Have you thought about what your first risk assessment might be?
How about Q1’s change from Clause 7.3 Design and Development in the 8th Edition to Clause 5.4 in the 9th Edition?
The 9th Edition includes the following new requirements, as an example:
a) Design input considerations:
- Requirements provided from external sources, including API product specifications
- Environmental and operational conditions
- Historical performance and other information derived from previous similar designs
- Results from risk assessments
b) Design output considerations:
- Include identification of, or reference to, products and/or components deemed critical to the design
c) Design and Development Verification now includes a “final review”
d) Design and Development Validation now includes an “approval”
The potential risk could be significant if you just consider the following statement shown in design input: “Requirements provided from external sources, including API product specifications.”
In other words, all API product specifications include “normative references.” Depending on the product specification, a significant number of normative references may need to be considered for design input.
- Specifically identified each external standard as a design input?
- Identified what design output or design documents are needed to satisfy each design input requirement?
- Identified which position in your company would be responsible for documenting each applicable design output document (e.g., NDE, welding, heat treating, storage and packaging requirements, including specific acceptance criteria)?
- Addressed whether or not the engineering department will be responsible for reviewing each of these design output documents?
If each specific normative reference has not been specifically addressed, can the design reviews and subsequent verification and validation activities be satisfactorily accepted?
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.
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