PPAP生产件批准程序中英文对照

1、PPAP生产件批准程序中英文对照(IATF16949-2016) 生产件批准程序PPAP （IATF16949-2016 1 1. Purpose 下的实际生产过程中，具有持续满足这些要求的潜在能力。 It aims to ensure that the company has understood all customer engineering design record and specification requirements properly and the process has the potential capability to produce product consis

2、tently meeting these requirements continuously during an actual production process at the quoted production rate. 2 2. Scope 适用于公司用于汽车制造顾客的所有生产和 特殊要求，必须按照客户的要求执行。 It applies to approval of all production parts needed for production and/or service of the auto manufacturing customer. If the customer h

3、as special requirements, it shall be implemented according to the requirements of the customer. 3 3. Definition 3.1 PPAP指Production Part Approval Proces 3.1 PPAP: Refer to English abbreviation of Production Part Approval Process. 3.2 程设置等，如：循环时压力等的过程设置下被制造出来的部件。 3.2 Production part: Refer to parts m

4、anufactured by using production tooling, measuring implement, technical process, material, operator, environment and processes setting such as cycle time/pressure in the production field. 4 4. Responsibilities 4.1APQP小组负责与顾客联系落实各种情况下提交PPAP 4.1 The APQP team shall contact the customerto carry out var

5、ious PPAP submission requirements under all kinds of conditions. 4.2项目经理负责将产零件PPAP 4.2 The project manager shall submitthe related data of the product/part PPAP to the customer for approval. 4.3各部门协助项目经理执行顾客对PPAP 4.3 Each department shall cooperate with the project team to implement various requirem

6、ents of the customer to PPAP and provide related data. 5、程序Procedure 5.1当顾客和公司有需求和要求时，项目经理和相关责任部门依本文件中的规定对提交给 顾客批准的生产件制作PPAP 其提交给顾客批准。 5.1 When the customer and the company have demand and requirement, the program manager and related responsible departments shall make PPAP data for the production pa

7、rt submitted to the customer for approval according to the provisions in this document, submit it to the project team leader for approval after it is reviewed by the project manager, and then submit it to the customer for approval according to the requirements of the customer. 5.2提交给顾客批准的生产件必须在量产第一批

8、产品发运前完成批准，除非顾客放弃该生 产件的批准要求（要求顾客签署姓名和日期并记录存档）；不论顾客有没有要求公司正式 提交生产件的PPAP资料，项目组都必须对PPAP文件中所有适用的项目进行评审和更新， 以反映生产过程的情况。提交给顾客批准的生产件必须取自重要的和有效的生产过程，该 生产过程必须是1到8小时的生产，且规定数量至少为300件连续生产的产/ 除非顾客或顾客授权的质量代表另有书面规定和要求。 5.2 The production part submitted to the customer for approval shall be approved before shipment

9、of the first batch of products in mass production, unless the customer waives the approval requirement of the production part (require the customer to sign the name anddate and record and file it); whether the customer requires the company to submit the production part PPAP data formally or not, the

10、 project team shall review and update all applicable items in the PPAP document to reflect the condition of the production process. The production part submitted to the customer for approval shall be taken from a significant and effective production process; the production process shall be from one

11、hour to eight hours of production, and with the specified production quantity to total a minimum of 300 consecutive products/parts, unless otherwise specified andrequired in written by the customer or the customer authorized quality representative. 5.2.1提交给顾客批准的生产件，其取自的生产过程必须在生产现场使用与量产生产环境 同的装配线或工作单

12、元，有关检验都必须对其进行测量和对代表性样件进行试验。 5.2.1 The production part submitted to the customer for approval shall be taken from the production process that produces the part by using the same tooling, measuring implement, process,materials and operators from the mass production environment at the productionsite. T

13、he parts from each production process, such as the same assembly line or work cell, shall be measured and the representative sample shall be tested. 5.2.2PPAP 5.2.2 The PPAP document shall cover the product approval department of the customer and the name of the person responsible for approval and t

14、he date. 5.3生产件提交给顾客批准的时机：对出现下述情况的生产性零部件，项目组必须在量产 第一批生产件发运到顾客之前提交PPAP 5.3 Opportunity of submitting the production part to the customer for approval: As to the production part in the following cases, the project team shall submit PPAP for approval before shipment of the first batch of products in ma

