风险分析案例

Risk Analysis 风险 分析 定性数据统计分析pdf销售业绩分析模板建筑结构震害分析销售进度分析表京东商城竞争战略分析 Page 页： 1 of 5 Form No.:******************************* Author: 起草: Date 日期: Sign 签名: Approved:批准: Date 日期: Sign 签名: Approved:批准: Date 日期: Sign 签名: Approved:批准: Date 日期: Sign 签名: Subject of risk analysis 项目 Risk Analysis of 0.2µm filtered compressed air 0.2µm 过滤的压缩空气风险分析 Objective of risk analysis 目的 Avoid potential risk in 0.2µm filtered compressed air 避免 0.2µm 过滤的压缩空气潜在的风险 Concept phase 概念阶段 Development phase 开发阶段 Pilot serial phase 试制阶段 Status of risk analysis 状态 Serial phase 连续阶段 Allocation of risk analysis subject (design enhancement, revalidation etc.) 分类(设计加强，重验证等) Design enhancement 设计改进 Responsible of risk analysis 负责人 Validation Technician 验证技术员 Production Engineer 生产工程师 Validation Engineer 验证工程师 Risk analysis team 小组成员 XXU Not For Public Release XXU Reviewed Risk Analysis 风险分析 Page 页： 2 of 5 Form No.:******************************* 1 Amendments to previous version 对前一版本的修改 N/A 不适用 2 Summary of risk analysis 总结 初级经济法重点总结下载党员个人总结TXt高中句型全总结.doc高中句型全总结.doc理论力学知识点总结pdf Critical process step / critical product function 关键工艺步骤/关键产品功能 RPN/S 风险顺序数/ 严重度 Improvement Measure 改进措施 Motor power of the air compressor insufficient 空气压缩机马达功能低 30 Install motor starter and safety device 安装马达启动器和安全装置 Compressor control system malfunction 压缩空气控制系统故障 30 Repair the compressor control system 维修压缩空气控制系统 3 Risk acceptance 风险接受 All presently known harms were considered 所有已知危害已被考虑 The residual risk 残存风险： is acceptable 可接受 is not acceptable 不可接受 not applicable 不适用 Risk – Benefit – Analysis: 风险-益处分析： Benefit predominates the risk 益处大于风险 yes no Justification:理由： Appendices:附录： XXU Not For Public Release Risk Analysis 风险分析 Page 页： 3 of 5 Form No.:************************** 4 Topic of the risk analysis 风险分析主 题 快递公司问题件快递公司问题件货款处理关于圆的周长面积重点题型关于解方程组的题及答案关于南海问题 Function/ Requirement 功能/需求 Pot. Failure 潜在故障 Consequence/ Hazard 结果/危害 S Class 分类 Cause 起因 O Actual Measure 现行措施 D RPN Improvement Measure 改进措施 Resp. 责任 Taken Measure 采取的措施 S O D RPN Stat us 状态 D: Demonstrate capability during validation 验证时证实其性能 Install motor starter and safety device 安装马达启动器和安全装置 Motor power insufficient 马达功率低 3 P: Under PM system 纳入预防性维护系统 1 30 Air compressor 空气压缩机 Compres sed air capacity low 压缩空气 量小 Production halt 生产中止 10 Se Compressor control system malfunction 压缩空气控制系 统故障 3 D: Compressor control system qualified during validation 验证时，确认控制系统 1 30 D: Checked before assemble 安装前检查 Air compressor malfunction 空气压缩机故障 5 P: Under PM system 纳入预防性维护系统 1 25 Air receiver 储气罐 Failure 失效 Pressure not steady 压力不稳定 5 M Air receiver leaks 储气罐泄漏 5 D: Install pressure gauge and pressure relief/safety valve 安装压力计和压力调节/安全阀 Change seal periodically 定期更换密封垫 Install automatic condensate drain 安装自动冷凝排水管 1 25 D: Checked before assemble 安装前检查 Demonstrate capability during validation 验证时证实其性能 Air dryer 压缩空气干燥器 Failure 失效 Pressure dew point of compressed air high 压缩空气压力露点 高 5 M Air dryer malfunction 干燥器故障 5 P: 1 25 XXU Not For Public Release Risk Analysis 风险分析 Page 页： 4 of 5 Form No.:************************** Function/ Requirement 功能/需求 Pot. Failure 潜在故障 Consequence/ Hazard 结果/危害 S Class 分类 Cause 起因 O Actual Measure 现行措施 D RPN Improvement Measure 改进措施 Resp. 责任 Taken Measure 采取的措施 S O D RPN Stat us 状态 D: Check the specification of filter material before assemble 安装前,检查过滤器 材料 关于××同志的政审材料调查表环保先进个人材料国家普通话测试材料农民专业合作社注销四查四问剖析材料 的 规格 视频线规格配置磁共振要求常用水泵型号参数扭矩规格钢结构技术规格书 Check particle with the particle counter at the end of the 0.22µm filter 在过滤器的末端用微粒计数器检查 微粒 Carry out the microorganism test 进行微生物检验 Periodic integrity test 定期进行完整性测试 Change 0.22µm filter 更换 0.22µm 过滤器 Filter material error 过滤器材料不正 确 3 P: 1 30 D: Periodic integrity test 定期进行完整性测试 Overload 过载 3 P: 1 30 D: Integrity test after assemble 安装后进行完整性测试 Leaked 泄漏 Products contaminated, Particle and bacteria exceed 产品被污染,微粒 和细菌超标 10 Se Assemble error 安装错误 3 P: 1 30 D: Assemble 0.45µm filter at the outlet of the compress air machine or before the 0.22µm filter 在空气压缩机的出口处或 0.22µm 过滤器之前安装 0.45µm 过滤器 Clean pipe periodically 定期清洗管路 Air inbreathed contains much dust and other impurity 吸入的空气中含 有大量的尘埃与 其他杂质 3 P: 1 15 0.22µm filter 0.22µm 过滤器 Blocked 阻塞 Waste energy Decrease compress air flow rate 浪费能源,降低压 缩空气流速 5 M Particle produced due to the fray of the compressed air 3 D: Change seal periodically 定期更换密封垫 Clean pipe periodically 定期清洗管路 1 15 XXU Not For Public Release Risk Analysis 风险分析 Page 页： 5 of 5 Form No.:************************** Function/ Requirement 功能/需求 Pot. Failure 潜在故障 Consequence/ Hazard 结果/危害 S Class 分类 Cause 起因 O Actual Measure 现行措施 D RPN Improvement Measure 改进措施 Resp. 责任 Taken Measure 采取的措施 S O D RPN Stat us 状态 machine and the fragment of airproof seal 由于空气压缩机 磨损和密封垫的 碎片而产生的微 粒 P: - End Of Document 文件结束- S=Severity of consequence / harm 严重度 O=Occurrence probability of failure / failure cause 失效频度 D=Detection probability 探测度 RPN=Risk Priority Number 风险顺序指数 D=Detection measure 已有措施 P=Prevention measure 预防措施 Se=Severe malfunction 严重故障 M=Main malfunction 主要故障 Sm=Subordination malfunction 次要故障 The risk is evaluated as acceptable if the RPN value is ≤100 or if the RPN value is ≤100 and the combination between S×O lies in the acceptable range, according to SOP ********************************* 根据 SOP******************************，如果风险顺序指数不超过 100 或如果风险顺序指数不超过 100 和严重度“S”与频度“O”的乘积的综合落在可接受的范围内，被评估的风险是可以接受的。 XXU Not For Public Release