I do quality Investigations for a variety of FDA regulated products.
The tools that make me successful go beyond traditional root cause and CAPA training. I made this site to highlight my thought process. I want to help with your investigations. Who knows, someday I may need a product you're making. This site will be a mash-up of videos and essays outlining my experience with these investigations. I'd love to chat about anything you see here! You can reach out to me on my linkedIn www.linkedin.com/in/jonkallay/ |
Why I finally created this website
I saw an elevator malfunction video. This one right here:
Someone commented with a very official sounding explanation of what happened. I don't know if they were an elevator mechanic or a kid in their parent's basement. But their "root cause" explanation got me thinking.
It's tempting to blame the maintenance worker. If work was done wrong, and a maintenance worker performed that work, then they're the root cause.
But wait...If insufficient maintenance is so common, something must be causing that. After picking the commentor's brain for a bit, we identified knowledge transfer gaps between system designers and contracted maintenance crews. If the elevator owner wants to prevent this from happening again in the future, they can't just reprimand the maintenance worker. They need to have access to the right maintenance procedures.
These root cause tools work outside just my arena in the FDA regulated industry, and I enjoyed the conversation. This page is my attempt to fostor more conversation.
Below is that elevator conversation in full.
- They blamed insufficient maintenance. Unfortunately, this usually turns into blaming a maintenance worker for doing the work incorrectly
- They talked about the issue as if it happens frequently.
It's tempting to blame the maintenance worker. If work was done wrong, and a maintenance worker performed that work, then they're the root cause.
But wait...If insufficient maintenance is so common, something must be causing that. After picking the commentor's brain for a bit, we identified knowledge transfer gaps between system designers and contracted maintenance crews. If the elevator owner wants to prevent this from happening again in the future, they can't just reprimand the maintenance worker. They need to have access to the right maintenance procedures.
These root cause tools work outside just my arena in the FDA regulated industry, and I enjoyed the conversation. This page is my attempt to fostor more conversation.
Below is that elevator conversation in full.