The Path Taken

We would love to say that it all came together from a plan that began long ago, however, it didn’t. It began with a thought of a better way to fix or improve a Quality Management System.

Various methods were developed utilizing multiple skill-sets, experience, trial and error. Next came the concept of a strategic solution that measures product and process quality to identify constraint, and enable responsible management to prioritize and improve what matters most. We had begun to think of what we needed to do in terms of utilizing our ‘methods’ in support of the entire medical device industry, where every QMS is different. Clearly there were obstacles that had to be overcome… and they were.

A strategic plan now describes the components of the methodology, in terms of sequence and interaction as a system of processes to achieve the objective. Process flow, procedure, instruction and training components were developed for each process.

Ready? Not just yet. Measurement creates data. Programs were created to process data and to interact in conjunction with the processes, providing a semi-autonomous system to measure manage and improve product and process quality.

E-mail us at to learn more about the Quality System(s) Management (QSM) solution.

Larry Mager