1、合格供應商年度稽查表A. Factory Con tact In formatio n（工廠的聯絡信息）A1. Holdi ng compa ny 控股公司Name:名稱公 司 印早：Address 地址Primary con tact pers on n ame: 主要聯系人名稱Title:職級Teleph one 電話Fax:傳真E-mail:A2. Factory 工廠En glish Name:英文名Chin ese Name中文名En glish Address: 英文地址Chin ese Address中文地址Primary con tact pers on n ame: 主要聯系

2、人名Title:職級Teleph one電話Fax:傳真E-mail:B. Checklist審核清單1. Quality Ma nageme nt System 質量管理系統Yes是No否Remark備注 1.1 Does the factory have any certified quality/environment management system such as ISO 9001/ ISO 14001?工廠是否建立類似ISO 9001/ ISO 14001公認的質量/環境管理系統？1.2 Has the manufacturer documented its quality sy

3、stem in a documentation of quality policy, quality objective and quality manu al?有無形成文件的質量方針，質量手冊，質量目標？是否有貫徹執行？ 1.3 Does the factory well define the responsibilities of Quality staff? 工廠是否確定質量人員的職責？1.4 Have the responsibilities and authorities of the management within the manu facturer bee n defi ne

4、d and established a procedure?是否有文件規定管理人員的職責及權限？1.5 Has a member of man ageme nt bee n appo in ted as a Man ageme nt Represe ntative with resp on sibilities and authorities?是否有指定管理者代表并明確其職責和權限？ 1.6 Is there an Organizational Chart? 是否有組織結構流程圖？1.7 Is there a In ternal Quality Audit Procedure? Does th

5、e manu facturer con duct the internal audi?是否有內部質量審核程序并按程序執行?1.8 Is there a procedure of Man ageme nt Review and impleme nted? 是否有管理評審程序并執行 ？ 1.9 Does the factory evaluate its ven dors periodically and keep a ven dor list? 工廠是否定期地評估供應商及保留一份供應商的目錄？ 1.10 Is there an effective procedure to define Ident

6、ification and Traceability through raw materials to fini shed product?從來料到最終產品的追溯是否有一項有效的程序來確認？Findin gs: 稽查的結果：2. Warehouse倉庫2.1 Warehouse man ageme 倉庫管理Yes是No否Remark備注2.1.1 Is there a procedure to con trol the incoming materials and impleme nted effective?是否有進料檢驗程序并有效執行？2.1.2 Is the storage area t

7、idy, clean and sanitary? 倉庫是否整潔、清潔、衛生？2.1.3 Is there a procedure to con trol the operati on in warehouse? 貨倉是否有控制程序？2.1.4 Does factory apply the FIFO (First- In-Fist-Out)? 工廠是否有實施物料發放先入先出？2.1.5 Are there wait ing check area, confirming area and nonconforming area and they are marked clearly?是否有待檢區、合

8、格區、不合格區且分區是否清楚？2.1.61s the materials/products separated and marked clearly? Do the Materials or products store meet the requireme nt? Is there a record for en teri ng or issu ing any materials /products?物料/成品分區是否明確？貨品的擺放是否符合要求？進出物料等是否有效 的記錄控制？2.1.7Are the materials/products identified clearly, in or

9、der to avoiding misuse? 物料/成品是否標識清楚，以防止誤用？Findin gs: 稽查的結果：2.2 Nonconforming products不 合格品2.2.1 Is there a procedure to con trol of nonconforming products and impleme nted Have the controls and related responsibilities and authorities for dealing with noncon form ing product bee n defi ned clearly?是

10、否有不合格品控制程序并執行？不合格控制及處置的有關職責和權利是否有明確的規定？?2.2.2Have the nonconforming products bee n marked and separated? Have actior bee n take n and records bee n mai ntai ned for the noncon form ing product? Are th physical character nonconforming products and en vir onmen tal substa nee noncon form ing products

11、separated and marked clearly?不合格產品是否有得到標識，隔離？物理性質不合格與環境有害物質不合格is是否分開放置？2.2.3 Have the nonconforming product bee n subject to re-verificati on to dem on strate con formity to the requireme nts after reworked?是否有不合格品的處置的相關措施及記錄？不合格品若返工后有無得到再次驗證？2.2.4 Have acti ons and preve ntive actions bee n take n

12、for the nonconforming product or any report ing of noncon formities (In cludi ng customer compla in ts)? Ha the records bee n maintain ed?是否有對不合格品或不合格報告(包括客戶投訴)進行糾正和預防改進?是 否有相關的記錄？ 2.2.5 Is there any failure of hazardous substance requirement in the past year (such as heavy metals and phthalates)?過去

13、一年內有無有害物質不合格(如重金屬及鄰苯二甲酸鹽)發生？Findin gs: 調查的結果：3. Manu facturi ng processes制造過程Yes是No否Remark備注3.1 Manu facturi ng man ageme nt 制造管理3.1.1 Are the workfloors clean and tidy? 工作地面是否干凈整潔？3.1.2 Have all main equipme nts used in in specti on, measur ing and test ing been con trolled and recorded effective?

