工藝設計和開發(fā)控制程序

1、 Procedure Document/程序文件Control Procedure for Process design and Development工藝設計和開發(fā)控制程序Document NO/ 編號：TY-QP7.3-01-15Revision /版本： Checked by/校對： Verified by/審核： Approved by/批準： Controlled Condition/受控狀態(tài)：Distribution No./分發(fā)號：質量管理體系更改記錄表Record Chart of Changes in Quality Management System of Quality

2、ManualTY-QR-TQD-031A更改單編號Change Order Number文件編號Document Number處數Section Changed標志Rev更改日期Release Change更改人Change ExecutorControl Procedure for Process design and Development/工藝設計和開發(fā)控制程序1 Purpose/目的This procedure is used to normalize the management of new product process design and development of the

3、 company so as to ensure that all the tasks on new product process design and development of the company are implemented effectively.本程序為了規(guī)范公司新產品工藝設計和開發(fā)的管理，確保公司新產品工藝設計和開發(fā)的各項工作得到有效實施。2 Scope/范圍This procedure is applicable to control of new product process design and development of the company. The co

4、ntent: The company doesnt cover the product design, just focusing on process design based on customer drawings.本程序適用于公司新產品工藝設計和開發(fā)的控制。但包括產品進行設計和開發(fā)。3 Terms/術語3.1 Process design output: the result of process design. Through the process design and development, the bases of process design are transformed

5、 into a series of process technical data of the process design output./工藝設計輸出：指工藝或過程設計的結果。通過對工藝設計和開發(fā)，將工藝設計的依據轉化為工藝設計輸出的一系列工藝技術資料。3.2 Process review: the process design is reviewed formally, roundly and systemically and the review result is documented./工藝評審：對工藝設計進行的正式、全面和系統(tǒng)的審查，并把審查結果形成文件。3.3 Overall

6、process program: based on product design requirement, production program and productivity, the guidance document is used to put forward the technology and prepare for concrete tasks and measures./工藝總方案：根據產品設計要求、生產綱領和生產能力，提出工藝技術準備具體任務和措施的指導性文件。3.4 First article (batch) inspection: after the ready con

7、dition of trial-manufacture is qualified through check, the first batch of trial-manufactured components and parts are checked for overall process and finished products in accordance with the requirements of product drawings and technological procedure to determine whether the production process and

8、 equipments can guarantee that the products conforming to design requirements are produced./首件（批）鑒定：在生產試制準備狀態(tài)檢查合格后，對首批試制生產的零、部（組）件按產品圖和工藝規(guī)程的要求進行全面的過程和成品檢查，以確定生產工藝和設備能否保證生產出符合設計要求的產品。3.5 Process planning: responsibilities and authorities for process design are distributed and interface management at

9、every stage of product process design is defined on the basis of technical documents such as product design drawing of the customer in accordance with schedules of product design and development, in order to guarantee that the process design, validation, etc are carried out as scheduled./工藝策劃：按照產品設計

10、和開發(fā)的進度要求，根據客戶產品設計圖樣等技術文件，對產品工藝設計職責和權限進行分工，明確產品工藝設計各階段接口管理，保證工藝設計和驗證等活動按計劃進行。4 Responsibility/職責4.1 Technical Quality Department shall be responsible for centralized management of process design and development and having the process design and development for new product implemented;/技術質量部是公司工藝設計和開發(fā)

11、過程的歸口管理部門；負責公司新產品工藝設計和開發(fā)工作的組織實施；4.2 Technical Quality Department shall be responsible for business management of process design and development and having the process design and development for new product implemented;/技術質量部門負責工藝設計和開發(fā)過程的業(yè)務管理；負責新產品工藝設計和開發(fā)工作的組織實施；4.3 All the related units of the compa

12、ny shall be responsible for cooperation in accomplishing all the tasks on the process design and development./公司各有關單位負責配合完成工藝設計和開發(fā)過程的各項工作。5 Working Procedure/工作程序5.1 Process Design and Development Planning/工藝設計和開發(fā)策劃5.1.1 Source of Process Design and Development Project/工藝設計和開發(fā)項目的來源a) After the new p

