质量监控计划

China
SHUANGCHENG FACTORY
1
August 2004
Quality Monitoring
Schem QMS 质量监控计划
China
SHUANGCHENG FACTORY
2
August 2004
What is the QMS 什么是QMS?
1。

A working document that summarizes our Quality Control Plan 是一份总结我们质量控制计划的文件
–Food safety parameters 关系食品安全的技术参数–Regulatory requirements 法律法规要求
–Other parameters related to Nestle rules on GMP, pathogen monitoring, contaminants, KQT, etc. 其它雀巢规定相关的参数，如良好生产操作，致病菌监控，污染物，储存期质量等
China
SHUANGCHENG FACTORY
3
August 2004
2。

Indicates the checks needed to monitor compliance to food safety (CCPs)and quality requirements (CPs)标识出为达到食品安全(关键控制点)和质量要求(控制点)必须进行的检查检测。

What is the QMS 什么是QMS?
China
SHUANGCHENG FACTORY
4
August 2004
QMS section of NSL 双城雀巢QMS 包括哪些部分
•Packaging Material 包装材料•Raw Material 原材料•Production 生产•Finished Good 成品
•Environmental Quality Monitoring 环境监控•Microbiology Quality Monitoring 微生物质量监控•Auxiliary Service 辅助设施
China
SHUANGCHENG FACTORY
5
August 2004
QMS 质量监控计划
The Element on QMS 构成元素
Item(What)项目(检查什么？)
Purpose(why)目的(为什幺？)
Sampling(when,where)
取样(何时，何处)Check(what, by whom, how
检查(内容，谁，方式)
Specification
标准
Report 报告
Action in case of deviation
如发生偏差采取措施
China
SHUANGCHENG FACTORY
6
August 2004
Quality Monitoring Scheme (QMS)
质量监控计划
Product 产品:All products 所有产品
Page 第1 页of 共1页
Section 区域:
Evaporation 蒸发
Sampling 取样
Examination 检验Item 项目
Purpose of Test 检验目的Where 位置No.
Frequency 频率By Whom 负责人Analysis 分析By Whom 负责人Method 方法Specification 标准Recorded 记录
1) Action in Case of Deviation 如有偏差采取措施2) Remarks 备注
UP (DSI)蒸汽喷射器
Ensure micro quality of product 确保产品微生物
质量Control penal 控制盘C CP
Per hour 每小时
Operator 操作工
UP temperature UP 温度Operator 操作工
Reading 读数Refer to running
condition 根据运行条件Log book 运行记录
1. Refer to Handbook QA4.2-1-1
根据工厂手册QA4.2-1-1Ensure steam quality
确保蒸汽质量Steam infuser 蒸汽喷射器Daily 每天Operator 操作工Organoleptic 感官质量
Taste penal 品尝组Visual/smell/taste 观察/闻/尝Clear/no foreign odor and
taste
澄清/无不良滋气味Tasting record 品尝记录 1. Inform Eng. 通知工程2. Resample 重新取样Concentrated
milk 浓奶
Verify density
meter 确认密度计
k Sampling point 浓奶取样口Per shift 每班
Operator 操作工TC%
Operator 操作工Microwave oven 微波炉
According to Microwave
result
根据微波炉结果Log sheet 运行记录Inform Engineer to calibrate 通知工程部校正To achieve max. TC before spray drying 喷雾干燥前达到最大
TC Control penal 控制盘
Per hour 每小时
Operator 操作工
TC%
Operator 操作工
Density meter 密度计
According to different
product 根据不同产品
Log sheet 运行记录
Adjust steam pressure 调整蒸汽压力Cleanness of concentrate milk 浓奶干净程度k Sampling point 浓奶取样口Start up/per 3hrs after 10hrs running 起车样/运行10小时后每3小时
Operator 操作工
Dirt test 杂质度
Operator 操作工
LI-08.043
According to instruction 根据操作说明规定Log sheet 运行记录
rm supervisor 通知工段长⍓
2.Re-separate it 重新净乳
Ensure micro quality
确保微生物质量
k Sampling point 浓奶取样口
Per batch 每个批次
Operator 操作工
TPC 总菌数Lab technician 实验室技师LI-00.701-1According to product SP
根据产品标准Lab record 实验室记录 1. Inform production manager
通知生产经理Coliform 大肠菌群
Lab technician 实验室技师LI-00.711-3
According to product SP
根据产品标准
Lab record 实验室记录⍓ 1.Perform detailed test 做详细实验⍓ 2.Source the origin 寻找来源
Evaporator 蒸发器Ensure no NO 2/NO 3确认 NO 2/NO 3阴性Evaporator 蒸发器After CIP CIP 后
Evaporator operator 蒸发器操作工
NO 2/NO 3 Operator 操作工Rapid test 快速实验Neg.阴性Log sheet 运行记录
1. Cleaning again 再清洗
2. Inform SCI 通知运行经理
Water 水
Operator 操作工
Visual 观察
Clean and clear 干净，澄清
-
Rinsing again 再冲洗
By 负责人:QA manager 质保经理
Production manager 生产经理Factory manager 工厂经理
Visa 批准:Date 日期:
2004-08-10
QMS sample 样本
China
SHUANGCHENG FACTORY
7
August 2004
Quality Monitoring Scheme (Quality Monitoring Scheme (QMS)
QMS)质量监控计划
Product 产品:All products 所有产品Page 第1 页of 共1页
Section 区域:
Evaporation 蒸发
Sampling Sampling
取样Examination 检验
Purpose of Test 检验目的
Where
位置
No .
