Exploring the effectiveness of defensive -receiving inspection for medical device manufacturers: A mixed-method study.

摘要

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.