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Capa

I am having a friendly discussion regarding CAPA. I contend that correct actions are linked to preventative actions, basically something occurs, you correct (immediate), then determine how to prevent from recurring anywhere else (long term). My colleague contends that the prevention from recurrence is part of the correct action and not the preventative portion of CAPA. Then, the preventative aspect is spurned from risk analysis (FMEA) of existing/new equipment or processes, and how you would prevent an issue from occurring. I have never seen the two separated like this, it seems to me that is why it is called CAPA and not CA PA.

Hi Meyert,

That is my understanding also, if you have a corrective action in a CAPA you must have a preventative measure also.

Anywhere I have worked, there is usually a design FMEA detailing any risk associated with the equipments functionality (could also be software driven) and also a Process FMEA detailing the risks associated with different stages of the process.

If a CAPA is opened, what might happen is that the PA of the CAPA might state that the FMEA needs to be upreved to allow more stringent validation to mitigate this risk in the future.

Definitions

Process Failure Mode and Effects Analysis: a risk assessment tool that identifies the potential failure modes, failure effects, risk, and means of controlling risk for a given process.

Design Failure Mode and Effects Analysis: a risk assessment tool that identifies the potential failure modes, associated failure effects and the risk associated with the failure effects for a given design/product

I know this is a brief description hope it makes some sense!

I am also working on a CAPA article at the moment which I hope to have completed by early next week.

I will be sending a link to members when completed.

Regards

I can’t believe my QA is holding on to this so tenaciously? I am trying to explain to them why you do CAPA or the history of it? I was taught that CAPA came about because issues would arise and get fixed, but the actual cause of the problem was never investigated nor solved. CAPA forces companies to think about things like root cause. So to clarify, they want to have a “correction” immediate action, “corrective action” long term action. Then preventative action are only for preventing something from ever occurring.

This is from the FDA web site…

Guidance-Quality Systems Approach to Pharmaceutical CGMP Regulations
CAPA is a well-known CGMP regulatory concept that focuses on investigating, understanding, and correcting discrepancies while attempting to prevent their recurrence. Quality system models discuss CAPA as three separate concepts, all of which are used in this guidance.

* Remedial corrections of an identified problem
* Root cause analysis with corrective action to help understand the cause of the deviation and potentially prevent recurrence of a similar problem
* Preventive action to avert recurrence of a similar potential problem

How do you investigate a OOS ,

[quote=gokeeffe]Hi Meyert,

That is my understanding also, if you have a corrective action in a CAPA you must have a preventative measure also.

Anywhere I have worked, there is usually a design FMEA detailing any risk associated with the equipments functionality (could also be software driven) and also a Process FMEA detailing the risks associated with different stages of the process.

If a CAPA is opened, what might happen is that the PA of the CAPA might state that the FMEA needs to be upreved to allow more stringent validation to mitigate this risk in the future.

Definitions

Process Failure Mode and Effects Analysis: a risk assessment tool that identifies the potential failure modes, failure effects, risk, and means of controlling risk for a given process.

Design Failure Mode and Effects Analysis: a risk assessment tool that identifies the potential failure modes, associated failure effects and the risk associated with the failure effects for a given design/product

I know this is a brief description hope it makes some sense!

I am also working on a CAPA article at the moment which I hope to have completed by early next week.

I will be sending a link to members when completed.

Regards[/quote]