Q: How does an organization determine the difference between a critical supplier and non-critical supplier as deemed in API Spec. Q1, Section 3.1.6?
A: The bottom line is that it is up to the licensee to determine which suppliers are critical. An auditor cannot fault the licensee if they disagree with the licensee’s interpretation.
I suggest considering the following when defining critical suppliers:
- Critical as it is defined in Q1, 5.4.3 (d) related to products and/or components deemed critical to the design
- Critical as it is defined in Q1, 6.2.2 criticality of the process being audited
As a rule of thumb, I suggest to my customers that the following suppliers be identified as “critical”:
- Calibration service suppliers – conformity is determined via measuring equipment; there needs to be traceability to international standards
- Design related services – based upon the importance of calculations vs. safety
- Processes requiring validation – due to the numerous technical requirements included in Q1, 220.127.116.11, “a” through “f”
Other types of suppliers can be determined critical based upon:
- The level of risk associated (with the product’s service, supplier’s ability to deliver, the scarcity of certain supplier types, etc.)
- The level of QMS control at a supplier (e.g., material distributors – API is developing a spec in this area)
— Bud Weightman
President, Qualified Specialists, International
Who We Are
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.
API Spec. Q1
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