1、確利達顧問有限公司,Production Part Approval Process 生產件批准程序,PPAP Third Edition (第三版),確利達顧問有限公司,SECTION I 1.1 GENERAL,The supplier shall obtain full approval (See 1.5.2.1) from the customer product approval activity for :1. a new part or product (i.e., a specific part, material, or color not previously suppli
2、ed to the specific customer). 2. correction of a discrepancy on a previously submitted part. 3. product modified by an engineering change to design records, specifications, or materials. 4. any situations required by section 1.3.NOTE: If there is any question concerning the need for production part
3、approval, contact the responsible customer product approval activity.,確利達顧問有限公司,第 1 部分 1.1 總則,供方必須對下列情況獲得顧客產品批準部門的完全批準 (見 1.5.2.1)：1. 一種新的零件或產品 (即：以前未曾提供給某個顧客的某種零件、 材料或顏色)。 2. 對以前提交零件不符合的糾正。 3. 由於設計記錄、規範或材料方面的工程更改引起產品的改變。 4. 第 1.3 部分要求中的任一種情況。注： 如果有涉及生產件批準的任何問題，請與顧客負責產品批準的 部門聯系。,確利達顧問有限公司,1.2 PPAP P
4、ROCESS REQUIREMENTS,1.2.1 Significant Production RunFor production parts. Product for PPAP shall be taken from a significant production run. This production run shall be from one hour to eight hours of production, and with the specific production quantity to total a minimum of 300 consecutive positi
5、on of a multiple cavity die, mold, tool or pattern, shall be measured and representative parts tested.This run shall be manufactured at the production site using the tooling, gaging, process, materials, and operators from the production environment. Parts from each unique production process, e.g. du
6、plicate assembly line and/or work cell, each position of a multiple cavity die, mold, tool or pattern, shall be measured and representative parts tested.,確利達顧問有限公司,1.2 PPAP 的過程要求,1.2.1 重要的生產過程對於生產件：用於 PPAP 的產品必須取自重要的生產過程。該過程必須是 1 小時到 8 小時的生產，且規定的生產數量至少為 300 件連續生產的部件，除非顧客授權的質量代表另有規定。該過程必須在生產現場使用與生產環境
7、同樣的工裝、量具、過程、材料和操作工進行生產。來自每一個生產過程的部件，如：相同的裝配線和/或工作單元、多腔沖模、鑄模、工具或模型的每一個位置，都必須進行測量和對代表性樣件進行試驗。,確利達顧問有限公司,1.2 PPAP PROCESS REQUIREMENTS,For bulk materials: No specific number of “parts” is required. If a sample is required to be submitted, it shall be taken in a manner as to assure that it represents :
8、“steady-state” operation of the process.NOTE: For bulk material. Production histories of current products may often be used to estimate the initial process capability or performance of new and similar products. In cases where no production history of a similar bulk material product or technology exi
9、sts. A containment plan may be put into effect until sufficient production has demonstrated capability or performance.,確利達顧問有限公司,1.2 PPAP 的過程要求,對於散裝材料：“零件” 沒有具體數量的要求。如果要求提交樣品，那麼樣品的選取必須能夠保証代表 “穩定的” 加工過程。 注： 對於散裝材料，現有產品的生產情況通常可以用於估計初始過 程能力或新的和類似產品的性能。如果在過去的生產中不存在 類似散裝材料產品或技術，則在証實過程能力或性能足夠的生 產量達到之前，可實施
10、遏制計劃。,確利達顧問有限公司,1.2 PPAP PROCESS REQUIREMENTS,1.2.2 PPAP RequirementsThe supplier shall meet all specified requirements. e.g. design record, specifications, and for bulk material, the Bulk Material Requirements Checklist (see 1.2.2.15 and Appendix F). Any results that are outside specification are c
