AS9100搬运储存包装保存和运输程序英文版
AS9100纠正和预防措施程序英文版
1.0PURPOSE1.1.The purpose is to provide a procedure for identifying Nonconformances and potentialNonconformances, investigating the cause, determining and taking actions to eliminatethe cause and follow-up activities to ensure agreed actions were taken and effective.2.0SCOPE2.1This procedure applies to all Nonconformances and potential Nonconformancesidentified within the Quality Management Systems.3.0RESPONSIBILITY3.1The Management Representative, or delegate, is responsible for:∙Assigning CAR numbers∙Assigning responsibility to investigate the cause and recommend action to be taken∙Reviewing cause, recommended action and implementation schedule for adequacy∙Assigning Internal Auditors to verify implementation and effectiveness of CARs∙Forwarding copy of closed CARs to the Observer∙Maintaining CAR database and copies of CARs∙Analyzing appropriate information in order to detect opportunities for preventive action3.2The appropriate personnel are responsible for investigating the cause ofnonconformance/potential nonconformance, recording the results of the investigation,recommending appropriate action, implementing agreed action and applyingsufficient controls to ensure action is effective.3.3The Observer of a nonconformance/potential nonconformance is responsible fororiginating a CAR and forwarding to the Management Representative.3.4The Internal Auditor is responsible for verifying that agreed action has beenimplemented and is effective.4.0GENERAL4.1The Management Representative forwards a CAR to the supplier when it isdetermined that the supplier is responsible for the root cause. If the supplier isinternal, the CAIR process is used.5.0DEFINITIONS5.1Potential Nonconformance: The prediction that conditions exist which may lead to anonconformance unless action is taken.5.2Nonconformance: The nonfulfillment of a requirement. Examples include:5.2.1The absence of a procedure required by the Quality Management System.5.2.2Failure to effectively implement a procedure required by the QualityManagement System.5.2.3 A confirmed customer complaint.5.2.4An out of calibration instrument or measuring device.5.2.5 A rejected product.5.2.6 A quality systems violation.5.3Corrective Action: action taken to eliminate the cause of a detected nonconformanceor other undesirable situation. Corrective actions prevent recurrence.5.4Preventive Action: action taken to eliminate the cause of a potential nonconformanceor other undesirable potential situation. Preventive actions prevent occurrence.5.5Observer: anyone observing a nonconformance/potential nonconformance orreceiving a customer complaint.5.6Immediate Action: corrective or preventive as appropriate to eliminate the cause of anonconformance/potential nonconformance in order to prevent recurrence/occurrence.5.7Root Cause: Underlying reason of why the discrepancy occurred, determined asresults of an investigation of the product, process and/or quality system.5.8Corrective Action Verification: Activity undertaken immediately afterimplementation of root cause correction to verify implementation5.9Follow-Up: Planned activity to determine if implemented root cause corrective actionis effective and being adhered to.5.10CAR – Corrective Action Request generated from any nonconformance.6.0PROCEDURE6.1The Observer of a nonconformance/potential nonconformance originates a QPF1400-1 CAR form by completing the detail section of the CAR. The Observer providessufficient details of the nonconformance/potential nonconformance to permit aneffective investigation of the cause.6.2The Observer forwards the CAR to the Management Representative.6.3The Management Representative reviews the details provided to ensure they aresufficient and request additional details as appropriate.6.4The Management Representative assigns a CAR number and other information suchas reference, procedure number, requirement section number, etc. as appropriate in the database.6.5The Management Representative assigns responsibility for investigating the cause ofthe nonconformance/potential nonconformance and forward a copy of the CAR to that individual.6.6The assigned individual investigates the cause of the nonconformance/potentialnonconformance, record the results of the investigation, recommend appropriateaction to be taken and forward the completed CAR to the Management Representative.6.7The Management Representative reviews the completed CAR to determine if thecause, recommended action and schedule for implementation are appropriate to the effects of the nonconformance encountered. The Management Representative re-issues using QPF 1400-2 for additional effort if the cause, recommended actions or schedule for implementation are considered inadequate.6.8The Management Representative assigns an Internal Auditor to verify that the agreedaction was taken and was effective. The Management Representative closes the CAR if no action is recommended.6.8.1The Internal Auditor closes the CAR if the agreed action is verified asimplemented and effective and forwards the CAR to the ManagementRepresentative.6.8.2The Internal Auditor returns the CAR to the Management Representativeif the agreed action was not implemented or could not be verified aseffective.6.8.2.1The Management Representative reassigns the ineffective CARrequesting additional information.6.9The Management Representative forwards a copy of each closed CAR to the Observerand update the database to reflect the status of CARs.。
AS9100产品和服务要求管理规范
文件制修订记录1.0目的为满足顾客对产品和服务的要求,保持与顾客沟通,充分了解顾客的需求和期望,通过评审确定与产品有关的要求,确保顾客满意。
2.0范围适用于与顾客的沟通及产品和服务要求的确定、合同评审等的控制与管理。
3.0参考文件AS9100D 《质量管理体系—航空、航天和国防组织的要求》《质量手册》《文件控制程序》《记录控制程序》《变更控制程序》4.0定义无。
5.0职责5.1销售市场部本程序的归口管理部门。
负责与顾客的沟通,识别客户要求和期望,对合同条款进行分解,组织评审小组对合同条款进行评审。
负责合同、订单及各类协议的签订。
负责对合同、订单进行归档。
负责售后技术支持及客户满意度调查。
5.2采购部采购部负责所需物资和设备设施的采购,确保生产及产品的及时交付。
负责供应商资质及供货能力的评审。
负责所需物资和设备的成本核算。
负责产品所需物料的交期及生产能力。
5.3研发部负责产品特殊要求设计满足能力的评审。
负责产品技术协议的编制和以及客户技术要求的评审。
负责产品满足客户要求。
负责生产工艺及设备保证能力要求的评估。
5.4适航质量部负责合同和订单中产品和服务质量要求及监视测量能力的评审。
负责合同和订单中涉及到的产品和服务方面质量管理及适航相关要求的识别和管控。
5.5项目管理部负责项目实施并进行全方位监控,跟进合同及订单的执行。
负责技术文件、外来文件、受控文件等归档并传递给各相关执行部门。
5.6生产部负责产品和服务的提供要求及交货期保证能力的评审。
负责产品包装、运输要求的评审,并在招投标阶段制定包装、运输方案。
5.7财务部负责项目或产品的成本核算。
合同结算方式或付款风险的识别与控制。
6.0工作程序6.1 工作要求6.1.1销售市场部就订单或合同内容进行仔细确认,识别相关风险及特殊要求。
6.1.2 针对识别出的风险和特殊要求,及时与客户及公司内部人员进行信息沟通交流,组织履行合同保证能力的评审。
6.1.3签订产品和服务的合同,须明确产品和服务要求及承诺。
搬运贮存包装防护和交付程序(含表格)
搬运、贮存、包装、防护和交付程序(ISO9001/ISO14001-2015/QC080000-2017)1.0目的确保材料/产品在仓储、搬运、生产、交接等过程中质量/HSF得到保证。
2.0适用范围适用于本公司库存物料与成品在搬运、贮存、包装、防护和交付的管理。
3.0职责3.1货仓部负责所有物料的接收、储存、发放、记录和标识,定期对仓库进行盘点和整理确保数据准确。
3.2运输部负责制成品的接收记录、入库保管、安排运送与交付。
3.3生产部负责在制品的运送、防护,制成品包装工序、及安排制成品的入库贮存。
4.0培训无特殊培训需求5.0运作程序5.1物料的搬运5.1.1主料、副料及其他物料的搬运。
5.1.1.1.原纸的搬运,应以夹车为主,搬运时亦必须留意速度,平稳性及不可超载。
夹车的操作员必须由有资格的员工担任,有关操作程序及注意事项参照“叉车操作指引”。
5.1.1.2主料、副料及其它物料在搬运过程中,应根据其特性(如体积、重量、容易损坏程度)选择合适的搬运工具和方法,防止物料损坏。
5.1.1.3.在搬运时,必须保持标识的衔接,清晰及有效,包括产品品名、批号、供方名称及环保标识等信息。
5.1.2在制品及制成品的搬运5.1.2.1.在生产过程中及搬运过程中,必须留意速度、平稳性及不可超载。
防止半成品、产品损坏。
5.1.2.2.所有制成品均以成品标贴及环保标识作为产品的标识,在搬运过程中必须保持标识的衔接、清晰及有效性。
5.1.3搬运工具的维护及保养操作员应注意夹车及搬运工具的检查与保养,并应制定适当的保养指引,具体可参考“设备保养工作指引”。
5.2物料的入库贮存、保管与发放5.2.1主料、副料及其他物料的入库、贮存、保管及发放。
5.2.1.1.所有采购的主料及副料,根据性质不同分别在原材料仓、辅料仓、化学品仓、不合格区等存放并作好标识,便于做到先进先出,存放过程中,尤其要注意HSF与HS材料的隔离与标识,避免交叉污染。
AS9100搬运储存包装保存和运输程序英文版
