Report No:
报告编号: 2007TS0176 Number:
序号: JZH-02 0 Major 严重 1 Minor 轻微
Has this nonconformance occurred in the recent past? yes__ no X
以前有没有发生过这个不符合项?
REQUIREMENT (Statement of or reference to specific requirement in standard and/or customer document): 要求(对标准和/或客户要求的描述):
7.5.1 Control of production and service provision 生产和服务提供的控制
NONCONFORMANCE (Statement of nonconformance to above requirement): 不符合(对上述要求的不符合事实的描述)
The controls used for the manufacturing process in the control plan did not conform to the actual operation.
控制计划中制造过程控制的控制方法与实际操作不一致.
OBJECTIVE EVIDENCE (Statement of or reference to examples/evidence): 客观证据(事例/证据的阐述或引用)
E.g.: On minutely grinding two planums process, the requirement of process sample (P/N: MR479Q-0201200) is 5PCS/shift on control plan, but in actual the first inspection is 3PCS, process inspection is 4PCS/4 Hours, end inspection is 3PCS.
如:在精磨两平面工序中,产品MR479Q-0201200的控制计划要求每班检五只,但是实际上现场首检为3只,过程检验为4只/4小时,末检为3只。
Date Opened 报告Date 日期:October 17, 2007 Response Due Date Response Due Date 整改期限:30 days
Interim Containment Action 临时遏止措施:
1、 办公室负责将产品MR479Q-0201200旧的《控制计划》收回,并作好回收记录。The General Office shall be responsible for recalling the obsolete “Control Plan” of product MR479Q-0201200 and maintaining a recalling record.
2、 技术部负责修订产品MR479Q-0201200的《控制计划》,将精磨两平面工序对应“样本频率”栏“班/次”改为“首检、巡检、末检”;“样本容量”栏“5件”改为各“3~5件”。 修订后的《控制计划》已经项目小组组长批准,并由办公室下发。The Technology Dept. shall be responsible for revising the “Control Plan” of product MR479Q-0201200 by changing “5 pcs” into “3-5pcs” in “Sample Capacity” column and “Shift/Times” into “FI, PI, EI” in the “Sample Frequency” corresponding to minutely grinding two planums process; The revised “Control Plan” is issued subject to the approval from the Project Team Leader.
3、 由办公室组织相关人员学习修订后的《控制计划》。 The General Office organizes relevant employees to study the revised “Control Plan”.
Response Due Date: 7days 整改期限:7天 Implementer:执行人:
Date: Oct. 18, 2007 日期:2007年10月18日
Validated Interim Containment Action 验证临时遏止措施:
1、 办公室已将产品MR479Q-0201200旧的《控制计划》收回,并作好回收记录。The General Office has recalled the obsolete “Control Plan” of product MR479Q-020120 and has maintained a record.
2、 技术部已修订产品MR479Q-0201200的《控制计划》,办公室已下发。 The Tech. Dept. has revised the “Control Plan” of product MR479Q-020120 and has issued it.
3、 办公室已组织相关人员学习修订后的《控制计划》。The General Office has organized relevant employees to study the revised “Control Plan”.
Effectiveness有效性: 100%
Date: Oct. 25, 2007 日期:2007年10月25日
根本原因分析 (RCA):
1、控制计划的评审小组中没有来自生产一线的人员,所以不能够及时发现控制计划与生产实际的不吻合,主要原因是《产品质量先期策划控制程序》5.4.7中对控制计划的评审人员组成规定不够清晰,仅仅要求有来自生产部门的人员,导致了工作的失误。There is no member directly involved in the production in the review panel of Control Plan, resulting in the failure to find that the Control Plan doesn’t comply with practical production. The root cause is that the make-up of the Control Plan review panel has been unclearly defined in 5.4.7 of “Product Quality Pre-Planning Control Program” which roughly requires the member shall be from the production departments.
Chosen Permanent Corrective Action 选择永久性纠正措施:
1、办公室立马将旧的《产品质量先期策划控制程序》收回,并作好回收记录。The General Office immediately recalls the obsolete “Product Quality Pre-Planning Control Program” and maintains a recalling record.
2、技术部修订《产品质量先期策划控制程序》,在5.4.7最后增加:“控制计划采用多方论证的评审方法,评审小组人员至少应当包括生产一线的员工。”经管理者代表批准后由办公室实施下发。The Tech. Dept. revises the “Product Quality Pre-Planning Control Program” by adding “The Control Plan adopts multi-party verification as its review method. The Review Panel shall include at least one member directly involved in the production.” to 5.4.7 which is issued by the General Office subject to the approval of Management Representative.
