机加工过程审核检查表-英文版
2016版VDA6.3过程审核检查表
是否对原材 污染。仓储区/加工区/容器必须达到零部件/产品所需的必要的
料进行适当 整洁/清洁要求。要定义清洁周期，并且加以监控。
的仓储，所 3.加工工位/装配线上的零部件/物料的供应必须便与安全操作
6.1.3
使用的运输 。 工具/包装设 4.必须通过合适的方法，监控为特殊材料/零部件规定的仓储时
备是否适合 间以及使用有效期（最长、最短仓储时间，规定的中间临时仓
量要求？ 性有影响的测量装置的校准。
4.对于影响到测量结果合试验的附属装置，要采取同样的方式
加以监控。
加工工位和
6.4.4
检验工位是 否满足具体
要求？
1.加工工位及周边布置的条件环境适合于生产操作和产品的要 求，从而可以预防或避免污染、损伤、混料。 2.这也适用于临时的和永久的返工返修、拣选、检验工位。 3.除此以外，还根据具体的工作任务，在人机工程学的基础上 对加工工位设计进行了调整。
P6.2
工作内容/过程流程（所有生产过程是否受控？）
控制计划里 的要求是否 6.2.1* 完整，并且 得到有效实 施？
1.基于控制计划的生产和检验文件完备。其中必须对检验文件 、检验设备、检验方法、检验频度/周期、重新评定等加以规 定。 2.这些文件必须随时可获取。 3.对于影响到产品特性/质量的过程参数必须加以完整地描述。 过程参数和检验特性必须带有公差。 4.在过程控制图上规定控制限，控制限可探测、可追溯。 5.针对过程要求和检验特性，要对发现的不符合项以及启动的 措施加以记录。 6.对过程异常所要采取的措施（反应计划），相关责任人必须 清楚，实施措施并加以记录。 7.如产品对生产工艺有特殊要求，那么相关的机器/工装/辅助 设备的参数数据要在控制计划和/或生产检验文件中加以规定 。 8.详细规定返工条件，并且在过程中加以保障（零部件标识， 重新检验）
VDA 6.3-2016过程审核检查表及报告(中英文功能强大版)
的策划
需回答问题: 4 过程 已回答问题: 5 / 5
Produkt-/Prozess-Audit
Data Input for Compiling Report
简要指导: 1. Activate macros启用宏 2. Select Language选择语言 3. Choose amount of processsteps (only for P6 evaluations)选择工序数量 4. Choose process elements (Table: Questions-Fragen)选择过程要素
没有缺点 10
Is there an escalation process established and is this effectively implemented?是否 建立事态升级程序，该程序是否得到有效执行?
没有缺点 10
100% 100%
需回答问题: 4
Planning the product and process development产品和过程开发 产品 已回答问题: 5 / 5
Certificate No.: P-6.3 -1702-B-15842
上次审核结果 / 证书
Suppl.-No.: 12345 D-U-N-S No.: 123456
供方: ABCDEFG 街道: 12 地址: Address 国家: B 生产地点（邮编）: 123456 电话号码: 123456789 传真号码: 123456789 签名 (组织): Wang ermazi
证书 / 审核号码: 签发日期 执行者
结果 / 证书编号.
姓名 高层管理: Zhang san 工厂管理: Li si 质量管理: Wang ermazi 客户支持 zhao wu
BIQS审核检查表中英文
GM at unnecessary risk.
Yellow: Quality system or process is in place, but is not followed/utilized as intended.
Red: Quality system or process is not evident, or the current system or process in place puts GM at significant risk.
nonconforming / suspect material.
Team members have standardized work and understand what to
do with non conforming / suspect material.
Confirm that conforming material is handled, stored and identified appropriately.
wrong parts, mixed parts, containment control, etc.)
