FBP-GPO101Advance to Next Audit Section 转入下一个稽核部分
SELF AUDIT ONL  3. Quality Management Organization 品质管理体系证据栏只能用英文填写
Item # 条款Question 问题点Self Assess
自评Audit 审核
Comments/Evidence 评论/证
据  1 - Deficient 不完善  2 - Marginal 接近可接受  3 - Acceptable 可接受  4 - Preferred 较完善  5 - World Class 世界级
Item # 条
款
3.01Does the supplier have a Quality Policy; is it communicated to all personnel, and regularly reviewed/maintained?
是否有质量方针；并传达给所有的职员工，且是否有规律地进行审查/维护?
43Documented policy; reviewed as
needed; communicated at
orientation.#
No policy.无品质方针
Undocumented policy; no regular review;
communicated verbally.
品质方针没有文件化，无定期的审核,
口头上的交流.
Documented policy; no regular review;
communicated in intranet.
有品质方针程序，没有规律的审核，内
部网络交流。
Documented policy; reviewed as needed;
communicated at orientation.
有品质方针程序，根据需要审核，全方
位交流。
Documented policy; reviewed yearly;
communicated quarterly.
有品质方针程序，年度审核，季度交流
。
3.01
3.02Does the supplier have an organization chart with responsibilities assigned?
是否有有责任分配的组织结构图.
42
Management chart with
responsibilities.#
No chart available.没有组织结构图
Limited chart with no responsibilities
有限的组织结构图，且没有职责分配
Limited chart with full responsibilities有职责分
配的简单架构图
Management chart with responsibilities.
有职责分配的管理和所有雇员架构图
Management and employee charts with
responsibilities.
有职责分配的管理和所有雇员架构图
3.02
3.03Is the Supplier's quality control systems adequately documented (e.g. Quality Manual, written inspection / test procedures, etc.)??
质量控制体系是否完全文件化.(如质量手册、书面的检查/测试程序，等等。）
52
Quality Manual; all employees
tested regularly#
No documentation or limited documentation; no
employee review
没有文件化或极少文件化；没有员工
评审
Quality documentation; employees review but
not tested
备有质量文件的证明; 有员工进行评
论但没有进行测试
Quality Manual; employees review but are not
tested.
质量手册; 有员工进行评论但没有进
行测试
Quality Manual; employees receive initial
testing at orientation.
质量手册；员式有接受最初的测试
Quality Manual; all employees tested regularly
质量手册；所有员工有规律的测试
3.03
3.04 Are process capability studies including Failure Mode Effect Analysis (FMEA's)  conducted where applicable? if no, is the Supplier willing to
implement studies?在可以用到的地方是否有包括FMEA在内的流程能力研究，如果没有，是否愿意进行流程能力研究
42
Process capability documented and
occurs as needed#
No formal process capability studies occur没
有流程能力研究
Process capability partially documented and
occurs infrequently流程能力部分文件化,
且很少出现
Process capability documented and occurs
regularly流程能力文件化，且有规律的
出现
Process capability documented and occurs as
needed流程能力文件化，需要时出现
Process capability is built into quality systems
and triggered automatically流程能力是品质
系统的一部分，且自动出现
3.04
3.05 Is the Supplier in possession of all relevant Standards / Specifications applicable  to their type of business (e.g. Welding, Plating standards,
etc.)?是否有所在行业的相关的标准/规格(如；焊接法，电镀标准等等）
43Review of standards occurs
regularly; processes qualified to
standards as needed#
No standards used.没有标准
No formal review of standards; process qual to
standards incomplete标准未经正式的审
核，流程评定标准化不完善
Review of standards occurs as needed;
processes qualified as needed.需要时审核
标准，和流程评定
Review of standards occurs regularly;
processes qualified to standards as needed有
规律的进行标准审核，需要时，流程标
准化
Review of standards built into quality process;
all processes qualified to standards.标准的
审核融进品质流程，所有流程都标准
化
3.05
3.06 Does the supplier perform scheduled product & system audits to assure compliance to defined Quality requirements?
是否进行有计划的产品和系统审核，以保证达到品质要求
43
Audit process documented and
occurs regularly#
No audit system occurring无审核系统
Informal audits occur infrequently很少进行
非正式的内审
Audit process defined and occurs as needed
定义了内审流程，需要时进行内审
Audit process documented and occurs
regularly内审流程文件，且有规律的进
行内审
Audits built into quality systems and occur
automatically内审是品质体系的一部分,
且自动进行内审
3.06
3.07 Are Systems and Product Audit results periodically reviewed by management?
管理层是否有定时性地对系统和产品所审核的结果进行检查。
43
Audit reviews occur regularly.#
No audit reviews occurring没有审核结果
审查
Audit reviews occur irregularly没有规律的
审核结果审查
Audit reviews occur as needed需要时管理
层会审查审核结果
Audit reviews occur regularly.有规律进行
审核结果审查
Audit reviews built into review methodology;
occur automatically审核结果融进审查方
法，且自动的进行审核
3.07
3.08Are Systems and Audit deficiencies subjected to timely Closed Loop Corrective Action?
系统和审核的不足点是否支配于及时终止循环的改善措施。
42Corrective action system
documented; closed within 2
quarters#
No corrective action system无改善行动系
统
Informal corrective action system; not all items
closed
非正式改善行动系统; 且不是所有改
善行动都关闭
Corrective action system documented; closed
within 3 quarters正式的改善行动系统; 且
在三月内才关闭
Corrective action system documented; closed
within 2 quarters改善行动文件化，在两个
月内关闭
Corrective action system built into quality
systems; closed within 1 quarter.改善行动
体系融进品质体系，且一个月内关闭
3.08
3.09Quality Improvement Programs:  Does management have a genuine commitment to develop a quality improvement program that strives for
continuous improvement and zero-defect mentality?
