1、生产件批准程序 Production part approval process,第四版 Fourth edition,黄建平 Jacky Huang,北京逖埃斯管理顾问有限公司,PPAP生产件批准程序 PPAP-Production part approval process,生产件批准程序（PPAP）定义了生产件批准的一般要求，包括生产件和散装材料（见术语）。Production part approval process (PPAP) defines generic requirements for production part approval, including producti
2、on and bulk material (see glossary). PPAP的目的是用来确定组织是否已经正确理解了顾客工程设计记录和规范的所有要求，以及该制造过程是否具有潜力，在实际生产运行中，依报价时的生产节拍，持续生产满足顾客要求的产品。The purpose of PPAP is to determine if all customer engineering design record and specification requirements are properly understood by the organization and that the manufactur
3、ing process has the potential to produce product consistently meeting these requirements during an actual production run at the quoted production rate.,适用性 Applicability,PPAP必须适用于提供生产件、服务件、生产原料或散装材料的组织的内部和外部现场（见术语）。散装材料不要求PPAP，除非由经授权的顾客代表规定。 PPAP shall apply to internal and external organization sit
4、es supplying productions parts, service parts, productions material, or bulk material. For bulk materials, PPAP is not required unless specified by the authorize customer representative.,第一部分 总则 Section 1 General,1.1 PPAP的提交 Submission PPAP 下列情况，组织必须获得经授权的顾客代表的批准： The organization shall obtain appro
5、val from the authorized customer representative for : 1. 一种新的零件或产品（即：以前未曾提供给某个顾客的某种零件、材料或颜色）。 A new part or product (e.g. a specific part, material, or color not previously supplied to the specific customer). 2. 对以前提交零件不符合的纠正。 Correction of a discrepancy on a previous submitted part. 3. 由于设计记录、规范或材料
6、方面的工程变更从而引起产品的改变。 Product modified by an engineering change to design records, specifications, or materials,. 4. 第3部分要求中的任一种情况。 Any situation required by Section 3 注：任何有关生产件批准的问题，请与经授权的顾客代表联系。 Note: If there is any question concerning the need of production part approval, contact the authorized cust
7、omer representative.,第二部分 PPAP的过程要求 Section 2 PPAP process requirements,2.1 有效的生产 Significant Production Run 对于生产件,用于PPAP的产品,必须取自有效的生产。该生产过程必须是1小时到8小时的量产，且规定的生产数量至少为300件连续生产的零件，除非有经授权的顾客代表另有规定。 For production parts, product for PPAP shall be taken from a significant production run. This significant
8、production run shall be from one hour to eight hours of production, and with the specific production quantity to total a minimum 300 consecutive parts, unless otherwise specified by the authorized customer representative.,第二部分 PPAP的过程要求 Section 2 PPAP process requirements,该有效的生产，必须在生产现场使用与量产环境同样的工装、
9、量具、过程、材料和操作人员。来自每个生产过程的零件，如：可重复的装配线和/或工作站、一模多腔的模具、成型模、工具或模型的每一个位置，都必须进行测量，并对代表性零件进行试验。 This significant product run shall be conducted at the production site, at the product rate (see glossary) using the production tooling, production gaging, production process, production materials and production o
10、perators. Parts of each unique production process, e.g. duplicate assembly line and/or work cell, each position of a multiple cavity die, mold, tool or pattern, shall be measured and representative parts tested. 对于散装材料：“零件”没有具体数量的要求。提交的样件必须出自“稳定”的加工过程。 For bulk materials: No specify number of “parts
11、” is required. The submitted sample shall be taken in a manner as to assure that it represents “steady-state” operation of the process.,2.2 PPAP要求 2.2 PPAP requirements,组织必须满足2.2.1至2.2.18所列的PPAP规定的要求,还必须满足顾客规定的其它PPAP要求。 The organization shall meet all specified PPAP requirements list below (2.2.1 th
12、rough 2.2.18). The organization shall also meet all customer-specified PPAP requirements. 生产件必须符合所有顾客工程设计记录和工程规范要求（包括安全性和法规的要求）。 Production parts shall meet all customer engineering design record and specification requirements (including safety and regulatory requirements). 散装材料要求检查表中，定义了散装材料的PPAP要求
13、。（见附录F）。 Bulk PPAP requirements are defined by a completed Bulk Material Requirements Checklist (see Appendix F). 任何零件若未达到规范要求，组织必须书面记录解决问题的方案，并联系经授权的顾客代表，以决定适当的纠正措施。 If any part specification can not be met, the organization shall document their problem-solving efforts and shall contact the authori