BIQS -3
0
Failure modes are comprehended in the PFMEA (i.e. wrong parts,
3C_工厂检查调查表（英文版）
3C_工厂检查调查表（英文版）Questionnaire for Factory InspectionName of Applicant:Name of Manufacturer:Name of Factory:Certification CenterQuality CertificationChina QualityChina1.1Factory’s registered name:Factory’s registered address:Note: Factory’s address should be filled in according to the fact, which may be different with the registered address. Factory’s address is the location of final assembling, implementing routine test and verification test, packing and bearing product nameplate and certification mark. If those working procedures mentioned above could not be completed in one location, a compared integrated location should be filled out here in which at least routine test and verification test, packing, product nameplate and certification mark bearing are implemented, moreover other locations should be indicated with geographical places.Tel: Fax: Postcode:E-mail:Directions of the best way of reaching the factory (nearest railway station, airport; attach one photocopy of local map if possible)1.2Manufacturer’s registered name:Manufacturer’s registered address:Tel: Fax: Postcode:E-mail:2.Applicant’s registered name:Applicant’s registered address:Tel: Fax: Postcode:E-mail:Contact person of certification: Department & position: Tel:3. The name, department and position held and telephone number of the factory quality assurance manager Name of the QA manager: Department & Position: Tel:4. Total number of employees in the factory (If products applied for the certification are only one part of the whole production, please indicate the total number of employees involved in the production and management of the products applied for certification)5.1The application number(s), name(s), model(s) /specifications and trade mark(s) of the product(s) applied for certification5.2Specify the standard(s) according to which the certification is made on the products6.1Has the factory established a documented quality system according to the requirement of the IMPLEMNENTATION RULES FOR COMPULSORY CERTIFICATION? Please provide:①organizational chart②list of the quality manual③ procedural documentation6.2Indicate the production processes of the products appliedfor certification performed in the factory. (Please provide the production flow chart, and fill in the Appendix 1 -- List of Key Production Equipments.)6.3Indicate which critical parts and materials are provided by the subcontractors.(Please indicate which have been already awarded the CCC or other equivalent certificates.)6.4 Please specify which inspection the factory is able to conduct during receiving inspection, process inspection and final inspection in order to ensure that the final products conform to corresponding standards. (Please provide a list of inspection documents and fill in Appendix 2 -- List of Main Test Instruments and Equipments).7.Please indicate the Certificates and the Marks already granted by other certification body/bodies for the products applied for certification.8.Has the manufacturer’s quality system been assessed and certified? If yes, please provide a copy of the certificate(s). Please specify the date and the conclusion of the last inspection.9.Date of factory inspection expected:Off day of factory: On duty time of factory:Could the inspection be done on off day:yes discussible no10.Are the inspectors of Certification Body allowed to access all locations concerning production and management processes of products applied for certification during normal working hours, after having contacted the quality assurance manager?Signature and stamp of the representative of the factory:Date:Note: On behalf of the manufacturer, the signatory to thisform is required to verify the accuracy of the information provided.Appendix 1List of Key Production EquipmentsName of factory: page of/doc/674072517.htmlof equipment Manufacturer ofequipmentMain technicaldataQuantity LocationAppendix 2List of Main Test Instruments and Equipments Name of factory: page of/doc/674072517.htmlof instruments& equipmentsManufacturer ofinstruments &equipmentRange of theMeasurementPrecision Quantity Location。
CQI-11 v2中英文检查表
7.12
Hale Waihona Puke Job (Shop) Order or Related Customer or Internal Reference Documentation PSA Question # Requirement客户或内部要 Requirement工作(车间)指 相关PSA问题# 求 令单或参考文件要求 1.2 1.4 1.6 1.2 1.4 1.6 1.11 1.17 2.11 2.13 1.17 2.6
2.9 2.9
2.3 2.3 2.9
Question Number问 题编号# 7.11
Job Audit Question作业审核问题 Were steps/operations performed that were not documented in the Control Plan? 有没有执行控制计 划中没有的步骤/操作？ If additional steps were performed, were they authorized?如果有另外的步骤被执行，这些步骤是否 被授权？
7.2
7.3 7.4
7.5 7.6
7.7
7.8
7.8.1
7.8.2
7.8.3
Requirement: Hydrogen Embrittlement Relief (if Applicable)要求：氢脆释放(如适用)
This includes the transition time from the plating bath to the oven plus heating time. The time to temperature is different for different customers. The most strict (shortest heating time) requirements shall be met. 这包括零件 从电镀槽到烘箱的时间加 上加温的时间，不同的顾 客对到达温度的时间要求 会不同。应满足最严厉的 要求(最短的加温时间)
fdaqsr820审核检查表英文版
Audited firm Annex of the directive Standards Type of considerationAnnex ll Annex V Annex Vl ISO 9001 / 2EN 46001 / 2FDA QSR’ｓcertification auditpre-auditsurveillance-auditfollow up-auditre-auditTelephone-Nr. Documentation review/report from Reference document of the firm Telefax-Nr. On-site audit carried out on (date)Lead auditor Co-auditor / technical expert Co-auditorAudited section/area (area of validation)Products:SUMMARY STATEMENTS:Scope and Aim of the Quality AuditThe audit performed on __________ at __________________ located in _________________ is de-signed to evaluate the quality system implemented according to the FDA Quality System Require-ments (QSR’s) as given in 21 CF R § 820, ISO 9001/2, and EN 46001/2. There was a particular em-phasis on the use of the ISO 9001/2, EN 46001/2 audit check list provided by this author of this report.The scope and aim of the audit is for the qualification of this Company (at this one facility only). Any other facility must be evaluated on its own merits.Critical Observations: __Major Observations: __ (None have an impact on Safety, Form, Fit, Function)Minor Observations : __Recommendations: __Date / Signature of Auditor(s)SUMMARY OF ASSESSMENTQM-SECTION QSR-SECTION SC OR E N/C NO.1. Management responsibility Subpart A - § 820.20 Management responsibility2. Quality management (QM)-system Subpart B - § 820.5 Quality System3. Contract review4. Design control Subpart C - § 820.30 Design controls5. Document and data control Subpart D - § 820.40 Document controls6. Purchasing Subpart E - § 820.50 Purchasing controls7. Control of customer-supplied product8. Product identification and traceability Subpart F - § 820.60 Identification § 820.65 Traceability9. Process control Subpart G -§ 820.70 Production and process controls§ 820.75 