AS9103
AS航空航天质量体系标准培训课件

应用
1.2 应用
本标准规定的所有要求是通用的,旨在适用于各种类型、不同规模 和提供不同产品的组织。
当本标准的任何要求因组织及其产品的特点而不适用时,可以考虑 对其进行删减。
除非删减仅限于本标准第7章中那些不影响组织提供满足顾客和适用 法律法规要求的产品的能力或责任的要求,否则不能声称符合本 标准。
3.术语和定义
本标准采用GB/TI9000中的术语和定义。 本标准表述供应链所使用的以下术语经过了更改,以反映当前的使用情
况: 供方——组织——顾客
本标准中的术语“组织”用以取代GB/TI9001-1994所使用的术语“供 方”,术语“供方”用以取代术语“分承包方”。
第二节 国际航空航天质量标准 产生的背景、演变和构成
2.1国际航空航天质量标准产生的背景
2.1.1 国际航空航天质量标准产生的背景
➢ 航空业界认识到ISO9001虽然提供了一个非常好的基础,但是却不 充分,不能完全满足航空业特定的需要。基于业界一系列的增值 期望而进行增补扩充,关注点提升至产品安全性、可靠性和耐飞 性;
➢ IAQG成员中的美国、欧洲共同体、日本等国家和地区依托其国家和地 区的欧洲航空业协会(AECMA),自动化工程协会(SAE)及日本航空 公司社团(SJAC)并以其名义发布了等同IAQS9100最终草案的EN9100 /AS9100 A/SJAC9100标准。并要求航空航天产品的供方贯彻和保持 IAQG规定的质量管理体系要求。
2.1国际航空航天质量标准产生的背景
2.1.2 国际航空航天质量协调组织( IAQG)成立带来的变化 ➢ IAQG分为三大部分:欧洲(EAQG),美洲(AAQG)和亚洲(APAQG)。
AS9100培训教材

2001年 发布航空航天质量体系标准AS9100A版标准 ,随后颁布AS9100B。
在中国,国家国防科学技术工业委员会于2003年09月 25日发布HB9100-2003;等同采用了AS9100标准要求 ,并于2003年12月1日颁布实施。
二、AS9100发展
AS9100培训教材
2020年5月22日星期五
课程简介
一、推行AS9100意义 二、AS9100发展 三、AS9100标准介绍
一、推行AS9100的意义
2007年3月7日印尼一架737-400客机在 印尼爪哇岛日惹机场降落时突然着火,
随后发生爆炸,造成百余人伤亡。由于 飞机起落架制动系统部件存在生产质量 问题导致。
AS9102A 2005-03-31
SJAC9102A 2004-06-16
9103 关键特性波动管理
AS9103 2001-10-01
SJAC9103 2002-04-30
9110 质量管理体系-航空航天— AS9110
对维修组织的要求
2003-01-11
9120 质量管理体系-航空航天— AS9120 对库存批发商的要求 2002-11-04
EAQG EN9100
EN9101 2007-03-29
EN9102 2006-04-27
EN9103 2005-12-07
EN9110 2005-12-07
EN9120 2005-12-07
二、AS9100发展
AS9100最新发展
2009年1月IAQG(The International Aerospace Quality Group)发布了AS9100 C版,同时提出了 过渡计划: 2009年1月-2009年6月:策划AS9100审核员的培 训。 2009年7月2010年6月:培训认证机构和审核员。 2010年7月-2011年6月:所有企业完成AS9100C的 监督审核或者按照AS9100C实施第一次认证。最 后截止日期为2011年6月份。
AS9102翻印版

REV.
AS9102 Technically
equivalent to AECMA prEN 9102
A A版
Issued 發行:2000-08
Revised 修訂:2004-01
Supersedes AS9012: 代替AS9012
(R) Aerospace First Article Inspection Requirement 航空航天首件檢驗標準
2.International Aerospace Standard 9103 —Variation Management in Key Characteristics“. 國際航空標準9103—主要特性的變化管理.