1.0 PURPOSE1.1The purpose of this procedure is to en sure that product is han died, stored, packaged, preserved anddelivered in manner to preve nt damage, loss, or deteriorati on.2.0 SCOPE2.1This procedure applies to all products, received, stored, packaged, and delivered by the ASC.2.2This procedure applies to customer fur ni shed material.3.0 RESPONSIBILITIES3.1All personnel are responsible for preventing damage, deterioration, and contamination, and for thehouseclea ning of storage areas and en suri ng that products are properly packaged and sealed.3.2Production personnel are responsible for the cleanliness of the work areas and for thepreve ntio n, detect ion and removal of foreig n objects.3.3R&T issues QC Cards that define special handling requirements for sensitive products.3.4R&T maintains the Web label database that includes applicable safety and hazardwarnin gs.3.5Operatio ns Man ager or delegate ide ntifies and docume nts special han dli ngrequireme nts for non-PRC products on the Work Order Rout ing, whe n n ecessary.3.6Corporate Purchas in g/Operati ons are resp on sible for the selecti on and qualificati on ofpackagi ng materials.3.7The Pla nning/lnven tory Con trol/Logistics pers onnel are resp on sible for issu ing material on afirst- in-first-out basis.3.8Quality Control is responsible for initiating requests for shelf life surveillanee testsand assuri ng dispositi ons are completed on expired materials.3.9Shipp in g/Reeei ving departme nt pers onnel are resp on sible for en suri ng that product isprotected after final in speeti on and test ing and, whe n eon traetually required, to protect theproduet un til reeeived by the eustomer.3.10Shipp in g/Reeei ving departme nt pers onnel are resp on sible for pack ing, marking, and shippinghazardous material in accordanee with Customer, Federal or International regulati ons.3.11Shipp in g/Reeei ving is resp on sible for plaei ng produet reeeived into storage accord ing to thein speet ion accepta nee status.4.0 GENERAL4.1Material Safety Data Sheets (MSDS) are accessible to all personnel on site. The MSDS file is mai ntained by5.0 DEFINITIONS5.1None&0 PROCEDURES6.1Ha ndling6.1.1Pers onnel invo Ived in the tran sport in g, load ing and uni oad ing of produet will operatethe follow ing equipme nt in a manner that does not cause damage or deteriorati on to theproduet:Forklifts*Delivery Vehicles*Hand Trucks*Pail Lifter*Drum Lifter*Pallet Jacks*Pallets*Stretch Wrapper*Strapping Equipment6.2.1All products, in cludi ng hazardous product, will be stored un der the proper con diti onsusing equipme nt n ecessary to preserve product in tegrity, appeara nee, and performa neewithout compromis ing the safety of the facility and pers onn el.6.2.2The warehouse personnel will take the necessary precautions to ensure that products arestored in accordance with the QC Card, label ormanu facturers in struct ions, to preve nt damage or deteriorati on.6.2.3Only products, which have passed all recei ving in specti ons and required tests are releasedfrom hold locati on in Mfg-Pro and placed in storage locati ons.6.2.4Where necessary, product requiring special handling considerations is placed in theappropriate storage en vir onment, pending approval.6.2.5Removal of product from storage areas is in accorda nce with the Workorder; Pick Ticket orother authoriz ing docume nts. Ref. QP 900, Process Con trol6.2.6 A periodic survey of the warehouse and storage areas is performed to detect damaged ordeteriorated product.6.2.7The survey results are placed on the QPF1500-1 Storage Inspection Checklist, which is keptby Operati ons.6.2.8Any damaged or deteriorated product observed during normal daily operations is correctedimmediately.6.2.9Noncon forma nces found that cannot be corrected immediately is docume nted on form QPF1500-1Storage In specti on Checklist.6.2.10Material that is non-conforming and is to be scrapped on site or material that is desig natedto be scrapped will be placed in an appropriate locatio n so as to preclude use in production.6.3 Packaging。
AS9100D-2016 内部审核全套资料
2018~2020 年度AS9100内审计划编制:批准:一、目的1、检查公司质量管理体系是否符合ISO9001:2015和AS9100D:2016标准要求;2、检查公司质量管理体系运行是否符合文件要求;3、检查公司质量管理体系的运行效果;4、及时发现管理体系运行中存在的问题,并对发现的问题采取纠正措施,持续改进公司的质量管理体系。
二、审核范围1、公司管理层及公司各部门等场所和人员;2、公司质量管理体系及相关的活动及结果。
三、审核依据1、ISO9001:2015和AS9100D:2016标准;2、公司质量管理体系文件;3、相关法律、法规、标准规范等;4、合同。
四、审核日期:2018年6月21~22日(共2天)五、审核组成员:审核组长:XX(A)审核组员:XX(B)、XX(C)、XX(D)、XX(E)、XX(F)(注:审核员不审核自己所属的部门,如有涉及,请在审核过程中所属部门的内审员自动回避;以上审核员均已获得内审员资格,见《内审员证书清单》)六、审核要求:1、审核员对受审部门进行审核时,要求对所有适用的质量管理体系过程都进行审核,按过程方法要求(该过程的输入、活动要求、考核目标、输出等内容)收集客观证据,寻找管理体系的薄弱环节,并作好完整的审核记录,以便跟踪落实纠正不合格项;2、请各部门安排好内审期间受审核部门陪同人员和审核组员的工作。
七、审核日程安排:拟制/日期:批准/日期:会议/培训记录内 部 质 量 审 核 检 查 表审核时间:2018-6-22 审核员: 被审核部门:销售部 陪审人员:备注:1.第1)部分到第6)部分,由审核员在内审前完成;2.第7)部分到第8)部分,由审核员在审核时填写;MAJ=Major Nonconformity(严重不合格);MIN=Minor Nonconformity(轻微不合格);OB=Observing(观察项) FM1803 A/0内部质量审核检查表审核时间:2018-6-22 审核员:被审核部门:工程部陪审人员:备注:1.第1)部分到第6)部分,由审核员在内审前完成;2.第7)部分到第8)部分,由审核员在审核时填写;MAJ=Major Nonconformity(严重不合格);MIN=Minor Nonconformity(轻微不合格);OB=Observing(观察项) FM1803 A/0内部质量审核检查表审核时间:2018-6-21 审核员:被审核部门:生产部陪审人员:备注:1.第1)部分到第6)部分,由审核员在内审前完成;2.第7)部分到第8)部分,由审核员在审核时填写;MAJ=Major Nonconformity(严重不合格);MIN=Minor Nonconformity(轻微不合格);OB=Observing(观察项) FM1803 A/0内部质量审核检查表审核时间:2018-6-22 审核员:被审核部门:销售部陪审人员:备注:1.第1)部分到第6)部分,由审核员在内审前完成;2.第7)部分到第8)部分,由审核员在审核时填写;MAJ=Major Nonconformity(严重不合格);MIN=Minor Nonconformity(轻微不合格);OB=Observing(观察项) FM1803 A/0内部质量审核检查表审核时间:2018-6-22 审核员:被审核部门:销售部陪审人员:备注:1.第1)部分到第6)部分,由审核员在内审前完成;2.第7)部分到第8)部分,由审核员在审核时填写;MAJ=Major Nonconformity(严重不合格);MIN=Minor Nonconformity(轻微不合格);OB=Observing(观察项) FM1803 A/0内部质量审核检查表审核时间:2018-6-22 审核员:被审核部门:销售部陪审人员:备注:1.第1)部分到第6)部分,由审核员在内审前完成;2.第7)部分到第8)部分,由审核员在审核时填写;MAJ=Major Nonconformity(严重不合格);MIN=Minor Nonconformity(轻微不合格);OB=Observing(观察项) FM1803 A/0内部质量审核检查表审核时间:2018-6-21 审核员:被审核部门:GM/MR 陪审人员:备注:1.第1)部分到第6)部分,由审核员在内审前完成;2.第7)部分到第8)部分,由审核员在审核时填写;MAJ=Major Nonconformity(严重不合格);MIN=Minor Nonconformity(轻微不合格);OB=Observing(观察项) FM1803 A/0内部质量审核检查表审核时间:2018-6-21 审核员:被审核部门:GM/MR 陪审人员:备注:1.第1)部分到第6)部分,由审核员在内审前完成;2.第7)部分到第8)部分,由审核员在审核时填写;MAJ=Major Nonconformity(严重不合格);MIN=Minor Nonconformity(轻微不合格);OB=Observing(观察项) FM1803 A/0内部质量审核检查表审核时间:2018-6-21 审核员:被审核部门:GM/MR 陪审人员:备注:1.第1)部分到第6)部分,由审核员在内审前完成;2.第7)部分到第8)部分,由审核员在审核时填写;MAJ=Major Nonconformity(严重不合格);MIN=Minor Nonconformity(轻微不合格);OB=Observing(观察项) FM1803 A/0 内部质量审核检查表审核时间:2018-6-22 审核员:被审核部门:品质部/生产部陪审人员:备注:1.第1)部分到第6)部分,由审核员在内审前完成;2.第7)部分到第8)部分,由审核员在审核时填写;MAJ=Major Nonconformity(严重不合格);MIN=Minor Nonconformity(轻微不合格);OB=Observing(观察项) FM1803 A/0内部质量审核检查表审核时间:2018-6-22 审核员:被审核部门:体系陪审人员:备注:1.第1)部分到第6)部分,由审核员在内审前完成;2.第7)部分到第8)部分,由审核员在审核时填写;MAJ=Major Nonconformity(严重不合格);MIN=Minor Nonconformity(轻微不合格);OB=Observing(观察项) FM1803 A/0内部质量审核检查表审核时间:2018-6-21 审核员:被审核部门:体系部陪审人员:备注:1.第1)部分到第6)部分,由审核员在内审前完成;2.第7)部分到第8)部分,由审核员在审核时填写;MAJ=Major Nonconformity(严重不合格);MIN=Minor Nonconformity(轻微不合格);OB=Observing(观察项) FM1803 A/0 内部质量审核检查表审核时间:2018-6-21 审核员:被审核部门:人力资源部陪审人员:备注:1.第1)部分到第6)部分,由审核员在内审前完成;2.第7)部分到第8)部分,由审核员在审核时填写;MAJ=Major Nonconformity(严重不合格);MIN=Minor Nonconformity(轻微不合格);OB=Observing(观察项) FM1803 A/0内部质量审核检查表审核时间:2018-6-21 审核员:被审核部门:生产部/IE部陪审人员:备注:1.第1)部分到第6)部分,由审核员在内审前完成;2.第7)部分到第8)部分,由审核员在审核时填写;MAJ=Major Nonconformity(严重不合格);MIN=Minor Nonconformity(轻微不合格);OB=Observing(观察项) FM1803 A/0内部质量审核检查表审核时间:2018-6-21 审核员:被审核部门:物控部陪审人员:备注:1.第1)部分到第6)部分,由审核员在内审前完成;2.第7)部分到第8)部分,由审核员在审核时填写;MAJ=Major Nonconformity(严重不合格);MIN=Minor Nonconformity(轻微不合格);OB=Observing(观察项) FM1803 A/0内部质量审核检查表审核时间:2018-6-22 审核员:被审核部门:品质部陪审人员:备注:1.第1)部分到第6)部分,由审核员在内审前完成;2.第7)部分到第8)部分,由审核员在审核时填写;MAJ=Major Nonconformity(严重不合格);MIN=Minor Nonconformity(轻微不合格);OB=Observing(观察项) FM1803 A/0内部质量审核检查表审核时间:2018-6-21 审核员:被审核部门:生产部/仓库陪同人员:备注:1.第1)部分到第6)部分,由审核员在内审前完成;2.第7)部分到第8)部分,由审核员在审核时填写;MAJ=Major Nonconformity(严重不合格);MIN=Minor Nonconformity(轻微不合格);OB=Observing(观察项) FM1803 A/0内部质量审核检查表审核时间:2018-6-22 审核员:被审核部门:品质部陪审人员:备注:1.第1)部分到第6)部分,由审核员在内审前完成;2.第7)部分到第8)部分,由审核员在审核时填写;MAJ=Major Nonconformity(严重不合格);MIN=Minor Nonconformity(轻微不合格);OB=Observing(观察项)内部质量审核检查表审核时间:2018-6-22 审核员:被审核部门:品质部陪审人员:备注:1.第1)部分到第6)部分,由审核员在内审前完成;2.第7)部分到第8)部分,由审核员在审核时填写;MAJ=Major Nonconformity(严重不合格);MIN=Minor Nonconformity(轻微不合格);OB=Observing(观察项)。