Process validation10. Inspection and testing11. Control of inspection, measuring and test equipment Subpart G -§ 820.72 Inspection, measuring, and testequipment12. Inspection and test status Subpart H - § 820.80 Receiving, in-process, and finisheddevice acceptance§ 820.88 Acceptance status13. Control of nonconforming product Subpart I - § 820.90 Nonconforming product14. Corrective and preventive action Subpart J - § 820.100 Corrective and preventive action15. Handling, storage, packaging, preserv. and delivery Subpart K - § 820.120 Device labeling§ 820.130 Device packagingSubpart L - § 820.140 Handling§ 820.150 Storage§ 820.160 Distribution§ 820.170 Installation16. Control of quality records Subpart M - § 820.180 General requirements§ 820.181 Device master record§ 820.184 Device history record§ 820.188 Quality system record§ 820.198 Complaint files17. Internal quality audits Subpart A - § 820.22 Quality audit18. Training Subpart A - § 820.25 Personnel19. Servicing Subpart N - § 820.200 Servicing20. Statistical techniques Subpart O - § 820.250 Statistical techniquesDate / Signature of Auditor(s)QM-SECTION 4.1 - MANAGEMENT RESPONSIBILITY / 1QUESTIONS COMMENTS(ISO 9001/2 - EN 46001/2 )(FDA QSR’s - 21 CFR 820 et.al.) WherefoundDocumentation Sc Practice Sc4.1.1 Quality policyIs this defined and documented?Is there understanding at all levelsof the organization? (e.g. through acircular letter, management assem-bly, notices, training programs, sem-inars) § 820.20 Management Responsibility(a)Quality Policy1.Management with executive re-sponsibility has established a policydemonstrating its objectives for andcommitment to quality.2.Management with executive re-sponsibility has ensured that the pol-icy is understood, implemented, andmaintained at all levels of the organ-ization.Reviews are documented.4.1.1 Quality GoalsDoes this quality policy provide cleardirections on quality goals andcommitment?Is there surveillance of these goals?Are these goals adapted or adjust-ed?4.1.2.1 Organization/Responsibility/AuthorityIs the responsibility, authority andthe interrelation of personnel whomanage, perform and verify work af-fecting quality (clearly) defined anddocumented?For example in the organizationalstructure, job description, matrices,workplace description. § 820.20 Management Responsibility (b)OrganizationThe manufacturer has establishedand maintained an adequate organi-zational structure.(1)Responsibility and authority1.The manufacturer has establishedthe appropriate responsibility, au-thority, and interrelation of all per-sonnel who manage, perform, andassess work affecting quality.2.The manufacturer has providedthe independence and authoritynecessary to perform these tasks.4.1.2.2 ResourcesIs there identification of resource re-quirements?Is there provision of adequate re-sources?Is there provision of trained person-nel (e.g. internal audits) ? 820.25- Personnel(a)GeneralThere are sufficient personnel withthe necessary education, back-ground, training, and experience toassure that all activities required bythis part are correctly performed.§ 820.20 Management Responsibility (2)ResourcesThe manufacturer has provided ad-equate resources, including the as-signment of trained personnel, formanagement, performance of work,and assessment activities, includinginternal quality audits.QM-SECTION 4.1 - MANAGEMENT RESPONSIBILITY / 2QUESTIONS COMMENTS(ISO 9001/2 - EN 46001/2 )(FDA QSR’s - 21 CFR 820 et.al.)WherefoundDocumentation Sc Practice Sc4.1.2.3 QM representativeIs there a QM representative ap-pointed?Has the QM representative thenecessary authority and compe-tence?§ 820.20 Management Responsibility (3)Management representativeManagement with executive respon-sibility has appointed and docu-mented a member of managementwho, irrespective of other responsi-bilities, has established authorityover and responsibility for:Ensuring that quality system re-quirements are effectively es-tablished and maintained in ac-cordance with this part;Reporting on the performanceof the quality system to man-agement with executive respon-sibility for review,4.1.3 Management reviewIs there revision/review of the qualitysystem, by the suppliers manage-ment, at defined intervals?Is this review documented?Were records of such QM reviewsmaintained?Please refer to records in Section4.16 § 820.20 Management Responsibility (c)Management review1.Management with executive re-sponsibility has reviewed the suita-bility and effectiveness of the qualitysystem at defined intervals and withsufficient frequency according to es-tablished procedures to ensure thatthe quality system satisfies the re-quirements and the establishedquality policy and objectives.2.The dates and results of qualitysystems reviews are documented.QM-SECTION 4.2 - QUALITY MANAGEMENT SYSTEM / 1QUESTIONS COMMENTS(ISO 9001/2 - EN 46001/2 )(FDA QSR’s - 21 CFR 820 et.al.)WherefoundDocumentation Sc Practice Sc4.2.1 QM-manualIs a QM-manual available?Does this include or make referenceto the quality system procedures?Does this outline the structure of thedocumentation used in the qualitysystem?(eventual reference to ISO 10013) § 820.5 Quality SystemThe manufacturer has establishedand maintained an appropriate quali-ty system.Particular requirements for all medical devices (EN 46001/2)Are the specified requirements es-tablished and documented? Note: When the quality system is used, the relevant requirements of the regula-tions should be included in the specified requirements.4.2.2 Quality system procedureDoes the QM manual contain doc-umented procedures?When no, are references made todocument procedures?In the documented procedures isreference made to work instructionsthat define how an activity is per-formed?§ 820.20 Management Responsibility Quality system procedures1.The manufacturer has establishedquality system procedures and in-structions.2.An outline of the structure of thedocumentation used in the qualitysystem has been established.Particular requirements for all medical devices (EN 46001/2)Does there exist for each product/product group a file (technical document/product file) containing, at least, the following: product specificationsclassification of the medical prod-uctsmanufacturing specificationsquality assurance specifications. The records that are not in a central ar-chive shall, within these files, refer to the location of these records.。
ccc工厂审查调查表英文版doc5
The certificates and marks been got by the productsapplied forcertification：
The expected factory inspection date：
Off dayof the factory：
Time of the factoryon/off duty：
Factory code：
Questionnaire f
Name ofthefactory:
Name oftheApplicant:
Name oftheManufacturer:
China Certification Center for Electromagnetic Compatibility
Questionnaire forFactoryInspection
The name,application No., model/specification, trademarkand pursuant standards of theproducts applied forcertification:
Name
ApplicationNo.
