TS16949审核不合格项，请各位给点建议！

"Requirement: The organization shall establish and implement the inspection or other activities necessary for ensuring that
purchased product meets specified purchase requirements…
Failure: The supplier monitoring and purchasing material inspection process was not always conducted sufficiently
Evidence:

1. No evidence demonstrated that the supplier quality management system developed with the goal of supplier

conformity with this Technical Specification.

1. 没有证据显示是以本标准作为供应商体系开发为目标
2. According to the on-site supplier audit report, it was shown:

根据现场供应商审核报告显示：
a) The ranking was not compliance /打分不一致
b) The meaning of the questionnaire with star was not understood/带星号的提问的含义不清楚

1. The delivery performance of the supplier was not monitored sufficiently
2. 供应商的交付表现的监控没有很好地实施

4.The without inspection list of the material was not updated timly. E.g. LGW-125

1. 免检清单没有及时更新。例：LGW-125
2. The incoming inspection method of the material ∮8 1.05 台阶 was not compliance with the WI

5.橡胶塞∮8 1.05 台阶的 进料检验方法和作业指导书不一致

1. The sample approval for the new material ""不干胶标识卡"" was not availiable

新材料""不干胶标识卡""的样品批准没有实施
"
"Requirement: The organization shall prepare contingency plans to satisfy customer requirements in the event of an
emergency such as utility interruptions, labour shortages, key equipment failure and field returns.
Failure: The contingency plan was not prepared sufficiently
Evidence:
The exist contingency plan could not reflect the actual situation
现存的应急计划不能反应实际的状况"
"Requirement要求: Customer satisfaction with the organization shall be monitored through continual evaluation of performance of
the realization processes. Performance indicators shall be based on objective data and include, but not be
limited to:
delivered part quality performance,
customer disruptions, including field returns,
delivery schedule performance (including incidents of premium freight), and
customer notifications related to quality or delivery issues.
Failure 失效: The customer satisfaction survey process was not fully effectively implemented.
Evidence 证据:
1,There was no objective data sucha as quality performance, field returns and customer notification for monitoring the performance for customer satisfaction.在顾客满意度监控过程中，没有质量表现，退货和顾客通知等相关的客观数据。
2,There was no data analysis for automotive customer satisfaction in 2012. 汽车客户2012年的满意度调查后，没有对数据进行汇总分析。
"
"Requirement要求: The organization shall use a multidisciplinary approach to prepare for product realization, including
development/finalization and monitoring of special characteristics,
development and review of FMEAs, including actions to reduce potential risks, and
development and review of control plans.
Failure 失效: The FMEA development process was not fully effectively implemented.
Evidence 证据:
1, The failure mode lifetest failure was not taken into consideration in the DFMEA for product NB50V22.
失效模式寿命失效没有在产品NB50V22的DFMEA中加以考虑。
2, The dection level was different for the same dection method such as sample testing， the dection level was judged as 2 or 3, and according to the FMEA control procedure(Fileno#AHYY/MSP-19,Rev.:B0), the dection level shoud be 5.
同样的探测方式，但却又不同的评分，如探测方法为样品测试，打分有2分和3分的。但是按照公司文件《FMEA控制程序》（文件编号：AHYY/MSP-19,Rev.:B0），应评分为5.
3,In PFMEA(Fileno#AHYY/WIE1026/A3), the seriousness level was reduced from 8 to 4 for the process electrolyte immersion, but there was no design revision at all.
在PFMEA(文件编号:AHYY/WIE1026/A3)中，过程浸电解液的严重度由8降为4，但是没有任何的设计更新。"
"Requirement:
The organization shall plan and carry out production and service provision under controlled conditions. Controlled conditions shall include, as applicable
Failure:
The production control was not effectively implemented.
Evidence:
The heating time for 400WV100昀 22*30 is 1.5H±10min (80-100min) per the requirement of Impregnation WI (AHYY/WIQ3002/A0), but it was found in the production record of Feb. 17, 2013, the actual heating time is 2H (120min).
根据含浸作业指导书AHYY/WIQ3002/A0的要求：400WV100昀 22*30电容的烘烤时间要求为1.5H±10min, 2月17日的生产记录显示：该产品的实际烘干时间为2H。
"
"Requirement:
The organization shall identify key process equipment and provide resources for machine/equipment maintenance and develop an effective planned total preventive maintenance system.

• planned maintenance activities,

Failure:
Equipment daily checking was not effectively implemented.
Evidence:
There are 2 Tension Meter (P1P2 & P3P3) in the Winding machine of Snap-in, but only 1 meter was included in the Equipment Daily Checking Form.
Snap-in 钉卷机上纸张力压力表有P1P2和P3P4两块压力表，但相应的“日常点检表”中只有一块压力表的点检记录（没有办法区分对哪块表进行了点检）。
"
"Requirement要求: Design and development validation shall be performed in accordance with planned arrangements (see
7.3.1) to ensure that the resulting product is capable of meeting the requirements for the specified
application or intended use, where known. Wherever practicable, validation shall be completed prior to the
delivery or implementation of the product. Records of the results of validation and any necessary actions
shall be maintained (see 4.2.4).

Failure 失效: Design validation for non-auto product was not always effective. 设计确认不是始终有效。
Evidence 证据: For product CD11GAS350V 10x18 to Philips, according to procedure AHYY/NSP-07, rev. B1, a customer acknowledgment
sheet shall be prepared and got customer signed. However this acknowledgment was not sighed by client or its representitive. 产品CD11GAS350V 10x18 Philip 没有按程序AHYY/NSP-07， rev. B1获得客户或其代表签字的承认书。"
"Requirement要求: The organization shall maintain manufacturing process capability or performance as specified by the customer
part approval process requirements.

Failure 失效: Process capability was not always effectively maintained. 过程能力不是始终有效维持。
Evidence 证据: According to contro plan for product CD11 GAS 350V, contact resistance was addressed as special characteristics, however this measurement result though acquired in system however xbar-R chart showed not in control status. Control limits was not fixed status. Relevant staff not competent identified abmormal variation. 产品 CD11 GAS 350V有按照控制计划做检查并自动录入系统， 但xbar-R图显示过程不受控， 很多查控制线情况， 控制线也不固定， 现场检验人员也不能有效识别异常信号。 "