AS9100D产品防护管理规定
产品防护管理规定文件编号:文件版本:编制:审核:批准:修订页目录1.目的 (4)2.范围 (4)3.参考文件 (4)4.定义 (4)5.职责 (4)5.1. 适航质量部 (4)5.2. 生产部 (4)5.3. 采购部 (4)6.工作程序 (4)6.1. 包装及标识要求 (4)6.2. 搬运 (5)6.3. 保护 (5)7.附录 (6)附录《产品防护措施情况记录》 (6)1. 目的在产品生产过程中直至交付到预定地点期间对产品及物料提供有效的防护措施(包括标识,搬运,包装,贮存,保护等),以防止在交付至顾客前破坏或降低产品特性。
2. 范围适用于公司及工程服务过程中在施工现场的原材料,半成品,成品的搬运,包装及贮存防护等方面的控制。
3. 参考文件AP-21-04 《生产批准和监督程序》CA-QP-05 《文件控制程序》CA-QP-06 《记录控制程序》CA-WI-QA-004 《产品标识和可追溯性管理规定》CA-WI-QA-009 《产品安全管理规定》CA-WI-PD-001 《仓储管理规定》CA-WI-QA-003 《成品检验管理规定》4. 定义产品:本文所指产品是生产和服务过程中需要向客户提供的产品及其组成部分,包括采购产品、中间产品和成品。
5. 职责5.1. 适航质量部负责对包装箱内物资的检查,以确保包装箱内物资符合“装箱清单”的要求。
5.2. 生产部5.2.1. 生产部工艺负责产品包装物的设计以及包装运输标识的确定,包装物可靠性的评估,产品防护方案的制定。
5.2.2. 生产部生产人员负责生产过程中的产品防护。
5.3. 采购部采购部仓库管理人员负责公司内存储期间及产品发货运输期间的产品防护。
6. 工作程序6.1. 包装及标识要求6.1.1. 工艺人员负责选用或制定相应产品规格最适合的包装材料、包装尺寸、包装方法,以满足包装要求以及顾客特殊包装要求,在包装箱上加相应包装标识、防护标识及运输标识,编制包装的作业指导书。
AS9100D仓储管理程序(范本)
仓储管理程序文件编号:文件版本:编制:审核:批准:修订页目录1. 目的 (4)2. 范围 (4)3. 参考文件 (4)4. 定义 (4)5. 职责 (5)5.1. 采购部 (5)5.2. 适航质量部 (6)5.3. 生产部 (6)5.4. 财务部 (6)5.5. 研发部 (7)5.6. 项目管理部 (7)6. 工作程序 (7)7. 附录 (12)附录1原材料送检入库单 (14)附录2退货单 (15)附录3仓库发料单 (16)附录4非生产订单领料单 (17)附录5生产送检入库单 (18)附录6成品领料单 (19)附录7退库单 (20)附录8盘点清册 (21)附录9报废申请表 (22)1. 目的1.1为明确规范外购材料的接收、送检、入库及退货的操作流程和准则;1.2 为明确规范产成品良品的入库、出库的操作流程和准则;1.3 为明确规范不良品处理的操作流程和准则;1.4 为明确规范库存物料的管理、仓库环境管理准则;1.5 为明确规范库存物料的盘点操作流程和准则。
2. 范围本规定适用于公司原材料和产成品的入库、出库和仓贮管理。
3. 参考文件AS9100D 《质量管理体系—航空、航天和国防组织的要求》AP-21--04 《生产批准和监督程序》CA-QP-05 《文件控制程序》CA-QP-06 《记录控制程序》CA-WI-MD-006 《湿敏元件及PCB管控作业规范》CA-WI-MD-013 《ESD防护及检测作业规范》CA-WI-MD-011 《包装管理规定》CA-WI-MD-016 《标签管理规定》4. 定义静电敏感元器件(SSD):在生产中,人们常把对静电反应敏感的电子器件称为静电敏感器件(static,sensitive device简称SSD),SSD的分级方法有多种,国家军用标准电子产品防静电放电控制大纲的分级方法:静电敏感度介于0~1990v的元器件为1级;介于2000~3999v 的元器件为2级;介于4000~15999v的为3级;静电敏感度为16000v或16000v以上的元器件、组件和设备被认为是非静电敏感产品。
APS-ST-2001B搬运、贮存、包装、防护和交付程序
搬运、贮存、包装、防护和交付程序1、目的:通过对公司所有物料、单品、成品的搬运、贮存、包装、防护和交付的控制,确保其在搬运、贮存、包装、防护和交付过程中符合规定的管理要求。
2、范围:适用于公司所有物料、单品、成品的搬运、贮存、包装、防护和交付的管理。
3. 相关文件:3.1 《记录控制程序》APS-DC-20023.2 《采购控制程序》APS-BS-20023.3 《外协加工管理办法》APS-BS-30013.4 《不合格品控制程序》APS-QA-20013.5 《产品标识和可追溯性程序》APS-QA-20033.6 《来料检验和试验控制程序》APS-QA-20043.7 《出荷检验和试验程序》APS-QA-20053.8 《文件和资料控制程序》APS-DC-20013.9 《产品搬运作业规范》APS-ST-30014. 主要职责与权限4.1 物流部门物料库负责物料投产前的搬运、贮存、防护和交付。
4.2 制造部负责生产过程中的物料、单品、成品的搬运、贮存、包装和防护。
4.3 成品库负责成品入库后的搬运`贮存、防护和交付。
4.4 物流部门仓库负责督查送货司机确保货物交付到客户的过程中的质量控制。
5.程序内容搬运5.1.1物流部门制定《产品搬运作业规范》,各部门搬运作业人员在搬运物料、单品、成品时应严格按照规范的要求进行搬运作业。
5.1.2 物料、单品、成品在装车、卸车、入库、出库、部门间转移以及部门内部转移时,应装叉板采用叉车搬运或采用拖板车、推车搬运,只有当数量少而重量轻、或部门内部转移距离较短的物品时,允许采用人力搬运,但必须轻拿轻放。
5.1.3 产品搬运过程中应注意运行速度,严格遵守重物置于叉板底部,重心置中,并注意各层面之间的防护,货物应整齐地堆放于叉板上,对立放在叉板不稳或极易倾斜的货物,要采取一定的防护措施加固,严禁超高、超快、超重等来搬运货物,不可急刹车,避免产品倾倒、跌落、碰撞,造成货物品质出现异常。
AS9100B-中英文对照
1. Quality management systems – Requirements1 Scope1.1 GeneralThis standard includes ISO 9001:2000 quality management system requirements and specifies additional requirements for a quality management system for the aerospace industry. The additional aerospace requirements are shown in bold, italic text.It is emphasized that the quality management system requirements specified in this standard are complementary (not alternative) to contractual and applicable law and regulatory requirements.This International Standard specifies requirements for a quality management system where an organizationa) needs to demonstrate its ability to consistently provideproduct that meets customer and applicable regulatory requirements, andb) aims to enhance customer satisfaction through theeffective application of the system, including processes for continual improvement of the system and the assurance of conformity to customer and applicable regulatory requirements.NOTE In this International Standard, the term“product”applies to the product intended for, or required by, acustomer.1.2 ApplicationAll requirements of this International Standard are generic and are intended to be applicable to all organizations, regardlessof type, size and product provided.Were any requirement(s) of this international Standard cannot be applied due to the nature of an organization and its product, this can be considered for exclusion.Where exclusions are made, claims of conformity to this International Standard are not acceptable unless these exclusions are limited to requirements within clause 7, and such exclusions do not affect the organization’s ability, or responsibility, to provide product that meets customer and applicable regulatory requirements.2 Normative referenceThe following normative document contains provisions which, 质量管理体系-要求1范围1.1通则本标准包括I S O9001:2000质量管理体系要求并规定了航空航天工业质量管理体系的附加要求。
AS9100一整套程序文件英文版(航空航天质量体系)
AS9100一整套程序文件英文版(航空航天质量体系)1.0P U R P O S E1.1T o e n s u r e t h a t p r o d u c t t h a t d o e s n o t c o n f o r m t o s p e c i f i e d r e q u i r e m e n t si s p r e v e n t e d f r o m u n i n t e n d e d u s e o r d e l i v e r y.2.0S C O P Ea)2.1T h i s p r o c e d u r e a p p l i e s t o p r o d u c t s t h a t d o n o t c o n f o r m t os p e c i f i c a t i o n s,o r o t h e r c r i t i c a l r e q u i r e m e n t s.T h i s i n c l u d e p r o d u c t sr e t u r n e d f r o m t h e c u s t o m e r a n d c o n f i r m e d b y t h e A p p l i c a t i o nS u p p o r t C e n t e r(A S C)t o b e n o n c o n f o r m i n g.3.0D E F I N I T I O N S3.1I n c o m i n g P r o d u c t–P r o d u c t r e c e i v e d f r o m P R C-D e S o t om a n u f a c t u r i n g s i t e s,f r o m o t h e r d i v i s i o n s o f P R C-D e S o t o(e.g.,o t h e rA S C’s),o r f r o m s u p p l i e r s.I n c o m i n g p r o d u c t i n c l u d e s b u l k m a t e r i a l sa n d r a w m a t e r i a l s t h a t w i l lb e d i r ec t l y i n c o r p o r a t ed i n t o t hef i n a lp r o d u c t a n d f i n i s h e d g o o d s.3.2P R C M a n u f a c t u r i n g S i t e–A P R C m a n u f a c t u r e r o f b u l k r a w m a t e r i a l(e.g.,M o j a v e,G l e n d a l e,S h i l d o n).3.3T r a c e a b i l i t y–T h e a b i l i t y t o t r a c e t h e h i s t o r y,a p p l i c a t i o n,o r l o c a t i o no f a n i t e m o r a c t i v i t y,o r s i m i l a r i t e m s o r a c t i v i t i e s,b y m e a n s o fr e c o r d e d i d e n t i f i c a t i o n.3.4C A I R-C o r r e c t i n g A d j u s t m e n t I n c i d e n t R e p o r t i n g.T h e C o r r e c t i n gA d j u s t m e n t/I n c i d e n t R e p o r t i n g S y s t e m(C A I R)i s i n t e n d e d t of a c i l i t a t e i n t e r n a l/e x t e r n a l c u s t o m e r f e e d b a c k.I t i s t o b e u s e d a s at o o l t o r e p o r t c u s t o m e r c o m p l a i n t s a n d o r n o n c o n f o r m i t i e s.3.5R&T–R e s e a r c h a n d T e c h n o l o g y,B u r b a n k,C a l i f o r n i a.3.6M a t e r i a l R e v i e w T e a m(M a n u f a c t u r i n g)-r e p r e s e n t a t i v e s f r o m Q u a l i t yC o n t r o l,E n g i n e e r i n g,R&T a n d/o r P R C M a n u f a c t u r i n g S i t e a n d a n yo t h e r d e p a r t m e n t a s d e e m e d n e c e s s a r y.3.7M a t e r i a l R e v i e w T e a m(A S C)-r e p r e s e n t a t i v e s f r o m Q u a l i t y C o n t r o la