Representative model/type
Derivative model/type
Trade mark
Pursuant standards
Appendix 2
List of main test instruments and equipments
Serial number
Name ofinstruments and equipments
Manufacturer
The amount of employeesfor thedesign, processing, assemblingandmanagementon the products appliedfor certification：
VDA6.3过程审核-2010 检查表-评分矩阵-中英文版
受审部门(或工序)Auditee Dept.(or Process)
编号No
检查内容Check contents
P2 项目管理Project management
审核情况描述describes
0
评分grade 4 6 8 10
是否制定项目质量计划，并实施和定 期监视遵守情况？Is there a QM 2.6 plan for the project ? is this implemented and monitored regularly for compliance ?
是否建立和有效实施在事态升级程
2.7*
序？Is there an established escalation process and is this
是否建立项目组织（项目管理），是 否确定项目管理者及团队成员任务和 权限？Is the project organisation 2.1 (project management) established and are tasks &authorities specified for the team leader and team members?
implemented effectively ?
是否对项目所需的资源进行策划和实 施，并及时调整？Are the resources 2.2* required for the project development planned and available and are all changes displayed?
是否项目计划到位并与顾客协调？Is 2.3 there a project plan and has this
ISO90012015内部审核检查表-英文版
ISO 9001:2015Quality Management System Assessment ChecklistRP-2Table of ContentsIntroductionAssessment Summary Sheet - SampleAssessment Summary Sheet4-Context of the Organization ........................5-Leadership ..................................................6-Planning for the Quality Management System 77167 7—Support 7777777777777777777777778-Operation 777777777777777777777779-Performance Evaluation 77777777777777710-Improvement 777777777777777777777The Quality System Checklists inten ded to help you gain a betterunderstanding of the requirements of ISO 9001:2015. ISO 9001:2015requires the adoptio n of the process approach which exte nds to internal quality audits. This checklist follows the structure of thesta ndard, thus it is not process based. For this reas on it is notinten ded to be used as the only tool for internal quality audits.You can gain a better un dersta ndi ng of ISO 9001:2015 Sta ndard asit applies to your company by reviewing these questions. You may wishto discuss them with your auditors to enhance every ones 'understanding of the ISO 9001:2015 requirements and the assessme ntprocess.You should be aware that although the follow ing questi ons in cludemost of the requireme nts of the ISO 9001:2015 sta ndard, they do notn ecessarily cover all aspects of the Stan dard. So, the use of thischecklist will give you only a sample of your orga ni zati on con formance to the ISO 9001:2015 stan dard.Assessment Summary SheetThe Assessment Summary Sheemt ay be used for visualizing the big picture:what areas were checked and where discrepancies were found. You from thesample Assessment Summary Sheetthat assessment of the Purchasing Processuncovered discrepancies for clauses 4.1, 5.3, 7.1.5, 8.1, 8.2, 8.3.1 and 8.5.3.This may be a sign of problems in that process, which warrant planning andclose monitoring of corrective actions. TheProcesses Assessedcolumn revealsthat for clause 7.1.2 forResource Requirements or 8.2 for Determination ofrequirements for products and services, discrepancies were uncovered in allapplicable areas. This may give evidence of a system breakdown.On the sampleAssessment Summary Shee, t he circled numbers correspond to thefollowing:The ISO 9001:2015 Assessment Standarcdorrespond to the ISO9001:2015 International Standard which your company has selected for assessment.The column ProcessAssessedlists the areas (i.e. process) where compliance to given clauses will be evaluated.These columns contain the list of clauses for the applicable ISO Standard to which compliance is being sought. NOTE: All clauses of the ISO 9001 Standardmust be addressed.See section 