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TESCO验厂TFMS标准评审内容--(1)危害分析和关键控制点(HACCP)


Section 1 第1 节
Hazard Analysis & Critical Control Points (HACCP) 危害分析和关键控制点(HACCP)
章节编号

级别

B基本
M中
H高
A期望)

Item
项目

Detail
评审细节

1.1
Base
基本
HACCP Plan
HACCP 计划

 

An effective, accurate HACCP Plan must be in place. The HACCP Plan must be developed using Codex Alimentarius HACCP principles with reference to relevant legislation, Tesco Codes of Practice and industry guidance.
一份有效、准确的HACCP 计划必须已经就绪。必须采用Codex Alimentarius HACCP 原则并参考相关法规、乐购指导规范及行业指南制定HACCP 计划。


The HACCP Plan must include a detailed scope referencing elements of sections 1.1-1.5, 1.10, 1.16, 1.17.
HACCP 计划必须包括参考1.1-1.5, 1.10, 1.16, 1.17 节内容的详细范围。

 

1.2
Base
基本

HACCP Team

 

The HACCP system must be developed by a multi-disciplinary team which must have product specific knowledge and expertise. If internal expertise is not available, expert advice may be obtained from other sources. The operation of the HACCP system must remain the responsibility of the site.
应由跨部门团队建立HACCP 体系,此团队必须具备具体产品的相关知识和专门技能。如果不能获得内部的专业知识,可从其他来源获取专家建议。HACCP 体系的运行必须是工厂的职责。


At least one member of the team must have completed a recognised qualification (minimum Intermediate HACCP or equivalent) and the other members must be suitably trained. Intermediate level training would consist of a 2 day training course with a mandatory examination at the end. A programme of refresher training to ensure up to date knowledge, must be considered.
团队中至少有一名成员已经完成了公认的资格认定(最低为中级HACCP 或相当水平) ,其他成员也必须接受过适当的培训。中级水平培训包括2 天的培训课程及课程结束时必须参加的考试。必须考虑实施更新培训计划,确保知识的更新。

 

1.2.1
ASPN
HACCP Team
HACCP 小组

At least one member of the team has completed a recognised qualification in Advanced HACCP.
至少一个小组成员完成认可的高级HACCP 资质。

1.2.2
ASPN
HACCP Team
HACCP 小组

Refresher training of the HACCP team is undertaken annually,
regardless of any change in production processes.
无论加工流程有什么改变,至少一年一次对HACCP 小组进行更
新培训。
1.3
Base
Pre-requisite
Programmes
前提方案

All environmental and operational controls that are necessary to produce of safe and legal food products must be in place. These cover good manufacturing practices throughout the site. They may include (not an exhaustive list) e.g.:
必须具备生产安全合法食品必需的所有环境和操作控制措施。这些措施包括整个工厂内的良好生产规范,可包括(但不限于),这些措施包括整个工厂内的良好生产规范,可包括(但不限于),如:
• Personal Hygiene 个人卫生
• Staff Training 员工培训
• Pest Control 虫害控制
• Cleaning procedures 清洁程序
• Glass/hard plastic control 玻璃/硬塑料控制
• Waste control 废弃物控制
• Maintenance Procedures 维护程序


The control measures and monitoring procedures for the pre-requisite programme must be clearly identified and documented.
前提方案的控制措施和监控程序需清楚地识别并文件化。

1.4
Base
Product
产品

A full description of the product must be documented including relevant safety information e.g.:
需提供一份文件化的全面的产品描述,包括相关安全性信息,如:
• Composition 成分
• Origin of ingredients配料来源
• Physical or chemical structure (e.g. water activity, pH etc.)物理或化学结构特性(如,水份活度,pH 等)
• Treatment and processing (e.g. heating, freezing, salting)处理和加工(如加热,冷冻,腌制)
• Packaging (e.g. modified atmosphere, vacuum)包装(如气调包装,真空包装)
• Storage and distribution conditions (e.g. with specified temperatures)仓储和配送条件(如在特定温度下)
• Durability and required shelf-life稳定性和要求的保质期
• Instructions for use 使用指导
1.5
Base
Intended Use
预期用途

