2007-8-22 Full_Factory_Evaluation
Target_Factory_Evaluation_SChinese--中英文对照
工厂评估工厂评估概述工厂评估就是评价工厂的能力能否满足 Target 的要求和预期。
Target 每年都会评估所有 Target Sourcing Services(TSS)和 Quality Assurance Initiative(QAI)工厂是否达到 Target 标准要求。
TCPS 在必要时可进行较频繁的评估。
这些评估由在全球各地的Target Compliance and Production Services( TCPS)负责执行。
备注:∙工厂评估是按每个工厂地址进行,而非供应商/工厂关系。
∙根据 TCPS 的决定,工厂评估可由 Target Approved External Business Partner (Target 授权外部商业合作伙伴)执行。
目录1. 工厂评估目的2. 工厂评估准备3. 工厂评估内容4. 工厂评估流程5. 推荐的工厂测试设备、能力和流程目标∙理解 Target 的工厂评估流程以及为何重要的原因∙了解何时进行工厂自身评估∙了解 Factory Evaluation Corrective Action Plan(工厂评估纠正行动计划,即 CAP)的预期目标∙了解测试产品所用的设备和工艺资源POL:产品开发 > 要求和程序 > 品质保证(服装或杂货)> 工厂评估/商业合作伙伴管理(BPM)1. 工厂评估的目的∙验证品质与制造工艺是否与 Target 的标准和需求相符,若有必要,提供改进日程表并由 TCPS 负责跟进。
∙记录工厂的产能和实力,以便在下达订单时作为参考。
这包括:o品质能力–在案品质计划及其在工厂的实施情况o产品能力–产品类型及所用原料o生产能力–生产产品所用的设备类型o处理能力–工厂(包括设备和工人)当前在多大程度上达到满负荷运行,以及增加产能的可用提升空间。
∙工厂评估结果与纠正行动计划将与工厂列表中的所有供应商共享,同时会复制给 BPM 中的工厂合作伙伴。
常识历次银行存款利率对照表
历次银行存款利率对照表2008年12月27日星期六 13:20 详细介绍单位:年息%调整日期活期整存整取零存整取年月日三个月半年一年二年三年五年八年一年三年五年1993 5 151993 7 11993 7 11 9 91996 5 11996 8 23 91997 10 231998 3 251998 7 11998 12 71999 6 102002 2 212004 10 292006 8 192007 3 182007 5 192007 7 212007 8 222007 9 15利率历次调整一览数据上调时间存款基准利率贷款基准利率消息公布次日指数涨跌调整前调整后调整幅度调整前调整后调整幅度上海深圳2011年07月07日% % %% % %%% 2011年04月06日% % %% % %%% 2011年02月09日% % %% % %%% 2010年12月26日% % %% % %%% 2010年10月20日% % %% % %%% 2008年12月23日% % %% % %%% 2008年11月27日% % %% % %%%历次存款利率调整一览表存款准备金率历史走势准备金率调整后股市表现利率问题的基本常识利率(Interest Rates),就其表现形式来说,是指一定时期内利息额同借贷资本总额的比率。
利率是单位货币在单位时间内的利息水平,表明利息的多少。
利率通常由国家的中央银行控制,当前,世界各国频繁运用利率杠杆实施宏观调控,利率政策已成为各国中央银行调控货币供求,进而调控经济的主要手段,利率政策在中央银行货币政策中的地位越来越重要。
合理的利率,对发挥社会信用和利率的经济杠杆作用有着重要的意义。
我国现阶段利率的决定因素(1)利润率的平均水平社会主义市场经济中,利息仍作为平均利润的一部分,因而利息率也是由平均利润率决定的。
根据我国经济发展现状与改革实践,这种制约作用可以概括为:利率的总水平要适应大多数企业的负担能力。
入党公示情况报告
入党公示情况报告篇一:入党积极分子报告、公示及结果77入党积极分子公示为加强对发展党员工作的民主监督,确保新发展党员的质量,现将经过“双推”的入党积极分子同志的有关情况公示如下:公示期:2007年8月22---28日。
公示期间,单位或个人对公示对象如有意见,可直接向党支部或上级党委反映,也可通过电话、信函等方式向党支部或上级党委反映。
反映问题时,要用真实姓名、单位、职务、联系电话和通讯地址。
所反映问题发生的时间、地点、经过、证人等事实要清楚或基本清楚,对反映问题事实不清或道听途说、没有调查线索的,不予受理。
联系电话:中共支部二○○七年八月二十二日公示结果农业局机关三支部于2007年8月22—28日对经过“双推”的入党积极分子同志进行了公示,经公示党员群众没有对该同志提出任何异议。
中共三支部二○○七年八月二十八日关于确定同志为入党积极分子的报告2007年8月22日,我支部召开确定入党积极分子“双推”大会。
现将有关情况报告如下:本支部共有党员14人,群众9人。
参加会议的党员13人,群众代表8人,经无记名民主推荐,具体得票情况为:同志所得赞成票均超过应到会党员和群众的半数。
根据该同志的一贯表现,经研究,同意该同志为入党积极分子。
支部书记:参加“两推”会党委代表:中共支部二○○七年八月二十八日篇二:入党积极分子公示情况汇报入党积极分子公示情况汇报我院遵照《中国共产党章程》和发展党员公示制度的有关规定,于___年__月__日至___年__月__日对拟确定的_____同志入党积极分子进行公示。
公示期无异议,原党支部确定____同志为入党积极分子。
特向党委汇报。
_______院党支部年月日篇三:预备党员转正公示情况报告关于XX同志预备党员转正公示情况的报告开发区党工委:我支部于XX年XX月XX日召开支部大会,研究讨论XX同志按期转为中共正式党员事宜。
本次会议应到党员XX人,实到XX人,有表决权的XX人。
经举手表决,同意该同志按期转为中共正式党员。
利丰验厂工厂自评问卷
Factory Evaluation Guide Bookfor(Hardlines) Vendors & Factories杂货供应商及工厂的评估指引(Section 3)第三部分自我评估问卷For Factory’s Self-Exercise Only)仅作工厂自我评估用处,1. Social Compliance 社会责任2. Technical Compliance 生产技术及设备3. C-TPAT Compliance 反恐部分Self-Assessment Form工厂自我评估问卷ForFactory’s self-practice prior toLi & Fung’s Factory Evaluation在利丰工厂评估之前由工厂自行进行测验Note: In case of documentary support is required, please bring along with the Self-Assessment Questionnaire during Factory Evaluation.注意:请根据问卷准备所需资料及文件以备利丰作工厂评估* * * Self Assessment Form * * ****自我评估问卷***Factory Name: 厂名 Mee Po Plastic & Metal Co.Production Country (Factory Location): 国家 ChinaSOCIAL COMPLIANCE 社会责任BASIC LAW 基本法例文本1Is factory in possession of a copy of the latest edition of the local/National Labor Code?If yes,please have it ready for verification during evaluation.工厂是否有最新版的国家劳动法规?如有,请在工厂评估时提交评估员核实。
1什么是验厂
什么是验厂验厂Factory Evaluation;又称为审核Audit或评估Assessment,是按照一定的标准对工厂进行审核或评估。
常见于外贸出口型企业,特别是制造型的工厂。
可以说,几乎所有的外贸工厂都要或多或少地面临验厂的问题。
验厂和认证,既有所区别也有所关联。
一般来说,认证是针对质量管理、产品管理等,采用通用标准对生产过程和体系进行评估,并颁发证书。
而验厂在很多时候,只是出具报告,并不颁发证书。
相同的是,验厂和认证都是对企业的某个体系进行评估,并且验厂结果也有颁发证书的形式。
所以,有些认证和验厂可以放在一起讨论。
验厂一般分为人权验厂、品质验厂、反恐验厂等。
认证包括质量管理体系认证、回收材料认证GRS、有机纺织品认证GOTS、有机含量认证OCS、环境验证Higg FEM、森林认证FCS等。
验厂和认证可分为通用标准和客户标准。
通用标准如:BSCI、SA8000、SLCP、ICTI、SEDEX、WRAP、ETI、C-TPAT、GRS、GOTS、ISO 体系认证、BRC食品体系等。
客户标准是各个品牌商自己制定的行为准则,如Wal-mart沃尔玛、Disney迪斯尼、Coca-cola可口可乐、Zara、Macy’s梅西、Target 塔吉特、COSTCO好市多、Li&Fung利丰、Sears/Kmart西尔斯卡马特、Kohl’s科尔士、DG、LOWE’S 、H&M、Home Depot家得宝、Guess 古依斯、Staples史泰博、GAP嘉普、PVH、NIKE耐克、JCPenny杰西潘尼、Marks&Spencer玛莎、Tesco特易购、BEST BUY百思买、Mattel美泰、Nordstorm诺斯通、Saks INC萨克斯、Dollar General、Levis李维斯、Kingfisher翠丰、Charming Shoppes(CHRS)真美、Reebok锐步、Puma彪马、Adidas阿迪达斯、Metro麦德龙、LIDL、Carrefour 家乐福、Décathlon迪卡侬、VF威富、ICS、Polo保罗、McDonald's 麦当劳、KFC肯德基、Michaels、Inditex、woolworths、Walgreens、Primark、AVON、NBC、TJX、BYER、L'oreal、IKEA等。
Factory Evaluation check list
Factory Evaluation Report2.Factory Review 2.Factory Review 工场整体评估工场整体评估Review item1. Personnel administration 1. Personnel administration 人事管理人事管理1.1.Is there establish the procedure of personnel administration?1.2.Is there all the factory rule within the operation law?1.3.Is there the employees resume all accord with the rule?1.3. The monthly &OT remuneration accord with the rule?1.5.Are there all person must recording when in/entry ?1.6. Are the employees all is health when join to factory?1.7. Are there body check for employees periodic?1.8 Are all worker working hour and holiday within the rule?1.9 Are there good condition rest and eat zone to worker?Remark备注:pls detail refer to "RULES" sheet 参考”规律”专页。
2.Factory layout(2.Factory layout(工场布置工场布置工场布置) )2.1.Is there establish the layout of factory?2.2.Is there layout of factory benefit to produce, quality, delivery?2.3.Is there factory activities accord with the layout?.3.Factory safety &health 3.Factory safety &health工场安全与健康工场安全与健康3.1.Is the factory construction premises safety?3.2.Is there establish the document of factory safety?3.4.Is there a document of recover -production after calamity?3.5.Is there procedure of prevent poison, chemical, fire ?3.6.Is there factory activities accord with the procedure?3.7.Are the drill of calamity conducted plan and recorded?3.8.Is there the drawing of left when calamity?3.10.Is there medical centre and staff on site?3.11.Is there enough aid/medical facilities available nearby?3.12. Are the aid/medical facilities check periodic?Remark备注:pls detail refer to SAFETY" sheet参考“安全”专页。
ENG-01 DIRECTOR OF ENGINEERING工程总监岗位职责
JOB DESCRIPTION岗位描述JOB TITLE : DIRECTOR OF ENGINEERING职务 : 工程总监DEPARTMENT : ENGINEERING部门工程部JOB CODE : ENG-01代码REPORT TO : GM/RM上级主管总经理/驻店经理Date: 2007/8/22GENERAL MISSION职责概述To take overall charge of the repair and preventive maintenance of mechanical and electrical service, general building grounds and contents repair and maintenance, and for the efficient and safe operation of all plants, equipment, building systems, absolute priority fire preventive alarm system. Teach all Eng. Staff theoretically and practically. Cost control and comsumption control and manning control systematically and efficiently. Report to GM/DGM/RM.总负责所有的机械、电的维修和整个大楼及其中所有设备的维修及预防维修,并且须保证所有设备、大楼系统的效率和安全操作,特别是火灾报警预防系统。
教工程部所有员工理论以及实践上的知识。
系统且有效地控制成本和消耗,以及人员控制。