14、zed customer representative for concurrence in determination of appropriate corrective action.,2.2.1设计记录 2.2.1 Design record,组织必须具备所有可销售产品/零件的设计记录,包括组件的设计记录或可销售产品/零件的详细信息。 The organization shall have the design record for the saleable product/part， including design record for components or details o
15、f the saleable product/part.2.2.1.1 零件材质报告Report of part material composition 2.2.1.2 聚合物的标识Marking of polymeric parts,2.2.2 任何授权的工程变更文件 2.2.2 Authorized engineering change documents,对于任何尚未录入设计记录中，但已在产品、零件或工装上呈现出来的工程变更，组织必须有该工程变更的授权文件。 The organization shall have any authorized engineering change do
16、cuments for those change not yet record in the design record but incorporated in the product, part or tooling.,2.2.3 顾客工程批准 2.2.3 Customer engineering approval,顾客要求时，组织必须具有顾客工程批准的证据。 Where specified by the customer, the organization shall have evidence of customer engineering approval.注：对于散装材料，在散装材料
17、要求检查表（附录F）“工程批准”一栏有签署即可满足本要求，和/或在顾客批准材料清单上有此种材料，也可满足本要求。 Note: For bulk materials, this requirement is satisfied by a singed “Engineering approval” line item on the bulk material requirements checklist (see appendix F) and/or inclusion on a customer maintained list of approved materials.,2.2.4 设计失效模
18、式及后果分析，如果组织有设计职责 2.2.4 Design failure mode and effects analysis, if the organization is product design-responsible,有产品设计职责的组织，必须按照顾客要求开发设计FMEA。 The product design-responsible organization shall develop a Design FMEA in accordance with, and compliant to, customer-specified requirements. 注1：同一份设计FMEA可
19、以适用于相似零件或材料族系。 Note 1: A single Design FMEA may be applied to a family or similar parts or materials. 注2：对于散装材料，参见附录F。 Note 2: For bulk materials, see appendix F.,2.2.5 过程流程图 2.2.5 Process flow diagram (s),组织必须使用组织规定的格式绘制过程流程图，清楚地描述生产过程步骤和流程，同时应适当地满足顾客规定的需要、要求和期望。 The organization shall have a proce
20、ss flow diagram in an organization-specified format that clearly describes the production process steps and sequence, as appropriate, and meets the specified customer needs, requirements and expectations. 对于散装材料，过程流程描述文件和过程流程图等效。 For bulk materials, an equivalent to a process Flow diagram is a proce
21、ss flow description.,2.2.6 过程失效式及后果分析 2.2.6 Process failure mode and effects analysis,组织必须按照顾客特殊要求，进行相应过程FMEA开发。 The organization shall develop a process FMEA in accordance with, and compliant to, customer-specified requirements. 注1：如果组织对新零件的通用性已经过评审，同一份过程FMEA可适用于相似零件或材料族系的生产过程。 Note 1: A single Pro
22、cess FMEA may be applied to a process manufacturing a family of similar parts or materials if reviewed for commonality by the organization. 注2：对于散装材料，见附录F。 Note 2: for bulk materials, see Appendix F.,2.2.7 控制计划 2.2.7 Control plan,组织必须制定控制计划，定义用于过程控制的所有控制方法，并符合顾客规定的要求。 The organization shall have a C
23、ontrol Plan that defines all methods used for process control and complies with customer-specified requirements. 注1：如果组织对新零件的通用性已经过评审，那么相似零件的“家族零件”控制计划是可以接受的。 Note 1:Control plans for “families” of parts are acceptable if the new parts have been reviewed for commonality by the organization. 注2：有些顾客可
24、能会要求批准控制计划。 Note 2: Control Plan approval may be required by certain customers,2.2.8测量系统分析研究 2.2.8Measurement system analysis studies,组织必须对所有新的或改进后的量具，测量和试验设备进行测量系统分析研究，如：量具的重复性和再现性、偏倚、线性和稳定性研究。 The organization shall have applicable Measurement System Analysis studies, e.g. gage R&R, bias, linearit
25、y, stability, for all new or modifies gages, measurement, and test equipment. 注1：测量系统分析参考手册中定义了量具重复性与再现性的接受准则。 Note 1: Gage R&R acceptability criteria are defined in the Measurement System Analysis reference manual. 注2：对于散装材料，测量系统分析可以不适用，但要获得顾客同意。 Note 2: For bulk materials, Measurement System Analy
