Clinical Chemistry AACC Online Job Center
HOME HELP FEEDBACK SUBSCRIPTIONS ARCHIVE SEARCH TABLE OF CONTENTS
QUICK SEARCH:   [advanced]


     

Clinical Chemistry 43: 866-872, 1997;
This Article
Right arrow Full Text
Right arrow Full Text (PDF)
Right arrow Submit an electronic Letter to
the Editor about this paper
Right arrow Alert me when this article is cited
Right arrow Alert me when eLetters are posted
Right arrow Alert me if a correction is posted
Services
Right arrow Email this article to a friend
Right arrow Similar articles in this journal
Right arrow Similar articles in ISI Web of Science
Right arrow Similar articles in PubMed
Right arrow Alert me to new issues of the journal
Right arrow Download to citation manager
Right arrow reprints & permissions
Citing Articles
Right arrow Citing Articles via HighWire
Right arrow Citing Articles via ISI Web of Science (9)
Right arrow Citing Articles via Google Scholar
Google Scholar
Right arrow Articles by Lasky, F. D.
Right arrow Articles by Boser, R. B.
Right arrow Search for Related Content
PubMed
Right arrow PubMed Citation
Right arrow Articles by Lasky, F. D.
Right arrow Articles by Boser, R. B.
Related Collections
Right arrow Laboratory Management
Right arrow Clinical Chemistry Forum
(Clinical Chemistry. 1997;43:866-872.)
© 1997 American Association for Clinical Chemistry, Inc.

Articles

Designing in quality through design control: a manufacturer's perspective

Fred D. Laskya and Robert B. Boser

a Author for correspondence. Fax 716-453-4402; e-mail: flasky{at}cldx.com

Quality by design is a comprehensive program that begins with understanding user needs and continues through (but does not end with) monitoring customer acceptance. Management tools and processes such as ISO 9000 standards and the Food and Drug Administration Quality System Regulations exist to guide medical device manufacturers in quality practices. The goal is to deliver products acceptable for their intended use. Quality control begins with defining attributes ranging from color to accuracy and precision. Failure mode and effects analysis and risk analysis consider both probability and severity of potential malfunctions and their effects on patients or operators. Tools used to implement design and production practices include Program Evaluation and Review Technique (PERT) charts and industry-conceived concepts, such as Six Sigma techniques. Their use varies with manufacturer, depending on product and customer needs and the manufacturer's specific quality practices. Verification confirms that input goals are met. Then, validation assures that intended clinical needs are continually satisfied by establishing adequate production specifications. Conformance is monitored to verify that stable, consistent processes are in place, and precise user instructions enable the device to satisfy its intended use. Finally, complaint tracking can help assess whether needs have been met. Modifications in service, hardware, or instructions (including quality control) might be required. Therefore, both manufacturers and users work in partnership for continual improvement. The manufacturer's knowledge of design, production, and service needs of its devices enable it to recommend appropriate quality-control protocols for clinical testing.


Key Words: indexing terms: product development • expert systems • quality control




The following articles in journals at HighWire Press have cited this article:


Home page
 Clin. Chem.Home page
R. W. Jenny and K. Y. Jackson-Tarentino
Causes of Unsatisfactory Performance in Proficiency Testing
Clin. Chem., January 1, 2000; 46(1): 89 - 99.
[Abstract] [Full Text] [PDF]


HOME HELP FEEDBACK SUBSCRIPTIONS ARCHIVE SEARCH TABLE OF CONTENTS
Copyright © 1997 by the American Association for Clinical Chemistry.