RESPONSIBILITIES职责TO TAKE OVERALL CHARGE OF ALL THE FOLLOWING ACTIVITIES:总负责以下事物:1.Ensure that effecitive control and productivity are maintained, whilst using every means to increase productivity andreduce costs. Periodically takes in reviewing the manning figures, keeping a balance between under andoverstuffing so that all employees are fully occupied during their hours on duty, whilst preventing excessive use of overtime or contractors. Completes annual Personnel Peformance Evaluations and salary, and position promotion.在设法增加产品并节约成本的情况下,确保维持产品的有效化和多样化。
高强度螺栓的扭矩系数.
查标准,我国的高强度螺栓的扭矩系数是一个从0.11~0.15的范围,标准同时规定,扭矩系数的标准差不得大于0.01。
查国外资料,发现扭矩系数与我国的规定很不一样,通常比我们大,这是为何?想来应该是与表面处理有关,如果我们的标准限制了新技术或者先进技术的应用吗?提问者:老陈发布时间:2007-4-28 20:10:00以下是回复内容:第1页,共1页扭矩系数与螺纹精度、表面粗糙度、尺寸精度、表面处理等方面都有关系,但是表面处理是影响扭矩系数的比较大的因素之一。
国家标准大六角头螺栓、螺母连接副的表面处理主要是磷化。
由于磷化的配方不同,扭矩系数也不同。
扭矩系数的大小范围是考核内容,但是扭矩系数的标准差是关键。
不能说国外的扭矩系数与我国规定的不同,就限制了新技术或者先进技术的应用。
答复者:张德利发布时间:2007-4-29 21:56:00本答案得分:5扭矩系数0.11~0.15,标准偏差小于0.01,仅仅是钢结构连接副的要求,并不是其他的高强度有要求。
注意'连接副"这一条件。
它是指一个螺栓,螺母,两个垫圈配套使用,并且表面处理也有严格控制。
一般的连接均没有垫圈,如果你用钢结构螺栓和螺母,用一般的垫圈或不用垫圈做扭矩系数试验,肯定不能达到0.11~0.15和0.01的要求。
扭矩系数主要与表面处理和被紧固件的表面状态有关。
答复者:吴明然发布时间:2007-5-11 21:50:00本答案得分:3磷化有什么重大意义吗,能得到相对稳定的扭矩系数吗——要满足“螺栓副”这个条件不难,但要施工中完全满足保管条件等,困难就大些?而且,扭矩系数0.11~0.15,这个范围太大,最好定在0.13~0.14之间,这样就可以大致定出螺栓的扭矩值来。
答复者:老陈发布时间:2007-5-19 21:29:00本答案得分:3看起来这个问题太复杂,没法回答。
答复者:老陈发布时间:2007-7-4 10:54:00本答案得分:3正如上几位的回答,影响扭矩系数的因素众多,不过,最主要的是表面状态,特别是润滑。
Microsoft Office 2007 完美版
中文名: Microsoft Office 2007 完美版英文名: Microsoft Office 2007 by A_Wind资源格式: 光盘镜像版本: 企业版+专业版+增值套件+自动安装发行时间: 2007年08月22日制作发行: Microsoft 的自动化办公软件。
啊风(A Wind)破解制作。
拥有强大的自动安装功能多种自动安装方案完全无人职守式安装。
适合企业用户和个人用户安装使用。
企业版+专业版+增值套件逐一分开基于MS原版ISO制作而成。
稳定完美的运行绝对免激活免KEY!!地区: 大陆,香港,台湾简介:Microsoft Office 2007 啊风完美版安装说明Microsoft发布了2007年的新版Office,我把得到的Microsoft Office 2007 专业版和企业版进行了免激活、和免序列号的处理并试用了一段时间。
在此之后,我觉得都很稳定,而且功能更完善,所将两个版本和Microsoft Office 2007 的增值套件集成到了这张光盘上,并且添加了自动安装脚本,希望您能喜欢!下面对本光盘的安装方式进行详细说明,请您在安装前务必仔细阅读以下说明:●1.版本说明:本光盘上的两个版本和增值套件都是MS发布的原版ISO文件,完整性不用质疑,稳定性也可靠(当然,这还取决于您的系统.)专业版包含:Access、Word、Outlook、powerpoint、excel、Visio Viewer、InfoPath 企业版包含:Access、Word、Outlook、powerpoint、excel、Groove、OneNote、Visio Viewer、InfoPath增值套件包含:Project、Share Point Designer(代替了以前的 FrontPage)、Visio建议:个人用户安装专业版(够用了),企业用户安装企业版(Groove很有用)对于开发用户而言,我建议再安装一下增值套件,因为MS的经营策略很精,我们也应该体验体验!=================================================================== ◆2.安装方式说明:分为手动安装和自动安装两大方式:手动安装:可以自主选择需要的组件、安装位置、注册信息等,可操作性强,但是需要输入序列号、填写注册信息。
美国GMP指南(英文)
GUIDELINE FORGOOD MANUFACTURING PRACTICESINSPECTIONSPAN AMERICAN NETWORK FOR DRUG REGULATORY HARMONIZATION WORKING GROUP ON GOOD MANUFACTURING PRACTICESMEMBERS*Justina Molzon*, Associate Director for International Programs, FDA/USA. Group CoordinatorArgentina: Carlos Chiale; Rodolfo Mocchetto*, Coordinator INAME/ANMATBrazil: Antonio Bezerra, Suzana Avila*, Inspección y Control de Medicamentos, ANVISACanada: France Dasereau, Stephen McCaul; Louise Jodoin*, Inspection Unit, Health CanadaChile: Magadalena Reyes*, Inspector GMP. Instituto de Salud Pública (ISP) Guatemala: Esmeralda Villagran; José Luis Aguilar; Norma de Pinto*, Jefe Monitoreo y Vigilancia de Medicamentos, Ministerio de SaludMexico: Rosa María Morales, Suleta García*, COFEPRISVenezuela: Elsa Castejón*, Asesora Dirección de Drogas y Cosméticos, Ministerio de Salud.ALIFAR: Miguel Maito, Gerente Laboratorios Farmacéuticos Argentina; Marisela Benaim*, CIFAR, VenezuelaFIFARMA, Marco Vega, QA/QC Manager, Lilly; Carmen Araujo, Laboratorios Elmor, Marisela Poot,* GSK Regulatory DirectorResource Persons:Rebecca Rodríguez, National Expert Drugs Investigator. FDA/USAMillie Barber, International Programa Manger, FDA/USASecretariatRosario D’Alessio, PAHO/WHOJuana M. De Rodriguez, PAHO-GuatemalaMiguel A. Lopez, PAHO-Venezuela*Current membersINTRODUCTIONThis Guideline for Good Manufacturing Practices Inspection for the pharmaceuticalindustry was prepared by the Working Group on Good Manufacturing Practices (WG/GMP), inMay 2003. The Guideline addresses the requirements of the WHO Technical Report onGood Manufacturing Practices # 32 and the particular considerations of all members of thegroup.The WG/GMP proposed a plan for Guideline validation, to the Steering Committee of thePan-American Network for Drug Regulatory Harmonization, which was approved and was developed in two parts:1. The Guideline was implementation in a pilot phase at volunteering pharmaceuticalindustry plants. PAHO/WHO Consultants, Drug Regulatory Officers and people from thepharmaceutical industry conducted the pilot implementation at several plants in differentcountries of the Americas Region. The guideline was later revised according to theircomments and suggestions regarding the contents and usefulness.2. The Guideline was published in the PAHO/WHO web page to promote participation anddiscussion by institutions and professional experts in this topic. This gave all those whowere interested, the opportunity to send suggestions, comments, or to simply give theiropinion. The Guideline remained in the web page since June 2004 in order to receivecomments and others input.Associations like (ALIFAR and FIFARMA) and countries (Argentina, Guatemala andVenezuela) also sent their comments.The GMP Working Group reviewed and analyzed all the comments received and preparedthis revised version of the Regional Guideline of GMP Inspection for the Americas, which is submitted for consideration to the IV Pan American Conference on Drug Regulatory Harmonization.Some of the advantages of the Guideline are:1. The guideline will help to establish the standards for GMP inspections;2. It will be more comprehensive than what is in place in the economic blocks (countries)and will send the message that countries need to work as a community to meetestablished standards; and therefore, improve the quality of pharmaceutical products;3. It will serve as a work model necessary for common criteria;4. It should not be used as a check list, but it should show principles important toconsider in association with an inspection;5. It can be used as a training document for GMP inspections; and6. It will be helpful to countries in educating inspectors with unified criteria.TABLE OF CONTENTSCHAPTER 1 (5)ADMINISTRATION AND GENERAL INFORMATION (5)CHAPTER 2 (8)PERSONNEL (8)CHAPTER 3 (10)PREMISES (10)GENERAL CONDITIONS (10)ANCILLARY AREAS (11)MAINTENANCE (12)CHAPTER 4 (13)WATER SYSTEMS (13)POTABLE WATER (13)PURIFIED WATER (14)WATER FOR INJECTION (17)CHAPTER 5 (21)STORAGE AREAS (21)CHAPTER 6 (29)RETURNED PRODUCTS (29)CHAPTER 7 (30)PRODUCTS RECALL (30)CHAPTER 8 (31)DOCUMENTATION (31)CHAPTER 9 (40)SAMPLING AREA (40)CHAPTER 10 (41)WEIGHING AREA (41)WEIGHING AREA (42)WEIGHING AREA (43)CHAPTER 11 (44)PRODUCTION (44)NON-STERILE PRODUCTS (44)PRODUCTION (53)SEGREGATED PHARMACEUTICAL PRODUCTS (53)PRODUCTION (54)STERILE PRODUCTS (54)CHAPTER 12 (68)QUALITY CONTROL (68)CHAPTER 13 (78)QUALITY ASSURANCE (78)CHAPTER 14 (83)VALIDATION (83)CHAPTER 1REF:ADMINISTRATION AND GENERAL INFORMATIONWHO 321 What is the company's name?________________________________________________________________________2 What is the company's legal address?_______________________________________________________________________3 What is the manufacturing site’s address?