全球食品安全倡议GFSI认证审核要求评估指南

全球食品安全倡议GFSI认证审核要求评估指南

Items
条款

B.A 1
Requirements
要求

Specifications including product release

指南

WHAT DOES IT MEAN?
Guidance
A. Food Safety Management Systems
食品安全管理体系

产品规范（包括产品放行）

The business shall ensure that product
什么意思？
specifications are adequate, accurate and
a
）

所有产品配料的规范要合适，以确保对相关
a) Specifications on all product ingredients should be appropriate to ensure compliance
ensure compliance with relevant safety,
安全、法律和顾客要求的遵守。
with relevant safety, legislative and customer requirements.
legislative and customer requirements.
b
）

产品规范要由指定的专人管理和控制，内容
b) Specifications will be managed and controlled by a designated person and should be
The business shall prepare and implement
最新、清晰，并且传达给企业内部的员工和外部
up-to-date, clear, communicated within the business and with customers to ensure
appropriate product release procedures.
的顾客，以保证透明度。
transparency.
企业应确保产品规范充分、准确并遵守
c
）

要有清晰的文件化产品放行程序，传达并实
c) A clear procedure for product release should be documented, communicated and
implemented to ensure released product meets the agreed specifications.
相关的安全、法律和顾客的要求。企业施以确保放行的产品满足达成一致的产品规范。

应准备并实施合适的产品放行程序。



WHAT DO I NEED TO DO?
B.A 1.1
Are specifications available for all product
我需要做什么？
a
）

你需要确保有专人负责产品规范的控制，产
a) You need to ensure there is an accountable person who is responsible for the control of
inputs (raw materials, ingredients,
additives, packaging materials, rework)
and finished products?
品规范要最新、合适并传达给相关人员。该人员
specifications, which should be up-to-date, appropriate and communicated to relevant
也要管理所有的变动。
people. This person will also manage all changes.
b
）

所有配料的产品规范应满足相关的安全、法
b) The specifications for all ingredients should meet relevant safety, legislative and
customer requirements and be agreed with each supplier.
律和顾客要求，并得到所有供应商的同意。
产品规范是否适用于所有的产品
投入品（ 原料、配料、添加剂、
包材、返工产品）和成品？

B.A 1.2
c
）

需要建立成品规范以便文件化的产品放行程
c) Finished product specifications should be available so that the documented product
Are the available specifications compliant
序能确保产品正确放行，或者当产品不合规范时
release procedure ensures the product is either properly released or held back due to
being out-of-specification.
而被阻止。
with relevant safety, legislative and
customer requirements?

WHAT WILL THE ASSESSOR DO?
The Assessor will:
- Discuss the control of specifications with the accountable person.
第 1 页 共 65 页
产品规范是否遵守相关的安全、
评估员将做什么？
评估员将：
法律和顾客的要求？

B.A 1.3
Are specifications up to date,
unambiguous and available to relevant
staff?
- Check that specifications for all ingredients and finished products are appropriate, clear
-
与负责的专人讨论产品规范的控制。
清晰并确
and ensure conformance with relevant safety, legislation and customer requirements.
-
检查所有配料和成品的规范是否合适、
保符合相关的安全、法律和顾客的要求。
- Check that the specifications are up-to- date and clearly communicated to relevant
并清晰传达给与食品安
people with responsibility for food safety and quality.
-
检查产品规范是否最新，
产品规范是否是最新的、清晰的，
- Discuss the product release procedure with relevant people to ensure that their actions
全和质量相关的人员。
并提供给相关人员？

B.A 1.4
Are changes to specifications clearly
communicated both internally and
externally?
-
与相关人员讨论产品放行的程序以确保无论成
establish effectively whether a finished product is either acceptable or out-of-specification.
品能被接受还是不合规范，他们的措施都有效
果。

什么意思？
a
）

所有产品配料的规范要合适，以确保对相关安全、法律和顾客要求的遵守。
b
）

产品规范要由指定的专人管理和控制，内容最新、清晰，并且传达给企 业内部的
员工和外部的顾客，以保证透明度。
c
）

要有清晰的文件化产品放行程序，传达并实施以确保放行的产品满足达成一致的
产品规范。
我需要做什么？
a
）

你需要确保有专人负责产品规范的控制，产 品规范要最新、合适并传达给相关人
员。该人员也要管理所有的变动。
b
）

所有配料的产品规范应满足相关的安全、法律和顾客要求，并得到所有供应商的
同意。
c
）

需要建立成品规范以便文件化的产品放行程序能确保产品正确放行，或 者当产品
不合规范时而被阻止。

评估员将做什么？
评估员将：
-
与负责的专人讨论产品规范的控制。
清晰并确保符合相关的安全、法律和顾客的要
-
检查所有配料和成品的规范是否合适、
求。
-
检查产品规范是否最新，并清晰传达给与食品安全和质量相关的人员。
他们的措施
-
与相关人员讨论产品放行的程序以确保无论成品能被接受还是不合规范，
都有效果。

B.A 2
Traceability
可追溯性


产品规范的修改是否明确传达给
内部和外部的相关方？

B.A 1.5
Is there a documented product release
procedure in place?
Does it effectively ensure that the final
product meets the specification?
是否制定了书面的产品放行程
序？该程序是否有效确保成品满
足产品规范？

B.A 1.6
Is there a designated person with
responsibility for controlling
specifications?
是否有指定的人员负责产品规范
的控制？


第 2 页 共 65 页

The business shall establish a traceability
什么意思？
product lots and their relation to batches
产任何产品所用原料的来源和采购人员。
of raw materials, primary and final
packaging materials, processing and
? Identification of any out sourced
product, ingredient or service.
WHAT DOES IT MEAN?
the raw materials used to produce each of their products.
system which enables the identification of
a
）

食品制造商必须能够向主管部门证实用于生
a) Food manufacturers are obliged to prove to the authorities the source and buyers of
b
）

任何与产品有直接接触的包材的来源与去向
b) The source and destination of any packaging materials that come into direct contact
with the product shall also be proven.
也要证实。

