工藝設(shè)計(jì)和開發(fā)控制程序

1、Procedure Document/程序文件Control Procedure for Process design andDevelopment工藝設(shè)計(jì)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(zhǔn):Controlled Condition/受控狀態(tài):Distribution No. /分發(fā)號：質(zhì)量管理體系更改記錄表Record Chart of Changes in Quality Management System of Quality Manu

2、alTY-QR-TQD-031A更改單編號Change OrderNumber文件編號Document Number處數(shù)SectionChanged標(biāo)志Rev更改日期ReleaseChange更改人 Change ExecutorControl Procedure for Process design and Development/工藝設(shè)汁和開發(fā)控 制程序1 Purpose/U 的This procedure is used to normalize the management of new product process design and development of the com

3、pany so as to ensure that all the tasks on new product process design and development of the company are implemented effectively.本程序?yàn)榱艘?guī)范公司新產(chǎn)品工藝設(shè)計(jì)和開發(fā)的管理，確保公司新產(chǎn)品工藝設(shè) 計(jì)和開發(fā)的各項(xiàng)工作得到有效實(shí)施。2 Scope/范圍This procedure is applicable to control of new product process design and development of the company. The conte

4、nt: The company doesn t cover the product design, just focusing on process design based on customer drawings 本程序適用于公司新產(chǎn)品工藝設(shè)計(jì)和開發(fā)的控制。但包括產(chǎn)品進(jìn)行設(shè)計(jì)和開發(fā)。3 Terms/術(shù)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(shè)計(jì)輸出：指工藝或過程設(shè)計(jì)的結(jié)果。通過對工藝設(shè)計(jì)和開發(fā)，將 工藝設(shè)計(jì)的依據(jù)轉(zhuǎn)化為工藝設(shè)計(jì)輸出的一系列工藝技術(shù)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】藝設(shè)計(jì) 進(jìn)行的正式、全面和系統(tǒng)的審查，并把審查結(jié)果形成文件。3. 3 Overa

6、ll 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(jù)產(chǎn)品設(shè)計(jì)要求、生產(chǎn)綱領(lǐng)和生產(chǎn)能力，提出工藝技術(shù)準(zhǔn)備具體 任務(wù)和措施的指導(dǎo)性文件。3.4 First article （batch） inspection: after the ready

7、 condition 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

8、 and equipments can guarantee that the products conforming to design requirements are produced. /首件（批）鑒定：在生產(chǎn)試制準(zhǔn)備狀態(tài)檢 查合格后，對首批試制生產(chǎn)的零、部（組）件按產(chǎn)品圖和工藝規(guī)程的要求進(jìn)行全 面的過程和成品檢查，以確定生產(chǎn)工藝和設(shè)備能否保證生產(chǎn)出符合設(shè)計(jì)要求的產(chǎn) 品。3. 5 Process planning： responsibilities and authorities for process design are distributed and interface manag

9、ement at 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

10、藝策劃:按照產(chǎn)品設(shè)計(jì)和 開發(fā)的進(jìn)度要求，根據(jù)客戶產(chǎn)品設(shè)計(jì)圖樣等技術(shù)文件，對產(chǎn)品工藝設(shè)計(jì)職責(zé)和權(quán) 限進(jìn)行分工，明確產(chǎn)品工藝設(shè)訃各階段接口管理，保證工藝設(shè)計(jì)和驗(yàn)證等活動按 計(jì)劃進(jìn)行。4 Responsibility/職責(zé)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(shù)

11、質(zhì)量部是公司工藝設(shè)計(jì) 和開發(fā)過程的歸口管理部門；負(fù)責(zé)公司新產(chǎn)品工藝設(shè)計(jì)和開發(fā)工作的組織實(shí)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(shù)質(zhì)量部門負(fù)責(zé)工藝設(shè)計(jì) 和開發(fā)過程的業(yè)務(wù)管理；負(fù)責(zé)新產(chǎn)品工藝設(shè)計(jì)和開發(fā)工作的組織實(shí)施；4.3 All the related uni

