跟踪验证报告
Non-conformity Number
符合项编号
Number
编号
1
of
14
Classification
类别
Major 严重
Minor轻微
Process过程
M4 内部审核
IATF Clause
IATF条款
9.2.2.4
QMS Document reference
QMS 参考文件
IP-0313
Document issue
文件版本
A1
Statement of nonconformity
不符合项陈述
产品审核未有完全有效实施
CSR or IATF Requirement
CSR 或IATF要求
9.2.2.4 Product audit
The organization shall audit products using customer-specific required approaches at appropriate stages of production and delivery to verify conformity to specified requirements. Where not defined by the customer, the organization shall define the approach to be used.
Objective Evidence
客观证据
最近一次对顾客xx的产品审核,其产品Φ12.7×1.2×5150对应的顾客订购单要求产品满足<xx环保标准>,顾客特殊要求<品质协议书>4.6环保要求也有规定,其产品审核对此要求未有进行验证。
Justify classification minor or major
严重或轻微分类的理由
Auditor raising NC
提出不符合项的审核员:
For completion by Client
顾客完成
Containment/Corrections within 15 days:
15天内的遏制/纠正
1、查此批材料已全部发货至xx顾客,品质客诉专员2018年3月31号通过电话与xx顾客品质部李x沟通,顾客回复进料检验和生产使用均无异常,环保检测也无异常。
2、将顾客的环保要求加入到《产品质量审核检验计划表》并于2018年4月3日进行审核。经对2017年6月15日材料的ROHS测试报告(报告#KA/2017/60849)比对,结果显示符合xx环保标准。(见附件:表单编号FM-351《产品质量审核检验计划表》、编号KA/2017/60849 RoHS报告)
Root cause including methodology used, analysis, and results:
根本原因分析包括使用的方法,分析和结果
1、为什么xx产品审核未进行产品环保要求的验证?
因为:《产品质量审核检验计划表》没有列出客户对环保的要求。
2、为什么《产品质量审核检验计划表》没有列出客户对环保的要求?
因为:因为策划人员对客户的要求识别不全。
3、为什么策划人员对客户的要求识别不全?
因为:IP-0313《内部审核作业程序》文件对产品审核准则不完善。(文件条款:6.3.4产品审核内容为产品尺寸、功能、包装和标签,以产品图纸、工艺规程、作业指导书所规定的内容为准)未对环保要求进行要求。
根本原因:产品审核依据准则不完善。
implemented systemic corrective actions to eliminate each nonconformity, including consideration of the impact to other similar processes and products:
已实施的为消除每个不符合项所采取的系统性的纠正措施,
括考虑了对其他类似过程和产品的影响
1.修改IP-0313《内部审核作业程序》文件,增加4.4产品审核准则:产品审核项目须依据客户品质协议书、交易合同、客户订单、产品图纸、客户环保标准等要求为准则,产品审核时依据审核准则制定产品审核计划表,进行审核验证,并于2018年04月08日发行执行。见附件修改后的IP-0313《内部审核作业程序》
2.2018年04月10日依据新发行《内部审核作业程序》重新对xxxx共4家汽车客户产品审核补充环保要求审核 ,审核验证全部共4家汽车客户均符合客户要求--见附件《产品审核检验报告》。
verification of effectiveness of implemented corrective actions
对纠正措施有效性的验证
纠正及遏制:
1.已将顾客的环保要求加入到《产品质量审核检验计划表》,并于2018年4月10日进行审核。经对报告日期为2017年6月15日材料的ROHS测试报告(报告#KA/2017/60849)比对,结果显示符合彩虹环保标准。
纠正措施:
1.2018年04月08日修改后IP-0313《内部审核作业程序》已发行,版本由A1变更为A2,4.4产品审核准则:产品审核项目须依据客户品质协议书、交易合同、客户订单、产品图纸、客户环保标准等要求为准则,产品审核时依据审核准则制定产品审核计划表,进行审核验证。--见附件修改后的IP-0313《内部审核作业程序》
2. 查编号FM-405《产品审核检验报告》xx、盛x、伟x业、x兴产品审核检验报告中有列入环保要求项目进行审核,审核结果为合格,符合客户要求
To be completed by SGS Auditor
由SGS审核员完成
Conclusion Acceptable
结论可以接收
Yes / No / 100% resolved with on site special audit required 100% 解决安排一个特殊审核
Objective evidence reviewed by SGS Auditor:
SGS审核员评审的客观证据
For Major non-conformities client corrections (containment)
对于严重不符合项,顾客纠正(遏制措施)
In exceptional case(s) when nonconformity is open but 100% resolved explain justification, action plan completion dates特殊情况下,不符合项处于开放但100%解决时,解释理由,措施计划的完成日期。
Agree follow-up audit date on site prior to the next visit by SGS Auditor
SGS审核员同意的在下次审核前的现场验证审核日期
Auditor must confirm date for the next special audit and this entered here for scheduling in Certnet
审核员必须确认下一次特殊审核日期,把该日期输入这里以便于Cernet计划员输入。
Evidences checked at the additional on site audit to close NCs previously considered 100% resolved
额外的现场审核确认的证据以关闭上次认为的100% 解决的不符合项
This section to be left blank if there were no NCs considered 100% resolved
Auditor must record objective evidence checked, not just reference 8D or see action plan
e.g. ID number, issue date, revision number, to evidences, action plans, documents and records reviewed
如果没有不符合项为100% 解决,本栏目可以留白。审核员必须记录评审过的客观证据,不能仅参考8D或看行动计划。例如:评审过的证据,行动计划,文件和记录的ID编号,发行日,版本号,
Non-conformity Number
不符合项编号
Number
编号
2
of
14
Classification
类别
Major 严重
Minor轻微
Process过程
M1公司环境
IATF Clause汽车附件
IATF条款
4.3.2;7.5.1.1
QMS Document reference
QMS 参考文件
IG
Document issue
文件版本
D/1
Statement of nonconformity
不符合项陈述
顾客特殊要求未有充分识别
CSR orIATF Requirement
CSR 或IATF要求
4.3.2 Customer-specific requirements
Customer-specific requirements shall be evaluated and included in the scope of the organization’s quality management system.
7.5.1.1 Quality management system documentation
The organization’s quality management system shall be documented and include a quality manual, which can be a series of documents (electronic or hard copy).
The format and structure of the quality manual is at the discretion of the organization and will depend on the organization’s size, culture, and complexity. If a series of documents is used, then a list shall be retained of the documents that comprise the quality manual for the organization.
The quality manual shall include, at a minimum, the following:
a) the scope of the quality management system, including details of and justification for any exclusions;
b) documented processes established for the quality management system, or reference to them;
c) the organization’s processes and their sequence and interactions (inputs and outputs), including type and extent of control of any outsourced processes;
d) a document (i.e., matrix) indicating where within the organization’s quality management system their customer-specific requirements are addressed.
NOTE A matrix of how the requirements of this Automotive QMS standard are addressed by the organization’s processes may be used to assist with linkages of the organization’s processes and this Automotive QMS.
Objective Evidence
客观证据
xx《品质协议书》,其识别为顾客特殊要求,但此协议条款4.4 4M变更、4.5 初物品管理要求、4.6环保的内容未有体现在《顾客特殊要求清单》、《顾客特殊要求矩阵》中。
Justify classification minor or major
严重或轻微分类的理由
Auditor raising NC
提出不符合项的审核员:
For completion by Client