1.PURPOSE:
Defines the process for generating, tracking, and completing an Internal Corrective Action (ICAR). The objective is to document conditions that have led to non-conformances or the need for process improvement and to correct or to create process to ensure that the conditions are eliminated and for continuous process improvement.
本程序规定了产生,跟踪和完成一个纠正措施(CAR)的过程,目的是找出不符合的原因并纠正或制定程序来确保这些原因得到消除并持续改进.
2.SCOPE:
This ICAR procedure applies to热闹的反义词是什么
SHG for all non-conformances and/or process improvements pertaining to product, process and continuous
improvement requiring ICARs. Corrective actions resulting from customer, supplier, or production yield out of control, are addresd via the CCAR/RMA, SCAR, and OCAP process, respectively. The ICAR address identification, removal, and prevention of recurrence of non-conformances from XY’s business process in order to optimize their performance or for quality process improvements.
声音放大
纠正措施程序适用于解决G全范围内在的不符合及改进,由客诉,供应商及产品合格率失控引起的不符合除外,后者由专门的CCAR/RMA, SCAR及OCAP程序来管理. ICAR 用以对不符合进行识别,消除和防止再发生。白菜大虾
3.RESPONSIBILITIES AND AUTHORITIES:
Any XY employee may initiate an ICAR. The initiator/originator must provide sufficient information in appropriate detail so that the nature of the discrepancy or improvement required is clear. Originator is responsible to describe the problem/issue and provide supporting details.
Quality Assurance coordinates the issuance, tracking, and closure of ICA R’s.
Owners review, resolve problems, document respon and implement corrective actions as required. Owners are responsible for the containment, root cau identification, corrective action plan definition and effective
金色满园implementation.
Quality Assurance, ICAR Owners, ICAR Teams are responsible for ensuring that any corrective actions,
containment actions or other steps taken in the cour of ICAR processing, are consistent with the XY Management Policy.
任何XY员工都可以申请ICAR,申请人应当对不符合进行足够详细的描述和提供足够的信息
QA负责ICAR的签发,跟踪和关闭
责任单位负责评估,解决问题,确定ICAR的临时措施,原因分析,纠正措施制定及对方案的有效实施
QA, 责任单位和ICAR团队负责确保任何临时措施/纠正措施的采取与XY的方针保持一致
作者简介英文4.APPLICABLE/ REFERENCE DOCUMENTS:
See Agile Bill of Material (BOM)
5.DEFINITIONS AND ACRONYMS:
Corrective Action– Action taken to correct or remove an existing nonconformity (defect) or other undesirable
situation or to improve/enhance existing process. Actions taken to: contain, determine root cau, define and verify solutions, implement solutions, and verify the effectiveness of the implemented corrective action.
纠正措施-对已存在的不符合或不理想状况所采取的消除行动. 该行动包括:临时措施,查找原因,制定和实施解决方案以及验证方案实施后的有效性
ICAR– Internal Corrective Action Request
ICAR-内部纠正措施表
Preventive Action– Action taken to eliminate the caus of a potential nonconformity (defect) in order to prevent occurrence.
预防措施-对潜在不符合进行消除所采取的预防性行动
Root Cau is analysis that helps identify what, how and why something happened. A root cau is a cau that is at a root of a nonconformance. A nonconformance can have more than one root cau. A root cau is the most basic reason for a defect or problem in a product or process. Elimination of the root cau leads to the elimination of the defect or problem.
根本原因-导致不符合发生的根源,这种根源可能不只一个,只有消除根本原因才能消除不符合
Containment is action(s) taken to prevent the nonconformance from growing and to isolate customers (internal or external) from its effects. The customer must be protected until permanent corrective actions can be implemented and verified. The effectiveness of the containment actions must be verified.
临时措施-为防止不符合漫延或为防止不符合流到客户所采取的行动.在纠正措施计划得以实施和效果验证前,必须确保不符合不漫延到客户.临时措施实施情况也必须验证
Validation is the prescribed process(es) for checking if the defined corrective actions satisfy the criteria established by the identified nonconformance. It is the process to verify that something is correct or conforms to the originally
documented standard and is effective.