13、roduct contract or technical agreement signed by Marketing Department and the customer, or market demand is reviewed, Marketing Department shall fill in Application for Setup of Process Design and Development Project and submit it to related departments and personnel for confirmation. After it is ap

14、proved by General Manager, it shall be issued to Chief Engineer./營銷部與顧客簽訂的新產品合同或技術協議，或市場需求，通過評審后，由營銷部填寫工藝設計開發(fā)立項申請書，經相關部門、人員確定后報總經理批準后下發(fā)到總工程師。b) After receiving Application for Setup of Process Design and Development Project, Chief Engineer shall transmit Assignment Book for Process Design and Develo

15、pment to lower levels and send the technical data concerning new product to Technical Quality Department./接到工藝設計開發(fā)立項申請書后由總工程師下達工藝設計和開發(fā)任務書，并將與新產品有關的技術資料轉交技術質量部。5.1.2 Chief Engineer shall determine the project leader based on the above project sources and transform the output of process design and dev

16、elopment planning into Process Design and Development Plan. The plan shall include the following contents:/總工程師根據上述項目來源，確定項目負責人，將工藝設計和開發(fā)策劃的輸出轉化為工藝設計和開發(fā)計劃書。計劃書內容包括：a) Division of the stages such as input, output, review, verification and confirmation of process design and development and main work co

17、ntent;/工藝設計和開發(fā)的輸入、輸出、評審、驗證、確認等各階段的劃分和主要工作內容；b) Responsibilities and authorities at all the stages, requirement of schedule and supporting unit;/各階段人員職責和權限，進度要求和配合單位；c) Requirement for resource allocation, e.g., personnel, information, equipment, fund guarantee and other related content./資源配置需求，如人員、信

18、息、設備、資金保證等及其他相關內容。5.1.3 The output document of process design and development planning shall be revised appropriately with the schedule of design and development in accordance with the related provisions of Control Procedure for Document./工藝設計和開發(fā)策劃的輸出文件隨著設計和開發(fā)的進展，在適當時予以修改，應執(zhí)行文件控制程序的有關規(guī)定。5.1.4 Interf

19、ace Management between Different Groups of Process Design and Development/工藝設計和開發(fā)不同組別之間的接口管理Different groups of process design and development may concern different functions or levels of the company, and the exterior of the company.工藝設計和開發(fā)的不同組別可能涉及到公司不同職能或不同層次，也可能涉及到公司外部。a) For the communication of

20、 important design and development information between the groups, the design and development personnel shall fill in Contact Form for Process Design and Development Information. After the contact form is approved by the project leader, it shall be issued to the groups. If some tasks need to be harmo

21、nized by the director of Technical Quality Department, they cannot be harmonized until they are approved by the director of Technical Quality Department./對于組別之間重要的設計和開發(fā)信息溝通，設計開發(fā)人員填寫工藝設計開發(fā)信息聯絡單，由項目負責人審批后發(fā)給相關組別，需要技術質量部主管進行協調工作的，由技術質量部主管審批后組織協調。b) Marketing Department shall take charge of contact with

22、the customer and information transfer to the customer./營銷部負責與顧客的聯系及信息傳遞。5.2 Process Design and Development Input/工藝設計和開發(fā)輸入5.2.1 The process design and development input should include the following contents:/工藝設計開發(fā)輸入應包括以下內容：a) Main characteristics and performance requirements for the product. These

23、requirements are mainly from the demand and expectation of the customer or market, normally included in the contract, order or project recommendation;/產品主要特點、性能要求。這些要求主要來自顧客或市場的需求與期望，一般應包含在合同、定單或項目建議書中；b) Applicable laws and regulations and mandatory national standards shall be met;/適用的法律、法規(guī)要求，對國家強制

