Exploring the effectiveness of defensive-receiving inspection for medical device manufacturers: A mixed-method study
by Devine, Christopher Joseph, Ph.D., NORTHCENTRAL UNIVERSITY, 2009, 205 pages; 3371249

Abstract:

Defensive-receiving inspection is a fiscally prohibitive quality process pursued by medical device manufacturers to preclude the introduction of nonconforming components into the manufacturing cycle. The defensive-receiving inspection process is marginally beneficial, with the prohibitive cost of program execution constantly measured against the effectiveness of the inspection process. The Code of Federal Regulations, Title 21 Part 820, and the Medical Device Directive, 93/42/EEC of 14 June 1993, delineate prescriptive regulatory requirements for manufacturers of medical devices, mandated by law within the United States and the European Union. The salient purpose of this study was the collection of empirical evidence needed to evaluate the effectiveness of defensive-receiving inspection for medical device manufacturers. A mixed-method study, supported by qualitative content analysis and linear regression analysis as evaluative techniques, was employed for ascertaining the effectiveness of defensive-receiving inspection. The participants selected for inclusion into this mixed-method study were machined-component suppliers employed by the medical device industry. Key findings identified during the execution of this study were the elevated p-values for the independent variables, 0.354, 0.152, and 0.792, which resulted in the acceptance of the null hypotheses statements. The p-values reinforced the conclusions of no correlation between process capability and the statistical significance of measurement data; complexity of machined components and the statistical significance of measurement data; and supplier performance and the supplier-assessment survey. Recommendations for additional research included: the execution of comparative studies examining dissimilar commodities; and the influence a global-recessionary economy has on quality assurance.

 
AdviserConrad Francis
SchoolNORTHCENTRAL UNIVERSITY
SourceDAI/A 70-08, p. , Oct 2009
Source TypeDissertation
SubjectsManagement
Publication Number3371249
Adobe PDF Access the complete dissertation:
 

» Find an electronic copy at your library.
  Use the link below to access a full citation record of this graduate work:
  http://gateway.proquest.com/openurl%3furl_ver=Z39.88-2004%26res_dat=xri:pqdiss%26rft_val_fmt=info:ofi/fmt:kev:mtx:dissertation%26rft_dat=xri:pqdiss:3371249
  If your library subscribes to the ProQuest Dissertations & Theses (PQDT) database, you may be entitled to a free electronic version of this graduate work. If not, you will have the option to purchase one, and access a 24 page preview for free (if available).

About ProQuest Dissertations & Theses
With over 2.3 million records, the ProQuest Dissertations & Theses (PQDT) database is the most comprehensive collection of dissertations and theses in the world. It is the database of record for graduate research.

The database includes citations of graduate works ranging from the first U.S. dissertation, accepted in 1861, to those accepted as recently as last semester. Of the 2.3 million graduate works included in the database, ProQuest offers more than 1.9 million in full text formats. Of those, over 860,000 are available in PDF format. More than 60,000 dissertations and theses are added to the database each year.

If you have questions, please feel free to visit the ProQuest Web site - http://www.proquest.com - or call ProQuest Hotline Customer Support at 1-800-521-3042.