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MGB驗廠評估清單（二）

MGB驗廠評估清單（二）
Section 6: Complain & Incidents Management
第6部分：投訴與事故管理

6.1 Is there a documented procedure for handling of complains, including clearly defined steps and responsibility?
是否有書面的客訴處理程序，包括步驟及職責？
6.2 Is there a documented procedure for handling of incidents, which do or potentially can negatively affect product quality, safety or legality?
針對影響到產(chǎn)品質(zhì)量，安全或合法性的事故，是否有書面的事故處理程序？
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?
如有意外事故會導致顧客收到不合格產(chǎn)品，是否有事故通報程序？
6.4 Are the complaints / incidents and the actions taken to resolve them being recorded?
投訴/事故及采取的措施是否保留記錄？

Section 7: Raw Material Control / Inventory
第7節(jié)：原料/庫存控制

7.1 Does the factory have inspection instructions for incoming materials?
是否建立進料檢驗規(guī)范？
7.2 Does the factory conduct incoming inspection in accordance with documented specifications and instructions? Are there inspection records available?
是否按照規(guī)格和檢驗規(guī)范要求實施進料檢驗？是否保留檢驗記錄？
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?
原材料存放是否適宜，如有特別的存放條件（溫濕度），是否建立相應的程序并遵照執(zhí)行？

Section 8: Training & Competency
第8節(jié)：培訓與能力

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
是否確保員工能力的勝任？培訓需求的識別；書面的
培訓程序和培訓記錄；培訓有效性評價及評審記錄；
工廠基本信息和特定的崗位培訓。
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?
直接影響產(chǎn)品安全，合法性和質(zhì)量的員工是否在上崗
前接受培訓？是否保留培訓記錄？
8.3 Are employees conducting or participating in risk
assessment adequately trained in risk assessment
methods? Are there training records available?
進行或參與風險評估的人員是否就風險評估的方法接受足夠的培訓？是否保留培訓記錄？

Section 9: Environmental Protection
第9條：環(huán)境保護

9.1 Has the factory defined an environmental policy,
objectives and targets?
是否建立環(huán)境方針和目標？
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.
是否有符合當?shù)丨h(huán)保要求的證明文件，如環(huán)評報告或
排污許可證？
9.3 Are the major environmental aspects defined?
是否定義重要的環(huán)境因素？
9.4 Does the factory retain records of any hazardous
waste disposal?
是否有危險廢棄物的處理記錄？

Section 10: Inspection / Training
第10節(jié)：檢驗/培訓
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
是否建立過程和成品檢驗規(guī)范？檢驗規(guī)范是否包
括：抽樣量；檢驗項目；接收標準；AQL；疵點分
類；拒收后的后續(xù)措施？
10.2 Does the factory conduct in-process inspection in
accordance with documented specifications and
instructions? Are there inspection records
available?
是否按照規(guī)格和檢驗規(guī)范要求實施過程檢驗？是否
保留檢驗記錄？
*10.3 Does the factory conduct final inspection in
accordance with documented specifications
and instructions? Are there inspection records
available?
是否按照規(guī)格和檢驗規(guī)范要求實施成品檢驗？是否
保留檢驗記錄？
10.4 Are the inspection procedure/ instruction approved
and reviewed when changes in production
methods or materials occurred?
如果生產(chǎn)方式或材料變更，對即定的檢驗規(guī)范是否
進行再確認和評估？
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
是否對檢驗過的產(chǎn)品有處理程序？內(nèi)容包括：返
工；重新包裝；處置。
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?
是否有適當?shù)娜藛T進行不合格品的評審，并保留相
關(guān)記錄？包括糾正措施記錄。
10.7 Does the factory have assessment/review recordsof product test need and product test plan?
是否有測試需求評審記錄和測試計劃？
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
是否有單個產(chǎn)品或產(chǎn)品組的書面的測試程序？如果
有，內(nèi)容是否包括：不同階段的測試；測試樣本
量；測試規(guī)范；接收標準？
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?
對于關(guān)鍵參數(shù)，是否由有資質(zhì)的實驗室（內(nèi)部或第3
方）或客人指定的實驗室進行測試，是否保留測試
報告？
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方進行測試，是否在測試申請單里清楚說
明測試的要求，包括測試標準或測試方法的編號，
日期和版本號？
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?
是否對測試失敗進行評審，并保留相關(guān)記錄？包括
糾正措施記錄。

Section 11: Manufacturing Operations / Capabilities
第11節(jié)：制造業(yè)務(wù)/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?
是否有作業(yè)指導書作為確保產(chǎn)品符合法規(guī)，質(zhì)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?
確認樣上是否有可追溯的信息和確認的信息？確認
樣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?
當生產(chǎn)新產(chǎn)品或產(chǎn)品本質(zhì)變更時，是否召開產(chǎn)前會
議來評估和確認相關(guān)的生產(chǎn)過程?是否保留會議記
錄？
11.4 Does the factory have first sample checking
record?
是否有首件樣確認記錄？
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?
是否對計量設(shè)備/工具進行校準或檢定？是否保留相
關(guān)的記錄及證書？
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?
是否有機修組對故障設(shè)備立即響應？或機修業(yè)務(wù)外
包的話，是否保證響應時間？響應時間是多少小
時？
11.7 Are there procedures in place for action to be taken
if equipment if found not to be operating within
specified limits?
如果發(fā)生設(shè)備失效或操作偏差，是否有程序在放行
前確認產(chǎn)品的安全狀況，并采取適當?shù)拇胧?br /> 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，成品的狀態(tài)是否充分標識，以確
?？勺匪菪裕浚ìF(xiàn)場的狀態(tài)標識：已檢，待檢，合
格，不合格，待處理等）
*11.9 Are final products suitably marked to allow
adequate identification and in accordance to
legislative and safety requirements and
customer specific requirements?
成品是否根據(jù)法規(guī)，安全要求和顧客的特殊要求加
以標識？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?
當影響產(chǎn)品質(zhì)量及安全合法性的物料來源于不同供
應商時，是否有可追溯體系確保能識別不同供應商
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?
影響產(chǎn)品質(zhì)量及安全合法性的物料、過程或組件的
變更是否可追溯？
11.12 Are there further traceability chain based on the risk
assessment and any legal or specific customer
requirements being established?
基于風險分析及法規(guī)的或顧客的具體要求，是否建
立進一步的追溯鏈？
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?
是否針對易燃易爆物質(zhì)，劇毒物質(zhì)，拒收及召回材
料或產(chǎn)品，有適當?shù)拇娣艆^(qū)域和指示?
11.14 Does the factory have mechanism prior to release
of all finished products?
是否有產(chǎn)品放行規(guī)定？

Section 12: Non-conforming Product Capabilities
第12條：不符合要求的產(chǎn)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?
是否有返工重驗的記錄？
12.3 Does the factory have recall procedure?
是否建立召回程序？
12.4 Are recall operations recorded?
是否保留召回記錄？