记录控制程序-中英文版本

ISO9001供应商控制程序SUPPLIER Control PROCEDURE 1.Revision History 修订记录2.Purpose目的:2.1.To define supplier management procedure, and ensure that the suppliermaterial will follow DXC quality requirements.确立供应商管理程序，确保供应商之产品能满足DXC公司品质要求。

3.Scope范围:3.1.This procedure applies to all DXC suppliers.该程序适用于DXC公司所有供应商。

4.Reference Document参考文件4.1.Quality Manual 品质手册4.2.Purchasing Procedure 采购程序4.3.Incoming Quality Control Procedure进料品质控制程序4.4.IQC monthly report IQC月报4.5.Sourcing Procedure. 供应商开发程序5.Definition定义5.1.AVL– Approved supplier list 合格供应商清单5.2.CPAR –Corrective and preventive action request.纠正与预防措施申请5.3.P.O.–Purchase order.采购订单6.Responsibility职责：6.1.QA Department 品质部:6.1.1.R esponsible for the verification of the supplier’s qualitymanagement system, imposed requirement for the corrective and preventiveaction.负责确认供应商质量管理体系，纠正与预防措施的要求。

1.1 PURPOSE 目的1.1 This procedure provides guidelines for minimum control requirements necessary for a document tobe controlled, to ensure the suitability, adequacy and effectiveness of *** Automotive Technologies Co., Ltd. management system documents.本程序是规定了****汽车科技有限公司对管理体系文件和资料的控制与管理，确保管理体系文件的适宜性、充分性和有效性。

1.2 SCOPE 范围2.1 This procedure applies to controlled documents identified as part of the Management System for alldocuments issued and controlled in MMK:本程序适用于MMK的管理体系有关的受控文件2.1.1 Quality manual, procedures, working instructions质量手册，程序文件，作业指导书；2.1.2 Technical documents (including internal and customer)；技术文件(包括内部的和从客户处获得的)；2.1.3 External documents: e.g. legal and other standards etc.外来文件：法律法规以及相关标准。

3.0 DEFINITIONS 定义3.1 Controlled Document：Any document essential to the functioning of a process that needs to beavailable in its latest form.受控文件：流程运作的基本文件，这些文件必须保持最新版本。

文件管理与控制程序Documents management and control procedure1.目的Purpose确保环境管理体系文件、适用的外来文件（有关的法律、法规、标准、相关方提供的文件或规范）使用的有效性。

To assure the2.适用范围 scope适用于对环境管理体系相关文件及适用的外来文件的控制。

It is apply to theenvironment management system relation documents and usable external documents’ control.3.职责Responsibility3.1 环工组：负责环境管理体系文件及适用的外来文件的归口管理；负责监控文件的执行。

The environment team: to manage and be in charge of environment management documents and external documents.3.2 各部门individual department：确保各相关场所均使用现行文件的有效版本。

To ensureThe relative workplace is using the current effective documents.4.工作程序Work procedure4.1文件控制范围包括：documents control’s scopea）环境管理手册；environment management manual;b）环境管理体系程序文件；environment management system procedure documents;c）环境管理体系作业指导文件；the work instruction documents for environment management system;d）环境记录表格；environment record form;e）外来文件。

文件和记录控制程序1.0 目的 Purpose对与管理体系有关的文件、资料和记录(含电子版)进行控制，确保所有使用部门使用的文件和记录(含电子版)都有效。

Control over documents and materials related to management system so as to ensure that all the documents and materials and records (electronic)used by each department are current and valid. 2.0 范围Scope合用于所有与管理体系等有关的文件、资料和记录(含电子版)的控制。

Applicable to the control over documents and materials and records (electronic) related to management systems.3.0 职责 Responsibility3.1 管理者代表负责手册(质量手册、 EHS 手册)及程叙文件的批准。

Management Representative is responsible for the approval of manuals (quality manual,EHS manual) and procedure files.3.2 质量部经理负责质量手册、 EHS 手册的审核，程叙文件的复核。

QM is responsible for verification of quality manual, EHS manual , recheck procedure files.3.3 体系工程师负责质量手册、 EHS 手册的编制、更改和控制；程叙文件的编写和三级文件的审核。

