Our 1st risk has been identified for Q1 9th Edition

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.

Have you:

• 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?