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Failure modes and effects analysis for testicular sperm extraction management process
Author(s) -
Canepa Pierandrea,
De Leo Caterina,
Casciano Ida,
Rizzo Camilla,
Sozzi Fausta,
Ambrosini Francesca,
Terrone Carlo,
De Rose Aldo F.,
Anserini Paola,
Scaruffi Paola
Publication year - 2020
Publication title -
andrologia
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.633
H-Index - 59
eISSN - 1439-0272
pISSN - 0303-4569
DOI - 10.1111/and.13506
Subject(s) - failure mode and effects analysis , traceability , multidisciplinary approach , process (computing) , risk analysis (engineering) , root cause analysis , risk management , risk assessment , reliability engineering , operations management , medicine , computer science , engineering , business , social science , computer security , software engineering , finance , sociology , operating system
Failure modes and effects analysis (FMEA) is a proactive risk evaluation to identify and reduce potential failures that may occur during a procedure within a quality management programme. One of the procedures performed in assisted reproduction technology centres is testicular sperm extraction (TESE) as treatment of azoospermic patients. To examine the risks associated with the ‘TESE management’ process, we applied the FMEA method, before and after implementation of corrective measures defined in a standard operative procedure (SOP). A multidisciplinary team was formed. Possible causes of failures and their potential effects were identified, and risk priority number (RPN) for each failure was calculated. The FMEA team identified 4 process activities, 19 process steps and 19 potential failure modes. The re‐evaluation after the corrective measures disclosed a reduction in the number of phases with high/moderate risk (pre‐SOP: n = 13; post‐SOP: n = 3). Improvements in the traceability system removed 11 out of 13 (85%) steps with a low risk of occurrence. In our experience, FMEA is efficient in helping multidisciplinary groups to strengthen knowledge and awareness on routine processes, identifying critical steps and planning practical improvements for a better compliance with criteria of traceability and conformity of biological samples and patients.