JL-7.3-4风险管理报告体温计(20150115英文板).doc

文件编号： V1.0 风险管理报告 第 PAGE 1页/共4页 模板版本：Ⅰ DN：SCBTM5000 FXBG01 V1.0 Risk Management Report JL-A/0-7.1-06 Risk Management Report （V1.0） Product/project name：ELECTRONIC THERMOMETER Model name：SCBTM5000 Project number： 2014- 01-YF03 Drafted by: Date Reviewed by: Date Approved by: Date DN：SCBTM5000 FXBG01 V1.0 Risk Management Report JL-A/0-7.1-06 History Revision NO Revision date Revision Description Version Drafter Approver 01 15年3月5日 Originated V1.0 徐浩 杨春兰 Page PAGE 4 of 4 Template：Ⅱ Table of Contents TOC \o 1-3 \h \z \u 1 Review 2 1.1 Introduction of product 2 1.2 Introduction on implementation of the risk management plan 2 1.3 Risk management team 2 2 Criteria of risk evaluation 3 3 Risk Management File 3 4 Risk Management Review 3 5 Review on Production and after Production 3 6 Risk Management File Reviewed 3 7 Conclusion of Risk Management Review 3 1 Review 1.1 Introduction of product SCBTM5000 Electronic Thermometer is used for medical department or family for measuring body temperature, can be used for axillary. . 1.2 Introduction on implementation of the risk management plan The project of SCBTM5000 THERMOMETER is approved on 2014-05-20( month, date, year), the risk management activity including the risk management plan was began at that time. The risk management plan has defined the acceptance criteria of risk, and has also arranged the risk management review activity. The risk management group is established to ensure the risk management activity of the current project will be implemented effectively according to the risk management plan. On the development phase and prototype phase of the SCBTM5000 THERMOMETER, the risk management group reviewed the risk management respectively, and documented the risk management files. The objective of this review is to