WHAT DO I NEED TO DO?
我需要做什么？
distribution records. Records shall include:

a
）

所有地点要有文件化的程序来保持贯穿产品
a) All locations should have documented procedures to maintain traceability throughout
? Records of batches of in process or final
转化所有阶段
all phases of product conversion from receiving incoming materials through production,
（从验收来料到生产、包装和分派）
product and packaging throughout the
production process.
? Records of purchaser and delivery
destination for all products supplied.
的可追溯性。这包括了保存订单、返工等。
packaging and dispatch. This includes hold orders, rework etc.
b
）

批次的标识（包括那些部分完成的），应当
b) Labelling of lots, including those that are partially finished, should be made during
在实际的包装时进行以确保清晰的可追溯性。
actual packing to ensure clear traceability.
c
）

如果货物在随后标识，要有针对临时批次的
c) Where goods are also labelled later, there should be specific lot labelling for temporary
batches.
企业应建立可追溯系统，以便能确认产具体标识。
品批号及其与原料、初级和消费者单元
d
）

批次大小取决于发生隔离或者召回时你承担
d) The batch sizes that are selected depends on your readiness to assume risk in the case
of quarantine or a recall.
包材批次、加工与分销记录的关系。 风险的意愿。
受控的文件作为证据，
e) Legal and customer requirements can be satisfied if you are able to provide credible,
企业应确保可追溯系统至少每年测试一
e
）

如果你能提供可信的、
controlled documents as evidence.
次并且在必要时更新。 就可以满足法律和顾客的要求。
记录应包括：
?
可追溯系统每年测试的记录。
?
适用时系统更新的记录。

B.A 2.1
Is a documented traceability system in
place for every product that meets
f
）

在产品召回时，你有义务快速通知有关主管
f) In the event of a product recall you have a duty to inform the authorities and provide
complete documentation quickly.
部门并提供完整的文件。

评估员将做什么？
评估员将：
WHAT WILL THE ASSESSOR DO?
The Assessor will:
- Inspect your traceability system expecting to see effective and documented procedures
from receipt to dispatch.
regulatory and customer requirements?
-

检查你的可追溯系统并期望看到有效的文件化

- Review whether the effectiveness of the system can be proven using documented test
是否为每个满足法规和顾客要求的产品
程序（从收货到发货）。
B.A 2.2
-
文件化的测试演练可以作为审查追溯系统的有
runs.
- Use current or retained samples to establish whether all responsible persons are
Is the traceability system, including work
效性的证据。
in progress, post-treatment and rework,
-
使用当前的或者保留的样品来确定所有负责人
delivering traceability procedures.
建立书面的可追溯系统？

fully operational and effective?

员是否能讲出可追溯程序。
- Look for evidence that there is complete labelling of all batches, partial batches, raw
第 3 页 共 65 页

部分批次和原料等有完
materials, etc.
可追溯系统（包括加工、后 处理和返工）
-
寻找能表明所有的批次、
是否充分运行且有效？

B.A 2.3
Are records enabling product
identification available through all
production stages: stock inventory, work
in progress, post processing, rework.
Are records available from purchase
through production and to immediate
destination for all raw materials and
packaging materials (primary and final
product)?
所有生产阶段（库存、加工、后处理、
返工）是否都有能够用来识别产品的记
录。 < br>从采购经生产到直接目的地，是否有所
有原料和包材（初级产品和成品）的记
录？

B.A 2.4
Are there clear labelling procedures that
ensure continuous identification of the
product through all stages of production
and delivery?
整标识的证据。

什么意思？
a
）

食品制造商必须能够向主管部门证实用于生产任何产品所用原料的来源和采购人
员。
b
）

任何与产品有直接接触的包材的来源与去向也要证实。

我需要做什么？
a
）

所有地点要有文件化的程序来保持贯穿产品 转化所有阶段（从验收来料到生产、
包装和分派）的可追溯性。这包括了保存订单、返工等。
b
）

批次的标识（包括那些部分完成的），应当在实际的包装时进行以确保清晰的可
追溯性。
c
）

如果货物在随后标识，要有针对临时批次的具体标识。
d
）

批次大小取决于发生隔离或者召回时你承担风险的意愿。
e
）

如果你能提供可信的、受控的文件作为证据，就可以满足法律和顾客的要求。
f
）

在产品召回时，你有义务快速通知有关主管部门并提供完整的文件。

评估员将做什么？
评估员将：
-
检查你的可追溯系统并期望看到有效的文件化程序（从收货到发货）。
-
文件化的测试演练可以作为审查追溯系统的有效性的证据。
-
使用当前的或者保留的样品来确定所有负责人员是否能讲出可追溯程序。
-
寻找能表明所有的批次、部分批次和原料等有完整标识的证据。

I.A 2
是否有清晰的标识程序以确保整
个生产阶段和交付中产品的持续
识别？

Traceability
可追溯性


第 4 页 共 65 页

The business shall establish a traceability
什么意思？
programme which enables the
identification of product lots and their
relation to batches of raw materials,
primary and consumer unit packaging
materials, processing and distribution
records.
WHAT DOES IT MEAN?
a
）

目标是测试可追溯方案，并识别可能限制召
a) The goal is to test the traceability programme and identify elements which might limit
the effectiveness or efficiency of a recall.
回有效性或者效率的因素。
b
）

作为功能性的可追溯方案的一部分，有效的
b) Effective lot identification as a part of a functional traceability programme provides a
批次识别为控制和减少食品安全风险和撤回与
cornerstone in controlling and minimising both food safety risks and the financial impact of
召回时的财务影响提供了基石。

product withdrawals and recalls.

WHAT DO I NEED TO DO? The business shall ensure the traceability
我需要做什么？
programme is tested at least annually and
a
）

要求至少每年做一次模拟召回来确保可追溯
a) At least annually, simulated recalls are required to ensure that the traceability
updated as necessary. programme works and testing should include:
方案起作用，测试应包括：
Records shall include
? Records of annual testing of the
traceability system.
? Records of updating the system as
applicable.
? Identification of item traced (i.e. ingredient or finished product).
-
对追踪的品项的确认（配料或者成品）。
完成的时间和追踪产
? Time for completion and percentage of product traced, according to both regulatory or
-
根据法规或者顾客的要求，
品的百分比。
-
主要的体会、差距分析、系统改进的机会。
-
收货和发货的一致性和不符。
customer requirements.
? Key learnings, gaps, system improvement opportunities.
? Receipt and dispatch discrepancy and reconciliation.
企业应建立可追溯系统，以便 能确认产
b
）所有员工要按照确认的和实施的程序与改进
b) All staff are to be trained in the procedures and improvements that are identified and
implemented.
品批号及其与原料、初级和消费者单元接受培训。
包材批次、加工与分销记录的关系。
c
）应总结和报告结果以提供系统验证的证据。
c) The results should be summarised and reported to provide evidence of system
verification.
企业应确保可追溯系统至少每年测试一
d
）记录主要的发现、不足和改进机会。
次并且在必要时更新。
记录应包括：
?
可追溯系统每年测试的记录。
?
适用时系统更新的记录。


评估员将做什么？
评估员将
-
通过评估过程检查完整的可追溯方案。
d) The expectation is that key findings, gaps and improvement opportunities are
addressed.