______________________________________________________________________4 Does the company have authorization, according to the regulations of each country, at other address(es)(warehouses, quality control laboratory, etc.) which are under the company’s responsibility?If "YES", indicate which companies and provide their addresses._______________________________________________________________________________________________________________________________________________________________________________________________________________5 Is there evidence of registration of the qualified person responsible by the Regulatory Authority?____________________________________________________________________________________________________________________________________________6 Is the qualified person responsible, according to company's organization chart, present at the time of theinspection?YESPROVIDE INFORMATION REGARDING THIS PERSON (WHO RECEIVES THE INSPECTION)________________________________________________________________________________________________________________________________________NO7 Is there evidence of a license to operate issued by the Regulatory Authority?Indicate all authorized activities.______________________________________________________________________________________________________________________________________REF:ADMINISTRATION AND GENERAL INFORMATIONWHO 328 Does the company develop exclusively those production and quality control activities properly authorizedby the Regulatory Authority?YESNO9 Does the company manufacture dietary supplements?YESNO10 Does the company manufacture cosmetic products?YESNO11 Does the company manufacture veterinary products?YESNO12 Does the company manufacture reagents for “in vitro” diagnostic use?YESNO13 Does the company manufacture reagents for “in vivo” diagnostic use?YESNO14 Does the company manufacture other products not indicated above?YESIf “YES” indicate below__________________________________________________________________________________________________________________________________NO15 Does the company manufacture products with beta-lactam active ingredients (penicillins /cephalosporins)?YESIf "YES", indicate in which pharmaceutical dosage form__________________________________________________________________________________________________________________________________NO16 Does the company manufacture products with cytostatic / cytotoxic active ingredients?YESIf "YES", indicate in which pharmaceutical dosage form__________________________________________________________________________________________________________________________________NO17 Does the company manufacture products with hormone active ingredients?YESIf "YES", indicate in which pharmaceutical dosage form__________________________________________________________________________________________________________________________________NOREF:WHO 32ADMINISTRATION AND GENERAL INFORMATION17.1 Does the company manufacture products with corticosteroids active ingredients?YESIf "YES", indicate in which pharmaceutical dosage form__________________________________________________________________________________________________________________________________NO18 Does the company manufacture products with active ingredients from biological origin?YESIf "YES", indicate in which pharmaceutical dosage form__________________________________________________________________________________________________________________________________NO19 Does the company manufacture products with active ingredients from biotechnological origin?YESIf "YES", indicate in which pharmaceutical dosage form__________________________________________________________________________________________________________________________________NO20 Is there a list available of current licensed products? Attach the listYESNO21 Is there a list available of marketed products? Attach the listYESNO21.1 Do all marketed products and its pharmaceutical presentations have current (valid) license?YESNO22 Are the updated building schematics approved by the Regulatory Authority shown, if required?YESNO23 Section 8. Does the company have contract production activities? YESNO24Section 8 Is there documentation certifying registration/authorization of the third party contracted by the Regulatory Authority?YESNO25 Section 8.15 Is there batch documentation issued by the third party in charge of production? YESNO26 Section 8 Does the company act as a third party producer? YESNO27 Sections 8.1, 8.3, 8.12 and8.13 If the company produces by or for third parties, are there contracts that link the parties? YESNOCHAPTER 2PERSONNELREF:WHO 32YES NO1 Sections 10.1, 10.4, 10.11,10.23. Are there Standard Operating Procedures (SOP) related to personnel, including professional qualification, training?2Section 10.3.Is there an updated organization chart of the company? Attach copy3 Section 10.3 Is there a description of the responsibilities and functions of production and quality control personnel?4 Section 10.6. Are the responsibilities of production and quality control personnel independent of each other?5 Section 10.7. Are there trained personnel for the supervision of production and quality control activities?6 Section 10.12. Is there a program for training new employees on GMP, including specific training appropriate to the duties assigned to them?6.1 Section 10.4,10.12. Is there a program for continuous training on GMP for all staff, including specific training appropriate to the duties assigned to them?6.2Section 10.12Are records kept?7 Section 10.15,10.23 Is there a SOP dealing with the use of proper clothing for other persons who enter production areas (technical service/maintenance, cleaning personnel, quality control inspectors, quality assurance inspectors, and visitors)?8 Section 10.23 Are there visible written instructions and/or diagrams for the right use of clothing in the change rooms and other areas where they are required?9 Section 10.16 Are the personnel required to undergo a medical examination prior to being employed (including sensitivity test to beta-lactam substances, if required)?10Section 10.1Are the personnel subject to periodic medical examinations, at least once a year?10.1Sections 10.18,10.19.Are the personnel required to report health problems?11 Section 10.16,10.18 Is there a procedure to prevent any person who has an apparent illness from entering areas in which they may adversely affect the quality of the product or affect their own health?12 Section 10.22 Is smoking, eating, drinking and chewing prohibited in production, storage and laboratory areas?REF:WHO 32PERSONNEL YES NO13Section 10.17Are the personnel instructed to wash their hands before entering production areas?13.1 Section 10.17 Are there signs posted outlining mandatory hand washing before exiting, in change rooms and washrooms?14Section 10.21.Are the personnel using the appropriate uniform for the specified area?12.1Section 11.12.Are the uniforms clean and in good condition?CHAPTER 3PREMISESGENERAL CONDITIONSREF:WHO 32YES NO1Section11.1Is the building exterior in good