24、性標準一定要滿足；c) Applicable information provided by previous similar process design and development;/以前類似的工藝設計和開發(fā)提供的適用信息；d) Other requirements necessary for process design and development./工藝設計和開發(fā)所必須的其他要求。5.2.2 The process design and development input shall be documented, List of Process Design and Devel

25、opment Inputs shall be completed and all kinds of relevant data shall be attached./工藝設計和開發(fā)的輸入應形成文件，填寫工藝設計和開發(fā)輸入清單，并附上各類相關的資料。5.2.3 The director of Technical Quality Department shall arrange the related process design and development personnel and associated departments to review the process design an

26、d development input and clarify the imperfect, vague or inconsistent requirements in order to ensure that the design and development input meets the requirements of the assignment book./技術質量部主管組織有關工藝設計和開發(fā)人員和相關部門對工藝設計和開發(fā)輸入進行評審，對其中不完善、含糊或矛盾的要求做出澄清和解決，確保設計開發(fā)的輸入滿足任務書的要求。5.3 Process Design and Developmen

27、t Output/工藝設計和開發(fā)的輸出0.0.1 The process design and development personnel shall launch the process design and development on the basis of Process Design and Development Plan and the program, and work out corresponding document on process design and development output, i.e., List of Process Design and De

28、velopment Outputs./工藝設計和開發(fā)人員根據工藝設計和開發(fā)計劃書及方案等開展工藝設計開發(fā)工作，并編制相應的工藝設計和開發(fā)輸出文件，即工藝設計和開發(fā)輸出清單。0.0.2 The document on process design and development output should be expressed in the form that it can be verified for process design and development input to prove that the input requirement is met and to provide

29、 suitable information for the production. The document on process design and development output shall vary with different products, including the parameters and documents for production guidance, e.g., conversion drawing, process document, part list, control plan, inspection and test plan, inspectio

30、n work instructions, list of purchased materials and design drawings of tooling and fixtures./工藝設計和開發(fā)輸出文件應以能針對工藝設計和開發(fā)輸入進行驗證的形式來表達，以便于證明滿足輸入要求，為生產運作提供適當的信息。工藝設計和開發(fā)輸出文件因產品不同而不同，包括指導生產等活動的參數和文件：如轉換圖紙、工藝文件、零件明細表、控制計劃、檢驗和試驗計劃、檢驗作業(yè)指導書、物資采購清單、工裝夾具設計圖紙等。0.0.3 Technical Quality Department shall assign a pers

31、on specially for checking the process data, especially checking whether the process data meet the product design requirement, the content is complete and correct, the working processes are harmonized and the processing is feasible and checkable./技術質量部指定專人負責校核工藝資料，重點校核工藝資料能否滿足產品設計要求；內容完整、正確；工序之間是否協調、

32、加工的可行性和可檢查性。0.0.4 Full (part) time standardization personnel of Technical Quality Department shall take charge of checking the data on process design and development output for standardization./技術質量部門的專（兼）職標準化員負責本部門對工藝設計和開發(fā)輸出資料標準化檢查。0.0.5 The project leader shall review the process output document a

33、nd fill in List of Process Design and Development Outputs. The output document cannot be issued until it is approved by Chief Engineer./由項目負責人對輸出工藝文件進行審核并填寫工藝設計和開發(fā)輸出清單，總工程師批準輸出文件后才能發(fā)放。5.4 Review of Process Design and Development/工藝設計和開發(fā)的評審5.4.1 The systemic and comprehensive reviews proposed by the

34、project leader of process design as usual should be carried out at the suitable stage of process design and development./在工藝設計和開發(fā)的適當階段應系統(tǒng)的、綜合的評審，一般由工藝設計項目負責人提出。5.4.1.1 The instruction process documents such as process design and development planning, overall process program (process route) and produ

35、ction instructions should be process reviewed before concrete process design and development./工藝設計和開發(fā)策劃、工藝總方案（工藝路線）及生產說明書等指令性工藝文件的工藝評審應在工藝具體設計和開發(fā)前進行。5.4.1.2 Technological procedure for new process, key article, important article and key process (working process) and special process document shall be

