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When to use Corrective Action and when to use CAPA?


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OG Bean

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Posted 06 July 2018 - 01:44 PM

Can findings from an Internal Audit simple have a corrective action without having to due a CAPA?

 

My thinking is CAPAs are for the "big" issues.

 

Thoughts?



FSQA

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Posted 06 July 2018 - 02:02 PM

Any observation/s during an internal audit should have a CAPA. 

Observation/finding is a deviation to a process/policy/program and Internal audit is the inspection of the implementation of these policies/programs/processes and has a dual function of detecting the current gaps in a system and proactively stopping any potential issues. Chances of having the same issue if a corrective action is implemented , without a follow up preventive action, are higher.

However, depending on the type and severity of the finding, the CAPA implementation can be done in a short term/long term span.


Edited by FSQA, 06 July 2018 - 02:11 PM.


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OG Bean

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Posted 06 July 2018 - 03:18 PM

Any observation/s during an internal audit should have a CAPA. 

Observation/finding is a deviation to a process/policy/program and Internal audit is the inspection of the implementation of these policies/programs/processes and has a dual function of detecting the current gaps in a system and proactively stopping any potential issues. Chances of having the same issue if a corrective action is implemented , without a follow up preventive action, are higher.

However, depending on the type and severity of the finding, the CAPA implementation can be done in a short term/long term span.

 

I'm just concerned this approach will water down our CAPA program making less effective.



Scampi

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Posted 06 July 2018 - 03:26 PM

It depends on how detailed you want to be .........let's assume you find a man-door open that should be closed....you closed the door and recorded that on your audit. Now, no doors have ever been open during monthly auditing before-----so do you really want to do a root cause analysis on this? I wouldn't, because odds are A) no one is going to tell you who left it open and B) you would have to correct it by monitoring the doors more often and that is not a good use of anyone's time for a 1 time issue of this nature

 

If it becomes an ongoing issue, then you'd need a CAPA?  I urge you to use common sense on this or all you'll be doing is CAPA and follow ups

 

Obviously, if you find a major or critical deviation that is a different kettle of fish and that definitely needs a RCA, again, common sense


Please stop referring to me as Sir/sirs


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FSQA

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Posted 06 July 2018 - 04:51 PM

I will partially agree with the above post.

 

However, as an auditing perspective the findings can be as simple as an "opportunity to improve" to a "critical" finding. IMO, opportunity to improve is the only finding which does not requires a CAPA, however, any other findings (minor, Major,Critical) requires a CAPA (including RCA, CA and a PA). Again, a preventive action implementation is a proactive approach to avoid repetition of the same finding/s.

 

In the above example (assuming door is there for parameter/ restricted access and this finding violates your Food Defense control), the following approach can be as simple:

 

Root cause analysis: Employee did not properly close the door (if that was the finding)

Corrective action: Door closed during the audit.

Preventive action (can vary on the approach and could be as simple as): A)Discuss/retrain the employee/s during the next refresher training on Food Defense or B) install self closing door.

 

However, it all depends on the type of your finding during the Internal audit, as how much emphasis should be given on the CAPA of that finding.

 

But again, this is just my two cents.... :doh:



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Charles.C

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Posted 07 July 2018 - 12:36 AM

Can findings from an Internal Audit simple have a corrective action without having to due a CAPA?

 

My thinking is CAPAs are for the "big" issues.

 

Thoughts?

 

Hi jcoomes,

 

My thoughts ?
 

IMO this "topic" has the potential to generate unlimited semantic confusion. For example consider these 2 “interpretations” -
 

 

Corrective action is an important part of any management system.  Corrective actions are proactive, rather than reactive responses to a deviation from regular operations.

 

(SQF8 Guidance)

 

Corrective [action] is reactive. Preventive is proactive. Although these two actions use similar processes and some of the same analytical tools, they are not necessarily used together.

 

https://www.smartshe...eventive-action

 

Personally I think SQF is incorrect however the following analysis implies, I think, that both the above "interpretations" may be valid ! –

 

Quality professionals frequently express confusion as to the difference between corrective and preventive action. A corrective action deals with a nonconformity that has occurred, and a preventive action addresses the potential for a nonconformity to occur. Many ISO 9000 registrar auditors tell their clients to use separate procedures and forms to document each type of action. Nothing in the standard says this must be done, but p. 13 includes the word “prevent” in the clauses on corrective and preventive action.

On closer reading, however, section 8.5.2 says corrective action eliminates the cause of nonconformities to prevent recurrence, and section 8.5.3 says preventive action determines and eliminates the causes of potential nonconformities … to prevent occurrence. See, there is a difference!

http://asq.org/quali...ive-action.html

 

Further on the ASQ link suggests a Scampi-like approach to have some benefits (ie risk-based) but I had already given up by then. :smile:

 

I suggest one solution is case-by-case depending on the context, ie what does your implemented FS Standard require you to (minimally) do ?. Then act accordingly.


Kind Regards,

 

Charles.C


mgourley

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Posted 09 July 2018 - 11:09 AM

The best answer? It depends.

 

Like Scampi said, how detailed do you want to be?
Every week I walk around my facility and do an audit of one section. I write down my findings. Do I really need to do a root cause analysis because I found some spider webbing under the stairs to the mezzanine?

Probably not....just have someone clean it. 

 

If you work for a company that is large enough and has the time and personnel available to do RCA and CAPA for every little thing, then have at it. In the real world, I find it's better to just correct things.

 

Marshall



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Mr. Wallace

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Posted 09 July 2018 - 04:31 PM

at my current employer we only update our CAPA log if one of our CAPA "triggers" have been met. These triggers are usually bigger issues ex downtime greater than 3 hours, more than 5 pallets placed on hold, NR from USDA, or any foreign objects in product found. Hope this helps 






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