Bringing—and keeping things—in alignment…Millstone Medical Outsourcing has announced that the company has added a new service, called Supplier Quality System Auditing, and has hired a full-time professional to manage the process. Meghan Barry, the firm’s new External Auditor/Internal Trainer, will help Millstone align its internal audit practices to those used by suppliers, and will establish and achieve consistency metrics, customize audits to suppliers and their classifications, and work with customers to serve as a Tier One supplier by directing supplier relationships.
Meghan Barry Joins Millstone Medical

The purpose of the new service will be to ensure a consistent process despite any changes in personnel or timing. Millstone provides advanced inspection, clean room packaging, loaner kit processing, and distribution services to medical and dental device manufacturers worldwide.
“We are excited to offer Supplier Quality System Auditing services to our customers. With a professional dedicated to the effort, we will be able to ensure that our customers receive a consistently superior level of quality from Millstone and their suppliers, ” said Chris Ramsden, Millstone Chief Executive Officer, in the news release. “We are happy to welcome Meghan to the Millstone team.”
Kelly Lucenti, President of Millstone Medical Outsourcing, told OTW,
Meghan will be establishing critical metrics for Millstone to help track suppliers’ performance. She will track a variety of metrics, including first pass yield, on time delivery, non-conformances, and audit performance.
As for how Barry will go about customizing the audits, Lucenti commented to OTW,
Meghan will use a risk-based approach to customize audits that will examine the criticality of the products or services provided and the classification of the suppliers. She will also identify any problem areas detected by the metrics to help narrow the focus of her audits.

Discussion
This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?
Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.
We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.
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