Response Due Date: 9 days 整改期限:9 天
Validated Permanent Corrective Action 验证永久性纠正措施:
1、办公室已将旧的《产品质量先期策划控制程序》收回,将修订后的《产品质量先期策划控制程序》下发,并填写好了《文件发放/回收登记表》。The General Office has recalled the obsolete “Product Quality Pre-Planning Control Program” and issued the revised “Product Quality Pre-Planning Control Program” while maintaining a “File issuing/recalling registry form “.
2、技术部已对《产品质量先期策划控制程序》进行修订。The Tech. Dept. has revised the “Product Quality Pre-Planning Control Program”
Systemic Prevent Action 系统预防措施:
1、对其他产品的控制计划进行检查,并对相关人员进行培训,防止类似事件发生。Conduct a check for Control Plan of other products and train relevant persons to prevent re-occurrence of the like incidences.
2、由管理者代表组织相关人员学习、培训修订后的《产品质量先期策划控制程序》,办公室负责培训工作的实施和培训后的考核评价。 The management representative organizes relevant persons to study the revised “Product Quality Pre-Planning Control Program” and the General Office shall be responsible for the implementation of training as well as the post-training examination and assessment.
Impersonality attestation list 客观证据清单:
(4)附件4 《文件发放/回收登记表》Attachment 4 File issuing/recalling registry form
(12)附件12 更改后的《产品质量先期策划控制程序》Attachment 12 Revised “Product Quality Pre-Planning Control Program”
(13)附件13 更改后的《控制计划》Attachment 13 Revised Control Plan
(1)附件1 《培训记录表》 Attachment 1 Training Record
ISO/TS16949 审核不符合项
纠正/预防措施报告
Report No:
报告编号: 2007TS0176 Number:
序号: JZH-01 0 Major 严重 1 Minor 轻微
Has this nonconformance occurred in the recent past? yes__ no X
以前有没有发生过这个不符合项?
REQUIREMENT (Statement of or reference to specific requirement in standard and/or customer document): 要求(对标准和/或客户要求的描述):
7.3.6.3 Product approval process产品批准过程
NONCONFORMANCE (Statement of nonconformance to above requirement): 不符合(对上述要求的不符合事实的描述)
PAP did not apply to the all suppliers.
生产件批件过程不能被应用于所有的供方.
OBJECTIVE EVIDENCE (Statement of or reference to examples/evidence): 客观证据(事例/证据的阐述或引用)
The rough supplier () and the plastic parts supplier () can not supply the PPAP.
毛坯的供方()和塑料件供方() 不能提供PPAP.
Date Opened 报告Date 日期:October 17, 2007 Response Due Date Response Due Date 整改期限:30 days
Validated Interim Containment Action 验证临时遏止措施:
1、供销部已制定《关于A类供应商提交PPAP的函告》的文件。The Supply and Marketing Dept. has prepared the “ Letter to Inform Class A Suppliers to Submit PPAP”
根本原因分析 (RCA):
1、《供方选择和评价控制程序》只规定必须对于供方应用PPAP,但是没有明确规定PPAP的时机以及信息传递的责任单位,导致没有相关人员要求MR479Q连杆毛坯的供方(温州江北锻造有限公司)和1706336油泵总成盖的供方(台州嘉顺塑业有限公司) 提交PPAP。The Supplier Selection and Assessing Control Program has only stated the suppliers shall use PPAP but neither clearly specified the time to submit PPAP and nor given the department to be responsible for the communication of information, resulting in failure to request the supplier of MR479Q rough (Wenzhou Jiangbei forging Co., Ltd) and the supplier of 1706336 oil pump cover (Taizhou Jiasun plastics Co., Ltd) to submit PPAP.
Chosen Permanent Corrective Action 选择永久性纠正措施:
1、由办公室将旧的《供方选择和评价控制程序》收回,并作好回收记录。The General Office shall be responsible for recalling the obsolete “Supplier Selection and Assessing Control Program”and maintaining a recalling record.