0.1. F“orward” , for further information.Use this grid to indicate where discrepancies are found by entering a into the corresponding boxes. Where no discrepancies are uncovered, enter an “ X”in the appropriate boxes.0.2 Process ApproachISO9001:2015 promotes the adoption of a process approach. As a first step, all processes of the organization need to be identified and theirinterrelation defined. A process is a set of activities that transform inputs into outputs. The outputs of one process may be the input of another process, or the finished product. Although a process map is not required, it is an effective method for demonstrating process interrelation. Any other method will equally meet the requirements of the standard as long as the process interaction is somehow shown.An example of a typical process map is noted on the next page. Please note that a process map is not a process flow diagram, but merely highlights the main processes of the organization that are needed to be effectively monitored to ensure “ consistent and predictable resAulsltos, theprocesses noted are not the names of the functions within the organization, but value added activities within the organization that may involve sub-processes that will have to be further defined.p 『o<苗 i o n p 「o du rJ r fl 、s T r <i c Sjpp.rt ProcesieiU14U 2E W 」一 nb①圧」OJE 04s n uAssessment Summary SheetSAMPLE* Use an “ X” to indicate that theselwas assessed in the area described. Use a “ D” to indicate that a discrepancy was foundAssessment Summary Sheet* Use an “ X” to indicate that the clause was assessed in the area described. Use a “ D” to indicate that a discrepancy was found。
机加工审核检查表
21 管理层
与最高管理层交流，了解组织对内外环境的分析，相关方对企业的期望或 要求，为完成质量环境安全方针、目标采取的措施，以及在持续改进方面 所做的工作，管理评审
GB/T19001-2016 5.2.2，7.3 7.4 5.3 7.2，7.1.2
7.1.3 7.1.4
对应条款 GB/T24001-2016
11
现场观察操作人员是否按规定进行首检、互检与专检，并做好检验记录 （记住本批产品及原材料）
12
现场观察操作人员是否按规定做好产品的防护、以及合格品、不合格品、 废的消防器材是否按期进行检查，讯问操作人员如何使用消防器 材？是否进行培训，并根据需要查询记录
根据操作人员使用的原材料，到仓库检查此原材料是否贯彻了先入先出的 14 原则？并同时现场观察物料的管理水平，如帐卡物是否一致？物料标示、
18 根据销售合同，查研发设计部的研发设计条款及设计变更，并查看是否考 研发部 虑了从生命周期的不同阶段考虑了环境、安全因素
19 质量部
根据操作者及使用的测量工具，到质量部查工具台帐及检测报告及周期内 的质量绩效情况（是否有改进），产品放行情况，让步接受情况（降 低），并同时检查环境、安全因素，内部质量审核
7.2，8.1，8.2 6.1，8.5.2，8.5.3，8.5.4
8.4，9.1.3
8.1
8.2，8.3，8.5.4，8.5.5 9.1.2，9.1.3
8.1
8.3，8.5.6
8.1
7.1.5，8.6，8.7 9.1.1，9.1.3，9.2，10.2，10.3
8.1
4.4.2，4.4.6，4.4.7 4.4.6 4.4.6 4.4.6 4.4.6
20 到操作工为例，人事部门查岗位职责、年度培训的编制情况，人员能力的 人事部 确认情况，培训效果的验证情况，关键岗位人员的流失情况
Process Audit Checklist_过程审核检查表
Responsibility 责任人
Findings 发现
Score 分数
0.0
50
KPI
Does the performance meet the target? Sub - Total 0.0
51 52
Resource Resource
Is the resource provided to this process? Is the resource evaluated and the equipment maintained? Sub - Total 0.0
Requirements 要求 Customer requriements collected and analyzed? Gap to meet CSR is bridged? Evidence requried Print released with update / revision? Process flow chart / Operation Cycle availabel and active? PFMEA generated and updated? Control Plan genereated and updated? Work Instruction generated and released with update? Sub - Total
过程审核表 Process Audit Checklist
Part Name 零件名称 Customer Name 客户名称 Date of Audit 审核日期 Auditor 审核员 Part Number 零件号 Revision 版本 OverallScore 总分 Auditee 受审人员
Revision Y
VDA6.3过程审核检查表(中英文版)6
B.变更在组织内部沟通 C.必要时，变更知会顾客
6.2 工作内容/流程（所有的生产过程是否受控）？Are all production processes controlled ? (process sequence)
6.2.1* 6.2.2
确认SOP与SIP是否包含控制计划
控制计划的所有内容是否在生产、检验和试验的 文件中全部详细列出？Are all the relevant details listed in the production and test/inspection documents, based on the production control plan ?
6.1 向过程输入了什么？（过程输入） What goes into the process ? (process input)
6.1.1*
确认是否输入下列方面
A.项目交接记录
项目是否在开发和批量生产之间进行交接？Has the project been transferred from development to serial production ?