n d O p e r a t i o n s a n d a n y o t h e r d e p a r t m e n t a s d e e m e d n e c e s s a r y.3.8R e p e t i t i v e–E v e t n o c c u r r i n g m o r e t h a n3t i m e s w i t h i n a6m o n t hp e r i o d(s o m e d i s c r e t i o n m a y b e a p p l i e d h e r e,b a s e d o n t h e o v e r a l lf r e q u e n c y o f t h e n o n c o n f o r m i ng o o p e r a t i o n)3.9S e v e r e–I n v i o l a t i o n o f c o m p a n y p o l i c y o r p r o c e d u r e r e s u l t i n g i ns i g n i f i c a n t e f f e c t o n p e r f o r m a n c e,i m p a c t o n p r o d u c t i o n c o s t s,o r c a u s ec u s t o m e rd i s s a t i s f a c t i o n.3.10M i n o r A d j u s t m e n t–A S C r e w o r k,w h i c h i s l i m t i e d t o l a b e l i n gc o r r e c t i o n s a nd p a c k a g i n g a l te r a t i o n s.4.0R E S P O N S I B I L I T I E S4.1A l l e m p l o y e e s a r e r e s p o n s i b l e f o r t h e i d e n t i f i c a t i o n a n d s e g r e g a t i o n o fn o n c o n f o r m i n g p r o d u c t a n d f o r r e p o r t i n g n o n c o n f o r m a n c e s,i n c l u d i n gn o n c o n f o r m i n g p r o c e s s e s,t o Q u a l i t y C o n t r o l.4.2Q u a l i t y C o n t r o l p r o c e s s e s n o n c o n f o r m a n c e s a n d d i s p o s i t i o n sn o n c o n f o r m i n g p r o d u c t a t P r e l i m i n a r y R e v i e w,i f a p p r o p r i a t e.4.3T h e M a t e r i a l R e v i e w T e a m(M R T)a t A S C A t l a n t a d i s p o s i t i o n sn o n c o n f o r m i n g p r o d u c t s t h a t a r e e x p i r e d,d a m a g e d d u r i n g t r a n s i t,g e n e r a t e d d u r i n g p a k c k a g i n g.A n y o t h e r d i s p o s i t i o n i s d o n e b y M R T a tm a n u f a c t u r i n g.4.4T h e M a t e r i a l R e v i e w T e a m(M R T)a t P R C M a n u f a c t u r i n g S i t e a n dE n g i n e e r i n g a n d/o r R&T d i s p o s i t i o n s n o n c o n f o r m i n g p r o d u c t n o ta l r e a d y d i s p o s i t i o n e d a t P r e l i m i n a r y R e v i e w.4.5O p e r a t i o n s M a n a g e r o r d e l g a t e i s r e s p o n s i b l e f o r e n s u r i n g t h e M R T(A S C)d i s p o s i t i o n,r e l a t e d t o o p e r a t i o n s i s i m p l e m e n t e d.4.6C u s t o m e r S e r v i c e M a n a g e r o r d e l e g a t e i s r e s p o n s i b l e f o r o b t a i n i n g aw a i v e r f r o m t h e c u s t o m e r t o r e l e a s e a p r o d u c t t h a t d o e s n o t m e e t t h ec u s t o m e r s p e c i f i c a t i o n,w h e n r e q u i r e d,a nd t o n o t i f y c u s t o me r s if an o n c o n f o r m i n g m a t e r i a l h a s b e e n d e l i v e r e d.4.7A S C B u s i n e s s M a n a g e r i s r e s p o n s i b l e f o r a l l f i n a n c i a l b u s i n e s sd e c i s i o n s.5.0G E N E R A L5.1Q u a l i t y C o n t r o l a n a l y z e s t h e n o n c o n f o r m a n c e s f o r r e p e t i t i v e t r e n d s,a n d e f f e c t i v e n e s s o f c o r r e c t i v e a c t i o n s.5.2I n v e s t i g a t i o n s o f n o n c o n f o r m a n c e s t a k e s i n t o a c c o u n t t h e p r o c e s s t h a tp r o d u c e d t h e p r o d u c t.5.3W h e r e r e q u i r e d b y c o n t r a c t,t h e u s e o f p r o d u c t w h i c h d o e s n o t c o n f o r mt o s p e c i f i e d r e q u i r e m e n t s h a l l b e r e p o r t e d t o t h e c u s t o m e r o r t h ec u s t o m e r s r e p r e s e n t a t i v e f o r c o n c e s s i o n.5.4Q u a l i t y C o n t r o l m a i n t a i n s r e c o r d s o f c o n c e s s i o n s w h i c h s h a l l c l e a r l yn o t e t h e d e s c r i p t i o n o f t h e n o n c o n f o r m i t y t h a t h a s b e e n a c c e p t e d a n dt h e a c t u a l c o n d i t i o n o f t h e p r o d u c t.5.5R e p e t i t i v e,s e v e r e o r p o t e n t i a l l y s e v e r e n o n c o n f o r m a n c e s w i l l r e s u l t i nt h e i s s u a n c e o f a C A I R.6.0P R O C E D U R E6.1T h e r e a r e t h r e e s o u r c e s o f n o n c o n f o r m i n g p r o d u c t:1)I n c o m i n g p r o d u c t r e j e c t e d a t r e c e i p t.a)P r o d u c t f r o m s u p p l i e r s t h a t f a i l s t o m e e t P.O.o rs p e c i f i c a t i o n r e q u i r e m e n t s.b)C u s t o m e r-f u r n i s h e d p r o d u c t t h a t i s r e j e c t e d a tr e c e i p t.2)I n t e r n a l r e j e c t i o n s.a)P r o d u c t t h a t f a i l s r e q u i r e d t e s t s o r i n s p e c t i o n s o rt h a t w a s i m p r o p e r l y t e s t e d o r i n s p e c t e d.b)P r o d u c t t h a t l a c k s t r a c e a b i l i t y t o r a w m a t e r i a l so r p r o c e s s i n g c o n d i t i o n s.c)P r o d u c t w i t h i n c o r r e c t o r m i s s i n gl a b e l/i d e n t i f i c a t i o n.d)P r o d u c t t h a t e x c e e d s i t s s h e l f l i f e.e)P r o d u c t n o t m e e t i n g t h e r e q u i r e m e n t s o f aP r o c e s s C o n t r o l D o c u m e n t(P C D)3)P r o d u c t r e t u r n e d f r o m c u s t o m e r s.6.2Documented nonconformances are assigned a sequential number andrecorded in the CAIR System. The CAIR assigned shall clearly definethe nonconforming characteristic, the requirement and/or idealcondition, the disposition, and corrective action, when applicable.6.3The CAIR is distributed to the department and/ or flowdown to thesupplier responsible for investigating the root cause and determiningcorrective action.6.4Indentification/Segregation of Nonconforming product shall beidentified per WI 1300-1, and where practical, the product shall bephysically segregated from conforming product.6.5Disposition of noncomforming products are as follow6.6The data and inventory status of the material shall be reviewed byQuality Control. If the reported nonconformance affects the approvalstatus of existing inventory and a final disposition cannot be madeimmediately, an interim status of “HOLD” is made.6.6.1In the event that non-conforming product has been delivered,the customer, subcontractor, internal organization, distributor,or regulatory agency, as applicable, shall be notified within 48hours in writing. Notification shall clearly define thenon-conforming characteristic, the item and/or customers partnumber, quantity and date(s) delivered, and if determined, arequest for return.6.6.2Repetitive, severe or potentially severe nonconformances willresult in the issuance of a Corrective Action Request, per QP1400, being issued to the responsible party. (How we want todo it)6.7Q u a l i t y C o n t r o l m a i n t a i n s r e c o r d s o f a l l n o n c o n f o r m i n g m a t e r i a l sd i s p o s i t i o n s,i n c l u d i n g c a u s e/c o r re c t i v e a c t i o n.6.8P r e l i m i n a r y R e v i e w d i s p o s i t i o n s m a y b e m a d e b y t h e Q u a l i t y M a n a g e ro r d e l e g a t e,t o i n i t i a l l y d e t e r m i n e t h e n a t u r e o f t h e d e f e c t a n d t h er e s p o n s i b i l i t y f o r t h e d i s c r e p a n t m a t e r i a l.T h e a c t i o n s t a k e n d u r i n gP r e l i m i n a r y R e v i e w d o n o t r e q u i r e M R T a p p r o v a l.6.9N o n c o n f o r m i n g m a t e r i a l s t h a t a r e n o t d i s p o s i t i o n e d a t P r e l i m i n a r y R e v i e w a r ed i s p o s i t i o ne d b y M R T a t m a n uf a c t u r i n g6.9.1T h e d i s p o s i t i o n a u t h o r i t y a t P r e l i m i n a r y R e v i e w i s l i m i t e da)R e j e c t e d/S c r a p p e d–P r o d u c t t h a t d o e s n o t c o n f o r m t os p e c i f i e d r e q u i r e m e n t s.P r o d