Аналіз результативності процесів системи управління якістю від вимог зацікавлених сторін до виявлення корінних причин невідповідностей

Anna Marinina, Sergey Stepanenko
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Abstract

This paper notes that the success of a quality management system depends on how effective and efficient the processes carried out under the control of this system will be. In accordance with the requirements of the ISO 9001:2015 standard, one of the main principles of the functioning of a quality management system is the application of a process approach. To date, the process approach is the most progressive; therefore, it is widely used in various fields of activity. It allows you to determine the cause and effect relationships of the occurrence of problems, as well as determine where and when the problem arose and what is the root cause of its occurrence. The choice of performance indicators and criteria for evaluating the effectiveness of the processes of the quality management system is the most important step in conducting this work since the results obtained should provide the top management of the enterprise with the most adequate data on the state of functioning of the controlled processes and outline possible ways to improve both the system itself and quality. values created because of each given process. A methodology for analyzing the effectiveness of processes is considered, starting with the definition of the context (business environment) in which the controlled process should be carried out. Having established the external and internal context that can affect the particular process being controlled, it is necessary to identify a set of stakeholder needs from which the risk and opportunity components for performing each process under consideration can be derived. To analyze risks and opportunities, it is proposed to apply a methodology for analyzing the types and consequences of potential defects, known as the FMEA method. Controlled indicators of the process and criteria for their effectiveness are selected based on the most rated needs of stakeholders. In the case when certain indicators of the effectiveness of the process do not satisfy the top management of the enterprise, a search is made for the reasons for the low level of the indicators of effectiveness. The goal is to determine the root cause of the nonconformity to organize work to eliminate it. The analysis is proposed to be carried out using Excel tables. An example of determining the root cause of the inconsistency of the “Aircraft Engine Design” process is given.
本文指出,质量管理体系的成功取决于在该体系控制下实施的过程的有效性和效率。根据ISO 9001:2015标准的要求,质量管理体系运作的主要原则之一是过程方法的应用。迄今为止,过程方法是最先进的;因此,它被广泛应用于各个活动领域。它允许您确定问题发生的因果关系,以及确定问题发生的地点和时间以及问题发生的根本原因是什么。选择评价质量管理体系过程有效性的绩效指标和标准是开展这项工作中最重要的一步,因为所获得的结果应向企业的最高管理者提供关于受控过程功能状态的最充分的数据,并概述改进体系本身和质量的可能方法。由于每个给定进程而创建的值。本文考虑了一种分析过程有效性的方法,首先定义应在其中执行受控过程的上下文(业务环境)。在建立了可能影响被控制的特定过程的外部和内部环境之后,有必要确定一组涉众需求,从中可以推导出执行所考虑的每个过程的风险和机会组件。为了分析风险和机会,建议应用一种方法来分析潜在缺陷的类型和后果,即FMEA方法。过程的受控指标及其有效性标准是根据利益相关者的最高评级需求选择的。当流程的某些有效性指标不能使企业高层满意时,就会寻找有效性指标水平低的原因。目标是确定不符合的根本原因,组织工作以消除不符合。建议使用Excel表格进行分析。给出了确定“飞机发动机设计”过程不一致的根本原因的实例。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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