| Time: 审核时间: | Performed by: 履行者:
Qualified Internal Auditor? 是否合格内审员? □ Yes 是 □ No 否 | Other companion: 其它成员: | visit status 审核状态 □ First visit 首次审核 □ Re-visit 再次审核 List previous DOC. NO: 列举前次审核文件编号: | ||||||
Vendor Information 供应商资料 | |||||||||
| Vendor name＆code: 供应商名称及代号: | Address: 地址:
Tel＆Fax: 电话及传真: | AVL status 在合格供应商名单内之状态 □ Yes 有
□ No 无
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| Vendor's primary bussiness/product: 供应商基本业务/产品: | |||||||||
| Product to be furnished: 将提供的产品: | |||||||||
| Key Management Representative:主要管理者代表:
Name 姓名 Position 职位 Remarks 备注 1.________________________________ _________________________________ _______________________________
2.________________________________ _________________________________ _______________________________ 3.________________________________ _________________________________ _______________________________ | |||||||||
| Number of employess:员工数量: Production Dept 生产部 Quality Dept 质量部 Total 总计
____________________ ____________________________ _____________
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| Put "V" in □ 将"V"填在正确格内 | |||||||
| 1）No activity (score: 0) 无此活动 (分数: 0分) | |||||||
| 2）Significant deficiency (score: 0.5) 重大缺陷 (分数: 0.5分) | |||||||
| 3）Needs Improvement (score: 1) 需作改进 (分数:1分) | |||||||
| 4）Satisfactory (score: 1.5) 满意 (分数:1.5分) | |||||||
| 5）Outstanding (score: 2) 优秀 (分数:2分) | |||||||
| Element #1: Quality Management System 质量管理体系 | 0 | 0.5 | 1 | 1.5 | 2 | ||
1. Does the Company/Factory have department which is concern with quality control of products or services? 公司/厂有否专职部门负责控制产品或服务的质量? | □ | □ | □ | □ | □ | ||
| 2. Is a Quality Assurance Manual written in the company/Factory? 公司/厂有否编写质量保证手册? | □ | □ | □ | □ | □ | ||
| 3. Are Quality Objectives and responsibility clearly stated, widely distributed and understood through the company/Factory? 公司/厂的质量目标和质量责任有否明确规定并广泛传达，以使整个公司/厂的人 员都能理解? | □ | □ | □ | □ | □ | ||
| 4. Are written quality plans sheets prepared and properly implemented as planned arrangement in quality activities? 有否制定书面的质量计划，及各质量活动是否按此计划实施？ | □ | □ | □ | □ | □ | ||
| 5. Do all departments understand their role in achieving Total Customer Statisfaction? 为充分达到顾客的满意,各部门是否明确其职责? | □ | □ | □ | □ | □ | ||
| 6. Does the company/Factory conduct internal quality audits on a regular time?, 公司/厂是否定期进行内部质量审核? | □ | □ | □ | □ | □ | ||
7. Do management personnel take corrective and preventive action to continously perfect quality management? 管理人员有否釆取纠正和预防措施以不断完善质量管理？ | □ | □ | □ | □ | □ | ||
| Score: 分 数: | |||||||
| Element #2: Documentation Control 文件控制 | 0 | 0.5 | 1 | 1.5 | 2 | |
1. To what extent Does the company/Factory have documented quality system? 公司/厂的质量体系是否文件化及达到何种程度? | □ | □ | □ | □ | □ | |
2. To what extent are documents under issue control? 文件的发行控制达到什么程度? | □ | □ | □ | □ | □ | |
3. How well does the system ensure that the most current customer specifications are avaliable to the manufacturing personnel? 用以保证作业人员使用当前客户规格的体系运用得如何? | □ | □ | □ | □ | □ | |
4. To what extent are incoming orders reviewed for revisions and issue changes? 当收到有关修订状况和发行变更要求时所进行的评审活动达到何种程度? | □ | □ | □ | □ | □ | |
5. To what extent are critical characteristics classified? 重要性(关键性)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质量记录的存盘? | □ | □ | □ | □ | □ | |
| Score: 分 数: | ||||||
| Element #3: Procurement Control 釆购控制 | 0 | 0.5 | 1 | 1.5 | 2 | |
