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Using Quality Management in Change Management Initiatives

There is a new concept being explored in the QMS community on using Quality Management capabilities in the use of Product and Process Changes. The theory is that PLM systems typically lack the flexibility, functionality and security to effectively manage the definition and design of the proposed change, the approval and execution of the change, and, ultimately the verification of its effectiveness.

The whole concept relies on the robust workflow and document management capabilities of the QMS to handle the large amount of coordination involved in the product lifecycle changes. The QMS change management function is not designed to replace PLM, but compliment it with functionality that is inherent in QMS systems. Thoughts?

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The Quality Hub: Using QMS as a Central Compliance Dashboard Across the Enterprise

I have been reading a lot from the analysts about the QMS becoming a "Quality Hub" whereby all Quality throughout the enterprise is tracked in a single QMS hub. The theory is that with all the various third-party systems that surround the enterprise, Quality is a constant.

That being said, post-production activities that come out of ERP are integrated and tracked in the QMS, Design and product changes are integrated into the PLM system, and soforth.

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Recall Management: A QMS Match Made in Heaven!

Check this out...been working on a few ideas on the concept of Recall Management. something to the tune of 45% of all recalls are medical device and 50% of all other recalls are food-related. That's a whopping 95% (if my math is correct). What I've learned is that recall management is that there is a lot of activities involved to execute a successful recall - dear doctor letters, product traceability, press releases, destruction of product, and it all has to be done within 30 days.

QMS is a prime environment for handling recalls. usually the QA and RA folks are the ones who are tasked with not only executing on recalls, but also running "mock" or desktop recalls to prove the efficiency of their recall process. furthermore, many device manufacturers have a retrieval process whereby they retrieve product for marketing/repackagin purposes.

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