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asme翻译--核质量控制--不合格控制程序

发布时间:2011-04-26 12:57:12
 

asme翻译--核质量控制--不合格控制程序

       Table of Content  目录

 

 

1.0                   Purpose               目的

2.0                   Scope                 范围

3.0                   Definitions             定义

4.0                   Responsibilities         职责

5.0                   Identification, Reporting and Segregation

标识、报告和隔离

6.0                   Nonconformance Review 不合格评审

7.0                   Disposition               处理

8.0                   Re-examination/inspection  再检验/检查

9.0            Records                  记录

10.0          References                参考文件

 

 

 

 

 

 

 

 

 

 

1.0     Purpose 目的

 

          The purpose of this procedure is to provide for a system and instructions and to assign responsibilities for the identification, documentation and disposition of non conforming items in order to prevent inadvertent use.

     为防止不合格物项被误用,特制订本程序为不合格物项的标识、记录和处理提供一套体系、指示要求,并划分职责。

2.0         Scope 范围

This procedure is applied to all nonconformance’s’ identified on site during inspection activity, manufacture and post delivery complaints received from customers.

本程序适用于所有检验和生产期间发现的所有不合格问题,以及交付后客户提出的不合格意见。

 

This procedure does not apply to the findings and observations recorded during internal or external audits.

本程序不适用于内部和外部审查期间,所记录的问题和有待观察的问题。

The vendor is responsible for handling any nonconformance identified at his site in accordance with their own documented QA programme including the recording, submission of non conformance reports to BPS with recommended disposition and technical justification for review and approval by BPS QAM or his authorized representative.

供应商负责根据其自编的文件化质量保证计划(QA),在其场所处理已标识的任何不合格问题,包括记录不合格问题,并将不合格报告,随附处理方案建议和技术论证一并提交给英伦管架有限公司(BPS),由英伦管架有限公司(BPS)的质量保证经理(QAM)或其授权代表评审和核准。

3.0     Definitions 定义

Non conformance: a deficiency in characteristic, documentation, or procedure that renders the quality of an item or activity unacceptable or indeterminate.

不合格问题:材料特征、文件或程序上的缺陷,这种缺陷降低了某物项的质量,或使某项活动部合格,或不正确。

 

Repair: the process of restoring a nonconforming characteristic to a condition such that the capability of an item to function reliably and safely is unimpaired, even though that item still does not conform to the original requirement.

维修:一种过程,即,修复某物项的不合格特征,确保该物项可靠和安全地使用,即便如此,该物项仍不符合原物项的要求。

 

Rework: the process by which an item is made to conform to original requirements by completion or correction.

返工:一种过程,即,通过修补,使某一物项符合原物项要求。

Use-as-is: a disposition permitted for a nonconforming item when it can be established that the item is satisfactory for its intended use.

 

照常使用:一种处理方式,即,如果不合格物项能被证明,符合目标用途,则允许照常使用该物项。

4.0         Responsibilities 职责

 

4.1     All employees are responsible for highlighting suspected nonconformances to the attention of personnel from the QA/QC department.

 

要求所有雇员负责标注不合格嫌疑的物项,引起质量保证(QA)/质量控制(QC)部门人员的注意。

4.2     QA/QC department is responsible for:

质量保证(QA)/质量控制(QC)部负责以下内容:

  • · Reviewing the suspected nonconformance against specified requirements.
  • · 对照规定要求,评审有不合格嫌疑的物项。
  • · Preparing and issuing nonconformance report (NCR).
  • · 编制和发放不合格报告(NCR)。
  • · Identification and quarantine of nonconforming items.
  • · 不合格物项的标记和隔离。

 

4.3     Relevant department managers and supervisors are responsible for:

     相关部门经理和主管人员负责以下内容:

  • · Reviewing non conforming characteristics.
  • · 评审不合格物项特征
  • · Propose disposition.
  • · 提出处理意见
  • · Ensure compliance with the agreed disposition.
  • · 保证遵照协定的处理要求处理。

 

4.4     QA department is responsible for:

     质量保证部门负责以下内容:

  • · Maintaining the NCR Control Log.
  • · 维护不合格报告控制日志
  • · Forwarding NCR’s to relevant personnel for input regarding the disposition and approval.
  • · 将不合格报告(NCR)提交给相关人员作为处理和核准的输入资料
  • · Issuing periodical report on NCRs for management review.
  • · 发放定期不合格报告(NCR),以实施管理评审
  • · Retention of records.
  • · 记录的保存

 

4.5     Production engineering department is responsible for issuing traveler variance sheets.

生产工程部负责发放流程变更表。

 

5.0  Identification, Reporting and Segregation 标识、报告和隔离

 

        5.1     Upon detection of a suspected nonconformance, it is brought to the attention of QA/QC department by the relevant personnel.