u c t d e s i g n a t e d a s s c r a p s h a l l b ec o n s p i c u o u s l y a nd pe r m a n e n t l y m a r k e d,o r p o s i t i v e l yc o n t r o l l ed u n t i l re n d e r e d p h y s i c a l l y u n u s a b l e.6.10M R T p e r s o n n e l a r e q u a l i f i e d a c c o r d i n g t o Q P1800T r a i n i n g p r o c e s su s i n g Q P F1300-4M R T C o m p e n t e n c y R e q u i r m e n t s7.0A s o c i a t e d M a t e r i a l s7.1W I1300-1R e d T a p i n g a n d T a g g i n g7.2Q P F1300-4M R T C o m p e n t e c y R e q u i r m e n t s7.3C A I R-C o r r e c t i n g A d j u s t m e n t I n c i d e n t R e p o r t i n g7.4Q P1600C o n t r o l o f Q u a l i t y r e c o r d sAS9100内部审核程序英文版1.PURPOSE1.1The purpose is to provide a procedure for conducting audits todetermine whether the quality management system:1.1.1 Conforms to the requirements of AS9100 and to quality managementsystem requirements established by PRC-DeSoto International.1.1.2 Is effectively implemented and maintained.1.1.3 Meet Contract and Regulatory Requirements.2.SCOPE2.1 This procedure applies to the ASC Quality Management System.Flow-down shall be areas described in the quality procedures, policies,and work instructions affecting the quality of work are audited,including delegated quality activities.3.RESPONSIBILITY3.1 The Management Representative – Ensures that internal audits areperformed according to established process. Ensures that auditors aretrained or plans for audit.3.2 Trained internal quality auditors (Audit Team) are responsible forconducting all internal audits.3.3The Management Representative ensures that internal auditors aretrained, prepares and keeps records of this training, prepares an auditschedule, completes the Summary of Findings and tracks and verifiesthe timely closure of corrective actions to Nonconformances andmaintains records.4.GENERAL4.1 The Audits are performed by trained internal auditors independent ofthe functions audited.5.DEFINITIONS5.1Audit - systematic, independent and documented process for obtainingobjective evidence and evaluating it to determine the extent to whichaudit criteria are fulfilled.5.2Audit criteria - set of policies, procedures or requirements used as areference.5.3 Auditor – Person with the competence to conduct an audit.5.4 Audit finding – Results of the evaluation of the collected auditevidence against the audit criteria.5.5Objective Evidence – Data that supports the existence of verification ofsomething.5.6Nonconformity – Non-fulfillment of a requirement.6.PROCEDURE6.1The Management Representative plans and implements an auditschedule ensuring that:•Quality management system requirements are audited•The frequency of audit is based on the status and importance of the process(s) and activity audited as well as previous audit results.The settime to complete audits is within the month assigned.6.2The Management Representative determines the audit scope, auditcriteria and assign an auditor(s) for completion of each audit. The selection ofauditors for each assignment ensures objectivity and impartiality of the auditprocess and those auditors do not audit their own work.6.3Management Representative notifies the department manager of theaudit by forwarding a copy of the schedule when developed and revised.6.4The internal auditor contacts the appropriate departments to schedule apre-audit meeting where specific audit dates/times based on department andauditor schedules are discussed. Internal auditors perform the audit.6.5Auditors performs audits in a structured manner to accomplish thescope of the audit assignment:•Review assignment to determine audit scope, audit criteria.•Schedule the audit with the audited.•Review audit criteria, such as policies, procedures, contracts, requirements of AS9100 and prepare a QPF1700-1 Audit Checklist as appropriate toaccomplish audit scope.•Hold an opening meeting with audited to explain purpose and scope of the audit.•Execute the audit by obtaining sufficient information or objective evidence to permit conclusions to be drawn regarding theconformance/nonconformance and effectiveness of the area being audit.•Collective information and objective evidence through interviews, examination of documents and records, observation of activities andconditions in the areas being audited.•Record observations for review to determine whether Nonconformances or potential Nonconformances exist.•Review observations, taking into account their significance and drawing conclusions about conformance/nonconformance and effectiveness of thearea at meeting requirements and achieving quality objectives.•Prepare nonconformance reports according to the Corrective andPreventive Action procedure taking care to include sufficient details andobjective evidence.•Hold a closing meeting with the audited to review and clarify the results and conclusions of the audit.•Prepare an audit report that summarizes the audit conclusions and forwards to the Management Representative.•Management Representative reviews the audit report and any recorded Nonconforming reports; obtains clarification from the auditor(s) asappropriate.6.6 A copy of the Internal Quality Audit Nonconformance Report is sent to theaudited, (department manager). The audited investigatesfindings/observations. Managers review audit findings. The audited completes corrective action responses and send to the Management Representative forreview and approval within stated due date defined in the NCR form.Management Representative input/close audit in the Nonconforming Database.6.7The Management Representative assigns follow-up/verification of correctiveaction based on the estimated completion date determined by the Manager.6.8Internal Quality Audit Nonconformance Reports are reviewed using theSummary of Findings at the Management Review Meetings. TheManagement Representative completes the Summary of Findings and tracksand verifies the timely closure of corrective actions to Nonconformances.6.9Management at the Quality Management Meetings determines theeffectiveness of implemented corrective actions and determines the need foradditional corrective actions or re-audits when necessary. If it is determined by Management that a corrective action is ineffective, the appropriateDepartment Managers are notified and are responsible for development of arevised plan for corrective action including completion dates. A new NCR is written, and this revised plan is also tracked through Management Reviews.Completion and verification of any issues are indicated on the AuditNonconformance Report.6.10Records of internal audits are kept for 7 years under the control of the QualityControl Department.7.REFERENCE DOCUMENTS7.1 QP 1600 – Control of Records7.2 QPF1700-1 Audit Checklist formAS9100纠正和预防措施程序英文版1.0PURPOSE1.1.The purpose is to provide a procedure for identifying Nonconformances andpotential Nonconformances, investigating the cause, determining and takingactions to eliminate the cause and follow-up activities to ensure agreedactions were taken and effective.2.0SCOPE2.1This procedure applies to all Nonconformances and potentialNonconformances identified within the Quality Management Systems.3.0RESPONSIBILITY3.1The Management Representative, or delegate, is responsible for:•Assigning CAR numbers•Assigning responsibility to investigate the cause and recommend action to be taken•Reviewing cause, recommended action and implementation schedule for adequacy•Assigning Internal Auditors