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Must We Audit Critical Suppliers? How often?

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Some Related Topic Tags
audits and auditing, class ii medical device, critical suppliers, foreign manufacturing, mdd (medical device directive), supplier audits, suppliers (general topics)
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  Post Number #1  
Old 14th December 2012, 12:24 AM
ugecha

 
 
Total Posts: 20
Question Must We Audit Critical Suppliers? How often?

Hello, everyone.

We had MDD audit this year and NB auditor said clearly "you must audit your foreign factory (making class II devices) at least ONCE A YEAR. NB must audit them according to ZLG3.9 B17 if you fail to show clear evidence of good controlling. "

My question is,
1. Is this true? If so, is there any document saying manufacture must audit critical suppliers once a year?

2. Is this just because NB is a German organization? How about other NB like SGS? I am told that other NBs never say such a thing.

3. How often should we conduct an audit for "critical supplier" It is not cheap to go there every once a year. One of critical suppliers is located abroad. How often do your company go and audit?

4. We don't have a staff member who speaks English and full of knowledge on regulations. How do you handle such situation in your company? One person never cover them all, two or three people must go visit suppliers. We can't afford that.

5. We will have an inspection from FDA soon. Are they going to say the same thing?

I appreciate for your help very much.

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  Post Number #2  
Old 14th December 2012, 07:22 AM
Angelika Hoess

 
 
Total Posts: 9
Re: Must We Audit Critical Suppliers? How often?

Hi ugecha,

ZLG is a German notifying authority performing the recognition and monitoring of testing laboratories and certification bodies in the area of medical devices and in vitro diagnostic medical devices. 3.9 B17 refers to the best practice guide from the European Notified Body Operations Group (NBOG BPG 2010-1) that ZLG just adopted without modifications. So it's nothing to do with your NB being German. Check out article 5 (criteria for audit of a supplier's premises), especially the note on page 5 and the last paragraph of this article. This should give your organization some leeway in decision-making.

Regards, Angelika.
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File Type: pdf ZLG_309_0410_B17.pdf (72.8 KB, 188 views)
Thank You to Angelika Hoess for your informative Post and/or Attachment!
  Post Number #3  
Old 14th December 2012, 10:08 AM
MIREGMGR

 
 
Total Posts: 3,685
Re: Must We Audit Critical Suppliers? How often?

Quote:
In Reply to Parent Post by ugecha View Post

5. We will have an inspection from FDA soon. Are they going to say the same thing?
21CFR 820.50 requires that you have component specifications and purchasing controls to assure that those specifications are met; and that you define what controls apply to each supplier, and document your application of those controls.

FDA does not have a specific onsite-audit requirement, or required audit frequency. However, if a supplier is identified by you or by the inspector as critical but you haven't defined more-rigorous controls for that supplier, you can expect the inspector to fault you for that lack of evidence that you have taken 820.50 seriously. An on-site audit program of some frequency, with other controls during periods between audit visits to provide evidence that specifications were continually met, would be one way to demonstrate 820.50 compliance.
Thank You to MIREGMGR for your informative Post and/or Attachment!
  Post Number #4  
Old 16th December 2012, 10:36 PM
ugecha

 
 
Total Posts: 20
Re: Must We Audit Critical Suppliers? How often?

Thank you, Miregmgr for your kind explanation. If you happen to know if other NB like SGS, TUV asks the same thing at audit, will you let me know.
Thank you.
  Post Number #5  
Old 17th December 2012, 04:11 AM
ssz102

 
 
Total Posts: 368
Re: Must We Audit Critical Suppliers? How often?

many standards had requires enterprise to control and evalute &verify them supplier qulificaiton and related to information

in this process, need to factory or firm to check on supplier site

like your situation, i think may be authorized certification body help to evaluate supplier, or send product to test body, let them help to validate these product whether are meet your specification or not
  Post Number #6  
Old 17th December 2012, 08:15 AM
pkost

 
 
Total Posts: 824
Re: Must We Audit Critical Suppliers? How often?

There is no specific requirement for the manufacturer to audit, just to have control. If you do audit, there is no requirement to do it x number of times a year.

As Angelika has said, the new code of practice for notified bodies has tightened the area for control of suppliers, however it is important to note that it still doesnt' require the manufacturer to carry out an audit, or specify how frequently. It also leaves a lot of room for interpretation by the NB as to whether the NB needs to audit the supplier.

That being said, if the NB says "you audit or we will" because that is their criteria for supplier control then that is their decision and if you don't like it you could argue the toss or move to another NB
Thanks to pkost for your informative Post and/or Attachment!
  Post Number #7  
Old 17th December 2012, 07:32 PM
ugecha

 
 
Total Posts: 20
Re: Must We Audit Critical Suppliers? How often?

Thank you all, so from what I have learned here, we would be better conduct an on-site audit at least once a year for the time being following advice from our NB auditor. He said regulation will be tougher due to PIP case in EU as well.
Also I agree that FDA will be happier if we have periodic audit plan for critical supplier. Can't be too careful. Thank you all again.http://elsmar.com/Forums/images/smilies/thankyou.gif
  Post Number #8  
Old 18th December 2012, 06:27 AM
chandaraasekar

 
 
Total Posts: 19
Re: Must We Audit Critical Suppliers? How often?

first you should have a supplier evaluation system on a regualr frequency , which includes the supplier QUality , Delivery , Continual imp[rovement and cost performance also include his response to ur queries. Now you can ask the supplier to give a countermeasure for poor scoring elements and let him visit your plant to explain corrective actions.If you still find the supplier is repeating the same complaints then prepare a supplier visit .
On a proactive basis you connduct supplier reassessment on a yearly ( local ) 3 year once for a overseas supplier.
Thanks to chandaraasekar for your informative Post and/or Attachment!
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