Can Corrective Action be the same as Preventive Action?

J

JJRegs

Hi,

I'm having a little difficulty with Corrective and Preventive action and worndered if anyone could help shed some light on it.

I have just implemented a new CAPA form and have been testing it with a current non-conformance.

NC - A certificate of analysis was found to have the wrong result on.
Root cause - Incorrectly translated from the test result software to the coa software (operator inputs test result into database, then later produced a coa by typing the result in the database into the certificate software)
CA/PA ? - We are in the process of implementing one database to both store test results and create certificates directly. Therefore is this CA or PA? - Can it be both?
 
H

HPLC_Help

Re: Can CA be the same as PA?

In my opinion, the corrective action would be the act of putting the correct result onto the COA. The preventive action would be the database implementation (and training on it) to ensure the problem doesn't happen again.

H_H
 

rob73

looking for answers
Re: Can CA be the same as PA?

jjreg
Corrective action - an action taken to prevent reoccurance of a non-conformance which has already occurred
Preventative action - an action taken when a POTENTIAL nonconformity is identified as the result of of an anlysis of reocrds and other relevantsources of information
Taken from ISO TR 14969
From you post "I have just implemented a new CAPA form and have been testing it with a current non-conformance."
As this is regards to a nonconformance your action is a corrective action, even though it is preventative in nature.
If you had discovered this BEFORE the nonconformance then it would be a truly preventative action.

Rob
 
P

phloQS

Re: Can CA be the same as PA?

jjreg
Corrective action - an action taken to prevent reoccurance of a non-conformance which has already occurred
Preventative action - an action taken when a POTENTIAL nonconformity is identified as the result of of an anlysis of reocrds and other relevantsources of information
Taken from ISO TR 14969
From you post "I have just implemented a new CAPA form and have been testing it with a current non-conformance."
As this is regards to a nonconformance your action is a corrective action, even though it is preventative in nature.
If you had discovered this BEFORE the nonconformance then it would be a truly preventative action.

Rob


Very good answer!!! As the name already says CA always corrective and PA always when there was actually no fault but there could occure one.

regards

phloQS
 

Randy

Super Moderator
Re: Can CA be the same as PA?

Just look at what elements are in a CA to begin with and you'll find your answer

Here's the short version.....

Identfy the problem

Investigate and determine cause

Fix the problem

PREVENT the problem from happening again (from original cause)

Verify that the solution is working (gotta be time based)


......CA always has to have a PREVENTIVE element in it to be
(1) in conformance
(2) Work
 
J

JJRegs

Re: Can CA be the same as PA?

Hi, Thanks for the replies, but i'm still not following.

If the CA is implementing the new software, does that mean there is no PA?

If thats the case, whats the point of a CAPA? - Why not just a CA form and a separate PA form?

:confused:

I'm SO confused!!
 
J

Jon Nonns

Re: Can CA be the same as PA?

Hi, Thanks for the replies, but i'm still not following.

If the CA is implementing the new software, does that mean there is no PA?

If thats the case, whats the point of a CAPA? - Why not just a CA form and a separate PA form?

:confused:

I'm SO confused!!

As others have said this is a corrective action. Correcting the CoA is simply a correction. The preventive action in this case is to evaluate and see if a similar database implementatoin could prevent a nonconformance from occurring in the first place. Do you have other processes that have multiple manual entry points of the same data? Just my :2cents:
 
J

JJRegs

Re: Can CA be the same as PA?

As others have said this is a corrective action. Correcting the CoA is simply a correction. The preventive action in this case is to evaluate and see if a similar database implementatoin could prevent a nonconformance from occurring in the first place. Do you have other processes that have multiple manual entry points of the same data? Just my :2cents:

Jon, thanks for this insight. There may well be other processes, not in the same area of application but in different departments. Doesn't the PA on the same CAPA form have to be related to the original NC?
 

rob73

looking for answers
Re: Can CA be the same as PA?

I would raise a new CAPA as a preventative action, maybe reference it to the orginal CA that brought about the review.:2cents:
They can then be treated seperately, the original corective action of a nonconformance, and a preventative action to stop it occuring in other areas.
 
D

db

Re: Can CA be the same as PA?

Hi, Thanks for the replies, but i'm still not following.

If the CA is implementing the new software, does that mean there is no PA?

If thats the case, whats the point of a CAPA? - Why not just a CA form and a separate PA form?

:confused:

I'm SO confused!!

If you are just addressing the symptom, you are performing correction.
If you are preventing recurrence, you are performing corrective action
If you are preventing the problem from happening in the first place you are performing preventive action.

In the purest form, anything you do following a problem will always be corrective in nature (either correction or corrective action). In your situation, I think the database would still be corrective action, since it is trying to stop a problem from recurring. If the problem had never occured, and you installed the database to keep it from happening, then it would a be preventive action. Some would say if you apply it somewhere else, then it would be preventive (although I would argue that, since you are still reacting to a problem).

But I would not get too tied up in name calling. Apply it. If you want to call it corrective action, if you want to call it preventive action, go for it. The important thing is to take action.
 
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