The intended use of the product must be defined, detailing the end user or consumer and suitability for vulnerable groups must be considered e.g. infants, elderly and allergy sufferers.
必须确定产品的预期用途,详细说明最终用户或消费者,必须考虑产品对弱势群体(如婴幼儿,老年人和过敏者)的适宜性。
1.6
Base
Flow Diagram
流程图

A flow diagram covering all steps in the operation including rework,water where used and waste must be constructed. This may be generic but it is critical that all process steps are included and identified by product.
绘制一份流程图,此图应涵盖操作中的所有步骤,包括返工,用水步骤和废弃物排放点。可为通用的图,但关键是应包括所有过程步骤,并根据产品加以识别。


The diagram must be verified within the production area. 此图必须在生产区域内得到验证。

1.7
Base
Hazards
危害

All potential hazards that may be reasonably expected to occur for each process step and product must be identified.
在各过程步骤和产品中,合理预期可能发生的所有潜在危害必须识别出来。


Hazards identified must be specific to the process step, generic descriptions such as ‘foreign body’ and ‘micro-organisms’ are not sufficient.
识别的危害必须在此过程步骤进行详细的描述,笼统的描述(如“外来异物”和“微生物”)是不充分的。

1.8
Base
Hazard Analysis
危害分析

The HACCP team must conduct a hazard analysis to identify hazards which need to be prevented, eliminated or reduced to acceptable levels.
HACCP 小组必须进行危害分析,以识别需要预防、消除或降低到可接受水平的危害。


The hazard analysis must include:危害分析必须包括:
• Likely occurrence and severity 发生的可能性和严重程度
• Survival or multiplication of micro-organisms 微生物的存活或繁殖
• Presence or production of toxins, chemicals or foreign bodies and allergens 是否存在或产生毒素、化学物质或外来异物和过敏物质
• Potential for adulteration/deliberate contamination 掺杂/有意污染的可能性

1.9
Base
Control
Measures
控制措施

The HACCP team must assess whether an existing pre-requisite adequately controls the hazard identified.
HACCP 小组必须评估既有的前提方案是否可充分控制已识别的危害。


The HACCP team must also consider what control measures (if any exist) for the remaining hazards can be applied to prevent, eliminate or reduce the risk to acceptable levels.
随后,此 HACCP 小组必须考虑,对于其余危害,目前有哪些(如果有)控制措施可用于运用,以防止、消除风险或将风险降低到可接受水平。


If no control measures have been identified the product /process must be modified so a control measure can be applied
如果没有确定的控制措施,必须修改产品/过程,以便能够采取控制措施。

1.9.1
Base
Control
Measures
控制措施

The documentation must show links to a specific pre-requisite, rather than generic comment i.e. ‘Pre-requisite’.
文件中必须引用具体的前提方案,而不是笼统描述为“前提方案”。
1.10
Base
Determination
of CCPs
CCPs 的确定

The Codex decision tree or equivalent must be used to determine if control measures are CCPs (Critical Control Points).
必须采用食品法典判断树或等同方法,以确定控制措施是否为CCPs(关键控制点)。
1.11
Base
Critical Lim its
关键限值

Critical limits must be defined and validated to ensure that the product is safe. The process must be capable of operating consistently within
the defined limits.
必须定义关键限值,并确认以确保产品是安全的。加工过程必须能够在规定限值内持续地运行。


Critical limits must be measurable and justification for their use must be documented.
关键限值必须可测量,应用关键限值的理由应形成文件。

1.12
Base
Monitoring
监控

 

Monitoring procedures must be established for each CCP to ensure compliance with the critical limits.
必须针对每个CCP 建立监控程序,确保关键限值的符合性。


The monitoring system must be able to demonstrate control and detect loss of control of CCPs.
监控系统必须能够证明CCP 处于受控,并能发现CCPs 的失控。