12、ts of the company shall be responsible for cooperation in accomplishing all the tasks on the process design and development. /公司各有關(guān)單位負(fù)責(zé)配合完成工藝設(shè)計(jì)和開發(fā)過程的各項(xiàng)工作。5 Working Procedure/工作程序5.1 Process Design and Development Planning/工藝設(shè)計(jì)和開發(fā)策劃3 1. 1 Source of Process Design and Development Project/工藝設(shè)計(jì)和開發(fā) 項(xiàng)目的來源

13、a) After the new product 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 confirmati

14、on. After it is approved by General Manager, it shall be issued to Chief Engineer /營銷 部與顧客簽訂的新產(chǎn)品合同或技術(shù)協(xié)議，或市場需求，通過評審后，由 營銷部填寫工藝設(shè)計(jì)開發(fā)立項(xiàng)申請書，經(jīng)相關(guān)部門、人員確定后報總 經(jīng)理批準(zhǔn)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 Proc

15、ess Design and Development to lower levels and send the technical data concerning new product to Technical Quality Department. /接到工藝設(shè)計(jì)開發(fā)立項(xiàng)申請書后由總工程師下達(dá)工 藝設(shè)計(jì)和開發(fā)任務(wù)書，并將與新產(chǎn)品有關(guān)的技術(shù)資料轉(zhuǎn)交技術(shù)質(zhì)量部。3 1. 2 Chief Engineer shall det ermine the project leader based on the above project sources and transform the output

16、of process design and development planning into Process Design and Development Plan. The plan shall include the following contents：/總工程師根據(jù)上述項(xiàng)目來源,確定項(xiàng)目負(fù)責(zé)人,將工 藝設(shè)計(jì)和開發(fā)策劃的輸出轉(zhuǎn)化為工藝設(shè)計(jì)和開發(fā)計(jì)劃書。計(jì)劃書內(nèi)容包括：a) Division of the stages such as input, output, review, verification and confirmation of process design and de

17、velopment and main work content;/工藝設(shè)計(jì)和開發(fā)的輸入、輸岀、評審、驗(yàn)證、確認(rèn)等各階段的 劃分和主要工作內(nèi)容；b) Responsibilities and authorities at all the stages, requirement of schedule and supporting unit;/各階段人員職責(zé)和權(quán)限，進(jìn)度要求 和配合單位；c) Requirement for resource allocation, e. g,personnel, information, equipment, fund guarantee and other re

18、lated content/資源酉i!置需 求，如人員、信息、設(shè)備、資金保證等及其他相關(guān)內(nèi)容。3. 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(shè)計(jì)和開發(fā)策劃的輸出文件隨著設(shè)計(jì)和開發(fā)的進(jìn)展，在適當(dāng)時

19、予 以修改，應(yīng)執(zhí)行文件控制程序的有關(guān)規(guī)定。3 1. 4 Interface Management between Different Groups of Process Design and Development/工藝設(shè)計(jì)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(shè)計(jì)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

20、及到公司外部。a) For the communication of 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 grou

21、ps If some tasks need to be harmonized 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(shè)訃和開發(fā)信息溝通，設(shè)計(jì)開發(fā)人員填寫工藝設(shè)計(jì)開發(fā)信息聯(lián)絡(luò)單， 山項(xiàng)U負(fù)責(zé)人審批后發(fā)給相關(guān)組別，需要技術(shù)質(zhì)量部主管進(jìn)行協(xié)調(diào)工作 的，山技術(shù)質(zhì)量部主管審批后組織協(xié)調(diào)。b) Marketing Departme

22、nt shall take charge of contact with the customer and information transfer to the customer/營卡肖部負(fù)責(zé)與 顧客的聯(lián)系及信息傳遞。5. 2 Process Design and Development Input/工藝設(shè)計(jì)和開發(fā)輸入3.2.1 The process design and development input should include the following contents：/工藝設(shè)訃開發(fā)輸入應(yīng)包括以下內(nèi)容：a) Main characteristics and performan

