质量风险管理表格

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
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
风险分级Risk Classification:
123
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
是Yes /否No
备注Comments:
评估人Assessor:
日期Date:
部门经理DepartmentManager:
日期Date:
QA/高级经理
QA/Senior Manager
日期Date:
签名Signature:_________________日期Date:___________
6.风险关闭Risk Close-out (完成风险管理/风险策略on completion of risk management/mitigation strategy)
风险是否被圆满的解决或接受Has the Risk been satisfactorily resolved or accepted?
*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
DepartmentManager:
日期Date:
QA/高级经理
QA/Senior Manager:
日期Date:
5.风险管理/缓解策略Risk management/mitigation strategy
CAPA号
CAPA Number:
CR号
CR Number:
描述（没有减低风险行动而想要接受的风险，必须由高级管理层批准）
Description(If the risk is to be accepted as is with no changes required, approval must be given by the senior management team):
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
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:
高High
风险分级
Risk Classification
3
关键Critical
高High
中Me
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
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.
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.
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