include requirements to gather and analyze customer feedback. Additionally, device manufacturers Steris, Philips Medical Systems and MEDRAD have used various methods to gauge customer satisfaction, and at the same time improve their quality systems...
DON’T LET SUPPLIERS GET AWAY WITH MISTAKES that could impact the quality of devices, experts say. Using a vendor report card and downgrading a supplier’s status on an approved vendor list are two ways companies can keep suppliers in line...
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| June 2008 |
Volume 12, Number 6 |
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Lack Of Procedures, Documentation Will Lead To Warning Letter, FDA Says
WARNING LETTERS ARE LIKELY FOR MANUFACTURERS that don’t document their quality system activities or create standard operating procedures, FDA says. CDRH official Cap Uldriks discusses the sorts of documentation lapses FDA sees at some companies, and describes what investigators look for during a facility inspection. Hitachi Chemical Diagnostics also describes the nitty-gritty of its document control system...
AS FDA CONSIDERS ACCEPTING ISO 13485 AUDIT REPORTS in place of its own inspections of foreign device manufacturers to help stretch its resources further, it is aware that any changes could eventually impact domestic firms. A former FDA investigator questions, however, whether ISO audits are comparable to the agency’s more rigorous inspections...
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| May 2008 |
Volume 12, Number 5 |
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GHTF Document: Firms Should Control, Audit ‘Sub-Tier’ Vendors When Needed
FDA SAYS SUPPLIER CONTROL PROBLEMS HAVE LED TO RECALLS, but device manufacturers can learn how to better handle vendor issues thanks to a new draft guidance from the Global Harmonization Task Force. Released April 25, the draft gives advice on various facets of supplier control, including the need to control and audit "sub-tier" suppliers, the use of risk management when selecting vendors, and pitfalls surrounding internal supplying. FDA plans ultimately to adopt the document as an agency guidance that will help companies better carry out Quality System Regulation requirements. "We see it as a valuable educational tool," FDA GMP expert Kim Trautman says...
ADVANCED BIONICS IS FACING $2.2 MILLION IN FDA CIVIL MONEY PENALTIES in relation to alleged supplier control problems. The cochlear implant manufacturer’s VP of regulatory and legal affairs talks with "The Silver Sheet" about how the company is handling the case...
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