Frequenc y 频率
By Whom 负责人
Analysis 分析
By Whom 负责人Method 方法
Specification 标
准
Recorded 记录
1) 1) Action in Case of Action in Case of Deviation
如有偏差采取措施2)
2) Remarks Remarks 备注Ensure micro quality of product 确保产品微生物
质量Control penal 控制盘
C CP
Per hour 每小时
Operator 操作工
UP temperature UP 温度Operator 操作工
Reading 读数
Refer to running
condition 根据运行条件
Log book 运行记录
1. Refer to Handbook QA4.2-1-1
根据工厂手册QA4.2-1-1Ensure steam quality 确保蒸汽质量Steam infuser 蒸汽喷射器Daily 每天Operator 操作工Organoleptic 感官质量
Taste penal 品尝组Visual/smell/taste 观察/闻/尝Clear/no foreign odor and
taste
澄清/无不良滋气味Tasting record 品尝记录 1. Inform Eng. 通知工程2. Resample 重新取样Verify density
meter 确认密度计
k Sampling point 浓奶取样口Per shift 每班
Operator 操作工TC%
Operator 操作工Microwave oven 微波炉
According to Microwave
result
根据微波炉结果Log sheet 运行记录Inform Engineer to calibrate 通知工程部校正To achieve max. TC before spray drying 喷雾干燥前达到最大
TC Control penal 控制盘Per hour 每小时Operator 操作工
TC%
Operator 操作工
Density meter 密度计
According to different
product 根据不同产品
Log sheet 运行记录
Adjust steam pressure 调整蒸汽压力Cleanness of concentrate milk 浓奶干净程度
k Sampling point 浓奶取样口Start up/per 3hrs after 10hrs running 起车样/运行10小时后每3小时
Operator 操作工
Dirt test 杂质度
Operator 操作工
LI-08.043
According to instruction 根据操作说明规定Log sheet 运行记录
rm supervisor 通知工段长⍓
2.Re-separate it 重新净乳
Ensure micro quality
确保微生物质量
k Sampling point 浓奶取样口
Per batch 每个批次
Operator 操作工
TPC 总菌数
Lab technician 实验室技师LI-00.701-1
According to product SP
根据产品标准Lab record 实验室记录
1. Inform production manager
通知生产经理Coliform 大肠菌群
Lab technician 实验室技师LI-00.711-3
According to product SP
根据产品标准
Lab record 实验室记录⍓ 1.Perform detailed test 做详细实验⍓ 2.Source the origin 寻找来源
Ensure no NO 2/NO 3确认 NO 2/NO 3阴性Evaporator 蒸发器After CIP CIP 后
Evaporator operator 蒸发器操作工
NO 2/NO 3
Operator 操作工
Rapid test 快速实验
Neg.阴性
Log sheet 运行记录
1. Cleaning again 再清洗
2. Inform SCI 通知运行经理
By 负责人:QA manager 质保经理
Production manager 生产经理Factory manager 工厂经理
Visa 批准:Date 日期:
2004-08-11
What product related to the QMS 与QMS 有关的产品
Where the QMS applied QMS 的应用区域
Approved date 批准日期
Management signature 管理层批准签字
China
SHUANGCHENG FACTORY
8
August 2004
Quality Monitoring Scheme (Quality Monitoring Scheme (QMS)
QMS)质量监控计划
Product 产品:All products 所有产品
Page 第1 页of 共1页
Section 区域:
Evaporation 蒸发
Sampling 取样
Examination 检验Item 项目
Purpose of Test 检验目的Where 位置No.
