Great discussion and perspectives are highly appreciated— for me its been a good refresher regarding the difference in CAPA definitions under ISO 13485 versus ISO 9001, and the way nonconformances are to be treated differently in product versus QMS contexts.
I particularly like how these distinctions tie into structured root-cause methodologies, such as:
1. The 3-Legged 5 Why Methodthe-3-legged-5-why-method
2. https://quality-one.com/wp-content/uploads/2017/02/5-Why-and-5-How-Example.pdf
I particularly like how these distinctions tie into structured root-cause methodologies, such as:
1. The 3-Legged 5 Why Methodthe-3-legged-5-why-method
2. https://quality-one.com/wp-content/uploads/2017/02/5-Why-and-5-How-Example.pdf
