Total Quality Management 2017
DOI: 10.1016/b978-0-12-811035-5.00026-x
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Failure Modes and Effects Analysis

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Cited by 16 publications
(12 citation statements)
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“…There are some techniques with qualitative or quantitative approaches that evaluate the safety and reliability of the system. Above all, these techniques enable us to identify failures that occur in micro medical devices that can mean potential harm or injury to patients, (Kiran, 2017). Their use depends on the complexity of the system, and the amount of data or information available from the system (Dyadem, 2003).…”
Section: Methodsmentioning
confidence: 99%
See 1 more Smart Citation
“…There are some techniques with qualitative or quantitative approaches that evaluate the safety and reliability of the system. Above all, these techniques enable us to identify failures that occur in micro medical devices that can mean potential harm or injury to patients, (Kiran, 2017). Their use depends on the complexity of the system, and the amount of data or information available from the system (Dyadem, 2003).…”
Section: Methodsmentioning
confidence: 99%
“…Moreover, in this part, a severity value is determined to the failure effect, which is the consequence or consequences of a failure mode on the operation, function, or status of a system or equipment. The severity represents the seriousness of the failure and not the mode of the failure and generally, the severity of the effect is given a severity number (S) from 1 (no danger) to 10 (critical) (Kiran, 2017), a failure effect can be caused by one or more failure modes (Ramakrishna, Tian, Wang, Liao, & Teo, 2015). Within the risk analysis, a probability of occurrence of the failure value is also assigned.…”
Section: Design Fmeamentioning
confidence: 99%
“…Nastoji se spriječiti nastanak kvara, odnosno na odgovarajući način riješiti posljedice ako se kvar nastupi. Analiza primjenom FMEA metode provodi se provedbom sljedećih aktivnosti: prepoznavanje potencijalnih kvarova, procjena parametara ozbiljnosti (S), učestalosti (O) i otkrivanja (D) kvara te na kraju računanje veličine prioriteta rizika (RPN), a formula za izračun je (Kiran, 2017): Parametri ozbiljnosti (S), učestalosti (O) i otkrivanja (D) kvara unose se u rangu od 0 do 10. Veća ocjena predstavlja najgori mogući slučaj, tj.…”
Section: Metoda Fmea I Način Prikupljanja Podatakaunclassified
“…With this values, RPN risk numbers of 1 to 5 is feasible. A threshold of RPN 60 andabove is set for variables (formulation, process and, delivery device) that potentially affect CQAs of the final product and are to be taken further for a screening study, while factors with an RPN 60 or lower are eliminated from the study [16].…”
Section: Risk Assessmentmentioning
confidence: 99%