WHAT WILL THE ASSESSOR DO?

第 5 页 共 65 页

I.A 2.5
Is the traceability system tested at least
annually?
Is the system updated as necessary and
records maintained?
-
期望通过文件能展示一个经过系统性测试的可
The Assessor will:
- Inspect your full traceability programme throughout the assessment process.
追溯过程。
-
审查是否可以通过文件化的测试来证实可追溯
- Expect that the documents will show a traceable process that is tested systematically.
- Review whether the effectiveness can be proven using documented test runs.
系统的有效性。
可追溯系统 是否至少每年测试（演练）
-
使用当前的或者保留的样品来确定所有负责人
- Use either current or retained samples to establish whether responsible people are
delivering traceability procedures.
一次？ 员是否能阐述可追溯程序。

该系统是否在必要时更新并保留记录？

什么意思？
a
）

目标是测试可追溯方案，并识别可能限制召回有效性或者效率的因素。
b
）

作为功能性的可追溯方案的一部分，有效的批次识别为控制和减少食品安全风险
和撤回与召回时 的财务影响提供了基石。

我需要做什么？
a
）

要求至少每年做一次模拟召回来确保可追溯方案起作用，测试应包括：
-
对追踪的品项的确认（配料或者成品）。
-
根据法规或者顾客的要求，完成的时间和追踪产品的百分比。
-
主要的体会、差距分析、系统改进的机会。
-
收货和发货的一致性和不符。
b
）所有员工要按照确认的和实施的程序与改进接受培训。
c
）应总结和报告结果以提供系统验证的证据。
d
）记录主要的发现、不足和改进机会。
评估员将做什么？
评估员将
-
通过评估过程检查完整的可追溯方案。
-
期望通过文件能展示一个经过系统性测试的可追溯过程。
-
审查是否可以通过文件化的测试来证实可追溯系统的有效性。
-
使用当前的或者保留的样品来确定所有负责人员是否能阐述可追溯程序。

B.A 3
Food Safety Incident Management
食品

安全事件管理


第 6 页 共 65 页

The business shall demonstrate the ability
什么意思？
WHAT DOES IT MEAN?
to withdraw and recall affected product,
a
）

事件是指已经发生并导致了不安全、不合法
a) An incident is an event that has occurred which results in the production or supply of
contact relevant customers and maintain
或者不合格的产品的生产或者供应的情况。
unsafe, illegal or non-conforming product.
b
）

应定义、实施和保持对事件管理和影响食品
b) A procedure should be defined, implemented and maintained for the management of
incidents and of resulting emergency situations that impact food safety, legality and
企业应证明其撤回和召回受影响产品、安全、合法性和质量的紧急情况的程序。
records of these incidents.
联系相关顾客以及保留事件记录的能
力。

B.A 3.1
Can the business withdraw and recall
affected product?
企业能否撤回和召回受影响的产品？

B.A 3.2
Are records of incidents maintained?
是否保留了事件记录？

c
）

这至少包括：危机处理小组的提名和培训、
quality.
包括供应商和顾客在内的紧急联系人清单、法律
c) This includes as a minimum: The nomination and training of a crisis team, an alert
咨询的来源、内部联系人的可联系性以及沟通计
contact list including suppliers and customers, sources of legal advice, the availability of
划（包括告知顾客的信息）。
internal contacts and a communication plan that includes information to consumers.
WHAT DO I NEED TO DO?

我需要做什么？
a
）

撤回程序实施的可行性、有效性和及时性应
a) The feasibility, effectiveness and timeliness of implementation of the withdrawal
当根据危害分析和相关风险进行定期的内部测
试，至少每年执行一次。
procedure should be subject to regular internal testing, based on hazard analysis and
assessment of associated risks but carried out at least once a year.
b
）

测试的方式要能确保程序的有效实施和运
b) This should be carried out in a manner to ensure the effective implementation and
operation of the procedure.
作。
c
）

企业有权启动事件管理过程的人员应始终联
c) A person of the business, with the authority to initiate the incident management
process, should be permanently available.
系得上。
d
）

记录能够获取：
-
涉及的产品、大小、制造地点。
d) Records to be available:
? Product involved, sizes, manufacturing location.
? Quantity of product affected.
-
受影响产品的数量。
-
受影响产品的详细信息：编码、批次、托盘。
? Details of product affected - codes, lots, pallets, batches.
-
生产和质量控制记录。
-
分销的数量和地点。
? Production and quality control records.
? Quantity distributed and location.
e
）能够获得更新的紧急联系人信息（比如供应
e) Updated emergency contact details (such as names and phone numbers of suppliers,
customers and competent authorities) should be available.
商、顾客和主管部门的姓名和电话号码）。

评估员将做什么？
评估员将
WHAT WILL THE ASSESSOR DO?
The Assessor will:
- Inspect the relevant process throughout the entire assessment.
-
在整个评估过程中检查相关的过程。
你能够提供满足所有要
- Expect when reviewing the documents that you are able to show a documented
-
期望在评审文件的时候，

第 7 页 共 65 页

求的文件化程序。
procedure that fulfils all requirements.
-
使用当前的或者保留的样品来确认相关负责人
- Use current or retained samples to identify whether responsible people are engaged
with these procedures.
员是否了解这些程序。
-
通过使用文件化的测试演练来检查程序的有效
- Review whether effectiveness of the procedure can be proven using documented test
runs.
性。

