Global Medical Device Podcast powered by Greenlight Guru cover image

Does Your CAPA Process Need a CAPA?

Global Medical Device Podcast powered by Greenlight Guru

CHAPTER

Is Kappa the Number One Reason Why Companies Are Getting 43s and Warning Letters?

Kappa, the complaints and NDRs are all measures of like effectiveness of a company's quality system and practices. So I guess one can postulate that if Kappa is the number one reason why companies are getting 43s and warning letters, then that might indicate they don't have a very effective quality system. And to that I have some suggestions, you know, for our company friends, as we'll get to further in our discussion,. But specifically how do you measure the effectiveness or what I call the efficacy of your Kappa system or of your QMS?

00:00
Transcript
Play full episode

Remember Everything You Learn from Podcasts

Save insights instantly, chat with episodes, and build lasting knowledge - all powered by AI.
App store bannerPlay store banner