Non-Conformance from recent Audit carried out on Purchasing

wayne.wilson7

Involved In Discussions
#1
We have recently gone through our surveillance audit and have been given a major Non-conformance for using ISO 9001 approved suppliers due to section 8.4.2

"The Organisation shall:
a. ensure that externally provided processes remain within the control of its quality management system;

b. define both the controls that it intends to apply to an external provider and those it intends to apply to the resulting output;

The above requirement could not be demonstrated for the examples noted below: -"

The auditor didn't seem to accept ISO 9001 as an acceptable standard for suppliers.
 
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qualprod

Trusted Information Resource
#3
We have recently gone through our surveillance audit and have been given a major Non-conformance for using ISO 9001 approved suppliers due to section 8.4.2

"The Organisation shall:
a. ensure that externally provided processes remain within the control of its quality management system;

b. define both the controls that it intends to apply to an external provider and those it intends to apply to the resulting output;

The above requirement could not be demonstrated for the examples noted below: -"

The auditor didn't seem to accept ISO 9001 as an acceptable standard for suppliers.
Was the audit based under 9001?
 

Ed Panek

QA RA Small Med Dev Company
Trusted Information Resource
#4
We also struggle with suppliers. Do you frequently purchase from these suppliers? Have you categorized them based on risk? What standard were you working at; 9001?
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#5
The auditor didn't seem to accept ISO 9001 as an acceptable standard for suppliers.
Was an exit meeting held, before the auditor departed? If so, were clarifications asked? We can only speculate and second guess here, without the full information, but it might be the case of the auditor identifying that no control over the incoming product exists. The ”resulting outputs” from the supplier, how are they verified and confirmed conforming? Are there CoC’s? Incoming inspection? Source inspection? If you send a part out for special process treatment, chances are, the vendor has to be Nadcap accredited. Are they? Are you flowing down Nadcap, when required? You can impose ISO 9001 to your suppliers, but that is NO REPLACEMENT for evidence of product conformity coming from them.

If the finding is not clear, you have the right and responsibility to request clarification from the auditor and the best time for that is DURING the audit, no later than the closing meeting. But, nothing prohibits you from communicating with the auditor after the event, to request such clarification.
 

Tagin

Trusted Information Resource
#6
The auditor didn't seem to accept ISO 9001 as an acceptable standard for suppliers.
Does your documentation state something to the effect of "providers of externally provided processes shall be ISO 9001 certified"? If so, 1) do you have those certs on file, along with some kind of approval record, and 2) do you have an ongoing review process (e.g., annual) to review those providers to ensure they are maintaining their certification?
 

Jim Wynne

Staff member
Admin
#7
We have recently gone through our surveillance audit and have been given a major Non-conformance for using ISO 9001 approved suppliers due to section 8.4.2

"The Organisation shall:
a. ensure that externally provided processes remain within the control of its quality management system;

b. define both the controls that it intends to apply to an external provider and those it intends to apply to the resulting output;

The above requirement could not be demonstrated for the examples noted below: -"

The auditor didn't seem to accept ISO 9001 as an acceptable standard for suppliers.
Details on "...the examples noted below,,," would be helpful. Please provide the entirety of the auditor's NC statement.
 

wayne.wilson7

Involved In Discussions
#9
Was an exit meeting held, before the auditor departed? If so, were clarifications asked? We can only speculate and second guess here, without the full information, but it might be the case of the auditor identifying that no control over the incoming product exists. The ”resulting outputs” from the supplier, how are they verified and confirmed conforming? Are there CoC’s? Incoming inspection? Source inspection? If you send a part out for special process treatment, chances are, the vendor has to be Nadcap accredited. Are they? Are you flowing down Nadcap, when required? You can impose ISO 9001 to your suppliers, but that is NO REPLACEMENT for evidence of product conformity coming from them.

If the finding is not clear, you have the right and responsibility to request clarification from the auditor and the best time for that is DURING the audit, no later than the closing meeting. But, nothing prohibits you from communicating with the auditor after the event, to request such clarification.
Hi Sidney
Basically the statement was if they are ISO9001 how do we know they controlling their process? we have all incoming parts supplied with minimum of C of C's and some with inspection reports but he was more interested in how did we know they were using correct materials to carry out the plating, were the baths to correct temperature, what was duration of soaking etc etc. I'm not sure even if we would have had frequent audits it would have been sufficient IMO.
 

wayne.wilson7

Involved In Discussions
#10
Details on "...the examples noted below,,," would be helpful. Please provide the entirety of the auditor's NC statement.
For purchase orders 81781, 81854 for the subcontract processing of metal finishing services, the Organisation had used a customer designated third party sources. Although the third parties were seen to be certified to ISO9001:2015, there was no evidence available to show how the Organisation had ensured the externally provided processes were within the control of its quality management system or what controls had been applied to these external providers or the resulting output of the processes.

Note: This was seen as a breakdown of a system to address an AS9100 Rev D requirement, therefore raised as a major NCR
 
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