I.V. ZYRIANOV, O.N. SHALATOVA, E.I. AMINEVA

VERIFICATION OF MANUFACTURED PRODUCTS AT THE DESIGN AND DEVELOPMENT STAGE

Abstract. In accordance with the ISO 9001 requirements, for effective management of design and development, the organization shall implement actions for verification their results. This allows you to improve the design and development process, minimize internal defects, reduce the time for correcting documentation, which eliminates the risk of nonconformities in manufactured products and, moreover, their repetition. How this activity is carried out in practice, we will consider the example of the Yakutniproalmaz Institute, which is a structural division of the PJSC «ALROSA».

Keywords: design and development, design and development, nonconformities, ISO 9001.

SHEWHART CONTROL CHARTS: INTERPRETATION EXAMPLES

Abstract. Shewhart control charts are one of the main tools for monitoring the manageability of production processes. That is why the MQM journal regularly publishes articles devoted to the rules for their construction and simple control of application issues when solving various problems. This material is somewhat different from most of the previous ones. It tells on the reading and interpreting control charts for the purpose of diagnosing the state of the process. Some cases are considered when operators and process engineers should, not limit themselves to simple process control, regulate it, which is caused by deviations in the conditions of its flow from normal.

Keywords: ISO 9001, risk-based thinking, value added, preventive actions, business strategy.

M.I. ROZNO

BUILT-IN QUALITY VS INSPECTION: ALTERNATIVE OR SUPPLEMENT?

Abstract. Until the end of 1920, significant efforts were made in Russia to improve product quality, including through the adoption of new methods and tools for improvement by enterprises. However, in recent years, there has been a growing trend in the number of defects and failures, especially in the production of domestic complex machinery products. In this regard, the idea of strengthening inspection of both products and processes is being revived. Thus we will lose not only in efficiency, but also in product safety, and ultimately in quality of life. The solution to this problem is seen only in the widespread development and application of built-in quality methods.

Keywords: quality improvement, built-in quality, quality inspection, defect-free production.

S. OJEDA

NINE RULES FOR EFFECTIVE INTERNAL AUDIT

Abstract. Internal audit provides the opportunity to identify process problems before they lead to customer complaints and/or regulatory sanctions. This is one of the reasons why internal auditing is a mandatory requirement of ISO management system standards. However, if compliance is the only reason you conduct an internal audit, its effect will be minimal. This article discusses nine rules that, if followed, improve the effectiveness of internal auditing, which focuses on extracting maximum benefits from the auditing efforts.

Keywords: management system, internal audit, documentation, nonconformities, corrective actions.

V.A. KACHALOV

BRIGHTNESS AND LUSTER OF MANAGEMENT SYSTEMS STANDARDS. PART 5. PROCESSES APPROACH (CONCLUSION)

Abstract. Many approaches to quality management included in ISO 9001 are not always fully implemented in practice, which does not allow them to play all their facets. Based on extensive experience in conducting audits of management systems, the author presents his observations and recommendations on how to polish the application of some of them, fully ensuring their inherent brightness and brilliance. The fifth part of the article is devoted to the consideration of the last, fourth facet of the process approach — monitoring and measuring processes in accordance with the requirement of clause 4.4 of the standard.

Keywords: process approach, process-event, process-phenomenon, process monitoring, process measurement.

M. MILLS

WHAT IS RISK-BASED THINKING?

Abstract. «Risk-based thinking» — it sounds simple. But is it really? Why does ISO, while calling risk-based thinking one of the foundations of quality management, never provide a strict definition? And why, when it first appeared in the 2015 version of ISO 9001, did this concept cause a major controversy in the quality community? Finally, did you know that risk-based thinking can be used as a business strategy in real practice, even if you ignore ISO and all its standards? All of this is true. Let’s find out.

Keywords: ISO 9001, risk-based thinking, corrective actions, preventive actions, business strategy.

A.YU. ROGATKIN

RISK-BASED THINKING: MUCH ADO ABOUT NOTHING

Abstract. Michael Mills’ article «What is risk-based thinking» was published in Quality Digest journal in April 2025. And this despite the fact that more than enough has been written about risk-based thinking over the previous 10 years: hundreds of materials have been devoted to the issues of its understanding and application within the framework of the QMS. Why did Mills decide to return to seemingly well-known basics? It seems that the main reason is that over all these years the concept of risk-based thinking has remained misunderstood by some, and not accepted by others at all. How convincing are the author’s arguments?

Keywords: ISO 9001, risk-based thinking, value added, preventive actions, business strategy.

J. HARRINGTON

THREE APPROACHES TO PROCESSES IMPROVEMENT

Abstract. There are three main approaches to systematically improving business processes by implementing scientific and technical achievements that ensure their breakthrough nature: revision (or redesign), ­reengineering (or radical modernization), benchmarking. A natural question arises: which of the above approaches is most useful for a given organization in a particular case? To answer it, it is necessary to study the features of each of these approaches and choose the one that best suits the current state of the process being improved and the scope of changes it requires.

Keywords: process, improvement, redesign, reengineering, benchmarking.