15、ss production, unless the product approval department of the customer waives this requirement. 5.3.1 5.3.1 A new part or product (that is:part or product never supplied to the customer previously). 5.3.2 寸或能力问题；供应商问题；试验，包括材料、性能、工作确认问题等）进行的纠正。 5.3.2 Correction of the inconformity(e.g.: product perfor

16、mance different from the requirements of the customer;size or capability problems; supplier problems; test, including problems arising from material, performance and working confirmation) of the part orproduct submitted to the customer for approval previously. 5.3.3 5.3.3 Changes caused by engineeri

17、ng change to design records, specifications or materials. 5.4 目经理必须通知顾客，并根据顾客要求保留生产件和提交生产件给顾客批准。 5.4 When the production part number,engineering change, production place, material supplier and production process of the product are changed, the project manager shall inform the customer, keep the prod

18、uction part and submit it to the customer for approval according to the requirements of the customer. 5.5当有下列情况发生改变时，项目经理应与顾客进行协商和沟通，并根据顾客的要求是 否在量产第一批产品发运到顾客之前需提交生产件批准资料，项目组对PPAP 项目必须重新进行评审、修订和更改。 5.5 When change happens in the following cased, the project manager shall consult and communicate with

19、the customer to decide whether it is necessary to submit the production part approval data before the first batch of products in mass production is delivered to the customer according to the requirements of the customer and shall review, revise and change all items specified in PPAP again. 5.5.1 5.5

20、.1 Comparing with the production part approved by the customer previously, other different materials are used. 5.5.2 装。 5.5.2 New or improved tooling (notincluding damageable tooling) and equipments, including additional and substitute tooling, are used. 5.5.3 5.5.3 Produce after modifying and readj

21、usting the existing tooling or equipments again. 5.5.4 5.5.4 Transfer the tooling or equipment to other production places or produce in another production place. 5.5.5供应商对零件、材料、或服务（如：D 耐久性或性能的要求。 5.5.5 Changes of the parts, materials or service (e.g.: ED, etc.) by the supplier influence the customer

22、 requirements for assembling, function, durability or performance. 5.5.6任何影响顾客要求的装配性、功能、性能或耐久性的更改（包括由公司内部制造的 必须就供应商提出的任何申请和要求先与顾客达成一致。 5.5.6 Any changes (including product and process changes of the production parts manufactured by the company or bythe supplier) influencing the customer s requiremen

23、ts for assembling, function,performance or durability. In addition, before submitting the production partto the customer, the company shall reach on agreement with the customer on the application and requirements of the supplier. 5.5.7试/ 5.5.7 Changes of the test/inspection methods (including use of

24、 new technology without influence on acceptance specifications). 5.5.8 5.5.8 The customer concerns about the quality of the product and require delaying supply of goods. 5.6 对公司提交给顾客批准的生产件，其所要求的内容项目（需要保存所提交的PPAP资 料）应根据顾客确定的生产件提交批准等级进行保存和提交下述项目 记录（若对生产件批准的必要性有任何疑问，项目组负责人应与负责顾客零件批准的部门 联系以消除疑问）。 5.6 As

25、 to the production part submitted to the customer for approval by the company, keep the content/items (needing tokeep the PPAP data submitted) required by the customer according to the production part submission and approval level defined by the customer andsubmit the documents, materials and record

26、s of the following items/content (Ifthere is any doubt concerning the need for production part approval, theproject team principal shall contact the responsible part approval departmentof the customer to remove the doubt). 5.6.1产品设计记录：项目组必须具备所有的可销售产品的设计记录，包括：部件的设计 记录或可销售产品的详细信息。若设计记录（如CAD/CAM数学数据、零件

27、图纸、规范 差的表格或图纸）来确定所进行的测量。 5.6.1 Product design record: The project team shall have all design records for saleable products, including design records for components or detailed information of the saleable products.When the design record is in electronic format, the company shall produce ahard cope (e

28、.g.: pictorial, geometric dimensioning and tolerancing sheets or drawings) to identify measurements taken. 5.6.2过程流程图：项目组必须使用公司规定的过程流程图格式（参见产品质量先期策 需求和要求及期望。 5.6.2 Process flow chart: The projectteam shall used the process flow chart (refer to the“process flow chart”in the APQP Procedure) specified

29、by the company to describe the step and order of the production process clearly and meet the demand, requirement and expectation specified by the customer. 5.6.3过程失效模式与效果分析（PFME 5.6.3 Process failure mode and effect analysis (PFMEA) 项目组必须对提交给顾客批准的生产件进行过程失效模式及后果分析PFMEA The project team shall perform