26、sis may not apply. Customer agreement should be obtained on actual requirements.,2.2.9全尺寸测量结果 2.2.9 Dimensional results,组织必须按设计记录和控制计划的要求，提供尺寸验证已经完成的证据，且测量结果符合规定的要求。对于每一个独立的加工过程，如：生产单元或生产线，和所有的多模腔、成型腔、模型或冲模，组织都必须有全尺寸测量结果。组织必须对设计记录和控制计划中注明所有的尺寸（参考尺寸除外）、特性和规格等项目，记录实际测量结果。 The organization shall provid
27、e evidence that dimensional verifications required by the design record and the Control Plan have been completed and results indicate compliance with specified requirements. The organization shall have dimensional results for each unique manufacturing process, e.g., cells or production lines and all
28、 cavities, molds, patterns. The organization shall record, with the actual results: all dimensions (except reference dimensions), characteristics, and specifications as noted on the design record and Control Plan.,2.2.10 材料/性能试验结果的记录 2.2.10 Records of Material/Performance Test Results,对于设计记录或控制计划中规定
29、的材料和/或性能试验，组织必须有试验结果记录。 The organization have all records material and/or performance test results for tests specified on the design record or Control Plan.材料试验结果 Material test results 性能试验结果 Performance test results,2.2.11初始过程研究 2.2.11 Initial process studies,在提交由顾客或组织指定的所有特殊特性之前，必须确定初始过程能力或性能指数的水平
30、是可以接受的。估计的初始过程能力指数在提交前必须获得顾客同意。 The level of initial process capability or performance shall be determined to be acceptable prior to submission for all Special Characteristics designed by the customer or organization. The organization shall obtain customer concurrence on the index for estimating ini
31、tial process capability prior to submission.,2.2.11初始过程研究 2.2.11 Initial process studies,2.2.12 合格实验室的文件要求 2.2.12 Qualified laboratory documentation,PPAP要求的检验和试验必须在按顾客要求定义的合格实验室内进行（例如：有资质认可的实验室）。合格实验室（包括组织的内部和外部实验室）必须定义实验室范围，并有文件证明该实验室可进行的测量和试验活动。 Inspection and testing for PPAP shall be performed b
32、y a qualified laboratory as defined by customer requirements (e.g. accredited laboratory). The qualified laboratory (internal or external to the organization) shall have a laboratory scope and documentation showing that the laboratory is qualified for the type of measurements or tests conducted. 若使用
33、外部/商业实验室，实验结果必须记录在有信头的实验室报告纸或标准的实验报告上。注明实验室名称、试验日期和使用的检验标准。 When an external/commercial laboratory is used, the organization shall submit the test results on the laboratory letterhead or the normal laboratory report format. The name of the laboratory that performed the tests, the date (s) of tests,
34、and the standards used to run the tests shall be identified.,2.2.13外观批准报告（AAR) 2.2.13 Appearance Approval Report,如果在设计记录上某一零件或零件系列有外观要求，则必须单独完成该产品/零件的外观批准报告（AAR）。 The separate Appearance Approval Report (AAR) shall be completed for each part or series of parts if the product/part has appearance requ
35、irements on the design record. 一旦完全满足所有准则，组织必须在ARR上记录所要求的信息。必须到顾客指定的地点，提交完成的ARR和代表性的生产产品/零件，并等候处置。按照所要求的提交等级，在最后交付时，ARR（填入零件接受情况和经授权的顾客代表的签名）必须与PSW一起提交。 Upon satisfactory completion of all required criteria, the organization shall record the required information on the ARR. The completed ARR and rep
36、resentative production product/parts shall be submitted to the location specified by the customer to receive disposition. ARRs (complete with part disposition and authorized customer representative signature) shall then accompany the PSW at the time of final submission based upon the submission leve
37、l requested. See customer-specific requirements for any additional requirements.,2.2.14生产件样品 2.2.14 Sample production parts,组织必须按照顾客的规定提供产品样品。 The organization shall provide sample production as specified by the customer.,2.2.15 标准样品 2.2.15 Master sample,组织必须保存一件标准样品，与生产件批准记录保存的时间相同，或a）直到生产出一个用于顾客批准
38、，而且是相同顾客零件编号的新标准样品为止；或b）在设计记录、控制计划或检验准则要求的地方，必须存放标准样品，作为参考或标准。必须对标准样品进行标识，并必须在样品上标出顾客批准的日期。对于多腔膜、成型模、工装或样板模型、或生产过程的每一个位置，组织必须各保留一件标准样品，除非顾客另有规定。 The organization shall retain a master sample for the same period as the production part approval records, or a) until a new master sample is produced for
