When all is said and done, avoiding FDA 483s depends most heavily on the organization’s expectations and culture. Attention to quality has to permeate an entire organization from the top down and the bottom up, our panel said.
Employees need to be motivated and incentivized to create products of the highest quality, and managers have to make sure employees aren’t afraid to speak up when they see something go wrong, the experts noted. In the end, all the preparations in the world don’t work if employees don’t care about their jobs.
The best way to gauge your organizational culture is to know what stories are being told. Are they about how hard they’re expected to work? How crazy management is? How awesome the other people on the team are? How attention to detail is celebrated (or shunned)? To change the culture, find a way to change that story.
Sometimes organizational culture is seen as a very “soft” squishy issue. Nonetheless, culture may very well be the most important aspect. It dictates every day behavior and performance, and it always propagates onto itself. One of my mentors always told me, “As a leader, you’re really only responsible for 2 things: culture and structure. Nail those two things, and you’ll be fine.”
Other 483 Resources
- The largest online 483s store (with thousands of FDA 483s in PDF format) Search by inspector or company>>. Readers of this blog receive 20% off – enter “fdazillablog” at checkout.
- The only searchable listing of 483s
- FDAzilla Inspector Rank – how often does your inspector issue 483s?
- FDA 483 article archives