to verify implementation and effectiveness of CARs•Forwarding copy of closed CARs to the Observer•Maintaining CAR database and copies of CARs•Analyzing appropriate information in order to detect opportunities for preventive action3.2The appropriate personnel are responsible for investigating the cause ofnonconformance/potential nonconformance, recording the results of theinvestigation, recommending appropriate action, implementing agreedaction and applying sufficient controls to ensure action is effective.3.3The Observer of a nonconformance/potential nonconformance isresponsible for originating a CAR and forwarding to the ManagementRepresentative.3.4The Internal Auditor is responsible for verifying that agreed action hasbeen implemented and is effective.4.0GENERAL4.1The Management Representative forwards a CAR to the supplier when itis determined that the supplier is responsible for the root cause. If thesupplier is internal, the CAIR process is used.5.0DEFINITIONS5.1Potential Nonconformance: The prediction that conditions exist which maylead to a nonconformance unless action is taken.5.2Nonconformance: The nonfulfillment of a requirement. Examples include:5.2.1The absence of a procedure required by the QualityManagement System.5.2.2Failure to effectively implement a procedure required by theQuality Management System.5.2.3 A confirmed customer complaint.5.2.4An out of calibration instrument or measuring device.5.2.5 A rejected product.5.2.6 A quality systems violation.5.3Corrective Action: action taken to eliminate the cause of a detectednonconformance or other undesirable situation. Corrective actions preventrecurrence.5.4Preventive Action: action taken to eliminate the cause of a potentialnonconformance or other undesirable potential situation. Preventiveactions prevent occurrence.5.5Observer: anyone observing a nonconformance/potential nonconformanceor receiving a customer complaint.5.6Immediate Action: corrective or preventive as appropriate to eliminate thecause of a nonconformance/potential nonconformance in order to preventrecurrence/occurrence.5.7Root Cause: Underlying reason of why the discrepancy occurred,determined as results of an investigation of the product, process and/orquality system.5.8Corrective Action Verification: Activity undertaken immediately afterimplementation of root cause correction to verify implementation5.9Follow-Up: Planned activity to determine if implemented root causecorrective action is effective and being adhered to.5.10CAR – Corrective Action Request generated from anynonconformance.6.0PROCEDURE6.1The Observer of a nonconformance/potential nonconformance originates aQPF1400-1 CAR form by completing the detail section of the CAR. TheObserver provides sufficient details of the nonconformance/potentialnonconformance to permit an effective investigation of the cause.6.2The Observer forwards the CAR to the Management Representative.6.3The Management Representative reviews the details provided to ensurethey are sufficient and request additional details as appropriate.6.4The Management Representative assigns a CAR number and otherinformation such as reference, procedure number, requirement sectionnumber, etc. as appropriate in the database.6.5The Management Representative assigns responsibility for investigatingthe cause of the nonconformance/potential nonconformance and forward a copy of the CAR to that individual.6.6The assigned individual investigates the cause of thenonconformance/potential nonconformance, record the results of theinvestigation, recommend appropriate action to be taken and forward the completed CAR to the Management Representative.6.7The Management Representative reviews the completed CAR to determineif the cause, recommended action and schedule for implementation areappropriate to the effects of the nonconformance encountered. TheManagement Representative re-issues using QPF 1400-2 for additional effort if the cause, recommended actions or schedule for implementation are considered inadequate.6.8The Management Representative assigns an Internal Auditor to verify thatthe agreed action was taken and was effective. The ManagementRepresentative closes the CAR if no action is recommended.6.8.1The Internal Auditor closes the CAR if the agreed action isverified as implemented and effective and forwards the CAR tothe Management Representative.6.8.2The Internal Auditor returns the CAR to the ManagementRepresentative if the agreed action was not implemented orcould not be verified as effective.6.8.2.1The Management Representative reassigns theineffective CAR requesting additional information.6.9The Management Representative forwards a copy of each closed CAR tothe Observer and update the database to reflect the status of CARs.6.10The Management Representative periodically reviews the status ofCARs in order to ensure the corrective/preventive action process is timelyand effective. The Management Representative initiates specific andappropriate action(s) to address an untimely or ineffectivecorrective/preventive action process. Actions may include, but are notlimited to:6.10.1Reporting CAR status to management responsible for the areawith request for action6.10.2Reassigning CAR to a higher management level within theorganization6.10.3Reassigning CAR to another individual6.10.4Providing assistance to resolve CAR6.10.5Providing training or other actions to improve effectiveness6.11Preventive Action6.11.1The Management Representative periodically reviewsappropriate sources of information such as complaint reports,audit results, nonconforming product, etc. in order to identifyopportunities for preventive action. The ManagementRepresentative originates a CAR for any identifiedopportunities for preventive action.6.11.2The Management Review activity potentially identifiesopportunities for preventive action as well. Refer to QP101Management Review procedure for additional details.6.11.3Internal auditors evaluate collected audit evidence in order todetermine existence of a potential nonconformance accordingto QP1700 Internal Audit procedure.7.0REFERENCE DOCUMENTS7.1QPF1400-1 CAR Form7.2QPF1400-2 Insufficient Root Cause/CAR form7.3QP 101 – Management Review7.4Ongoing CAR status database7.5CAIR databaseAS9100记录控制程序英文版1.PURPOSE1.1The purpose is to provide a procedure for the identification, storage, protection,retrieval, retention, maintenance and disposition of records.2.SCOPE2.1This procedure applies to records resulting from quality systems activities.3.RESPONSIBILITY3.1Authors/Owners – are responsible for determining the identification, storage,protection, retrieval, retention, maintenance and disposition of records.3.2Refer to the Records Table for additional details on responsibilities.4.GENERAL4.1Quality records are suitable in format, accuracy, completeness, and detail topermit analysis. Where variable data is required, the actual numerical resultsobtained are indicated. Where defective or nonconforming articles areinvolved, the records include the results of analysis and corrective actiontaken.4.2Quality records are legible, identifiable, indexed, and stored in a way that theyare readily retrievable.4.3Electronic records are password protected and are periodically backed up toprevent loss.4.4Quality records that contain confidential information are handled, distributed,and retained in a secure manner that does not violate their confidential nature.4.5A lost record may be replaced when other records are available