过程审核检查表Process Audit Check List
审核员(日期)Auditor(Date)
受审部门(或工序)Auditee Dept.(or Process)
编号No
检查内容Check contents
审核情况描述describes
评分grade 0 4 6 8 10
P6 过程分析/生产Process analysis / production
A.过程能力及设备能力调查 B.工艺参数 C.人机料法环变更时重新做首件检 验、SPC管制图
6.2.3*
ISO90012015内审检查表-英文版
ISO 9001:2015Compa ny: Clie nt- no.:DateLead Auditor(s)Note:1 Objective audit evide nee shall be docume nted and uploaded to iCert.2This Audit questi on list is reeomme nded as the primary source of docume ntatio n of objective audit evide nces. Alter natively, audit no tes, process sheets, etc. could be used.3As a rule, documented audit evidence (audit question list, audit notes or process sheets) should be completed separately for each audit and for each site (if applicable), for the pert inent process eleme nts.4The evaluatio n can be en tered in the audit evaluati on colu mn (E): 1 = Con formity (in cludi ng pote ntial for improveme nt, where applicable). 2 = Minor noncon formity (lower-level non-con formity). 3= Noncon formity (major noncon formity)n.a. = not applicable5The final result of the evaluati on shall always be docume nted in the action list (Ann ex1)Compa ny:Clie nt- no.:Requireme nts (Audit notes identified withAudit no tes“ * ” are to be reported in the Audit Report)(Implementation / Documented Information / reviewed evidence ...)Order- no.:4 Con text of the orga ni zati on4.1Understanding the org. and its contextdetermine external and internal issues monitor and reviewinfo.4.2Understanding the needs and expectations ofinterested partiesdetermine:a)the interested parties relevant to the QMSb)the req. of these interested parties monitor and review info. about interested parties and their relevant req.4.3Determining the scope of theQMSdetermine the boundaries and applicabilityof the its scope.consider:a)the external and internal issuesb)the req. of relevant interested partiesc)the prods & servs of the org.apply all the req. of this Standard if they are applicable within the scope of its QMS. The scope shall be docu. info . state the types of prods and servs covered, and provide justification for any req. not applicable. *Min. of 1 ex.: context of the org.*Min. of 1 ex.: interested parties*Min. of 1 ex.:statutory/regulatory req.*Appropriateness of scope:4.4 QMS and its processes *Min. of 1 ex.:Order- no.:Order- no.:Order- no.:Compa ny:Clie nt- no.:Requireme nts (Audit notes identified withAudit no tes“ * ” are to be reported in the Audit Repoit)(Implementation / Documented Information / reviewed evidence ...)Order- no.:resources:a)are suitable for the specific type of monitoring andmeasurementb)are maintained to ensure their fitness retain docu. Info. of fitness for purpose of monitoring and measurement resources.measuring equipment shall be:a)calibrated or verified, or both, at specified intervals, to measurement standards; when no standards exist, the basis for calibration shall be retained as docu. Info.b)identified to determine thestatusc)safeguarded from adjustments, damage or deteriorationdetermine if the validity of previous measurement results has been adversely affected when measuring equipment is found unfit for its intended purpose, and take action .7.1・6 Organizational knowledgedetermine knowledge for the operation of its processes and conformity of prods & servs.knowledge shall be maintained and made available.When addressing changing needs and trends, consider current knowledge and determine how to acquire additional knowledge and required updates.7.2 Competencea)determine the competence