FDAnews Device Daily Bulletin
Medical Devices / Regulatory Affairs

Risk Rankings Can Help Manage Suppliers, Expert Says

Feb. 17, 2017
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Combining various risk metrics into a single number can help manufacturers rank suppliers according to risk and identify those that might need to be dropped.

Device manufacturers should explore the use of additional risk factors to supplement traditional quality metrics when assessing their suppliers, said James Shore, principal of Quality Lean Solutions, in an FDAnews webinar.

Traditional supplier management metrics — such as incoming inspection, on-time delivery, and responsiveness to supplier corrective action requests — are “fine as a foundation” but do not help in monitoring supplier risks, and traditional supplier report cards often fail to show meaningful distinctions between suppliers, he said. — Jeff Kinney

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