designklarering

Designklarering is a formal process in design management for obtaining official clearance of a design from internal stakeholders and external authorities before progressing to production or construction. The purpose is to ensure that the design meets defined requirements, standards, safety considerations, and feasibility constraints, and that risks are identified and mitigated.

The scope covers physical products, infrastructure, software with safety implications, and complex systems where regulatory or safety considerations apply. It ensures alignment with project objectives, budget, schedule, manufacturability, and serviceability.

The typical process includes planning and criteria definition, cross-functional design reviews (for example preliminary and critical design reviews), risk assessment and regulatory mapping, verification and validation activities and prototype testing, documentation and traceability, and formal approval or sign-off leading to design freeze. In regulated contexts, regulatory clearance or certification from authorities may be required before mass production or deployment.

Governance is usually led by a project manager or design authority with involvement from engineering, quality assurance, regulatory/compliance, manufacturing, and procurement. Clear acceptance criteria and documented sign-offs are essential to ensure accountability and auditability.

Designklarering relates to other design-process concepts such as design control, design reviews, and change management, and it often produces a design history file or equivalent records for traceability.

See also: design review, design control, design freeze, regulatory compliance.