API Q1 9th ed Addendum 2 - Vendor Assessment for critical products

Eredhel

Quality Manager
#11
Are you looking to be API certified?

In your post you mention that you are talking about critical suppliers. Section 5.6.1.3 is for "noncritical purchases" where section 5.6.1.2 is for "critical purchases". I might be misunderstanding but I think you may need to focus on 5.6.1.3.

Have I understood you correctly?
 
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jmech

Trusted Information Resource
#12
Dear Mr. Eredhel, This is Neeraj, working in Oil & Gas based company as a Quality Control. I have a same issue in regards to assessement of critical vendors According to API Q1 section 5.6.1.2 addendum 2, we have to follow section a, b & c . According to section C : 1) Performing an on site evaluation of relevant activities, ( we never do ) OR, 2) Performing first article inspection ...... (we perform on just few materials because for many materials it's not possible , for example: steel bar, API Dope, protectors , copper plating/ Zn / Mn chemicals...etc), 3) identifying how the supplied product, component or activities confirms to stated requirements when limited by proprietary, legal and or contractual arrangement. (for almost materials we just follow section 3 by confirming materials against material COC, MSDS, certificates and other legal documents). Recently one of our customer audit interrupted us and ask to follow either section C.1 or C.2 only, not C.3 (because according to auditor section C.3 not applicable for us) . Please help me to explain section C.3 to clear my doubt . Sincerely Thanks
The intent of 5.6.1.2 c) 3) is that you can only use it if you are unable to perform 1 or 2 due to "proprietary, legal, and/or contractual arrangements". For example, if you are purchasing a proprietary thread (so you do not know the required dimensions and therefore can't do a reasonable first article inspection) and your contract with your supplier doesn't allow you to visit their site (so you can't perform an on-site evaluation), then you can use 5.6.1.2 c) 3). If you are able to perform 1 or 2, then 3 is not intended to be an option for you.
Do you have any "proprietary, legal, and/or contractual arrangements" that prevent you from performing an on-site evaluation and from performing a first article inspection?
 
#14
Due diligence established by the original Purchse Order, I.e. Contract, should insure full documentation of the original manufacturer regardless of the number of suppliers it goes through, It should also contain documented audit and full traceability
 
#15
I got API Non-conformance:
Verification of control on supply chain has not been made evident for any of the sampled critical supplier.Verification of control on supply chain has not been made evident for any of the sampled critical supplier.
Evidence: Facility has included the requirement of API Q1 -9th Ed. Add. 2 in procedure but, no mechanism has been documented to verify controls on the supply chain.Also verification of controls on supply chain is not evident on any of critical supplier.
Help: Kindly provide a sample copy of procedure to overcome issues.
 

roneljdsilva

Involved In Discussions
#16
I got API Non-conformance:
Verification of control on supply chain has not been made evident for any of the sampled critical supplier.Verification of control on supply chain has not been made evident for any of the sampled critical supplier.
Evidence: Facility has included the requirement of API Q1 -9th Ed. Add. 2 in procedure but, no mechanism has been documented to verify controls on the supply chain.Also verification of controls on supply chain is not evident on any of critical supplier.
Help: Kindly provide a sample copy of procedure to overcome issues.
Hello! We're on the same boat on this one with the mentioned finding, and I am still working on an appropriate way of addressing the nonconformance through the procedure.

In my view, at the moment, I am identifying the suppliers considered critical to my organization and based on the type of product, component, or activity, making a list of QMS requirements and 'Extent of Control on Supply Chain' requirements, and including the same in the procedure, which will later be used as basis for preparing a supplier questionnaire to address the same. Please share your view on this approach, as I believe you've taken the necessary corrections and corrective actions to address the nonconformity.

Any guidance on this subject by the experts we have here is much appreciated!

Best Regards,

Ronel Dsilva
 
#17
The first thing you should do is identify why they are "Critical Suppliers". With that established you can define necessary controls and document how you verify the results are within the required parameters. .
 
#18
Our present practice of identifying 'Critical' and 'Non-Critical' suppliers is based on the material/item criticality, defined by Product Engineering department based on the application/service/functional requirements. Is this a correct way, or shall we consider defining the criticality from purchasing point of view alone (Considering the lead time, High cost, Limited suppliers, Geographical location, etc.,)?
 

jmech

Trusted Information Resource
#19
Your current way is correct.

Note that you are not required by Q1 to identify "critical suppliers", but rather you are required to identify "products, components or activities" that are critical and then apply the required controls to the suppliers of those purchases. It is common to refer to these suppliers as "critical suppliers", but that is not a term normatively used currently in Q1 and can lead to confusion.

Some of the other factors you listed may be relevant per 5.3b if you do a risk assessment on the supplier, but are not relevant to whether or not they are a supplier of critical "products, components or activities".
 
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