Frequency 频率By Whom 负责人Analysis 分析By Whom 负责人Method 方法Specification 标准Recorded 记录
1) Action in Case of Deviation 如有偏差采取措施2) Remarks 备注
UP (UP (DSI)DSI)蒸汽喷射器
Ensure micro quality of product 确保产品微生物
质量Control penal 控制盘C CP
Per hour 每小时
Operator 操作工
UP temperature UP 温度Operator 操作工
Reading 读数
Refer to running
condition 根据运行条件
Log book 运行记录
1. Refer to Handbook QA4.2-1-1
根据工厂手册QA4.2-1-1Ensure steam quality 确保蒸汽质量Steam infuser 蒸汽喷射器Daily 每天
Operator 操作工Organoleptic 感官质量
Taste penal 品尝组Visual/smell/taste 观察/闻/尝Clear/no foreign odor and
taste
澄清/无不良滋气味Tasting record 品尝记录
1. Inform Eng. 通知工程
2. Resample 重新取样
Concentrated
milk 浓奶
Verify density
meter 确认密度计k Sampling point 浓奶取样口Per shift 每班
Operator 操作工TC%
Operator 操作工Microwave oven 微波炉
According to Microwave
result
根据微波炉结果Log sheet 运行记录Inform Engineer to calibrate 通知工程部校正To achieve max. TC before spray drying 喷雾干燥前达到最大
TC Control penal 控制盘Per hour 每小时
Operator 操作工
TC%
Operator 操作工
Density meter 密度计
According to different
product 根据不同产品
Log sheet 运行记录
Adjust steam pressure 调整蒸汽压力Cleanness of concentrate milk 浓奶干净程度k Sampling point 浓奶取样口Start up/per 3hrs after 10hrs running 起车样/运行10小时后每3小时
Operator 操作工Dirt test 杂质度Operator 操作工
LI-08.043
According to instruction 根据操作说明规定Log sheet 运行记录
rm supervisor 通知工段长⍓
2.Re-separate it 重新净乳
Ensure micro quality
确保微生物质量
k Sampling point 浓奶取样口
Per batch 每个批次
Operator 操作工
TPC 总菌数
Lab technician 实验室技师LI-00.701-1
According to product SP
根据产品标准Lab record 实验室记录 1. Inform production manager
通知生产经理
Coliform 大肠菌群
Lab technician 实验室技师LI-00.711-3
According to product SP
根据产品标准
Lab record 实验室记录⍓ 1.Perform detailed test 做详细实验⍓ 2.Source the origin 寻找来源
Evaporator 蒸发器Ensure no NO 2/NO 3确认 NO 2/NO 3阴性Evaporator 蒸发器
After CIP CIP 后
Evaporator operator 蒸发器操作工
NO 2/NO 3 Operator 操作工Rapid test 快速实验Neg.阴性Log sheet 运行记录
1. Cleaning again 再清洗
2. Inform SCI 通知运行经理
Water 水
Operator 操作工
Visual 观察
Clean and clear 干净，澄清
-Rinsing again 再冲洗
By 负责人:QA manager 质保经理
Production manager 生产经理Factory manager 工厂经理
Visa 批准:Date 日期:
2004-08-11
The WHAT in QMS ，QMS 检验项目
Can be a raw or packaging material, finished product, process step,
equipment, environment, etc that needs to be checked.
可以是原材料，包装材料， 成品，加工步骤，设备，环境等需要检查的内容
China
SHUANGCHENG FACTORY
9
August 2004
Quality Monitoring Scheme (Quality Monitoring Scheme (QMS)
QMS)质量监控计划
Product 产品:All products 所有产品
Page 第1 页of 共1页
Section 区域:
Evaporation 蒸发
Sampling 取样
Examination 检验
Item 项目
Purpose of Test 检验目的
Where 位置No.
