Empirical study of ill-supported activities in variation risk identification and assessment in early stage product development

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.