GB/T19001-2016 过程方法

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二、条款解析

标准提倡组织运用过程方法，而通过采用过程方法建立、实施质量管理体系将有利于过程的连续控制和过程的持续改进，从而高效地得到期望的结果

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2、 Clause Analysis



The standard advocates the use of process methods by organizations, and establishing and implementing a quality management system through the use of process methods will facilitate continuous control and improvement of the process, thereby efficiently achieving the expected results

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1.对过程的理解

（1）过程是“利用输入实现预期结果的相互关联或相互作用的一组活动”

①一个过程的输出是其他过程的输入，并把整个网络或体系联系起来。

②输入和预期的输出可以是有形的（如设备、原料或部件），也可以是无形的（如能源或信息）。输出也可以是非预期的，如废物或污染。

③每个过程都有其顾客和其它相关方（对组织来说，他们可以是内部的、也可以是外部的），这些顾客和相关方的需求和期望决定了过程所要求的输出。

④所有的过程都应与组织的目标、范围和复杂性保持一致，应为组织提供增值服务。

⑤过程的有效性和效率能够通过内部或外部评审过程实施评价。

（2）过程的数量和类型组织应确定其所需过程的数量和类型以实现其业务目标。然而，对每个组织来说，过程的数量和类型都有其独特性，组织需要识别其典型的过程并确定过程特性。

（3）过程特性组织的管理体系的过程主要由管理过程、支持过程、运行过程、绩效评价过程等组成，其每一个过程既有过程的共同属性又有其各自的独特性。组织在管理体系的建立和实施中应识别过程并确定其过程特性

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1. Understanding the process






(1) A process is a set of interrelated or interactive activities that utilize inputs to achieve expected results






① The output of one process is the input of other processes and connects the entire network or system.






② The input and expected output can be tangible (such as equipment, raw materials, or components) or intangible (such as energy or information). The output can also be unexpected, such as waste or pollution.






③ Each process has its own customers and other stakeholders (which can be internal or external to the organization), and the needs and expectations of these customers and stakeholders determine the output required by the process.






④ All processes should be aligned with the organization's goals, scope, and complexity, and should provide value-added services to the organization.






⑤ The effectiveness and efficiency of the process can be evaluated through internal or external review processes.






(2) The organization should determine the number and type of processes required to achieve its business objectives. However, for each organization, the number and type of processes have their own uniqueness, and organizations need to identify their typical processes and determine process characteristics.






(3) The process characteristics of an organization's management system mainly consist of management processes, support processes, operational processes, performance evaluation processes, etc. Each process has both common attributes and its own uniqueness. Organizations should identify processes and determine their process characteristics in the establishment and implementation of management systems

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2.过程方法的理解和应用

过程方法是通过管理过程中活动和相关资源来实现预期结果的方法。尽管GB/T19001的条款结构是依照策划-实施-检查-处置的顺序编排的，但过程方法仍是QMS的根本概念。

（1）过程方法的应用可为顾客和其它相关方创造价值，是组织开展管理活动行之有效的办法。

（2）组织的管理过程需要识别与确定，由于其过程关系的复杂性往往呈现为过程网络，所以组织通常采用纵向一体化的方式实施管理。

（3）组织结构中的每一个过程都有其职能和目标。对于每一个过程的管理者而言，首先都会关注自身过程目标的实现。值得注意的是，对组织来说，最终顾客或有关相关方并不总是显性的，因此，过程间管理界面出现的问题往往不及过程本身的短期目标优先。这导致组织内各过程间出现的问题可能没有任何改进，因为改进措施仅可能着眼于其功能而非组织的预期结果。此外，由于过程网络的复杂性，某一具体过程的管理者还往往容易忽视组织的整体目标。

（4）过程方法引入了横向管理，跨越了不同职能部门之间的壁垒，把他们的关注焦点集中到组织的主要目标上。过程方法同样提高了对过程界面的管理，为受关注的和需优先安排的改进活动提供机会。（5）运用“过程方法”需开展的活动

