MGB验厂评估清单（二）

MGB验厂评估清单（二）
Section 6: Complain & Incidents Management
第6部分：投诉与事故管理

6.1 Is there a documented procedure for handling of complains, including clearly defined steps and responsibility?
是否有书面的客诉处理程序，包括步骤及职责？
6.2 Is there a documented procedure for handling of incidents, which do or potentially can negatively affect product quality, safety or legality?
针对影响到产品质量，安全或合法性的事故，是否有书面的事故处理程序？
6.3 Are there procedures to ensure that customers are notified immediately if an incident arises that could result in or has resulted in customers receiving nonconfirming products?
如有意外事故会导致顾客收到不合格产品，是否有事故通报程序？
6.4 Are the complaints / incidents and the actions taken to resolve them being recorded?
投诉/事故及采取的措施是否保留记录？

Section 7: Raw Material Control / Inventory
第7节：原料/库存控制

7.1 Does the factory have inspection instructions for incoming materials?
是否建立进料检验规范？
7.2 Does the factory conduct incoming inspection in accordance with documented specifications and instructions? Are there inspection records available?
是否按照规格和检验规范要求实施进料检验？是否保留检验记录？
7.3 Are raw materials and components stored under suitable conditions and special storage conditions (i.e. required temperature and humidity) are defined and according to established procedures?
原材料存放是否适宜，如有特别的存放条件（温湿度），是否建立相应的程序并遵照执行？

Section 8: Training & Competency
第8节：培训与能力

8.1 Does the factory ensure that all employees are able
to demonstrate competence with regards to their
activity?
　?identify the need for training
　?document training procedures and records to
demonstrate that training is effective and regularly
reviewed
　?ensure that training included both general
information on the factory and specific job training
是否确保员工能力的胜任？培训需求的识别；书面的
培训程序和培训记录；培训有效性评价及评审记录；
工厂基本信息和特定的岗位培训。
8.2 Are employees performing work that direct affects
product safety, legality and quality (including
temporary employee and contractors) appropriately
trained and instructed prior to commencing work？
Are there training records available?
直接影响产品安全，合法性和质量的员工是否在上岗
前接受培训？是否保留培训记录？
8.3 Are employees conducting or participating in risk
assessment adequately trained in risk assessment
methods? Are there training records available?
进行或参与风险评估的人员是否就风险评估的方法接受足够的培训？是否保留培训记录？

Section 9: Environmental Protection
第9条：环境保护

9.1 Has the factory defined an environmental policy,
objectives and targets?
是否建立环境方针和目标？
9.2 Does the factory have any documents that in
compliance with the local environment law and
regulation? Such as environmental impact
assessment report or pollutant ejection permit.
是否有符合当地环保要求的证明文件，如环评报告或
排污许可证？
9.3 Are the major environmental aspects defined?
是否定义重要的环境因素？
9.4 Does the factory retain records of any hazardous
waste disposal?
是否有危险废弃物的处理记录？

Section 10: Inspection / Training
第10节：检验/培训
10.1 Does the factory have in-process and final
inspection instructions, which include the following?
　?sample size to be taken
　?inspection items
　?acceptance / rejection criteria
　?defined AQL
　?defect classification
　?actions to be taken in the case of rejection
是否建立过程和成品检验规范？检验规范是否包
括：抽样量；检验项目；接收标准；AQL；疵点分
类；拒收后的后续措施？
10.2 Does the factory conduct in-process inspection in
accordance with documented specifications and
instructions? Are there inspection records
available?
是否按照规格和检验规范要求实施过程检验？是否
保留检验记录？
*10.3 Does the factory conduct final inspection in
accordance with documented specifications
and instructions? Are there inspection records
available?
是否按照规格和检验规范要求实施成品检验？是否
保留检验记录？
10.4 Are the inspection procedure/ instruction approved
and reviewed when changes in production
methods or materials occurred?
如果生产方式或材料变更，对即定的检验规范是否
进行再确认和评估？
10.5 Does the factory have procedure to handle the
inspected goods, which include the following?
　?Policy/rule on returning inspected goods to
production
　?Repacking requirements
　?Disposal
是否对检验过的产品有处理程序？内容包括：返
工；重新包装；处置。
10.6 When inspection results are outside the defined
acceptance level, does the factory evaluate and
review non-conforming products by a competent
person? Where necessary, are corrective action
taken and documented?
是否有适当的人员进行不合格品的评审，并保留相
关记录？包括纠正措施记录。
10.7 Does the factory have assessment/review recordsof product test need and product test plan?
是否有测试需求评审记录和测试计划？
10.8 Is there a documented testing procedure /
programme established for each product or a
group of similar products? If yes, does the testing
procedure / programme include the following?
　?different stages (e.g., pre-production, production)
at which testing is to be performed
　?test sampling plan
　?test specification
　?pass or fail criteria
是否有单个产品或产品组的书面的测试程序？如果
有，内容是否包括：不同阶段的测试；测试样本
量；测试规范；接收标准？
10.9 Is the testing of critical parameters undertaken by
accredited laboratory (in-house or third party) or
the customer‘s designated testing laboratories as
agreed? Are there test reports available?
对于关键参数，是否由有资质的实验室（内部或第3
方）或客人指定的实验室进行测试，是否保留测试
报告？
10.10 Where testing is carried out by third parties, does
the factory clearly defined the testing requirements
including the reference to number, date and
version of the test standard or method to be used?
如果由第3方进行测试，是否在测试申请单里清楚说
明测试的要求，包括测试标准或测试方法的编号，
日期和版本号？
10.11 When test results are outside the defined
specification, are they evaluated and reviewed by a
nominated person responsible for safety, legality
and quality? Where necessary, are corrective
action taken and documented?
是否对测试失败进行评审，并保留相关记录？包括
纠正措施记录。