of person(s)b)ensure that persons are competentc)actions to acquire the necessary competence, evaluate the effectiveness of the actionsd)retain docu. Info. of competence7.3Awarenessensure that persons are aware of:a)Q-policyb)Q-objectivesc)their contribution to the QMS, including the benefits of improved performanced)implications of not conforming with the QMS req.7.4Communicationdetermine the communications relevant to the QMS:a)whatb)whenc)with whomd)how *Evidence of fitness for purpose of monitoring and measurement resources:*Evidence of basis used for calibration or verification (if applicable):*Min. of 1 ex.:Order- no.:Order- no.:Order- no.:Order- no.:。
轴类零件机械加工检验卡(中英文)
签字-日期
Signature-date
备注
Notes
轮位
Location of wheel
直径diameter A
长度length C
轴承颈
Neck of bearing
直径diameter A
长度length C
密封位
Location of seal
直径diameter B
长度length C
槽长C
Length of key trough
对称度A
symmetry
注：需热处理的轴应在粗加工后留有足够余量的情况下进行，该余量应经技术主管审批。检验员在相应检验记录栏中附加字母R。
Notes: The heat treatment of the shaft should be carried out in the condition of the tolerance must be approved by technical charge. The insprttor must fill work the letter “R” in the relevant sheet.
槽深B
Depth of key trough
槽长C
Length of key trough
对称度A
symmetry
大链轮位键槽及其对轴线的对称度
Key of big chain wheel and its symmetry to axes
槽宽A
Width of key trough
槽深B
Depth of key trough
编制draft：审核checked：批准approved：
轴类零件机械加工检验卡
过程审核检查表
提 问 项 目检 查 方 法记 录评价P6.1 什么是过程输入什么是过程输入？？过程输入过程输入（（Input）P6.1.1 是否在研发和批量生产之间进行了项目交接？APQP项目计划 PFMEAPPAP批准 PPF(胃纳率)P6.1.2 在约定的时间，所需数量/加工批量的原材料是否能够被送至指定的仓库/工位？JIT(准时生产的生产计划) 合适的搬运工具仓库管理变更状态P6.1.3 是否按照实际需要对原材料进行了仓储，所使用的运输工具/包装设备是否与原材料的特殊特性相互适应？标识、标记材料防护、贮存容器（汤勺、桶、坩埚）整洁、清洁P6.1.4 必要的标记/记录/放行是否到位，并且相应与原材料进行了关联？客户对特采的特殊要求标识和追溯性要求特殊特性(比如：304钢的成分化验) 生产控制计划P6.1.5 在量产过程中，是否对产品或者过程变更开展了跟踪和记录？检具、图纸的变更 PFMEA的变更过程控制文件的变更 变更周期关联供应商的变更P6.2 所有生产过程是否受控所有生产过程是否受控？？工艺流程提 问 项 目检 查 方 法记 录评价P6.2.1 在生产控制计划表的基础上，是否在具体的生产和检验文件中完整的说明了所有相关信息？生产控制计划过程参数（压力，温度，时间，速度，...）机器/模具/辅助工具的相关数据（模具和机器编号）检验要求（特殊特性，属性特性，检验工具，方法，检验频度） 针对夹持/基准点的要求工艺流程卡上的处置界限操作说明书作业指导书检验指导书针对检验和过程处置/整改的记录和证明文件维护保养指导书P6.2.2 对生产工艺流程是否进行了放行，并且对设置数据进行了采集？生产批准变更的产品/过程设备停机/过程中断，重新批准生产维修，模具更换更换材料（例如更换批次）-变更了的生产参数首件检验，包括记录熔炼、浇注、热处理过程–加工工位上的整洁和清洁 模具和检验工具的包装，批准，变更状态极限样件P6.2.3 使用的生产设备是否可以满足客户对具体产品提出的要求？针对特殊特性/关键过程参数的机器/重要参数的强制控制/调节 石川因果分析提 问 项 目检 查 方 法记 录评价在偏离极限要求/参数情况下的警告（例如指示灯，喇叭，切断电源）防错解决方案检验结果（例如测量记录）产品审核的结果备用模具夹持，夹紧装置等的可维修性模具/设备/机器的维护保养状态（包括计划的维护保养）应急计划表P6.2.4 在生产环节是否对特殊特性进行了控制管理？P FMEA生产控制计划质量记录，统计分析 SPC分析，工艺流程卡 能力证明Cpk，Ppk，... 检验过程适用性证明检验结果产品审核的结果不受技工影响（防错）P6.2.5 对于报废零部件、返工零部件以及调机用零部件，是否单独放置并且相应加以了标记？报废零部件，返工零部件和设置用零部件的标记用于存放报废零部件，返工零部件和设置用零部件的容器的标记 在生产环节定义的剔除/返工工作站隔离仓库，隔离区域企业内部多余零部件的标记，包括仓储提 问 项 目检 查 方 法记 录评价返工和报废记录[根据特性归类]P6.2.6 是否采取了措施，防止在材料/零部件流转的过程中，发生混合/搞错的情况P FMEA防错措施加工，检验和使用状态标记批次标记，批次装配或者批次生产的可追溯性不同材料的失效日期清理无效的标记带有零部件/生产主数据的加工作业单据结构设计状态，原材料和成品材料流转分析（价值流）P6.3 哪些岗位为过程提供支持哪些岗位为过程提供支持？？人力资源P6.3.1 在监控产品/过程质量方面，是否将相关的责权和权限委托给了员工？岗位描述，任务描述；员工参与改进计划车间技工自检过程批准（设置批准/首件检验/末件检验）过程调节（对控制卡的解读）隔离权限，整洁和清洁开展或者安排维修和维护保养零部件提供/仓储开展/安排检验/测量工具的设置和调整产品培训，质量信息（设定参数值/实际参数值） 零缺陷计划改进建议；自愿的特殊行动（培训，QCC）提 问 项 目检 查 方 法记 录评价P6.3.2 员工是否有适合完成委托的任务，其资质是否始终有效？指导/培训/资质培训证明对产品以及发生的故障的认识针对劳动安全/环境的培训针对“需要特殊验证的零部件/产品”的操作培训能力证明（例如焊接工证书，视力测试，驾驶员执照） 过程和工艺技术发生变更时的培训规划产品培训–起因产品责任培训质量信息（设定参数值/实际参数值）-零缺陷计划改进建议自愿的特殊行动（培训，质量小组）低的病假率为质量改进做出的贡献-自评信息流，组织方面的落实研讨会P6.3.3 是否编制了人力资源安排计划表？班次计划表（针对具体的委托）资质证明（资质培训表）信息流，组织方面的落实记录的代位规则P6.4 通过哪些资源落实了过程通过哪些资源落实了过程？？物质资源物质资源？？提 问 项 目检 查 方 法记 录评价P6.4.1 生产设备/工具的维护及保养是否受控？计划的/定期维护保养作业关键过程生产装置的零备件到位情况遵守规定的维护保养周期计划的开销与实际开销相互一致对开展的维护保养作业加以记录所安排的员工的资质工作证明的存档对于计划的维护保养周期，定期开展可行性检验零备件的安排，零备件的到位情况针对维护保养作业，委托外部服务提供商模具管理体系P6.4.2 通过使用的测量和检验装置，是否能够有效地监控质量要求？