质量风险管理表.docVIP

质量风险管理表 Quality Risk Management Form 1. 风险描述Risk Description 风险类型 Risk Type 风险管理号 Risk Management No. 工艺/系统/产品影响 Process/System/Product affected: 产品代码/系统号/标识符 Product Code/System Number/GIN or Identifier: 风险确认描述（包括引用的NCR/OOS/DR’S等） Description of Identified Risk:(Include references to any NCR/OOS/DR’s etc) 是否需要风险评估？ Is a Risk Assessment required? 是YES ? 否NO ? 如果“否”请说明理由 Justification if NO*:(ensure that form is still closed off) 签名Signature:_______________ 日期Date:___________ 2. 风险分级Risk Classification 风险发生可能性Risk likelihood: 理由Justification*: 低Low ? 中Med ? 高High ? 风险严重性Risk severity: 理由Justification*: 低Low ? 中Med ? 高High ? 风险分级矩阵 Risk classification matrix: (圈选一个circle one) 风险发生可能性Risk Likelihood 高High 中Medium 低Low 影响的严重性 Severity of Impact 高High 3 3 2 中Medium 3 2 1 低Low 2 1 1 * 在需要的地方附上支持性文件attach supporting documentation where necessary 接上页continued 3. 风险优先级Risk priority 风险分级Risk Classification: 1 ? 2 ? 3 ? 监测概率Probability of detection: 理由Justification*: 低Low ? 中Med ? 高High ? 风险优先级矩阵 Risk priority matrix: 监测概率Probability of detection 低Low 中Medium 高High 风险分级 Risk Classification 3 关键Critical 高High 中Medium 2 高High 中Medium 低Low 1 中Medium 低Low 低Low (圈选一个circle one) 评估风险的优先级Assessed risk priority: ?关键 Critical: 需要立即行动，当天通知高级管理者 Immediate action required; Senior management team to be notified same day. ?高 High: 需要采取紧急行动，3天内通知高层管理者 Urgent action required; Senior management to be notified within 3 working days. ?中 Medium: 需要适当的行动做为日常变更需求/预防整改系统的一部分，两周内通知高层管理者 Appropriate action required as a part of routine CR/CAPA system; Senior management to be notified within 2 weeks. ?低 Low: 行动可能需要作为日常CR/CAPA 系统的一部分, 若可接受的风险是没有变更需要的情况下可不通知高层管理者 Action may be required as a part of routine CR/CAPA system; Senior management notification not required unless the risk is accepted as is with no changes required *在需要的地方附上支持性文件 attach supporting documentation where necessary 4. 评估批准Assessment approval 执行者Performed by: 日期Date: 部门经理 Department Manager: 日