质量改善计划：管理层是否以达到品质持续改善及零缺限的概念来推行品质改善计划。
42
Documented policy with regular
improvements in quality targets#
No policy or targets无品质方针及目标
Informal policy with infrequent changes to
quality targets很少改变品质目标的非正
式品质方针
Documented policy with improvements in
quality targets as needed有品质目标的品
质方针文件，需要时改善
Documented policy with regular improvements
in quality targets有品质目标的品质方针
文件，有规律的改善
Full system with recurring improvements in
quality targets有品质目标的全面品质方
针文件，且连续的改善
3.09
3.10Do the company quality policies meet one of the following standards: ISO 9000 (1994 or 2000), QS9000, or TL9000?
质量方针是否能满足以下的标准体系：ISO9000 （1994或2000），QS9000或TL9000
43
Company certified to one standard;
recerts regularly.#
No certification held or planned没有证书或
计划取得证书
Company in process of certifying.Company in
process of certifying.公司正在申请
Company certified to one standard; recerts as
needed.取得了其中一个认证，需要时换
证
Company certified to one standard; recerts
regularly.取得了其中一个认证，有规律
的换证
Company certified to one or more standards;
automatic recerts.取得了其中一个或多个
认证，有自动的换证
3.10
3.11Does the company's have adequate resources in place to support the quality policy (personnel, skills, equipment, software, etc)?
是否有足够的资源支持品质方针？（人员、技术、设备、软件配置、等等
42
Fully documented policy in place
with fully staffed quality group#
No policy resources无品质方针资源
Informal policy with responsible manager有责
任管理者的非正式品质方针
Fully documented policy in place with quality
managers in place有责任管理者的品质
方针文件
Fully documented policy in place with fully
staffed quality group有足够人员的品质团
队，全面的品质方针文件
Fully automated system in place with fully
staffed quality group有足够人员的品质团
队，自动运行的品质方针文件
3.11
3.12Are quality control plans with critical specifications, statistical requirements, and gauging developed on new products and/or processes?
对新产品或流程是否有控制计划，研究关键的标准，统计要求，测量要求等)?
42Documented system requires
quality system deliverables for
product release.#
No system and no deliverables before product
release没有产品投产前的控制体系及
相应的数据或报告
Limited system with no deliverables required
before release产品投产前，没有要求提供
相应的数据或报告的很有限的体系
Documented system allows discretion on
deliverables before release.有产品投产前
要求判断相应的数据或报告是否可以
生产的文件体系
Documented system requires quality system
deliverables for product release.程序要求产documented evidence
品投产前，有可以使用的品质体系
Automated system requires quality system
deliverables for product release系统自动要
求产品投产前，有可以使用的品质体
系
3.12
3.13Does the company have a formal documentation and change control system? (new document initiation, change initiation, approval,
implementation, recall of obsolete materials, etc)
是否有文件及文件变更控制程序?(文件发放，文件变更发放，审批，执行，废弃文件或资料的回收管理)
43
Documented system with change
management group#
No change control system无文件变更控制
系统
Informal system with local group management
由部门管理的的非正式文件控制体系
Documented system with individual group
responsibility对独立文控小组负责管理
的文控体系
Documented system with change
management group有变更管理小组的文
控体系
Automated system manages change control
requirements自动运行的体系管理文件
控制及变更
3.13
3.14Is there a system in place to notify customers when changes are made to products, processes,  drawings or specifications which may affect
the customer?是否有程序保证会知会客户会影响客户的产品，流程，图纸或标准更改?
43Documented system with change
management group generates
notices#
No notification system没有通知系统程序
Informal system with local group management
to generate notices由部门管理产生通知
的非正式系统
Documented system with individual group
responsibility to generated notices由独立部
门管理产生通知的文件系统
Documented system with change
management group generates notices工程变
更管理小组负责通知的文件系统
Automated system automatically generates
change notices体系自动的通知客户变
更
3.14
3.15Does the supplier maintain documented procedures for identification, collection, access, filing, storage, maintenance, and disposition of quality
records? Are they readily retrievable?是否有品质记录的保管程序，且是否易于取得?
43Documented system with quality
management group to maintain
records#
No system to maintain quality records品质记
录的保管程序
Informal system with local group management
of quality records由部门保存品质记录的
非正式系统
Documented system with individual group
responsibility for quality records由独立部门
负责品质记录的管理的文件系统
Documented system with quality management
group to maintain records品质管理团队管
理品质记录的文控系统
Automated system maintains all active and
archived records系统自动保存所有的品
质记录
3.15
3.16Is there a system to ensure that the most current customer specifications and drawings are available to the manufacturing personnel?是否
有一个系统确保最新的客户标准和图纸，提供给生产人员使用?
43Documented system with quality
management group to maintain
compliance#
No system in place没有系统
Informal system maintained by local groups由
部门保存品质记录的非正式系统
Documented system with individual group
responsibility to maintain compliance由独立
部门负责管理客户图纸和标准的文控
体系
Documented system with quality management
group to maintain compliance品质管理团队
管理客户图纸和标准的文控系统
Automated system controls document
compliance系统自动控制生产用客户图
纸和标准
3.16 COMPLETE THIS SECTION 完成此部分的评估
Scoring Guidelines 评分准则

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