23、ce requirements for the product. These requirements are mainly from the demand and expectation of the customer or market, normally included in the contract, order or project recommendation;/產(chǎn)品主要特點(diǎn)、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(yīng)包含在合同、定單或項(xiàng)H建議書 中；b) Applicable laws and regulations and mandatory national

24、 standards shall be met;/適用的法律、法規(guī)要求，對國家強(qiáng)制性標(biāo)準(zhǔn)一定要滿足；c) Applicable information provided by previous similar process design and development;/以前類似的工藝設(shè)訃和開發(fā)提供的適用信息；d) Other requirements necessary for process design and development / 工藝設(shè)計(jì)和開發(fā)所必須的其他要求。5 2. 2 The process design and development input shall be d

25、ocumented, List of Process Design and Development Inputs shall be completed and all kinds of relevant data shall be attached. /工藝設(shè)計(jì)和開發(fā)的輸入應(yīng)形成文件,填 寫工藝設(shè)計(jì)和開發(fā)輸入清單，并附上各類相關(guān)的資料。3 2. 3 The director of Technical Quality Department shall arrange the related process design and development personnel and associat

26、ed departments to review the process design and 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(shù)質(zhì)量部主管組織有關(guān)工藝設(shè)計(jì)和開發(fā)人員和相關(guān)部門對工藝設(shè)計(jì)和 開發(fā)輸入進(jìn)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(shè)

27、 計(jì)開發(fā)的輸入滿足任務(wù)書的要求。5. 3 Process Design and Development Output/工藝設(shè)訃和開發(fā)的輸出531 The process design and development personnel shall launch the process designand development on the basis of Process Design and Development Plan and the program, and work out corresponding document on process design and developm

28、ent output, i e., List of Process Design and Development Outputs. /工藝設(shè)計(jì)和開發(fā)人員根據(jù)工藝設(shè)計(jì)和開發(fā)計(jì)劃書及方案等開展工 藝設(shè)計(jì)開發(fā)工作，并編制相應(yīng)的工藝設(shè)汁和開發(fā)輸出文件，即工藝設(shè)訃和開發(fā) 輸出清單。5.3.2 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 prov

29、e that the input requirement is met and to provide 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,

30、control plan, inspection and test plan, inspection work instructions, list of purchased materials and design drawings of tooling and fixtures. /工藝設(shè)訃和開發(fā)輸出文件應(yīng)以能針對匸藝設(shè)訃和 開發(fā)輸入進(jìn)行驗(yàn)證的形式來表達(dá)，以便于證明滿足輸入要求，為生產(chǎn)運(yùn)作 提供適當(dāng)?shù)男畔?。工藝設(shè)計(jì)和開發(fā)輸出文件因產(chǎn)品不同而不同，包括指導(dǎo) 生產(chǎn)等活動的參數(shù)和文件：如轉(zhuǎn)換圖紙、工藝文件、零件明細(xì)表、控制計(jì) 劃、檢驗(yàn)和試驗(yàn)訃劃、檢驗(yàn)作業(yè)指導(dǎo)書、物資采購清單、工裝夾具設(shè)計(jì)圖 紙等

31、。5.3.3 Technical Quality Department shall assign a person specially for checking theprocess 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.

32、/技術(shù)質(zhì)量部指定專人負(fù)責(zé)校核工藝資料，重點(diǎn)校核工藝資料能否滿 足產(chǎn)品設(shè)計(jì)要求；內(nèi)容完整、正確：工序之間是否協(xié)調(diào)、加工的可行性和可檢查 性。5.3.4 Full (part) time standardization personnel of Technical Quality Departmentshall take charge of checking the data on process design and development output for standardization. /技術(shù)質(zhì)量部門的專（兼）職標(biāo)準(zhǔn)化員負(fù)責(zé)本部門 對工藝設(shè)計(jì)和開發(fā)輸出資料標(biāo)準(zhǔn)化檢查。5.3.5 The

