Q: According to API Spec. Q1 sections 220.127.116.11 and 18.104.22.168, we are basically supposed to perform supplier audits annually on “critical” suppliers. I have an audit planned for suppliers of critical products and services. That’s OK. However, I found a few critical suppliers that are companies abroad with a global presence, and I don’t have any doubt of their capability, as they are a leading provider of steel cord! Should I audit them? Is it really necessary?
A: Keep in mind a few key points:
- There is no singular Q1 requirement to perform annual audits of critical suppliers.
- One criterion for approving critical suppliers is an audit, but this is not the only method.
- With regards to re-evaluation, it can be performed through Section 22.214.171.124 (c) receiving inspection and by monitoring supplier nonconformances.
As for the audit of companies abroad; let’s go through Section 126.96.36.199:
If you want, you can have an audit performed; you can contract a competent 3rd-party auditing company in that geographical area to do the audit for you to specified requirements.
With regards to critical supplier controls, Section 188.8.131.52 (a) requires an organization to determine if a supplier meets the organization’s QMS. This can be done in one or more ways. As an example:
- Does the supplier have a QMS certification such as ISO 9001 / API Q1 or a certification to another internationally recognized scheme? If so, this can be used.—OR—
- You can request a copy of their QA Manual; review it and accept it. —OR—
- You can document a quality plan or inspection and test plan requirements; make it a controlled document under Section 4.4.3 and attach it to your PO according to Section 5.6.2, Purchasing Information. —AND— you can ask the supplier to furnish a Certificate of Conformity to your quality plan or inspection and test plan.
In addition to Section 184.108.40.206 (a), you are required to meet one or more of the requirements shown in Section 220.127.116.11 (b): (i), (ii) or (iii).
i. would be the performance of an audit as described earlier herein.
ii. would be asking the supplier to furnish a product sample for your review, inspection, test and /or analysis, or some other physical or contractual confirmation. This primarily applies to a new supplier/product.
iii. would be identifying how you meet proprietary, legal, and/or contractual requirements. Proprietary or legal would be up to the specific organization’s agreements with their supplier if these conditions apply. However, the term “contractual arrangements” could mean requirements identified in an organization’s material specification, quality plan, and/or inspection and test plan as examples. Where “contractual arrangements” are used for this purpose, the conditions identified in item (3) above related to 18.104.22.168 (a), “Certificate of Conformity,” could apply.
— Bud Weightman
President, Qualified Specialists, International
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Qualified Specialists, International (QSI) is a professional consulting, training, and management systems technology firm headquartered in Houston, TX. Founded by R.T. (Bud) Weightman in 1989, QSI has a global presence and has implemented and assessed management systems in over 28 countries world-wide – with certifications ranging from ISO 9001, ISO 14001, OHSAS 18001, API Spec. Q1 / Q2, and more.
Our specialty spans quality, health and safety, and environmental (QHSE), and our products and services have been applied in engineering, manufacturing, fabrication, distribution, service, projects, and operations.
We excel in helping our clients to achieve regulatory compliance, certification, and industry licensing through our superior software solutions, consulting services, and industry-leading training.
Bud Weightman, President of QSI, is an international management systems expert involved with management and technical systems for over 40 years. As President of QSI, Bud is involved with the industry committees responsible for emerging requirements, including: revision of API specifications, leading various API Task Groups, and lead auditor for the accreditation of SEMS Audit Providers through the Center for Offshore Safety. Bud’s experience includes working with ISO 9001, ISO 14000, and OHSAS 18000 management systems, as well as industry-specific certification schemes such as API Q1 and Q2, AS9100, ASME systems, and numerous other standards.
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