Title Page
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Site conducted
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Vendors Name
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Fly Name
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Address
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Evaluation Start Date and Time
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First MAST evaluation
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List previous REF #
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Number of Employee
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No.of Machines
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Last Evaluation Date
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Name of Contact Person
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Title of Contact Person
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Rating
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Phone
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Fax
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Email
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Evaluator
INCOMING MATERIALS CONTROL
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1. Are there written procedures for the receipt, identification, storage, handling, sampling, testing and approval of raw materials, component parts, sub-components and package? properly implemented?是否有书面程序规定原材料、包材部件、零部件和外包装的收货、识别、储存、处理、取样、测试和批准?能否妥善执行?
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2. Are raw materials, component parts, sub-components and package withheld fromproduction until released by QA/QC?在QA/QC放行前，是否保暂存原材料、包材部件、零部件和包装?
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3. Is status of raw materials/component parts/package identified with a status label and or are they held in corresponding quarantine areas? And were they kept off floor?原材料/包材部件/包材的状态是否有状态标签，或是否存放在相应的检疫区?是否远离地面?
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4. Is there a representative sized sample taken from raw materials, component partssub-components and package inspected at receipt (within 72hours)? And any report?在收货时(72小时内)是否有对原材料、包材部件、零部件和包装中具有代表性的样品进行检验?是否有报告?
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5. Is there incoming insepction standard including sample, product spec. and defective category list?是否有来料检验标准，包括样品、产品规格和不良品类别清单?
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6. Are incoming material samples labeled with lot number, the date and the person who collected the sample? Are they resealed in a manner & in an area to prevent contamination?来料取样是否标示批号、日期、收集样品的人?是否重新密封以防止污染?
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7. Do COAs/COCs exist for raw material, conponent parts,sub-components and package ?原料、包材部件、零部件和包装是否有COAs/ COCs ?
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8. Are representative samples of each lot of raw material pulled and tested/examined for physical and/or chemical characteristics as specified? Testing report ?每批原材料的代表性样品是否按照规定进行物理和/或化学特性测试/检验?是否有测试报告?
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9. Is there a quarantine system for rejected/expired raw materials, component parts, sub-components and package designed to prevent their use? And follow up and records?对不合格/过期的原材料、包材部件、零部件和包装是否有检疫系统以防止其使用?是否进行跟踪和记录?
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10. Is there MRB (material review board) practice on raw materials, component parts, sub-components and package? If yes, any nofication to clients and proper follow up on MRB material?是否有材料审查委员会（MRB)对原材料，包材部件，零部件和包装进行检查?如果是，是否通知客户并对MRB材料进行适当的跟踪?
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11. Chemicals/high risk components are properly marked and stored in proper area to prevent risk of contamination?化学品/高风险成分是否有适当的标记并储存在适当的区域以防止污染风险?
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12. Is FIFO used for raw materials, component parts, sub-components and package? Any record and identification on bulk?先进先出原则是否用于原材料、包材部件、零部件和包装?散装货物有任何记录和标识吗?
SUPPLIER MANAGEMENT
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1. Are there written procedures for control to suppliers of raw materials, component parts, sub-components
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and package including selection and approval process, tracking and evaluation reliability/performance?是否有书面的程序控制供应商的原材料，零部件，子部件和包装，包括选择和批准过程，跟踪和评估可靠性/表现?
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2. Does factroy keep qualified supplier list? Did all incoming material come from the qualified suppliers?
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Any exceptional?工厂是否保留合格供应商名单?所有来料都来自合格的供应商吗?有例外吗？
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3. Does factory monitor and evaluate suppliers quality performance and reliability? Any record?工厂是否监控和评估供应商的质量表现和可靠性?有记录吗?
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4. Does factory onsite audit the suppliers periodictly?'Does QC team join? What's frequency? any record?工厂是否定期对供应商进行现场审核?QC团队加入了吗?按什么频率?有记录吗?
PROCESS AND PRODUCTION CONTROL
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1. Are there written procedures for process and manufacturing control?是否有书面的工艺和生产控制程序?