The precision limits and tolerances of the monitoring equipment must be considered when defining limits e.g. tolerance of temperature probes.
定义限值时,必须考虑监控设备的精密度限值和公差,如温度传感器的公差。


Monitoring procedures must contain details on how the measurements are taken and the frequency.
监控程序必须包括如何进行检测以及检测频率的具体内容。

 

1.13
Base
Monitoring
Records
监控记录

 

Monitoring records must be signed by the person doing the check and then verified by an authorised person.
监控记录必须由实施检查的人员签名,随后由获得授权的人员验证。

 

1.14
Base
Corrective
Actions
纠正措施

 

The corrective actions to be taken when a CCP deviates from critical limits must be detailed and documented by the HACCP team.
必须具体说明CCP 偏离关键限值时采取的纠正性措施,并由HACCP 小组在文件中详细描述。


The corrective actions must ensure that the CCP has been brought under control and any material that may have been produced whilst the CCP was not in control must be identified, isolated and a full risk assessment completed.
纠正措施必须确保CCP 回到受控状态,对CCP 未受控期间可能产生的任何产品/物料必须进行识别和隔离,并对其进行全面风险评估。


Product and or materials must be disposed of if the safety of the product is in doubt.
如果对产品的安全性不确定,必须对产品或物料进行处理。


If the risk assessment deems the product to be safe, it must not be supplied to Tesco without first discussing the issue and submitting documented evidence to support product safety with the relevant Tesco TM. (see also 11.3)
如果风险评估认为产品是安全的,在没有首先与相关Tesco 的技术经理讨论该事项并提交文件性的证明时,产品不得提供给Tesco。(也可参见11.3)

 

1.14.1
Base
Corrective
Actions
纠正措施

 

The HACCP must be reviewed at the earliest opportunity following accepted deviation from the defined critical limits. (see also 1.18)
当定的关键限值出现可以接受的偏离时,应第一时间对HACCP进行评审。(也可参见1.18)

 

1.15
Base
Training
培训

 

Personnel in the factory who monitor CCPs must have an understanding of HACCP and have specific training against the latest version of the relevant monitoring procedure.
工厂内监控CCP 的人员必须了解HACCP,并接受专门的针对相关监控程序的最新版本的培训。

 

1.15.1
ASPN
Training
培训

 

All production personnel should have a basic understanding of HACCP and how it relates to the area they work in.
所有生产人员都应对HACCP 以及HACCP 与其工作区域之间的联系有基本的了解。

 

1.16
Base
Verification
验证

 

The operation of the HACCP plan must be verified to confirm that it is effective.
必须对HACCP 计划的运行进行验证,以确定其是有效的。
This may include:验证可包括:
• Internal audits内部审核
• Review of customer complaints对客户投诉的评审
• Review of hazard measurements e.g. microbiological results.对危害检测结果的评审,如微生物学检测结果

 

1.17
ASPN
Verification
验证

 

The HACCP plan is verified by a 3rd party with specialist knowledge of food microbiology, food chemistry and food processing
technologies if applicable e.g. thermal processing.
如适用,HACCP 计划由具备食品微生物学、食品化学和食品加工技术专业知识的第三方验证,例如热加工。

 

1.18
Base
Review
评审

 

The HACCP plan must be reviewed at a pre-determined frequency (minimum annually) or prior to changes of product/process which may affect product safety.
HACCP 计划必须按照预先规定的频率(最少每年一次)进行评审,或在发生可能影响产品安全性的产品/过程改变前进行评审,包括以下方面的改变:


This may include changes in (not an exhaustive list):
这包括以下方面的变化(不是一个详细的清单):
• Process steps 过程步骤
• Supply or specification of raw materials 原料的供应或规格
• Ingredients/recipe 配料/配方
• Packaging, storage or distribution etc. 包装,仓储或配送
• Introduction of new or modification to existing equipment 新设备的引进或者现有设备的变更
• Change in factory layout or product flow 工厂布局或者产品物流的变化

 




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