3.International Aerospace Standard 9131 —Quality Systems - Nonconformance Documentation“.
2. REFERENCES.參考.............................................................................. ......... 3.EFINITIONS .定義............................................................................
國際航空標準9131—品質體系—不合格品的文件化
3. DEFINITIONS: 定義
ATTRIBUTE DATA: A result from a characteristic or property that is appraised only as to whether it does or does not conform to a given requirement (for example, go/no-go, accept/reject, pass/fail, etc.).
AS9100D【朱雅云】

L o g o专业/科学/务实AS9100D (2016)航空、航天和防卫组织质量管理体系要求主讲:朱雅云AS9100产生背景AS9100产生背景AS9100产生背景AS9100产生背景AS9100推行意义AS9100的认证是企业进入航空航天行业的通行证,尤其是美国波音公司、法国的空客和目前中国的大飞机计划均需要供应商获得AS9100的认证搞门砖AS9100的认证同时是帮助企业提高管理水平的有效途径。
即使企业不生产航空航天产品也可以获得认证。
推进器AS9100推行意义已经有ISO9001,为什么还要针对航空航天行业的质量管理体系标准?针对性不足ISO9001适用于所有行业,针对性不足,因此,现在ISO9001已发展出IATF16949、ISO13485、AS9100等AS9100的发展历程AS9100标准草案AS9100标准正式版本AS/EN9100标准最终草案AS9100标准正式版本IAQS9100:2001最终草案1995年SAE航空航天部开始航空航天质量标准的准备工作,并于1996年10月第一次发布AS9000标准草案1997年5月SAE发布AS9000标准正式版本《航空航天基本质量体系》1999年6月IAQG/SAE/AECMA共同发布国际航空航天质量标准AS/EN9100标准最终草案1999年11月SAE以ISO9001:1994为基础正式发布AS9100标准正式版本《航空航天质量体系——设计、开发、生产、安装和服务的质量保证模式》2001年3月26日IAQG发布国际航空航天质量标准(IAQS)9100:2001的最终草案AS9100的发展历程ISO9001:1987诞生ISO9001:1994战术性换版ISO9001:2000战略性换版ISO9001:2008编辑性修正ISO9001:2015里程碑换版AS9100A :2001AS9100B :2004AS9100C :2009AS9100D :2016美国航空航天质量AAQG欧洲航空航天质量EAQG亚太航空航天质量协调组织APAQGAS9100D转换计划2016年10月2017年6月2018年9月AS9100D发布AS9100C不在认证AS9100C证书失效123AS9100系列标准标准号名称9100航空航天质量体系标准9101质量管理体系9102航空航天首件检验要求9103关键特性波动管理0.1 总则采用质量管理体系是组织的一项战略决策,能够帮助其提高整体绩效,为推动可持续发展奠定良好基础。
8.关键特性值变异管理流程

鉚合致 工件損 傷
頂歪
STEP 3 : 製造過程之數據收集
1. 成員將分析後的文件匯整,編訂管制計畫標準程序,包括 建立 SPC 管制計畫與品保檢驗計畫書,管制計畫如下 :
關鍵特性值 Key Characteristics , KCs
是指材料、製程及零組件的品質特性值 中,其變異對產品的符合性、績效、製程或 生命週期,會有顯著的影響者,針對影響關 鍵特性值之變異做分析與管理,以符合客戶 需求。
品質月刊 (95.1/42卷1期) P 21 AS 9103 品質變異管 理之探討與個案研究 作者 : 董明棠與李明賢
機具 鉚釘槍
未執行 磨損 毛邊
人
歪斜
鑚板
不足
壓傷
失手 頂歪
訓練
遺漏 不符
殘屑 拿錯 錯誤 遺漏
5S 環境
錯誤
重工
程序
鉚接致 工件損 傷
遺漏
材料
方法
魚骨圖 與 FMEA
1.魚骨圖是依據 4M1E 分析(人、機、料、法及環 境),透過小組成員「腦力激盪」運作。 2.為了找出對策,有效杜絕這些缺點,於是進一步 應用失效模式與效應分析(FMEA),發掘出潛在失 效的潛因與影響。 3.魚骨圖強調經驗法則,以腦力激盪方式匯集成員 的經驗。 4.FMEA 著重於機能失效(Function failure) 分析。 5.FMEA 分析製程的重要關鍵,正確定義出「機能」, 然後才從「機能」觀點寫出失效模式。 6.例如 : 機能為鉚接工作之兩個常發生之失效模 式 : 「壓傷」和「頂歪」(沒正確鉚接)
AS9102-FAI首件检验

AEROSPACE STANDARD(R) Aerospace First Article Inspection Requirement®AS9102Technically equivalent to AECMA prEN 9102REV. AFOREWORDIn December 1998, the Aerospace Industry had established the International Aerospace QualityGroup (IAQG) with the purpose of achieving significant improvements in quality and reductionsin cost throughout the value stream.This organization, with representation from Aerospace companies in Americas, Asia and Europeand sponsored by SAE, SJAC, and AECMA has agreed to take responsibility for the technical contents of this standard. TABLE OF CONTENTS1. INTRODUCTION.......................................……….............. ..31.1 Scope (3)1.2 Pu rpose (3)1.3 Convention (3)2. REFERENCES (3)3. DEFINITIONS (4)4. APPLICABILITY (5)5. REQUIREMENTS (5)5.1 Par t Requirements (5)5.2 Evaluation Activities (6)5.3 Partial or Re-accomplishment of First Article Inspection (6)5.4 Nonconformance Handling (7)5.5 Documentation (7)5.5.1 Forms (7)5.5.2 Characteristic Accountability (8)5.5.3 Record of Results (8)5.6 Control of Records (8)6. NOTES (9)APPENDIX A FORMS AND GUIDELINES TO COMPLETE THE FORMS ..101. INTRODUCTION:1.1 Scope:This SAE Aerospace Standard (AS) establishes requirements for performing anddocumenting the First Article Inspection (FAI).1.2 Purpose:The purpose of the First Article Inspection is to give objective evidence that allengineering, design and specification requirements are correctly understood, accounted for, verified, and recorded. The purpose of this standard is to provide a consistent documentation requirement for aerospace components FAI.1.3 Convention:The following convention is used in this Standard.• The words .shall. and .must. indicate mandatory requirements.• The word .should. indicates mandatory requirements with some flexibility allowed incompliance methodology. An Organization is permitted to show that its approach meets the intent of the requirement and this standard. 航空标准航空首件检查要求版本:A前言1998年12月,航空工业成立的国际航空质量部门(IAQG),目的是为了提高质量和降低成本。
