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asme翻译--核质量程序---审查程序3

发布时间:2011-05-04 14:03:50
 

ASME翻译--核质量程序---审查程序3

8        Definition of non conformance 不合格的定义

              8.1  A non conformance is defined when an activity is not performed or documentation generated                               is not in accordance with the prescribed controls or documents defined by the QAP.

当某种活动,或者某一文件不符合质量保证程序(QAP)规定的控制措施,或者文件的要求,则该活动或文件定义为不合格。

              8.2  Non conformances may be classified as major and minor.

不合格问题分为重大不合格问题,和次要不合格问题。

 

              Major non conformance – 重大不合格问题

a)      When an activity is performed without sufficient control or when prescribed controls are not adequately implemented so that product quality is affected.

如果某一活动执行时缺乏足够的控制,或者当规定的控制措施未能充分实施,从而导致产品质量问题。

b)      When documentation produced is insufficient to demonstrate that the prescribed quality requirements have been achieved in the defined manner.  

如果编制的证明文件,不足以证明已经以规定的方式达到了规定的质量要求。

c)      The defined Quality programme and associated quality procedures have not been effectively implemented at all stages within the organization or department.

规定的质量计划和相关质量程序,并未在所有阶段,在组织或部门内有效执行。

 

                     Minor non conformities  次要不合格问题

a)      When errors occur within documentation that whilst having no direct affect on product quality or the ability of documentation in confirming product quality are noted,

虽然文件发生错误,但是并未直接影响到产品质量,也未影响文件确定产品质量的能力。

b)      That procedural controls have not been fully implemented but these have no effect on maintaining or documenting product quality

   虽然程序上的控制措施并未全面实施,但是不影响产品质量的保持,或记录。

 

 

                     Minor non conformities will be recorded during that audit process and if sufficient minor NC’s are                   recorded that indicate that the QAP is not effective then the lead auditor may consider the                                            raising of a major non conformity.

    在审查期间,将记录下次要不合格问题;如果所记录的次要不合格问题不断累积,最终使质量保证程序(QAP)失效,则主审查员可以考虑将其升级为重大不合格问题。

    .

8.3  Observations 有待观察的问题

                     These are instances noted during the audit process which whilst not in conflict with the QAP                                  may offer the potential for improvement if implemented.

这些问题为审查过程中,注意到的问题,这些问题与质量保证程序无冲突,通过整改,可以改善。

 

9                   Recording of non conformity 不合格问题的记录

9.1  When a nonconformance is noted, it is brought to the attention and discussed with the                                                          responsible personnel at the time of discovery. They will be asked to respond and confirm                                            acceptance of the non conformance and be provided with an opportunity to correct the non                                         conformity if possible during the audit.

一旦发现不合格的问题,应在发现当时,提请相关责任人注意,并与其展开讨论。要求相关责任人做出回应,并承认不合格问题,并且在审查期间,尽量给予其整改机会。

9.2  On completion of the audit, the Lead Auditor shall consolidate all audit non conformities                                                             identified by the audit team members on the Corrective Action Request proforma.

审查结束后,主审查员应将审查组成员发现的所有不合格问题,记录到整改要求表中。

9.3 Auditors complete only the first section of the CAR, detailing the agreed nonconformance.

审查人员只需要完成整改要求的第一项,即,了解不合格问题详情。

9.4  The CAR is then handed over to the responsible manager who completes its second section                                 detailing the proposed corrective action that is to be implemented to correct the NC.

然后将整改要求(CAR)转交给责任经理,由其负责完成整改要求的第二步,即,制订详细的整改方案,以对不合格问题(NC)进行整改。

9.5  At the conclusion of the audit, a post-audit meeting shall be held with the representatives of the                             audited department or organization to present audit results.

审查结束,召开审查后会议,被审查部门或组织代表,负责提交审查结果。

10          Audit report 审查报告

10.1 An audit report shall be issued by the Lead Auditor within 7 days of the completion of the audit.

审查结束后,主审查员应在七日内发出审查报告。

10.2 The audit report shall be approved by QAM, except for audit of the QA department, whose audit                   report will be approved by the Managing Director, prior to circulation.

审查报告应由质量保证经理(QAM)负责核准,但是,质量保证部门(QA)的审查报告,应由常务董事核准,经核准后,将这些审查报告发放。

10.3 The QAM will review non conformances raised during the audit process and the agreed                                           corrective action programme that has been established for correction of the non conformities.

质量保证经理(QAM)将对审查期间提出的不合格记录,以及经协定的不合格问题整改方案进行评审。

10.4 The audit report will include:

审查报告应包括:

  • A summary of the scope of the audit
  • 审查范围总结
  • Reference to any documentation reviewed during the audit process that demonstrates effective implementation of the QA programme,
  • 审查期间,证明质量保证计划(QA)有效实施的任何证明文件。
  • Audit checklist
  • 审查核对表
  • A record all reported nonconformance or observations,
  • 所有报告的不合格或有待观察问题的记录。
  • Details of corrective action programme and implementation schedule
  • 整改计划和整改计划实施时间进度安排详情。
  • Any recommendations that may be considered appropriate by the audit team to enable improvement of the QA  programme.
  • 审查组认为有助于改进质量保证计划的任何建议。

10.5       The approved audit report will be circulated between the departmental manager/supervisor                                           (internal audit) or vendor QA representative (external audit).