conditions?2 Section 11.2. Are there any sources of environmental contamination in the area surrounding the building?2.1Section11.2.If "YES", are protective measures undertaken?3 Section 11.2. Are the free and non-productive areas belonging to the company in good clean and orderly conditions?4 Section 11.2. Are the roads leading to the building tarred and/or built so that dust from the road is not a source of contamination inside the plant?5 Section 11.6 Is there any protection against the entry of rodents, insects, birds and other animals?6Section14.46(f)Is there a written pest control program with its respective records?7Section14.46(f)Is there a SOP for pest control?7.1 Does the SOP indicate the substances used for pest control?7.2 Does the Regulatory Authority authorize the used substances?8 Section 4.1 Does the SOP ensure the avoidance of contamination of starting materials, packaging materials, in process-products and finished products with rodenticides and/or fumigant agents?9 Sections 11.1;11.2and 11.21 Is the flow of personnel and materials such that they prevent product contamination?10 Are corridors free of in-transit materials?11 Sections 11.5 and 11.26 Are air conditioning and/or ventilation systems for each area in accordance with the operation to be carried out?WHO 32GENERAL CONDITIONSYES NO12Section11.5.Are visible electric installations in good conditions?13 Section 12.4. Are water, gases, electricity, steam, compressed air and other gas pipelines identified?14 Does the company comply with the national legislation on fire control andprevention?15 Sections 13.38 13.39 Are there SOPs for waste classification and treatment? Are they followed (or complied with)?16Sections13.38 and13.39Is waste treatment undertaken in the premises?16.1 Sections 13.38 and 13.39 If "YES", is there a specific area for waste treatment, completely separated from manufacturing areas?REF:WHO 32 ANCILLARY AREAS YES NO 1Section11.8.Are there general change rooms in the plant?2 Section 11.8. Are toilets, change rooms and showers separated from manufacturing areas?Are they of easy access, and in good condition with respect to cleanliness, sanitation, order and conservation?Are they adequate for the number of users?3 Section 11.7 Are the dining room, social areas and cafeteria (rest and snacks) separated from production areas?4 Sections 10.21 and 10.23. Are plant staffs (temporary and permanent) provided with proper working clothes for each area, including protective coverings to avoid direct contact with products and to protect themselves?5 Are there SOP’s for washing uniforms separately depending on the type of area(sterile, non sterile, maintenance, special products)?6 Is there a laundry area for uniforms which is separate from production areas?7 If an outside laundry facility is used, are personnel and the person responsibleinstructed about the corresponding SOP?7.1 Are there instruction records?WHO 32 ANCILLARY AREAS YES NO7.2 Is this outside laundry facility periodically audited?7.3 Are there audit records?REF:WHO 32 MAINTENANCE YES NO 8Section11.9.Are the maintenance areas physically separated from production areas?9 Is there a SOP of the use, cleaning and maintenance of different servicegenerated equipment?10 Are there preventive maintenance programs for equipment and critical supportsystems?Are performance records for this preventive maintenance program kept?11 Sections 18.18 and 12.11 Is equipment identified as out-of-service or in reparation identified as such? Are they removed from production areas as soon as possible?12 Section 14.46 (c) Is there a preventive maintenance program for the premises?Are there performance records for this preventive maintenance program?13Section14.47 (c)Are records of the usage of critical equipment showed?14 Section 12.1 Is there a preventive maintenance program for quality control equipment? Is there a performance record for this preventive maintenance program?REF:WHO 32 GENERAL SERVICES YES NO15Section15.11Is there a pure steam generator, if necessary?16Section15.11Is there a compressed air generator free of oil, if necessary?17 Sections 15.17Is there an electricity generator for the maintenance of critical systems and processes to be used in case of problems with the electricity supply occur?18Section11.2Are the system generators for different services separated from production areas?19 Do they use gases that will be in direct contact with products?19.1 Are gas piping and valves in good conditions and are they dedicated for each gas?CHAPTER 4 WATER SYSTEMSREF: WHO 32POTABLE WATERYes No NA What is the source of water used in the company?Public Network?Artesian Well, semiartesian well?1Others?2 If necessary, is any treatment for making water potable undertaken before the water isstored?2.1 Does the selected treatment assure potability, according to each country’s requirements?3 Are the system schematics shown?Are the distribution network layouts shown?Are the sampling points shown?4 Does the company have water tanks?4.1 What materials is the water tanks made of?5 Are the cleaning and disinfecting procedures for water and cistern tanks documented?Does the procedure include a justifiable frequency and sampling points?5.1 Are performance records shown?6 Are physicochemical tests of potable water undertaken?Are physicochemical tests of potable water recorded?Indicate frequency7 Is potable water used as a source of purified water or water for injection production?8 Is microbiological control of potable water undertaken?Is microbiological control of potable water recorded?Indicate frequency9 Is potable water used for the initial washing of equipment and tools?10 Is the visible piping used for the transportation of potable water maintained in goodconditions?WHO 32 POTABLE WATER Yes No NA11 Is there a preventive maintenance program that includes the potable water system?Is there a performance record for this preventive maintenance program?REF:WHO 32 PURIFIED WATER Yes No NA1 Is the purified water used, produced by the company?Which is the system used to obtain purified water?Ionic exchange resins?Reverse Osmosis?Distillation?2Others (specify which)?3 Section 17.33 Are the system schematics shown?Are the distribution network layouts shown? Are the sampling points shown?4Section17.33What is the production capacity in liters/hour?4.1 What is the average consumption?5Section14.35Are there written procedures for the operation of the system?7Section17.33Is the purified water stored?7.1 What is the reservoir capacity?7.2 Is the reservoir constructed of sanitary type material?8 If purified water remains stored longer than 24 hours, is there any treatment to preventmicrobiological contamination?8.1Section17.33Does the selected treatment prevent microbiological contamination?9 Are the pipes and valves used to distribute purified water made of sanitary material?10Section15.21Are the visible piping used in water distribution maintained in good conditions?11Sections15.2117.42Is the distribution system of purified water sanitized?WHO 32 PURIFIED WATER Yes