ISO specialist is responsible for compilation, alternation and control of quality manual and EHS manual and procedure documents and review thesupportive documents.3.4 文控室负责检查文件编号、控制，外来文件的控制、管理。

1 目的Objective确保质量记录的有效性、完整性，为质量体系有效运行和产品质量是否符合要求提供客观证据，并为有追溯要求的场合提供证实。

The objective of this procedure is to ensure the effectiveness and integrity of quality records, so as to provide evidence if the quality system is effective and if the product quality meets the requirements, and in case of traceability occasions, to provide witness.2 适用范围Applicable Scope适用于本公司所有与质量有关的质量记录及来自分承包方和顾客质量记录的控制。

This is applicable to the control of all AICQ quality records related to quality and the quality records from the sub-contractors and customers.3 职责Responsibility3.1 各职能部门负责本部门范围内的专业性质量记录的归档。

Each functional department is responsible for filing of professional quality records within its respective business scope.3.2 质量部负责质量记录的管理。

The Quality Department is responsible for the management of quality records.3.3 总经办负责公司级质量文件和记录的归档和管理The GM Office is responsible for the filing and management of company-level quality documents and records.4 工作程序Work Procedures4.1 凡是用于证明产品是否符合规定的要求和质量体系是否有效运行的质量记录，都属于需控制的范围，包括但不限于：All the quality records that are used to serve as evidence if the product quality meets the requirements and if the quality system is effective shall fall in the state of control. They include, but are not limited to:a. 合同评审记录；Contract Review Records;b. 检验/试验记录（包括检验记录、试验报告等）；Inspection / Test Records (including inspection report, test report, etc);c. 产品认可/过程认可记录（包括样品认可报告、制造工程部批准/批量认可报告、CPK/PPK能力测定报告、人员培训/鉴定记录等；Product / Process Certification Records (including sample certification report,Manufacture Engineering Department approval / batch quantity certification report, CPK /PPK capability test report, personnel training / appraisal records, etc);d. 质量审核（体系/过程/产品/供应商审核报告）；Quality Audit (system / process / product / supplier audit report);e. 材料检验/试验报告；Material Inspection / Test Report;f. 质量控制图；Quality Control Diagram;g. 顾客索赔记录；Customer Claim Records;h. 与纠正预防措施有关记录；Records related to corrective and preventative actions;i. 设备/模具/工夹具保养、维修记录；Maintenance & repair records of equipment / moulds / tools & clamps;j. 测量设备校准记录。

ISO9001文件管理程序Document Control Procedure文件更改历史记录Amendment History版次Revision更改日期Change Date更改概要Description of Changes更改人Prepared by批准人Approved byPrepared by编制Reviewed by审核Approved by批准ISO9001文件管理程序Document Control Procedure1.0 Purpose目的Define the requirements and responsibilities for Document control.定义出文件控制的要求和权责。

2.0 Scope范围This procedure applies to all QMS documentation, including: quality manual, procedure, WI, external document and form.适用于与质量管理体系有关的所有文件。

包括:手册、程序文件、操作指导书、外来文件及表单。

3.0 Definitions定义3.1 Quality Manual: According to the requirements of International and national standard (such as ISO9001), describe quality management system documentation in Co-active.3.1质量手册：根据相关国际或国家标准(如ISO9001)要求，阐述本公司质量管理体系的文件。

3.2 Procedure: Define the function of QMS requirement allocation bydepartment. Such as document control, management review, internalaudit procedure.3.2程序文件：描述为实施质量管理体系要求所涉及的各职能部门的活动的文件。

QUALITY SYSTEMS PROCEDUREStatistical Process Control统计过程控制REFERENCES: (a)SPC User's Guide(b)STA-200 X(bar)-R(c)STA-300 Capability Studies1.0PURPOSE(目的 )To define the Statistical Process Control applications for our production inspect process.为了规范生产检验过程的SPC的控制。

2.0SCOPE（范围）This procedure is applied to all the production part and process need to SPC control.本文件适用于公司内有SPC监控要求的所有产品及工艺。

3.0 FUNCTIONS AFFECTED（涉及部门）Quality（质量部）Production （生产）Project （项目）Design （设计）Engineering （工程）Quality System （质量系统）4.0DEFINITIONS（定义）4.1 The primary determinate in control chart selection is Data Type.选择控制图最基本的决定条件是数据类型。