AS9110质量管理体系综述PPT(60张)

供方(外委量负责(包括顾客指 定的供方);
• 任何影响产品符合要求的外包过程,该外包方按供 方控制; 其输出按采购监视;
• 组织从无资格证书的供方采购时,应满足有关管 理当局的要求;--22条器材(三,四);
• 顾客的验证不应被组织用作供方有效控制质量的 凭证,并且也不应减免组织提供接受产品的责任, 也不应排除顾客随后拒收产品;
质量管理体系基础(三)
• 八项质量管理原则是AS9100系列标准的基 础,为组织的最高管理者进行质量管理和 持续改进QMS的基本准则。
• 12条质量管理体系基础是组织建立,实施和 评价质量管理体系的原则要求和基础说明
这些概念具体地运用在AS9110标准中
AS9110标准要点摘要
• AS9110新增定义 • 维修组织资格控制 • 关键特性/构型管理 • 供方管理 • 特殊过程 • 维护与维修 • FOD控制 • 召回制度 • 培训 • 监视和测量装置控制 • 内部审核
• 外委:CCAR-145第2章15条,17条(二)规定。
供方(外委)管理--供方管理体系管理要求
• 组织应制定选择、评价和重新评价供方的准则(按 组织的要求提供产品的能力 );
• 评价结果及相应措施的记录应予以保持; • a) 保持批准供方,包括批准范围,的注册登记; • b) 定期评审供方业绩, 其作确定控制级别的基础; • c) 对不满足要求的供方,规定需要采取的措施; • d) 要求时, 组织或供方,使用顾客批准的特种工艺
AS9110新增定义(三)
• 人为因素:认可从事工作的人员受体力健康、 生理特性、个性、压力、疲劳、分神、沟 通和态度的影响;
• 放行证书:证明进行的维修活动、及完成的 结果符合制定的组织、当局和合同要求的 文件。
AS 9103 关键特性变动管理 本文翻译版

AEROSPACE STANDARDAS9103 Issued 2001-10Variation Management of Key Characteristics關鍵特性變動管理FOREWORD 序言In December1998,the Aerospace Industry had established the International Aerospace Quality Group(IAQ G)with the purpose of achieving significant improvements in quality and reductions in cost throughout the value 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 sponso red by SAE,SJAC,and AECMA has agreed to take responsibility for the technical contents of this standard.該組織由美國,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 Stan dard also specifies general requirements and provides a process to achieve those requirements.The Standar d requires a thorough assessment of the part production process with the primary goals being to control an d 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。
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SAE Technical Standards Board Rules provide that: “This report is published by SAE to advance the state of technical and engineering sciences. The use of this report is entirely voluntary, and its applicability and suitability for any particular use, including any patent infringement arising therefrom, is the sole responsibility of the user.”SAE reviews each technical report at least every five years at which time it may be reaffirmed, revised, or cancelled. SAE invites your written comments and suggestions.Copyright 2001 Society of Automotive Engineers, Inc.All rights reserved.Printed in U.S.A.TO PLACE A DOCUMENT ORDER: (724) 776-4970 FAX: (724) 776-0790 SAE WEB ADDRESS: 400 Commonwealth Drive, Warrendale, PA 15096-0001AEROSPACE STANDARD AS9103Issued 2001-10Variation Management of Key CharacteristicsFOREWORDIn 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 costthroughout the value stream.This organization, with representation from Aerospace companies in Americas, Asia and Europe andsponsored by SAE, SJAC, and AECMA has agreed to take responsibility for the technical contents ofthis standard.INTRODUCTIONThis 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 assessment of the part production process with the primary goalsbeing to control and minimize variation in characteristics being produced by this process.Specifically, the Standard mandates:•Understanding process elements that affect Key Characteristics•Disciplined determination of process Key Characteristics using appropriate analysis tools for variation control and reduction to satisfy Customer requirements•Control and capability assessment to ensure variation is well understood•Process Control Documentation that defines specific control of Key Characteristics and manufacturing process parametersThis standard does not:•Mandate rejection of any part that conforms to engineering specification.