No NA 11.1 Is there a SOP for the sanitation of purified water storage and distribution system?11.2 What is the sanitation method used?11.3 In the case of an open distribution system that is not used in 24 hours or more, issanitation undertaken the day before its use?11.4 Are records kept?11.5 In the case of chemical sanitation, are sanitizing agent residues tested?11.6 Arethererecords?12 Is there any type of filter in the distribution system?12.1 In the case that filters exist, are they sanitized?12.2 Are the filter sanitation records shown?12.3 Are the filter replacement records shown?12.4 In the case of open distribution system not used in 24 hours or more, is sanitation donethe day before its use?13 Is any other system, to reduce bacterial burden from purified water, used in thedistribution system?Which type?14 Is the purified water used as a raw material to manufacture non-parenteral products?15 Is the purified water used for washing production equipment and utensils?15.1 Is the purified water used for the final rinse of the equipment used in the manufacture ofnon-parenteral products?15.2 Is the purified water used for the final rinse of the equipment used in the manufacture ofnon-parenteral products?16 Is a non-continuous purified water production system used?16.1 Section 17.42 Does each batch or production day release, by Quality control, undergo physicochemical test established official pharmacopoeias or by alternative validated methods?16.2Section17.42Are microbiological controls undertaken on the day of use?16.3 Is an action limit established?16.4 Is the action limit no more than 100 cfu / mL?WHO 32 PURIFIED WATER Yes No NA 16.5 When the action limit is exceeded, is an investigation always undertaken to ensurequality of the batches of products made with such water?16.6 Is the documentation shown?17 Is a continuous system of purified water production used?17.1Section17.42Is there a continuous monitoring of the quality of the purified water?17.2 Is there an automatic system to prevent use of the purified water, if this is out ofspecifications?17.3 If there is an automatic system, is this checked to verify that it is functioning properly?17.4 Are physicochemical analyses undertaken daily or with an established frequencyaccording to the procedures established by current editions of official pharmacopoeias orby alternative validated methods?17.5 Are microbiological analysis undertaken on the days of use or with an establishedfrequency which is properly validated?17.6 Is an action limit established?17.7 Is the action limit no more than 100 cfu / mL?17.8 When the action limit is exceeded, is an investigation always undertaken to ensurequality of the batches of product made with that water?17.9 Is the documentation shown?18Section17.42Are the sampling points rotated to cover all points of use?19 Is there a SOP for sampling?20 If the water that feeds the system is chlorinated, is there a system to remove thechlorine?21 Are ionic exchange resins used?21.1 Section 17.42 Is there a SOP that considers the criteria to follow for the regeneration of resins and the frequency of regeneration?21.2Section17.42Are records kept?22 Are there SOPs for the sanitation of the purified water system?22.1 What is the sanitation system used?WHO 32 PURIFIED WATER Yes No NA 22.2 What is the sanitation frequency?22.3 Are records kept?23 Is there a preventive maintenance program that includes the components of the purifiedwater system?23.1 Are records kept?REF:WHO 32 WATER FOR INJECTION Yes No NA1 Which treatment system is used to get Water for Injection?2 Section 17.33Are system schematics shown?Are distribution network layouts shown? Are sampling points shown?3Section14.35Are there written procedures for the operation of the system?4Section17.33What is the production capacity in liters/hour?4.1 What is the average consumption?5 If a reverse osmosis system is used:5.1 Is a two-steps system or double osmosis system used on line?5.2 Is the water that feeds the system pre-treated?5.3 What is the pre-treatment system?5.4 Is the system sanitized?5.4.1 What is the sanitation frequency?5.4.2 Are records kept?5.5 In case that chemical sanitation is undertaken, are sanitizing agent residuesinvestigated?5.5.1 Are records kept?6 If distillation is used:6.1 Is the water that feeds the system pre-treated?WHO 32 WATER FOR INJECTION Yes No NA6.2 Which is the pre-treatment system?____________________________________________________________________________________________________________________________7 Is there a storage tank for the Water used for injection?7.1 Is the tank made of sanitary material?7.2 What is its capacity?7.3 Does it have a hydrophobic vent absolute filter?7.4 Are periodic integrity tests undertaken?7.5 Are records kept?8 Are pipes used in the distribution of Water for Injection up to the point of use?8.1 Are pipes made of sanitary material?8.2 Is there any type of heat exchanger in the system?8.3 If “YES", are there guarantees that the heat exchanger is not a source of contamination?9 Is there a SOP for the sanitation of the water storage and distribution system?9.1 What is the sanitation method used?9.2 What is the sanitation frequency?9.3 Are records kept?9.4 In case of chemical sanitation, is the existence of sanitizing agent residues investigated?9.5 Are records kept?9.6 If sanitation is thermal, is it undertaken periodically by a fluent steam circulation?9.7 Are records kept?10 Section 17.33 If water is not used the same day of its production, is the water maintained above 80 °C or below 4º and with constant recirculation through a loop up to points of use?11 If recirculation is below 4o C, ¿are additional precautions taken to prevent access ofmicrobial contaminants and its proliferation?WHO 32 WATER FOR INJECTION Yes No NA 11.1 What are those precautions?________________________________________________________________________________________________________________________________________________________________________________________11.2 Do the storage and recirculation of the water at this temperature ensure its qualityaccording to its use?12 If the water is produced by reverse osmosis, is there any system to maintain its quality?13 If the company manufactures parenteral products, does it use water for injections as araw material?14 If the company manufactures parenteral products, does it use water for injections for thefinal rinse of equipments and components used in manufacturing?15 Is a non-continuous and non-recirculated production system of Water for injection used?15.1 If this is the case: is water used only during the day of its production?15.2 Is water disposed at end of the day of its production?15.3 Is each batch released by Quality control by physicochemical and bacterial endotoxinstests according to the procedures established by current editions of officialpharmacopoeias or by alternative methods validated?15.4 Are microbiological tests of each batch undertaken?15.5 Is an action limit established?15.6 Is action limit no more than 10 cfu /100mL ?15.7 When the action limit is exceeded, is an investigation of the system always undertaken?15.8 Is the investigation report shown?15.9 Are measures undertaken?15.10 What measures are undertaken?16 Is there a continuous system of for the production of water for injections used?Is there a continuous monitoring of the water quality?16.1Section17.4216.2 Is there an automatic system to prevent the use of the water for injections, if it is out ofspecifications?。