I.A 3

Food Safety Incident Management
食品

WHAT DOES IT MEAN?
安全事件管理

The business shall have an effective
incident management procedure for all
products including reporting,
什么意思？
任何情况都
a) An incident is defined as any situation, which, if not properly managed, has the
a)
事件的定义是如果没有正确管理，
potential to develop into a crisis.
有可能发展成危机。
（比如食品污染、非
b) If a crisis or a incident occurs (e.g. food product contamination, illegal ingredients or communicating with customers, product
b)
如果发生了危机或者事件
withdrawal and recall. negative reporting in the press), it is important that you are able to do the following:
法的配料或者媒体的负面报道），你要能够做到：
Records of annual review, testing and
verification of the system shall be
available.
? To survey the situation in your business as fast as possible.
-
尽快调查贵司的情况。
（内部和外
? To reach all persons (internal and external) who are able to help solve the problem.
-
联系到所有能够帮助解决问题的人员
部）。
? To communicate effectively, including making sure that only named representatives
包括了明确只有指定的人员代表企业
speak for the business (note: serious incidents attract the press in no time. Any of your
对于所有产品，企业应有有效的事件管
-
有效 沟通，
理程序包括报告、与客户沟通、产品撤讲话（注意：严重的事件要立刻邀请媒体。任何
p eople may be approached for comment). Frequent, clear and accurate communication
回和召回。
练）和验证记录？

I.A 3.3
Is a documented incident management
system in place that addresses incident
reporting, product withdrawal and
product recall?
员工可以提建议）。高频率、清晰和准确的沟通
can pre-empt or reduce the scale or complexity of a crisis.

WHAT DO I NEED TO DO?
a) There are two stages in defining a threat: first in terms of its severity and imminence,
second in terms of its topic. No matter how insignificant an event seems, it could
性。

我需要做什么？
是否保留了该 系统的每年审查，测试（演常常能占得先机或者降低危机的程度或者复杂
a
）定义威胁有两个阶 段：第一个是本身的严重
develop into a major, business- threatening crisis if it is ignored. It is important that every
性和危急，第二个是它的传播。不管一个事件看
incident is treated as a full-blown crisis until you can be certain that it is not.
是否建立了处理事件报告、产品撤回和
上去如何微不足道，如果被忽视，它都可能发展
b) To develop, implement and maintain a crisis management procedure to include the
成为一个重大的威胁企业的危机。将每个事件当
following:
召回的书面的事件管理体系？


第 8 页 共 65 页

I.A 3.4
Is an effective communication plan in
place with a designated, responsible
作一个十足的危机来对待直到确认不是危机，这
○ Detail about the steps to be taken to manage a crisis.
点非常重要！
○ The nomination and training of a crisis team, an alert contact list, sources of legal
person identified to provide information
b
）

为了建立、实施和保持危机管理程序，应包
advice (if necessary), contacts availability, customer information and a communication
to customers, consumers and regulatory
括：
plan, including information to your people, customers and consumers.
authorities?
○危机管理所采取的步骤的详细内容。
c) Communications is not a tactical option, it’s a strategic necessity and a core
responsibility of the Crisis Team. Controlling and targeting of information to internal
是否建立了有效的沟通计划，并指定专○危机处理 小组的提名和培训、紧急联系人清
信息？

I.A 3.5
Is the incident management system
人负责向顾客、消费者和监管部门提供单、 法律咨询的来源（如果有必要）、联系人的
audiences can make or break a crisis. Colleagues need to be informed and external
可联系性、顾客信息和沟通计划（包括告知你的
stakeholders need to be notified and reassured.
员工、顾客和消费者）。
d) The incident management system should be tested at least annually. It is important
reviewed, tested and verified at least once
c
）沟通不是企业的战术选项，而是战略必要，
that these processes are reviewed, practiced and mastered with a broad base of
也是危机处理小组核心职责。控制和限制内部人
employees.
a year?
事件管理体系是否至少每年评审、测试
员的信息沟通以导致或者恶化一个危机。同事需

WHAT WILL THE ASSESSOR DO?

并验证一次？

要及时告知，并通知外部利益相关方使其放心。

I.A 3.6
Are all incidents recorded and assessed to
d
）事件管理体系至少每年测试一次。让广大的
The Assessor will:
- Check for a procedure that describes the approach to such situations
establish their severity and consumer risk?
雇员们评审、实践和掌握这些程序是非常重要

是否记录和评估了所有的事件并确定其
的。

严重程度和消费者风险？

评估员将做什么？
评估员将
- Review the emergency contact list of all relevant persons. Check it is up to date and
available to all that need it.
- Interview people to establish that they are aware of their responsibility, at least in part
(e.g. when serious process failures occur, instant information to superiors, receipt of
serious complaints, and instant information to the crisis team).
-
检查描述各种危机情况处理方法的程序。
检查其是
-< br>评审所有相关人员的紧急联系人清单。
否是最新的，且包括所有需要的人。
至
-
通过与员工的询问确认他们了解自己的职责，
少是一部分（比如当遇到严重工艺错误时，立即
通知上级；收到重大投诉时，立即通知危机处理
小组）。

B.A 4
Control of non-conforming product
不

合格品控制


第 9 页 共 65 页

The business shall ensure that any product
什么意思？
WHAT DOES IT MEAN?
which does not conform to requirements
a
）要求有标准的操作程序以确保没有达到标准
a) Standard operating procedures are required to ensure that substandard material or
is clearly identified and controlled to
的材料或者成品被标识和控制，这样不会污染其
finished product is labelled and controlled so that it does not contaminate other products
prevent unintended use or delivery.
它产品或者被放行用于销售或消费。

or get released for sale or consumption.