•Inhibit shipment or use of product during production process capability assessment.Although Aerospace Standard AS9103 is focused on production and variation control of Key Characteristics, this process can also be used as a model for other characteristics, such as those that affect cost and delivery.TABLE OF CONTENTS1.SCOPE (4)1.1Purpose (4)1.2Convention (4)2.REFERENCES (4)3.DEFINITIONS (5)4.APPLICABILITY (6)5.GENERAL REQUIREMENTS (6)6.PROCESS REQUIRMENTS AND OUTPUTS (8)APPENDIX A GUIDELINES TO MEETING REQUIREMENTS FOR VARIATIONMANAGEMENT OF KEY CHARACTERISTICS (10)APPENDIX B PROCESS CONTROL DOCUMENT EXAMPLE (14)1.SCOPE: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 processes that influence the variation of Key Characteristics.1.1Purpose:This Aerospace Standard is designed to drive the improvement of manufacturing processes through adequate planning and effective management of Key Characteristic variation. The KeyCharacteristic focus is intended to improve confidence for part features whose variation has asignificant influence on to end-product form, fit, performance, service life and manufacturability.1.2Convention:The following conventions are used in this standard:•The words shall, will or must indicate mandatory requirements.•The word “should” indicates a requirement with some flexibility allowed in compliancemethodology. Producers choosing other methods to satisfy a “should” must be able to show that their approach meets the intent of the requirements of this standard.•Words “typical”, ”example”, “for reference” or “e.g.” indicate suggestions given for guidance only.•“Notes” are used for additional clarifications.•Words or phrases with specific meaning pertaining to this document are capitalized and defined in Section 3, Definitions.2.REFERENCES:2.1Aerospace Standard AS9100 “Quality Systems- Aerospace- Model 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 inDesign, Development, Production, Installation and Servicing”, Published by AECMA-STAN, 1999. 2.3Aerospace Standard SJAC 9100 “Quality Systems- Aerospace- Model for Quality Assurance inDesign, Development, Production, Installation and Servicing”, Published by JSA, Tokyo, Japan, 1999.2.4Aerospace Standard AS9102: “Aerospace Standard for First Article Inspection Requirements”,Published by SAE, Warrendale, PA, USA, 2000.2.5International Standard EN9102: “Aerospace Standard for First Article Inspection Requirements”,Published by AECMA-STAN, 20002.6Aerospace Standard SJAC 9102: “Aerospace Standard for First Article Inspection Requirements”,Published by JSA, Tokyo, Japan20003.DEFINITIONS:3.1Key Characteristic (KC):AS9100/EN-9100/JISQ 9100 definition: The features of a material or part whose variation has a significant influence on product fit, performance, service life, or manufacturability.This definition is further explained as follows:•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 Customer Satisfaction.•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.•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 becontrolled to ensure conformance.3.2Producer:An organization that performs any process affecting the manufacture of the part.3.3Customer:The organization which provides Part or System Key Characteristics via engineering drawings,specifications or purchase order/contract requirements. For example, a Customer may be aninternal engineering department for a company which has design authority, in addition to the external Customer who specifies system Key Characteristics.3.4Key Characteristic Owner:Key characteristic owner is the person or function who defines the Key Characteristics andrecognizes 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.3.5Key Characteristic Process Owner:The Key Characteristic Process Owner is the person or function who uses Key Characteristic data to maintain and improve the process.3.6Process Control Document (PCD):A Process Control Document (PCD) is a written description of manufacturing plan developed tocontrol variation in Key Characteristics. It is a living document and is updated to reflect the addition / deletion of Key Characteristics.3.7Special Cause: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.4.APPLICABILITY:This Aerospace Standard applies to assemblies and all levels