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1、Put V in 將V填在正確格內(nèi)Date of visit:審核日期:Time:審核時間:Performed by:履仃者:Qualified Internal Auditor? 是否合格內(nèi)審員? Yes 是 No 否Other companion:其它成員:visit status審核狀態(tài) First visit首次審核 Re-visit再次審核List previous DOC. NO: 列舉前次審核文件編號:Vendor Information 供應(yīng)商資料Vendor name & code:供應(yīng)商名稱及代號:Address:地址:Tel & Fax:電話及傳真:AVL status

2、在合格供 應(yīng)商名單內(nèi)之狀態(tài) Yes 有 No無Vendors primary bussiness/product: 供應(yīng)商基本業(yè)務(wù)/產(chǎn)品:Product to be furnished: 將提供的產(chǎn)品:Key Management Representative:主要管理者代表:Name 姓名Position 職位Remarks 備注1.2.3.Number of employess:員工數(shù)量:Production Dept 生產(chǎn)部Quality Dept 質(zhì)量部Total 總勺、計1) No activity (score: 0)無此活動(分數(shù):0分)2) Significant defici

3、ency(score: 0.5)重大缺陷(分數(shù):0.5分)3) Needs Improvement(score: 1) 需作改進(分數(shù):1 分)4) Satisfactory (score: 1.5) 滿意(分數(shù):1.5 分)5) Outstanding (score: 2) 優(yōu)秀(分數(shù):2分)Eleme nt #1: Quality Management System 質(zhì)量管理體系00.511.521. Does the Company/Factory have department which is concern with quality control of products or s

4、ervices?公司/廠有否專職部門負責(zé)控制產(chǎn)品或服務(wù)的質(zhì)量?2. Is a Quality Assurance Manual written in the company/Factory? 公司/廠有否編寫質(zhì)量保證手冊 ?3. Are Quality Objectives and responsibility clearly stated, widely distributed and understood through the company/Factory?公司/廠的質(zhì)量目標和質(zhì)量責(zé)任有否明確規(guī)定并廣泛傳達,以使整個公司/廠的人員都能理解?4. Are written quality

5、plans sheets prepared and properly implemented as planned arrangement in quality activities?有否制定書面的質(zhì)量計劃,及各質(zhì)量活動是否按此計劃實施?5. Do all departments understand their role in achieving Total CustomerStatisfaction?為充分達到顧客的滿意,各部門是否明確其職責(zé)?6. Does the company/Factory conduct internal quality audits on a regular t

6、ime?, 公司/廠是否定期進行內(nèi)部質(zhì)量審核?7. Do managemen t personnel take corrective and preventive action to continously perfect quality management?管理人員有否釆取糾正和預(yù)防措施以不斷完善質(zhì)量管理?Score:分數(shù):Eleme nt #2: Docume ntation Co ntrol文件控制00.511.521. To what extent Does the company/Factory have documented quality system? 公司/廠的質(zhì)量體系是否

7、文件化及達到何種程度?2. To what extent are documents under issue control? 文件的發(fā)行控制達到什么程度?3. How well does the system ensure that the most current customer specifications are avaliable to the manufacturing personnel?用以保證作業(yè)人員使用當(dāng)前客戶規(guī)格的體系運用得如何?4. To what extent are incoming orders reviewed for revisions and issue

8、changes? 當(dāng)收到有關(guān)修訂狀況和發(fā)行變更要求時所進行的評審活動達到何種程度?5. To what extent are critical characteristics classified?重要性(關(guān)鍵性)文件的保密程度如何?6. Does the company have documented procedures to control the retention a filling of quality records?公司是否有文件化的程序用以控制質(zhì)量記錄的存盤?Score:分數(shù):Eleme nt #3: Procureme nt Co ntrol釆購控制00.511.521.

9、Does the company control purchase/sub-contract to include assessment activities? 公司有否一套評估程序以控制釆購或分承包方?2. Is a list of approved sources maintained and periodically reviewed? 有否保持合格供應(yīng)商清單并定期進行評審?3. Are recieving inspection records maintained and analyzed for conformance to quality requirements and need

10、 for corrective action?是否保存來料檢驗記錄并對其進行分析,用以證明供給的產(chǎn)品質(zhì)量符合要求和需否釆取糾正措施?4. Are purchase orders reviewed to assure the incorporation of applicable drawings, specifications, and quality requirements?是否對釆購訂單進行了審核以保證所應(yīng)用的圖紙、規(guī)格和質(zhì)量要求相一致?5. Is a log kept of these purchase order reviews? 有否保存釆購訂單審核之記錄?6. Is this p

11、urchased material periodically verified? 釆購的物料有否進行定期查驗?Score:分數(shù):Eleme nt #4: Material Co ntrol物料控制00.511.521. Does the company/Factory have method of controlling supplied materials?公司/廠是否有一套控制物料供應(yīng)的方法?2. Are incoming material properly identified pending acceptance and qualified foodsafety?來料在驗收之前有否被適