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2. Does factory conduct pre-production meeting for key project prior to startup of production? Are critical quality and safety checks reviewed, identified, and actions for improvement documented during Pre-production meeting ?工厂是否在关键项目开始生产前召开生产前会议?是否对关键的质量和安全检查进行了评审和识别，并在生产前会议上记录改进措施?
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3. Does factory conduct “pilot-run” to validate through PP meeting action points, also review product quality against specification sheet and document results with corrective actions prior to production?工厂在生产前，是否通过“试运行”对产前会议行动点进行验证，并根据规格表对产品质量进行审核，且记录纠正措施的结果?
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4. Are all production processes performed within specifically defined areas to prevent contamination or mix-ups?所有生产过程是否在特定的区域内进行，以防止污染或混淆?
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5. Does all production processes setup make sense, without unnecessary back-forth transferring to avoid damage, contaimination or mix-ups? Are different lines with consistent setup/jigs for same item production?所有生产过程是否合理，没有不必要的来回转移以避免损坏，污染或混淆?对于相同的产品，不同的生产线是否有相同的设备/夹具?
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6. Does factory have the resonable flow chart at key process and follow it? Does production lines ran smoothly without piling up?工厂是否有合理的关键工艺流程图并遵循?生产线是否运行平稳而不堆积?
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7. Does factory IPQC or QC leader compare first article samples with approval sample and specification sheet? And any record?工厂IPQC或QC主管是否将首件样品与认可样品和规格书进行比较?是否有记录?
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8. Are there adequate approved samples, first article samples and work instructions provided to workers? Do workers follow work instructions to operate and were monitored?是否有足够的批准样品，首件样品和作业指导书提供给工人?工人是否按照作业指导书操作并受到监控?
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9. In-line inspections are performed by QC at every operation process (IPQC) ? what's roving check frequency? Is there batch release practice for key processes ?And records?在每个操作过程(IPQC)都有QC进行在线检验吗?巡查频率是多少?是否有关键工艺的批放行规范和记录?
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10. Does factory perform full check/test by specific person who cannot clean on final products before packing?工厂是否有专人在包装前对成品进行全面检查/测试?
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11. Are there written proceduce of non-conformance control during manufactoring?any procedure/red box implemented? Does IPQC and IPQC leader has authority to stop production if serious quality issue ocurred? If yes, any CAP record and follow up?在生产过程中是否有不合格项管理的书面程序?实施了什么程序?如果发生严重的质量问题，IPQC和IPQC领导是否有权停止生产?如有，是否有CAP记录和跟踪?
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12. Is line clearance between batches documented?批次间的清线记录是否有记录?
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13. Is all major equipment identified and documented in the production record? Traceability record?生产记录中是否有所有主要设备的标识和文件记录?可追溯性记录?
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14. Are representative samples of semi-products or finished goods pulled and tested/examined for function/physical characteristics as specified? And testing report ?半成品或成品的代表性样品是否按规定进行功能/物理特性测试/检验?有没有测试报告?
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15. Are semi-products and finished goods inspected to ensure compliance to specifications, batch releasing? And report? For one item produced by different lines, any periodical comparsion?是否对半成品和成品进行检验以确保符合规格和批次放行标准?是否有报告?对于一个由不同生产线生产的产品，是否定期进行比较?
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16. Are tempo. storage of semi-products, finished goods and defects clearly marked and quanranteed very well?半成品、成品和残次品的临时存放是否有明确的标识和量化?
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17. Are there good housekeeping in all areas of production sections?生产部门的所有区域是否有良好的管理?
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18. Are standards of finished product stored in proper manner that prevents accelerated aging and contamination and retained for four years?成品标样是否以适当的方式储存，以防止加速老化和污染，并保留四年?
- Excellent
- Good
- Fair
- Poor
- Unsatisfactory
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19. Does factory implement strict cutting devices control procedure to prevent scissors,knives,blades and needles to be mixed with production?Any delegated person to manage the sharp tool control system?工厂是否实施严格的切割设备控制程序，以防止剪刀、刀、刀片和针混入生产中?是否有授权人员管理刀具控制系统?