of parts within an assembly, including castings and forgings, and to organizations that are responsible for producing the designcharacteristics of the product. Producers and their Subcontractors shall be responsible for flow down of the requirements of the applicable revision of this Aerospace Standard to Subcontractors who produce design characteristics, and for ensuring that Key Characteristics conform to Customerrequirements.5.GENERAL REQUIREMENTS:Section 5 provides the following general requirements which must be met regardless of the variation management methodology applied.5.1Variation management activities must be performed on identified Key Characteristics and processesuntil they are in control and process capability has been established. Appropriate monitoringmethodology should then be implemented to ensure continued performance.5.2 The Producer shall maintain appropriate documentation of Key Characteristics and manufacturingprocess elements 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:a.Customer defines a Key Characteristic or a key process parameter.b.Lower level or Substitute Key Characteristics are required to control variation of higher level KeyCharacteristics.c.Analysis performed as part of a process improvement activity to meet quality objectives requiredby AS9100 results in the identification of a key characteristic or process.5.3If statistical process control is chosen as the method of control for the Key Characteristic, thefollowing requirements must be met:a.Process capability 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 instatistical control, using sound statistical methods and/or appropriate control chartsb.The process shall be capable, with Cpk > 1.33, or as specified by the Customer.Note: A Key Characteristic is considered capable if its Cpk exceeds 1.33. Other comparablemeasures of process capability may be used. If the process does not meet capabilityrequirements, the Producer may have several options as described in this section.c.When similar Key Characteristics from different products are combined on the same control chart(a part or product family, or process output control approach), the characteristics shall havesimilar variability and be traceable to the specific part or product.d.If process capability is used to justify reduced frequency of inspection, the process capability orequivalent fallout rate shall be calculated using industry standard statistical methods.e.Processes that cease to be in control and/or capable and the product feature is under a reducedinspection plan, normal end-item inspection shall resume for acceptance of the product feature until the cause has been identified, corrected and process capability and control are re-established.5.4Other variation control methods such as tooling, control of process settings, standard processes andmistake proofing may be used to ensure process stability and capability. However, measurable evidence must demonstrate that the controls are effective.5.5Focusing on Key Characteristics does not relieve the Producer from meeting all drawingcharacteristics, specifications and other customer requirements and/or invoked standards.5.6In some cases, it may be impossible or prohibitively expensive to meet the stability and capabilityrequirements of Section 5. These exceptions must be documented by the Producer and may require customer approval.6.PROCESS MODEL AND OUTPUTS:Appendix A describes a model that may be used in fulfilling the requirements of this Standard and is presented for illustration and clarity.The model consists of several stages, starting with the definition of Key Characteristics and ending with the monitoring of product manufacturing process performance. Other methods or processes may be employed to achieve compliance. The Producer in either case must show that compliance with the requirements in Section 5 has been achieved and the method by which compliance was obtained.FIGURE 1 - Preferred Model for Key Characteristic Variation Management