It’s Easy to Get into Trouble Because of CAPA summaries an audio conference on Implementing an Effective CAPA System: What You Need to Know (pdf) sponsored by FOI Services.
Creating a corporate culture that can carry out a quality system plan is a big challenge, especially for new medical device companies. As this figure aptly shows (hacked from page 42), aligning the organization with a formal project Mission Statement, Scope, Goals, and Communication Plan is a key component for implementing an effective CAPA system.
The survey statistics on the use of risk management tools and CAPA effectiveness are interesting. Of particular interest of course are the number of firms sited by the FDA for CAPA deficiencies. The slides detailing CAPA implementation and advice are also quite informative.
I stared at the "Big C" (page 23) for a while. I know it's trying to show the relationship between CAPA (820.100, "little c"?) and the rest of the quality system. I thought I figured it out a couple of times, but in the end I was not able to decipher its true meaning. I could buy the audio CD to find out or maybe Jan can just clarify it for us.
Inside the “big C” are the provisions of the medical device regulations that relate specifically to CAPA. Outside of it are the provisions that aren’t specifically related to it, yet have an effect on it in some way.