1、AEROSPACE STANDARDAS9103 Issued 2001-10Variation Management of Key Characteristics關鍵特性變動管理FOREWORD 序言In December 1998, the Aerospace Industry had established the International Aerospace Quality Group (IAQG) with the purpose of achieving significant improvements in quality and reductions in cost thro
2、ughout thevalue stream.1998 年 12 月，航空航天工業建立了國際航空航天質量集團（IAQG） ，目的是在整個價值流中實現質量的顯著提高和成本的降低。This organization, with representation from Aerospace companies in Americas, Asia and Europe and sponsored by SAE, SJAC, and AECMA has agreed to take responsibility for the technical contents of this standard.該組織
3、由美國，亞洲和歐洲的航空航天公司代表，SAE，SJAC 和 AECMA 贊助，同意對本標準的技術內容負責。INTRODUCTION 介紹This Aerospace Standard establishes variation management requirements for Key Characteristics. The Standard also specifies general requirements and provides a process to achieve those requirements.The Standard requires a thorough as
4、sessment of the part production process with the primary goals being to control and minimize variation in characteristics being produced by this process.該航空航天標準確定了關鍵特性的變更管理要求。 該標準還規定了一般要求，並提供了實現這些要求的過程。該標準需要對零件生產過程進行全面評估，其主要目標是控制和最小化由該過程產生的特性變化。Specifically, the Standard mandates: 具體來說，標準規定： Underst
5、anding process elements that affect Key Characteristics 了解影響關鍵特性的過程元素 Disciplined determination of process Key Characteristics using appropriate analysis tools for variation control and reduction to satisfy Customer requirements使用適當的分析工具進行變更控制和縮減，以滿足客戶要求，對過程進行紀律確定 Control and capability assessment t
6、o ensure variation is well understood控制和能力的評估可被確保其變化很好被理解 Process Control Documentation that defines specific control of Key Characteristics and manufacturing process parameters關鍵特性和製造過程參數的具體控制在過程控制文件中要被定義This standard does not: 本標準不是要 Mandate rejection of any part that conforms to engineering speci
7、fication.受意拒絕符合規定的工程規範。 Inhibit shipment or use of product during production process capability assessment.在生產過程能力評估過程中禁止出貨或使用產品。Although Aerospace Standard AS9103 is focused on production and variation control of Key .雖然航空航天標準 AS9103 專注於生產和關鍵變更控制。Characteristics, this process can also be used as a
8、model for other characteristics, such as those that affect cost and delivery.特性，該過程也可以作為其他特性的模型，例如這些特性影響成本和交貨的特徵。TABLE OF CONTENTS 1.SCOPE.41.1 Purpose41.2 Convention.4 2.REFERENCES.43.DEFINITIONS.54.APPLICABILITY65.GENERAL REQUIREMENTS.66.PROCESS REQUIRMENTS AND OUTPUTS8APPENDIX A GUIDELINES TO MEE
9、TING REQUIREMENTS FOR VARIATION MANAGEMENT OF KEY CHARACTERISTICS.10 APPENDIX BPROCESS CONTROL DOCUMENT EXAMPLE14 1. SCOPE: 範圍This Standard is primarily intended to apply to new parts, but can also be applied to parts currently in production. The Standard shall be applicable to all production proces
10、ses that influence the variation of Key Characteristics.本標準主要適用於新零件，但也適用於目前生產的零件。 該標準適用於影響關鍵特性變化的所有生產過程1.1 Purpose: 目的This Aerospace Standard is designed to drive the improvement of manufacturing processes through adequate planning and effective management of Key Characteristic variation. The Key Ch
11、aracteristic focus is intended to improve confidence for part features whose variation has a significant influence on to end-product form, fit, performance, service life and manufacturability.該航空航天標準旨在通過適當規劃和有效管理關鍵特性變化來推動製造過程的改進。 關鍵特性的重點是提高對零件特徵的可信度，這些零件特性的變化對最終產品形式，配合，性能，使用壽命和可製造性有重要影響。1.2 Conventi
12、on:慣例The following conventions are used in this standard: 本標準中使用以下約定： The words shall, will or must indicate mandatory requirements.shall, will or mus 表明強制性要求。 The word “should” indicates a requirement with some flexibility allowed in compliance methodology. Producers choosing other methods to satis
13、fy a “should” must be able to show that their approach meets the intent of the requirements of this standard. “應該”一詞表示符合性方法允許的一些靈活性的要求。 選擇其他方法以滿足“應該”的生產者必須能夠表明他們的方法符合本標準要求的意圖。 Words “typical”, ”example”, “for reference” or “e.g.” indicate suggestions given for guidance only.“Notes” are used for addi