Frequency 频率
By Whom 负责人Analysis 分析By Whom 负责人Method 方法
Specification 标准
Recorded 记录
1) Action in Case of Deviation 如有偏差采取措施2) Remarks 备注
UP (UP (DSI)DSI)蒸汽喷射器
Ensure micro quality of product 确保产品微生物
质量Control penal 控制盘C CP
Per hour 每小时Operator 操作工
UP temperature UP 温度Operator 操作工
Reading 读数Refer to running
condition 根据运行条件Log book 运行记录
1. Refer to Handbook QA4.2-1-1
根据工厂手册QA4.2-1-1Ensure steam quality 确保蒸汽质量Steam infuser 蒸汽喷射器Daily 每天Operator 操作工Organoleptic 感官质量
Taste penal 品尝组Visual/smell/taste 观察/闻/尝Clear/no foreign odor and
taste
澄清/无不良滋气味Tasting record 品尝记录 1. Inform Eng. 通知工程2. Resample 重新取样Concentrated
milk 浓奶
Verify density
meter 确认密度计
k Sampling point 浓奶取样口Per shift 每班
Operator 操作工TC%
Operator 操作工Microwave oven 微波炉According to Microwave
result
根据微波炉结果Log sheet 运行记录Inform Engineer to calibrate 通知工程部校正To achieve max. TC before spray drying 喷雾干燥前达到最大
TC Control penal 控制盘
Per hour 每小时
Operator 操作工
TC%
Operator 操作工
Density meter 密度计
According to different
product 根据不同产品
Log sheet 运行记录
Adjust steam pressure 调整蒸汽压力Cleanness of concentrate milk 浓奶干净程度k Sampling point 浓奶取样口Start up/per 3hrs after 10hrs running 起车样/运行10小时后每3小时
Operator 操作工
Dirt test 杂质度
Operator 操作工
LI-08.043
According to instruction 根据操作说明规定
Log sheet 运行记录
rm supervisor 通知工段长⍓
2.Re-separate it 重新净乳
Ensure micro quality
确保微生物质量
k Sampling point 浓奶取样口
Per batch 每个批次
Operator 操作工
TPC 总菌数
Lab technician 实验室技师LI-00.701-1
According to product SP
根据产品标准Lab record 实验室记录 1. Inform production manager
通知生产经理Coliform 大肠菌群
Lab technician 实验室技师LI-00.711-3
According to product SP
根据产品标准
Lab record 实验室记录⍓ 1.Perform detailed test 做详细实验⍓ 2.Source the origin 寻找来源
Evaporator 蒸发器Ensure no NO 2/NO 3确认 NO 2/NO 3阴性Evaporator 蒸发器After CIP CIP 后
Evaporator operator 蒸发器操作工
NO 2/NO 3 Operator 操作工Rapid test 快速实验Neg.阴性Log sheet 运行记录
1. Cleaning again 再清洗
2. Inform SCI 通知运行经理
Water 水
Operator 操作工
Visual 观察
Clean and clear 干净，澄清
-Rinsing again 再冲洗
By 负责人:QA manager 质保经理
Production manager 生产经理Factory manager 工厂经理
Visa 批准:Date 日期:
2004-08-11
The WHY in QMS 目的
Reason for monitoring- to ensure that the points influencing food safety and quality are under control
检查的目的-保证影响食品安全和质量的控制点达到要求
China
SHUANGCHENG FACTORY
10
August 2004
Quality Monitoring Scheme (Quality Monitoring Scheme (QMS)
QMS)质量监控计划
Product 产品:All products 所有产品
Page 第1 页of 共1页
Section 区域:
Evaporation 蒸发
Sampling Sampling
取样Examination 检验
Item 项目
Purpose of Test 检验目的Where 位置
No.
