The FDA mandates that medical device companies establish and maintain a quality system that ensures they deliver safe and effective products to the consumer. Still, even the most perfectly designed quality system falls apart without the right people to run it. Effective quality managers use quality management tools to understand, diagnose, and eventually resolve quality issues. Quality management tools is a relatively broad term that encompasses the full "quality arsenal" - graphical techniques, techniques for analysis, statistical analysis, template documents and personnel management techniques are all imperative to the successful quality manager.
We could probably write a whole book on graphical analysis tools for quality managers. Graphical analysis is powerful because it allows quality managers to visualize a problem in a way that's easily presentable and communicable to others, and on top of that, it gets results! Here are three the most important graphical analysis tools that every quality manager should master:
Organized quality managers effectively keep tabs on potential sources of non-conformance as a proactive measure. A "living document" is an organizational tool that allows quality managers to keep their fingers on the pulse of the company, making it easier to understand and even predict where quality issues could emerge. Here are three documents that successful quality managers should maintain:
Back when a medical device company's QMS was stored in a filing cabinet, quality managers spent hours of the day digging through mountains of disorganized paperwork. Greenlight Guru's QMS Software helps quality managers access, organize, modify and update their most important managerial and investigative tools each day, empowering them to focus on the most important aspect of their role: ensuring the quality and safety of medical devices that reach the end user.