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20. Is there a change control process and are all changes to package component specifications properly documented? Any case?是否有变更控制流程，所有对包装组件规格的变更是否有适当的文件记录?有示例吗?
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21. Are all production related instructions/records and quality reports retained well? Are production records/quality reports retained for 4 years (either hardcopy or softcopy)?Are records retrievable within 24 hours?所有与生产相关的指令/记录和质量报告是否保留完好?生产记录/质量报告是否保留4年(硬拷贝或软拷贝)?记录能在24小时内恢复吗?
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22. Do the personnel use protective apparel such as head, face and arm coverings properly to protect human being and to prevent product contamination?工作人员是否正确使用防护服，如头、脸和手臂覆盖物，以保护人员和防止产品污染?
HOLDING AND DISTRIBUTION
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1. Are there written warehousing procedures for withholding all in-processes and finished goods until approved by QA/QC?是否有书面的仓库程序来扣留所有的半成品和成品，直到QA/QC批准?
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2. Are all in-process and finished goods tagged with correct identification card?所有半成品和成品都有正确的标识卡吗?
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3. Is there a quarantine area for rejected in-process parts and finished product?是否有拒收的半成品和成品检疫区?
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4. Are there written procedures for disposal of rejected in-process parts and finished product in a manner that assures it is not used?是否有书面的程序来处理被拒绝的半成品和成品，以确保它没有被使用?
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5. Is there a SOP on finished product release to assure compliance to client's requirements - specification compliance, standard samples and documents?是否有成品放行的SOP以确保符合客户的要求，比如规范符合性，标准样品和文件?
QUALITY ASSURANCE/QUALITY CONTROL
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1. Is there a QA/QC unit independent out of Production division? Are factory and QC team orgnization chart available?是否有独立于生产部门的QA/QC部门?是否有工厂和QC团队组织结构图?
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2. Has factory existed quality policy and objective that is appropriate to their products and procedures? Are Workers & Supervisors familiar to these quality policies and objectives？Any slogan presented?工厂是否有适合其产品和程序的质量方针和目标?工人和主管是否熟悉这些质量方针和目标?是否有贴示标识?
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3. Does the QA/QC unit have written procedures to approve or reject raw materials, component parts, sub-components, package, in-process materials, and finished products? QA/QC部门是否有书面程序来批准或拒绝原材料、包材部件、零部件、包装、中程原料和成品?
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4. Are adequate in-house laboratory facilities available to the QA/QC unit for testing and approval or rejection of raw materials, component parts, sub-components,package, in-process materials and finished product? Any working instruction?是否有足够的内部实验室设施供QA/QC部门测试和批准或拒绝原材料，包材部件，零部件，包装，中程原料和成品?是否有作业指导书?
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5. Does the QA/QC unit approve all procedures and specifications that impacting the identity and quality of the product? QA/QC部门是否批准所有影响产品标识和质量的程序和规范?
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6. Does factory have separate inspection area with inspection table and proper envirement for quality control activities (IQC/IPQC/FQC/OQC)?工厂是否有单独的检验区域和检验表，以及适当的环境来进行质量控制活动(IQC/IPQC/FQC/OQC)?
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7. Are finished goods inspected properly by QA/QC prior to release for shipping?成品在放行装运前是否经过QA/QC的检验?
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8. Are QC members qualified? Do they have good quality awareness and sensitivity? Do they have enough knowledge about product and be familiar with quanlity standards?QC成员是否具备资质?他们是否有良好的质量意识和敏感性?他们是否有足够的产品知识和熟悉质量标准?
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9. Do production management and QC team have a peroidical meeting to review and discuss - defect statistics shared ? Does QC team have an internal periodical meeting to share quality issues? and any record?生产管理和QC团队是否定期开会审查和讨论缺陷数据?QC团队是否定期召开内部会议来分享质量问题?是否有任何记录?
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10. Product standards and guidelines are readily available and in use by the inspectors?产品标准和指南是不是现成的，检查员是否在使用?
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11. Is all testing completed before the shipping release was signed?所有的测试是否在发货放行单签署前完成?
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12. Is there an appropriate CAPA system in place to identify and resolve quality based issues? Any case?是否有适当的CAPA系统来识别和解决质量问题?有示例吗?