to substantiatethe acceptance of previous operations; otherwise, tests/inspections areperformed to re-establish the lost record.4.6Where agreed contractually, quality records are available for review andevaluation by representatives of the customer, government, or regulatoryauthorities.5.DEFINITIONS5.1Identification – what records are required for the quality system todemonstrate conformity to requirements and the effective operation of thequality system.5.2 Storage/Protection – where the records are stored and how they are stored toprotect against loss, damage or deterioration.5.2Maintenance – who is responsible for maintaining the records?5.4Disposition – how are records disposed of.5.5Retention time – the minimum amount of time a record is kept.5.6Retrieval - who is authorized to retrieve records?5.7Author/Owner – process owner or individual assigned responsibility fordocumenting a process within the quality system.5.8Retrievable – Records that are kept on site are retrievable within 24 hrs. Whilerecords that are stored off site are retrievable within 72 hrs.6.PROCEDURE6.1The Author/Owner of a process, procedure, work instruction, etc. shall identifyquality related records associated with the process, including any records thatare created by or retained by suppliers, and define the controls for retentiontime, storage/protection, maintenance, retrieval and disposition of thoserecords.6.2When an error is discovered in a record, the error is lined out, not obliterated(i.e. white out), and the correction is entered and validated by the signature,initials, or stamp of the correcting party and the date.6.3Quality records are retained for a minimum of seven (7) years after completionof the contract except where specific customers, government agencies, orregulatory authorities require longer quality record retention times.6.4See attached records table for complete definition of Control of Records6.5Individuals with responsibility for collecting/maintaining records shall ensurethat:•All records are legible and traceable to the product concerned where appropriate.•All records are stored in a manner that protects against loss, damage or deterioration.•Ease of retrieval is provided for•Records are available for review by customers and regulatory authorities in accordance with contract or regulatory requirements.。
ISO900 程序文件 搬运、储存、包装、防护控制程序
5.2.7仓库应具有:防风、防雨、防鼠、防盗、防火等功能。
5.2.8仓库灯光应满足充足照明,无阴暗角落。
5.2.9仓库应按规定来配置灭火器,以防火灾发生。
5.2.10库存管理系统
5.2.10.1综合计划部利用计算机库存管理工具,实行对所有物料出入及产品出入数据的控制。
5.1.7叉车或堆高机操作驾驶人员必须持证上岗,严格执行操作规程,在使用叉车或堆高机搬运产品时,禁止超高、超重等违规作业,在转弯或进出库房交叉口时应注意减速、避让、鸣笛或打转向灯。
5.2储存
5.2.1原材料、半成品、成品等在使用或交付前的存放均应在原材料库(包括场地)、半成品库、工具库、成品库内,以避免产品的损伤、变质。仓管人员于每次发出物料产品时,应检视产品外包装是否完好,若有损坏情形,应详细查核内装产品,并通知品保鉴定。对于工模具的储存参见<<工模具管理方法>>。
5.2.10.2综合计划部通过库存管理系统监察可用物料存量及库存周转期,优化库存周转时间,确保货物周转受控,并确保安全库存量,必要时采取适当的改进行动。
5.2.10.3原材料、半成品库存周转率由综合计划部门计算,成品库存周转率由业务部门计算。
5.2.11仓库温度控制范围设在16℃-28℃,相对湿度在80%以下。危险品按说明书规定另处存放,并作好“环境记录”。
三职责:
3.1技术工程部负责各产品、器具的设计和包装技术条件的编制。
3.2生产部负责各车间物资流转过程中的搬运、贮存、防护。
3.3综合计划部负责仓储的原材料、外购外协件、半成品及成品搬运、贮存、包装、防护。
3.4综合计划部负责仓储的原材料、外购外协件、半成品及成品贮存条件和贮存状况的检查和记录。
AS9100D生产和服务提供过程管理程序(范本)
生产和服务提供过程管理程序文件编号:文件版本:编制:审核:批准:修订页目录1 目的 (3)2 范围 (4)3 参考文件 (4)4 定义 (4)5 职责 (5)5.1 生产部: (5)5.2 采购部 (5)5.3 适航质量部 (5)5.4 研发部 (5)6 过程策划和记录图 (6)7 工作程序 (6)7.1 生产和服务提供过程的控制 (6)7.2 产前准备 (6)7.3 生产过程验证 (7)7.4 生产过程更改的控制 (8)7.5 生产设备、工装和软件程序的控制 (8)7.6 生产和服务提供过程的确认 (8)7.7 生产和服务提供过程的实施 (8)7.8 联调测试流程 (9)7.9 应急措施 (9)7.10 生产和服务提供过程的监控 (9)7.11 产品标识和可追溯性管理 (9)7.12 产品防护 (10)8 附录 (11)1 目的对生产和服务提供过程的各环节和因素进行有效的控制,确保各生产和服务提供过程按规定的方法在受控状态下进行,使产品符合规定要求。
2 范围本程序对生产和服务提供过程的内容和方法等规定了具体要求,适用于产品生产和服务提供过程的策划、实施、确认、标识和可追溯性以及顾客财产、产品防护等环节的控制和管理。
3 参考文件AS9100D 《质量管理体系—航空、航天和国防组织的要求》CCAR-21-R4 《民用航空产品和零部件合格审定规定》AP-21-AA-2010-04R4 《生产批准和监督程序》CA-QP-06 《记录控制程序》CA-WI-QA-004 《产品标识和可追溯性管理规定》CA-QP-18 《过程的监视与测量管理程序》CA-QP-15 《特殊过程管理程序》CA-QP-14 《首件鉴定控制程序》CA-QP-05 《文件控制程序》CA-WI-MD-003 《工装管理规定》CA-WI-MD-001 《生产工具设备管理规定》4 定义4.1 关键过程:1) 对成品的质量性能、功能、寿命、可靠性及成品等有直接影响的工序2) 产品重要质量特性形成的工序3) 工艺复杂、质量容易被波动,对工人技能要求高或问题发生较多的工序4.2 特殊过程:1) 产品质量不能通过后续的测量和监控加以验证的工序2) 产品质量需要进行破坏性试验或采用昂贵的方法才能测量或只能间接监控的工序。
as9100内部审核程序英文版
Subject:Rev. A QP 1700INTERNAL AUDITEffectivePage 1 of 4Date:ASC Procedure Approved By:1.PURPOSE1.1The purpose is to provide a procedure for conducting audits to determine whetherthe quality management system:1.1.1 Conforms to the requirements of AS9100 and to quality management systemrequirements established by PRC-DeSoto International.1.1.2 Is effectively implemented and maintained.1.1.3 Meet Contract and Regulatory Requirements.2.SCOPE2.1 This procedure applies to the ASC Quality Management System. Flow-down shallbe areas described in the quality procedures, policies, and work instructionsaffecting the quality of work are audited, including delegated quality activities.3.RESPONSIBILITY3.1 The Management Representative – Ensures that internal audits are performedaccording to established process. Ensures that auditors are trained or plans foraudit.3.2 Trained internal quality auditors (Audit Team) are responsible for conducting allinternal audits.3.3The Management Representative ensures that internal auditors are trained,prepares and keeps records of this training, prepares an audit schedule, completesthe Summary of Findings and tracks and verifies the timely closure of correctiveactions to Nonconformances and maintains records.4.GENERAL4.1 The Audits are performed by trained internal auditors independent of the functionsaudited.INTERNAL AUDITASC Procedure Page 2 of 45.DEFINITIONS5.1Audit - systematic, independent and documented process for obtaining objectiveevidence and evaluating it to determine the extent to which audit criteria arefulfilled.5.2Audit criteria - set of policies, procedures or requirements used as a reference.5.3 Auditor – Person with the competence to conduct an audit.5.4 Audit finding – Results of the evaluation of the collected audit evidence againstthe audit criteria.5.5Objective Evidence – Data that supports the existence of verification ofsomething.5.6Nonconformity – Non-fulfillment of a requirement.6.PROCEDURE6.1The Management Representative plans and implements an audit scheduleensuring that:Quality management system requirements are auditedThe frequency of audit is based on the status and importance of the process(s) andactivity audited as well as previous audit results.T he set time to complete audits iswithin the month assigned.6.2The Management Representative determines the audit scope, audit criteria andassign an auditor(s) for completion of each audit. The selection of auditors for eachassignment ensures objectivity and impartiality of the audit process and those auditors do not audit their own work.6.3Management Representative notifies the department manager of the audit byforwarding a copy of the schedule when developed and revised.6.4The internal auditor contacts the appropriate departments to schedule a pre-auditmeeting where specific audit dates/times based on department and auditor schedules are discussed. Internal auditors perform the audit.INTERNAL AUDITASC Procedure Page 3 of 46.5Auditors performs audits in a structured manner to accomplish the scope of theaudit assignment:Review assignment to determine audit scope, audit criteria.Schedule the audit with the audited.Review audit criteria, such as policies, procedures, contracts, requirements of AS9100and prepare a QPF1700-1 Audit Checklist as appropriate to accomplish audit scope.Hold an opening meeting with audited to explain purpose and scope of