①确定组织的目标；

②识别顾客和其它相关方及他们的要求和期望，以确定组织期望的输出；

③确定为实现组织的质量目标所需的过程和职责；

④识别过程并清晰的确定过程特性及其过程的管理者；

⑤确定和提供必需的资源和信息；

⑥建立和应用对每个过程实施监视和/或测量及分析的方法；

⑦建立和应用持续改进质量管理体系有效性的过程。

区分过程和活动十分重要。组织经常会识别很多的过程，但实际上其中一些或全部只不过是活动，而不符合GB/T19001中过程概念的本义。组织需要根据总体目标的要求，根据活动的重要程度、风险等因素重新定义其过程。

（6）过程方法、风险思维和PDCA①基于风险的思维、过程方法、PDCA，这三者共同构成新版GB/T19001标准的核心概念。可影响目标和结果的风险必须由管理体系来应对。在整个过程方法中运用基于风险思维并辅以PDCA工具的使用，可促进企业的质量管理体系实现预期结果。

②组织内存在的过程，可能是正式的或非正式的。本标准并不要求正式定义的过程目录或列表。

③组织宜确定哪些过程需要在风险思维的基础上形成文件。过程正式形成文件可以通过若干方法，如图形表示、用户描述、书面指南、检查表、流程图、视觉媒体或电子方法包括图形化和系统化。

（7）运用过程方法可带来以下益处：

重点关注更重要的（“高风险”）过程及其输出；

提高对相互依存的过程的理解、定义和整合；

将过程和管理体系作为一个整体按照策划、实施、检查和改进进行系统化管理；

更好地利用资源和提高责任感；

在方针和目标、预期结果及整体绩效实现方面更为一致；

过程方法有助于任何管理体系的实施；

通过满足客户要求来提高客户满意度；

增强对组织的信心

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2. Understanding and Application of Process Methods






The process approach is a method of achieving expected results by managing activities and related resources in the process. Although the clause structure of GB/T19001 is arranged in the order of planning, implementation, inspection, and disposal, the process method is still the fundamental concept of QMS.






(1) The application of process methods can create value for customers and other stakeholders, and is an effective way for organizations to carry out management activities.






(2) The management process of an organization needs to be identified and determined, and due to the complexity of its process relationships often presented as a process network, organizations usually adopt a vertically integrated approach to management.






(3) Each process in the organizational structure has its own functions and objectives. For every process manager, they first focus on achieving their own process goals. It is worth noting that for organizations, the end customer or relevant parties are not always explicit, therefore, problems that arise in the inter process management interface often do not prioritize the short-term goals of the process itself. This leads to issues that may arise between processes within the organization without any improvement, as improvement measures may only focus on their functionality rather than the expected outcomes of the organization. In addition, due to the complexity of process networks, managers of a specific process often overlook the overall goals of the organization.






(4) The process approach introduces horizontal management, crossing barriers between different functional departments, and focusing their attention on the main goals of the organization. The process approach also improves the management of process interfaces, providing opportunities for focused and prioritized improvement activities. (5) Activities to be carried out using the 'process method'






① Determine organizational goals;






② Identify customers and other stakeholders, as well as their requirements and expectations, to determine the output of organizational expectations;






③ Determine the processes and responsibilities required to achieve the organization's quality objectives;






④ Identify the process and clearly identify the process characteristics and their managers;






⑤ Identify and provide necessary resources and information;






⑥ Establish and apply methods for monitoring and/or measuring and analyzing each process;






⑦ The process of establishing and applying a continuous improvement quality management system for its effectiveness.






It is important to distinguish between processes and activities. Organizations often recognize many processes, but in reality, some or all of them are just activities and do not conform to the original meaning of the process concept in GB/T19001. Organizations need to redefine their processes based on the overall objectives and factors such as the importance and risks of activities.






(6) Process approach, risk thinking, and PDCA ① Risk based thinking, process approach, and PDCA together constitute the core concepts of the new GB/T19001 standard. The risks that can affect goals and outcomes must be addressed by the management system. The application of risk based thinking and the use of PDCA tools throughout the entire process method can promote the achievement of expected results in the quality management system of the enterprise.






② The processes that exist within an organization may be formal or informal. This standard does not require a formally defined process catalog or list.






③ Organizations should determine which processes need to be documented based on risk thinking. Formally document the process