外包过程作业指导书(中英文)

外包过程作业指导书

1．Purpose目的

Establish the instruction to manage subcontract process, including subcontractor selection, assessment, and control. Ensure all subcontract processes in VICTOR within control condition.

建立外包过程控制指导书来指导对公司的外包方进行选择,评价与管理控制, 确保外包过程具有满足本公司规定要求的能力。

2．Scope-适用范围

This instruction applicable all subcontract process: a.Plastic&Casting Parts Painting Process; b.AM2000:2008 Dental Unit Assembly Process.

适用于公司所有外包过程.本公司的外包过程包括: 塑料件与机加工件的喷漆过程与AM2000:2008牙科治疗机的整机装配过程.

3．Responsibility-职责

Purchase Department: Research, collect and provided potential qualified subcontractor, conduct subcontractor assessment and audit activities.

采购部：收集,搜寻,提供潜在的合格外包方信息,主导外包商的评价与审核过程. Quality Department: Participating subcontractor audit process, leading subcontractor quality system evaluation and subcontract parts quality inspection and verification. 质量部:参与外包商的审核,主导外包商的品质保障评价,外包产品质量的检验与验证.

Technical Department: Participating subcontractor audit process, leading subcontractor technical aspect including equipment evaluation. Providing technical support to subcontractor, if necessary.

技术部:参与外包商的审核,主导外包商的技术能力与设备的评价.必要时,提供技术支持给予外包商

Production Department: Participating subcontractor audit process, leading subcontractor production capability, material management, production management 生产部:参与外包商的审核,主导外包商的生产能力评价,包括物料管理,生产管理评定等.

Management Representative: Coordinate and planning subcontractor assessment process, summarize audit result and report to GM.

管理者代表:协调与策划外包商的评价,汇总评价结果,汇报至总经理

4．Terms and Definitions-术语与定义

Potential Subcontractor: Subcontractor which have the potential qualify to provided subcontract service to our company, but not do business with us momently

候选外包方：欲向本公司提供服务,本企业尚未使用的供方

Qualified subcontractor: Subcontractor which with the competence to provided subcontract service to our company via our systematical investigation and evaluation 合格外包方：经本公司调查、评价和选择，具有向本企业提供满意服务能力的外包方

5．Procedure-程序

5.1 Subcontractor selection and evaluation

外包方的评价和选择

5.1.1 Principle of subcontractor selection

外包方的选择原则

(a) Have a satisfied performance. Efficient production capability and process

capability

具有使用满意的历史业绩.充足的生产能力与工艺要求；

(b) Solid credit background Including quality management level, service, resources, or quality certification proof etc.

良好的企业信用等级.包括质量管理能力、服务、资源配备，或相关的体系认证等；

(c) Similar servicing history to other customer

对比类似服务的历史情况或对比其他使用者的使用经历.

(d) For dental unit subcontractor, must be obtained SFDA license and guarantee follow the SFDA regulations strictly

对于整机的外包商,其必需获得国家药监局的相关许可证,并保证严格遵照国家医疗行业相关的法规来运作.

5.1.2 Regular evaluation of exist subcontractor

现有外包商定期评价和确认

(a) In principle, VICTOR should do regular assessment of exist subcontractor once a year.

原则上,每年应进行至少一次对现有外包商的整体评价

(b) Purchase department evaluate the service aspect of the

subcontractor, give a score base its on time delivery,(total 40’) cost down performance etc.Fill in “Supplier Regular Assessment Record”.

采购部负责对外包商的服务业绩及配合度进行评价,并根据其到料准时,价格因素等方面赋予分值,总分40分,填入《供方定期评定表》

(c) QC department evaluate the quality aspect of the subcontractor, give a score base