Failure Mode and Effects Analysis (FMEA) integrating quality indicators for risk assessment of the total testing process in human papillomavirus genotyping testing: a proactive risk analysis model for molecular diagnostics
This study developed an integrated FMEA-QI model for HPV genotyping testing, establishing both a traditional FMEA framework and a molecular diagnostics-specific MQI. The combined approach improves risk assessment objectivity and enables multidimensional analysis compared to conventional methods.
Authors
- Chun‐Min Kang (ORCID: https://orcid.org/0000-0002-9053-2371)
- Hongmei Wang (ORCID: https://orcid.org/0000-0002-2703-3406)
- Shunwang Cao (ORCID: https://orcid.org/0000-0002-7714-1392)
- Chang Wen
- Yuting He (ORCID: https://orcid.org/0000-0001-7133-9501)
- Yuanhao Chen (ORCID: https://orcid.org/0009-0002-0793-0940)
- Yi Wang (ORCID: https://orcid.org/0000-0002-0811-3742)
- Tingting Li (ORCID: https://orcid.org/0000-0003-2975-6445)
- Chengyu Zhang (ORCID: https://orcid.org/0000-0001-7257-9689)
- Peifeng Ke (ORCID: https://orcid.org/0000-0003-2106-6327)
Institutions
- Guangzhou University of Chinese Medicine (CN)
- Sun Yat-sen University (CN)
- The First Affiliated Hospital, Sun Yat-sen University (CN)
- Guangzhou Medical University (CN)
Publication Details
- Journal
- Clinical Chemistry and Laboratory Medicine (CCLM)
- Published
- 2025-08-29
- DOI
- https://doi.org/10.1515/cclm-2025-0598
- Primary Topic
- Statistical Methods in Clinical Trials
- Type
- article
- Field-Weighted Citation Impact
- 0.00
Funders
- Basic and Applied Basic Research Foundation of Guangdong Province