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Fail -Safe FMEA

机译:故障安全FMEA

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摘要

Qualty risk management principles are used effectively in many areas of business and governmentincluding finance, insurance, occupational safety and public health-and by the agencies regulating these industries. Risk management's widespread use isn't a surprise because every product and every process has an associated risk. But while there are some examples of the use of quality risk management in the medical product manufacturing industry, they are limited and do not take full advantage of what risk management has to offer. After all, inadequate or ineffective quality risk management can harm patients, product users and company value.
机译:质量风险管理原则已在商业和政府的许多领域得到有效使用,包括金融,保险,职业安全和公共卫生以及监管这些行业的机构。风险管理的广泛使用不足为奇,因为每个产品和每个过程都有相关的风险。但是,尽管在医疗产品制造业中有一些使用质量风险管理的例子,但它们是有限的,不能充分利用风险管理所提供的优势。毕竟,质量风险管理不充分或效率不高会损害患者,产品使用者和公司价值。

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