A
ANNABELLA
Hello
I am sorry if this topic has been dicussed before....
We currently follow the following criteria when we are assessing if an NC warrants a CAPA, if the NCs meets any of the criteria below then a CAPA is required:
The nonconforming product escaped and has a severity rating >S2
The NC is systemic in nature?
The NC can recurre with Permantant correction in place?
What we are finding is that the number of CAPAs opening is less. The ration is currently 1:16??
Do you think our criteria is robust enough?
How many times is a recurrence more than once, twice etc.
I have been asked to put in place a "simple" decision tree - any suggestions?
What are your thoughts.
Thank you
I am sorry if this topic has been dicussed before....
We currently follow the following criteria when we are assessing if an NC warrants a CAPA, if the NCs meets any of the criteria below then a CAPA is required:
The nonconforming product escaped and has a severity rating >S2
The NC is systemic in nature?
The NC can recurre with Permantant correction in place?
What we are finding is that the number of CAPAs opening is less. The ration is currently 1:16??
Do you think our criteria is robust enough?
How many times is a recurrence more than once, twice etc.
I have been asked to put in place a "simple" decision tree - any suggestions?
What are your thoughts.
Thank you