33、 project leader shall review the process output document and fill in List ofProcess Design and Development Outputs The output document cannot be issued until it is approved by Chief Engineer. /ill項(xiàng)目負(fù)責(zé)人對輸出工藝 文件進(jìn)行審核并填寫工藝設(shè)訃和開發(fā)輸出清單，總工程師批準(zhǔn)輸出文件后才 能發(fā)放。5. 4 Review of Process Design and Development/J藝設(shè)計(jì)和開發(fā)的評

34、審3. 4 1 The systemic and comprehensive reviews proposed by the project leader of process design as usual should be carried out at the suitable stage of process design and development. /在工藝設(shè)計(jì)和開發(fā)的適當(dāng)階段應(yīng) 系統(tǒng)的、綜合的評審，一般曲工藝設(shè)計(jì)項(xiàng)目負(fù)責(zé)人提出。3 4.1 1 The instruction process documents such as process design and develo

35、pment planning, overall process program （process route） and production instructions should be process reviewed before concrete process design and development. /工藝設(shè)計(jì)和開發(fā)策劃、匸藝總方案（工藝路 線）及生產(chǎn)說明書等指令性工藝文件的工藝評審應(yīng)在工藝具體設(shè)計(jì)和開發(fā)前進(jìn) 行。5 4. 1. 2 Technological procedure for new process, key article, important article a

36、nd key process （working process） and special process document shall be reviewed before first article inspection. /新工藝，關(guān)鍵件、重 要件、關(guān)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(jìn)行。5. 4. 2 Review Content/評審內(nèi)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 correctn

37、ess, advancement, economy and feasibility;/審查工藝總方案的正確性、 先進(jìn)性、經(jīng)濟(jì)性和可行性；b) The overall 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(chǎn)品設(shè)計(jì)及生產(chǎn)綱領(lǐng)的要求：c) The product process division and route shall be determined reason

38、ably and feasibly;/產(chǎn)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 special tooling factors shall be reviewed;/審查專用工裝系數(shù)的確定依據(jù)；e) The bases and rationalities for new process, new technique and new equipment;/新工藝、新技術(shù)、新設(shè)備采用的依據(jù)及合理性；f) The requirements for standardization of process technical docume

39、nts; /工藝技術(shù)文件的標(biāo)準(zhǔn)化要求；g) The principles for determination and control of material 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(guān)鍵件、重要件的評 審a) The control factors and contents of the process documents on key processes (working processes) o

40、f key article and important article shall be reviewed for correctness, rationality and inspectability;/審查關(guān)鍵件、重要件中關(guān)鍵過程(工序)工藝文件的控 制因素及內(nèi)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(shí)關(guān)鍵過程(工序)的工序能力指數(shù)；c) The process methods and detection requirements

41、for key processes (working processes) of key article and important article shall be reviewed for rationality and feasibility;/審查關(guān)鍵件、重要件中 關(guān)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 (worki

42、ng process) shall be reviewed for correctness, rationality and feasibility;/審查與關(guān)鍵過程（工序）的質(zhì)量特性形成，涉及的關(guān)聯(lián) 工序及檢驗(yàn)工序設(shè)置的正確性、合理性、可行性；精品e) The technical breakthrough measure for key process (working process) shall be reviewed;/審查關(guān)鍵過程(匸序)的技術(shù)攻關(guān)措施：f) The content of key process (working process) shall be reviewed

43、for completeness. /審查關(guān)鍵過程(工序)H錄的完整性。5. 4. 3 1 Technical Quality Department shall issue the review content or related data to the reviewing units. /技術(shù)質(zhì)量部將評審內(nèi)容或有關(guān)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(zé)5. 4. 4. 1 Review Organization/評審組織The process review group shall be co

44、mposed of reviewers of which the chief is competent technical leader or his/her representative由參評人員組成工藝評審組，組長由主管技術(shù)領(lǐng)導(dǎo)或由他指定的委托人擔(dān) 任。5. 4. 4. 2 Responsibilities of Review Group Chief/評審組長職責(zé)a) Preside over the meeting;/主持會議；b) Collect the problems and suggestions put forward in the review, give opinions

