Design Assurance Framework for ISO 9001
We were pleased to be engaged by this global supplier of fabrication, installation and refurbishment services to the oil, gas and wind power industries. The brief was to develop a formal design review process. The goals were to raise awareness of the role and methodology of design review, and to respond positively to ISO 9001 audit findings. Time and budget were tight, but we do like a challenge
We began by gathering context and stakeholder information in teleconferences with the client. Identifying an additional need to clarify design review versus verification and validation, we proposed a “Design Assurance” framework based on BS EN 61160. A two-tier design review process allowed scalability between large, multi-discipline projects and smaller peer reviewed assignments.
Deliverables comprised a Design Assurance Framework supported by a Design Review Procedure and Design Review Guide with combined flow charts and RACI tables. As a bonus, we provided templates for complementary Design Verification and Design Validation Guides.