EN-P-001 New Development Procedure 新产品开发程序.doc

New Developments Procedure新产品开发程序EN-P-001Revision No 版本A/01Revision Date 版本日期08日09月09年Page 6 of 6New Developments Procedure新产品开发程序Document Revision History 文件变更记录Version版本Revision Date变更日期Revised Content变更内容Reviser修订者A/0108日09月09年First releaseEdited by编制Verified by核准Approved by批准Date 日期:Date 日期:Date 日期:1. Purpose 目的The objective of this document is to define the procedure for the development of new materials, products and production processes. This guideline should be followed in order to assure a traceability of the new development, checking the plans of the project, verifying the validation of the product and working processes; analyze the corrective actions and establish all steps required in order to satisfy the final customer.本文确定了新材料、新产品以及新的生产工艺的开发程序。为确保新事物开发的可追溯性，核准项目计划，核实产品及生产工艺的有效性，分析更改措施，建立所需步骤，从而满足最终客户需求。2. Introduction 介绍The definition of a procedure for the new developments has some advantages such as early identification of the changes needed in the product, production processes and new material within the schedule defined, with low cost and customers requirements.The figure below is a sketch of the chronogram with the main steps of the development of the new product, material or process.新产品开发程序的确定优点如，对产品、生产工艺以及新材料在计划内所需的变更的提早确认，以及在低成本和客户需求下的变更的提早确认。Figure 01 Chronogram of the activities 过程记录图2.1. Development of a test 测试开发:This document shall be followed by all applicants that request a new development for materials, products or processes.新材料、新产品或新生产工艺的开发申请以及测试相关程序Responsible 责任人Activities 职责Applicant申请人- Define the objectives of the new development;- 确定新产品开发目标- Check together with the Engineering Department the directions of the tests, how to proceed and define the main points;- 与工程部共同商量如何进行测试以及主要问题点的确定- Define target schedule and evaluate it together with the Engineering Department;- 与工程部共同确定并评估进度表- Register, together with the Documents Control Center Archivist, the test title, objectives and responsible.- 在文控中心登记测试名称，测试目的以及责任人R&D Engineers研发工程师- Define test procedure; 确定测试程序- Perform the tests requested according to the procedure established; 根据已建立的程序执行相关要求- Write a detailed report with proper conclusions;- 编制详细的测试报告，并有恰当的结论- Send the report to Documents Control Center for register- 将测试报告发给文控中心进行登记Documents Control Center文控中心- Register the tests and, if requested, send a copy of the test report to the Applicant.- 登记测试报告，如果需要，将测试报告发放给申请人Table 01 Responsibilities definitions 责任确定2.2. Methodology 方法With this methodology, it is possible to define:以该方法，可确定如下：a) Improve the communication process;改善信息交流过程b) Identify potential products and processes failures;识别产品及工序的潜在失效性c) Verify the precision of some instruments used to approve the products;核实用于产品确认的仪器精度3. Procedure 程序The following flowchart identifies the steps of the procedure to be followed程序流程表如下：Figure 01 Flowchart of the activities before final approval 最终确认前的过程流程图Every survey or customers request can generate a need of new development. The technical feasibility should include:每份调查或客户要求都可能产生新产品开发需求。技术可行性分析应包括：- Achieve the objective proposed by the applicant 目标是否可达到- The cost of the final product is within the estimated 最终产品的成本是否在预估内- It does not implicate in quality problems 是否牵涉到质量问题The definition of the chronogram should be established based on the Production schedule, since the trials will affect the production line and according to development needs and objectives.记录图应该建立在生产日程表的基础上，因为根据开发需求及目标进行的试生产将影响到生产线作业。A test should be performed before first trial in the Production. After this first test, a report should be produced by the applicant and this should send it to Documentation Control Center for approval and archiving.在进行试生产之前应先做测试。测试完成后，将测试报告发给文控中心进行批准归档。After getting the approval of all responsible for the test and from all of head of departments, the Project will be validated and a try-out shall be performed in line production with the authorization of the Production Department Management. Production Department shall be responsible to define Production Control Plan and Operational Instructions, together with the specifications from the Engineering Department.项目经所有相关人员批准后确定，并在生产部的授权下进行试生产。生产部将负责生产控制计划以及操作指示的制订。The new Product, Material or Process can only be approved for Production if it passes the first try-out.新产品、新材料或者新工序在第一次试生产成功后只能用于生产。Further checks after implementation should be done periodically to verify corrective actions and feed-backs.实施后定期进行进一步检查以核实更正措施并反馈。4. Test Request 测试需求Any request for new development test can be done by a formal request sent by e-mail or by an RDA Research & Development Application Form, which is available in the server. This form should be fulfilled and registered in the Documents Control Center. In case the request is made by e-mail, the following contents should be in the content:任何新产品测试需求可通过邮件或服务器上的研发申请单进行申请。这个表单需要填写并登记在文控中心。如果申请通过邮件，需包括以下内容：- Title of the test;- 测试名称- Objective of the test;- 测试目的- Test procedure;- 测试程序- Reasonable schedule;- 合理的安排表The e-mail should also be registered in the s