4.1.1 Continuous data: the data from testing, for example: label dimensions.计量型数据: 通过测量得到的数据,如标签尺寸。

4.1.2 Attribute data: the data from counting, the attribute data have two outcome (Pass/Fail,Good/NG).计数型数据: 通过点数得到的数据, 计数型数据只有两个值(合格/不合格, 通过/不通过)。

控制计划控制程序（IATF16949-2016）1、目的1. Purpose对控制零件和过程的体系，通过控制特性的过程监视和控制方法来最大限度地减少过程和产品变差；并随着测量系统和控制方法的评价和改进对其进行修订，使控制计划在整个产品寿命周期中得到保持和使用，确保按顾客的要求制造出优质的产品。

It aims to control the part and process systems and reduce process and product variations to the utmost extent through process monitoring and control methods of the control characteristics; the control plan shall be revised along with the evaluation and improvement of the measurement system and the control methods and shall be maintained and used in the whole product life cycle so as to ensure that high qualify product is manufactured according to the requirements of the customer.2、适用范围2. Scope适用于本公司内产品的样件、小批量试产和批量生产所用的控制计划。

如客户有特殊要求，必须按照客户的要求执行。

It applies to the control plans used in the product sample, small-lot trial production and volume production of the company. If the customerhas special requirements, it shall be implemented according to the requirements of the customer.3、定义3. Definition无None4、职责4. ResponsibilitiesAPQP项目小组负责控制计划的策划，质量部负责编制与维护The APQP project team shall be responsible for planning of the control plan and the quality department shall be responsible for preparation and maintenance of it.5、程序5. Procedure5.1 当顾客和公司有需求和要求时，项目小组在不同阶段制订出相应的控制计划（即：样件控制计划、试生产控制计划、生产控制计划），项目组按工艺文件将其发行至相关部门，由其执行。

Identification of environmental factors环境因素的区分和控制程序的评估1、目的PurposeTo have clear methods, steps and assessment standards for effectively identifying theenvironment factors in Simona Tanning.2、范围Scope适用全公司生产活动、产品和服务中所涉及环境因素的识别、评价及登记管理。

To identify, appraise and register the environment factors in production, product and service in Simona Tanning.定义Define环境因素Environment factor：指公司在活动、产品或服务过程中能与环境发生相互作用的要素。

重要环境因素Important environment factor：指具有或可能具有重大环境影响的环境因素。

It means the environment factor have or may have the important environment influence.3、职责Responsibility4．1环工组组建由内审员组成的环境因素识别小组，定期对公司所有活动、产品和服务进行环境因素识别，找出环境因素。

The environment team organize the environment distinguish team which consist of internal auditors, they will distinguish the environment factor through the activities that Simona tanning hold, products and service , so as to find out the environment factor. 4．2环工组负责确定环境因素的评价标准，组织对环境因素进行评价，幷确定重要环境因素。

ISO9001不合格品控制程序Control of Nonconforming Product 1.Revision History 修改记录2. purpose目的为有效地杜绝不合格的物料、半成品及成品的误用、流出; 并对其予以恰当处理.To avoid nonconforming materials, semi-finished products and finished products from misuse and Outflow, and dispose them properly.3. scope范围适用于不同阶段的产品及物料：如进料、制程、成品、库存及客户退货.Applicable for material and products in different level: Incoming, process, finished goods, stock and customer returns.4. Reference Document参考文件4.1《MRB运作程序》 MRB operation procedure4.2《记录管理程序》 Record control procedure4.3《进料品质控制程序》 Incoming quality control procedure4.4《过程质量控制程序》 Process quality control procedure4.5《出货质量控制程序》 Outgoing quality control procedure4.6《纠正与预防措施管理程序》 Corrective and preventive action managementprocedure4.7《产品标识及追溯性管理程序》Product identification and traceabilitymanagement procedure5. Definition定义5.1 合格：满足要求.Conforming: Satisfy the requirement5.2 不合格：未满足要求.Nonconforming: Disatisfy the rewuirement.6. Responsibility职责6.1 品质部：负责对不合格原料及成品的检验判定及标识。