Technical evaluation (中英文版) for Factory
Technical Evaluation & Quality SystemAssessment- Apparel01_Quality Leadership品质领导力02_Essential Supply-chain Capabilities必要的供应链能力2-4There is a system to maintain product standards and specifications.应有系统保持产品标准和规格。
2-5There is a procedure to ensure that design or specification changes are reviewed, approved and controlled and customer updates are communicated to all area's of production.应该有一个程序确保设计或规格变更被评审、批准以及受控,并确保客户补充资料在生产的2-6There are statistical techniques for controlling product performance during each stage of production.在生产的各个阶段应该有统计技术控制产品性能。
1-10There is a quality system co-ordinator on site and a systems audit schedule and system control accreditation procedure (Quality Management Service team) (ISO 9000)应有一个品质体系现场协调员和体系审核计划,以及体系体系控制认证程序(品质管理服务Inspection points检查点Management管理2-1There is a up to date company profile available应有最新的公司简介。
2007年8月22日第四次加息
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适 当增加 百姓 存款 利益 收益 , 可缓解 目前 因物 价上 涨 给百姓 带来 的不 利影 响 。
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响 , 月 份全 国居 民消 费价格 总水平 同 比上 涨到 5 6 7 .%。这 是 我 国 C I 续 5个 月 同 比上涨 P连 达到 3 %以上 , 是近 1 也 0年来 C 1 度涨 幅最 高 的一个 月 。 P月 “ 行如 此密 度频 繁加息 , 在更加 明确 地通 过 货 币 政 策传 递 紧 缩信 号 , 而 更 有 效地 央 是 从 影 响企 业和 个人 的 的预 期 。 中国社科 院金融 专 家易宪 容接 受新 华社 记者 采访 时表 示 。 ” 算上 此 次加息 , 央行 半年 内 四度 上 调贷 款 基 准利 率 共 计 0 9 .9个百 分 点 , 递从 紧 信号 传
化工厂分析员员工自我评价
化工厂分析员员工自我评价英文回答:As an analyst at a chemical factory, I believe that my self-evaluation is crucial in order to assess my performance and identify areas for improvement. I wouldlike to evaluate myself based on several key aspects.Firstly, in terms of technical skills, I consider myself proficient in analyzing chemical samples and interpreting data. I have a strong understanding of various analytical techniques, such as chromatography and spectroscopy. For example, I am skilled in operating gas chromatography-mass spectrometry (GC-MS) to identify and quantify chemical compounds in samples. This expertise allows me to accurately analyze the composition of raw materials and finished products, ensuring quality control and compliance with industry standards.Secondly, I believe that effective communication is avital skill for an analyst. I am confident in my ability to convey complex technical information to both technical and non-technical stakeholders. For instance, I often prepare detailed reports and present my findings to the management team, using clear and concise language to ensure understanding. Additionally, I actively participate in team meetings and collaborate with colleagues to share knowledge and address challenges collectively.Moreover, I consider myself highly organized anddetail-oriented. I pay meticulous attention to every step of the analysis process, from sample preparation to data interpretation. This attention to detail helps me identify any anomalies or inconsistencies in the results, ensuring accuracy and reliability. Furthermore, I am skilled in managing multiple projects simultaneously, prioritizing tasks, and meeting deadlines. This ability to handle a heavy workload while maintaining quality is essential in the fast-paced environment of a chemical factory.In terms of personal qualities, I believe that I am a proactive and adaptable individual. I am always eager tolearn and stay updated with the latest developments in the field of chemical analysis. For example, I regularly attend conferences and workshops to enhance my knowledge and skills. Additionally, I am open to feedback and constantly seek opportunities for self-improvement. This willingness to adapt and grow allows me to thrive in a dynamic andever-evolving industry.Overall, I am confident in my abilities as an analyst at a chemical factory. My technical expertise, effective communication, organizational skills, and personalqualities contribute to my success in this role. I strive to continuously improve and deliver accurate and reliable results to support the operations of the factory.中文回答:作为一名化工厂的分析员,我认为自我评价对于评估我的表现和找出改进的方向非常重要。
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铸件得细晶区、柱状晶区及等轴晶区、JPG(627、21 KB)
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福州市物价局关于闽清县电网峰谷分时电价计费办法的批复-榕价商[2007]48号
福州市物价局关于闽清县电网峰谷分时电价计费办法的批复正文:---------------------------------------------------------------------------------------------------------------------------------------------------- 福州市物价局关于闽清县电网峰谷分时电价计费办法的批复(榕价商[2007]48号2007年8月22日)闽清县物价局:你局梅价[2007]40号《关于闽清县电网实行峰谷分时电价政策的请示》悉。
根据《福建省物价局关于进一步完善趸售县峰谷分时电价政策等有关问题的通知》(闽价商[2007]95号)精神,经研究,现将你县电网峰谷分时电价计费办法有关事项批复如下:一、峰谷时段划分:上网侧和销售铡的峰、平、谷时段统一划分为:高峰时段:8:30-11:30、14:30-17:30、19:00-21:00低谷时段:23:00-次日7:00其余为平时段。
二、上网侧峰谷分时电价实施范围和浮动幅度:实施范围:上闽清县电网的所有水力发电企业。
浮动幅度:以有权价格主管部门审批的上网电价为基础,高峰时段电价上浮20%,低谷时段电价下浮20%,平时段执行有权价格主管部门审批的上网电价。
三、销售侧峰谷分时电价实施范围和浮动幅度:实施范围:大工业用户、受电变压器容量100千伏安及以上的非普工业用户的电度电价。
24小时连续生产的用户,可根据自愿原则决定是否申请实行峰谷分时电价。
浮动幅度:以有权价格主管部门审批的目录电价为基础,高峰时段电价上浮25%,低谷时段电价下浮25%,平时段执行有权价格主管部门审批的目录电价。
电度电价内代征的政府性基金不实行浮动。
四、实行峰谷分时电价的用户需装置分时电度表,并由电力部门统一安装、管理。
以上批复自2007年9月20日抄见电量起执行至2008年8月20日止,如遇国家峰谷电价政策调整,按国家规定政策执行。
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FACTORY EV ALUATIONAPPROVED□ RECOMMENDATION □HOLD FOR INSTRUCTION □DISAPPROVED□(Recommendation is For Technical Evaluation only)Customer:Factory Name&address:1.0FACTORY DETAILS: order product:_____________1.1 QUICK OVERVIEW:Total Factory Area :Production Area: Office Area: Dormitory:Total No. of Employees: Turnover Rate: % Local: Other Provinces:Overseas:No. of Operators In:Processing: Design:Assembly: Office:Inspection:Packing: Quality Assurance:No. of workers in factory during visit:No. of workers in factory during peak season:Production Capacity: doz/mth Product produced: Minimum Order Quantity:Production Leadtime: days for an order of 1,5000-2,0000 pcs. Utilities:Electric Power: □self sufficient □power station □bothWater Supply: □self sufficient □town water □bothGoods Made During Plant Evaluation:Brands: Type:Quallity of The Goods Made:Randomly select and inspect 20 pieces of the goods made,□Good Quality – no major found□Acceptable Quality – 1 major found□Unsatisfactory Quality – 2 or more majors found□Unsatisfactory Quality – 5 or more minors foundDeseription of The Manufacturing Processing:1.2 NATURE OF BUSINESSThe manufacturing facility can do the following processing and can make the following products ( Tick the appropriate box)Product/Process Specific Type Product/Process Specific Type Screws□Plastic Molds □Bolts□Machined Metal Parts □Nuts□Machined Plastic Parts □Washers□Extruded Metal □Nylon Fasteners□Wire / Wire harnesses □Rubber Seals / O-Rings□Electronic Components □Stampings□Heat Treating □Wire Forms□Light Assembly □Raw Metal Casting□Heavy Assembly □Plating□Welding □Painting□□Powder coating□□□□□□1.3 EXPORT MARKETThe market(s) of the factory is / are : (Tick the apppropriate box and□give percentage ) USA□%Canada□% Europe□%Australia□% South America□%Japan□% China□%Others(Please Specify)□%1.4 MAJOR CUSTOMERSThe five main customers in descending order are:1.5 TYPE(S) OF MANUFACTURING(Tick the appropriate box□and give percentage)OEM (Original Equip □%Assembly Line System □% Manufacturing)ODM (Own Design □%Product Line System □% Manufacturing)Module (self contained □%Others(Please specify)□% Manufacturing units)2.MANAGEMENT / HOUSEKEEPING2.1 PLANT LAYOUTYes No 2.1.1Is there a written plant layout?