确认-判定已执行的纠正措施是否有效
Verification– Confirmation, through the provision of objective evidence that specified requirements have been fulfilled. The verification process is the act of reviewing, inspecting, testing, checking, auditing, or otherwi
establishing and documenting whether items, process, rvices, or documents conform to specified requirements after implementation of corrective action.
验证-检查纠正措施是否实施
QCN: Quality Ca Number
CCAR: Customer corrective action request
RMA: Return material authorization
SCAR: Supplier corrective action request
OCAP: Out of control action plan
6.EQUIPMENT AND TOOLS:
N/A
7.QUALITY RECORDS:
1101651 ICAR, SHG
ICAR records kept in folder: \\Cn-file01\public\Quality\Quality Ca Summary
?Originator
?QA Manager
?Global ICAR Team •Any Finisar employee may initiate an ICAR to QA thru e-mail. The initiator/originator must
provide sufficient information details so that the
nature of the discrepancy is clear
•The request e-mail is saved in QCN share folder: \ \Cn-file01\public\Quality\Quality Ca Summary •任何员工都可以通过邮件向QA申请签发ICAR,但需提供足够详细的信息,QA将申请信息保存
在QCN中
?QA ICAR Coordinator •ICAR coordinator reviews the ICAR request, and determines the ICAR validity
•QA专门人员审核ICAR申请以确定是否需要签发ICAR
立即用英语怎么说
•ICAR coordinator assigns and issues ICAR to owner, and record in QCN share folder: \\Cn-
file01\public\Quality\Quality Ca Summary •Rejection only when mis-assigned, ICAR coordinator then reassign to the right owner •ICAR should be issued, replied, and verified in English
•QA 专门人员签发ICAR给责任单位并在QCN中记录,ICAR需要使用英文签发,回复和验证
•只有在错发责任人的情况下可以拒收ICAR,这时,QA专门人员重新发给正确的责任人
?ICAR Owner
?Manager of ICAR Owner •ICAR owner needs to determine if containment actions are required. If needed, owners needs to
respond with the containment action to QA within
2 working days
•ICAR owner to analyze root cau and determines the corrective action plan, submit the plan to
manager for approval, manager submits to QA for review and target implement date
•Finisar target turn around time for this process is
10 working days
•责任单位确定是否需要采取临时措施,如需要,则在2个工作日内回复QA
•责任单位分析原因和提出纠正措施计划并交其经理审核,由其经理再交QA审核.这个过程目标在10个工作日
•ICAR Coordinator reviews the containment action within 1 working day
•ICAR Coordinator reviews the root cau and corrective action plans and submits to QA
manager for approval, QA manager then submits
to Global ICAR team for approval
无奈的诗句•QA 专门人员审核临时措施并在一个工作日内r 反馈责任单位
•QA专门人员审核原因及纠正措施计划,如果接受递交QA经理批准,之后,QA经理递交总公司
ICAR组批准
?ICAR Owner
?ICAR Coordinator •Owners implement the correction actions according to the approved plan
•QA tracks the status through weekly meeting •ICAR owner to submit details/evidence to QA once the corrective actions have been
implemented.
•责任单位按计划实施整改
•在这个过程中,QA举行周会来跟踪整改进程•责任单位完成整改后,应向QA提供相应资料/数据
?ICAR Coordinator ?QA Manager
?Global ICAR Team •Validation period is indeterminate to ensure effectiveness of corrective actions •Validation evidence need to be filed at QCN share folder: \\Cn-file01\public\Quality\Quality Ca
Summary
•Once justified that the ICAR is effective, ICAR coordinator nds to QA manager for approval,
QA manager then nds to Global ICAR team for approval
•确认ICAR是否有效所需的时间是不定的
射干的功效
•确认ICAR有效的证据需保存在QCN文件夹\\Cn-file01\public\Quality\Quality Ca Summary •一旦判断纠正措施有效后,送QA经理批准,QA经理再送总公司ICAR组批准
•Save the ICAR and all supporting evidence in QCN folder::
•将ICAR及验证资料保存在QCN文件夹中:: \\Cn-file01\public\Quality\Quality Ca Summary
?ICAR Coordinator