Quality management touches everything in a regulated environment, and generally we think of it preventing us from making bad or unsafe products. But it dictates everything a company does. What follows is a specific example of how a quality management system impacts consumer health and safety, just not in the way you may think.

A large medical device firm makes imaging equipment. The firm receives a notification that the bolts used for mounting large monitors in observation booths are no longer available. The firm finds a new supplier. To maintain their production schedule, they don’t take the time to ensure the bolts will be sufficient for the intended use, or user needs. According to their quality management system there are change control systems and material controls systems that are in place that should have applied to the change of supplier

Because the quality management system was not followed, the change of bolts was not evaluated properly. The new bolts are made of a lower-grade steel and aren’t strong enough to hold the weight of the large observation monitors. During use the monitor falls off the wall due to bolt failure and a technician is severely injured.

Failing to follow the quality management system can have very serious unintended consequences. I just want to emphasize as a technician you need to follow all instructions and procedures as they are derived from the quality management system and they in turn are derived from the regulations, and ultimately the regulations are there to protect the consumers.

Learning Objectives:

- 1.3 - Explain how a quality management system helps a company meet the guidelines from regulatory bodies.