PREPARED UNDER THE JURISDICTION OFSAE COMMITTEE G-14, AMERICAS AEROSPACE QUALITY GROUPAPPENDIX AGUIDELINES TO MEETING REQUIREMENTS FOR VARIATIONMANAGEMENT OF KEY CHARACTERISTICSA.1STAGE 1: REVIEW KEY CHARACTERISTICS AND REQUIRED PERFORMANCE:A.1.1Producer establishes an appropriate cross-functional team, which has an understanding ofcustomer requirements and the producer’s manufacturing processes. The cross-functional team reviews customer requirements - specifically the Key Characteristics on the product (if any).A.1.2Key Characteristics and the required performance are documented on the Process ControlDocument or equivalent.A.1.3Stage 1 Outputs:•Documentation of customer Key CharacteristicsA.2STAGE 2: PLANNING A MANUFACTURING PROCESS:A.2.1The producer defines a manufacturing process by developing a new or by reviewing an existingmanufacturing 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.A.2.2The producer performs cause effect analysis to identify any process Key Characteristics. Ifsubstitute Key Characteristics are used, the producer demonstrates association of substitute Key Characteristics with customer defined Key Characteristics. The producer establishes a minimum acceptable capability ratio for each Key Characteristic.A.2.3The producer identifies a Process Owner for each Key Characteristic. The Process Owner isresponsible to maintain and improve the process performance that generates the KeyCharacteristic.A.2.4 A disciplined review of each process generating Key Characteristics is conducted to identifysources of variation and potential risks. Plans are developed to manage those risks.A.2.5Detailed work instructions and measurement instructions are developed to manage sources ofvariation.A.2.6The producer updates the Process Control Document (PCD) after completing activities of thisstage (see PCD Example, Appendix B).A.2.7Stage 2 Outputs:•Flow chart of the manufacturing process or equivalent documentation•Cause/Effect Analysis•Key process elements and their reference to Key Characteristics•Process Key Characteristics•Substitute Key Characteristics and association with Customer defined KCs•Identification of the Process Owner•Potential sources of variation•Work instructions•Measurement instructions•Updated PCD or equivalentA.3STAGE 3: OPERATE THE PROCESS ON TRIAL BASIS TO GENERATE DATA:A.3.1The producer creates a data collection plan(s) for all Key Characteristics that reflects the sourcesof variations. The plan specifies who, what, where, frequency and how many parts will be included and under what conditions the data will be collected. The producer determines the type of control chart to be used.A.3.2The producer manufactures parts according to previously defined work instructions. The trial partsare manufactured in a representative production environment.A.3.3The producer collects data on control charts according to the data collection plan. Any deviation tothis plan is documented.A.3.4 A first article inspection (FAI) may be performed at this stage (Reference AS/EN/ SJAC 9102). A.3.5The producer updates the Process Control Document as required.A.3.6Stage 3 Outputs:•Data collection plan•Control chart•Updated PCD or equivalentA.4STAGE 4: ANALYZE DATA FOR ACTION:A.4.1The producer reviews control charts to determine if the process is stable. The producer calculatesprocess capability and provides evidence to demonstrate statistical reasoning and justification, in addition to the calculation method. The process capability index (e.g., Cp. and Cpk.) is calculated only when the process is stable.A.4.2If the process is not stable, the producer investigates to determine the root cause using suitableproblem resolution tools. Investigation results are documented.A.4.3If the process is stable, but the capability does not meet the customer requirements, the producerprioritizes common cause sources of variation, to identify the most influential source(s).Subsequent investigation determines root cause(s) of this variability. If the capability meetscustomer