IFAI_Internal_First_Article_Inspection(FAI)_Control内部首件鉴定控制程序
Revision History 修订记录
Distribution List 下发
Change Control更改控制
This document is maintained under change control. Any requests for change should be addressed to: 此为更改控制文件。如有更改要求，请同以下部门联系：
QM department 品管部
Ultimate Co., Ltd. 178 Zhuzhou Road, Hi -Tech Zone, Qingdao,欧特美股份有限公司青岛高科园株洲路178号Post code电话: +86 (532) 68868115 Email邮箱: pgb@https://www.sodocs.net/doc/a719014201.html,
Confidentiality and copyright 机密性和版权
?Ultimate All rights reserved.?欧特美版权所有。
IFAI_Internal_First_Article_Inspection(FAI)_Control内部首件鉴定控制程序
Content
目录
1. Purpose 目的 (4)
2. Scope 范围 (4)
3. Reference 参考文件 (4)
4. Terminology and Definition 术语及定义 (4)
5. Responsibility Description职责描述 (5)
7. Input of IFAI内部首件鉴定的输入 (8)
8. Output of IFAI内部首件鉴定的输出 (8)
9. Conditions to keep the process under Control确保过程受控的条件 (9)
10. Process Performance & KPI过程绩效 (10)
11. Records control记录控制 (10)
1. Purpose 目的
This procedure specifies the first article inspection (FAI) requirements which verify that the product can be manufactured and tested in accordance with the prerequisite design, process, manufacture, and customer specification.
对首件鉴定的实施要求进行规定，以验证产品的生产、检验和验证符合事先规定的设
计、工艺、生产及顾客规范等要求，特制定本程序。
2. Scope 范围
This document is applicable to Internal FAI for UTM products and components.
适用于公司内部实施的产品及零部件首件鉴定。
3. Reference 参考文件
4. Terminology and Definition 术语及定义
First Article: Under prospective condition of batch production, the first representative products which are manufactured by using device and process.
首件：在批量生产预期的条件下，使用预期的设备和工艺首次生产的有代表性的产品。First Article Inspection (FAI): Inspection, verification and documentation of a representative item from the first serial production run of a new product or major upgrade of an existing Product.
首件鉴定（FAI）：新零件或现有零部件的重要升级，其首次生产时对其代表性零件的检验、验证和文件化。
Internal First Article Inspection (IFAI): First article inspection is carried out internally.
内部首件鉴定（IFAI）:公司内部组织的首件鉴定。
Product Process Review (PPR): Review and validation to all production process before batch production
产品工艺审核：产品批量生产前对工艺过程的确认审核。
5. Responsibility Description职责描述
O: process owner过程所有者 C: process customer过程顾客I: involved functions相关职能
5.1Technical Centre responsibility技术中心职责：
--To prepare safety ,critical & important product and part list for IFAI输出用于内部首件鉴定的安全关键及重要产品及部件清单；
-- To prepare technical documents using for IFAI, which includes drawings, technical specification, test procedure, ect. 输出首件鉴定所需的技术图纸、检查验收标准等技术文件；
--Take part in IFA，co-sign IFAI report, take corrective actions according to OIL.参与内部首件鉴定，会签内部首件鉴定报告，相关开口项的整改；
--Distribute batch production notice.下发批量生产的技术通知。
5.2 Project manager responsibility项目经理职责：
--Prepare project planning covering critical milestone, and define the time of IFAI.制定项目计划，在项目计划的关键里程碑中规定内部首件鉴定的时间要求。
--Distribute CFAI notice according to customer’s requirement.依据客户要求，下发客户首件鉴定的通知。
5.3 Planning dept. responsibility计划部职责：
--Prepare detail First Article production scheduling covering all production processes according to project planning.依据项目计划要求，制定首件产品的生产计划，需细化分解到各相关工序；
--Make or update production scheduling according to result of FAI.依据首件鉴定的结果，制定或调整相应生产计划。
5.4 Process dept. responsibility工艺部职责：
--Product process review of First Article首件产品的工艺过程审核；
--Fixture design and validation for First Article首件产品所需的工装设计及验证；
--Validation of special process for First Article首件产品所需的特殊工艺确认；
--Take part in IFAI, co-sign IFAI report, take corrective actions according to relative open items.参与首件鉴定，会签内部首件鉴定报告，相关开口项的整改。
5.5Purchasing dept.采购部职责：
--按生产计划要求，提供IFAI所需的采购材料；
--按材料采购质量要求，提供采购材料的证明文件；
--Take part in IFAI, co-sign IFAI report if necessary, take corrective actions according to relative open items.参与首件鉴定，必要时会签内部首件鉴定报告，相关开口项的整改。
5.6品管部职责：
--Issue IFAI notice, organize IFAI, prepare and issue IFAI report.发出内部首件鉴定通知，组织内部首件鉴定，出具内部首件鉴定报告；
-- Follow up the close situation of Open Item List.内部首件鉴定开口项的跟踪验证；
--Implement product , process and fixture inspection，prepare and submit the inspection records. 实施产品、过程及工装的检验，出具并提交相关检验记录；
--Carry out type test, prepare and submit type test report 进行型式试验，出具并提交型式试验报告。