WHAT DO I NEED TO DO?
企业应当确保任何不符合要求的产品被

明确识别并控制以防非故意的使用或者我需要做什么？
交付。

B.A 4.1
Is a documented procedure in place to
identify and manage all non-conforming
raw materials, product inputs,
semi-finished and finished products,
processing equipment and packaging
materials?
a
）

建立文件化的不合格材料或者成品的管理程
a) Establish and document procedures for the management of non- conforming materials
or finished product.
序。
b
）

确保相关人员理解程序，确保有针对问题做
b) Ensure that relevant people understand the procedure and that there are defined
出决定（对不合格产品是继续使用还是废弃处
responsibilities for making decisions about the use or disposal of non- conforming product,
置）的明确职责。
as appropriate to the issue.
c
）

这些程序包括报告、标识、隔离、废弃处置
c) These procedures would include reporting, labelling, isolation, disposal and corrective
actions.
以及整改措施。

WHAT WILL THE ASSESSOR DO?
是否建立书面的程序以识别和管理所有

不合格的原料、产品投入品、半成品和
评估员将做什么？
B.A 4.2
The Assessor will:

成品、加工设备和包材？

评估员将

并在适用
- Review documents and compare records to establish that procedures exist and are
Is the control of non-conforming product
-
评审文件并比较记录以确定程序存在，
managed by competent people?
时遵守。
followed when appropriate.
暂停使用隔离、还是
- Look for evidence that non-conforming product is effectively identified and segregated
是否由具有能力的人员管理不合格品的
-
寻找不合格品被有效识别、
pending decisions on use or disposal.
废弃处置的证据

控制？

B.A 5

Corrective Action
整改措施

WHAT DOES IT MEAN? The business shall ensure that corrective
什么意思？
action be undertaken as soon as possible
a
）当有关于不合格材料、成品或者程序的问题
a) When an issue occurs regarding non-conforming materials, finished products or
to prevent further occurrence of
发生时，遵循相应的步骤以了解不符合的根本原
procedures, a process is followed to understand the root cause of the non-conformity and
non-conformity.
符合的再次发生。

actions are taken to correct the problem so that there are no further occurrences.
因，并采取措施整改问题，避免问题再一次发生。

WHAT DO I NEED TO DO?
我需要做什么？
企业应确保整改措施尽快实施，以防不

第 10 页 共 65 页

B.A 5.1
Is a documented corrective action
procedure in place to analyse any
complaints and investigate
a
）建立文件化的程序以识别不符合、确定不符
a) Establish and document procedures for identifying non- conformities and problem
solving activities to determine how the non-conformities occurred.
合发生的原因及解决措施。


WHAT WILL THE ASSESSOR DO?
The Assessor will:
non- conformities to prevent reccurrence?
评估员将做什么？
是否建立了书面的整改程序来分析任何评估员将
包含整改措施程序，是否有效沟
- Review documentation that corrective action procedures exist, are effectively
投诉和调查不符合，以防不 符合的再次
-
评审相关文件，
communicated and followed when required.
发生？

通，必要时是否遵守。

B.A 5.2
Are corrective actions (i.e. release,
rework, quarantine, rejectiondisposal)
identified and effectively implemented?
整改措施（即放行、返工、隔离、拒收

废弃处置 ）是否得到识别，并有效实施？

B.A 6

Management Responsibility
管理者职

什么意思？

WHAT DOES IT MEAN?
责

The business shall ensure there is
management commitment to provide the
a
）

要有对生产管理者清晰的责任说明。
a) There should be clear accountability for the production management team.
resources to develop, implement and
b
）

管理者应证明其提供了相应的资源为满足建
b) The team should demonstrate commitment to provide the appropriate amount of
comply with their food safety programme.
立、实施和确保对食品安全计划符合性的承诺。
resources to develop, implement and ensure compliance with the food safety programme.

企业应确保有管理者承诺，为开发、实
c
）

尽管这些活动中有许多是由质量保证和食品
c) Although development of many of these activities may be conducted by quality
施和遵守食品安全计划提供资源。

安全的人员主导的，但生产管理者也应积极参与
assurance and food safety people, the production management team should be actively

第 11 页 共 65 页

B.A 6.1
Is there evidence that management is
committed to provide the resources to
implement and comply with their food
safety programme?
遵守其食品安全计划提供资源？

支持和领导这些活动。
involved in the support and leadership of these activities.
d
）

食品安全计划不应只是
“
属于质量人员
”
的活
d) The food safety programme should not be a Instead,
动，相反，管理者应显示主要的领导力以建立食
management should show active leadership to ensure a food safety culture.
品安全文化。
我需要做什么？

WHAT DO I NEED TO DO?
a) The production management team should have systematic documented discussions
是否有证据表明管理层致力于为实施和
a
）

作为员工定期会议的一部分，生产管理者应
about the food safety programme as part of its periodic staff meetings where
针对食品安全计划做出系统性的文件化讨论；在
non-conformance trend analysis, resources allocation, corrective action and strategy for
会上要对不符合趋势分析、资源分配、整改措施
continuous improvement will be actively discussed.
和持续改进的策略做积极的讨论。
b) Management should show that food safety is as important as production and people's
b
）

管理者应表明食品安全与生产、人员健康与
health and safety and operates with an adequate budget.

安全、充足的操作预算一样重要。

评估员将做什么？
评估员将
WHAT WILL THE ASSESSOR DO?
The Assessor will:
- Check for evidence that food safety programme elements are discussed and
-
检查是否有证据表明食品安全计划要素在生产
documented in production management team staff meetings, looking for prominent
管理层会议上得到讨论和形成文件，并寻找突出
discussions and follow-up activities.
的讨论内容与跟进活动。
- Interview the quality team about management commitment for appropriate resources,
了解管理者对提供合适资
support for their activities and to ensure that those employees with responsibility for food
-
对质量人员进行询问，
源和支 持质量活动做出的承诺，并确保与食品安
safety activities are held accountable for compliance.
全相关的员工对合规性负责。
否乐于接受持续改进的建议。

I.A 6
Management Responsibility
- Ask production operations people about management commitment, seeking to
寻求管理者是
establish whether management are receptive to continuous improvement suggestions.
-
向生产操作人员了解管理者承诺，
管理者职

责


第 12 页 共 65 页

The business shall ensure there is
什么意思？
WHAT DOES IT MEAN?
management commitment to provide the
a
）

除了在
B.A 6
中已经明确的内容，生产管理
a) In addition to those items already identified in Requirement B. A. 6, production
resources to develop, implement and
者还应有文件化化的组织架构以支持食品安全
management should document the organizational structure which supports the food
comply with their food safety programme.
计划和影响产品安全的活动。

文件化化的职位说
safety programme and the activities that impact product safety. Documented job
The business shall establish a clear
organizational structure with job
明和汇报关系也应包括在内。

descriptions and reporting relationships should be included.