30、process failure mode and effect analysis (PFMEA) to the production part submitted to the customer for approval. 5.6.4 成，以及其结果表明符合规定要求的证据。 5.6.4 Result of dimension: The quality department shall provide evidence that the dimension verification required in the design record and the control plan has be

31、en finished and the results meet the specified requirement. A 实际测量结果记录在“检查数据表”中。 A) The quality department shall record all dimension (except reference dimension) characteristics marked in design record and the control plan and the normative practical measuring result in theinspection data sheet”. B

32、 录中的、经授权的工程更改文件。 B) The project team shall mark the date and change level of the design record and any authorized engineering change documents not yet included in the design record of the parts manufactured. C C) The project team shall determine aspecifications sample from the parts measured and ide

33、ntify it clearly and keep it. D 关的辅助图）上记录更改的等级、绘图日期、公司名称和零件编号。根据保留/提交要求 表，这些辅助材料的复印件也必须与检查数据表一起提交。 D) The project team shall record the changed level, drawing date, company name and part ID in all auxiliary documents (e.g.: section plan, geometric dimension and tolerance diagram, orother auxiliary c

34、harts related to the parts). According to the reservation/submission requirements, copies of those auxiliary materials shall be submitted along with the inspection data sheet. 5.6.5材/ 5.6.5 Records of material/performance test results 关于设计记录或控制计划中规定的试验，项目组必须有材料 The project team shall have records of

35、 the material/performance test results for tests specified in the design record or the control plan. HYPERLINK Material test result 1 和产品材料进行试验。 1) When chemical, physical and metallographic requirements are specified by the design record or the control plan, the quality department shall perform tes

36、ts for all part and product materials. 2 记录于材料试验结果表中。对于尚未纳入设计记录中的任何授权的工程更改文件也应将其 进行注明。 2) As to all tests requited by the design record and related specifications, the quality department shall record the quantity tested and the actual results of each test in the material test result form. Also indic

37、ate any authorized engineering change documents that have not yet been incorporated in the design record. 3 3) The report of the test result of the production part approval materials shall include the following content: a 级。 a) Design record change level of the parts tested, and the number, date and

38、 change level of the technical specifications to which the part was tested. b b) The date on which the testing took place. c 料供应商代号码。 c) Name of the material supplier, when required by the customer, the code number of the material supplier from the customer-approved supplier list. d 上的供应商采购材料或服务（如：D

39、等）。 approved supplier list, the purchasing department shall procure materials or services (e.g.: ED, etc.) from suppliers on that list. 性能试验结果：当设计记录或控制计划中规定有性能或功能要求时，质量部必须 报告必须包括以下内容： HYPERLINK Performance test results: When performance or function requirements are specified by the design record or

40、the control plan, the quality department shall perform tests for all parts orproducts and record it in the performance test result form. The report of thetest result of the production part approval performance shall include the following content: a 级。 a) Design record change level of the parts teste

41、d, and the number, date and change level of the technical specifications to which the part was tested. b b) Any authorized engineering change documents that have not yet incorporated in the design record. c c) The date on which the testing took place. 5.6.6 5.6.6 Initial process capability study 的水平

42、是可以接受的。 Before submitting all special characteristics appointed by the customer or the company, the project team shall make sure that the level of the initial process capability or performanceis acceptable. 使用的测量设备进行测量系统分析，进行测量系统分析的具体工作由质量部依SPC 指导书进行作业。 HYPERLINK The project team shall perform measu

43、rement system analysis to the measuring equipment used to the production part submitted to the customer for approval to understand how the measurement error is affecting the study measurements, and the quality department shall dospecific work related to measurement system analysis according to the S

44、PC Operation Instruction. 1 顾客事前批准，也可采用其它更适用的替代方法。 1) The index for estimating process capability or performance will be agreed upon by the customer and the company;other methods more appropriate for certain process or product may be substituted with prior customer approval. 2 环境的变差的影响，但仍需利用控制图来收集和分

45、析数据。 2) Initial process capability study is short-term and will not predict the effects of time and variation in people,materials, methods, equipments, measurement systems and environment, control chart shall be used to collect and analyze data. 3）对于能够使用于XbarR 件中最少5个子组的数据，并至少在得到100 究。 3) For those c

46、haracteristics that can be studied by using Xbar-R chart, a short-term initial process capability study shall be based on a minimum of 25 subgroups containing at least 100 readings from consecutive parts of the the significant and effective production process. 4 特定的过程，若有顾客的事前批准，可使用替代的分析工具（如：单值移动极差图）

