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

Quality Audits

By Dr. Christopher Joseph Devine
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The Food and Drug Administration (FDA) will evaluate the effectiveness of your internal quality audits and review the corrective actions pursued as part of the overall quality audit system. If a nefarious approach to executing quality audits is pursued, the reward will be a Form 483. If the FDA feels the violation is egregious, a warning letter will be forthcoming. In monopoly speak, “do not pass go and do not collect your two hundred dollars.” Warning letter violations As you can see by the abundance o…

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

Management Responsibility

By Dr. Christopher Joseph Devine
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I begin this edition of Devine Guidance  (DG) by reinforcing the importance of DG Rule #1 – Compliance to regulations is not optional, compliance is mandatory and dictated by law. In my belief, management responsibility is what the doctor likes to call the “catch-all requirement.” What does that mean Dr. D? Simply put, if your organization fails to comply with any part of the QSR, rest assured, the reward will be in the form of a Form 483 for the specific transgression, by the agency. Additionally,…

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

Nonconforming Products

By Dr. Christopher Joseph Devine
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In a perfect world, there would never be a need to handle non-conformances from your supplier base. However, the world of medical device manufacturing is far from perfect (please do not tell the regulators). You may call it fate, destiny, or bad luck, but Dr. D. calls it problem suppliers. Rest assured some of your suppliers will eventually deliver nonconforming product and at some point in the not-so-distant future, I will address managing nonconforming products as a whole. Warning letter violation Vio…

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

Purchasing Controls

By Dr. Christopher Joseph Devine
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Over the past two months, Dr. D has focused on supplier management from a quality and regulatory perspective. However, the successful execution of a well-defined supplier-management system, and the overall organizational success within the medical device industry, is premised on a strong cross-functional approach to quality. It takes a collegium (may need to look it up) of dedicated professionals, in multi-functional roles, to ensure all aspects of the supplier management system function efficiently. In…

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

Supplier Maintenance Assessments

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

Supplier Metrics

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

SCARs and Rules

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

Gage R & R and Reduced RI Programs

By Dr. Christopher Joseph Devine
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Since the concept of writing a weekly blog and actually having a following is somewhat foreign to me, I was not sure what to expect or the reception I would receive writing a weekly column. So far, the support and responses have been overwhelmingly positive; and for that, I would personally like to thank the readers. Additionally, I will continue to write about and provide relevant information associated with supplier quality (four installments remaining) and will eventually begin addressing quality and…

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