1 Quality System Assessment Checlist bilingual.docx

1、1 Quality System Assessment Checlist bilingual Supplier Quality System Assessment Checklist供应商品质管理系统评审检验清单Company Name:公司名称:Factory Address:工厂地址:Date: 日期:Audited by: 审核员:1.0 MANAGEMENT RESPONSIBILITY/QUALITY SYSTEM管理职责/品质管理系统 1.1 Is there a documented quality system, including a manual, policy, obje

2、ctive and commitment? 是否有记载品质管理系统 - 其中包括品管手册、政策、目標、承诺？ 0 No system exists. 没系统存在。 1 The supplier claims to support a quality policy, objectives and commitment; responsibilities have been defined, but there is little or no supporting documentation. 供应商声称支持质量方针、目标和承诺;责任已经确定，但有很少或根本没有相关支持文档。 2 Quality

3、policy, objectives and commitment are the responsibility of the suppliers quality function with some involvement from other departments/areas. 质量管理系统政策、目標、承诺是品管部門的責任，其他部門也作部份參與。 3 Quality policy, objectives and commitment are well defined with specific responsibilities identified for most of the app

4、ropriate functional activities in the suppliers organization. Evidence indicates that quality performance and commitment occurs according to these responsibilities. 质量管理系统政策、目標、承诺及各功能的具体责任清楚界定。並有证据顯示各部門按照功能责任承诺质量表現。 4 There is evidence that the quality policy, objectives and commitment are extremely

5、 well defined and executed by all. Continuous improvement is evident. 有足够证据证明品质的政策、目標、承诺清楚定义及執行， 并有持续改进。Remark备注: 1.2 Are quality procedures available and revised? 是否有品质程序并有更新？ 0 Quality procedures do not exist. 品质程序不存在。 1 An initial plan has been developed and some quality procedures have been writ

6、ten. 有计划制定程序, 并有部分程序文件。 2 The supplier has documented quality procedures, but has no provisions for revisions. 有品质程序文件但没有更新/更改记录。 3 The supplier has documented quality procedures with adequate provisions for revisions. 有程序文件并有相应更新。4 As per 3, with a method for purging obsolete/revised procedures.按照3

7、, 並有相应清除/终止/修改程序文件。 Remark备注: 1.3 Does the quality system include a procedure for customer notifications of major changes/deviations in raw material, process or product? 质量系统是否有规范的程序通知客户原料、生产过程、产品的更改/偏差？ 0 No procedure exists. 程序不存在。 1 The supplier follows a process change procedure, however, change

8、s are not pre-approved and communications are after the fact with the customer. 有產品更改程序，但在更改前没有预先与客户沟通并得到确认。 2 As per 1, except process changes are communicated and approved in advance of supplier implementation with the customer. 按照1，既有程序，又有预先与客户沟通并得到确认。 3 As per 2, with the supplier assigning a sp

9、ecific representative to communicate with the customer from initial notification, to successful implementation into the using plant. 按照2，并委派专门人员与客户沟通。4 As per 3, with the interaction of all affected advanced quality planning tools and teams.按照3，并有互動作用在相关品质计划工具和团队。Remark备注: 1.4 Is managements commitm

10、ent to quality evident in good housekeeping throughout the facility? 管理層有否承诺良好的廠房管理(如摆设、布局、清洁)? 0 The suppliers plant cleanliness, housekeeping and working conditions are inappropriate for quality production and may have negative effects. 工厂车间清洁, 廠房管理和工作环境不适合优质品生产，並可能有负面影响。 1 The need to improve fac

11、tors is understood by supplier management, and an initial plan has been developed. 工厂知道需要改进，并制定初步计划。 2 Supplier management has provided the necessary tools for work environment and housekeeping, but evidence indicates implementation is inconsistent throughout the company. 管理層有指导及要求于工作环境和设备摆设，但执行不够一致

12、。 3 As per 2, with the work environment and housekeeping beneficial in most situations. 按照2，大部份区域都具有良好的工作环境和廠房管理。4 As per 3, with the work environment and housekeeping beneficial in all areas.按照2，所有区域都具有好的工作环境和廠房管理。Remark备注: 2.0 CONTRACT/PURCHASE ORDER REVIEW采购/合同评审 2.1 Does the supplier have a proc

13、edure for contract and/or purchase order review? 供应商是否有合同及訂貨單的评审程序文件? 0 No procedure exists. No review is conducted. 没有程序及评审。 1 No procedure exists, but review is conducted. 没有程序，但有评审。 2 A procedure exists, but there is no evidence that it is being complied to. 有程序，但没证据证明有符合程序。 3 A procedure exists,

14、 with documented evidence, but system is lacking in one or more areas. 有程序及文件证据，但糸统不全面执行。4 As per 3, with evidence of compliance and with the system not lacking in any areas.按照3，全面地良好执行。Remark备注:3.0 DRAWING/SPECIFICATION CONTROL图纸/规格控制 3.1 Does the supplier have a procedure for drawing and specifica

15、tion control? 供应商是否有图纸和规格控制的程序文件? 0 No procedure exists. 没有程序。 1 A procedure exists, but drawing and specification control is not being complied to (e.g. misfiled, incorrect revision level, obsolete drawings not purged, etc.). 有程序，但图纸和规格控制不规范。(如归错文挡，错误的修正标准，旧图纸没有清除.等等。) 2 A procedure exists for mini