5.7 Factory responsibility生产分厂职责：
-- To submit requirements of IFAI application提交内部首件鉴定申请需求；
-- To prepare fixture, products, components used for IFAI准备内部首件鉴定的工装，产品及部件；
-- To take part in IFAI，carry out corrective actions take corrective actions according to relative open items.参与内部首件鉴定，依据开口项进行整改。
5.8 人力部职责：
-- Ensures workers for special process is be trained and qualified确保所有从事特殊工序的操作人员经过培训，并具有相应资质。
DE: design engineer设计师 FM: factory manager生产主任PE: process engineer工艺工程师PM项目经理QE: quality engineer质量工程师
7. Input of IFAI内部首件鉴定的输入
●Safety ,critical & important product and part list for IFAI用于内部首件鉴定的安全关
键及重要的产品及部件清单
●Drawing and , technical documents图纸及技术文件;
●Process documents工艺文件
●Quality documents质量文件
●Material certification材料证明
●Fixture conformed合格工装
●PPR check list产品工艺审核清单
●Production planning生产计划
●Product or part for IFAI内部首件鉴定的产品或部件
●All inputs of IFAI , according to “IFAI input check list”所有详细输入列表见《IFAI输入
检查清单》。
8. Output of IFAI内部首件鉴定的输出
●IFAI Report and Open item list 内部首件鉴定报告及开口项清单
●IFAI document pack 内部首件鉴定文件包
●Product & Parts approved批准的产品及部件
●CFAI Notice客户首件鉴定通知
●Batch production notice批量生产通知
9. Conditions to keep the process under Control确保过程受控的条件
9.1 Time of IFAI内部首件鉴定的时机
●When first production of new product and new critical & important part defined by
engineer.
新产品及新的关键及重要部件（由设计师定义）首次生产时；
●When customer requires客户要求时；
●When carry out Product Process Review产品工艺审核之后；
● A change in manufacturing processes, location, tooling, or materials with the
potential of affecting form, fit or function, may cause previous FAI invalid.
影响部件外形，安装或功能的设计、生产工艺，地点，工艺或材料发生更改，可能会导致先前的首件鉴定结果失效时；
●When required as part of corrective action for a part with repetitive rejection history.
需要对反复出现的不合格产品进行纠正时；
● A break in production of 6 months or more.停产6个月年或以上的产品、零部件重新
生产时；
9.2 Condition of IFAI内部首件鉴定的条件
9.2.1 Process engineer shall carry out PPR（Product Process Review）before production, ensure IFAI part is produced under regulated process condition；PPR includes：
工艺部工艺师确保在内部首件鉴定之前进行产品工艺审核，确保首件鉴定的产品及部件是在规定的工艺条件下生产的。产品工艺审核包括：
a) The validation of critical fixtures use for IFAI are conformed. Refer to
首件鉴定所需的关键工装均验证合格，参见《工艺装备管理程序》Q-MSP-0017；
b). The verification and validation of special process. Refer to
所有的特殊工艺已进行验证确认，参见《特殊工序管理规定》 Q-GRD-PC-0002；
c). The open items of PPR are corrective. Refer to
产品工艺审核的问题已整改完成，参见《工艺管理手册》Q-GRD-PC-0001
9.2.2 Production director ensures生产主任确保：
--Finish producing first article timely as per production requirements; Ensure internal first article could be inspected in regulated time.
按生产计划要求按时完成首件鉴定产品的生产，保证内部首件鉴定产品和部件在规定的日期和时间可以接受检验。
--Effectual preservation of IFAI product and parts.
内部首件鉴定的产品及部件得到有效的防护。
9.2.3 Involved depts. ensure related IFAI documents complete, and take part in the IFAI according to the requirement of IFAI Application & notice.
相关部门按《内部首件鉴定申请&通知表》的要求，确保内部首件鉴定所需的文件齐全，在规定的时间、地点参加内部首件鉴定。
9.2.4Quality dept. shall implement type test according to design verification and validation requirement. Type test shall be done before IFAI or no late than IFAI .
型式试验由品管部依据设计师的设计验证及确认要求进行，型式试验应在IFAI之前或不晚于IFAI。
9.2.5 Technical center shall issue Batch Production Notice according to FAI results once FAI passed; The notice shall give defined the scope of batch production under batch production limited condition.
首件鉴定通过后，技术中心视首件鉴定情况签发批量生产通知；对于有限定条件的批量生产，通知中应对批量生产的适用范围进行明确说明。
9.2.6 Change cause by FAI shall be conformed with Change Management Procedure. 因首件鉴定产生的变更，执行《变更管理程序》。
10. Process Performance & KPI过程绩效
IFAI process performance is supervised monthly by QE engineer. At the beginning of every month, QE engineer statistic below data and report IFAI performance of last month.
内部首件鉴定过程绩效由质量工程师进行月度监督。每个月初，质量工程师统计如下数
据报告上一个月的内部首件鉴定绩效。
●IFAI completion quantity VS IFAI failure quantity on the 1ST time;
●内部首件鉴定完成数量VS内部首件鉴定第一次失败次数；
●IFAI planning date VS IFAI actual date;
●内部首件鉴定计划日期VS内部首件鉴定实际日期；
●Time that need to close open item VS appointment time
●需要关闭开口项项点的时间VS约定的时间
11. Records control记录控制
注：记录的管理保存执行《记录控制程序》Q-MSP-0003