11、ause for the supplier not to submit the parts. documentation and/or records. Every effort shall be made to correct the process so that all design record requirements are met. If the supplier is unable to meet any of these requirements. the customer shall be contacted for determination of appropriate
12、 corrective action.,確利達顧問有限公司,1.2 PPAP 的過程要求,1.2.2 PPAP 要求供方必須滿足所有的規定要求，如：設計記錄、規範，對於散裝材料，滿足散裝材料要求檢查表 (見 1.2.2.15 和附錄 F)。若不能滿足這些要求，供方則不提交零件、文件和/或記錄。為了滿足所有設計記錄的要求，必須進行一切努力對過程進行糾正。如果供方不能滿足其中的任何要求，為了確定合適的糾正措施必須與顧客取得聯系。,確利達顧問有限公司,1.2 PPAP PROCESS REQUIREMENTS,Inspection and testing for PPAP shall be perf
13、ormed by a qualified laboratory (see QS-9000, Third Edition, c1.4.10.6). Commercial/independent test laboratories used shall be accredited facilities (see QS-9000, Third Edition, c1. 4.10.7, and 4.11.2.b.1). When a commercial laboratory is used, the supplier shall submit the test results on the labo
14、ratory letterhead, or the normal laboratory report format. The name of the laboratory that performed the tests, and the date(s) of the tests, and the standards used to run the tests shall be indicated. Blanket statements of conformance are unacceptable for any test results.,確利達顧問有限公司,1.2 PPAP 的過程要求,
15、PPAP 的檢驗和試驗必須由有資格的實驗室 (見 QS-9000，第 3 版，4.10.6) 完成。所使用的商業的/獨立的實驗室必須是獲得認可的實驗室 (見 QS-9000，第 3 版，4.10.7 和 4.11.2.b.1)。當使用商業的實驗室時，供方必須使用實驗室的信箋紙或使用正式的實驗室報告格式提交試驗結果。必須注明進行試驗的實驗室名稱、試驗日期和進行試驗所使用的標準。對任何試驗結果只籠統地描述其符合性是不可接受的。,確利達顧問有限公司,1.2 PPAP PROCESS REQUIREMENTS,The supplier shall have the applicable items a
16、nd records (See QS-9000, Third Edition, c1. 4.16), listed below, for each part, or family of parts, regardless of the part submission level. These records (1.2.2.1 - 15 and 19 if any) shall be in a PPAP part file, or referenced in such file and be readily available. The items below (1.2.2.16 - 18) s
17、hall be readily available for customer use in PPAP. The supplier shall obtain prior approval (see QS-9000, Third Edition, c1. 4.16), from the customer approval activity for exceptions or deviations to PPAP requirements.,確利達顧問有限公司,1.2 PPAP 的過程要求,對於每一種零件、或零件系列，無論其提交等級如何，供方必須有如下列出的適用項目和記錄 (見 QS-9000，第
18、3 版，4.16)。這些記錄 (1.2.2.1-15 和 19 (若有的話) 必須在零件的 PPAP 文件中列出，或在該類文件中有所說明，並隨時備查。以下項目 (1.2.2.16-18) 必須隨時供顧客在 PPAP 時使用。供方若想例外或偏離 PPAP 要求，必須事先得到顧客產品批準部門的批準 (見 QS-9000，第三版，C1. 4.16)。,確利達顧問有限公司,1.2 PPAP PROCESS REQUIREMENTS,NOTE1: The supplier may, upon special arrangement, have tests performed by the custome
19、rs laboratories.NOTE2: All 1.2.2 items or records may not necessarily apply to every customer part number from every supplier. For example, some parts do no have appearance requirements, and others do not have color requirements. In order to determine with certainty which items must be included, con
20、sult the design record, e.g. part print, the relevant Engineering documents or specifications, and your customer responsible part approval activity.,確利達顧問有限公司,1.2 PPAP 的過程要求,注1： 供方可以根據特殊的安排，由顧客的試驗室進行試驗。 注2： 1.2.2 中的所有項目或記錄並不一定適用於每個供方的每個顧客 零件編號。例如：有些零件沒有外觀要求，還有些部件沒有顏 色的要求。為了確定必須包括哪些項目，應該參考設計記錄的 要求，如：