39、the same customer part number for customer approval, or b) where a master sample is required by the design record, Control Plan or inspection criteria, as a reference or standard. The master sample shall be identified as such, and shall show the customer approval date on the sample. The organization
40、 shall retain a master sample for each position of a multiple cavity die, mold, tool or pattern, or production process unless otherwise specified by the customer.,2.2.16检查辅具 2.2.16 Checking aids,如果顾客提出要求，组织必须在提交PPAP时同时提交任何零件特殊装配辅具或部件检查辅具。 If required by the customer, the organization shall submit wi
41、th the PPAP submission any part-specific assembly or component checking aid. 组织必须证明检查辅具的所有内容与零件尺寸要求一致。提交时，组织必须将和检查辅具相关的工程设计变更形成文件。组织必须在零件寿命周期内（见术语“在用零件”），对任何检查辅具提供预防性维护。 The organization shall certify that all aspects of the checking aid agree with part dimensional requirements. The organization sha
42、ll document all released engineering design changes that have been incorporated in the checking aid at the time of submission. The organization shall provide for preventive maintenance of any checking aids for the life of the part (see Glossary “Active Part”). 必须按照顾客的要求进行测量系统分析，如：量具的重复性与再现性、准确度、偏移、线
43、性和稳定性研究。 Measurement system analysis studies, e.g. gage R&R, accuracy, bias, linearity, stability, studies, shall be conducted in compliance with customer requirements.,2.2.17顾客的特殊要求 2.2.17 Customer-specified requirements,组织必须有与所有适用的顾客特殊要求相符合的记录。对于散装材料，在散装材料要求检查表上必须对所有顾客特殊要求有文字记录。 The organization s
44、hall have records of compliance to all appliance customer-specified requirements. For bulk materials, appliance customer-specified requirements shall be documented on the Bulk Material Requirements Checklist.,2.2.18零件提交保证书 2.2.18 Part submission Warrant,在完成所有要求的测量和试验后，组织必须完成零件提交保证书（PSW）。 Upon comple
45、tion of all PPAP requirements, the organization shall complete the Part Submission Warrant (PSW). 对于每一顾客零件编号都必须完成一份单独的PSW，除非经授权的顾客代表同意其他的形式。 A separate PSW shall be completed for each customer part number unless otherwise agreed to by the authorized customer representative.,第3部分 顾客的通知和提交要求 Section 3
46、 Customer notification and Submission Requirements,3.1顾客的通知 Customer notification 任何经计划的设计、过程和现场变更，组织必须通知经授权的顾客代表，见下表列举的情况 The organization shall notify the authorized customer representative of any planned changes to the design, process, or site. Examples are indicated in the table below:,1、和以前被批准的
47、零件或产品相比，使用了其它不同的结构或材料。Use of other construction or material than was used in the previously approved part or product. 2、使用新的或改进的工装（不包括易损工装）、模具、成型模、模型等，包括补充的或替换的工装。Production from new or modified tools (except perishable tools), dies, molds, patterns, etc. including additional or replacement tooling.
48、 3、在对现有的工装或设备进行升级或重新布置之后进行生产。Production following update or rearrangement of existing tooling or equipment.,4、工装和设备转移到不同的工厂，或在一个新增的厂址进行生产。Production from tooling and equipment transferred to a different plant site or from and additional plant site. 5、供方的零件、不同的材料、或服务（如：热处理、电镀）的变更，从而影响顾客的装配、成型、功能、耐久性或
49、性能要求。 Change of supplier for parts, nonequivalent materials, or services (e.g. heat-treating, plating). 6、工装停止批量生产达12个月以后重新启用进行生产。 Product produced after the tooling has been inactive for volume production for twelve months or more. 7、涉及由内部制造或由供方制造的生产件的组件，其产品和过程的更改。 Product and process changes relat
50、ed to components of the production product manufactured internally or manufactured by supplier. 8、试验/检验方法的变更新技术的采用（不影响其接受准则）。 Changes in test/inspection method-new technique (no effect on acceptance criteria.),附加要求，只针对散装材料： Additionally, for bulk materials: 9、新的或现有的供方提供的新原材料；New source of raw materials from new or existing supplier. 10、产品外观属性的变更。Change in product appearance attributes.,
