Tag Archives: Supplier Corrective Action requests

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

Supplier Maintenance Assessments

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

If a supplier scored well on their original selection assessment, or scores well on repeat maintenance assessments—say, a score of 90 percent or above for argumentative sake—and your organization is receiving 100 percent conforming product (yes, imagine a perfect world), what is the value of performing an annual or regularly scheduled maintenance assessment? Dr. D does not see any upside. Now I could write a philippic (yep, look up time again) that takes medical device organizations to task in regards t…

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

Supplier Metrics

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

To ensure supplier surprises are kept to a bare minimum, an organization cannot simply rely on thaumaturgy (go ahead and look it up). Supplier performance must be continuously gauged for effectiveness, and a feedback loop created to ensure suppliers are receiving accurate information in regards to their overall performance. Additionally, supplier performance metrics should be included into your management review process. Management must be informed of parlous issues that can result in the need for field…

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

SCARs and Rules

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

Welcome back to this sixth installment of Devine Guidance . I am not one to assume a Panglossian view (time to pull out the dictionary again) when dealing with problem suppliers and the need to pursue corrective action. However, at times the ugly SCAR becomes unavoidable. In fact, evidence of effective corrective action, as it pertains to suppliers is a requirement and the FDA, notified bodies, and other regulatory bodies will verify the effectiveness of the approach pursued by your organization. Additi…

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