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EN
Pipelines transporting oil, gas, water, and other substances form part of the critical infrastructure of the society and are mostly controlled by advanced automation technology. This automation enables remote control and monitoring of pipeline operations by means of wide area networks that include microwaves, satellites, and cellular technologies. Often these pipeline control systems are also connected to the Internet to permit their operational control from anywhere. However, this bridging of the so-called “air-gap” between the critical infrastructure control system and the Internet has also introduced cybersecurity weaknesses that allows malicious actors to take control away from legitimate users of the system. While cybersecurity needs to be built into the system during the design phase itself, it is important, especially after a cybersecurity incident, to know the actual causes behind the incident so that appropriate countermeasures may be taken quickly to avoid a recurrence of the incident. Typical techniques to identify these root causes include five whys, fishbone diagrams, and causal factors analysis; this paper presents an alternate technique to identify root causes for pipeline cybersecurity incidents based on the NFR Approach where NFR stands for Non-Functional Requirements of the pipeline system. The NFR Approach starts with the requirements for the system in the first place, establishes the relationships between the design of the system and its requirements, and then identifies the root causes in a structured manner. In this paper, the NFR Approach is applied to analyze root causes of the Florida water system attack that occurred in February 2021. The advantages of the NFR Approach over traditional methods to identify root causes especially for pipeline incidents include the traceability of the causes to the requirements of the system, identification of synergistic and conflicting operational goals, and historical record-keeping.
EN
Purpose: The purpose of the paper is to present the essence of the complaint handling process as an element of the process of improving the quality of manufactured medical devices, ensuring their safety of use and meeting the declared by the manufacturer efficiency of the medical devices. Detailed analysis of complaints received from the customers in order to identify the root cause of the reported problems allows initiating the appropriate actions by the company. The remedial actions are designed to eliminate defects reported by customers, while the corrective actions are carried out to eliminate the causes of the reported defects. All these actions taken by the company in course of the complaint handling process are the important element influencing not only the effectiveness of the complaint handling process but also improvement of the product, elimination of defects, and thus the safe use of the device by the user. Design/methodology/approach: The analysis of the main causes of the reported failures and actions taken was conducted through a survey questionnaire forwarded to 24 medical device manufacturers in Poland. Findings: The results of this survey allowed to identify the categories of root causes, which are the most frequent reasons for complaints concerning medical devices and to identify the most frequent corrections and corrective actions based on the example of selected companies manufacturing medical devices in Poland. Originality/value: The results of the survey regarding the main causes of the reported failures and actions taken during the complaint handling process may provide guidance for the manufacturers during the evaluation of the reported failures.
EN
The G8D method is one of the methods used in quality management using quality management tools and designed to solve problems occurring in production processes. The method consists of 8 disciplines and ensures the required quality of both production processes and finished products. It may also be applied to the optimization of production processes, while ensuring their safety. In the article, the authors presented the method of using the D4 discipline algorithm of the G8D method allowing to detect the root cause of the problem in the process and to indicate the so-called escape point. The authors presented the course of action for discipline D4 undertaken when the root cause of the problem is to be analysed. The procedure is presented on an exemplary process of the projection welding of a nut.
PL
Celem artykułu jest przedstawienie trudności w odnajdywaniu rzeczywistych przyczyn opóźnień, propozycja sposobu określania przyczyn źródłowych oraz zestawienie tychże przyczyn dla wybranego okresu czasu w przedsiębiorstwie o produkcji małoseryjnej i wieloasortymentowej. W artykule przedstawiono charakterystykę produkcji małoseryjnej i wieloasortymentowej ze szczególnym uwzględnieniem jej specyfiki w zakresie przyczyn opóźnień. Przedstawiono propozycję algorytmu odnajdywania przyczyn źródłowych oraz narzędzia analizy przyczynowo - skutkowej, które mogą być z powodzeniem zastosowane do determinacji przyczyn źródłowych opóźnień oraz zaprezentowano ich przykładowe zastosowanie. Zestawiono również rzeczywiste przyczyny źródłowe w wybranym okresie czasu w przedsiębiorstwie o produkcji małoseryjnej i wieloasortymentowej.
EN
The aim of the article is to explain how the root causes of delays can be determined in the small lot and multi - assortment production. Difficulties in the determination are listed and commented. The delay cause finding algorithm is presented with associated root - cause analysis tools. The examples of their use are shown. The real root - causes of delays in a production company with the small lot and multi - assortment production are presented.
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