Product safety culture as a concept for the development of safety–critical products in regulated industries

Abstract

This contribution examines the still young concept of product safety culture in the development area in medical technology and the automotive industry as authoritative representatives of regulated industries. It is investigated to what extent the concept of safety culture can be used for product development, because there are considerable situational differences: While safety culture is concerned with the impact on occupational safety and the safe operation of services and facilities (e.g., nuclear power plants), product safety culture is concerned with creating a product that is safe for users. To identify differences, a mixed methods approach was used: Firstly, a qualitative interview study with 10 interviews was conducted to re-examine the concept of product safety culture by Suhanyiova et al. (2020). Secondly, the latent variable product safety culture (PSC) was constructed. Thirdly, the construct was examined quantitatively with N = 124 out of 126 completed survey returns. The qualitative and quantitative research results were triangulated and compared with literature to achieve a valid construction of PSC. It turns out that some factors already identified in safety culture also apply to PSC: Safety systems, management commitment, economic influence, encouragement, blame, sense of responsibility, knowledgeability, and involvement. Additionally, one more factor was clearly identified as being characteristic of product safety culture and distinguishes the concept significantly from safety culture: Ethics. Two more factors are possibly idiosyncratic too: Holism and knowledgeability. Finally, the results were discussed with relation to existing theories of safety culture.