requirements, take no further action on the process, and finalize the PCD.A.4.4Process Key Characteristics are re-evaluated based on understanding of the observed processbehavior to determine if any need to be added or do not apply.A.4.5The producer updates the Process Control Document. Reference to associated documentation isincluded.A.4.6Stage 4 Outputs:•Process capability, including calculation method•Investigation results of out-of-control points•Investigation results of sources of variation•New or revised Key Characteristics identified•Updated PCD or equivalentA.5STAGE 5: TAKE ACTION FROM STUDY OF KEY-CHARACTERISTIC PERFORMANCE:A.5.1When a process is not stable, and the special cause is known, corrective action is taken to removepermanently or minimize the cause. Effectiveness of corrective action is verified.A.5.2When a process is not capable or the special cause continues to be evident, the producerinvestigates gage variation. If a Measurement Systems Analysis (MSA) has already beenperformed, the producer verifies the results.A.5.3If a process is stable but still not capable, the producer investigates centering of the process.A.5.4If a process continues to be stable but not capable, the producer takes appropriate actions onsources of variation that influence the process performance.A.5.5If after performing the previous actions, the process is not stable or not capable, the producerimplements a Product/Process protection plan until such time that the process is proven capable and stable.A.5.6 A first article inspection (FAI) may be performed (Reference: AS/EN/SJAC 9102), unless it hasbeen performed previously in Stage 3 and the process is unchanged.A.5.7Whenever actions are taken that change the manufacturing process, the producer will takeappropriate action in Stage 2 through Stage 5.A.5.8The Process Control Document is finalized as soon as the process is stable and capable.A.5.9Stage 5 Outputs:•Corrective action documentation for out of control points•Measurement Systems Analysis•Corrective action documentation for sources of variation•Product/process protection plan•Updated PCD or equivalentA.6STAGE 6: CONTINUE TO MONITOR THE PROCESS:A.6.1When a Key Characteristic is meeting capability requirements, then the producer will periodicallyverify that the process remains in control and capable. The producer should continue to measure process performance to identify opportunities for process improvement through variation reduction.If learning from monitoring the process results in a change in the method of production, theproducer will operate to Stage 7.A.6.2To ensure that valid producer Key Characteristics have been identified the producer shouldcontinually review business indicators as appropriate. This may result in eliminating someproducer Key Characteristics and adding others. All additional producer Key Characteristics will follow the requirements of this standard from Stage 2 and beyond.A.6.3Stage 6 Outputs:•Ongoing controls on Key Characteristics•Ongoing analysis of business indicators•Updated PCD or equivalentA.7STAGE 7: PROCESS CHANGE MANAGEMENT:A.7.1The producer documents any planned change to the manufacturing process.A.7.2The producer follows the requirements of A.1 to A.5 prior to implementing any planned change tothe approved manufacturing process, as related to the affected Key Characteristics.A.7.3Stage 7 Outputs:•Process change documentation•Updated PCD or equivalentAPPENDIX BPROCESS CONTROL DOCUMENT EXAMPLEProcess Control Document (PCD) shown in Appendix B is the preferred method of fulfilling the documentation requirements of this Section, any other equivalent method of documentation may be accepted.1.Process Control Document (PCD) Number - Enter the process control document number used fortracking. It may be made of any combination of letters and/or numbers.2.Part Number / Part Family / Latest Change Level - Enter the number of the assembly, or part numberbeing controlled. The process designation / specification number and part