2、修订《供方选择和评价控制程序》5.2.2规定:“在批量认可前,由供销部制定《关于A类供应商提交PPAP的函告》的文件,通知供应商提交PPAP并且负责跟踪”,经管理者代表批准后由办公室下发,并填写《文件发放/回收登记表》。Revise the stipulation of 5.2.2 of “Supplier Selection and Assessing Control Program”: “Prior to mass-approval, the Supply and Marketing Dept. shall prepare a “Letter to Inform Class A Suppliers to Submit PPAP” document which shall be issued by the General Office subject to the approval of management representative to inform the suppliers to submit PPAP and be responsible for tracing. A “File Issuing/Recalling Registry Form” shall be filled out.
3、管理者代表组织相关人员学习修订后的《供方选择和评价控制程序》。The management representative organizes relevant persons to study the revised “Supplier Selection and Assessing Control Program”
Validated Permanent Corrective Action 验证永久性纠正措施:
1、办公室已将旧的《供方选择和评价控制程序》收回,将修订的《供方选择和评价控制程序》下发,并填写好了《文件发放/回收登记表》。The General Office has recalled the obsolete “Supplier Selection and Assessing Control Program”, issued the revised “Supplier Selection and Assessing Control Program” and filled out the “File Issuing/Recalling Registry Form”.
2、供销部已修订好《供方选择和评价控制程序》,经管理者代表批准后由办公室下发到相关部门。The Supply and Marketing Dept. has revised the “Supplier Selection and Assessing Control Program” which has been issued by the General Office subject to the approval of management representative.
Systemic Prevent Action 系统预防措施:
1、对其他A类供应商提交PPAP情况进行检查,防止类似事件发生。Conduct a check over other Class A suppliers against the submitting situation of PPAP in order to prevent the reoccurrence of the like incidence.
Impersonality attestation list 客观证据清单:
(7)附件7 Attachment 7 《关于A类供应商提交PPAP的函告》 Letter to Inform Class A Suppliers to Submit PPAP
(8)附件8 Attachment 8 温州江北锻造有限公司提交MR479Q连杆毛坯的PPAP文件PPAP documents concerning MR479Q rough submitted by Wenzhou Jiangbei forging Co., Ltd.
(9)附件9 Attachment 9 台州嘉顺塑业有限公司提交1706336油泵总成盖的PPAP文件PPAP documents concerning 1706336 oil pump cover submitted by Taizhou Jiasun plastics Co., Ltd.
(10)附件10 Attachment 10《文件更改通知单》Document Chang Notice
(11)附件11 Attachment 11修订后的《供方选择和评价控制程序》Supplier Selection and Assessing Control Program
(4)附件4 Attachment 4《文件发放/回收登记表》 File Issuing/Recalling Registry Form
ISO/TS16949 审核不符合项
纠正/预防措施报告
Report No:
报告编号: 2007TS0176 Number:
序号: JM01 0 Major 严重 1 Minor 轻微
Has this nonconformance occurred in the recent past? yes__ no X
以前有没有发生过这个不符合项?
REQUIREMENT (Statement of or reference to specific requirement in standard and/or customer document): 要求(对标准和/或客户要求的描述):
7.6.1 of ISO/TS 16949
NONCONFORMANCE (Statement of nonconformance to above requirement): 不符合(对上述要求的不符合事实的描述)
MSA没有包括所有的测量系统。
MSA was not covered all measuring and test equipment system.
OBJECTIVE EVIDENCE (Statement of or reference to examples/evidence): 客观证据(事例/证据的阐述或引用)
审核JL376Q1004300连杆的APQP发现,气动量仪测量系统没有进行MSA。
Referring to the APQP of connecting rods (PN/ JL376Q1004300), the Pneumatic dimension test machine Measurement system was not implemented MSA.
Interim Containment Action 临时遏止措施:
1、停止检验。立即对气动量仪进行量具重复性和再现性分析。 Stop inspection. Conduct an immediate analysis on the measuring repeatability and reproducibility of Pneumatic dimension test machine.
Response Due Date: 15 days 整改期限:15 天
Validated Interim Containment Action 验证临时遏止措施:
1、品质部计量室已对气动量仪进行了重复性和再现性分析(详见《气动量仪的MSA报告》),结果显示可用于测量过程变差。The Quality Department has conducted a repeatability and reproducibility analysis on the
Pneumatic dimension test machine (refer to “MSA Report of Pneumatic dimension test machine” for details). The results show the machine is capable for measuring process variation.
Effectiveness有效性:100%
根本原因分析 (RCA):
1、三层支持性文件《MSA分析作业规范》中规定的MSA研究对象为:“控制计划中规定的测量特性”,这样的规定比较模糊容易导致工作的失误。The MSA study objects are specified in the supportive document “MSA Analysis Specifications” as follows: “The measuring features specified in the Control Plan” which is not clear enough and may lead to mal-operation.