    经核准的审查报告,将发放给部门经理/主管(内部审查),或供应商的质量保证代表(外部审查)。

 

11                 Corrective action request (CAR) 整改要求(CAR

11.1.1    The Department manager/supervisor or vendor’s representative shall investigate any audit                                findings and scheduled CAR’s including measures to prevent recurrence and notify the Lead         Auditor in writing of action taken or planned within two (2) weeks of receipt of the audit report.

     部门经理/主管或供应商代表,应对任何审查工作中发现的问题,以及计划安排的整改要求等进行调查,调查对象还包括防止质量问题再次发生应采取的措施,并且应在收到审查报告两(2)周内,以书面形式,将已采取,或计划采取的措施通知主审查员。

11.1.2    Evidence of the successful implementation of the agreed corrective action will be established                               by either further visits to the department or vendor facility or by formal confirmation from the                                       responsible personnel or vendor that the agreed corrective action programmes have been                                            fully implemented.

      协定的整改方案的执行情况,可以通过以下方式调查了解:对相关部门或供应商设施进行再次考察,或者取得责任人员或供应商的正式确认,证明经协定的整改方案已经全面实施。

11.1.3    The adequacy of written response and nature of the NC shall be evaluated by the Lead                                         Auditor and QAM to determine if further follow up visits are required to confirm acceptance of         the implemented CAR.

     主审查员和质量保证经理(QAM),负责评估书面反馈文件的完备性,以及不合格问题的状况,以决定是否需要开展跟踪调查,以确定整改要求执行情况的是否合格。

11.1.4    If further verification is deemed appropriate, within 1 week of the due date for implementation         of CAR, the auditor will visit the department or vendor to determine if that the agreed                                              corrective action has been implemented and is effective in addressing the recorded NC.

     如果认为需要进行再次验证,则在整改要求(CAR)执行期满后的一周内,审查员将对相关部门或供应商进行考察,确定是否协定的整改活动已经实施,并且有效消除了所记录的不合格问题。

11.1.5    When objective evidence is available that the corrective action is effective, the CAR is                                                  completed.

     如果有客观证据,证明整改活动有效,则整改要求(CAR)可以被视为完成。

11.1.6    If the Lead auditor considers additional work is required to fully implement the CAR, a further              follow-up date will be agreed and further visits performed until the Lead auditor is completely         satisfied that implementation has been fully established and that the recorded NC has been                     fully addressed.

     如果主审查员认为有必要做额外的工作,确保整改要求(CAR)全面实施,则应拟定跟踪调查的日期,并进行进一步考察,直到整改活动全面实施,所记录的不合格问题得到彻底解决,完全符合主审查员的要求。

11.1.7    The Lead auditor will report to the QAM on any delays occurring during the process of                                                                       implementation of CAR. The QAM will intervene to resolve the situation to the satisfaction of                                           all parties ensuring that the PSL QA progarmme requirements are fully achieved.

     整改要求执行期间,如发生任何延误,主审查员应通知质量保证经理(QAM)。质量保证经理(QAM)将介入,并解决问题,使各方满意,确保执行情况完全符合管架有限公司(PSL)的质量保证计划(QA)要求。

11.2       External audit – vendor approval. 外部审查-供应商核准

11.2.1    Subject to acceptance of the above, the final audit report together with implemented                                                                          corrective actions will be reviewed by the QAM and the approval status of the vendor will be                                           established.

      对上述整改结果验收后,由质量保证经理(QAM)对最终审查报告,以及实施的整改情况进行评审,并确定是否对该供应商给予核准。

11.2.2    Vendors who have demonstrated by audit that their documented QA programme and the                                                    successful implementation of any agreed corrective actions to ensure compliance with the                                                  PSL QAP, will be included within the nuclear approved vendors register in accordance with                                           section 7 of this NQAM.

      以下供应商将被记录到本核质量保证手册(NQAM)第7节中核产品核准供应商登记薄中:该供应商已经通过审查证明,其文件化的质量保证计划,以及任何协定的整改活动,已经成功履行,符合管架有限公司(PSL)的质量保证程序(QAP)的要求。

12          Records 记录

12.1   The NQAE shall file and retain the audit document in accordance with QA Record Control                              Procedure (NQAP-15/01)

核质量保证工程师(NQAE)应当按照质量保证(QA)记录控制程序(NQAP-15/01)的要求,记录并保存审查文件。

13 Related proformas: 相关预编表

1) FN 16/02-1      Internal Audit Schedule

FN 16/02-1     内部审查时间计划表

2) FN 16/02-2      External Audit Schedule

2) FN 16/02-2   外部审查时间计划表

3) FN 16/02-3                    Audit Plan

3) FN 16/02-3   审查计划

4) FN 16/02-4            Audit Checklist

4) FN 16/02-4   审查核对表

5) FN 16/02-5            Audit Report

5) FN 16/02-5   审查报告

6)    FN 14/01-1                 Corrective action report

6)    FN 14/01-1     整改报告

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