QUESTION:
From: Joe St. J.,
Sent: May 1, 2014
To: ATCS – QBlog, Ask The Experts
Subject: API Q1, 9th Edition, Critical Suppliers
Joe St. J, asks the following about APIQ1:
Hello,
Our company remains in the process of transitioning to API Q1, 9th edition.
While reading sections 5.6.1.2 and 5.6.1.3, one of our suppliers we purchased materials from for our final product that some of his products we deem as “critical” for our final product and other products as “non-critical“.
Under Initial Supplier Evaluation – Critical Purchases, section sub. a states : “Verification that the supplier’s quality management system conforms to the quality system requirements specified for suppliers by the organization”
When we spoke to our supplier, he states he doesn’t have a “Quality Management System“. We’ve used this supplier for the past few years and would like to keep purchasing from them because their product meets our requirements.
Since this supplier does not have an established QMS, is there any way we can satisfy the requirements of API Q1, section 5.6.1.2, by using other methods for critical supplier qualification, such as customer/supplier performance history or other documented evidence that the supplier could provide? Any information that will help us meet this criteria would be greatly appreciated.
RESPONSE:
From: Bill Aston, ATCS – QBlog, Ask The Experts
Sent: May 2, 2014
To: Joe St.J.,
Subject: API Q1, 9th Edition, Critical Suppliers
Hello Joe,
Thanks for submitting your question to ATCS’s QBlog.
In regard to your question, note that in my opinion, API Q1, section 5.6.1.2, only requires the organization to verify that the supplier’s quality management system (QMS) conforms to the quality system requirements that have been specified by the organization.
API Q1, does not require the organization to ensure that its suppliers have a certified QMS, unless the organization has deemed this to be a requirement. It’s the organization’s responsibility to identify supplier quality system requirements. API Q1, is not prescriptive in this area.
If the organization determines that a certified or documented QMS is required, then the organization must verify that the supplier’s quality system conforms to those requirements.
However, where no documented or certified QMS exists, the organization may want to consider other criteria that the supplier must meet to demonstrate their capabilities. This criteria should be based upon the criticality of the product or service to be provided and may include, onsite evaluation of the supplier’s capability to provide as applicable, material/product traceability, calibration records, personnel qualifications, documented procedures for processes that require validation (i.e., heat treat, welding and NDT), control of external suppliers, internal controls for documents, records and nonconforming product, that are associated with the product or services to be supplied.
I hope this helps.
Best regards,
Bill
