Failure Mode and Effects Analysis: A Tool for Identifying Risk in Community Pharmacies

Prospective systemic risk analysis of the dispensing process in German community pharmacies

“…The prospective systemic risk analysis was conducted by using FMEA, a team‐based approach consisting of the following steps: At the outset, a highly vulnerable area for proactive evaluation was defined. The process selected for assessment included dispensing of all categories of prescription medicines, because of both the potential to harm patients and evident research gap regarding the medication safety risks in community pharmacies. Then, an expert team was assembled, consisting of a leader experienced in performing FMEA who managed the entire process, and 8 community pharmacists and PTAs, as subject matter experts, involved in dispensing prescription medicine on a daily basis and hence, able to provide insight into the factual system vulnerabilities.…”

“…The prospective systemic risk analysis was conducted by using FMEA, a team-based approach consisting of the following steps 12 : Step 1. At the outset, a highly vulnerable area for proactive evaluation was defined.…”

“…Various tools are available for this type of assessment, such as Hazard Analysis and Critical Control Point, Six Sigma, Total Quality Management, and the Socio‐Technical Probabilistic Risk Assessment. However, a technique acknowledged as a cornerstone of prospective risk management is the failure mode and effects analysis (FMEA), a stepwise approach where multidisciplinary teams work toward pinpointing sensitive areas that need proactive correction, as well as devising specific improvement strategies . Invented back in the 1960s, FMEA was primarily used in industries involving a high level of risk, aiming to provide “simultaneous analysis of failure modes, their consequences and associated factors, in order to identify and prevent process incidents before they occur” .…”

“…However, a technique acknowledged as a cornerstone of prospective risk management is the failure mode and effects analysis (FMEA), a stepwise approach where multidisciplinary teams work toward pinpointing sensitive areas that need proactive correction, as well as devising specific improvement strategies. 12 Invented back in the 1960s, FMEA was primarily used in industries involving a high level of risk, aiming to provide "simultaneous analysis of failure modes, their consequences and associated factors, in order to identify and prevent process incidents before they occur". 13 However, since then, FMEA has come a long way toward serving other purposes, such as a proactive risk reduction in various healthcare processes, including dispensing of medicines, where it has proved to be highly effective.…”

Application of Failure Mode Effect Analysis (FMEA) to Improve Medication Safety in the Dispensing Process – A Study at A Teaching Hospital, Sri Lanka

“…At the rst meeting the researcher introduced the FMEA process to team members with illustrations (7,25). To ensure that all were knowledgeable about the concept of a safety culture in the hospital, all the team members previously (Five months prior to this FMEA) attended a workshop on medication safety organised by the research team where various aspects of medication safety were emphasised.…”