Quality 4.0 is the new paradigm in the field of quality management, due to the advent of technological advancement and digital transformation of many organizations. The field of Quality 4.0 is still in its nascent stage, and there is no self-assessment tool to assess whether an organization is ready or not in implementing Quality 4.0. This study uses a five-phase approach to develop a Quality 4.0 readiness self-assessment tool. Phase 1 of the study was devoted to a literature review to identify the readiness factors and sub-factors. In Phase 2 experts’ opinions sought sure that none of the readiness factors are missed out in our research. Phase 3 was devoted to questionnaire development. Phase 4 was devoted to data collection. In this phase, we identified 6 packaging companies that were willing to participate in the research. Phase 5 was devoted to data analysis and readiness assessment for each of the factors and sub-factors across the participating organizations. The readiness factors identified in the study were: top management commitment and support, leadership, organizational culture, employee competency, and ISO QMS Standard in place. Further, a methodology was developed to classify the participating organizations into five different quality readiness assessment levels.

由于技术进步和许多组织的数字化转型的出现，质量 4.0 是质量管理领域的新范式。质量4.0领域仍处于起步阶段，没有自我评估工具来评估组织是否准备好实施质量4.0。本研究采用五阶段方法来开发质量 4.0 准备情况自我评估工具。该研究的第一阶段致力于文献综述，以确定准备因素和子因素。在第二阶段，专家的意见旨在确保我们的研究中不会遗漏任何准备因素。第三阶段致力于问卷开发。第四阶段致力于数据收集。在此阶段，我们确定了 6 家愿意参与研究的包装公司。第五阶段致力于对参与组织的每个因素和子因素进行数据分析和准备情况评估。研究中确定的准备因素包括：高层管理人员的承诺和支持、领导力、组织文化、员工能力和现有的 ISO QMS 标准。此外，还开发了一种方法将参与组织分为五个不同的质量准备评估级别。