MGB Fty Selfassessment Template V2文档格式.docx

1、（no. of units）200Employees Details （no. of people） Supervisors/Managers1AdministrationQuality Control2Engineering3Design & DevelopmentPermanent Workers50Temporary WorkersGrand TotalWorking Hour （how many shift, from when to when?）No. of subcontractors used Name & process of main subcontractors Secti

2、on 1: General Organization StructureItemQuestionResultRemarkYesNoN/A1.1Does the factory have the up to date organizational chart? If yes, please attach a copy of organization chart.是否有最新的组织结构图？如有，请提供一份组织结构图。 1.2Are there appropriate arrangements in case of absence of key staffs? Are there any suppor

3、ting document or record?主要人员不在时是否有替代安排?有何种支持性的文件或记录？ 1.3Does the factory have the definition of responsibility & accountability for key staffs involved with activities impacting product safety, legality and quality?对于负责产品安全性、合法性和质量的主要人员，是否有规定的职责和权限？Section 2: General Facility Management2.1Is the fac

4、tory site being maintained to minimize potential for product contamination and damage?厂房是否维护良好，避免产品被污染或损害？2.2Does the factory free of any process running outside/outdoors or only with a sunshade?是否没有工序或操作在室外或只在有顶棚的外部区域进行？2.3Does the factory have the process flow diagram? If yes, please attach a copy

5、 of flow diagram.是否有工序流程图？如是，请提供流程图复印件。2.4Does the factory site allow sufficient working space and storage capacity to enable all operations to be conducted under safe and necessary hygienic conditions? 是否有足够的作业及储存空间，使生产处于安全和卫生的条件下进行？2.5Does the factory effectively segregate raw material, work in pr

6、ogress, rework, packaging and finished products to minimize the risk of cross-contamination?是否对原材料、半成品、返工产品、包装材料及成品等进行有效隔离，防止交叉污染？2.6Are all machine and equipment adequately maintained and operated to product safety, quality and legality? Are there maintenance plan and records available?所有的设备是否维护良好，

7、以满足产品安全，合法性及质量的要求？是否有设备保养计划和记录？2.7Are cleaning and pest control chemicals suitably identified, labelled, controlled and adequately stored to prevent risk of product safety, quality and legality?用于清洁和灭虫的化学品是否适当标识，控制和储存，以免影响到产品的安全，质量和合法性？2.8Are documented cleaning procedures available （both in-house a

8、nd outsourced） and maintained for the factory site, utilities, plants and all equipment? Following information should be included responsible person for cleaning item/area to be cleaned frequency of cleaning method of cleaning cleaning materials to be used cleaning records and responsible person for

9、 verification revalidation procedure 对于厂区（内外部），公共设施及设备是否有书面的清洁程序，内容包括：负责人；清洁区域，范围；清洁频次；清洁方式；使用的清洁工具；清洁记录和验证人；消毒和清洁程序的再确认。2.9Are cleaning, sanitation and housekeeping carried out by trained personnel in accordance with procedures, effectiveness, corrective actions verified and documented and records

10、maintained?清洁消毒等是否由经过培训的人员实施，是否有相应的清洁记录和必要的验证及纠正措施记录？2.10Is there any license or registry required from the appropriate government agency? If yes, please attach a copy of license or registry.是否有获得适当政府机构所发出的营业执照？如是，请提供营业执照的复印件。Section 3: Quality Management Systems3.1Is this an ISO9000 accredited fact

11、ory? If so, please attach a copy of certification.是否获得ISO9000质量体系认证？如是，请提供质量体系认证证书复印件。3.2Does the quality management system include quality policy, measurable quality objectives , quality manual, product safety, procedure and work instructions and reviewed at least annually?质量管理体系是否包括质量方针，可测量的质量目标，质

12、量手册，产品安全性，程序文件，作业指导书及年度评审？3.3Is there an adequate system for controlling customer requirement?是否有足够的系统来控制顾客的要求？3.4Does the factory establish specifications for raw materials, components, and bought-in parts including packaging, intermediate/semi-processed and any product or service which could impac

13、t the integrity of the finish product?对于所有影响最终产品的原材料，零部件，包材，半成品等，是否建立相关的规格要求？3.5Does the factory have clearly product specifications？是否有成品规范？*3.6Are specifications accurate and complying to relevant safety, legislative and customer requirements?规范是否正确并符合相关安全标准、法规及顾客要求？3.7Is there an up-to-date suppl

