Dr. Christopher Joseph Devine, President, Devine Guidance International
Devine Guidance

Supplier Metrics

By Dr. Christopher Joseph Devine

…Retrieved February 12, 2010, from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ Foxton, J. (1996). Negotiating quality through customer communications. Managing Service Quality, 6(5). Retrieved November 5, 2008, from http://proquest.umi.com Medical Device Directive. (1993). Council Directive…

…Retrieved February 12, 2010, from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ Foxton, J. (1996). Negotiating quality through customer communications. Managing Service Quality, 6(5). Retrieved November 5, 2008, from http://proquest.umi.com Medical Device Directive. (1993). Council Directive…

Continue reading

Dr. Christopher Joseph Devine, President, Devine Guidance International
Devine Guidance

SCARs and Rules

By Dr. Christopher Joseph Devine

complies with the various regulations. Believe me, the medical device industry grows more complex by the day due to the ongoing evolution of regulations. For example, we are all familiar…

complies with the various regulations. Believe me, the medical device industry grows more complex by the day due to the ongoing evolution of regulations. For example, we are all familiar…

Continue reading

Dr. Christopher Joseph Devine, President, Devine Guidance International
Devine Guidance

Gage R & R and Reduced RI Programs

By Dr. Christopher Joseph Devine

…of a non-conforming component or the rejection of an acceptable component. According to Mehta and Kauffman, “normally, for the acceptable measuring system, no more than 9 percent of the tolerance…

…of a non-conforming component or the rejection of an acceptable component. According to Mehta and Kauffman, “normally, for the acceptable measuring system, no more than 9 percent of the tolerance…

Continue reading

Dr. Christopher Joseph Devine, President, Devine Guidance International
Devine Guidance

1st Article Inspection and Supplier Statistical Data

By Dr. Christopher Joseph Devine

…specification. The process commences with the supplier and the manufacturer agreeing on the data and format, completing the FAI, and then analyzing the data for accuracy and correlation. The concept…

…specification. The process commences with the supplier and the manufacturer agreeing on the data and format, completing the FAI, and then analyzing the data for accuracy and correlation. The concept…

Continue reading

Dr. Christopher Joseph Devine, President, Devine Guidance International
Devine Guidance

For an Effective Supplier Selection Process

By Dr. Christopher Joseph Devine

…procured component and the influence a failed component could have on the finished medical device. Early in the design and development process, link the component failure risk back to the…

…procured component and the influence a failed component could have on the finished medical device. Early in the design and development process, link the component failure risk back to the…

Continue reading

Dr. Christopher Joseph Devine, President, Devine Guidance International
Devine Guidance

Manage Your Suppliers

By Dr. Christopher Joseph Devine

…the QSR is not overly prescriptive when it comes to the details of a system, organizations are free to develop supplier-management systems tailored to their manufacturing and operational environment. A…

…the QSR is not overly prescriptive when it comes to the details of a system, organizations are free to develop supplier-management systems tailored to their manufacturing and operational environment. A…

Continue reading