It isn’t surprising when production workers focus on just getting product out the door.  They are expected to reach their production numbers for the day, the week, the month, and if production employees don’t reach the goal set to them by management, they sometimes get a semi-public shaming in one form or another.

Depending on the factory, some production employees may find it surprising that management has an important role to play in a quality system.  21 CFR 820.20 mandates that “Management with executive responsibility shall establish objectives for, and commitment to, quality”.[1]  The Federal Government expects that management takes an active interest in improving the output of their company, at least in the case of medical device manufacturers.

In the case of the rules surrounding medical devices, the FDA does not care how a company improves its product, or implements a quality system; only that the company defines who is in charge of quality, and that they have all the authority vested in their office, and resources at their disposal, to make any and all necessary changes, revisions, and activities needed in order to maintain quality.

This wasn’t always the case; in the 1950s, the Ford Motor Company paid little to no attention to the quality of automobile rolling off their factory lines.  Factory managers could lie about how many parts were left over after a build, and nobody from the corporate offices would bother to check.  Excess parts were sometimes dumped into a nearby waterway just to get rid of them.[2] 

Now, managers are expected to set the tone within the company to make sure that the process is continually improved, the instructions are followed, and that the result is a product that behaves as it is expected to do.

The experts at EMMA International can help you implement your quality management system, if/when you decide to go after the medical products market.  You can call us at (248) 987-4497, or e-mail us at

[1] U.S. Food and Drug Administration.  (2002, November 29).  CFR – Code of Federal Regulations Title 21.  Retrieved from

[2] Halberstam, David.  The Reckoning.  New York, NY: Avon Books.

Ethan Benedict

Ethan Benedict

Mr. Benedict has experience in FDA compliance for both medical devices and pharmaceuticals. He has experience with many different elements of quality and regulatory compliance. Mr. Benedict holds a Bachelor of Science in Mechanical Engineering from York College of Pennsylvania, and a Bachelor of Science in Physics from Ursinus College.

More Resources

Ready to learn more about working with us?

Pin It on Pinterest

Share This