Empirical study of ill-supported activities in variation risk identification and assessment in early stage product development
Editor: Anja Maier, Stanko Škec, Harrison Kim, Michael Kokkolaras, Josef Oehmen, Georges Fadel, Filippo Salustri, Mike Van der Loos
Author: Bjarklev, Kristian; Mortensen, Niels Henrik; Ebro, Martin
Institution: 1: Technical University of Denmark, Denmark; 2: Novo Nordisk A/S, Denmark
Section: Design Methods and Tools
The purpose of this paper is to present findings from an industrial case study about the support of activities related to identifying and assessing variation-related issues in the design during the concept- and embodiment design stages. The case study investigates a large world-leading mechanical medical device company by interviewing six key employees that work in the variation risk identification and assessment process. It is found that there are several ill-supported activities, and that the project teams rely heavily on tolerance experts’ assistance and experience in order to identify and assess the variation risk. Ill-supported activities are found to be: Balancing hardness of requirements and the screening; communicating mechanism understanding; predicting user input and internal component movement; documenting and communicating tolerance analysis; implementing robustness in the early definition of the projects; and implementing statistical information in the calculations. It is suggested these areas should be supported further.