生产控制计划可靠性、功能和耐腐蚀性检验，...测量精度/检验工具能力检验过程能力证明数据采集和可评估性检验工具校准证明和客户协商沟通，对检验工具/测量方法加以调整提 问 项 目检 查 方 法记 录评价P6.4.3 加工工位以及检验工位是否满足具体的要求？符合人机工程学的加工工位设计照明整洁和清洁检验室加工工位组织安排环境/加工工位上零部件的搬运劳动安全（事故预防和保险方面的法律基础） 加工工位上零部件的存储生产体系P6.4.4 是否根据要求，正确的存放工具，装置和检验工具？不会导致损伤的仓储；定义的仓储地点整洁和清洁受控的发放环境因素的影响状态标记；客户财产标记，提供的产品/模具/检验工具 定义的批准和变更状态货架管理装置/用于运输和仓储的生产资料P6.5 过程落实的效率如何过程落实的效率如何？？效率效率，，效能效能，，避免浪费P6.5.1 针对产品和过程是否制定了目标要求？人员的出勤和缺勤设备和机器的利用率量产条件下，量产周期时间内的山脊线产量计划/核算出的报废率生产的产量；每时间单位加工的零部件数量提 问 项 目检 查 方 法记 录评价返工，报废质量特性参数（例如故障率，评审结果）生产周期不合格（故障成本）；成本优化；减少浪费（例如报废和返工）过程特性参数（过程能力）；确定特性参数的判断依据P6.5.2 对收集的质量和过程数据是否可以开展评价？故障记录工艺流程卡数据采集、特殊特性过程参数的记录装置（温度，时间，压力，...）生产数据采集（例如设备停机，断电，程序故障报警） 参数变化过程能力故障类型/故障频度故障成本（不合格）过程参数报废/返工隔离通知/分拣行动周期时间，生产周期可靠性/失效表现SPC（统计过程控制）柏拉图分析因果图提 问 项 目检 查 方 法记 录评价FMEA（故障模式及影响分析）P6.5.3 一旦与产品和过程要求不符，是否对原因进行了分析，并且检验了整改措施的有效性？补充的尺寸，材料，功能，耐久性试验 因果图故障模式及影响分析/故障分析过程能力分析质量控制闭环体系/质量循环8D方法分析评价方法直至客户的信息流转5W方法故障时间记录P6.5.4 对过程和产品是否定期开展审核？技术规范特殊特性功能过程参数/能力标记，包装确定的过程/程序流程措施和时间监督审核计划表（针对所有部门，针对产品和过程审核）；对于计划内的、以及具体事件触发的审核，应相应加以标记产品审核的频度产品审核的要求提 问 项 目检 查 方 法记 录评价审核结果，审核报告审核核人员资质管理评审过程中的评审结果落实措施前后特性参数的变化过程成果（（Output）过程应取得怎样的成果？？过程成果P6.6 过程应取得怎样的成果P6.6.1 在产品和过程方面，是否满足了客户要求？与客户的质量协议/技术协议客户的具体要求（过程设计任务书）客户针对特殊特性标记的要求发货审核耐久度检验/长期试验（考察失效表现）检验规范仓储/订单处理/零部件供应/发货功能检验检验/测量设备适用性调整的检验方法（测量点，紧固方案，检验工具，...）技术规范的更新状态为达到零缺陷目标而进行的目标约定提 问 项 目检 查 方 法记 录评价P6.6.2 产量/生产批量是否是根据需要确定的，并且被以适当的方式提供给接下来的过程步骤？合适的运输工具定义的仓储位置看板管理Just in Time仓库管理变更状态产量记录/分析评价仓库库存根据客户需求调整产量P6.6.3 是否根据实际需要对产品/零部件进行了仓储，所使用的运输工具/包装设备是否与产品/零部件的特殊特性相互适应？仓储量防止损伤的产品防护零部件定位整洁，清洁，过量装填（仓储位置，容器） 监控仓储时间环境因素的影响具体客户的包装要求（提供的包装材料） 有关可用库存的信息备用包装P6.6.4 对必要的记录/ 放行是否进行了管理，并且相应开展了存档？客户技术规范特殊特性，客户针对标记的要求过程描述文献记录表，包括不同文件和记录的保存期限提 问 项 目检 查 方 法记 录 评价客户针对存档期限的要求存放规定/要求（电子格式，印刷体，消防要求，可读性，...）P6.7 P6.7 零部件搬运零部件搬运搬运作业规范受审核过程： 受审过程相关人员： 过程审核总符合率：受审核方代表：审核员：6. 生产（机械加工—过程审核表）过程/要素 提 问 要 求 / 说 明 考 虑 要 点 备 注 6. 生产◇此要素中的每一个提问适用于每一个生产过程◇产品生产过程的每道工序都必须使其技术和人员素质达到所策划的要求，并加以监控。
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ME/PROD ME PROD PROD ALL
Findings / Notes :
ME ME PROD PE PE ME/PROD ME PROD
9 10 11 12 13 14
Was 1st piece approval accomplished on first attempt? Tolerances within range of machine used? Inspection gages available and adequate? Gages tagged/calibrated? Tooling and fixtures available and in good conditions? Are the inspections recorded or log-in? Employee gages certification is current? SAFETY
PROCESS / ROUTING MACHINING AUDITS
DATE DEPT / AREA PART NO OPERATION # EMPLOYEE AUDITORS
Item DOCUMENTATION
1 2 3 4 5 6 7 8
Description
Yes
No
Байду номын сангаас
N/A
Auditor
Production Rate correct at ±20% per historical data, cycle check or time study? Operation description adequate/correct on Routing? Operations performed in correct Work Center? BOM correct? Correct material being used? Drawing features, dimensioning clear to operator? Layout/Set-up sheet provides adequate information and it is being followed? Set-up time reasonable at ±20% per historical data? Is Close Process Checklist applicable/followed? INSPECTION / TOOLS / GAGES
PROD PROD ME/PROD
18 19 20 21 22
CNC Program correct and followed? Current WO/Part Number is the only programm in the CNC? Completed operations signed-off? Are Non-Conformance parts identified/labeled and segregated? Area clean/organized? No food or open drinks.
PE PE QA TOOL/PROD QA PROD
15 16 17
Are chemicals used properly identified and labeled? (oils, greases, etc) Are the chemicals being used within the expiration date? Operator wearing proper PPE? (safety glasses, gloves, safety shoes, etc) PROCESS