|
|
Article: Quality systems - Risk analysis seen benefitting firms in recall situations.(Fran Akelewicz, Becton-Dickinson and Co.)(Brief Article)
- Article from:
- Validation Times
- Article date:
- October 1, 2000
- Author:
CopyrightCOPYRIGHT 2000 Washington Information Source, Inc. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
|
ROCKVILLE, MD Risk analysis, which is one of the chief tenets of ISO 9000 and FDA's medical device QS requirements, can be helpful in product recalls in terms of giving RA/QA personnel a road map to figure out the severity of the problem.
That's what Fran Akelew-icz used at Becton-Dickinson
(B-D) when her company faced a product recall recently, she told the Assn. of Medical Diagnostics Manufacturers' annual meeting here Sept. 21."
Akelewicz, worldwide director of QA management and regulatory affairs, said she "got a call late one night. Someone said a patient died due to a product we introduced. Nobody was able to answer questions and the ...