□□□□2.1.2Does the written plant layout include all the departments in thefactory?□□2.1.3Are all manufacturing equipment / machines drawn in the writtenplant layout?2.1.4Was the written plant layout look to be effective?□□2.1.5Does the actual plant layout look to be effective?□□Remarks:2.2 GENERAL HOUSEKEEPINGYes No N/A 2.2.1 Were the warehouse(s) clean and well organized? □□□2.2.1 Were the workshop(s) clean and well organized? □□□□□□2.2.3 Were the machine(s) & production equipment clean and wellorganized?2.2.4 Were the tool / jig & fixture storage(s) clean and well organized? □□□2.2.5 Were the open area(s) clean and well organized? □□□2.2.6 Were the maintenance room(s) clean and well organized? □□□Remark:2.3 MAINTENANCE OF THE PREMISES Yes No N/A□□□2.3.1 Does the factory maintain a plan for maintaining the facilities(e.g. lighting, lift, electrical supply, computer network, walls,water supply, windows)?□□□2.3.2 Does the factory maintain a checklist for the inspection thefacilities in the premises?2.3.3 Is the data in the premises inspection checklist valid? □□□□□□2.3.4 Does the factory maintain a maintenance record for inspectionof premises?2.3.5 Are the records maintained and organized well? □□□Remark:2.4 MANAGEMENT AND MAINTENANCE OF THE PRODUCTIONEQUIPMENT AND MACHINES Yes No□□2.4.1 Does the factory maintain procedures / plan for managing andmaintaining production equipment and machinery?□□2.4.2 Does the factory possess a master list for all production equipment andmachines?□□2.4.3 Does the factory identify the critical production equipmentand machines?□□2.4.4 Does the factory possess the work instructions or specificationsfor inspecting and maintaining the critical production equipmentand machinery?□□2.4.5 Does the factory maintain a checklist showing the schedulefor inspecting each critical production equipment and machinery?□□2.4.6 Does each of the critical production equipment and machinerypossess a maintenance record?Remark:2.5 MANAGEMENT OF TOOLS / JIGS & FIXTURES Yes No N/A□□□2.5.1 Does the factory designate a special area for storage of tools /jigs & fixtures?2.5.2 Are the tools / jigs & fixtures stored well in this area? □□□□□□2.5.3 Does the factory maintain a master list recording all its tools /jigs & fixtures□□□2.5.4 Do the tools / jigs & fixtures have any identification (i.e. the toolnumber / tool name)□□□2.5.5 Does the factory record the position of the tool / jigs & fixturesStorage in the designated area?□□□2.5.6 Are the tools / jigs & fixtures put in the right place as stated inthe record?□□□2.5.7 Can the factory trace where the tool / jigs & fixtures has beenstored?□□□2.5.8 Does the factory maintain receive and release records of itstools / jigs & fixtures?□□□2.5.9 Does the factory have adequate resources to repair tooling ordics and molds?□□□2.5.10 In cases where tooling management is not an in-house capability,is the factory capable to monitor its tooling subcontractors?Remark:2.6 MANAGEMENT OF WAREHOUSES Yes No N/A□□□2.6.1Does each material / each batch of finished producthave any label or tag with QC approval for identification inthe warehouse(s)?2.6.2 Are materials handled to prevent damage or deterioration? □□□2.6.3 Are materials stored and recorded in designated areas? □□□□□□2.6.4 Are there formal procedures to control inventorytransactions to and from these areas?□□□2.6.5 Are materials preserved and segregated while underthe factory’s control?□□□2.6.6Is the product (material and end product) suitablyprotected after test / final inspection?Remark:3.1 PURCHASING Yes No□□3.1.1 Are procedures documented and maintained to ensurethe specified requirements for all purchased products andservices are fully met?□□3.1.2 Are purchase orders completed with sufficient data toclearly describe the product ordered?□□3.1.3 Are there any procedures to describe the selection andevaluation of all suppliers?□□3.1.4 Does purchasing or other departments maintain a SupplierHistory in terms of quality, quantity and time of delivery?□□3.1.5 Are there any provisions for the factory to verify purchasedproducts at their supplier’s premises when necessary?Remark:3.2 MATERIAL CONTROL Yes No□□3.2.1 Has the factory assigned special personnel(s) to deal withmaterial control?□□3.2.2 Are procedures documented for controlling the materialsin/out of the storage?3.2.3 Are materials in / out records maintained?□□3.2.4 Was the data in the records valid and accurate?□□□□3.2.5Does the factory have any computer system / programhandling the material control?3.2.6 Does the factory record the data manually?□□3.2.7 How often does the factory update the material in / out records?□□□□3.2.8 Does the factory have stock take on a regular base? Did thefactory have any stock take records?□□3.2.9 Are there procedures for the verification, storage, andmaintenance of customer- supplied materials?□□3.2.10 Is there a system for recording and reporting customer-suppliedor self purchased products lost ,damaged or unsuitable for use?Remark:3.3 PRODUCTION PLANNING Yes No 3.3.1 Does the factory maintain a master production plan? □□□□3.3.2 Does the factory maintain a production plan which definedthe quantity and lastest completion date of each process for allthe purchase orders?3.3.3 Does the factory have any regular weekly review cycle? Does □□the factory maintain meeting records?□□3.3.4 Does the factory organize pre-production meeting? Who areat the meeting? Please list.3.3.5 Does the factory maintain a daily production report? □□3.3.6 Does the factory maintain a weekly production report? □□□□3.3.7 Does the factory have any verification between the productionplan and production reports?3.3.8 Does the factory operate in a JIT(just-in-time) environment? □□Remark:3.4 SHIPPINGYes No ★3.4.1 How many staff are responsible for shipping in the factory?★3.4.2 How many years have they worked in handling the shipping?3.4.3 Does the factory have any container loading facilities? □□□□3.4.4 Does the factory keep adequate records and documents such asinvoice, packaging list, country of origin, foam A or B/L aftershipping the products?3.4.5 Were these shipping documents accurate? □□□□3.4.6 How many days does the factory require to arrange the trailer(s)or container(s) prior to the ship day(s) date in the purchaseorder?Remark:4. DESIGN / ENGINEERING Yes No ★4.1.1 Do the factory have Design / Engineering / R & D department(s)? □□★4.1.2 What are they?Product Design □Graphic Design □Packaging Design □Model Shop □Mechanical Eng □Electronic Eng □Industrial Eng □Packaging Eng □Quality Eng □Remark:4.1 DESIGN CONTROL Yes No□□4.2.1 Does the factory have the ability / capacity for Design?