16、mum control and it is being complied to. 有程序，但不全面执行文控。 3 A procedure exists which covers all the necessary elements of the suppliers system (design if applicable) and the procedure is being complied to. 有程序并包括所需细節执，且全面执行。 4 As per 3, with procedure calling for review of drawings and specifications b

17、y Quality and other pertinent departments before acceptance of customer drawings. 按照3，在接受客户图纸前，有內部规格评审程序，并包括品质部和其它相关部门参与。Remark备注: 4.0 SUPPLIER CONTROL供应商控制 4.1 Is there a system for qualification of new suppliers? 是否有新原料供应商资格评审系统? 0 No system exists. 没有系统。 1 A qualification system is under developm

18、ent. 系统正在制定。 2 A qualification system exists, with evidence of use for critical suppliers. 有系统，有证据证明与主要供应商。 3 As per 2, with evidence of a qualification system which includes initial part/product sampling and an on-site survey. In addition, suppliers are given feedback on their performance. 按照2，有详细的

19、评审系统，包括首样及查厂调查。另外，供应商會收到反馈。 4 As per 3, with statistical evidence that the supplier is improving overall. Qualification system also includes process control, quality history, delivery and responsiveness to customer problems. 按照3，有统计數据证明供应商不斷改善。评审系统包括工艺控制，品质记录，交货情况及对客户投诉的反应。Remark备注: 4.2 Is there a s

20、ystem for control of purchased and contracted material to ensure that it meets the buyers requirements? 是否有系统确保采购或外包材料符合客户要求? 0 No system exists. 没有系统。 1 Requirements are defined verbally or in an inconsistent manner. Purchase orders do not consistently request information to satisfy requirements (e

21、.g. specifications, Certificate of Analysis (COA), and statistical analysis). 物料要求品是口头定义或用不一致的方式表達，定单沒有全面要求資料证明附合要求 (如规格, 分析证书(COA)和统计分析)。 2 Requirements are documented. Evidence is received that assures conformance to these requirements. However, there are still occasional quality problems. 有記载物料要求

22、程序。有证明供应商物料附合要求，但偶尔有品质问题。 3 As per 2, however, the system provides for timely resolution of problems. 按照2，系统包括及时解决问题。4 As per 3, with evidence of continuous improvement through quality indicators. 按照3，通过品质指标，持续改善品质。Remark备注: 4.3 Does the system provide for a list of approved suppliers?系统是否有经核准的供应商清单

23、? 0 There is no list of approved suppliers. 没有经核准的供应商清单。 1 An approved supplier list has been developed, but is inconsistently used and is not properly maintained. 有制定经核准的供应商清单，但不全面使用及保存。 2 A signed and dated approved supplier list has been developed and is in constant use. 有制定经核准的供应商清单，并全面使用。 3 As

24、per 2, with provisions for removal based on performance reviews and a method for requalification. 按照2，有删除供应商和重新核准的机制规定。4 As per 3, with a documented system, which includes formal rating and certification status.按照3，有程序文件，并包括正式评级和证书状态。Remark备注: 5.0 PRODUCT IDENTIFICATION/TRACEABILITY产品标识/追溯 5.1 Are w

25、ritten procedures and positive controls in effect to accurately retain part identification and traceability of product throughout processing, storage, packaging and shipping? 在零件的标识和追溯性，是否有程序文件和有效控制涵盖整个工序，仓储，包装以至付运等? 0 No system exists. 没有系统。 1 A control system exists, but is not well defined and is

26、 inconsistently used throughout the company. 有系统，但没有清楚全面定义。 2 Written procedures and positive controls are in effect to accurately retain part identification, quality status and traceability of product throughout processing, storage, packing and shipping. 有清楚程序文件和有效控制零件的标识，涵盖整个工序，仓储，包装以至付运等。 3 Exten

27、sive evidence of lot control and traceability exists through the process, from raw material to finished product. 从原料到程序成品， 每批都有控制和追溯证据。 4 As per 3, with continuous improvement evident through the reduction of internal corrective actions. 按照3，有持续改进方案减少內部错误。 Remark备注: 5.2 Is there a system to control

28、raw and in-process materials, and finished goods having shelf life restrictions? 是否有系统控制原材料，制程零件和成品的保质期? 0 No system exists. 没有系统。 1 A system exists, but is inadequately documented and inconsistently applied. 有系统存在， 但没有清楚全面执行。 2 A complete, well documented system exists, and is consistently applied.

29、 有完整及良好的系统，并执行良好。 3 As per 2, with evidence that the system/procedures are audited by authorized personnel determining compliance. 按照2，有证据证明，该系统/程序有定期考核。 4 As per 3, with evidence the system is improving through corrective actions taken via audits. 按照3，有证据证明在定期考核后，有持续纠正行动。Remark备注:6.0 PROCESS CONTRO

30、L制程控制 6.1 Are there documented operating procedures defining the manner of production and operating conditions? 是否有程序文件去定义生产方式和操作条件? 0 Production or operating procedures are not documented. 没有相关生产/操作指引。 1 Some operating procedures exist, however, they are incomplete. 有些工位有操作指引，但不全面。 2 Approved procedures are documented and available for most significant functions. A sy