S
snoopy2017
Hi everyone. Thanks for all the helpful advice on this forum.
My department inherited a large number CAPAs from the previous regulatory/quality staff. There are 4 categories
1. Issues misidentified as CAPAs.
2. CAPAs with no effectiveness verification
3. CAPAs with incomplete action items (e.g. the corrective plans were not completed)
4. CAPAs with poor root cause analysis (e.g. the root cause identified is not the fundamental cause).
Some have been open since 2016. There is a new team of regulatory/quality staff. Would it be wise to close out some of the CAPAs falling into #1? Since they are not really CAPAs. What should we do about #4? (poor root cause analysis).
I would appreciate any help.
Thanks.
My department inherited a large number CAPAs from the previous regulatory/quality staff. There are 4 categories
1. Issues misidentified as CAPAs.
2. CAPAs with no effectiveness verification
3. CAPAs with incomplete action items (e.g. the corrective plans were not completed)
4. CAPAs with poor root cause analysis (e.g. the root cause identified is not the fundamental cause).
Some have been open since 2016. There is a new team of regulatory/quality staff. Would it be wise to close out some of the CAPAs falling into #1? Since they are not really CAPAs. What should we do about #4? (poor root cause analysis).
I would appreciate any help.
Thanks.