WHAT DO I NEED TO DO? descriptions, responsibilities and reporting
我需要做什么？
relationships of at least those staff whose
a
）

创建清晰的组织架构图并保持更新。
a) A clear organizational chart should be created and kept updated.
activities affect product safety.
b
）

明确食品安全计划的相关人员的活动和职
b) Employees whose activities and responsibilities support the food safety programme
企业应确保有管理者承诺，为开发、实责。
施和遵守食品安全计划提供资源。
should be identified.
c
）

文件化的职责应与相关人员分享和讨论以确
c) These documented responsibilities should be shared with and discussed with relevant
employees to ensure understanding of their accountabilities.
企业应建立清晰的组织架构，至少明确保其了解责任义务。
其活动对食品安全有影响的员工的职位
说明、职责和汇报关系。

I.A 6.2
Is an up-to-date organizational chart
评估员将做什么？
评估员将

WHAT WILL THE ASSESSOR DO?
The Assessor will:
outlining the business' structure available?
-
检查生产管理者对食品安全计划做出承诺的证
- Check for evidence of production management's commitment to the food safety
programme
是否有最新的组织机构图表明公司的组
据。
织架构？

I.A 6.3
Are documented, clearly defined
responsibilities regarding product safety
and legality available and communicated
to staff?
是否明确定义了关于产品安全和法律的
职责，形成书面文件，并传达给员工？

B.A 7
Record Keeping Requirements
记录保

并寻找食品安全计划
- Check to ensure the organizational chart is up-to-date and will look for documents (such
-
检查组织架构图是最新的，
as job descriptions) which define indivuals responsibilities that support the food safety
的相关人员的职责文件（如职位说明）。
-
讨论生产管理者如何支持和传达各项职责。

programme.
- Discuss how production management supports and has communicated the
responsibilities.
存的要求


第 13 页 共 65 页

The business shall ensure that records are
什么意思？
available to prove the business is
complying with the food safety system
WHAT DOES IT MEAN?
a
）

企业需要证明其同时满足了适用于企业产品
a) The business needs to prove it is meeting both regulatory and customer requirements
that apply to its product and process.
和加工过程的法规和顾客的要求。
which includes all relevant regulatory and
b
）

记录提供了
“
你做了你所说的制造、储存和
b) Records provide legal proof that you did what you said you were going to do to
分销
”
的法律证明。
customer food safety requirements. manufacture, store and distribute products.
企业应确保有记录来证明企业遵守食品
c
）

你需要明确记录什么时候要完成，由谁来完
c) You need to identify when records will be completed and who will complete them.
d) These records are kept for a period of time (this is 'record retention'). The period of
安全体系（包括了所有相关的法规和顾成。
客的食品安全要求）。

B.A 7.1
Are records available to support the
d
）

这些记录要保存一段时间（即记录保留）。
time will be mandated by law or by customers and will depend on the type of products,
保留的时间将根据法律或者顾客的要求，同时取
processes and product liability.
e) Identify which of these time periods is longest to decide on your record retention
compliance of the business with the food
决于产品的类型、过程和产品的责任。
safety system which includes all regulatory
e
）

明确这些保留时间中哪个是最长的以便对你
policy.
and customer food safety requirements
that apply?
的记录保留政策做出决定。
f) You can set the same retention policy for all of your records or have different time
f
）

你可以为你所有的记录设置相同的保留时间
periods for specific records.
g) These records can be in paper form or they can be electronic and should be factual and
是否有记录来支持企业遵守食品安全体
或者为特殊的记录设置不同的保留时间。
系（包括了所有适用的法规和顾客的食
g
）

这些记录可以是纸质的也可以是电子的，但
genuine.
品安全要求）？

B.A 7.2
应是真实的。

WHAT DO I NEED TO DO?
a) You need to identify the requirements within the food safety system for which you
Has the business set timescales for record

retention which comply with regulatory or
我需要做什么？
customer requirements?
a
）

你需要识别在食品安全体系内用于证明合规
need to prove compliance, including both customer and regulatory, .
b) Some of these records may come from your suppliers (e.g., letter of conformity,
企业是否设置了记录保留的时间长度，
性的要求，包括顾客的要求和法规的要求。
b
）

这些记录中的一部分可能来源于你的供应商
specification, etc.).
以遵守法规和顾客的要求？

（比如合格证书、产品规范等）。
c) You will also need to create forms which will allow you to record your own
information.
c
）

你也需要创建能让你记录自己信息的表格。


评估员将做什么？
评估员将
WHAT WILL THE ASSESSOR DO?
The Assessor will:
-
检查你是否识别

了你需要保留的记录并设置了
- Check whether you have identified the records that you need to retain and set the
timescales for retention.
保留的时间。
-
抽样审核记录证实它们的存在以及能在保留时
- Review a sample of your records to prove they exist and that they are available for the

第 14 页 共 65 页

间内获得。

set period of time.
I.A 7

General Documentation Requirements

什么意思？

WHAT DOES IT MEAN?
总体文件要求

The business shall establish and
implement procedures to ensure that all
a
）

文件为员工提供指导使他们能够执行他们的
a) Documents provide instruction for people so they can do their job and deliver a safe
documents are maintained and kept up to
工作和交付安全和稳定的产品。
and consistent product.
date.
These documents are required to
demonstrate the effective operational
control of its processes and its
management of product safety.
b
）

文件也提供了记录使得企业能够收集数据并
b) Documents also provide records so that the business is able to collect data and
提供证据表明其符合顾客、法规以及本检查表的
provide evidence to show that it is meeting customer and regulatory requirements as well
要求。
as the requirements of this checklist.
c
）

文件应当得到维护、控制并保持最新，确保
c) They should be maintained, kept up to date and controlled so to ensure that only
correct documents are used.
只使用正确的文件。
企业应建立并实施相关程序以确保所有
d
）

员工使用过期的文件不仅可能导致不符合规
d) Usage of out of date documents by people may not only resulting a product that is out
的文件得到维护并更新。

范的产品，也可能会导致证明合规性的数据无法
of conformance with specifications but also that the appropriate data to prove compliance
I.A 7.1
Is a written documentation procedure in
收集。

place and effectively implemented?
是否建立并有效实施了书面的文件程
序？

我需要做什么？
is not gathered.