21、零件圖紙，有關的工程文件或規範，還可以咨詢你 的顧客負責零件批準的部門。,確利達顧問有限公司,1.2 PPAP PROCESS REQUIREMENTS,1.2.2.1 Design Records The supplier shall have all design records for the saleable product, including design records for components or details of the saleable product. Where the design record, e.g. CAD/CAM math data, part d
22、rawings, specifications, is in electronic format, e.g. math data, the supplier shall produce a hard copy (e.g. pictorial, geometric dimensioning & tolerancing GD&T sheets, drawing) to identify measurements taken.,確利達顧問有限公司,1.2 PPAP 的過程要求,1.2.2.1 設計記錄 供方必須具備所有的可銷售產品的設計記錄，包括：部件的設計記錄或可銷售產品的詳細信息。若設計記錄，如
23、 CAD/CAM 數學數據、零件圖紙、規範等是以電子版形式存在，如：數學數據，則供方必須製作一份硬體拷貝 (如：帶有圖例、幾何尺寸與公差 GD&T 的表格或圖紙) 來確定所進行的測量。,確利達顧問有限公司,1.2 PPAP PROCESS REQUIREMENTS,NOTE1: For any saleable product, part or component, there will only be one design record, regardless of who has design- responsibility. The design record may reference
24、 other documents making them part of the design record. NOTE2: For bulk materials, the design records may include identification of raw materials, formulations, processing steps and parameters, and final product specifications or acceptance criteria. If dimensional results do not apply, then CAD/CAM
25、 requirements are also not applicable.,確利達顧問有限公司,1.2 PPAP 的過程要求,注1： 對於任何可銷售的產品、零件或部件，無論誰具有設計責任， 應只有唯一的設計記錄。設計記錄可引用其他的文件來形成該 設計記錄的部分。注2： 對於散裝材料，設計記錄可以包括原材料的標識、配方、加工 步驟和參數，以及最終產品的規範或接收準則。如果尺寸結果 不適用，那麽 CAD/CAM 的要求也不適用。,確利達顧問有限公司,1.2 PPAP PROCESS REQUIREMENTS,1.2.2.2 Any authorized Engineering Change do
26、cuments The supplier shall have any authorized engineering change documents not yet recorded in the design record but incorporated in the product, part or tooling.1.2.2.3 Engineering Approval, when requiredWhere specified by the design record, the supplier shall have evidence of customer engineering
27、 approval.,確利達顧問有限公司,1.2 PPAP 的過程要求,1.2.2.2 任何授權的工程更改文件 供方必須具有尚未記入設計記錄中、但已在產品、零件或工裝上體現出來的任何授權的工程更改文件。1.2.2.3 要求時的工程批準 在設計記錄有規定時，供方必須具有顧客工程批準的証據。,確利達顧問有限公司,1.2 PPAP PROCESS REQUIREMENTS,NOTE: For bulk-materials, this requirement is satisfied by a signed “Engineering Approval” line item on the Bulk Ma
28、terial Requirements Checklist (Appendix F) and/or inclusion on a customer maintained list of approved materials.,確利達顧問有限公司,1.2 PPAP 的過程要求,注： 對於散裝材料，在散材料要求檢查表 (附錄 F) 上 “工程批準” 一 欄有批準的簽字和/或在顧客批準的材料清單上包括該材料即可 滿足本要求。,確利達顧問有限公司,1.2 PPAP PROCESS REQUIREMENTS,1.2.2.4 Design Failure Mode and Effects Analysis
29、 (Design FMEA), if the supplier is design responsible. See Potential Failure Mode and Effects Analysis reference manual.The supplier shall have a Design FMEA developed in accordance with, and compliant to, QS-9000 third edition requirements for parts or materials for which they are design-responsibl
30、e. For bulk materials, a Design Matrix (See Appendix F), when required by the Bulk Material Requirements Checklist (See 1.2.2.15), shall be prepared prior to developing the Design FMEA.NOTE: For bulk materials, Design FMEA rankings (Severity, Occurrence, Detection) as discussed in Appendix F, may be
