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SCOPE 范围
This document describes the procedures to be followed when any safety alert and advisory notice is necessary to be handled. 本文件描述的程序是用于处理预警和忠告性通知发布所必须遵守的流程。
PURPOSE 目的
To handle safety alert and advisory notice in time so as to avoid the re-occurrence of similar affairs.
为及时处理预警、忠告性通知，防止同类事件的再次发生。
ASSOCIATED DOCUMENTS 相关文件
Advisory Notice 忠告性通知书
Adverse Event Reporting Procedure 不良事件报告控制程序
Corrective & Preventive Actions Control Procedure 纠正和预防行动控制程序
DEFINITIONS AND ACRONYMS 定义和缩写
Advisory Notice of medical devices: After the delivery of medical devices, the complementary information or advisory actions issued by organization related to the aspects in usage, modification,recall and destruction of devices. 医疗器械忠告性通知：在医疗器械交付后，由组织发布的通知，在器械的使用、改动、召回、销毁方面给出的补充信息或建议采取的措施。
RESPONSIBILITIES 职责
5.1 Quality dept. is responsible for the analysis, investigation, management of quality informations, and reporting the related situation. 质量部统筹对质量信息的分析、调查、处理工作，并协调通报相关的情况。
5.2 Production dept., Engineering dept., Material dept., Purchasing dept. should take part in the analysis, investigation, and management of the quality information. 生产部门、工程部、物料部、采购部参与对质量信息的分析、调查、处理。
5.3 Related personnel responsibility of early safety alert system refer to attachment one"Safety alert system Function matrix". 早期预警系统的各部门相关人员职责详见附件一 “预警系统职能矩阵表”。
PROCEDURE 程序
Early safety alert syst