Please allow me a moment of your time. My name is Sarah Christie and I am a Doctoral Candidate at Florida Tech that is gathering data about a topic that I believe will help all of us in the Quality field. I am trying to see if certain types of quality management practices have an impact on non-conformances. I hope to see if there is a connection between certain quality management practices and FDA 483 observations. The survey will take approximately 10 minutes to answer. I plan on sharing the results with everyone once I compile the data!
Please note that no one's name or company's name will be shared. This information will be coded to ensure confidentiality. I truly thank everyone for their time and effort. I need to obtain quite a few more survey results and appreciate everyone's help.
Here is the link:
Hi Grace, FDA 483 observations are findings/non-conformances identified that document deficiencies in your quality system.
Are FDA 483 observation translatable to a machine shop? I work in a machine shop.
Hi Sarah, the survey seems intended toward folks who work for companies. I am a consultant so didn't feel that I could provide a relevant response. What I might suggest is a simple read of an ASQ Quality Press book titled “Unleash Quality”. I think it will provide a perspective on how management (should) play a part in reducing non conformances as well as improving bottom line profit.
Thanks Arron! I am trying to see if I can see if there is a connection to specific quality management practices that organizations have in place and their ability to preventing major non-conformances. I will definitely check your book out!