A comparison of two prospective risk analysis methods: Traditional FMEA and a modified healthcare FMEA

Abstract

Purpose: To examine the abilities of a traditional failure mode and effects analysis (FMEA) and modified healthcare FMEA (m-HFMEA) scoring methods by comparing the degree of congruence in identifying high risk failures. Methods: The authors applied two prospective methods of the quality management to surface image guided, linac-based radiosurgery (SIG-RS). For the traditional FMEA, decisions on how to improve an operation were based on the risk priority number (RPN). The RPN is a product of three indices: occurrence, severity, and detectability. The m-HFMEA approach utilized two indices, severity and frequency. A risk inventory matrix was divided into four categories: very low, low, high, and very high. For high risk events, an additional evaluation was performed. Based upon the criticality of the process, it was decided if additional safety measures were needed and what they comprise. Results: The two methods were independently compared to determine if the results and rated risks matched. The authors' results showed an agreement of 85% between FMEA and m-HFMEA approaches for top 20 risks of SIG-RS-specific failure modes. The main differences between the two approaches were the distribution of the values and the observation that failure modes (52, 54, 154) with high m-HFMEA scores do not necessarily have high FMEA-RPN scores. In the m-HFMEA analysis, when the risk score is determined, the basis of the established HFMEA Decision Tree™ or the failure mode should be more thoroughly investigated. Conclusions: m-HFMEA is inductive because it requires the identification of the consequences from causes, and semi-quantitative since it allows the prioritization of high risks and mitigation measures.

Preventive risk analysis in the maintenance of patency of the peripherally inserted central catheter

“…The processes are designed based on the premise that nothing will go wrong; when something does go wrong, the individuals involved are punished, trained again, penalized. This premise is mistaken; errors can be reduced by continuous process analysis within a strong security culture promoted by leadership through proactive risk analysis (9) .…”

“…The HFMEA is performed through five steps: 1) identification of topic, affected areas or vulnerabilities; 2) assemble of a multidisciplinary team, related to the topic, affected areas or vulnerability; 3) description of process and subprocesses flows; 4) conducting a risk analysis, classifying the failure modes according to the severity and probability of each subprocess; 5) definition and implementation of actions to reduce failure modes, identifying responsible individuals and expected outcomes (8) . However, since hazard analysis is a subjective process, the variables of this tool should be evaluated according to the characteristics of each context (9) .…”

Aus- und Fortbildung in der Infektionsprävention: Didaktik und Risikoanalyse

“…Wenn möglich werden vorhandene Daten hinzugezogen, z. B. Surveillance-Datenpool, Patienten-und Mitarbeiterbefragungen, Verbrauchsdaten, Critical-Incident-Reporting-System-Fälle, Beschwerden, Meldungen besonderer Vorkommnisse, Screening-Daten, Fokusgruppen, Prozess- [2] und Schadensfall-Analysen etc.…”

A Method to Build a Risk Evaluation Weighted Indicators System and an Application Example in Online Shopping Risk Evaluation

“…FMEA is made by addressing problems in an order from the biggest risk priority number (RPN) to the smallest ones calculated by product of three factors (Severity (S), Occurrence (O), Detection (D)) [3].…”

“…[1] Failure mode and effects analysis (FMEA) has proven to be a useful and powerful tool in assessing potential failures and preventing them from occurring [2] and has been widely adopted by reliability practitioners [3,4,5].…”