GB/T19001-2016 基于风险的思维

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1.基于风险的思维是实现质量管理体系有效性的基础

本标准给出的质量管理体系要求采用过程方法，正如在引言的总则中所述，过程方法结合了PDCA循环与基于风险的思维方法，换句话说，基于风险的思维是过程方法的重要组成部分，是实现质量管理体系有效性的基础。质量管理体系的主要用途之一是作为预防工具，它可以帮助组织最大限度地降低不利影响，并最大限度地利用出现的机遇，如果一个组织在其质量管理体系中能将基于风险的思维贯彻到每一个过程中，采用切实可行的风险管理理念和技术，有效地降低不利影响，及时抓住机遇，无疑将会大大提高质量管理体系的有效性，增强顾客和相关方的满意

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1. Risk based thinking is the foundation for achieving the effectiveness of quality management systems



The quality management system provided in this standard requires the use of a process approach.

As stated in the general principles of the introduction, the process approach combines the PDCA cycle with a risk based thinking approach.

In other words, risk based thinking is an important component of the process approach and the foundation for achieving the effectiveness of the quality management system.
One of the main uses of a quality management system is as a preventive tool, which can help organizations minimize adverse impacts and maximize opportunities that arise.

If an organization can implement risk based thinking in every process of its quality management system, adopt practical and feasible risk management concepts and technologies, effectively reduce adverse impacts, and seize opportunities in a timely manner, Undoubtedly, it will greatly improve the effectiveness of the quality management system and enhance customer and stakeholder satisfaction

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2.风险的概念

“影响是指偏离预期，可以是正面的或负面的”。

这里的预期可以理解为想要达到的目标，所以我们也可以理解为风险是指不确定性对实现目标的影响。这里对预期的偏离不仅仅是负面的，它也可以是正面的。如两个生产同样产品的组织，组织甲建立了严格的供应商评价、选择机制，而组织乙只考虑价格因素选择供应商，则组织乙因原材料质量问题而导致产品质量问题的可能性就大于组织甲，因此尽管因原材料质量问题而导致组织生产的产品质量问题的后果是一样的，但组织乙发生的可能性大于组织甲，因此组织乙发生质量问题的风险大于组织甲

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2. Concept of risk



Impact refers to deviation from expectations, which can be positive or negative.





The expectation here can be understood as the desired goal, so we can also understand that risk refers to the impact of uncertainty on achieving the goal.
The deviation from expectations here is not only negative, it can also be positive. If two organizations that produce the same product have established strict supplier evaluation and selection mechanisms, while Organization B only considers price factors to select suppliers, the likelihood of product quality problems caused by raw material quality issues in Organization B is greater than that of Organization A. Therefore, although the consequences of product quality problems caused by raw material quality issues in Organization A are the same, the likelihood of occurrence in Organization B is greater than that in Organization A, Therefore, the risk of quality issues occurring in Organization B is greater than that in Organization A

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3.为满足本标准的要求，组织需策划和实施应对风险和机遇的措施

基于风险的思维要求组织在策划质量管理体系之初，就要充分识别组织可能面临的风险和机遇，特别是可能导致不利情况的风险，在此基础上制定相应的规则、准则和应对措施，以有效应对风险和机遇，为提高质量管理体系有效性、获得改进结果以及防止不利影响奠定基础。

要求组织应根据其所处的环境和相关方的要求，确定需要应对的风险和机遇，策划应对这些风险和机遇的措施.并通过后面的运行过程实施这些措施组织的各个过程均可能存在不同程度的风险，这些风险带来的正面或负面的影响对于不同的组织也不尽相同。组织可以总结以往的经验，特别是以往遇到的问题、出现的不期望的情况或不合格，为防止这些问题、情况和不合格再发生，在策划质量管理体系时就要制定相应的过程运行准则、方法、控制要求和应对措施，这就是我们常说的问题导向，针对出现的问题采取对策。

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3. To meet the requirements of this standard, the organization needs to plan and implement measures to address risks and opportunities



Risk based thinking requires organizations to fully identify the risks and opportunities they may face, especially those that may lead to adverse situations, at the beginning of planning their quality management system. Based on this, corresponding rules, guidelines, and response measures should be formulated to effectively respond to risks and opportunities, laying the foundation for improving the effectiveness of the quality management system, obtaining improvement results, and preventing adverse impacts.







Organizations are required to determine the risks and opportunities that need to be addressed based on their environment and the requirements of relevant parties, plan measures to address these risks and opportunities, and implement these measures through subsequent operational processes. Each process of the organization may have varying degrees of risk, and the positive or negative effects of these risks may vary for different organizations. Organizations can summarize their past experience, especially the problems, unexpected situations, or non conformities they have encountered in the past. To prevent these problems, situations, and non conformities from happening again, when planning a quality management system, it is necessary to develop corresponding process operation guidelines, methods, control requirements, and response measures. This is what we commonly refer to as problem orientation, and to take countermeasures against the problems that arise.

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4.利用机遇

。本标准要求组织运用基于风险的思维，其意图不仅希望组织能最大限度降低不利影响，还希望组织能有一个快速反应的机制，能及时识别可能的机遇，一旦机遇出现，能迅速做出正确的决策，采取有效的应对措施抓住机遇，以吸引新顾客、开发新产品和服务，提高质量管理体系的有效性，增强顾客满意，因此组织在采取措施应对机遇时也要考虑进行必要的风险识别和管理

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4. Utilize opportunities



This standard requires organizations to apply risk based thinking, with the intention not only to minimize adverse impacts, but also to have a rapid response mechanism that can identify potential opportunities in a timely manner. Once opportunities arise, the organization can make correct decisions quickly, take effective response measures to seize opportunities, attract new customers, develop new products and services, improve the effectiveness of the quality management system, and enhance customer satisfaction, Therefore, organizations should also consider necessary risk identification and management when taking measures to address opportunities

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5.正确利用风险管理的方法和技术

识别风险和机遇可能需要应用一些风险管理方法和分析技术。但标准并不要求一定要运用正式的风险管理方法或将风险管理过程形成文件，也不要求组织一定要使用复杂的风险分析技术来识别风险和机遇。基于风险的思维的方法和技术使用到什么程度，取决于组织所处的环境，如果是一个很小的组织，生产和服务非常简单，可能不需要有非常正式的风险管理的方法、技术和风险分析。总之，识别风险并采取相应措施来消除风险、减低风险或者减缓风险，贯穿在整个标准里，旨在帮助组织充分识别风险和机遇，识别不确定性的影响，使有显著影响的风险可见可控，也使可能的机遇可见可用