FMEA — Something Old , Something New
نویسنده
چکیده
anaging risk is not optional for organizations. Clause 0.1 of ISO 9004 mentions risk management in the same breath with cost and benefit considerations as being important to an organization, its customers and interested parties. Clause 5.4.2 also includes risk assessment and mitigation data as necessary inputs for efficient and effective quality planning. Some sectors, particularly aerospace and automotive, have used failure mode and effects analysis (FMEA) to manage risk for many years. FMEA was used by NASA in the 1960s and adopted by Ford Motor Co. engineering in the 1980s and the Automotive Industry Action Group in the 1990s. To other sectors such as healthcare, it is a fairly new tool. In its accreditation standard LD.5.2, the Joint Commission for Accreditation of Healthcare Organizations now requires hospitals to select at least one high risk process for proactive risk assessment each year. Clauses 7.1.3.3 and 7.3.1 of ISO 9004 list FMEA among the examples of risk assessment tools, referring to it as “fault mode and effect analysis.” Dr. Tom Reiley pointed out that given the fact that medication errors or accidents represent more than 10% of all medical errors, FMEA provides pharmacies an opportunity to apply an industry tool to prevent such errors.
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