Jump to content

  • Quick Navigation
Photo

Rejecting Audit CAPAs

Share this

  • You cannot start a new topic
  • Please log in to reply
5 replies to this topic

Scottaha

    Grade - Active

  • IFSQN Active
  • 12 posts
  • 0 thanks
0
Neutral

  • United States
    United States

Posted 21 February 2017 - 05:24 PM

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! 



Charles.C

    Grade - FIFSQN

  • IFSQN Moderator
  • 20,542 posts
  • 5662 thanks
1,544
Excellent

  • Earth
    Earth
  • Gender:Male
  • Interests:SF
    TV
    Movies

Posted 21 February 2017 - 06:11 PM

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.


Kind Regards,

 

Charles.C


Scottaha

    Grade - Active

  • IFSQN Active
  • 12 posts
  • 0 thanks
0
Neutral

  • United States
    United States

Posted 21 February 2017 - 06:26 PM

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!



Charles.C

    Grade - FIFSQN

  • IFSQN Moderator
  • 20,542 posts
  • 5662 thanks
1,544
Excellent

  • Earth
    Earth
  • Gender:Male
  • Interests:SF
    TV
    Movies

Posted 21 February 2017 - 07:37 PM

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.


Kind Regards,

 

Charles.C


GMO

    Grade - FIFSQN

  • IFSQN Fellow
  • 2,791 posts
  • 721 thanks
225
Excellent

  • United Kingdom
    United Kingdom

Posted 22 February 2017 - 12:57 PM

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.

 



Foibe

    Grade - Active

  • IFSQN Active
  • 14 posts
  • 1 thanks
0
Neutral

  • Namibia
    Namibia

Posted 14 March 2017 - 09:53 PM

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.



Thanked by 1 Member:


Share this


Also tagged with one or more of these keywords: Audit, CAPA, Reject

0 user(s) are reading this topic

0 members, 0 guests, 0 anonymous users