Robert Keur

Quality, what is it?

Quality managers don’t have a magic wand that can turn a bad product into a good product. We probably shouldn’t even be deciding what a good product is other than to verify safety and effectiveness.

Medical Device quality requires closed loop controlThe English language isn’t always precise and one of the best examples of this is the word quality. Ask someone if they understand the word and they will quickly say yes. Ask them to define it, and that is when the long pause occurs.

There is a subjective aspect to most people’s understanding of quality that is very difficult to define. Which is higher quality mahogany or pine? Is an expensive luxury car higher quality car than a modestly priced compact?  The concept of quality is often associated with cost or scarcity when really there is no connection other than the anecdotal impression that high quality items are expensive and rare.

From a quality management perspective we need to have an objective definition for quality if we are to assure its existence and control it to a specific level. ISO defines quality as the ability to meet requirements.

The fundamental concept is that quality requires closed loop control. A goal must be set and then measurements taken to determine if the goal was met. The other approach of trying to do the best and hoping for success is equivalent to open loop control.

If we think of a company as a process and the quality department as the feedback portion of a closed loop control system, the role becomes clear. Non-conformances are simply deviations from set-point. The quality department affects quality only indirectly, by measuring the output and exerting influence on the system.  The best the quality department can do is to ensure we are making the product we said we would.


Rob Keur is the regulatory affairs expert at Starfish Medical.   Please visit our Regulatory Support and Quality Management pages for more information on how Quality is defined at Starfish Medical.

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