          发现有不合格嫌疑的物项后,相关人员应通知质量保证(QA)/质量控制(QC)部门。

5.2     QA/QC department will review the suspected nonconformance against specified requirements and establish whether it is valid.

     质量保证(QA)/质量控制(QC)部门根据规定要求,评审有不合格嫌疑的物项,并证明是否属实。

5.3     If the suspected nonconformance is valid, details are recorded on the nonconformance report (NCR) by QA/QC personnel.

如果不合格嫌疑的物项确实不合格,则质量保证(QA)/质量控制(QC)人员应将详情记录到不合格报告(NCR)。

          5.4     Nonconforming items will be identified using ‘Hold’ label. If identification of each individual item is not practical, the container or package will be identified.

          不合格物项将贴附“停用”标签。如果无法对每个物项作出标识,则应在集装箱或包装上标记。

          5.5     Nonconforming items shall be segregated, when practical, by placing them in the quarantine area until the NC has been dis-positioned.

          不合格物项应与其他合格物项分开放置,如有可能,应放在隔离区,直到不合格(NC)问题处理完毕。

          5.6    When segregation is impractical or impossible due to physical conditions such as size, weight etc, care will be taken to ensure that the ‘Hold’ label is attached firmly to the item and is clearly visible, to preclude inadvertent use of a nonconforming item.

           如果由于物理条件,例如尺寸和重量等因素,使不合格物项无法分开放置,则应将“停用”标签贴附到不合格物项显眼处,防止不合格物项被误用。

          5.7     The NCR will be recorded and the relevant details entered onto the NCR Control Log.

          将不合格问题记录到不合格报告(NCR)上,并将相关详情记录到不合格报告(NCR)控制日志。

          5.8     QA department will allocate a sequential number to the nonconformance report.

          质量保证部门(QA)负责为每个不合格报告配置一个序列号。

          5.9     Nonconformance report number will be identified on the Hold label attached to the nonconforming item. All identification shall be legible.

           在不合格物项上粘贴的“停用”标签上,标记不合格报告编号。所有标识均应清晰可辨。

          5.10   Written communications relating to the nonconforming item will quote the nonconformance report number for reference purposes.     

           与不合格物项相关的书面通讯录上,将引用不合格物项报告编号,以作参考。

          5.11   Nonconforming items will not be processed further until approval of the agreed disposition plan.

                协定的处理计划通过核准后,才可对不合格物项进行进一步处理。

6.0  Review of NC 不合格物项的评审

          6.1     QA department will contact relevant department managers and supervisors to enable a review of nonconforming characteristics and determine action that is to be taken for disposition of the nonconforming item.

          质量保证部门将联系相关部门经理和主管人员,对不合格特征进行评审,并确定不合格物项的处理方案。

          6.2     Nonconformance to design requirements will require a review by Engineering department personnel.

          设计要求方面的不合格物项,由工程部人员评审。

          6.3    Disposition review may include the following:

          处理方法评审内容包括以下方面:

a)      Method for removing the nonconformance from the product.

清除产品不合格问题的方法

b)      Review and segregation of other items from the same batch which may be potentially

   affected by the detected nonconformance.

对同批次中,可能受到不合格物项影响的其他物项进行评审和隔离。

c)      Identify the cause of the nonconformance.

确定不合格原因。

d)      Determine the disposition action i.e. use-as-is, repair, rework, or reject.

确定应采取的措施,例如,照常使用、维修、返工或拒收。

e)      Method for implementing the disposition action.

处理措施的实施方法

f)        Communications that are to take place with suppliers in the case of NC raised during receipt inspection activities.

对于来料检验时发现的不合格物项,应评审与供货方的通讯记录。

g)      Communications that are to take place with affected clients.

