2024 Author: Howard Calhoun | [email protected]. Last modified: 2023-12-17 10:16
Risk-oriented thinking has received the greatest development abroad. This concept was further developed with the release of the international standard ISO 9001:2015.
Risk management concept
This direction is a fairly new trend in the development of an economic entity.
It was first mentioned in an American article back in 1956. Its meaning was that legal entities should hire risk management specialists to reduce economic losses.
Starting from the second half of the last century, these publications have become regular. In the 1970s, risk assessment consulting services began to emerge.
The concept of risk and its management
Risk is the effect of uncertainty. This definition is given in GOST R ISO 9001-2015. This indicates that risk-based thinking is being built into the quality management system.
Under uncertainty you canunderstand inaccurate or incomplete information provided under the terms of the project. Any entrepreneurial activity is associated with this concept.
In order to manage risks, they must be identified, analyzed and resolved. This management process should be carried out in consultation with stakeholders to modify it so that it does not require further processing.
Risk-Based Thinking in ISO 9000 2015
To implement it, an economic entity must create a set of agreed methods and activities to manage and control risks that can make it difficult for the organization to achieve its goal.
This requirement, introduced in the 2015 version of the standards, essentially replaces the requirement to take preventive action from the 2011 version.
As well as risks, opportunities need to be implemented. The latter is understood as the ability of an object to produce a product that meets the requirements at the output.
The reason for this replacement of preventive actions with risk-based thinking is that the former were not perceived as a means of continuous improvement, as a result of which the latter were carried out at a rather low level and haphazardly.
According to the new version of the standard, business entities wishing to be certified forcompliance with this QMS, should identify risks as well as opportunities and determine actions to address them. Legal entities must decide how to make these actions part of their quality management system, how control, analysis and evaluation of the effectiveness of these processes and actions will be carried out.
Top management will be involved in the process of identifying, registering, reducing and eliminating risks, in accordance with the requirements of this standard.
The new version of ISO 9001 does not require any special document to describe the risk-based approach of a legal entity. But to ensure uniformity, it is better to create instructions for identifying and assessing risks.
Connection of the phenomenon under consideration with the process approach
The current version of the above standard implies the mandatory application of this approach.
It includes the implementation of the PDCA cycle. At the planning stage (P), an analysis of both the internal and external environment of the business entity is carried out using various quality management methods: data stratification using checklists, brainstorming, Shewhart control charts, Pareto and Ishikawa charts, scatter, SWOT and PEST -analysis, benchmarking, Delphi method.
At the do (D) stage, the risk is assessed and acted upon using the above methods, as well as FMEA analysis, expert method, HACCP and some others.
Stage "Control" (C) involves monitoring and measuringrisk identification and assessment strategy implemented.
Step "Act" (A) involves reviewing the organization's risk policy, designing and implementing various measures to improve the functioning of the risk management process.
Thus, the process approach and risk-based thinking are interrelated. This is confirmed by the fact that the phenomenon under consideration is given in the ISO 9001:2015 standard in the section "Process approach".
Risk assessment and identification
The ideology of risk-based thinking implies the mandatory implementation of these steps.
Risk assessment includes its identification, as well as analysis and calculation. It can be carried out in various ways and methods. With this assessment comes a better understanding of the risks, which allows you to make the right decisions on the best approach to handle them. The results of this stage serve as input for decision-making processes.
Risk identification is the process of identifying, recognizing and registering risks. It is carried out in order to assess what could potentially happen that will affect the achievement of the goals that the organization has set for itself.
Risk identification methods include those based on evidence, a systematic team approach and inductive reasoning. To carry out this operation, it is necessary to determine the factors influencing stable activitybusiness entity.
Examples
Let's consider the application of risk-based thinking in the enterprise.
Assume that a plumbing system with a significant length has passed into the scope of responsibility of a plumber. During his vacation, an accident occurs at one of the sections of the water supply, and the features of the infrastructure and structure of the latter are known only to this plumber. It takes time to study them, consumers want to transfer the system of pipes through which water is supplied to other competitors.
Applying risk-based thinking in this example, a legal entity must determine the competence of the persons who work for it, which affect the effectiveness of the QMS, provide training for these persons, take other actions aimed at acquiring the required competence, and evaluate them performance, record and retain information that demonstrates competence.
In closing
Risk-based thinking is one of the requirements of the international standard in the field of quality management systems. It is associated with a process approach and should be carried out systematically. Responsibility for making such decisions in the field of QMS lies with the top management of the company. Wrong actions in the risk-based approach can lead to losses for the business entity.
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