CIP设计风险评估

3.1实施
在交付和实施工作期间，在通用生产解决方案设计中阶段的强制性关键活动“卫生风险评估”（HRA）应该是
执行。
工厂应根据欧盟立法或其他适用立法进行设计，例如PMO、FDA。在TP公司卫生设计标准欧盟和美国描述了标准。
HRA程序在公司标准HRA中有描述，但本文件没有研究工厂级工程。本说明书旨在作为指导/解释用于在工厂层面进行HRA。
有必要验证应用程序、解决方案和组件是否满足适用于工厂所在国的卫生规则。
本指南具有一般性，可适用于任何国家。
请注意，很多时候有必要使用当地能力来解释当地法规和标准。
应在项目中花费必要的努力来处理以下卫生风险在评估中找到。
最终确定的HRA表格应作为项目文件的一部分。
3.1 Implementation 
During the Deliver and implementation work, in General Production Solution Design 
phase the Mandatory Key Activity “Hygienic risk assessment” (HRA) should be 
performed. 
The plant shall be designed according to EU legislation or other applicable legislations, 
for example PMO, FDA. In TP Corporate Standards for Hygienic Design EU and US 
standards are described. 
The HRA procedure is described in Corporate Standard HRA but this document is not 
looking into Plant level engineering. This instruction is meant as a guideline/interpretation 
for doing HRA on plant level. 
It is necessary to verify that applications, solutions and components are fulfilling the 
hygienic rules that apply in the country where the plant should be built. 
This guideline is general and could be applied to any country. 
Note that many times it is necessary to use local competence on the interpretation of 
local regulations and standards. 
Necessary efforts should be spent in the project to take care of the hygienic risks that are 
found in the assessment. 
The finalized HRA form should be part of the documentation of the project.
3.2程序
应按照以下步骤进行HRA。
# 1.准备工作
阅读公司标准HRA，学习正确的表达方式等。
# 2.建立一个小组
建立一个小组进行HRA，参见标准B2153.05 ch 5。
# 3.安排会议
按照以下顺序安排会议进行评估。邀请正确的宪法每次会议的参与者人数。风险集中在卫生风险的左侧
评估表将形成会议记录。
参见示例

|会议|文 件|操作|
|--|--|--|
1|方框图|主要文件SoO工厂模型SoO生产层面的卫生风险为评估。功能模型是否支持计划的生产？
2|厂房布局 通用系统：•CIP•实用程序•通风•排水管等|在工厂布局层面上发现了哪些风险？
是否使用了正确的卫生区域。
通风是否敏感
地区。
CIP是否存在污染风险
系统等？
清洁蒸汽是否用于接触食物？
是否所有介质都可以在联系人中使用
有食物吗？

3 组件 
通用的验证 根据项目选择
列表
在的设计和使用中发现了哪些风险
每个组件？
是否使用了正确的材料，裂缝是否
是否可以清洁储罐？
模块
子供应商
我们的供应商是否履行了适当的
向我们工厂供应指令？
我们的首选供应商，如Alfa Laval Flow，
TP D&B、Endress和Hauser被认为
即使完成也要满足要求
证明这一点的文件仍然可能
缺失（将适用更严格的可追溯性规则
从2006-10-27）。
4流程解决方案拆分

PID水平

操作顺序

安装图纸

PID层面存在哪些风险？

媒体和

食品，安装组件有风险吗

有难以清理的死胡同等？

组件是否以适当的方式使用？

# 步骤4风险验证

卫生风险评估表中的所有风险将根据严重程度和

可能性

最好是在开始思考之前，同时针对所有风险采取这一行动

针对每种风险采取的行动。

# 步骤5风险措施

逐一分析风险，并决定需要纠正或采取哪些行动

至少可以将风险降至最低。

说明谁负责处理风险是很重要的。很多时候它是

当涉及到公用事业、原材料等的质量时，请联系客户。此信息是

与客户沟通非常重要。

# 步骤6剩余风险的处理
采取措施后，用新信息更新卫生风险评估表。
例如，在适用的情况下，将“危险”字段从“是”更改为“否”。
如果风险不能完全纠正，也可以讨论补充措施，因为示例添加维护说明。

3.2 Procedure 
The following steps should be followed to perform a HRA. 
Step 1 Preparations 
Read the Corporate Standard HRA to learn the correct expressions etc. 
Step 2 Establish a group 
Establish a group for performing the HRA, see standard B2153.05 ch 5. 
Step 3 Arrange meetings 
Arrange meetings to do the assessment in the below order. Invite the correct constitution 
of participants for each meeting. Risks are gathered in the left side of the Hygienic Risk 
Assessment form which will form the minutes of meeting. 
See example 
Meeting Documents Actions 
1 Block chart 
Main document SoO 
Plant model SoO 
Hygienic risks on production level are 
assessed. Is the functional model supporting 
the planned production? 
2 Plant layout 
General Systems: 
• CIP 
• Utility 
• Ventilation 
• Drains 
Etc 
What risks are found on plant layout level? 
Are the correct hygienic zones used. 
Is the ventilation separated between sensitive 
areas. 
Is there a risk for contamination via the CIP 
system, etc? 
Is clean steam used in contact with food? 
Are all media acceptable for using in contact 
with food? 
3 Components 
Validation of general 
choice according to Item 
list 
What risks are found in the design and use of 
each component? 
Are the correct materials used, are the crevices 
on tanks possible to clean? 
Modules 
Subsuppliers 
Are our suppliers fulfilling the appropriate 
directives in their supply to our plant? 
Our Preferred Suppliers like Alfa Laval Flow, 
TP D&B, Endress&Hauser are considered to 
fulfil the requirements even if complete 
documentation to prove this still could be 
missing (harder rules on tracability will apply 
from 2006-10-27). 
4 Process solutions split on 
PID level 
Sequence of operations 
Installation drawings 
What risks are found on PID level? 
Are there any risks for mixing of media and 
food, are there risk for mounting components 
with difficult to clean dead-ends, etc? 
Are the components used in appropriate way? 
Step 4 Validation of risks 
All risks in the Hygienic Risk Assessment form will be evaluated according severity and 
probability. 
Best is to do this action for all risks at the same time before starting thinking about 
actions on each risk. 
Step 5 Actions on risks 
Go through the risks one by one and decide what actions that are needed to correct or at 
least to minimize the risk. 
It is important to state who is responsible for handling the risk. Many times it is the 
customer when it comes to qualities of utilities, raw material etc. This information is 
important to communicate to the customer. 
Step 6 Handling of remaining risks 
Update the Hygienic Risk Assessment form with new information when actions are done. 
For example change in the “Hazard” field from “Yes” to “No” when applicable. 
Discuss also complimentary actions if the risks can not be corrected completely, for 
example add maintenance instructions.