Frequency 频率
By Whom 负责人
Analysis 分析By Whom 负责人Method 方法
Specification 标准
Recorded 记录
1) Action in Case of Deviation 如有偏差采取措施2) Remarks 备注
UP (UP (DSI)DSI)蒸汽喷射器Ensure micro quality of product 确保产品微生物
质量Control penal 控制盘C CP
Per hour 每小时Operator 操作工
UP temperature UP 温度Operator 操作工
Reading 读数
Refer to running
condition 根据运行条件Log book 运行记录
1. Refer to Handbook QA4.2-1-1
根据工厂手册QA4.2-1-1Ensure steam quality 确保蒸汽质量Steam infuser 蒸汽喷射器Daily 每天
Operator 操作工Organoleptic 感官质量
Taste penal 品尝组Visual/smell/taste 观察/闻/尝Clear/no foreign odor and
taste
澄清/无不良滋气味Tasting record 品尝记录 1. Inform Eng. 通知工程2. Resample 重新取样Concentrated
milk 浓奶
Verify density
meter 确认密度计
k Sampling point 浓奶取样口Per shift 每班
Operator 操作工TC%
Operator 操作工Microwave oven 微波炉
According to Microwave
result
根据微波炉结果Log sheet 运行记录Inform Engineer to calibrate 通知工程部校正To achieve max. TC before spray drying 喷雾干燥前达到最大
TC Control penal 控制盘Per hour 每小时
Operator 操作工
TC%
Operator 操作工
Density meter 密度计
According to different
product 根据不同产品
Log sheet 运行记录
Adjust steam pressure 调整蒸汽压力Cleanness of concentrate milk 浓奶干净程度k Sampling point 浓奶取样口Start up/per 3hrs after 10hrs running 起车样/运行10小时后每3小时
Operator 操作工
Dirt test 杂质度
Operator 操作工
LI-08.043
According to instruction 根据操作说明规定Log sheet 运行记录
rm supervisor 通知工段长⍓
2.Re-separate it 重新净乳
Ensure micro quality
确保微生物质量
k Sampling point 浓奶取样口
Per batch 每个批次
Operator 操作工TPC 总菌数Lab technician 实验室技师LI-00.701-1
According to product SP
根据产品标准Lab record 实验室记录 1. Inform production manager
通知生产经理Coliform 大肠菌群
Lab technician 实验室技师LI-00.711-3
According to product SP
根据产品标准
Lab record 实验室记录⍓ 1.Perform detailed test 做详细实验⍓ 2.Source the origin 寻找来源
Evaporator 蒸发器Ensure no NO 2/NO 3确认 NO 2/NO 3阴性Evaporator 蒸发器After CIP CIP 后
Evaporator operator 蒸发器操作工
NO 2/NO 3 Operator 操作工Rapid test 快速实验Neg.阴性Log sheet 运行记录
1. Cleaning again 再清洗
2. Inform SCI 通知运行经理
Water 水
Operator 操作工
Visual 观察
Clean and clear 干净，澄清
-
Rinsing again 再冲洗
By 负责人:QA manager 质保经理
Production manager 生产经理Factory manager 工厂经理
Visa 批准:Date 日期:
2004-08-11
Where do sampling or check 检查或在哪里取样
The frequency of sampling or check 检查或取样频率Responsible person 负责人
CCP 关键控
制点
China
SHUANGCHENG FACTORY
11
August 2004
Quality Monitoring Scheme (Quality Monitoring Scheme (QMS)
QMS)质量监控计划
Product 产品:All products 所有产品
Page 第1 页of 共1页
Section 区域:
Evaporation 蒸发
Sampling Sampling
取样Examination 检验
Item 项目
Purpose of Test 检验目的Where 位置
No.
Frequency 频率
By Whom 负责人
Analysis 分析By Whom 负责人Method 方法
Specification 标准
Recorded 记录
1) Action in Case of Deviation 如有偏差采取措施2) Remarks 备注
UP (UP (DSI)DSI)蒸汽喷射器Ensure micro quality of product 确保产品微生物
质量Control penal 控制盘C CP
Per hour 每小时Operator 操作工
UP temperature UP 温度Operator 操作工
Reading 读数
Refer to running
condition 根据运行条件Log book 运行记录
1. Refer to Handbook QA4.2-1-1
根据工厂手册QA4.2-1-1Ensure steam quality 确保蒸汽质量Steam infuser 蒸汽喷射器Daily 每天Operator 操作工Organoleptic 感官质量
Taste penal 品尝组Visual/smell/taste 观察/闻/尝Clear/no foreign odor and
taste
澄清/无不良滋气味Tasting record 品尝记录 1. Inform Eng. 通知工程2. Resample 重新取样Concentrated
milk 浓奶
Verify density
meter 确认密度计k Sampling point 浓奶取样口Per shift 每班
Operator 操作工TC%
Operator 操作工Microwave oven 微波炉
According to Microwave
result
根据微波炉结果Log sheet 运行记录Inform Engineer to calibrate 通知工程部校正To achieve max. TC before spray drying 喷雾干燥前达到最大
TC Control penal 控制盘
Per hour 每小时
Operator 操作工
TC%
Operator 操作工
Density meter 密度计
According to different
product 根据不同产品
Log sheet 运行记录
Adjust steam pressure 调整蒸汽压力Cleanness of concentrate milk 浓奶干净程度k Sampling point 浓奶取样口Start up/per 3hrs after 10hrs running 起车样/运行10小时后每3小时
Operator 操作工
Dirt test 杂质度
Operator 操作工
LI-08.043
According to instruction 根据操作说明规定
Log sheet 运行记录
rm supervisor 通知工段长⍓
2.Re-separate it 重新净乳
Ensure micro quality
确保微生物质量
k Sampling point 浓奶取样口
Per batch 每个批次
Operator 操作工
TPC 总菌数
Lab technician 实验室技师LI-00.701-1
According to product SP
根据产品标准Lab record 实验室记录 1. Inform production manager
通知生产经理
Coliform 大肠菌群
Lab technician 实验室技师LI-00.711-3
According to product SP
根据产品标准
Lab record 实验室记录⍓ 1.Perform detailed test 做详细实验⍓ 2.Source the origin 寻找来源
Evaporator 蒸发器Ensure no NO 2/NO 3确认 NO 2/NO 3阴性Evaporator 蒸发器
After CIP CIP 后
Evaporator operator 蒸发器操作工
NO 2/NO 3 Operator 操作工Rapid test 快速实验Neg.阴性
Log sheet 运行记录
1. Cleaning again 再清洗
2. Inform SCI 通知运行经理
Water 水
Operator 操作工
Visual 观察
Clean and clear 干净，澄清
-Rinsing again 再冲洗
By 负责人:QA manager 质保经理
Production manager 生产经理
Factory manager 工厂经理
Visa 批准:Date 日期:
2004-08-11
WHAT WHAT –
– the parameter to be checked (e. g. temperature, cleanliness, moisture, etc.)
