Products intended for the oil and gas sector encounter a diverse range of operating conditions, which encompass challenging environments like deep wells, high pressure, high temperature, exposure to hydrogen sulfide, and naturally occurring radioactive materials.

There are multiple articles available that analyze the risks encountered by oil and gas producers, as well as numerous articles that delve into the commonalities associated with industry accidents.

Nevertheless, despite the abundance of information available on industry risks, limited information is accessible concerning the potential impact of changes to quality management system requirements.  The changes from the 9th to the 10th Edition of API Spec Q1, which pertains to the Quality Management System Requirements for Organizations Providing Products for the Petroleum and Natural Gas Industry, may prompt some critical thinking regarding the nature of these revisions¹.

API’s mission is to promote safety across the industry globally and to influence public policy in support of a strong, viable U.S. oil and natural gas industry.

The organizations currently certified that are required to comprehend the extent of the changes, adjust to them, and execute them will face a challenging path due to the alterations and reorganization introduced by the 10th Edition.   These changes will be foreboding for some organizations and may be akin to learning a new language.

These modifications may expose users to potential risks owing to the magnitude of the changes. Several of these risks are associated with the inclusion of “services-based” terminology in a specification that has conventionally been focused on manufacturing and servicing for thirty-seven (37) years, including the relaxation of long-standing requirements. 

The document poses additional risks due to the significant modifications made to align with the new product definition in the 10th Edition². The word “product” is referenced approximately 248 times within the document causing many of its requirements to be reworded and broadened.

3.1.17 product Output of an organization intended to be provided to a customer. Note: As used in this document, the term ‘product’ can include, but is not limited to, hardware, software, production activities, or product-related activities such as: servicing, storage, distribution, and logistics.

The industry experienced its most substantial changes since the release of the Q1, 1st Edition (January 1, 1985) with the incorporation of risk assessment & management, contingency planning, and management of change in the Q1, 9th Edition (2013/effective 2014). Additionally, the definition and requirements for the supply chain were introduced in Addendum 2 to the 9th Edition (2018/effective 2019), marking a significant shift four (4) years later following the findings of BSEE’s QC-FIT Report³:

Bureau of Safety and Environmental Enforcement (BSEE) Quality Control-Failure Incident Team (QC-FIT) Report Industry should evaluate API Specification Q1, Ninth Edition, June 2014 including the addendums, “Specification of Quality Management Systems Requirements for Manufacturing Organizations for the Petroleum and Gas Industry” for the following: Consider including oversight and auditing of subcontracted second-tier, third-tier and lower tiered vendors who perform a manufacturing process into API Specification Q1. This requirement would ensure that all components manufactured throughout the supply chain are “fit for service.” Ensure that the API monogram program provides a sufficient auditing mechanism such that the OEMs are in full compliance with API Specification Q1 Ninth Edition. Consider including fasteners for critical equipment in the API monogram program.

Despite having used the 9th Edition for nine (9) years and Addendum 2 for the last four (4) years, numerous organizations have yet to fully comprehend the complete significance of these requirements. How much time will it require for organizations to adapt to the modifications introduced in the 10th Edition?  Furthermore, what potential risks might these changes pose to organizations that must comply with it?  Lastly, what risks might oil and gas producers face if products are exposed to risks resulting from these changes?

Potential risks to organizations could include:

• Failing to establish a strong change management procedure
• Inadequate integration of external document requirements into the existing process
• Taking advantage of lenient or unclear requirements, such as the removal of the need for a quality manual
• Limited comprehension of updated or new requirements
• Incorrect execution of identified modifications
• Partial adherence to the changes contained in the 10th Edition
• Neglecting to adequately address deficiencies in the quality management system that may affect product requirements

These potential risks could be further magnified by contributors such as:

• The accuracy and robustness of an organization’s quality management system structure and content
• The level of experience and competencies of an organization’s personnel
• The certified body’s practices, including audit personnel experience and competencies
• The extent and effectiveness, or the absence thereof, of audits conducted by the certified body
• The robustness and accuracy of root cause analyses and corrective actions, by certified organizations and the effectiveness of verification by the certified body

Organizations will require a considerable amount of time to fully comprehend, incorporate, and adjust to the modifications introduced in the 10th Edition.  

The API Monogram Program is dependent on Spec Q1 as the binding element that brings together all product specifications and quality management system requirements. Given the widespread usage of API Spec Q1, there is a possibility of potential risks impacting products utilized in various industry sectors.

It may take a lengthy period, possibly spanning years, for any potential risks associated with the product to become apparent. The appearance of product-related risks could manifest itself in some of the following ways:

• Product rejected upon receipt by the customer
• Product installation or operational issues
• Nonproductive time
• Product failure
• Accidents, or worse

The industry has already seen failure as a result of complex systems and unclear communication, and while there is a history of addressing challenges, it remains to be seen whether oil and gas producers will take proactive measures to assess new potential risks related to their safety culture or increase supply chain controls in response to these changes.

Clear communication and collaborative efforts across the industry will be essential in navigating these new risks and ensuring the continued safety and reliability of oil and gas sector products.

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¹ American Petroleum Institute. (n.d.). Industry mission. Washington, D.C. https://www.api.org/about/industry-mission

² American Petroleum Institute, API Specification Q1, Quality Management System Requirements for Organizations Providing Products for the Petroleum and Natural Gas Industry, 10th Edition ed., Washington, D.C., 2023.

³ Bureau of Safety and Environmental Enforcement, Bureau of Safety and Environmental Enforcement (BSEE), Quality Control-Failure Incident Team (QC-FIT), Office of Offshore Regulatory Programs, Washington, D.C. https://www.bsee.gov/what-we-do/offshore-regulatory-programs/emerging-technologies/systems-reliability-section/qc-fit