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1

Risk assessment system in the production process of medical devices on the basis of dynamics spine corrector

Kaczmarek W., Kamiński G., Mianowski K., Rosołek R., Gołaszewski T., Woch M., Głyda K.

Journal of Polish Safety and Reliability Association

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2017

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Vol. 8, No. 1

67--72

EN

The article presents the methodology involved in creating a risk analysis of medical devices. General regulations contained in the PN-EN ISO 14971 provide manufacturers of medical basis for the concretization of standards in the form of risk assessment system for a particular process and product. However, there is no top-down regulations defining the level of acceptable risk and the decision to determine its value rests with the manufacturer. Effectiveness of taken measures was tested on the example of a analysis of dynamics spine corrector – medical device that is allowing independent rehabilitation under the supervision of a physiotherapist and current control of the kinematics and dynamics of the human spine.

2

Application of fuzzy logic with genetic algorithms to FMEA method

Belu N., Ionescu L.

Zeszyty Naukowe Politechniki Poznańskiej. Organizacja i Zarządzanie

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2014

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Nr 62

5--19

EN

Failure Mode and Effect Analysis (FMEA) is one of the well-known techniques of quality management that is used for continuous improvement in product or process design. One important issue of FMEA is the determination of the risk priorities of failure modes. The purpose of this paper is to compare three different methods for prioritizing failure modes in a process FMEA study. These methods are traditional approach, fuzzy logic and Genetic Algorithms using a risk-cost model of FMEA - to estimate the weight of risk factors. According to the findings, the integration of Genetic Algorithms and fuzzy revealed a difference in prioritizing failure modes among the methods. Because these methods eliminate some of the shortcomings of the traditional approach, they are useful tools in identifying the high priority failure modes. They can also provide the stability of process assurance.

PL

Analiza przyczyn i skutków wad (FMEA) należy do dobrze znanych technik zarządzania jakością; jest wykorzystywana do ciągłego doskonalenia projektów, produktów lub procesów. Jedną z ważnych kwestii FMEA jest ustalanie priorytetów ryzyka niezgodności. Celem niniejszej pracy jest porównanie trzech metod ustalania poziomu ryzyka niezgodności: podejścia tradycyjnego, logiki rozmytej i algorytmów genetycznych na potrzeby analizy FMEA. Integracja algorytmów genetycznych i logiki rozmytej ujawniła różnicę w ustalaniu znaczenia przyczyn niezgodności. Ponieważ metody te eliminują niektóre wady podejścia tradycyjnego, są użytecznymi narzędziami w identyfikacji przyczyn niezgodności o wysokim ryzyku. Mogą również zapewniać stabilność procesu.

3

Proposal of new maintenance system of air brake system on semi-trailer combination aimed at increase of operational safety

Grenčík J., Ruman F.

Autobusy : technika, eksploatacja, systemy transportowe

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2013

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R. 14, nr 3

1385-1392

EN

The paper deals with the proposal of new maintenance system of air brake system on a semitrailer combination. The structure of semi-trailer and the current maintenance system of trailers are described with focus on the basic air brake system design. Analysis of wear and damage of air brake system components used on the semi-trailer combination based on real experience from practice and creation of the FMECA analysis of the system using software support are presented. Based on the analysis performed, a new system of maintenance was designed which was aimed at reduction of the risk related to failure consequences. The proposed system uses RPN (risk priority number) values resulting from the proposed preventive maintenance system and is compared with the currentmaintenance system. Main objective was to reduce the impact of any failure in any component on the air brake system. On the basis of the analysis subsequently new methods of failures detection of air brake system components, preventive measures, and suggested new intervals of preventive maintenance for the air brake system are also proposed. Proposed intervals of preventive maintenance execution are based on the calculation of the total costs associated with the consequences of failuresthat may arise from them and compared with costs associated with service inspections carried out on the analysed semi-trailer fleet. The proposed maintenance system has decreased RPN values in comparison with the current system and in practical operation is expected to increase safety of semitrailer combinations, thus minimize probability of a failure in any component of the air brake system.

4

Characteristic of quality improvement the proposal of measurement the process improvement managed by FMEA

Rewilak J.

Advances in Manufacturing Science and Technology

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2011

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Vol. 35, nr 4

51-62

EN

The paper presents a concept of index for measuring the quality of improvement managed by FMEA (Failure Mode and Effects Analysis). Quality assessed only by RPNs (Risk Priority Numbers) does not properly describe achieved improvement in terms of risk reduction, which can be obtained by preventive and / or detective controls. With increasing criticism of RPN based FMEA philosophy, a need for more relevant measures of quality improvement arises. The paper introduces a set of indices which can help FMEA teams / leaders, project managers, quality managers, SQA (Supplier Quality Assurance) engineers, etc. to identify at each stage of product/process development what improvement strategy has been applied - focusing on detection of problems or rather preventing their causes.

PL

W pracy przedstawiono nową koncepcję wskaźników opisujących skuteczność doskonalenia jakości uzyskiwanej przez zastosowanie metody FMEA (Failure Mode and Effects Analysis - Analiza Rodzajów i Skutków Wad). Podstawą przyjętej koncepcji jest postulat kwestionujący jednoznaczność oceny efektów doskonalących uzyskiwanych przy użyciu wskaźnika RPN (Risk Priority Number) podstawowego dla metody FMEA. Nie uwzględnia bowiem strategii uzyskiwania zmniejszenia ryzyka, która może być nastawiona na działania prewencyjne lub kontrolne (w konstrukcji wyrobu lub projekcie procesu). Nasilająca się krytyka wskaźnika RPN jako miary ryzyka stwarza konieczność stosowania innej miary doskonalenia jakości. Przedstawiono zestaw wskaźników istotnie wspomagających analizę ryzyka wyrobu / procesu (liderzy zespołów, kierownicy projektów, kierownicy jakości, osoby odpowiedzialne za jakość dostawców) w ocenie realizowanej strategii zmniejszenia ryzyka. Zaproponowane wskaźniki pozwalają na ilościową ocenę udziału i skuteczności działań kontrolnych - wykrywających wady lub przyczyny oraz działań zapobiegawczych, eliminujących przyczyny powstawania wad, z uwzględnieniem ich następstw dla wyrobu, procesu i klienta.

5

Failure mode and effects analysis (FMAE) of the tapered roller bearings

Michalska J.

Advances in Materials Science

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2007

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Vol. 7, nr 2(12)

334-339

EN

Failure Mode and Effects Analysis (FMEA) is a methodology for analyzing the potential reliability problems. FMEA is used to identify the potential failure modes, determine their effects on the operation of the product, and identify actions to mitigate the failures. In this paper FMEA procedure was described. In the frames of own research it was done the product FMEA analysis in the selected company of the machine industry on the example of the tapered roller bearings.