12、當(dāng)?shù)貥俗R并符合食品安全?3. Are all materials identified to assure storage and disgursement to applicablerequirements?所有物料有否標識以保證入庫和交付符合要求?精品文檔4. Are stock rooms/stores periodically audited? 倉庫/庫存量有否定期進行審查?5. Are all identifications maintained throughout production process? 所有的標識是否在整個生產(chǎn)過程中被保持?6. Is Non-conformin

13、g material controlled by segregation and identification? 不合格品有否通過隔離和標識來控制?Score:分數(shù):Eleme nt #5: In spect ion檢驗0.5r 11.5021. Does the company have Inspection & Test procedures to ensure the product suitability at receipt、in processes and completion?公司是否有一套檢驗和試驗程序以確保在進貨、過程和最終的產(chǎn)品能符合規(guī)定要求?2. Are inspecti

14、on instructions which establish acceptance criteria availiable at allinspection operations?檢驗指示是否標明驗收標準?并應(yīng)用在所有的檢驗過程中?3. Is 100% or adequate sampling inspection used in IQC/IPQC/FQC?在來料檢驗/過程檢驗/最終檢驗中,產(chǎn)品是否100%檢驗或運用適當(dāng)?shù)某闃臃桨高M 行檢驗?4. Is periodic training provided for inspection personnel? 有否對檢驗人員提供定期培訓(xùn)?5.

15、Are repaired and reworked materials identified and re-inspected? 返修和返工的物料/產(chǎn)品有否被標識和重新檢驗?6. Are inspection and test status and its disposition properly indicated? 檢驗和試驗狀態(tài)及其處理結(jié)果是否有適當(dāng)?shù)臉嗣鳎?. Are inspection records avaliable for on-site examination by customer repersenta- tive upon request?當(dāng)客戶代表要求時,檢驗記錄能否

16、進行現(xiàn)場審查?Score:分數(shù):Eleme nt #6: In spect ion and Test Equipme nt檢驗和試驗設(shè)備00.511.521. Has a calibration system been established in the Company/Factory? 公司/廠有否建立一套校準體系?2. Are inspection gauges,measuring devices,and test equipment inspected and recalibrated at specified intervals?檢驗、測量和試驗設(shè)備有否周期性的檢驗和重 新校準?3.

17、 Are records of calibration,specifying recalibration dates,available? 校準記錄是否有標明下次校準日期和校準的有效性?Score:分數(shù):不合格品00.511.52Score:分數(shù):4. Are the primary working standards used to calibrate equipment traceable to theNational Insitute of standards and Technology? 校準設(shè)備所使用的基本標準能否 追溯到國家或國際標準和技術(shù)?5. Is test and meas

18、urement equipment identified by decal or other means to indicate current calibration status?試驗和測量設(shè)備有否用印花或其它方法標識以標明目 前的校準狀態(tài)?6. Is all calibrate and maintenance equipment properly documented?所有設(shè)備的校準和保養(yǎng)有否適當(dāng)?shù)赜涗??Element #7: Noncon formi ng Materials1. Does the company have procedure to control nonconform

19、ing product that prevent inadvertent use of defective materials?公司/廠是否有一套程序以控制不合格品以 防止不合格品非預(yù)期使用?2. Are nonconforming supplies identified and removed from normal production lots? 當(dāng)不合格品提供使用時有否被標識并與正常生產(chǎn)批量隔離?3. Are reworked parts and products reinspected by original responsible department? 返工的部件和產(chǎn)品有否被原來

20、的責(zé)任部門重新檢驗?4. Has a corrective action system allowed prompt remedial action? 有否建立糾正措施體系以對不合格品釆取實時的糾正措施?5. Does the corrective action system allow for verification of the effectivity of remedial action?糾正措施體系能否驗證糾正措施實施的效果?6. Are reports of Non-Conforming materials regularly prepared and reviewed by ma

21、nagement for action?不合格品報告有否定期制定并交管理層評審,以制定相應(yīng)行動?Eleme nt #8: statistical Tech niq ues統(tǒng)計技術(shù)00.511.521 Does the company/Factory operate any sampling / statistical techniques? 1公司/廠有否運用過任何形式的抽樣/統(tǒng)計技術(shù)?2. Are statistical process control techniques used in line?統(tǒng)計過程控制技術(shù)有否運用于生產(chǎn)線?3. How qualified are the peop

22、le who are responsible for guiding the implementationof statistical tools?負責(zé)指導(dǎo)實施統(tǒng)計方法/工具的人員資格如何?4. Are operators trained in use of apporiate statistical techniques and are theyproperly applying them?應(yīng)用統(tǒng)計技術(shù)的人員有否經(jīng)過培訓(xùn)且他們能否適當(dāng)?shù)剡\用統(tǒng)計技術(shù)?5. Are control charts and other process controls properly implemented?控制圖表和其它過程控制是否正確實施? 6. When detect or suspect product characteristic and/or process capability are unusual during actual manufucturing, will statistical techniques implemented be added、deleted or changed ?當(dāng)發(fā)現(xiàn)或懷疑在實際制造過程中存在產(chǎn)品特性及/或過程能力發(fā)生變異時,會否增加、刪除或修改應(yīng)用的統(tǒng)計技術(shù)?Score:分數(shù):

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