检查什么？-要检查的内容(如温度，清洁，水分等)
HOW HOW –
– method or equipment used to check the parameter; clearly mention the procedure or instruction (LI, SP or WI), if applicable
如何检查？-用于检查的方法或仪器，如可能，清楚标出操作程序或说明
China
SHUANGCHENG FACTORY
12
August 2004
Quality Monitoring Scheme (Quality Monitoring Scheme (QMS)
QMS)质量监控计划
Product 产品:All products 所有产品
Page 第1 页of 共1页
Section 区域:
Evaporation 蒸发
Sampling Sampling
取样Examination 检验
Item 项目
Purpose of Test 检验目的Where 位置
No.
Frequency 频率
By Whom 负责人
Analysis 分析By Whom 负责人Method 方法
Specification 标准
Recorded 记录
1) Action in Case of Deviation 如有偏差采取措施2) Remarks 备注
UP (UP (DSI)DSI)蒸汽喷射器Ensure micro quality of product 确保产品微生物
质量Control penal 控制盘C CP
Per hour 每小时Operator 操作工
UP temperature UP 温度Operator 操作工
Reading 读数
Refer to running
condition 根据运行条件Log book 运行记录
1. Refer to Handbook QA4.2-1-1
根据工厂手册QA4.2-1-1Ensure steam quality 确保蒸汽质量Steam infuser 蒸汽喷射器Daily 每天Operator 操作工Organoleptic 感官质量
Taste penal 品尝组Visual/smell/taste 观察/闻/尝Clear/no foreign odor and
taste
澄清/无不良滋气味Tasting record 品尝记录 1. Inform Eng. 通知工程2. Resample 重新取样Concentrated
milk 浓奶
Verify density
meter 确认密度计k Sampling point 浓奶取样口Per shift 每班Operator 操作工TC%
Operator 操作工Microwave oven 微波炉According to Microwave
result
根据微波炉结果Log sheet 运行记录Inform Engineer to calibrate 通知工程部校正To achieve max. TC before spray drying 喷雾干燥前达到最大
TC Control penal 控制盘
Per hour 每小时
Operator 操作工
TC%
Operator 操作工
Density meter 密度计
According to different
product 根据不同产品
Log sheet 运行记录
Adjust steam pressure 调整蒸汽压力Cleanness of concentrate milk 浓奶干净程度
k Sampling point 浓奶取样口Start up/per 3hrs after 10hrs running 起车样/运行10小时后每3小时
Operator 操作工
Dirt test 杂质度
Operator 操作工
LI-08.043
According to instruction 根据操作说明规定
Log sheet 运行记录
rm supervisor 通知工段长⍓
2.Re-separate it 重新净乳
Ensure micro quality
确保微生物质量
k Sampling point 浓奶取样口
Per batch 每个批次
Operator 操作工
TPC 总菌数
Lab technician 实验室技师LI-00.701-1
According to product SP
根据产品标准Lab record 实验室记录 1. Inform production manager
通知生产经理
Coliform 大肠菌群
Lab technician 实验室技师LI-00.711-3
According to product SP
根据产品标准
Lab record 实验室记录⍓ 1.Perform detailed test 做详细实验⍓ 2.Source the origin 寻找来源
Evaporator 蒸发器Ensure no NO 2/NO 3确认 NO 2/NO 3阴性
Evaporator 蒸发器
After CIP CIP 后
Evaporator operator 蒸发器操作工
NO 2/NO 3
Operator 操作工Rapid test 快速实验Neg.阴性
Log sheet 运行记录
1. Cleaning again 再清洗
2. Inform SCI 通知运行经理
Water 水
Operator 操作工
Visual 观察
Clean and clear 干净，澄清
-Rinsing again 再冲洗
By 负责人:QA manager 质保经理Production manager 生产经理Factory manager 工厂经理Visa 批准:Date 日期:
2004-08-11
Measurement of the object; usually based on legal requirements or technical instructions (CP, MI, PTC
documents, etc.)检查项目的判定标准，通常来源于法律法规或技术说明
If quantitative, specific values are mentioned with minimum and maximum 如可以量化，给出最大值或最小值范围