36、 reviewed before first article inspection./新工藝，關鍵件、重要件、關鍵過程（工序）的工藝規(guī)程以及特殊工藝文件的評審在首件鑒定前進行。5.4.2 Review Content/評審內容5.4.2.1 Review of Overall Process Program/工藝總方案的評審a) The overall process program shall be reviewed for correctness, advancement, economy and feasibility;/審查工藝總方案的正確性、先進性、經濟性和可行性；b) The ov

37、erall process program shall be reviewed to determine whether it meets the requirements of product design and production program;/審查工藝總方案是否滿足客戶產品設計及生產綱領的要求；c) The product process division and route shall be determined reasonably and feasibly;/產品的工藝分工和工藝路線的確定是否合理、可行；d) The bases used to determine spec

38、ial tooling factors shall be reviewed;/審查專用工裝系數的確定依據；e) The bases and rationalities for new process, new technique and new equipment;/新工藝、新技術、新設備采用的依據及合理性；f) The requirements for standardization of process technical documents;/工藝技術文件的標準化要求；g) The principles for determination and control of material

39、consumption quota shall be reviewed./審查材料消耗定額確定及控制的原則。5.4.2.2 Review of Key Article and Important Article/關鍵件、重要件的評審a) The control factors and contents of the process documents on key processes (working processes) of key article and important article shall be reviewed for correctness, rationality an

40、d inspectability;/審查關鍵件、重要件中關鍵過程(工序)工藝文件的控制因素及內容的正確性、合理性、可檢查性；b) The process capability index of key process (working process) shall be verified;/核實關鍵過程(工序)的工序能力指數；c) The process methods and detection requirements for key processes (working processes) of key article and important article shall be re

41、viewed for rationality and feasibility;/審查關鍵件、重要件中關鍵過程(工序)的工藝方法、檢測要求的合理性和可行性；d) The setup of associated working procedure and inspection process related to formation of quality characteristic of key process (working process) shall be reviewed for correctness, rationality and feasibility;/審查與關鍵過程(工序)

42、的質量特性形成，涉及的關聯工序及檢驗工序設置的正確性、合理性、可行性；e) The technical breakthrough measure for key process (working process) shall be reviewed;/審查關鍵過程(工序)的技術攻關措施；f) The content of key process (working process) shall be reviewed for completeness./審查關鍵過程(工序)目錄的完整性。5.4.3.1 Technical Quality Department shall issue the re

43、view content or related data to the reviewing units./技術質量部將評審內容或有關的資料送交各參評單位。5.4.4 Organization and Responsibility of Review/評審組織及職責5.4.4.1 Review Organization/評審組織The process review group shall be composed of reviewers of which the chief is competent technical leader or his/her representative.由參評人員

44、組成工藝評審組，組長由主管技術領導或由他指定的委托人擔任。5.4.4.2 Responsibilities of Review Group Chief/評審組長職責a) Preside over the meeting;/主持會議；b) Collect the problems and suggestions put forward in the review, give opinions and make conclusions;/匯集評審提出的問題和建議，寫出評語和結論；c) Assign a recorder to sort and work out the process review

45、 reports;/指定記錄人員整理、寫出工藝評審報告；5.4.4.3 Responsibilities of Reviewer/評審人員職責a) Ready for the review in advance;/提前做好參評準備；b) Give opinions fully./充分發(fā)表意見；5.4.5 Review Steps/評審步驟5.4.5.1 The review group chief shall describe the meeting and assign a recorder;/評審組組長作會議說明并指定記錄人員；5.4.5.2 The process design repr

46、esentative shall introduce the process design;/工藝設計代表介紹工藝設計情況；5.4.5.3 The reviewers shall give the opinions on the review;/參評人員發(fā)表評審意見；5.4.5.4 The review group chief shall define the items and contents to be improved on the basis of collected opinions, and summarize the review results to give his/her