47、。 4) With customer concurrence, the initial data requirements may replaced by longer-term results from the same or similar processes; for certain process, alternative analytical tools (e.g.:individual and moving range chart) may be used with prior customer approval. 质量指数：项目组应使用能力或性能指数对初始过程研究进行总结。初始过

48、程研 明统计受控状态等。 HYPERLINK Quality indices: The project team shall summarize the initial process study by using capability or performance indices. The initial process study results are dependent on the purpose of the study, data normality, data collection method, sampling method,amount of data and demon

49、stration of statistic control, etc. . 1）Cp 1) Cpk: Refer to capability index forstable process. The estimate of the standard deviation () is based on within subgroup variation. 2）Pp 2) Ppk: Refer to capability index. The estimate of the standard deviation ) is based on total variation. 3）当公司可能得到历史的数

50、据或有足够的初始数据来绘制控制图时（至少0 本），可以在过程稳定时计算Cpk。 3) When historical data is available orenough initial data exist to plot a control chart (at least 100 individual samples), Cpk can be calculated when the process is stable. 4）对于输出满足规范要求且呈可预测的波形的长期不稳定过程，公司应使用Ppk 4) For chronically unstable processes with outpu

51、t meeting specifications and a predictable pattern, Ppk should beused. 5）当不能得到足够的数据（小于100 得联系，并制定一个适当的计划。 5) When not enough data is available(100 samples), the project team shall contact the part approval department of the customer and develop a suitable plan. HYPERLINK Acceptance criteria for init

52、ial study 对于稳定过程，公司在评价初始过程研究结果时，接收准则为过程能力指数Cpk1.3 或过程性能指数Pp1.67。 The company shall use the process capability index Cpk1.33 or the process performance index Pp1.67 as the acceptance criteria for evaluating the initial process study results for processes that appear stable. 组在提交PPAP之前，必须识别、评价和在可能的情况下

53、消除变差的特殊原因。 HYPERLINK Unstable processes: Depending on the nature of the instability, an unstable process may not meet customer requirements. The project team shall identify, evaluate, wherever possible,eliminate special causes of variation prior to PPAP submission. HYPERLINK Processes with one-sided

54、 specifications or non-normal distributions 正态分布的原因和如何处理变差。 The project team shall determine with the customer an alternative acceptance criteria, know the reasons for the non-normal distributions and manage the variation for processes with one-sided specifications or non-normal distributions HYPERL

55、INK Strategy when acceptance criteria are not satisfied 如果过程不能改进，项目组必须与顾客取得联系；如果项目组在PPAP 仍不能达到接收准则，则项目组必须向顾客提交一份纠正措施计划和一份包括100%检验的 修改的控制计划，以供顾客批准，并持续进行减少变差的努力，直到Ppk或Cpk到1.33 或更大，或直到从顾客那里获得完全批准为止。 If the process can not be improved, the project team shall contact the customer; if the acceptance crite

56、ria can not be attained by the PPAP submission promise date, the project team shall submit to the customer for approval a corrective action plan and a modified control plan providing for 100% inspection. Continue variation reduction efforts until a Ppk or Cpk of 1.33 or greater is achieved, or until

57、 customer full approval is received. 5.6.7 5.6.7 Measurement system analysis studies MSA分析指导书进行作业。 The project team shall have applicable measurement system analysis studies (e.g.: gage repeatability and reproducibility, bias, linearity, stability studies) for all or improved measurement and test eq

58、uipments, and the quality department shall do specific work related to measurement system analysis according to the SPC Operation Instruction. 5.6.8 5.6.8 Qualified laboratory document requirements 公司必须具备实验室范围和表明所用的实验室具备TS16949 的具体工作依实验室管理手册进行作业。 The company shall have a laboratory scope and documen

59、t showing that laboratories used comply with the requirements of TS16949. Specific work related to laboratory test shall be done according to the Laboratory Management Manual. 5.6.9 5.6.9 Control plan 公司必须具备规定用于过程控制的所有控制方法的控制计划，并应符合TS16949 进行控制计划制定的具体工作由质量部依控制计划控制程序进行作业。 The company shall have a con

60、trol plan that defines all control methods used for process control and complies with the requirements of TS16949; the quality department shall develop the control plan according to the Control Plan Procedure. A A) Control plans forfamiliesof similar parts are acceptable if the new parts have been r