31、 utilized to provide proper differentiation of risk factors.,確利達顧問有限公司,1.2 PPAP 的過程要求,1.2.2.4 設計失效模式及後果分析 (設計 FMEA)，如果供方有設計責 任。見潛在失效模式及後果分析參考手冊。供方對於所負有設計責任的零件或材料，必須按照 (QS-9000 第三版的要求進行設計FMEA 分析。對於散裝材料，當散裝材料要求檢查表上要求時 (見 1.2.2.15) 必須在進行設計 FMEA 之前準備一份設計矩陣表 (見附錄F)。 注： 對於散裝材料，附錄F中討論的設計 FMEA 的定級標準 (嚴重度、 頻
32、度、探測度)。可以用來對風險因素進行適當的區別。,確利達顧問有限公司,1.2 PPAP PROCESS REQUIREMENTS,1.2.2.5 Process flow diagrams The supplier shall gave a process flow diagram in supplier-specified format that clearly describes the production process steps and sequence, as appropriate and meets the specified customer needs, requirem
33、ents and expectations (see Advanced Product Quality Planning and Control Plan reference manual). For bulk materials, an equivalent to a Process Flow Diagram is a Process Flow Description. NOTE: Process flow diagrams for “families” of similar parts are acceptable if the new parts have been reviewed f
34、or commonality.,確利達顧問有限公司,1.2 PPAP 的過程要求,1.2.2.5 過程流程圖 供方必須具備使用供方規定的格式、清楚地描述生產過程的步驟和次序的過程流程圖，同時應恰當地滿足顧客規定的需要、要求和期望 (見產品質量先期策劃和控制計劃參考手冊)。對於散裝材料，相對於過程流程圖的等效文件是一份過程流程的描述。注： 如果對新零件的共通性已經過評審，那麼類似零件的 “系列” 產 品的過程流程圖是可接受的。,確利達顧問有限公司,1.2 PPAP PROCESS REQUIREMENTS,1.2.2.6 Process Failure Mode and Effects Anal
35、ysis (Process FMEA). See Potential Failure Mode and Effects Analysis reference manual.The supplier shall have a Process FMEA developed in accordance with, and compliant with QS-9000 Third Edition requirements.NOTE: A single Design or Process FMEA may be applied to a process manufacturing a family of
36、 similar parts or materials. For bulk materials, see Appendix F for severity, occurrence, and detection ranking system to provide proper differentiation of risk factors.,確利達顧問有限公司,1.2 PPAP 的過程要求,1.2.2.6 過程失效模式及後果分析 (過程 FMEA)。見潛在失效模式及 後果分析參考手冊。供方必須按照 QS-9000 第三版的要求進行過程 FMEA。注： 同一份設計或過程FMEA可適用於相似零件或材料
37、的生產過程。 對於散裝材料，附錄F中給出了嚴重度、頻度和控測度的定級標 準，用來對風險因素進行適當的區別。,確利達顧問有限公司,1.2 PPAP PROCESS REQUIREMENTS,1.2.2.7 Dimensional results The supplier shall provide evidence that dimensional verifications required by the design record and the Control Plan have been completed and results indicate compliance with spe
38、cified requirements. The supplier shall have dimensional results for each unique manufacturing process, e.g. cells or production lines and all cavities, molds, patterns or dies (see 1.2.2.13).The supplier shall indicate the date of the design record, change level, and any authorized engineering chan
39、ge document not yet incorporated in the design record to which the part was made.,確利達顧問有限公司,1.2 PPAP 的過程要求,1.2.2.7 尺寸結果供方必須提供設計記錄和控制計劃要求的尺寸驗証已經完成，以及其結果表明符合規定要求的証據。對於每一個的加工過程，如：單元或生產線和所有的型腔、模型、樣板或沖模 (見1.2.2.13)，供方必須有尺寸結果。 供方必須標明設計記錄的日期、更改等級和任何尚未包括在製造零件所依據的設計記錄中的、經授權的工程更改文件。,確利達顧問有限公司,1.2 PPAP PROCESS
40、 REQUIREMENTS,The supplier shall identify one of the parts measured as the master sample (See 1.2.2.17).The supplier shall record the change level, drawing date, supplier name and part number on all auxiliary documents (e.g. supplementary layout results sheets, sketches, tracings, cross sections, CM