2、对MSA计划的审批没有具体规定,工作存在一定的随意性,导致气动量仪没有列入MSA计划。No rule on the approval of MSA plan is available, which leads to arbitrariness in work and results in the failure to involve Pneumatic dimension test machine in the MSA plan.
Chosen Permanent Corrective Action 选择永久性纠正措施:
修改《MSA分析作业规范》 The revised “ MSA Analysis Specifications”:
1、 将“控制计划中规定的测量特性”修改为“控制计划中规定的每种类型的测量设备” Change “ The measuring features specified in the Control Plan”into “Measuring equipment of various kinds specified in the Control Plan”。
2、 明确计量室主管负责MSA计划的审核,品质部部长负责MSA计划的批准。To define the chief of measuring unit as the reviewer of MSA plan and the director of Quality Dept. as the approver of MSA plan.
Validated Permanent Corrective Action 验证永久性纠正措施:
1、已修改《MSA分析作业规范》。“MSA Analysis Specifications”has been revised.
2、在《MSA分析作业规范》中已明确了计量室主管负责MSA计划的审核,品质部部长负责MSA计划的批准,并通过审核,补充了对气动量仪的重复性和再现性分析。In the “MSA Analysis Specifications”, it has been clearly defined that the chief of measuring unit is the reviewer of MSA plan and the director of Quality Dept. is the approver of MSA plan, which has been approved. Has added repeatability and reproducibility analysis on the Pneumatic dimension test machine.
Implementer: Mao Ronghua 执行人:茅荣华
Date: Oct. 26, 2007 日期:2007年10月26日
Systemic Prevent Action 系统预防措施:
1、举一反三检查其他测量系统的MSA,检查结果无类似问题。Check other measuring system’s MSA and find no like problem existing.
2、组织测量系统分析的相关人员培训学习理论知识和修改后的《MSA分析作业规范》。Organize the relevant persons engaged in measuring system analysis to study theories and the revised “MSA Analysis Specifications”.
Date: Dec. 4, 2007 日期:2007年11月4日
Impersonality attestation list 客观证据清单:
(1)附件1《培训记录表》 Attachment 1 Training Record Form
(2)附件2 气动量仪的MSA报告 Attachment 2 MSA report on the Pneumatic dimension test machine
(3)附件3 修改后的《MSA分析作业规范》 Attachment 3 the Revised “ MSA Analysis Specifications”
ISO/TS16949 审核不符合项
纠正/预防措施报告
Report No:
报告编号: 2007TS0176 Number:
序号: JM02 0 Major 严重 1 Minor 轻微
Has this nonconformance occurred in the recent past? yes__ no X
以前有没有发生过这个不符合项?
REQUIREMENT (Statement of or reference to specific requirement in standard and/or customer document): 要求(对标准和/或客户要求的描述):
7.1.1 of ISO/TS 16949
NONCONFORMANCE (Statement of nonconformance to above requirement): 不符合(对上述要求的不符合事实的描述)
Customer requirements and references to its technical specifications do not be included in the planning of product realization as a component of the quality plan.
顾客要求和引用的顾客技术规范没有包括在产品实现的策划中作为质量计划的一部分。
OBJECTIVE EVIDENCE (Statement of or reference to examples/evidence): 客观证据(事例/证据的阐述或引用)
审核JL376QE-1005101曲轴的APQP发现,顾客图纸要求的产品硬度为HB225-305但是进货检验规范规定硬度为HB241-321,进一步审核发现最终检验按照产品图纸进行。
Referring to the APQP of crankshaft (PN: JL376QE-1005101), the hardness bust be HB225-305 required by customer drawing, however the incoming inspection spec ordain the hardness as HB241-321.The further audit found that final inspection was according to the drawing.
Interim Containment Action 临时遏止措施:
1、品质部立马停止对现场JL376QE-1005101曲轴硬度的检验,并将此批产品隔离、标识。The Quality Dept. stops the inspection of hardness of crankshaft (PN: JL376QE-1005101) and segregate and identify this lot.
2、技术部马上组织相关人员对JL376QE-1005101曲轴硬度实际值的确认。The Tech. Dept. organizes a confirmation of actual hardness of crankshaft (PN: JL376QE-1005101).
3、品质部按实际硬度值对隔离、标识的曲轴进行复检。The Quality Dept. conducts a re-inspection on the segregated and identified crankshafts according to their actual hardness.
