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asme翻译--核质量程序--整改程序

发布时间:2011-04-27 13:00:11
 

asme翻译--核质量程序--整改程序

Table of Content  目录

 

 

1.0                   Introduction           简介

2.0                   Scope                 范围

3.0                   Responsibilities        职责

4.0                   General                 概述

5.0                   Issue of CAR            整改要求的发放

6.0                   Respondence of CAR     整改要求的回应

7.0                   Disposition of CAR       整改要求的处理

8.0                   Forms                   表格

 
1.0  Introduction 简介

          This procedure provides a system and an instruction to report and correct significant conditions adverse to quality to assure that they are identified promptly and corrected as soon as practical to preclude recurrence.

     为及时识别重大质量问题,尽快整改,避免质量问题再次发生,特制订本程序,为重大质量问题的报告和整改工作提出一套体系和指导要求。

2.0     Scope 范围

          The corrective action applies to both internal and external (vendor) corrective action.

    整改活动包括内部整改和外部(供应商)整改。

3.0    Responsibilities 职责

          The QAM shall be responsible for assuring that significant conditions adverse to quality are promptly identified and corrected.

     质量保证经理负责及时识别和纠正重大质量问题。

          The NQA Engineer shall conduct follow-up activities to verify that the corrective action is implemented by the due date using the CAR Register. (Form No.: FN 14/01-2)

      核质量保证工程师(NQA)应采用整改要求登记薄(表号:FN14/01-2)对整改工作进行跟踪,确保整改活动按规定日期实施。

4.0     General 概述

The corrective action as a result of NCR disposition, audit findings (both internal and external), shall be controlled in accordance with this procedure.

对不合格报告和审查结果(内部和外部审查)中不合格部分的整改工作,遵照本程序要求进行控制。

The corrective action required by Authorized Nuclear Inspector Supervisor (ANIS) and customer shall be considered and controlled in the same manner as internal corrective action.

由授权核检验主管(ANIS)和客户提出的整改要求,应采用内部整改相同的方式,进行控制。

In the case of significant conditions adverse to quality, such as failures, malfunctions, deviations, defective material and equipment non-conformances, and quality system inefficiencies, require corrective action in accordance with this procedure.

对于重大质量问题,例如故障、偏差、缺陷材料和不合格设备、质量体系不完善等,需遵照本程序要求进行整改。

5.0         Issue of CAR 整改要求的发放

When a significant condition adverse to quality is identified by a NCR disposition, or requested by ANIS or Customer, a Corrective Action Request (Form No.: FN 14/01-1) shall be prepared by the NQA Engineer.

对于不合格报告中发现的重大质量问题,或者美国国家标准协会(ANIS)或客户提出整改要求时,核质量保证工程师(NQA)应编制整改要求单(表号:FN14/01-1)。

The Auditor is responsible for preparation of the CAR for the audit findings including external (vendor) audit.

审查过程中发现的不合格问题,包括外部(供应商)审查过程中发现的不合格问题,由审查员负责编制整改要求单。

The CAR with identification of the quality problems to be corrected shall be approved by the QAM or by the BPS Managing Director in the case of audit findings on the QA Department.

整改要求单上应说明待整改的质量问题,并应由质量保证经理(QAM)核准,如果审查出来的不合格问题,属于质量保证(QA)部门,则整改要求单,由英伦管架有限公司(BPS)的常务董事负责核准。

6.0         Respondence of CAR 整改要求的回应

The CAR shall be forwarded to the applicable department or vendor for identification of a propsed course of action to be taken to prevent recurrence of the NC and a date for the completion of the proposed corrective action.

整改要求单应转发给相关部门,或供应商,告知其计划采取的,防止不合格问题再次出现的整改工作流程,以及计划整改工作的完成日期。

The CAR response date shall be agreed by all parties. If an extension is required the relevant personnel will communicate this to the QA department with the reason for required extension and a new completion date will be agreed.

整改要求单的回应日期由各方协定。如果需要延期,则相关人员应与质量保证部(QA)沟通,说明需要延期的原因,之后,再协商确定一个新的完成日期。

The corrective action measures shall be approved by the QA Manager or by BPS Managing Director in case of audit findings in the QA Department, prior to implementation.

整改工作开始之前,整改方案由质量保证经理(QA)核准,对质量保证部(QA)的整改方案,由英伦管架有限公司(BPS)常务董事核准。

When the proposed corrective action to be considered  inappropriate, the CAR shall be returned to the applicable Department or vendor for the implementation of a more appropriate corrective action.

如果计划的整改方案不适用,则整改要求单将退还给相关部门或供应商,要求其采取更合适的整改措施。

The auditor for shall monitor corrective measures against recorded audit findings to ensure prompt completion and verify the implementation of the corrective action as per the scheduled completion date.

审查员应根据所记录的审查过程中发现的问题,对整改活动进行监控,确保整改工作遵照计划时间要求及时完成,并得到验证。

7.0         Disposition of CAR 整改要求的处理

After acceptable implementation and verification of the corrective action, the CAR with the supporting documents, if any, shall be forward to the QA Manager or to BPS Managing Director in case of audit findings on the QA Department, for final approval, ensuring that the close-out date is recorded onto the CAR Register.

整改工作结束,并得到验证后,整改要求单以及证明文件(如果有)应提交给质量保证经理(QA)最终核准,或者,当质量保证部(QA)为整改对象时,整改要求单和证明文件应提交给英伦管架有限公司(BPS)常务董事最终核准,确保将整改结束日期正确记录到整改要求登记薄。

If the disposition of corrective action is deemed unacceptable, the CAR shall be forwarded to the QA Manager or BPS Managing Director in case of CA on raised against the QA Department for resolution and a new CAR shall be issued.

如果整改处理被认为不合格,应将整改要求单转交给质量保证经理,或者,当质量保证部为整改对象时,应将整改要求单转交给英伦管架有限公司(BPS)常务董事,由质量保证经理,或常务董事提出解决方案,并发出新的整改要求单。

If a qualified vendor fails to take the required corrective action, he will be disqualified and removed from the Approved Vendors List.

如果具有资质的供应商未能按要求实施整改,则将取消该供应商的资质,并将其从核准供应商名录中除名。

 

The NQA Engineer shall review and update the CAR register on a monthly basis to monitor close-out status and to take follow-up action.

核质量保证工程师(NQA)负责每月评审和更新整改要求登记薄,以便对整改结果状态进行监控,并采取整改跟踪措施。

 

8.0         Forms 表格

1) FN 14/01-1        Corrective Action Request

1) FN 14/01-1   整改要求

2) FN 14/01-2                 CAR Control Log.

2) FN 14/01-2      整改要求控制日志

NQCP14 series refers.

参见NQCP14系列

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