41、M inspection point results, geometric dimensioning and tolerance sheets. or other auxiliary drawings used in conjunction with the part drawing). Copies of these auxiliary materials shall accompany the dimensional results according to the Retention / Submission Requirements Table. A tracing shall be
42、included when an optical comparator is necessary for inspection.,確利達顧問有限公司,1.2 PPAP 的過程要求,供方必須在所測量的零件中確定一件為標準樣品 (見1.2.2.17)。 供方必須在所有的輔助文件 (例如：補充的全尺寸結果清單、草圖、描制圖、剖面圖、CMM 檢查點結果、幾何尺寸和公差圖、或其他的與零件圖相關的輔助圖) 上記錄更改的等級、繪圖日期、供方名稱和零件編號。根據保留/提交要求表，這些輔助材料的複印件也必須與尺寸結果一起提交。當需要使用光學分析儀進行檢驗時，提交材料中還必須包括描制圖紙。,確利達顧問有限公司,1
43、.2 PPAP PROCESS REQUIREMENTS,NOTE1: All dimensions (except reference dimensions), characteristics, and specifications as noted on the design record and Control Plan should be listed in a convenient format with the actual results recorded. The Dimensional Results form in Appendix C, or a checked prin
44、t where the results are legibly written on a part drawing including cross- sections, tracings, or sketches as applicable may be utilized for this purpose.NOTE2: Dimensional results typically do not apply to bulk materials.,確利達顧問有限公司,1.2 PPAP 的過程要求,注1： 所有在設計記錄和控制計劃中注明的尺寸 (參考尺寸除外)、特 性和規範均應將實際的結果記錄在簡捷的
45、表格中。為此，可使 用附錄 C 中的尺寸結果表。或使用將結果清楚地寫在零件圖 (包括適用的剖面圖、描制圖或草圖等) 上的檢查圖方法。注2： 通常，尺寸結果不適用於散裝材料。,確利達顧問有限公司,1.2 PPAP PROCESS REQUIREMENTS,1.2.2.8 Record of material / performance test results The supplier shall have records of material and/or performance test results for tests specified on the design record or
46、 Control Plan.1.2.2.8.1 Material Test ResultsThe supplier shall perform tests for all part(s) and product material(s) when chemical, physical, or metallurgical requirements are specified by the design record or Control Plan.,確利達顧問有限公司,1.2 PPAP 的過程要求,1.2.2.8 材料/性能試驗結果的記錄 關於設計記錄或控制計劃中規定的試驗，供方必須有材料和/或性
47、能試驗結果的記錄。1.2.2.8.1 材料試驗結果當設計記錄或控制計劃中規定有化學、物理或金相的要求時，供方必須對所有的零件和產品材料進行試驗。,確利達顧問有限公司,1.2 PPAP PROCESS REQUIREMENTS,All tests required by the design record and related specifications should be listed in a convenient format along with the quantity tested and the actual results of each test. Also indicat
48、e any authorized engineering change documents that have not yet been incorporated in the design record.,確利達顧問有限公司,1.2 PPAP 的過程要求,設計記錄和有關規範要求的所有試驗均應使用簡捷的格式將試驗的數量和每項試驗的實際結果列出。尚未納入設計記錄中的任何授權的工程更改文件也應進行注明。,確利達顧問有限公司,1.2 PPAP PROCESS REQUIREMENTS,The material test report (See Appendix D) shall indicate t
49、he: design record change level of the parts tested, and the number, date, and change level of the specifications to which the part was tested; date on which the testing took place; material subcontractors name and, when required by your customer, their supplier code number for the material from the customer-approved subcontractor list.For products with customer-developed material specifications and a customer-approved subcontractor list, the supplier shall procure materials and/or services (e.g. painting, plating, heat-treating) from subcontractors on that list.,