If variable, this is linked to a separate document that can be easily updated 如有不同值，可与单独的文件项关联以便于更新
China
SHUANGCHENG FACTORY
13
August 2004
Quality Monitoring Scheme (Quality Monitoring Scheme (QMS)
QMS)质量监控计划
Product 产品:All products 所有产品
Page 第1 页of 共1页
Section 区域:
Evaporation 蒸发
Sampling Sampling
取样Examination 检验
Item 项目
Purpose of Test 检验目的Where 位置
No.
Frequency 频率
By Whom 负责人
Analysis 分析By Whom 负责人Method 方法
Specification 标准
Recorded 记录
1) Action in Case of Deviation 如有偏差采取措施2) Remarks 备注
UP (UP (DSI)DSI)蒸汽喷射器Ensure micro quality of product 确保产品微生物
质量Control penal 控制盘C CP
Per hour 每小时Operator 操作工
UP temperature UP 温度Operator 操作工
Reading 读数
Refer to running
condition 根据运行条件Log book 运行记录
1. Refer to Handbook QA4.2-1-1
根据工厂手册QA4.2-1-1Ensure steam quality 确保蒸汽质量Steam infuser 蒸汽喷射器Daily 每天Operator 操作工Organoleptic 感官质量
Taste penal 品尝组Visual/smell/taste 观察/闻/尝Clear/no foreign odor and
taste
澄清/无不良滋气味Tasting record 品尝记录 1. Inform Eng. 通知工程2. Resample 重新取样Concentrated
milk 浓奶
Verify density
meter 确认密度计k Sampling point 浓奶取样口Per shift 每班Operator 操作工TC%
Operator 操作工Microwave oven 微波炉According to Microwave
result
根据微波炉结果Log sheet 运行记录Inform Engineer to calibrate 通知工程部校正To achieve max. TC before spray drying 喷雾干燥前达到最大
TC Control penal 控制盘
Per hour 每小时
Operator 操作工
TC%
Operator 操作工
Density meter 密度计
According to different
product 根据不同产品
Log sheet 运行记录
Adjust steam pressure 调整蒸汽压力Cleanness of concentrate milk 浓奶干净程度k Sampling point 浓奶取样口Start up/per 3hrs after 10hrs running 起车样/运行10小时后每3小时
Operator 操作工
Dirt test 杂质度
Operator 操作工
LI-08.043
According to instruction 根据操作说明规定
Log sheet 运行记录
rm supervisor 通知工段长⍓
2.Re-separate it 重新净乳
Ensure micro quality
确保微生物质量
k Sampling point 浓奶取样口
Per batch 每个批次
Operator 操作工
TPC 总菌数Lab technician 实验室技师LI-00.701-1
According to product SP
根据产品标准Lab record 实验室记录 1. Inform production manager
通知生产经理Coliform 大肠菌群
Lab technician 实验室技师LI-00.711-3
According to product SP
根据产品标准
Lab record 实验室记录⍓ 1.Perform detailed test 做详细实验⍓ 2.Source the origin 寻找来源
Evaporator 蒸发器Ensure no NO 2/NO 3确认 NO 2/NO 3阴性Evaporator 蒸发器After CIP CIP 后
Evaporator operator 蒸发器操作工
NO 2/NO 3 Operator 操作工Rapid test 快速实验Neg.阴性Log sheet 运行记录
1. Cleaning again 再清洗
2. Inform SCI 通知运行经理
Water 水
Operator 操作工
Visual 观察
Clean and clear 干净，澄清
-
Rinsing again 再冲洗
By 负责人:QA manager 质保经理
Production manager 生产经理Factory manager 工厂经理
Visa 批准:Date 日期:
2004-08-11
Where the check results recorded 检查结果的记录文件
China
SHUANGCHENG FACTORY
14
August 2004
Quality Monitoring Scheme (Quality Monitoring Scheme (QMS)
QMS)质量监控计划
Product 产品:All products 所有产品
Page 第1 页of 共1页
Section 区域:
Evaporation 蒸发
Sampling Sampling
取样Examination 检验
Item 项目
Purpose of Test 检验目的Where 位置
No.