14、iers & sub-contractors list and suppliers / sub-contractor control procedure available?是否有最新的合格供方（供应商，分包商）清单，及供应商/分包商的控制程序？3.8Are there internal audit procedure and records available?是否有内审程序和记录？3.9Does the factory have document control procedure?是否有文件控制程序？3.10Does the factory have record control pro

15、cedure?是否有记录控制程序？3.11Does the factory document all process and product changes?过程和产品的变更，是否都保留记录？3.12Does the factory have CAPA procedure?是否有纠正预防措施程序？3.13Are the management review conducted at least annually, documented and include the evaluation of below? Internal, customer and external audits Previ

16、ous management review documents, corrective action plans and time frames Customer performance indicators, complaints and feedback Incidents, non conforming materials and corrective actions An assessment of process performance Review of the product risk assessment system Review of the results of moni

17、toring and testing Developments in legal requirements or scientific information associated with the products in scope Resource requirements Improvement for the validity of quality management system 是否进行年度管理评审，记录包括：1. 内部的，第2或第3方的审核报告2. 以往的管理评审记录，纠正措施计划和时间表3. 客户业绩指标，投诉和反馈4. 事故，不合格品及纠正措施5. 过程业绩的评估6. 产品

18、风险评估系统的评审7. 监控和测试结果的评审8. 与产品相关的法规要求或科技信息的开发和改进9. 资源需求10. 质量管理体系及其过程有效性的改进3.14Do finished products （including re-work） have a full traceability to raw material source and vice versa?是否能从成品追溯到原材料，或反之亦然?3.15Does the factory test the traceability system to ensure the effectiveness of the system? Is the

19、frequency of test conduct at least annually? Results being retained? Time taken to complete the test being measured and recorded?对该追踪系统有效性的测试，是否至少每年做一次，是否保留结果？是否测算并记录测试所需要的时间?Section 4: Hazard & Risk Management Systems4.1Is there a documented procedure in place for changing in product design?是否有订立文件

20、程序来处理产品设计的更改？4.2Does the factory define and list the legal statutes and mandatory standards applicable to each product and to the materials from which it is made, relevant in the regions of intended sale?是否列明所有与产品相关的符合销售国的法律法规和强制指令？4.3Does the factory establish a Product Risk Assessment procedure fo

21、r each product or a group of similar products?是否对单个产品或产品组建立产品风险评估程序？4.4Does the Product Risk Assessment ensure the following? Hazard/risk identification Risk level for each hazard/risk Whether the risk is acceptable considering the probability or the severity and potential consequences of the effect

22、s on consumer safety The person responsible for the assessment The date performed and the evidence New Product Risk Assessment for product with modified design （The risk assessment may be provided by internal or external resources）产品风险评估记录是否包括：风险识别；风险评级；是否考虑到对消费者安全影响的可能性，严重性和潜在性；评估负责人；评估日期，证据；对于设计更改

23、的产品的重新评估？4.5Is risk assessment conducted and verified by competent personnel prior to production?是否在生产前由有资质的人员进行风险评估和验证？4.6Is the risk assessment regularly and at least annually reviewed （while the products are still in production） taking account of complaints or incidents with the product or simila

24、r group of products and reflects any changes in legislation. 考虑到投诉或生产事故或法规的更改，是否进行至少每年一次的风险评估的评审？*4.7Does the factory have testing results of a representative product from a qualified and accredited laboratory （internal or external） as a supporting in risk assessment?是否有有资质的实验室（内部或第3方）提供的测试结果作为风险评估的

25、依据？*4.8Does the factory document and verify the identity, qualification and/or license of the person producing the safety review or risk assessment?是否记录及验证实施安全评审或风险评估的人员的身份、资格和执照?Section 5: Compliance to Laws and Regulations*5.1Has the factory a system to ensure it is kept informed of changes to rel

26、evant legislation, product standard, safety, industry/customer codes of practices relevant to the product in scope and regions of intended sale? If yes, by which way?是否建立获取最新法规，产品标准，安全性，行业标准的体系？如果有，通过什么方式获取？5.2Is a documented process exist for incorporating changes in legislation, standards, safety etc, into the factorys procedures?是否有将相应的变更融入公司程序的书面程序？5.3Are the copies of legislation, product standard, product safety, industry norm and customer code of practices available to the staff?员工是否能随时查阅相关的法规，产品安全，行业规范及标准？Section 6: Training & Competency6.1Does the factory e