风险管理程序Risk Management Procedure.doc

风险管理程序 Risk Management Procedure 文件编号Document No.：QP7101 版本Revision：A 生效日期Effective Date： 拟制/日期 Prepared by/Date 审核/日期 Review by/Date 批准/日期 Approved by/Date This Document is made out in both English and Chinese versions. In case of any discrepancy between the English and Chinese versions, the English version shall prevail. 本文由英文版和中文版构成。如英文版本与中文版本有差异，概以英文版为准。 文件更改记录 Document Change History 版本号 Rev. No 变更原因和内容描述 Reason and Description of Change 受影响的页面 Affected Pages 拟制人 Prepared by 发行日期 Release Date A 新拟制 New Release  1. 目的 Objective 按照《ISO14971: 2007医疗器械--风险管理》中的标准，明确风险管理的方法、流程和职责。 Based on the standard of 《ISO14971: 2007 medical device-risk management》, definitude the method of risk management, flow and responsibility. 2. 适用范围 Scope 适用于公司所有医疗器械产品风险管理过程。 Apply to the risk management process of all medical devices. 3. 定义 Definition 风险：发生危害的可能性和这种危害严重性的综合结果。 Risk: possibility of harm and comprehensive result of this harm severity. 伤害（harm）：人身损伤或对人员健康的损害，或者对财产和环境产生破坏。 Harm: injury on person or personal health, or destroy on property and environment. 危害（hazard）：潜在的伤害源 。 Hazard: potential harm source. 危害情形（hazardous situation ): 人员、财产或环境处于一个或多个危害之中的境遇。 Hazardous situation：circumstance in which people, property, or the environment are exposed to one or more hazard(s) 剩余风险(residual risk ): 采取风险控制措施后余下的风险。 Residual risk: risk remaining after risk control measures have been taken FTA：Failure Tree Analysis 失效分析树。 FMEA：Failure Mode and Effect Analysis 失效模式及后果分析。 PPM：Part Per Million 百万分率，即一百万个产品中出现某一情况的数量。 Part Per Million means the quantity that one situation happens in one million products. 4. 职责 Responsibility 研发部组织风险管理小组，负责产品生命周期内的风险管理。成员需包括：医学专家，操作者，设计工程师，市场人员和管理人员。其中应至少有一名医学专家。 RD organize risk management group to see to risk management of product lifecycle. Members need contain: medicinal expert, operator, design engineer, marketing person and managing person. The team shall include one medicinal expert at least. 5. 风险总体可接受性的评判准则 overall acceptable criteria of ri