45、and make conclusions;/匯集評審提出的問題和建議， 寫出評語和結(jié)論；c) Assign a recorder to sort and work out the process review 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(zé)a) Ready for the review in advance;/提前做好參評準(zhǔn)備；b) Give opinions fully. /充分發(fā)表意見；5.4.5 Review Steps/評審步驟345 1 The review grou

46、p 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；3452 The process design representative shall introduce the process design;/工藝設(shè)計(jì)代表介紹工藝設(shè)計(jì)情況；5 4. 3. 3 The reviewers shall give the opinions on the review;/參EF人員 發(fā)表評審意見；3 4 5 4 The review group chief shall define the items and

47、contents to be improved on the basis of collected opinions, and summarize the review results to give his/her opinion or make a conclusion;/評審組組長在集中 意見的基礎(chǔ)上，明確需要改進(jìn)的項(xiàng)LI和改進(jìn)內(nèi)容，對評審結(jié)果總結(jié)形成評語或結(jié) 論；3453 The recorder shall sort the meeting records and fill in Report on Process Design and Development Review. /記錄

48、人員整理會議記錄，填寫工 藝設(shè)計(jì)和開發(fā)評審報告。5. 4. 6 Measure Implementation and Data Perfection/落實(shí)措施，完善資料Technical Quality Department 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(shù)質(zhì)量部認(rèn)真分析評審會議提出的問題和改進(jìn)意見

49、，制定并落實(shí)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 article (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 Ne

50、w Product Trial-manufacture Plan. /技術(shù)質(zhì)量部根據(jù)下達(dá)的新產(chǎn)品試制計(jì)劃，擬訂首件(批)鑒定計(jì)劃，提出 鑒定要求，明確試制鑒定組織人員，并組織實(shí)施。5. 4. 2 Trial-manufacture of First Article (Batch)/首件(批)試制Manufacturing Department shall trial-manufacture the first article (batch) on the basis of New Product Tri al-manuf ac ture Plan and the following requi

51、rements： 制造部根據(jù)新產(chǎn)品試制計(jì)劃和下列要求組織進(jìn)行首件(批)試制：a) The process device, production equipment, test equipment, environmental condition, 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(chǎn)設(shè)備、試驗(yàn)設(shè)備及環(huán)境條件 等滿足工藝文件的規(guī)定，并經(jīng)試制準(zhǔn)備狀態(tài)檢查合格；b

52、) The article shall be processed in each working process strictly in accordance with the requirements of process document, 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(yīng)嚴(yán)格按工藝文件的要求加工，技術(shù)人員及時處理、記錄每道 工序試制中的問題；c)

53、 The inspector shall check the processed article and make related records. /檢驗(yàn)人員進(jìn)行加工后的檢測，做好相關(guān)記錄。5. 4. 3 Inspection for First Article (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 issue

54、d process document and work instructions for trial-manufacture After it is qualified, the condition on inspection for first article (batch) working process shall be possessed. /首件(批)工序(零、部)件嚴(yán)格按照下發(fā)的試 制工藝文件和作業(yè)指導(dǎo)書進(jìn)行檢驗(yàn)。合格后才能具備首件(批)工序鑒定條件。 3 4. 3 2 When the condition on inspection for first article (batc

55、h) working process shall be possessed, Manufacturing Department shall fill in aApplication Form for Inspection (Type Approval) of First Article (Batch) Working Process M 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

56、序(零、部)件鑒定(定型)申請表”交技術(shù) 質(zhì)量部門組織對首件(批)的工序?qū)嵤╄b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544.1 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(shù)部門負(fù)

57、責(zé)組織鑒定組成員，進(jìn)行首件(批)零、部件鑒 定。3 4 4. 2 The situation on the inspection for first article (batch) working process and the processing quality of the 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(zhì)量，驗(yàn)證以下內(nèi)容:a) Completeness, correctness and effectiveness of proc

58、edure document and work instructions; /工藝文件、作業(yè)指導(dǎo)書的完整、止確、有效性；b) Configuration of measuring equipment like measuring tool and effectiveness of the equipment for product quality control;/fi 具等測量設(shè)備的配置及對產(chǎn)品質(zhì)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 wel