My department inherited a large number CAPAs

#1
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.
 
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Ajit Basrur

Staff member
Admin
#3
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.
It would be definitely wise to close some of the CAPAs under #1 but be sure to document why those were not considered as CAPAs, and if those issues have been adequately addressed. For category#4, you could prioritize based on risk and identify timelines.

Kronos147 gave very valuable advise on "contain" and "correct".
 

yodon

Staff member
Super Moderator
#4
While it probably sounds like piling on, you probably want to take a structured approach to resolving these issues... which sounds like a systemic issue = CAPA. I think Kronos was alluding to this but I'll toss out some more thoughts.

Why were issues misidentified as CAPAs? Presumably each is at least arising from a nonconformity. Do your current processes support proper vetting of issues to determine if they should be elevated to CAPAs?

Why did some have no effectiveness verification? Was the means to assess effectiveness not well defined? Was it a resource issue?

Why were action items incomplete? Were they too vague and not have objective completion criteria? Were there too few resources?

Why were poor root cause analyses allowed? Is no process in place to drive a structured means to define root cause(s)? Were personnel involved in the analyses not sufficiently trained or have suitable experience to drive to the true root cause(s)?

What Ajit said is all valid but you should probably be able to answer the question why such things would not happen again (and having a new staff is an incomplete answer).
 

Ninja

Looking for Reality
Trusted Information Resource
#5
FWIW...I would initiate another Corrective Action...if you have it, call it a Quality System Improvement (PA rather than CA) to cover all of the inherited CA's

"Previous CA system misidentified and potentially mishandled CA requests. This CA/PA is to catch up with older CA and improve the timliness of the CA/PA system."

This will put a stopper on audit findings based on (we found it ourselves and we're on it). ...and give you time to dig out from under.

Bucket the open CA's like you have, and get 'em done. (Dead, fixed, pursued as needed). Then keep on top of it from now on.

If a written CA is crap...kill it.
If a CA is valid, but not followed up timely...get it done now.
If root cause is not done well...do it now.
If the plan is in place but not done yet...git 'er done.
If verification was never done...do it now.

Life is messy....clean it up. But putting in a "We know this went wrong" CA/PA can help save some angst...and give you a deadline to git 'er done by...

HTH
 
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