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13. Are there written procedures for calibration of equipments and instruments?是否有书面的设备和仪器校准程序?
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14. Is there an instrument and equiments list? Does factory have a calibration plan and record? Does internal calibration operator have certificate?是否有仪器设备清单?工厂是否有校准计划和记录?内部校准操作员是否有证书?
BUILDING AND FACILITIES
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1. The outside of the building is maintained free of trash and debris that provide harborage.建筑的外部没有垃圾和装修的残骸。
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2. The building size and construction facilitate cleaning maintenance and operations.建筑物的大小和结构便于清洁、维护和操作。
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3. Is there adequate space to prevent mix-ups of raw materials, component parts sub-components, package, in-process materials and finished products and to prevent contamination?是否有足够的空间防止原料、包材部件、零部件、包装、中程物料和成品的混淆，并防止污染?
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4. Are measures in place of production workshops to prevent contamination (eg.window closed or screened)?在生产车间采取了哪些措施来防止污染(例如:关窗或屏蔽)?
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5. Is there adequate lighting,especially in QC areas?是否有足够的照明，特别是在QC区域?
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6. Is there adequate filtered ventilation to production operations especially where finished product is exposed?生产操作是否有足够的过滤通风，特别是成品暴露的地方?
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7. Are there adequate drains for equipment and to prevent standing water?是否有足够的排水设备，防止积水?
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8. Are there proper machines in factory to produce the product Mast Global intends to buy? Machine list?工厂是否有合适的机器来生产Mast Global打算购买的产品?有没有机器清单?
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9. Is there a maintenance function to maintain production equipment? Is it provided by certified personnel ? Can it provide immediate response to machinery problems that affect production?生产设备是否有维护部门?是否由认证人员维护?维护人员能对影响生产的机械问题立即作出反应吗?
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10. Are machines / equipment periodically maintained, and checked to ensure efficient operation? Is there a documented preventative maintenance schedule? And record?机器/设备是否定期维护和检查以确保高效运行?是否有书面的预防性维护计划?并记录?
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11. Are there written procedures or sub-contract agreement for pest control including a drawing or floor plan showing the placement of control devices?是否有控制虫害的书面程序或分包协议，包括显示控制装置放置的图纸或平面图?
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12. Are there power generator(s)? Ready to support if any power source shortage?有发电机吗?是否准备好支持任何电源短缺?
TRAINING
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1. Is there a on-boarding training including particular operations and quality awareness for new employees and any record?是否有对新员工的入职培训，包括特定的操作和质量意识，并有培训记录?
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2 Is there an annual training plan in GMP/ISO:9001 concept/practice?是否有GMP/ISO:9001概念/实践的年度培训计划?
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3. Any record of training properly retained?是否妥善保存培训记录?
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4. Is the training conducted by a qualified individual?培训是否由合资格人士进行?
LOSS PREVENTION
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1. Are there adequate controls to prevent the loss of finished goods and/or component from the facility? components with logo were managed by delegated person, storage with limited access?工厂是否有足够的控制措施来防止成品和/或零部件的损失? 有商标的部件是否由授权人员管理，只有被授权人才能接触?
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2. Are visitors requested to register? Any visitor badge presence required during plant tour? Is facility access controlled and monitored after hours? Are the access records reviewed periodically by management?访客是否需要登记? 参观工厂期间需要出示访客证吗? 下班后是否对设施的进出进行控制和监控? 管理人员是否定期审查访问记录?
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3. Are procedures in place for the proper notification and destruction of unacceptable/obsolete finished goods and/or package components? Any record?是否有适当的程序通知和销毁不可接受/废弃的成品和/或包装部件?有记录吗?
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4. Are products shipped in a controlled & secured manner to prevent tampering, contamination or loss during transit?产品是否以受控和安全的方式运输，以防止在运输过程中篡改、污染或损失?
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5. Is there any CT-PAT practice (certificate)?是否有CT-PAT实践(证书)?
SIGN OFF
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Report Prepared By (Name and Signature)报告编制人(姓名及签名)
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Report Approved By (Name and Signature)报告批准人(姓名及签字)
