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4.1 - general requirements, audit nonconformances and findings, audits and auditing, outsourced products and processes, qms (quality management system), quality manuals (general)
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  #25  
Old 15th April 2012, 10:59 PM
azsportsfan azsportsfan is offline
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Re: 3rd Party Audit Finding Not Clear - 4.1 Outsourced Processes

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In Reply to Parent Post by AndyN View Post

Back in post #5, I asked if this was a Stage 1... Jim brings up some good points, however, shouldn't this have been resolved at the stage 1 (if this audit isn't it)?
This was a transition audit to C.

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  #26  
Old 16th April 2012, 09:22 AM
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Thumbs up Re: 3rd Party Audit Finding Not Clear - 4.1 Outsourced Processes

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This was a transition audit to C.
OK, thanks! So, they were doing the "right thing" if not necessarily the "right way"...

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  #27  
Old 17th April 2012, 12:00 AM
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Re: 3rd Party Audit Finding Not Clear - 4.1 Outsourced Processes

Hello,

The way to address this is to list all the outsourced processes-e.g R&D, Maintenance, Calibration, Transportation, raw materials, etc and correspondingly list how they are controlled, and refer to another clause 7.4.1 of the manual.

In section 8 there is also a clause about monitoring performance of outsourced supplier. One metric could be their thesponse to Supplier Corrective Actions. Hope this helps.
  #28  
Old 17th April 2012, 12:43 AM
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Re: 3rd Party Audit Finding Not Clear - 4.1 Outsourced Processes

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In Reply to Parent Post by LUV-d-4UM View Post

Hello,

The way to address this is to list all the outsourced processes-e.g R&D, Maintenance, Calibration, Transportation, raw materials, etc and correspondingly list how they are controlled, and refer to another clause 7.4.1 of the manual.

In section 8 there is also a clause about monitoring performance of outsourced supplier. One metric could be their response to Supplier Corrective Actions. Hope this helps.
Where is that clause in section 8?
  #29  
Old 17th April 2012, 02:22 AM
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Thank You! Re: 3rd Party Audit Finding Not Clear - 4.1 Outsourced Processes

Also cited Risk ManagementThere is no evidence of risk management for suppliers as required by 7.4.1f

Please can someone tell me where can I find the clause 7.4.1f in the TS16949 standard? Thank you.
  #30  
Old 17th April 2012, 03:37 AM
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Re: 3rd Party Audit Finding Not Clear - 4.1 Outsourced Processes

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In Reply to Parent Post by LUV-d-4UM View Post

Also cited Risk ManagementThere is no evidence of risk management for suppliers as required by 7.4.1f

Please can someone tell me where can I find the clause 7.4.1f in the TS16949 standard? Thank you.
This thread is about AS9100, not TS 16949.
  #31  
Old 17th April 2012, 09:57 AM
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Re: 3rd Party Audit Finding Not Clear - 4.1 Outsourced Processes

coming a bit late to this, but my first thought was to control your outsourced processes (processors) on your Approved Vendors list. You will have to have the company that performs the process listed, along with scope of the approval. 9100C 7.4.1 lists all the controls needed for Suppliers. Since the 'product' you are purchasing is a process, the controls should all come from what you have documented (or do in practice) to maintain all the requirements of 7.4.1 in your system.
  #32  
Old 17th April 2012, 10:39 AM
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Re: 3rd Party Audit Finding Not Clear - 4.1 Outsourced Processes

Hi Big Jim. It is in 8.4d Analysis of data.
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