family can be entered into this block if applicable. Enter the latest engineering change level.3.Part Name / Description - Enter the name and description of the part / process being controlled.4.Producer / Plant - Enter the name of the company and appropriate division / plant / departmentpreparing the Process Control Document.5.Manufacturing Code - Enter the identification number as requested by the procuring organization.For example this could be Producer Code, vendor identification code, Mfg. Id Number, etc.6.Process Owner - Enter the name of the person who uses Key Characteristic data to maintain andimprove the process.7.Is Flow Chart Created? Answer yes or no.8.Producer Approval and Date - Enter the person(s) name that is responsible for producing andapproval of the manufacturing plan and date signed.9.Customer Approval and Date - Obtain the approvals from customer organizations (such asEngineering, SQA, etc.) if required.10.Date (original) - Enter the date that the original Process Control Document was compiled. Usuallythe end of Stage 1.11.Date (Rev) - Date that the Process Control Document was revised.12.Key Characteristic No. - Enter the KC number that would uniquely identify that KC.13.KC Name - Enter name of the key characteristics, e.g. Diameter, Temperature, etc.14.Process ID - Identify type of manufacturing process by its unique producer specific number (orname).15.Operation Number - Enter the Operation number from the work instruction.16.Work Instruction Number/Change Level - Enter the work instruction number and change level.17.Minimum Requirement of Cp and Cpk - Enter the customer requirement for Cp and Cpk or theminimum as determined by the producer.18.Origin of KC - Enter the source of KC from the following: Customer Given, Producer or ProducerManufacturing Generated.19.Are Sources of Variation Identified - Answer Yes if a study has been adequately performed and canbe supported, else answer No.20.Is Risks Mitigation Specified - Answer Yes if there was a need and the risk analysis complete, elseanswer No.21.Preliminary Process Capability Study - This section identifies details of preliminary capability study.The study could be based on historical information, or new study conducted specific to the subject part. Historical study may just be referenced, however, produced if requested.22.Hist/New - Enter HIST for historical study and NEW for new study23.Date - Enter when the study was conducted (Month/year)24.Gage - Enter type of gage.25.Gage Number - Enter the number of the gage26.M.S.A. % - Enter the results of the Measurement System Analysis study. Depending on the type ofM.S.A., enter the appropriate percentage, categories or probability.27.N = Enter the number of observations that were made for the Key Characteristic being studied. Thisis commonly called sample size. Mandatory Entry if Field 22 = “New”28.Frequency - Enter the frequency of the observations that were made. Mandatory Entry if Field 22=“New”29.Type of Control Chart - Enter abbreviation for the control chart (e.g. - Average and range chart [xand R]. Individual and moving range [IX-bar and MR], etc.)30.Stable - Enter Yes if the control chart shows stability and No if there are out-of-control conditions ornon-random indications.31.Calculations - Enter the calculations for the mean (X-bar), standard, deviation (S, or R/d2) Cp andCpk. If the process is not stable, then enter N/A (Not Applicable) for Cp and Cpk.32.Action from Study - If there are any actions required from the study, enter Yes, else No.33.Ongoing Monitoring Methods - This section identifies the methods used to monitor the process andspecifies what the frequency of monitoring:-Type: Enter the method of monitoring the process (e.g. control charts)-Frequency: Enter the Frequency of data collection-Process Capability Review frequency: Enter what is the time period or part quantity manufactured after which the process capability performance is re-evaluated (e.g. years or part quantity).FIGURE B1FIGURE B1 (Continued)。