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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…

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

SCARs and Rules

By Dr. Christopher Joseph Devine

…for my rules, you could probably come up with dozens of your own. Once again, the approach pursued is the employment of common sense to achieve compliance. Until next time,…

…for my rules, you could probably come up with dozens of your own. Once again, the approach pursued is the employment of common sense to achieve compliance. Until next time,…

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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…

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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…

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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…

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