WHAT DO I NEED TO DO?
a
）

你需要有文件化的程序并执行，保持文件的
a) You need to document and implement a procedure for keeping documents up to date
and assuring out of date documents are not used.
更新并确保过期的文件不被使用。
b
）

你需要指定专人负责文件并承担批准文件的
b) You should appoint an individual to be responsible for documents with accountability
for approving documents.
职责。
c
）

只有被授权的人员才能够对当前的文件做更
c) Only authorised people are able to replace existing documents so they should be
protected against unauthorised change.
换，所以文件应得到保护以防未经授权的修改。
d
）

当修改文件时应有控制和归档废弃文件的方
d) As procedures change there should be a way to control and archive obsolete
documents.
法。

评估员将做什么？
评估员将

WHAT WILL THE ASSESSOR DO?
The Assessor will:
第 15 页 共 65 页
-
检查是否有用于文件控制的程序并得到有效执
- Check there is a procedure there has been implemented effectively for document

行。
control.
-
在评估期间检查程序和表格是否得到正确使用
- Check procedures and forms during the assessment looking for correct usage including
issues such as dates, signatures and frequency of recording.
包括日期、签名和记录频率等问题。

B.A 8

Control of Measuring & Monitoring
Devices

WHAT DOES IT MEAN? Measuring and monitoring devices critical
什么意思？
to food safety and regulatory
requirements shall be reliable.
a
）

企业应识别其过程中可能造成食品安全问题
a) The business should identify the critical control points in their process that may create
a food safety issue.
的关键控制点。
b
）

一旦这些控制点得到识别，你应有能够使用
b) Once those points have been identified you should have a means to measure and
monitor the process using appropriate devices.
合适的设备测量和监测这些过程。
c) Those devices should be verified on a regular basis to ensure their reliability.
c
）

这些设备应定期验证以确保其可靠性。
d
）例如，为了确保消灭生奶中所有的致病微生
d) For example, to ensure destruction of all pathogenic microorganisms in raw milk,
物，应规定巴氏杀菌步骤中时间和温度的组合。
time and temperature combinations of the pasteurization process should be regulated. A
制造商需要确保用于测量和监测时间和温度的
设备是准确和可靠的。

我需要做什么？
manufacturer will need to ensure that the device used to measure and monitor the time
and temperature is accurate and reliable.

WHAT DO I NEED TO DO?
B.A 8.1
Are measuring and monitoring devices
critical to food safety and regulatory
requrements reliable?
a
）

建立控制食品安全所要求的所有测量和监测
a) Create a master list of all measuring and monitoring devices required to control the
的设备的总清单，并列出校准和维护的方法和频
food safety of your food and list the method and frequency for calibration and
率。
maintenance.
b
）

每台测量和监测单元要有独特的标识以及能
b) Each measuring and monitoring unit should have a unique identifier and the
acceptable variance range identified.
够接受的差异范围。
c
）

对食品安全非常关键的测量和监测设备，例
c) Examples of measuring and monitoring devices critical to food safety include
thermometers and metal detectors
如包括了温度计和金探仪。

评估员将做什么？
评估员将


WHAT WILL THE ASSESSOR DO?
The Assessor will:
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-
检查测量和监测设备是否准确测量了需要的参
- check that the measuring and monitoring device is accurately measuring the required

数。
parameters
检查是否有证据表明
- select a measuring and monitoring device and check that there is evidence that it is
-
抽查一台测量和监测设备，
calibrated to a recognised standards.
其按照认可的标准做了校准。

I.A 8

Control of Measuring & Monitoring
Devices
测量与监测设备的控制

The business shall identify measuring and
什么意思？
WHAT DOES IT MEAN?
monitoring devices critical to food safety,
a
）

除了
B.A 7
中已经明确的内容，企业应确保
a) In addition to those items already identified in Requirement B. A. 7, the business shall
ensure that they are calibrated and
对食品安全非常关键的测量和监测设备的校准
ensure that calibration of measuring and monitoring devices that are critical to food safety
traceable to a recognised national or
international standard.
是根据认可的国家或者国际标准进行的。

is undertaken against a recognised national or international standard.


WHAT DO I NEED TO DO?
对食品安全和法规要求至关重要
我需要做什么？
a
）建立所有测量和监测设备的总清单，确保每
a) Create a master list of all measuring and monitoring devices, ensure there is unique
的测量与监测设备要可靠。

I.A 8.2
Are measuring and monitoring devices
台设备有独特的标识符，并明确了可以接受的差
identification for each and that the acceptable variance range is identified.
b) Examples of measuring and monitoring devices critical to food safety include:
critical to food safety identified, calibrated
异范围。
and traceable to recognised standards and
b
）对食品安全非常关键的测量和监测设备包括
Thermometers, Metal detectors, X-Ray units, pH and water activity meters, scales, oven
are they effectively controlled?
了：温度计、金探仪、
speeds and other important processing measuring and monitoring units.
X
光机、
pH
计和水活度计、
c) Develop Standard Operating Procedures (SOP) for each listed device to provide
detailed, written instructions that will achieve uniformity of performance.
对食品安全至关重要的测量与监测设备
天平、烤炉和其它重要的 加工的测量和监控设
是否得到识别、校准并可溯源至经过认
备。
可的标准，并被有效控制？

为每个列出的设备建立标准操作程序（
SOP
），
d) Each SOP should list what the device is, why it is needed, how it is used, who is
c
）

第 17 页 共 65 页

I.A 8.3
Are actions taken and recorded when
measuring and monitoring devices are
found to be outside of specified limits?
当发现测量与监测设备超出规定限值
时，是否采取措施并记录？

提供详细的文件化指导，以获得设备性能的一致
authorised to use it and when it is to be calibrated.
性。
e) Each SOP should include requirements for documented corrective action and
d
）
SOP
应列出该设备名称、用途、如何使用、
remediation in the event of deviation to standards.
f) Maintain and retain records of the following activities: calibration, service providers
谁被授权使用以及何时需要校准。
e
）每个
SOP
应包括文件化整改措施的要求，以
with contact information; maintenance records, monitoring frequency signed by approved
operator, deviation and corrective action.
及偏离标准时的补救办法。
f
）维护和保留以下活动的记录：校准、服务供应
g) Implement a training programme to ensure all relevant people are adequately trained.
商的联系人信息、维护记录、授权操作者签名的

监控频次、偏离和整改措施。
WHAT WILL THE ASSESSOR DO?

