Rejecting Audit CAPAs

Hello!

 

I recently performed an audit of a supplier in China (I am in US).  They have responded with proposed corrective actions, some of which are inadequate.  What are some thoughts on responding.  My colleague in China proposed responding with the phrase "not accepted" with justification.  I have not used this phrase when responding the CAPAs in the past, as it seems somewhat abrasive. 

 

Does anyone have any thoughts on responding to the CAPA in this manner, or any other?  

 

Thanks in advance! 

Hello!

 

I recently performed an audit of a supplier in China (I am in US).  They have responded with proposed corrective actions, some of which are inadequate.  What are some thoughts on responding.  My colleague in China proposed responding with the phrase "not accepted" with justification.  I have not used this phrase when responding the CAPAs in the past, as it seems somewhat abrasive. 

 

Does anyone have any thoughts on responding to the CAPA in this manner, or any other?  

 

Thanks in advance! 

Hi Scottaha,

 

Opinions lkely relate to details of the product/process/defects.

 

Difficult to comment without context.

Hello Charles!

 

Thank you once again for the response!

 

As an example, the supplier did not mark bags or pallets of material in a manner that we felt was sufficient to prevent mix-ups and appropriately control the material (soy).  Their response of placing a paper sign in the area is not adequate, as it will not result in alleviating the concern (the sign can be moved, destroyed, a pallet can be moved, etc.).  The proposed response is: not accepted: does not allow for control of material, not documented, etc.

 

Thanks!

Hi Scottaha,

 

Thks for example.

 

IMEX  the nature of any subsequent dialog will depend on aspects such as -

 

(a) the objective/scope of the audit and its conclusion. This presumably will relate to the product/process/etc and the defects observed.

(b) whether significant defects were related to safety or 'quality" with the former prioritised.

© the significance of observed safety-related defects,eg  whether they were considered as Mi/Ma/Se/Cr defects within the overall result for (b).

(d) the significance of observed quality-related defects within the overall result for (b)

 

Generically, from a business POV, I suggest that if you don't like a proposed corrective action, it behooves you to suggest what you consider a more (minimally) appropriate response. The emphasis will logically relate to (a-d) above. For example, if considered a Safety - Critical defect, it needs to be clearly expressed as such.

I would go back to them to ask for their root cause analysis of the non conformity and whether they feel the correction sufficiently addresses root cause?  You could go on to say that in your experience although you appreciate the aims the correction does not appear to be sufficiently robust to prevent recurrence.

 

Firstly the root cause analysis has to be done properly then corrective action taken or to be taken must address the root cause of the problem. The auditor then reviews the submitted CA and assess whether it's relevant or appropriate to the non conformance raised and that it will solve the root cause identified. If you're not satisfied with that then you can kindly tell them that the finding cannot be closed off due to inappropriate CA / insufficient evidence submitted.