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Supplier Audit Corrective Action Request Responses
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Supplier Audit Corrective Action Request Responses
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effectiveness, iso 13485 - medical device qms, supplier audits, supplier corrective & preventive action
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  Post Number #1  
Old 20th February 2014, 12:45 PM
QACen

 
 
Total Posts: 44
Please Help! Supplier Audit Corrective Action Request Responses

Hello Quality Gurus!

Is it necessary to include a corrective action report from a supplier? From my understanding of ISO 13485 requirement, we define the evaluation process and this can mean anything. I've checked and read through a few templates posted on the cove and it seems as if its up to the company.

Have any of your suppliers actually responded to your CAR request from an audit? Is it effective?

I want to keep it simple. If the supplier responds, great! If not, because they are not required by their ISO 9001 standards, then fine.

Thanks for any incite.

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  Post Number #2  
Old 20th February 2014, 01:55 PM
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Ninja

 
 
Total Posts: 1,031
Re: Supplier Audit Corrective Action Request Responses

Quote:
In Reply to Parent Post by QACen View Post

Have any of your suppliers actually responded to your CAR request from an audit? Is it effective?
Howdy,

My company is ISO900, not ISO 13485.
We get 100% response rate from suppliers to whom we issue a CAR request.

Some things contributing to this response rate:
1. The CAR request is issued after many joint meetings and/or visits, and the request is far from a surprise when it is issued. At that point, the verbal walkthrough of what happened (or could) and what the supplier can and is willing to do has already been established.
2. The CAR request is formalizing something that is already going on...it is not the initiating event.
3. We do not require that they fix things our way...just that they fix things enough for us to be satisfied.
4. A response of "No. Go pound sand." is a response...not one we want, but a response none0the-less.
  Post Number #3  
Old 31st December 2017, 01:01 AM
myusoffice

 
 
Total Posts: 17
Re: Supplier Audit Corrective Action Request Responses

Hi,

We often forget that supplier plays a critical role in every company's success. I have seen many companies, auditors treat suppliers like one of their greatest enemies. As if they have made a mistake becoming their supplier. The ideal purpose of an audit is not to find rabbit hole and then blaming your supplier for their poor performance or even some cases, threatening them to put on probation.

A supplier is your partner. It is your responsibility to work with a supplier, co-operate to develop them where they are weak, empower them with your knowledge and help them when needed most. When there is finding during an audit, explain it to supplier what that means to you as a customer and how they can improve in that specific area. Offer help when needed.

To answer your question, if there is a finding during your supplier audit, it doesn't necessarily always have to be a formal CAR request. You can explain it to the supplier that they need to improve/have a fix on that finding and the importance of the compliance. The response from the supplier can be any format, an email with evidence of fixes, powerpoint presentation, or a formal CAR.

Hope this helps

Regards,
Ziaur
Thanks to myusoffice for your informative Post and/or Attachment!
  Post Number #4  
Old 16th January 2018, 06:36 PM
ritamuse's Avatar
ritamuse

 
 
Total Posts: 3
Re: Supplier Audit Corrective Action Request Responses

I love this response. I wish all supplier auditors understood this as their role. well said.
  Post Number #5  
Old 17th January 2018, 07:59 PM
QuinnM

 
 
Total Posts: 19
Re: Supplier Audit Corrective Action Request Responses

Hi QACen,

We receive a high response from suppliers. Being a medical device, class II and III, often I would hope the suppliers investigations were more in-depth, but we work together. As an alternative, I have excluded correction action reports in our audit closure reports, but this is when we go back to the supplier sooner (typically with in 6 months). I work with suppliers when doing this by training and even helping with suppliers processes. At the end of the day, our product improves and the supplier gets better.

My 2C
Quinn
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