The increased levels of complexity in manufacturing lead to increased potential occupational health and safety (OHS) and operational risks. Dealing with this requires new approaches that are able to not only analyze complex systems in detail but also provide analysts an overall understanding of the studied system. This study aims to introduce a novel approach integrating Functional Resonance Analysis Method FRAM and Systems-Theoretic Process Analysis STPA for OHS and operational risk analysis of assembly in industry 4.0. This integrated approach combines the specific strengths of both methods to provide a detailed analysis of the studied system. The proposed approach will be applied to two assembly 4.0 case studies, and it will be validated using data from previous studies. The results showed that the integrated approach could provide a better understanding of the system compared to the sole application of either FRAM or STPA. Moreover, it could identify risks that were not identified when solely using FRAM or STPA. The new approach provides an in-detail analysis of organizational functions. However, more studies are required to confirm this capability firmly.

Although the proposed approach is helpful to conduct a risk analysis in the context of assembly 4.0, its efficiency needs to be examined in other contexts in future studies.

制造业复杂程度的提高导致潜在的职业健康与安全 (OHS) 和运营风险增加。处理这个问题需要新的方法，这些方法不仅能够详细分析复杂的系统，而且能够让分析师全面了解所研究的系统。本研究旨在介绍一种将功能共振分析方法 FRAM 和系统理论过程分析 STPA 相结合的新方法，用于工业 4.0 中的 OHS 和装配操作风险分析。这种集成方法结合了两种方法的具体优势，可以对所研究的系统进行详细分析。拟议的方法将应用于两个装配 4.0 案例研究，并将使用以前研究的数据进行验证。结果表明，与单独应用 FRAM 或 STPA 相比，集成方法可以更好地理解系统。此外，它可以识别仅使用 FRAM 或 STPA 时无法识别的风险。新方法提供了对组织功能的详细分析。然而，需要更多的研究来证实这种能力。

尽管所提出的方法有助于在装配 4.0 的背景下进行风险分析，但在未来的研究中需要在其他背景下检查其效率。