The Assessor will:
g
）实施培训项目以确保相关人员接受充分培训。
- Check for procedures for the operation of measuring and monitoring devices critical to

评估员将做什么？
评估员将
food safety.
- Check the calibration and maintenance log to validate that devices are maintained and
-
检查对食品安全非常重要的测量和监测设备的
calibrated against in recognised national or international standard as recommended by
the manufacturer.
操作程序。
-
检查校准和维护记录以确认设备根据制造商推
- Review samples of signed operator logs for accuracy and to verify corrective action and
荐的经过认可的国家或者国际标准进行了维护
remediation for any documented deviations.
和校准。
发生偏差时采取的整改措施和补救办法。
寻找他们接受充分培
-
检查相关人员的培训记录，
训的证据。

B.A 9

Training
培训

WHAT DOES IT MEAN? The business shall ensure that all people
什么意思？
- Check training records for the relevant people, looking for evidence that they have been
-
抽样检查签过名的操作员记录的准确性并验证
adequately trained.
所有从事影响产品安全，法
a) All new people performing work that affects product safety, legality and quality shall are adequately trained in food safety and
a)
基于风险评估，
practices according to their job
规和质量工作的新员工应具备与之工作相适应
have the required competence by education, work experience and training, that matches
responsibilities.
的工作能力，如教育，工作实践和培训。
their work, based on risk assessment.
企业应保证所有员工根据其工作责职接
b)
培训应针对个人健康和安全以及避免污染
b) Training should address both personal health and safety as well as relevant food safety
issues with a focus on avoiding contamination.
受足够的食品安全培训和实践。

的相关食品安全问题。


第 18 页 共 65 页

B.A 9. 1
Have all new people been effectively
trained?
是否所有新员工都有效地接受培训？

B.A 9.2
Have all relevant people received
refresher training?
是否所有相关人员接受了再培训？

c)
所有员工（管理层，专职，兼职，或者临时
c) All people (management, full-time, part-time, or temporary) shall receive relevant
training.
工）都应接受相关培训。
d)
各项与最佳实践和食品安全相关的资格或
d) Each qualification or competency related to best practise and food safety shall be
者能力都应系统地
“
重复培训
”
并确认。

systematically

我需要做什么？

WHAT DO I NEED TO DO?
a)
保证员工了解并明白不恰当的食品处理的后
a) Ensure that people are aware and understand the consequences of improper food
handling.
果。
b)
确保新员工的培训是针对他们在企业中未
b) Make sure that induction training of new employees is targeted towards their future
duties in your business.
来的工作职责。
将所有
c) For members of the management team, create an induction programme that takes
c)
管理团队成员应制定一个到职程序，
into account all relevant processes and departments.
相关过程和部门都包括在内。
d)
应定期进行培训，并应适应当前的业务情
d) Training should be conducted regularly and the contents should be adapted to current
况，如事故、改进和目前的法律情况。

business conditions such as incidents, improvements and current legal situation.
e)
针对简单的任务制定一个相关题目的检查
e) For simple tasks create a check list with relevant topics that can be efficiently
communicated.
表以便有效地沟通。
f)
你需要提供关于培训主题的证据，包括在
f) You will need to provide evidence about training topics, including hygiene and safety in
工作场所的卫生和安全，参与培训的员工，和再
the workplace, with participating employees and refresher training..
培训
..


评估人员做什么？
评估人员将：

WHAT WILL THE ASSESSOR DO?
The Assessor will:
- Check whether you can prove that all your people have undergone relevant training,
-
检查你是否能证明你所有的员工都接受过相关
with special attention to induction for temporary and part-time people.
的培训，特别注意刚入职的临时工和兼职人员
- Interview people and ask them about the training they have received and how
-
询问人员并询问他们受过的培训，是否适合
appropriate it was for the job that they must do.
- Check that you can prove that you have delivered refresher training to all relevant
他们从事的工作。
-
检查你是否可以证明你已经向所有相关人
people.
- Review whether the refresher training content has been adapted to current business
员提供过再培训。
conditions such as incidents, improvements and current legal situation.
-
检查再培训内容是否适应当前企业的情况，

第 19 页 共 65 页

比如事故，改进和当前法律状况。

I.A 9

Training
培训

ensure that all people are adequately
safety principles and practices that
matches their work.

WHAT DOES IT MEAN? The business shall implement a system to
什么意思？
所有从事影响产
a) All people performing work that affects product safety, legality and quality should
a)
基于危害分析和风险评估，
trained, instructed and supervised in food
品安全，法规和质量工作的员工应该具备与之工
have the required competence by education, work experience and training, that matches

作相适应的工作能力，如教育，工作实践和培训。

their work, based on hazard analysis and risk assessment.

b)
培训计划应该适用所有员工，包括兼职和临
b) A training programme should apply to all people, including part-time and temporary
workers.
时工。

企业应实施一个系统以保证所有
员工在工作相匹配的实践和食品
c)
开始工作前，他们应按照培训计划接受培
c) Before starting work, they should be trained in accordance with the training
programme.
训。
安全准则方面，受到足够的培训，


指导和监督。

I.A 9.3
Is a people training programme in place
and effectively implemented?
WHAT DO I NEED TO DO?

需要做什么？
a)
企业应该实施一个和产品要求和员工需求
a) The business should implement a training programme relevant to the product
requirements and the training needs of the people which should include:
? training content
? training frequency
? people’s tasks
? relevant language
? qualified trainer
? evaluation methodology
是否建立并有效地实施员工培训计划？

相关的培训计划，应包括：
?
培训内容
?
培训频率
?
员工的任务
?
相关语言
?
合格的培训师
?
（效果）评估方法
b) There should be a procedure that proves the effectiveness of training.
b)
应有一个证明培训效果的程序
c)
应对培训计划内容进行评审，系统性地更
c) The contents of the training programme should be reviewed and updated
新，考虑特殊问题，食品安全，食品相关的法规
systematically to take into account specific issues, food safety, food related legal
要求和产品，以及工艺过程更改的情况。
requirements and product and process modifications.

d) You will need to prove what training topics have been delivered for each individual.
d)
需要证明每个人的什么培训内容已被实施。
e)
培训内容包括工作场所的
HACCP
，

卫生和
e) Training topics include HACCP, hygiene and safety in the workplace.

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