No one genuinely enjoys doing paperwork.  At best, people may dislike paperwork less than other parts of their jobs.  Yet the FDA requires a certain amount of paperwork to document processes and results for the medical devices under their jurisdiction.[1]

In my own professional history, I have had to file my fair share of paperwork.  While working for a manufacturer of medical devices, I had to fill out and file paperwork documenting how long I worked at a given workstation, and the number of units that I produced during that time.  The time that I, and each of my colleagues, spent on completing our paperwork could have easily been used to produce product; so why did management ask us to spend time on an unprofitable task?

When trying to explain issues like this, I like to give the analogy of a conductor (management, in this metaphor) trying to ensure that the orchestra (labor) is in tune and working together as intended.  In the orchestra, the conductor has their ears, listening to each section, and each instrument, making sure that the performers are each hitting the right notes, at the right time, in the right way, in order to perfectly blend the sound together for the audience.  In manufacturing, there are just as many people needing to work in concert (no pun intended), who may not be able to experience the end result on their own.  Not all managers can tell how well the factory is operating just by listening, so labor needs to tell management all the important information.  This information must be given on paper (or electronically), because it needs to be preserved; That way, lower management can make the case for more resources, training, and/or oversight to the upper levels who control the purse strings.

If one person, one machine, one batch of raw material, falls out of tune, the audience, or the customer, is left unsatisfied.

Experts at EMMA International can help companies keep their Quality Management Systems in tune; Contact them today by phone at (248) 987-4497, or by email at info@emmainternational.com


[1] U.S. Food & Drug Administration.  (2022, November 29).  CFR – Code of Federal Regulations Title 21.  Retrieved from <https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=820&showFR=1&subpartNode=21:8.0.1.1.12.13>

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.

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