评审与受不合格影响的客户的通讯记录。

h)      Communications that are to take place with relevant employees involved in the implementation of the disposition action.  

评审与执行处理措施的相关雇员之间的通讯记录。

          6.4     The proposed disposition with technical justification will be recorded in the nonconformance report and forwarded for approval by PSL QA manager or his authorized representative.

          处理建议和技术论证应记录到不合格报告中,并提交给管架有限公司(PSL)质量保证经理(QA)或其授权代表,由其核准。

          6.5     Nonconformance to design requirements dispositioned repair, or use-as-is shall be subject to design control measures commensurate with those applied to the original design.

           设计要求的不合格项,应按照设计控制措施要求,进行维修或照常使用,该设计控制措施要求与用于原始设计的控制措施相匹配。

          6.6     Any non conformance which requires reporting to clients and/or external authorities will be handled as per project specifications. QA department personnel will liaise with the Contracts manager to ensure compliance to client’s project specific requirements.

               任何要求汇报给客户和/或外部机构的不合格物项,应根据项目规范要求进行处理。质量保证部人员应与合同经理联系,确保符合客户的具体项目要求。

7.0  Disposition 处理

          7.1     When the approved disposition is use-as-is, QA/QC department will remove the Hold label from affected item, update NCR and inform to the relevant department manager and supervisor.

          如果核准的不合格处理方式是照常使用,则质量保证(QA)/质量控制(QC)部门应将“停用”标签,从受不合格影响的物项上撕除,更新修改不合格报告(NCR),并通知相关部门经理和主管。

          7.2     When the approved disposition is rejecting, QA/QC department will remove the Hold label and attach Rejected label, update NCR and inform the relevant department manager and supervisor.

          如果核准的不合格处理方式是拒收,则质量保证(QA)/质量控制(QC)部门应撕除“停用”标签,并贴附“拒收”标签,更新修改不合格报告(NCR),并通知相关部门经理和主管。

          7.3     When the approved disposition is repair or rework, QA/QC department will forward the agreed disposition plan to the relevant department manager and supervisor for implementation.

           如果核准的不合格处理方式是维修或返工,则质量保证(QA)/质量控制(QC)部门应将协定的处理方案提交给相关部门经理和主管,由其按要求实施。

          7.4     A traveller variance sheet prepared by production engineering department and approved by QA department, for items requiring repair/rework or rejected items with the referenced NCR number will be issued to the relevant departments to ensure that rework or replacement activities are effectively controlled as per the original component.

          流程变更表由生产工程部负责编制,并由质量保证部门(QA)核准,对于需要修补/返工的物项,或被拒收的物项,应将不合格报告参考编号发送给相关部门,确保按照原装件要求,有效控制材料的返工或更换。

                    

8.0  Re-examination/inspection  再检验/检查

 

          8.1     Repaired, or reworked items will be re-examined by QC department in accordance with applicable procedures and with the original acceptance criteria unless the nonconforming item disposition has established alternate acceptance criteria.

          维修后的物项,或返工后的物项,由质量控制部门(QC),按照适用程序,以及按照原始验收标准的要求(除非,为处理不合格物项,建立了替代性验收标准),进行重新检验。

          8.2     Implementation of the disposition will be verified by QA/QC department and NCR will be signed and forwarded to PSL QA Manager or his authorized representative for approval.

               不合格物项的处理情况,由质量保证(QA)/质量控制(QC)部门负责验证,不合格记录(NCR)签名后,提交给管架有限公司(PSL)的质量保证经理(QA)或其授权代表核准。

9.0         Records 记录

 

9.1     Completed NCR’s along with supporting documents, external approvals and re-Examination Reports will be forwarded to the QA department for retention.

      完整的不合格报告,以及证明文件、外部核准文件和再检验报告,将提交给质量保证部门(QA)保存。

9.2     As-built records, if required, shall reflect the accepted deviation.

     竣工记录(如果需要)上应注明容许偏差。

9.3     NCR control register will be updated by QA department upon closing the NCR.

                                 不合格记录(NCR)完成后,不合格记录控制登记薄由质量保证部门负责更新。

19.0              References 参考文件

 

1)      FN 13/01-01: Nonconformance Report

FN 13/01-01:  不合格报告

 

2)      FN 13/01-02: NCR Control Register

FN 13/01-02: 不合格报告控制登记薄

 

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