Design qualification
The design process can be divided into several phases: the concept phase, basis of design (BoD) and the detailed design. During these phases, design deliverables must be sufficiently developed, and risks must be identified and mitigated.
Design qualification ensures design deliverables are consistent with the URS (User Requirement Specification) and the mitigation control strategies established during the system risk assessment. The design qualification consists of several steps:
• Design review;
• Design qualification.
The design qualification provides documented verification that the design of a new or modified direct impact system will result in a system that is suitable for the intended purpose. The design qualification process can only be performed if the following prerequisites are met:
• URS must be approved;
• Functional requirements must be established for automated systems;
• System risk assessment must be performed;
• All design issues that affect CAs/CDEs, CPPs and CQAs must be finalised and included in the final design.
The most common mistakes that can occur during design qualification are:
• The URS documents are not approved or created;
• A system risk assessment is not conducted, or is not attended by all departments involved;
• Design issues are not identified and solutions are not developed;
• Design qualification is not performed, or is performed at a later stage of facility development or project phase.
What we offer
By joining a project team at an early stage, Adryan can support the effort that suppliers need to put into the design review phase. This approach leads to a cost-effective design qualification, with less duplication of work and fewer costly design changes.