Validated Interim Containment Action 验证临时遏止措施:
1、品质部已停止对现场JL376QE-1005101曲轴硬度的检验,并已隔离、标识。The Quality Dept. has stopped the inspection of hardness of crankshaft (PN: JL376QE-1005101) and segregated and identified this lot.
2、经技术部及相关人员的确定,《控制计划》及顾客图纸要求硬度为HB225-305是正确的。The Tech. Dept. and relevant persons confirm that the hardness of HB225-305 specified in the Control Plan and the Customer’s drawing is correct.
3、对隔离、标识的产品按顾客图纸要求复检,发现此批产品都是合格的,故此批产品可以出库。The re-inspection on the segregated and identified crankshafts according to the customer’s drawing finds that this lot is qualified, and thus be allowed for delivery.
4、产品追溯:无。因为最终检验都按顾客图纸要求检验的,所以不会将不合格产品发往客户。Product Tracing: N/A. Because the end inspection is according to customer’s drawing, it’s impossible to deliver unqualified products to the customer.
Effectiveness有效性:100%
根本原因分析 (RCA):
1、《文件控制程序》对文件的一致性审查规定的不够详细,使得在批准《进货检验规程》时没审查它与顾客图纸
是否一致,导致了错误的产生。The “File Control Program” has failed to define the file consistency reviewing in details, which leads to the failure to review whether the “Incoming Inspection Spec.” is consistent with the customer’s drawing when approving it, and results in mal-operations.
Date: Oct. 18, 2007 日期:2007年10月18日
Chosen Permanent Corrective Action 选择永久性纠正措施:
1、办公室马上将JL376QE-1005101曲轴的《进货检验规程》和《文件控制程序》收回,并作好回收记录。The General Office recalls the File Control Program and the Incoming Inspection Spec. of crankshaft (PN: JL376QE-1005101), and maintains a recalling record.
2、技术部负责将JL376QE-1005101曲轴的《进货检验规程》中硬度值改为HB225-305,经管理者代表批准后由办公室下发,并作好下发记录。The Tech. Dept. is responsible for changing the hardness in the Incoming Inspection Spec. of crankshaft (PN: JL376QE-1005101) into HB225-305 which is issued by the General Office with an issuing record subject to approval from the management representative.
3、修改《文件控制程序》,对文件的一致性审查作详细规定,将5.3.3②“各文件之间是否协调;”改为“审查各文件之间如各类检验规程是否与其《控制计划》、顾客图纸等一致。” Revise the File Control Program and define the file consistency review in details by changing 5.3.3② “ whether various files are compatible” into “ To review the consistency between various files such as various inspection specifications are consistent with the Control Plan and the customer drawing or not.”
4、管理者代表组织相关人员学习修改后的《进货检验规程》和《文件控制程序》。The management representative organizes relevant persons to study the revised Incoming Inspection Spec. and the File Control Program.
Response Due Date: 5 days 整改期限:5 天
Date: Oct. 19, 2007 日期:2007年10月19日
Validated Permanent Corrective Action 验证永久性纠正措施:
1、办公室已将JL376QE-1005101曲轴的《进货检验规程》和《文件控制程序》收回,将修改好的《进货检验规程》和《文件控制程序》下发,并填写好了《文件发放/回收登记表》。The General Office has recalled the File Control Program and the Incoming Inspection Spec. of crankshaft (PN: JL376QE-1005101), issued the revised File Control Program and the revised Incoming Inspection Spec. and filled out the File Issuing/Recalling Registry Form.
2、相关人员已学习过了修改后的《进货检验规程》和《文件控制程序》。Relevant persons have studied the revised Incoming Inspection Spec. and the File Control Program.
Date: Oct. 24, 2007 日期:2007年10月24日
Systemic Prevent Action 系统预防措施:
1、检查其他产品的《进货检验规程》,是否与控制计划及顾客图纸等一致,防止类似事件发生。Check the Incoming Inspection Spec. of other products for consistency with the Control Plan and customers’ drawing to prevent reoccurrence of like incidences.
Date: Oct. 25, 2007 日期:2007年10月25日
Impersonality attestation list 客观证据清单:
(4)附件4 《文件发放/回收登记表》Attachment 4File Issuing/Recalling Registry Form
(5)附件5 更改后的《进货检验规程》Attachment 5 Revised Incoming Inspection Spec.
(6)附件6 更改后的《文件控制程序》Attachment 6 Revised File Control Program
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