(If No, skip to section 4.3)□□4.2.2 Does the company have documented procedures for thecontrol and verification of design activities?□□4.2.3 Is there objective evidence that design personnel possessadequate resources and equipment?□□4.2.4 Are the methods used to communicate design activities betweenfunctional groups defined and documented?□□4.2.5 Are the applicable and regulatory requirements for design inputidentified and documented?□□4.2.6 Are incomplete, ambiguous, and/or conflicting requirementsresolved with those responsible for imposing the requirements?□□4.2.7 Are there formal documented reviews of design planned andconducted?4.2.8 Are records of design reviews maintained? □□□□4.2.9 Has design validation been performed to insure that productconforms to defined user needs and/or requirements?□□4.2.10 Are design changes and modifications identified, documented,reviewed and approved by authorized personnel prior to theirapplication.Remark:4.2 INDUSTRIAL ENGINEERING Yes No N/A□□□4.3.1 Is there a manufacturing flow chart/line layout for eachprocess or product, with inspection points?□□□4.3.2 Are critical processes/materials identified in themanufacturing flow chart/line layout?4.3.3 Are there work instructions for each process or product? □□□□□□4.3.4 Do the factory maintain a pilot run report for each of thenew product prior to bulk production ?□□□4.3.5 Do the factory have any production engineers? Do theymaintain any performance data for each process of eachproduct?Remark:5.IN-HOUSE QUALITY ASSURANCE5.1 GENERAL COMMENT FOR INSPECTION AND TESTINGGood Fair Poor Incoming □□□In-process □□□Final □□□5.2 INSPECTION AND TESTING5.2.1 Are there document instructions for inspection and test activitiesIncoming Yes□No□In-process Yes□No□Final Yes□No□5.2.2 Is the quality plan (or documented procedure) provided for required inspection, testing, and records?Incoming Yes□No□In-process Yes□No□Final Yes□No□5.2.3Are products inspected, indentified, and tested according to quality plans /procedures?Incoming Yes□No□In-process Yes□No□Final Yes□No□5.2.4If product is released for urgent production purposes prior to verification, is itpositively identified and recorded?Incoming Yes□No□In-process Yes□No□Final Yes□No□5.2.5Are all inspections, tests, and records completed before release?Incoming Yes□No□In-process Yes□No□Final Yes□No□5.2.6Do procedures and practices prevent the release of product that has not passedinspections and test?Incoming Yes□No□In-process Yes□No□Final Yes□No□5.2.7Are Quality Control Inspectors responsible for production work in addition to theirregular duties?Incoming Yes□No□In-process Yes□No□Final Yes□No□5.2.8Is there a statistically valid sample plan for all inspection activities, and are AQLlevels for inspections appropriate for the product produced?(see AQL Guide) Incoming Yes□No□In-process Yes□No□Final Yes□No□5.2.9Are records of inspections establisted and maintained?Incoming Yes□No□In-process Yes□No□Final Yes□No□5.2.10Is a product/dock audit completed on a regular frequency to insure all specificrequire ments were met?Yes □ No □Yes No□□5.2.11 Are there documented procedures for the identification,collection, indexing, access, filing, storage, maintenance, anddisposition of quality records?5.2.12 Are quality records legible and retrievable? □□5.2.13 Is the retention time for all records specified and adhered to? □□5.2.14 Does the factory management review the quality records? □□5.3CONTROL OF NONCONFORMING SEMI-FINISHED/FINISHEDPRODUCT Yes No□□5.3.1Are nonconforming semi-finished/finished products documented,identified and segregated?□□5.3.2Are nonconforming semi-finished/finished products traceable toa quality record?□□5.3.3 Do Quality Assurance have the authority to stop productionand shipment of nonconforming lots?□□5.3.4 Has the authority for the evaluation and dispositionof nonconforming semi-finished/finished products beenidentified?Remark:5.4 CORRECTIVE AND PREVENTIVE ACTION Yes No□□5.4.1 Are records of nonconforming materials published and actedupon for corrective action?□□5.4.2 Are records of nonconforming materials reviewed and analyzedfor repetitive discrepancies?5.4.3 Are corrective actions effective? □□□□5.4.4 Are appropriate sources of information utilized to detect, analyzeand eliminate potential causes?5.4.5 Are corrective/preventive action investigation results reviewed □□by upper management?□□5.4.6 Are corrective/preventive actions taken and confirmed byconcerned parties?Remark:5.5 CONTROL OF INSPECTION MEASURING AND TEST EQUIPMENTYes No N/A□□□5.5.1 Are there documented procedures for the control ofinspection, measuring, and test equipment?□□□5.5.2 Are all inspection, measuring and test equipmentused to verify product quality verified and calibratedbefore release for use?□□□5.5.3 Are all inspection, measuring and test equipmentcapable of measuring the required attribute?□□□5.5.4 Are all inspection, measuring and test equipmentsuitably identified as to their calibrated status?□□□5.5.5 Are all inspection, measuring and test equipment ona suitable recall system, i.e. traceable when therearise a problem?5.5.6 Are calibration records maintained? □□□□□□5.5.7 Are the environmental conditions suitable for thecalibrations, inspections, measurements and testbeing carried out?Remark:5.6 PRODUCT SAFETY Yes No N/A6. QUALITY SYSTEM6.1 QUALITY SYSTEMYes No N/A□□6.1.1 Is there a Quality Manual, and has it been reviewd byupper management?□□□6.1.2 Are there Quality Procedure Sections in the QualityManual for control of activities affecting quality?□□6.1.3 Is there any working instruction at each of the workstation?6.1.4 When was the Quality Manual last reviewed? □□□□□6.1.5 Does Quality Assurance have the support of UpperManagement? How is this demonstrated?□□□6.1.6 Are the Quality Policy and supporting proceduresknown and undertood at all levels?□□□6.1.7 Is the quality system evaluated to be efficient and effectivein the manufacturing facilities?□□□6.1.8 Is the Quality manual found to be comprehensive andfulfilled the ISO 9001 quality management systemstandard?6.1.9 To whom does the head of Quality Department report to? □□□Remark:7. CONCLUSIONS AND RECOMMENDATIONShas been assessed to be in the Hardline technical evaluation.The results of the assessing areas were summarized as follows:A-Excellent, B-Good, C-Acceptable, M-Marginal, F-Fail1. Management / Housekeeping………………………………………………( )2.Material Control / Production Planning / Shipping ………………………( )3.Design / Engineering…………………………………………………………( )4.Capacity and Facilities………………………………………………………( )5.In-house Quality Assurance…………………………………………………( )6.Quality System………………………………………………………………( )Overall Rating ( ) Other comments:Inspector:_____________________________ Date:________________________________Please insert pictures on the following table:。