December 2013

For Medical Device Companies

An Argument for Quality Management Systems

by Kamaal Anas, Wright Medical Technology

All too often, quality management systems are seen as a cost of doing business – a requirement of regulators (e.g., 21 CFR 820), customers (e.g., ISO 9001:2008) or overbearing parent companies – rather than as a tool for management to effectively manage their organizations. However, quality management systems that are effectively designed, implemented, utilized and continuously improved upon provide management with quality information, delivered in a timely fashion, which facilitate data-driven decision making. Designing and implementing a quality management system that provides the appropriate information for management to make educated decisions requires careful thought and detailed planning. Once accomplished, management will have the tools to effectively allocate resources to risk-prone areas and reduce the cost of poor quality.

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How to Confuse Your Trainees in 10 Easy Steps!

by Jill Drummond, Blood Systems

On-the-job training is usually conducted one-on-one or in small groups so it can be challenging to confuse trainees; but fear not — when employees start a new job, they are usually a little nervous or apprehensive. They want to make a good impression and they want to be successful in learning their new tasks. This is when they are most vulnerable and they are easy pickings for total confusion. Follow these simple steps and you will have your new hires running for the hills and totally flabbergasted and ineffective in their jobs.

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10 Guidelines for Writing Superior SOPs

by Robyn Barnes, MasterControl Inc

Will you be prepared when tasked to write a standard operating procedure (SOP)? Writing SOPs--- shorthand for a written document that helps ensure accuracy and repeatability when executing a task---is an integral part of assembling a successful quality system. When poorly written, they are of limited value. Using the following 10 guidelines, you can create a successful SOP document.

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