Frequency 频率
By Whom 负责人
Analysis 分析By Whom 负责人Method 方法
Specification 标准
Recorded 记录
1) Action in Case of Deviation 如有偏差采取措施2) Remarks 备注
UP (UP (DSI)DSI)蒸汽喷射器Ensure micro quality of product 确保产品微生物
质量Control penal 控制盘C CP
Per hour 每小时Operator 操作工
UP temperature UP 温度Operator 操作工
Reading 读数
Refer to running
condition 根据运行条件Log book 运行记录
1. Refer to Handbook QA4.2-1-1
根据工厂手册QA4.2-1-1Ensure steam quality 确保蒸汽质量Steam infuser 蒸汽喷射器Daily 每天Operator 操作工Organoleptic 感官质量
Taste penal 品尝组Visual/smell/taste 观察/闻/尝Clear/no foreign odor and
taste
澄清/无不良滋气味Tasting record 品尝记录 1. Inform Eng. 通知工程2. Resample 重新取样Concentrated
milk 浓奶
Verify density
meter 确认密度计
k Sampling point 浓奶取样口Per shift 每班Operator 操作工TC%
Operator 操作工Microwave oven 微波炉
According to Microwave
result
根据微波炉结果Log sheet 运行记录Inform Engineer to calibrate 通知工程部校正To achieve max. TC before spray drying 喷雾干燥前达到最大
TC Control penal 控制盘
Per hour 每小时
Operator 操作工
TC%
Operator 操作工
Density meter 密度计
According to different
product 根据不同产品
Log sheet 运行记录
Adjust steam pressure 调整蒸汽压力Cleanness of concentrate milk 浓奶干净程度
k Sampling point 浓奶取样口
Start up/per 3hrs after 10hrs running 起车样/运行10小时后每3小时
Operator 操作工Dirt test 杂质度Operator 操作工
LI-08.043
According to instruction 根据操作说明规定Log sheet 运行记录
rm supervisor 通知工段长⍓
2.Re-separate it 重新净乳
Ensure micro quality
确保微生物质量
k Sampling point 浓奶取样口
Per batch 每个批次
Operator 操作工
TPC 总菌数
Lab technician 实验室技师LI-00.701-1
According to product SP
根据产品标准Lab record 实验室记录 1. Inform production manager
通知生产经理
Coliform 大肠菌群
Lab technician 实验室技师LI-00.711-3
According to product SP
根据产品标准
Lab record 实验室记录⍓ 1.Perform detailed test 做详细实验⍓ 2.Source the origin 寻找来源
Evaporator 蒸发器
Ensure no NO 2/NO 3确认 NO 2/NO 3阴性
Evaporator 蒸发器
After CIP CIP 后
Evaporator operator 蒸发器操作工
NO 2/NO 3 Operator 操作工Rapid test 快速实验Neg.阴性
Log sheet 运行记录
1. Cleaning again 再清洗
2. Inform SCI 通知运行经理
Water 水
Operator 操作工
Visual 观察
Clean and clear 干净，澄清
-Rinsing again 再冲洗
By 负责人:QA manager 质保经理Production manager 生产经理Factory manager 工厂经理
Visa 批准:
Date 日期:
2004-08-11
A corrective action must be taken as soon as exam result does not meet the specifications.如检查结果不符合标准，必须立即采取纠正行动
Action to be taken must be clear and specific 纠正行动要明确
Define necessity to block or reject output; need for re-evaluation?确定是否扣置或停车，是否重新评估
What are the actions to correct the problem?采取什么措施纠正？
Additional: Evaluate reason of deviation and instigate measures to prevent recurrence 另外：找出偏差原因避免重复发生
China
SHUANGCHENG FACTORY
15
August 2004
•Review and update at least once a year 最少每年回顾一次
–After review of HACCP study –HACCP 回顾之后
–New product / recipe 新产品，新配方–Changes in process conditions, methods, equipment, sampling
–加工条件，方法，设备，取样等发生改变–New legislation 新法律法规
Updating the QMS 文件更新。