47、 opinion or make a conclusion;/評審組組長在集中意見的基礎上，明確需要改進的項目和改進內容，對評審結果總結形成評語或結論；5.4.5.5 The recorder shall sort the meeting records and fill in Report on Process Design and Development Review./記錄人員整理會議記錄，填寫工藝設計和開發(fā)評審報告。5.4.6 Measure Implementation and Data Perfection/落實措施，完善資料Technical Quality Department

48、 shall earnestly analyze the problems and improvement opinions put forward in the review meeting, work out the measures, have them taken and perfect the process data.技術質量部認真分析評審會議提出的問題和改進意見，制定并落實措施，完善工藝資料。5.5 First Article Inspection/首件鑒定5.4.1 Technical Quality Department shall draw up a first artic

49、le (batch) inspection plan, propose the inspection requirement, assign a person to arrange the trial-manufacture inspection and arrange the plant implementation on the basis of issued New Product Trial-manufacture Plan./技術質量部根據下達的新產品試制計劃，擬訂首件（批）鑒定計劃，提出鑒定要求，明確試制鑒定組織人員，并組織實施。5.4.2 Trial-manufacture of

50、 First Article (Batch)/首件（批）試制Manufacturing Department shall trial-manufacture the first article (batch) on the basis of New Product Trial-manufacture Plan and the following requirements:制造部根據新產品試制計劃和下列要求組織進行首件（批）試制：a) The process device, production equipment, test equipment, environmental condition

51、, etc shall meet the provisions of process documents, and the ready condition of trial-manufacture shall be qualified through check;/工藝裝置、生產設備、試驗設備及環(huán)境條件等滿足工藝文件的規(guī)定，并經試制準備狀態(tài)檢查合格；b) The article shall be processed in each working process strictly in accordance with the requirements of process document,

52、and the problems found during the trial-manufacture in each working process shall be handled and recorded by the technician in time;/每道工序應嚴格按工藝文件的要求加工，技術人員及時處理、記錄每道工序試制中的問題；c) The inspector shall check the processed article and make related records./檢驗人員進行加工后的檢測，做好相關記錄。5.4.3 Inspection for First Art

53、icle (Batch) Working Process/首件（批）工序鑒定5.4.3.1 The article (part or component) in first article (batch) working process shall be inspected strictly in accordance with issued process document and work instructions for trial-manufacture. After it is qualified, the condition on inspection for first arti

54、cle (batch) working process shall be possessed./首件（批）工序（零、部）件嚴格按照下發(fā)的試制工藝文件和作業(yè)指導書進行檢驗。合格后才能具備首件（批）工序鑒定條件。5.4.3.2 When the condition on inspection for first article (batch) working process shall be possessed, Manufacturing Department shall fill in “Application Form for Inspection (Type Approval) of Fi

55、rst Article (Batch) Working Process” and submit it to Technical Quality Department to inspect the first article (batch) working process./具備首件（批）工序鑒定條件時，由制造部填寫“首件（批）工序（零、部）件鑒定（定型）申請表”交技術質量部門組織對首件（批）的工序實施鑒定。5.4.4 Inspection of Part and Component in First Article (Batch) Working Process/首件（批）工序零、部件鑒定5.

56、4.4.1 Technology Quality Department shall take charge of assign the inspectors to inspect the part and component in the first article (batch) working process./技術部門負責組織鑒定組成員，進行首件（批）零、部件鑒定。5.4.4.2 The situation on the inspection for first article (batch) working process and the processing quality of t

57、he working process shall be spot checked, with the following contents verified:/抽查首件（批）工序鑒定情況及工序加工質量，驗證以下內容：a) Completeness, correctness and effectiveness of procedure document and work instructions;/工藝文件、作業(yè)指導書的完整、正確、有效性；b) Configuration of measuring equipment like measuring tool and effectiveness o

58、f the equipment for product quality control;/量具等測量設備的配置及對產品質量控制的有效性；c) Conformance of processing in working process to process document;/工序加工與工藝文件的符合性；d) Qualities of raw material, parts and auxiliary equipment as well as blank;/原材料、配套件、坯件質量；e) Whether the precision of production equipment meets the processin