14、tional clarifications.“典型” ， “示例” ， “參考”或“例如”表示僅供參考的建議。“備註”用於進一步說明。 Words or phrases with specific meaning pertaining to this document are capitalized and defined in Section 3, Definitions.文件的單詞或短語的含意在第 3 節“定義”中給出了明確定義。2. REFERENCES:參考文獻2.1Aerospace Standard AS9100 “Quality Systems- Aerospace-Model
15、for Quality Assurance in Design, Development, Production, Installation and Servicing”, Published by SAE, Warrendale, PA, USA, 1999.2.2International Standard EN 9100 “Quality Systems- Aerospace-Model for Quality Assurance in Design, Development, Production, Installation and Servicing”, Published by A
16、ECMA-STAN, 1999.國際標準 EN 9100“質量體系 - 航空 - 設計，開發，生產，安裝和維修質量保證模型 ”，由 AECMA-STAN 出版，1999 年。2.3Aerospace Standard SJAC 9100 “Quality Systems- Aerospace-Model for Quality Assurance in Design, Development, Production, Installation and Servicing”, Published by JSA, Tokyo, Japan, 1999.航空航天標準 SJAC 9100“質量體系 -
17、 航空航天 - 設計，開發，生產，安裝和維修質量保證模型” ，由日本東京 JSA 出版，1999 年。2.4Aerospace Standard AS9102: “Aerospace Standard for First Article Inspection Requirements”, Published bySAE, Warrendale, PA, USA, 2000.航空航天標準 AS9102：“美國賓夕法尼亞州沃倫達萊”SAE 出版的“第一條檢驗要求的航空航天標準” 。2.5International Standard EN9102: “Aerospace Standard for F
18、irst Article Inspection Requirements”, Publishedby AECMA-STAN, 2000 國際標準 EN9102：2000 年 AECMA-STAN 出版的“第一條檢驗要求的航空航天標準”2.6Aerospace Standard SJAC 9102: “Aerospace Standard for First Article Inspection Requirements”, Published by JSA, Tokyo, Japan2000航空航天標準 SJAC 9102：日本東京 JSA 出版的“第一條檢驗要求的航空航天標準 ”3.DEFI
19、NITIONS:名詞定義3.1Key Characteristic (KC):關鍵特性AS9100/EN9100/JISQ 9100 definition: The features of a material or part whose variation has a significant influence on product fit, performance, service life, or manufacturability.AS9100 / EN9100 / JISQ 9100 定義：其變化對產品配合，性能，使用壽命或可製造性有重大影響的材料或零件的特徵。This defini
20、tion is further explained as follows: 這個定義進一步解釋如下： Key Characteristics for a part, subassembly or system are those selected geometrical, material properties, functional and/or cosmetic features, which are measurable, whose variation control is necessary in meeting Customer requirements and enhancing
21、 Customer Satisfaction.零件，子組件或系統的關鍵特性是可選擇的幾何，材料特性，功能和/或化妝品特徵，可測量，其變化控制在滿足客戶要求和提高客戶滿意度方面是必需的。 Key Characteristics for a process are those selected measurable parameters of a process whose control is essential to manage variation of part or system Key Characteristics.過程的關鍵特性是其控制對於部分或系統關鍵特性的變化至關重要的過程的選
22、定可測量參數。 Substitute Key Characteristics may be identified when a Customer-defined Key Characteristic is not readily measurable within the production setting and other characteristics may need to be controlled to ensure conformance.當客戶定義的關鍵特性在生產環境中不容易測量時，可以確定替代關鍵特性，並且可能需要控制其他特性以確保一致性。3.2Producer:製造者An
23、 organization that performs any process affecting the manufacture of the part.組織中在任何過程中執行影響零件製造的人3.3Customer:客戶The organization which provides Part or System Key Characteristics via engineering drawings, specificationsor purchase order/contract requirements. For example, a Customer may be an interna
24、l engineering department for a company which has design authority, in addition to the external Customer who specifies system Key Characteristics.通過工程圖紙，規格或採購訂單/合同要求提供零件或系統關鍵特性的組織。 例如，除了指定係統關鍵特性的外部客戶之外，客戶可能是具有設計權限的公司的內部工程部門。3.4Key Characteristic Owner:關鍵特性所有者Key characteristic owner is the person or
25、function who defines the Key Characteristics and recognizes the reasons for the selection of the Key Characteristic. Typically, these responsibilities are held by Internal or External Customer Design, Quality or Manufacturing Engineering, and should be identified by a cross-functional team.關鍵特性所有者是定