Section 11: Manufacturing Operations / Capabilities
第11节：制造业务/功能
11.1 Are working instructions available for operator as a
guideline at an accessible place or work station to
ensure legality, quality & safety of product?
是否有作业指导书作为确保产品符合法规，质量和
安全的指引？
11.2 Is there any traceability and confirm information
on the approved sample? Are the samples well
stored and controlled?
确认样上是否有可追溯的信息和确认的信息？确认
样是否良好地存放和控制？
11.3 Are there pre-production meetings conducted prior
to production of new or substantially changed
products, and to evaluate and approve the
processes? Are the meeting records available?
当生产新产品或产品本质变更时，是否召开产前会
议来评估和确认相关的生产过程?是否保留会议记
录？
11.4 Does the factory have first sample checking
record?
是否有首件样确认记录？
11.5 Does the factory adjust or calibrate the identified
measuring and monitoring devices to ensure
accuracy? Verification and maintenance at defined
period and recorded?
是否对计量设备/工具进行校准或检定？是否保留相
关的记录及证书？
11.6 Does the factory have a well organized
maintenance team to give immediate response to a
machinery breakdown or emergency that affects
production? Or have maintenance cover subcontracted
with a guaranteed response time? What
is guaranteed time?
是否有机修组对故障设备立即响应？或机修业务外
包的话，是否保证响应时间？响应时间是多少小
时？
11.7 Are there procedures in place for action to be taken
if equipment if found not to be operating within
specified limits?
如果发生设备失效或操作偏差，是否有程序在放行
前确认产品的安全状况，并采取适当的措施？
11.8 Are raw materials, semi-processed products, partused
materials, finished products and materials
pending investigation adequately identified to
ensure traceability?
原材料，半成品，成品的状态是否充分标识，以确
保可追溯性？（现场的状态标识：已检，待检，合
格，不合格，待处理等）
*11.9 Are final products suitably marked to allow
adequate identification and in accordance to
legislative and safety requirements and
customer specific requirements?
成品是否根据法规，安全要求和顾客的特殊要求加
以标识？如CE，WEEE
11.10 When the same component or material is sourced
from more than one supplier, can the traceability
system ensure that the lots / batches from each
supplier can be identified if the component /
material are identified as critical to safety, quality or
legality?
当影响产品质量及安全合法性的物料来源于不同供
应商时，是否有可追溯体系确保能识别不同供应商
的物料批次？
11.11 Are the changes in materials, processes or
components traceable if they could affect the
safety, quality or legality of the product?
影响产品质量及安全合法性的物料、过程或组件的
变更是否可追溯？
11.12 Are there further traceability chain based on the risk
assessment and any legal or specific customer
requirements being established?
基于风险分析及法规的或顾客的具体要求，是否建
立进一步的追溯链？
11.13 Does the factory has appropriate storage
arrangement and instructions such as special and
segregated areas for storage of flammable and
explosive substances, highly toxic substances,
rejected and recalled materials or returned goods?
是否针对易燃易爆物质，剧毒物质，拒收及召回材
料或产品，有适当的存放区域和指示?
11.14 Does the factory have mechanism prior to release
of all finished products?
是否有产品放行规定？

Section 12: Non-conforming Product Capabilities
第12条：不符合要求的产品的能力

*12.1 Does the factory have non-conforming
materials control procedure?
是否建立不合格品的控制程序？
12.2 Does the factory have re-inspection records for reworked
products?
是否有返工重验的记录？
12.3 Does the factory have recall procedure?
是否建立召回程序？
12.4 Are recall operations recorded?
是否保留召回记录？