1. Does the company control purchase/sub-contract to include assessment activities? 公司有否一套评估程序以控制釆购或分承包方? | □ | □ | □ | □ | □ | |
2. Is a list of approved sources maintained and periodically reviewed? 有否保持合格供应商清单并定期进行评审? | □ | □ | □ | □ | □ | |
3. Are recieving inspection records maintained and analyzed for conformance to quality requirements and need for corrective action? 是否保存来料检验记录并对其进行分析,用以证明供给的产品质量符合要求和需 否釆取纠正措施? | □ | □ | □ | □ | □ | |
4. Are purchase orders reviewed to assure the incorporation of applicable drawings, specifications, and quality requirements? 是否对釆购订单进行了审核以保证所应用的图纸、规格和质量要求相一致? | □ | □ | □ | □ | □ | |
5. Is a log kept of these purchase order reviews? 有否保存釆购订单审核之记录? | □ | □ | □ | □ | □ | |
6. Is this purchased material periodically verified? 釆购的物料有否进行定期查验? | □ | □ | □ | □ | □ | |
| Score: 分 数: | ||||||
| Element #4: Material Control 物料控制 | 0 | 0.5 | 1 | 1.5 | 2 | |
| 1. Does the company/Factory have method of controlling supplied materials? 公司/厂是否有一套控制物料供应的方法? | □ | □ | □ | □ | □ | |
| 2. Are incoming material properly identified pending acceptance and qualified food safety? 来料在验收之前有否被适当地标识并符合食品安全? | □ | □ | □ | □ | □ | |
| 3. Are all materials identified to assure storage and disgursement to applicable requirements? 所有物料有否标识以保证入库和交付符合要求? | □ | □ | □ | □ | □ | |
| 4. Are stock rooms/stores periodically audited? 仓库/库存量有否定期进行审查? | □ | □ | □ | □ | □ | |
| 5. Are all identifications maintained throughout production process? 所有的标识是否在整个生产过程中被保持? | □ | □ | □ | □ | □ | |
| 6. Is Non-conforming material controlled by segregation and identification? 不合格品有否通过隔离和标识来控制? | □ | □ | □ | □ | □ | |
| Score: 分 数: | ||||||
| Element #5: Inspection 检 验 | 0 | 0.5 | 1 | 1.5 | 2 |
1. Does the company have Inspection＆Test procedures to ensure the product suitability at receipt、 in processes and completion? 公司是否有一套检验和试验 程序以确保在进货、过程和最终的产品能符合规定要求? | □ | □ | □ | □ | □ |
2. Are inspection instructions which establish acceptance criteria availiable at all inspection operations? 检验指示是否标明验收标准?并应用在所有的检验过程中? | □ | □ | □ | □ | □ |
3. Is 100% or adequate sampling inspection used in IQC/IPQC/FQC? 在来料检验/过程检验/最终检验中,产品是否100%检验或运用适当的抽样方案进 行检验? | □ | □ | □ | □ | □ |
4. Is periodic training provided for inspection personnel? 有否对检验人员提供定期培训? | □ | □ | □ | □ | □ |
5. Are repaired and reworked materials identified and re-inspected? 返修和返工的物料/产品有否被标识和重新检验? | □ | □ | □ | □ | □ |
6. Are inspection and test status and its disposition properly indicated? 检验和试验状态及其处理结果是否有适当的标明? | □ | □ | □ | □ | □ |
7. Are inspection records avaliable for on-site examination by customer repersenta- tive upon request? 当客户代表要求时,检验记录能否进行现场审查? | □ | □ | □ | □ | □ |
| Score: 分 数: | |||||
| Element #6: Inspection and Test Equipment 检验和试验设备 | 0 | 0.5 | 1 | 1.5 | 2 |
1. Has a calibration system been established in the Company/Factory? 公司/厂有否建立一套校准体系? | □ | □ | □ | □ | □ |
2. Are inspection gauges,measuring devices,and test equipment inspected and recalibrated at specified intervals? 检验、测量和试验设备有否周期性的检验和重 新校准? | □ | □ | □ | □ | □ |
| 3. Are records of calibration,specifying recalibration dates,available? 校准记录是否有标明下次校准日期和校准的有效性? | □ | □ | □ | □ | □ |
| 4. Are the primary working standards used to calibrate equipment traceable to the National Insitute of standards and Technology? 校准设备所使用的基本标准能否 追溯到国家或国际标准和技术? | □ | □ | □ | □ | □ |
| 5. Is test and measurement equipment identified by decal or other means to indicate current calibration status? 试验和测量设备有否用印花或其它方法标识以标明目 前的校准状态?
