Konstruktionskontrolle

Konstruktionskontrolle (design control) is a systematic framework for planning, documenting, and conducting engineering design activities to ensure that a product fulfills defined requirements and regulatory expectations. It integrates risk management, traceability, and formal change management throughout the development process.

Its core elements typically include: design planning; design inputs (requirements, constraints, standards); design outputs (specifications, drawings, prototypes); design reviews; verification (demonstrating that outputs meet inputs) and validation (confirming that the final product meets user needs); design transfer to production; and ongoing design changes controlled by a formal change process. Configuration management and documentation support traceability from initial requirements to release.

Lifecycle models commonly used in Konstruktionskontrolle include the V-model and stage-gate approaches, which emphasize early planning, concurrent verification and validation, and structured reviews. In many industries, especially regulated sectors, Konstruktionskontrolle is closely linked to quality management systems such as ISO 9001 and sector-specific standards (ISO 13485 for medical devices, IEC 62304 for software, ISO 14971 for risk management).

Responsibilities typically involve a cross-functional team with a design owner, a quality representative, and design reviewers. The approach yields improved product conformity, easier audits, reduced development costs, and better risk management, but can incur documentation effort and process overhead. In practice, Konstruktionskontrolle supports product development across fields such as mechanical engineering, electronics, automotive, and medical technology.