26、義關鍵特性的人或功能，並認識到選擇關鍵特性的原因。 通常，這些職責由內部或外部客戶設計，質量或製造工程負責，並應由跨職能團隊確定。3.5Key Characteristic Process Owner:關鍵特性過程所有者The Key Characteristic Process Owner is the person or function who uses Key Characteristic data to maintain and improve the process.關鍵特性過程所有者是使用關鍵特性數據維護和改進過程的人員或職能3.6Process Control Document
27、 (PCD): 過程控制文件（PCD）：A Process Control Document (PCD) is a written description of manufacturing plan developed to control variation in Key Characteristics. It is a living document and is updated to reflect the addition / deletion of Key Characteristics.過程控製文件（PCD ）是開發用於控制關鍵特性變化的製造計劃的書面描述。 它是一個活的文件，並更
28、新以反映關鍵特性的添加/刪除3.7Special Cause: 特殊原因：The term special cause in this standard can be substituted by assignable cause. The terms have their usual meanings relative to Statistical Process Control methodology.本標準中的“特殊原因”可以由“可分配原因”代替。這些術語與“統計過程控制”方法有相同的含義。4. APPLICABILITY:適用性This Aerospace Standard appli
29、es to assemblies and all levels of parts within an assembly, including castings and forgings, and to organizations that are responsible for producing the design characteristics of the product. Producers and their Subcontractors shall be responsible for flow down of the requirements of the applicable
30、 revision of this Aerospace Standard to Subcontractors who produce design characteristics, and for ensuring that Key Characteristics conform to Customer requirements.該航空航天標準適用於組件內的組件和各個級別的零件，包括鑄件和鍛件，以及負責生產產品設計特性的組織。 生產商及其分包商應負責將本航空航天標準適用修訂版本的要求下載給生產設計特性的分包商，並確保關鍵特性符合客戶要求。5. GENERAL REQUIREMENTS: 一般要
31、求：Section 5 provides the following general requirements which must be met regardless of the variation management methodology applied.第 5 節提供了必須滿足的以下一般要求，而不管應用變體管理方法如何。5.1Variation management activities must be performed on identified Key Characteristics and processes until they are in control and pr
32、ocess capability has been established. Appropriate monitoring methodology should then be implemented to ensure continued performance.必須對確定的關鍵特性和過程進行變更管理活動，直到控制和過程能力建立。 然後應實施適當的監測方法，以確保持續的成果。5.2 The Producer shall maintain appropriate documentation of Key Characteristics and manufacturing process ele
33、ments that influence variation in Key Characteristics as well as their control techniques and measurement methods. This documentation shall be developed when any of the following occurs:生產者應保持適當的文件化藉著控制技術及量測方法,紀錄關於生產過程的基本要素影響關鍵特性的變化。 當發生以下任何情況時，應制定本文檔：a. Customer defines a Key Characteristic or a ke
34、y process parameter.客戶定義了關鍵特性或關鍵過程參數。b. Lower level or Substitute Key Characteristics are required to control variation of higher level Key Characteristics. 需要較低級別或替代鍵特性來控制較高級別的關鍵特性的變化。c. Analysis performed as part of a process improvement activity to meet quality objectives required by AS9100 resul
35、ts in the identification of a key characteristic or process.作為過程改進活動的一部分進行的分析，以滿足 AS9100 所要求的質量目標，從而確定關鍵特性或過程。5.3If statistical process control is chosen as the method of control for the Key Characteristic, the following requirements must be met 如果選擇統計過程控製作為關鍵特性的控制方法，則必須滿足以下要求： :a. Process capabilit
36、y shall be established for Key Characteristics. The process capability index (e.g., Cp and Cpk) shall be calculated only when the process is shown to be stable and in statistical control, using sound statistical methods and/or appropriate control charts.對關鍵特性建立過程能力。 僅當過程顯示為穩定並且在統計控制中使用充分的統計方法和/或適當的控
37、製圖時才能計算過程能力指數（例如 Cp 和 Cpk）b. The process shall be capable, with Cpk 1.33, or as specified by the Customer.該過程能力應具有，Cpk 1.33 或客戶指定Note: A Key Characteristic is considered capable if its Cpk exceeds 1.33. Other comparable measures of process capability may be used. If the process does not meet capabil
