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Featured Articles

May 2011

Jim Shore

The Use of "Poka Yoke" with Medical Device Design and Manufacturing

by Jim Shore
Principal Quality Engineer, Endoscopy Design QA, Boston Scientific

In 1961, a Japanese manufacturing engineer named Shigeo Shingo working at Masushita Electric developed the idea into a formal tool for achieving zero defects and eventually eliminating quality control inspections. The term "poka-yoke" generally translates as "mistake proofing" or as "to avoid inadvertent errors."

The idea is to respect the intelligence of workers by taking over repetitive tasks or actions that depend on vigilance or memory, and free a worker's time and mind to pursue more creative and value-adding activities. A poka-yoke device is any mechanism that either prevents a mistake from being made or makes the mistake obvious at a glance.

The value proposition to implement Poka Yoke into Medical Device Manufacturing is it will increase product yields and reduce rework and scrap. The great thing about poka-yoke is implementation can be very simple while very effective.

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Management Review: Measuring the "Heartbeat" of Your Quality Management System

by John Gagliardi
MidWest Process Innovation, LLC

Management Review is sometimes viewed with some ambiguity because there are so many different ways to conduct these planned sessions. Most of the approaches taken by medical device companies to organizing these reviews are (just) compliant and even go so far as to fulfill only the very basic requirements of the required Regulations (21 CFR, Part 820) and Standards (e.g. ISO 13485:2003 and ISO 9001:2000). Being compliant and fulfilling perceived needs is not enough, however. Management Review is commonly driven by the use of various quality tools depending upon the caliber of deliverables that are expected and the sophistication of your planned metrics. The following article is not a primer for management review but does contain information regarding experiential outputs and top-level guidance derived from practical approaches toward process orientation and communication techniques. This sometimes indescribable information relates to those subtle demands that combine your company's Quality Management System (QMS) with business goals and objectives. You'll find that management reviews commonly have your company's unique "signature" embroidered on the agenda.

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Do you know the FDA's current approach to innovation? Margaret Hamburg, Commissioner of Food and Drugs, FDA, recently spoke about innovation at the FDLI Annual Conference. Learn more about Hamburg's emphasis on innovation and real-life examples that are making innovation work.
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