Incorporating Risk Management into CAPA

M

Metriculator

#1
Hello all!

I am looking to incorporate our Risk Management process into our CAPA process. Hence, I am looking for an example of a CAPA form that incorporates Risk Management. Any help or tips would be greatly appreciated.

Thanks in advance!
Marc
 
Elsmar Forum Sponsor
D

Duke Okes

#2
A matrix (e.g., 5x5) of X = probability of occurence and Y = seriousness of impact is often used to evaluate risk. If it is low for both X and Y then perhaps a less in-depth investigation is warranted, while if high for both then obviously a very in-depth investigation is necessary. You can set the level of response (low, medium & high) based on where the failure falls into the matrix.
 

Marcelo

Inactive Registered Visitor
#3
Although not having a CAPA form, you might want to take a look at the document "Implementation of Risk Management Principles and Activities Within a Quality Management System" from SG3 of the GHTF (http://www.ghtf.org/sg3/sg3-final.html). Figure 1 of this document shows how the relevant parts of the risk management process can be incorporated in the CAPA process.

Although Duke´s example is a good general on, remeber that if you´re using the process from ISo 14971 you have to take into account your risk acceptability criteria as defined in your risk management plan (and obviously based on your oolicy for risk acceptability :))
 
M

Metriculator

#4
Thanks for the replies!

I already have the 5x5 risk evaluation matrix. What I am considering is utilizing the CAPA process to document any investigations and actions as a result of the risk evaluations.

I am trying to determine if anyone else had tried this, and if so, how they had incorporated risk investigations into a corrective action form.

Thanks also for the GHTF document. That was very helpful also.:)
 
M

Metriculator

#6
Jennifer,

Thank you for the feedback and the welcome to the cove forum!

I hope I am able to provide as much support to others as they are providing for myself and others.

Regards, Marc
 
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