the audit.Execute the audit by obtaining sufficient information or objective evidence to permitconclusions to be drawn regarding the conformance/nonconformance andeffectiveness of the area being audit.Collective information and objective evidence through interviews, examination ofdocuments and records, observation of activities and conditions in the areas beingaudited.Record observations for review to determine whether Nonconformances or potentialNonconformances exist.Review observations, taking into account their significance and drawing conclusionsabout conformance/nonconformance and effectiveness of the area at meetingrequirements and achieving quality objectives.Prepare nonconformance reports according to the Corrective and Preventive Actionprocedure taking care to include sufficient details and objective evidence.Hold a closing meeting with the audited to review and clarify the results andconclusions of the audit.Prepare an audit report that summarizes the audit conclusions and forwards to theManagement Representative.Management Representative reviews the audit report and any recordedNonconforming reports; obtains clarification from the auditor(s) as appropriate.6.6 A copy of the Internal Quality Audit Nonconformance Report is sent to the audited,(department manager). The audited investigates findings/observations. Managers review audit findings. The audited completes corrective action responses and send to theManagement Representative for review and approval within stated due date defined in the NCR form. Management Representative input/close audit in the NonconformingDatabase.6.7The Management Representative assigns follow-up/verification of corrective action basedon the estimated completion date determined by the Manager.6.8Internal Quality Audit Nonconformance Reports are reviewed using the Summary ofFindings at the Management Review Meetings. The Management Representative。
AS9100C实用标准(中英双版)
Quality Management Systems – Requirementsfor Aviation, Space and Defense Organizations1.Scope1.1GeneralThis standard includes ISO 9001:2008 quality management system requirements and specifies additional aviation,space and defense industry requirements, definitions andnotes as shown in bold, italic text.It is emphasized that the requirements specified in thisstandard are complementary (not alternative) tocontractual and applicable statutory and regulatory requirements. Should there be a conflict between the requirements of this standard and applicable statutory or regulatory requirements, the latter shall take precedence.This International Standard specifies requirements for aquality management system where an organizationa) needs to demonstrate its ability to consistently provideproduct that meets customer and applicable statutory andregulatory requirements, andb) aims to enhance customer satisfaction through theeffective application of the system, including processes forcontinual improvement of the system and the assurance ofconformity to customer and applicable statutory andregulatory requirements.NOTE 1In this International Standard, the term “product” only applies toa) product intended for, or required by, a customer,b) any intended output resulting from the product realizationprocesses.NOTE 2Statutory and regulatory requirements may be expressed aslegal requirements.质量管理体系-航空,航天和国防组织的要求1范围1.1总则本标准包括I SO9001:2008质量管理体系要求,规定了附加的航空,航天和国防的行业要求,定义和注释.附加要求以加粗斜体表示。
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1.0PURPOSE
1.1The purpose of this procedure is to ensure that product is handled, stored, packaged,
preserved and delivered in manner to prevent damage, loss, or deterioration.
2.0SCOPE
2.1This procedure applies to all products, received, stored, packaged, and delivered by
the ASC.
2.2This procedure applies to customer furnished material.
3.0RESPONSIBILITIES
3.1All personnel are responsible for preventing damage, deterioration, and contamination,
and for the housecleaning of storage areas and ensuring that products are properly
packaged and sealed.
3.2Production personnel are responsible for the cleanliness of the work areas and for the
prevention, detection and removal of foreign objects.
3.3R&T issues QC Cards that define special handling requirements for sensitive products.
3.4R&T maintains the Web label database that includes applicable safety and hazard
warnings.
3.5Operations Manager or delegate identifies and documents special handling
requirements for non-PRC products on the Work Order Routing, when necessary.
3.6Corporate Purchasing/Operations are responsible for the selection and qualification of
packaging materials.
3.7The Planning/Inventory Control/Logistics personnel are responsible for issuing
material on a first-in-first-out basis.
3.8Quality Control is responsible for initiating requests for shelf life surveillance tests
and assuring dispositions are completed on expired materials.
3.9Shipping/Receiving department personnel are responsible for ensuring that product is
protected after final inspection and testing and, when contractually required, to
protect the product until received by the customer.
3.10Shipping/Receiving department personnel are responsible for packing, marking, and
shipping hazardous material in accordance with Customer, Federal or International
regulations.
3.11Shipping/Receiving is responsible for placing product received into storage
according to the inspection acceptance status.
4.0GENERAL
4.1Material Safety Data Sheets (MSDS) are accessible to all personnel on site. The
MSDS file is maintained by
5.0DEFINITIONS
5.1None
6.0PROCEDURES
6.1Handling
6.1.1Personnel involved in the transporting, loading and unloading of product
will operate the following equipment in a manner that does not cause
damage or deterioration to the product:
∙Forklifts
∙Delivery Vehicles
∙Hand Trucks
∙Pail Lifter
∙Drum Lifter
∙Pallet Jacks
∙Pallets
∙Stretch Wrapper
∙Strapping Equipment
∙
6.2Storage
6.2.1All products, including hazardous product, will be stored under the proper
conditions using equipment necessary to preserve product integrity,
appearance, and performance without compromising the safety of the
facility and personnel.
6.2.2The warehouse personnel will take the necessary precautions to ensure that
products are stored in accordance with the QC Card, label or
manufacturers instructions, to prevent damage or deterioration.
6.2.3Only products, which have passed all receiving inspections and required
tests are released from hold location in Mfg-Pro and placed in storage
locations.
6.2.4Where necessary, product requiring special handling considerations is
placed in the appropriate storage environment, pending approval.
6.2.5Removal of product from storage areas is in accordance with the
Workorder; Pick Ticket or other authorizing documents. Ref. QP 900,
Process Control
6.2.6 A periodic survey of the warehouse and storage areas is performed to
detect damaged or deteriorated product.
6.2.7The survey results are placed on the QPF1500-1 Storage Inspection
Checklist, which is kept by Operations.
6.2.8Any damaged or deteriorated product observed during normal daily
operations is corrected immediately.
6.2.9Nonconformances found that cannot be corrected immediately is
documented on form QPF1500-1 Storage Inspection Checklist.
6.2.10Material that is non-conforming and is to be scrapped on site or material
that is designated to be scrapped will be placed in an appropriate location
so as to preclude use in production.
6.3Packaging。