| □ | □ | □ | □ | □ |
| 6. Is all calibrate and maintenance equipment properly documented? 所有设备的校准和保养有否适当地记录? | □ | □ | □ | □ | □ |
| Score: 分 数: | |||||
| Element #7: Nonconforming Materials 不合格品 | 0 | 0.5 | 1 | 1.5 | 2 |
1. Does the company have procedure to control nonconforming product that prevent inadvertent use of defective materials? 公司/厂是否有一套程序以控制不合格品以 防止不合格品非预期使用? | □ | □ | □ | □ | □ |
2. Are nonconforming supplies identified and removed from normal production lots? 当不合格品提供使用时有否被标识并与正常生产批量隔离? | □ | □ | □ | □ | □ |
3. Are reworked parts and products reinspected by original responsible department? 返工的部件和产品有否被原来的责任部门重新检验? | □ | □ | □ | □ | □ |
4. Has a corrective action system allowed prompt remedial action? 有否建立纠正措施体系以对不合格品釆取实时的纠正措施? | □ | □ | □ | □ | □ |
5. Does the corrective action system allow for verification of the effectivity of remedial action? 纠正措施体系能否验证纠正措施实施的效果? | □ | □ | □ | □ | □ |
6. Are reports of Non-Conforming materials regularly prepared and reviewed by management for action? 不合格品报告有否定期制定并交管理层评审, 以 制定相应行动? | □ | □ | □ | □ | □ |
| Score: 分 数: | |||||
| Element #8: statistical Techniques 统计技术 | 0 | 0.5 | 1 | 1.5 | 2 | ||||
| 1. Does the company/Factory operate any sampling / statistical techniques? 公司/厂有否运用过任何形式的抽样/统计技术? | □ | □ | □ | □ | □ | ||||
| 2. Are statistical process control techniques used in line? 统计过程控制技术有否运用于生产线? | □ | □ | □ | □ | □ | ||||
| 3. How qualified are the people who are responsible for guiding the implementation of statistical tools? 负责指导实施统计方法/工具的人员资格如何? | □ | □ | □ | □ | □ | ||||
4. Are operators trained in use of apporiate statistical techniques and are they properly applying them? 应用统计技术的人员有否经过培训且他们能否适当地运用统计技术? | □ | □ | □ | □ | □ | ||||
5. Are control charts and other process controls properly implemented? 控制图表和其它过程控制是否正确实施? | □ | □ | □ | □ | □ | ||||
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？ 当发现或怀疑在实际制造过程中存在产品特性及/或过程能力发生变异时,会否 增加、删除或修改应用的统计技术？ | □ | □ | □ | □ | □ | ||||
| Score: 分 数: | |||||||||
| Total score : 总 分 : | |||||||||
Qualification Disposition 资格决策 | |||||||||
| □ Approved 合格 (score≧66) (66分以上) □ Conditional Approved 条件性合格 (Score 51~65) (51~65分) □ Disapproved 不合格 (Score≦50) (50分以下) | The necessary procedures and control have been implemented to control the quality of products. 对产品的质量已实施必要的程序和控制措施 Most of the procedures and controls have been implemented but vendor should take corrective actions as per the deficiencies in above questions. 大多数程序和控制措施已实施，但供应商对上述问题缺陷还需釆取纠正措施 Disapproved-Deficiencies which were observed as per the recommenda- tion in above questions are major. 从上述问题观察到所犯为严重缺陷，故判为不合格。 | ||||||||
Other Questions:其它问题: | ||||
| 1. Venor's commitments: 供应商的承诺:
____________________________________________________________________________________________ _______________________________________________________________________________________ _______________________________________________________________________________________ _______________________________________________________________________________________ 2. Surveyor's Recommendations: 审核员的建议: _____________________________________________________________________________________________ _______________________________________________________________________________________ _______________________________________________________________________________________ _______________________________________________________________________________________ 3. Other Notes: 其它备注: _____________________________________________________________________________________________ _____________________________________________________________________________________________ _______________________________________________________________________________________ _______________________________________________________________________________________
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| Review Board 评审委员会
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Pur.Dept 釆购事业部 | Quality Dept 质管部 | Production Dept 生产事业部 | CEO 总裁 | |
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