14、In cludi ng maintain effectivAre the records of daily maintain ed? And termly maintenance kept?在用的主要設備是否有控制及記錄？包括有效的保養？日常維護和定期維護的記錄是否得到保存？3.1.3 Is the quality en sured by the clear manufacture con trol procedure? Can th control information and process abnormity disposing records be provided? 是否有明確的生

15、產控制程序來確保質量？是否能提供控制數據和制程異 常處理記錄？e3.1.4 Is the main and special process con trolled effective? Any Records can be reviewed?對關鍵和特殊過程是否得到有效控制，并有記錄可查？3.1.5 Is the SOP in the work locale? Is the regulati on clear? Do the operators d( as the SOP?作業指導書是否懸掛在作業現場？規定是否清楚明了？操作員是否按照 作業指導書的規定作業？3.1.6 Is suitable

16、In-process quality con trol adopted in product ion? 生產中是否采取有效的質量控制？3.1.7 Is suitable quality con trol adopted to en sure the fini shed product compl yin with requireme nt?是否采取恰當的質量控制來保證成品符合要求？g3.1.8 Is there a Training procedure? Have the pers ons who affect the quality an work in special process be

17、en trained?是否有培訓程序？是否對所有從事質量有影響和特殊工作的人員進行了 培訓？d3.2 Traceability and Identification追蹤及確認3.2.1 Are the raw materials, WIP and finished product in the workshop clearly ide ntified?在車間原材料，半成品和最終產品是否清楚地區分？3.2.2 Does factory maintain clear records on traceability? 工廠是否保留清楚的追蹤記錄？3.2.3 Are all in-process an

18、d fini shed goods activities records traceable to a specific lot?所有的半成品和成品是否都具有可追溯性？Findin gs: 調查的結果：4. Measureme n測量Yes是No否Remark備注4.1 Is there a procedure to con trol the producti on process? Do the operators perform in specti on and accepta nee criteria comply with the procedure? 是否有制程檢驗程序？是否能按照程

19、序規定檢驗?4.2 Have the measuri ng devices bee n con trolled effective? In cludi ng calibrati on method/accepted criteri on /calibrati on period and the releva nt procedure and impleme ntati on. Have the measuri ng devices bee n con trolled effective? In cludir calibrati on method/accepted criteri on/cal

20、ibrati on period and the releva nt proced and impleme ntati on.疋否有對測量裝置進行有效的控制？包括疋否有校準方法/驗收準則/校驗周期及相應的程序及執行？gjre4.3 Are the equipments/devices use for inspection under the scope of controllin( Is there a list of all equipme nts used in in specti on, measuri ng and test ing? 檢驗用的儀器/設備是否都在控制范圍？是否有一覽表包

21、括了所有的檢驗 儀器/設備？J?4.4Is there a Calibration Plan for the testing equipment? 是否有測試儀器的校準計劃？4.5Are all measuring devices under use identified with available label and calibrati on record?在用的儀器/設備是否有有效的校正狀態標志和校準記錄？4.6 Are there process con trols in place to assure that desig ns meet the in put requireme n

22、ts, contain reference data, meet QSOPs such as 0006-3600 for Hea Elements and 0006-3610 for Plasticizers, and fulfill customer requirements?是否有客戶設計開發控制程序，客戶要求是否都在控制范圍內，包含0006- 3600 HE 與 0006-3610 PH要求。4.7 Is there a fini shed goods in spect ion program in place in cludi ng the requireme nts of QSOP

23、3600 and QSOP 3610?完成品檢查項目是否包含 QS0P3600和QSOP 3610?4.8Does factory main tai n legible testi ng reports for I ncomi ng materials, semifinished goods and finished product?工廠是否保留清楚的來料，半成品及最終產品的測試報告？Findin gs: 調查的結果：5. Purchase and suppliers man agemenft 購和供應商管理Yes是No否Remark備注5.1 Is there a procedure to

24、con trol the purchase process? Do the operators perf purchase comply with the procedure?是否有采購控制程序？是否能按照程序規定進行采購？orm5.2 Has the conforming suppliers list? 是否有合格供應商清單？5.3 Has the purchasing information described the specified purchase requireme and the requirements for approval or qualification of pro

25、duct? And is it impleme nted effective?采購數據是否有訂購產品的技術要求及放行要求及得到有效的執行？nts5.4Has the manufacturer evaluated its suppliers and established the procedure? What to do If the evaluati on is non-con form?是否有對供應商進行評定及相關程序？當供應商評審不合格時如何處理？ 5.5 Does the factory sig ned any related DOC or Declarati on? 工廠是否簽署了相

26、關 DOC或聲明書？5.6 Does factory mai ntai n the effective MSDS? 工廠是否保持有效的 MSDS?Findin gs: 調查的結果6. packing material suppliers managemer包裝材料供應商管理Yes是No否Remark備注6.1包裝材料上有些什么涂層 ？檢查項目是否包括 QSOP0006-3600與 QSOP0006-3610.What s the Paint content opacking materia? Is therepacking material inspection program in place including the requirements of QSOP 3600 and 3610?6.2包裝材料的噴涂工序 是否外發？如外發，是