38、ity requirements, the Producer may have several options as described in this section.備註：如果 Cpk 超過 1.33，則認為關鍵特性被認為是有能力的。 可以使用其他可比較的過程能力的措施。 如果該過程不符合能力要求，則生產者可能會具有本節所述的多種選項。c. When similar Key Characteristics from different products are combined on the same control chart(a part or product family, or p
39、rocess output control approach), the characteristics shall have similar variabilityand be traceable to the specific part or product.當同一控制圖（部件或產品系列或過程輸出控制方法）組合不同產品的相似關鍵特性時，其特性應具有相似的變異性，可追溯到特定零件或產品。a. If process capability is used to justify reduced frequency of inspection, the process capability or e
40、quivalent fallout rate shall be calculated using industry standard statistical methods.如果過程能力被用來證明檢查頻率降低是適當的，則可以使用行業標準統計方法計算過程能力或等效的附帶結果。b. Processes that cease to be in control and/or capable and the product feature is under a reduced inspection plan, normal end-item inspection shall resume for acc
41、eptance of the product feature until the cause has been identified, corrected and process capability and control are re-established.過程不再具有控制和/或能力，產品功能處於減少的檢查計劃之下，正常的終端檢驗應恢復，以接受產品特徵，直到原因被識別，更正，處理能力和控制重新 建立。5.4Other variation control methods such as tooling, control of process settings, standard proce
42、sses and mistake proofing may be used to ensure process stability and capability. However, measurable evidence must demonstrate that the controls are effective.可以使用其他變量控制方法，例如加工，過程設置控制，標準過程和錯誤校樣，以確保過程的穩定性和能力。 然而，可衡量的證據必須證明控制是有效的。5.5Focusing on Key Characteristics does not relieve the Producer from m
43、eeting all drawing characteristics, specifications and other customer requirements and/or invoked standards.專注於關鍵特性並不會使生產者滿足所有的圖面特性及規格和其他客戶要求和/或調用標準。5.6 In some cases, it may be impossible or prohibitively expensive to meet the stability and capability requirements of Section 5. These exceptions mus
44、t be documented by the Producer and may require customer approval. 在某些情況下，滿足第 5 節的穩定性和能力要求可能是不可能的或者非常昂貴的。這些例外情況必須由生產商記錄，並可能需要客戶批准。6. PROCESS MODEL AND OUTPUTS: 過程模型和產出：Appendix A describes a model that may be used in fulfilling the requirements of this Standard and is presented for illustration and
45、clarity. 附錄 A 描述了可用於滿足本標準要求的模型，並提供了明確清晰的說明。The model consists of several stages, starting with the definition of Key Characteristics and ending with themonitoring of product manufacturing process performance. Other methods or processes may be employed to achieve compliance. The Producer in either ca
46、se must show that compliance with the requirements inSection 5 has been achieved and the method by which compliance was obtained. 該模型由幾個階段組成，從關鍵特性的定義開始，到產品製造過程性能的監測結束。 可以採用其它方法或方法來實現承諾。 生產者在任何一種情況下都必須表明符合第 5 節的要求已經達到，並且獲得遵守的方法。APPENDIX A 附錄 AGUIDELINES TO MEETING REQUIREMENTS FOR VARIATION MANAGEMEN
47、T OF KEY CHARACTERISTICS關於關鍵特性變更的會議要求指南A.1STAGE 1: REVIEW KEY CHARACTERISTICS AND REQUIRED PERFORMANCE:階段 1：審查主要特點和要求的性能：A.1.1Producer establishes an appropriate cross-functional team, which has an understanding of customer requirements and the producers manufacturing processes. The cross-functional
48、 team reviews customer requirements -specifically the Key Characteristics on the product (if any)生產者建立了一個適當的跨職能團隊，了解客戶需求和生產者的製造流程。 跨職能團隊審查客戶要求 - 特別是產品的主要特徵（如果有）A.1.2Key Characteristics and the required performance are documented on the Process Control Document or equivalent.關鍵特性和所需性能在過程控製文件或等效文件中有記錄
49、。A.1.3Stage 1 Outputs: 階段 1 輸出： Documentation of customer Key Characteristics 客戶關鍵特性檔案A.2STAGE 2: PLANNING A MANUFACTURING PROCESS: 階段 2：規劃製造流程：A.2.1The producer defines a manufacturing process by developing a new or by reviewing an existing manufacturing process flowchart. This includes the identification of key elements that influence variation of Key Characteristics. Knowledge of existing process capability and customer capability requirements is considered.生產者通過開發新的或通過審查現有的製造流程圖來定義製造過程。這包括確定影響關鍵特性變化的關鍵要素。考慮了現有流程能力和客戶能力要求的知識。A.2.2The producer performs cause effect analy
