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asme翻译--核质量程序--审查程序2

发布时间:2011-05-03 13:18:50
 

ASME翻译--核质量程序--审查程序2

4.0        Audit Planning (AP) 审查计划(AP

4.1     The audit plan is prepared prior to any audit activity and is implemented for both internal and external audit activities.

在开展任何审查活动之前,应编制审查计划,并且在内部审查或外部审查活动时,都需遵循该审查计划。

4.2       The AP is completed by the allocated lead auditor, approved by the QAM and defines the following information:

该审查计划由质量保证经理(QAM)核准指派的主审查员负责编制,并应确定以下信息:

  • Type of audit – internal or external
  • 审查类型-内部审查,或外部审查
  • Proposed audit dates
  • 计划审查日期
  • Identifies the department or external organization to be audited.
  • 明确待审查的部门,或外部组织
  • Identifies audit team members
  • 明确审查组成员
  • Allocates the audit report number to be referenced on audit documentation.
  • 审查报告编号,使其可以通过审查文件查找。
  • Defines the scope of the audit, referencing appropriate documentation that will be basis of any audit checklist implemented during the audit.
  • 明确审查范围以及相关参考文件,这些参考文件为审查期间,所用的审查核对表的依据。
  • Is endorsed by the Lead auditor and approved by the QA Manager.
  • 该审查计划由主审查员批注,并由质量保证经理(QA)核准。

4.3       The AP applicable for audit of the QA department will be approved by Managing Director

适用于质量保证部门(QA)审查活动的审查计划,由常务董事负责核准。

5            Audit Team 审查组

5.1  Personnel are assigned by the QAM to perform audits ensuring that they are independent of those having direct responsibility for the audited activity.

审查组人员由质量保证经理(QAM)指定,确保这些审查人员与以下人员无关:对被审查活动负有直接责任的人员。

5.2  The audit shall be led by a qualified and certified Lead Auditor assisted, if required, by qualified audit personnel.  

审查工作由具有资质的,持证主审查员领导,如必要,另派具有资质的审查人员,协助主审查员的工作。

5.3  Audit personnel will be qualified in accordance with NQAP-16/01 - Audit Personnel Qualification Procedure.

审查人员应根据NQAP-16/01—审查人员资质鉴定程序的要求取得资质。

5.4  Assistance from other personnel with specialist knowledge may be requested to assist in the audit activity if required. The use of such personnel will be subject to approval of the QAM.

如有必要,在审查活动中,可以安排其他具有专业知识的人员协助审查。该协助审查人员由质量保证经理(QAM)核准。

5.5  Audit personnel will possess appropriate knowledge relating to the scope of the internal audit activity or in the case of external vendor audits, have appropriate knowledge relevant to the proposed scope of supply.

审查人员应具有内部审查范围相关的知识,如果是对外部供应商的审查,则审查人员应具有与计划供应范围相关的知识。

6            Preparing for audit审查前的准备工作

6.1       Audit personnel prepare for an audit by fully familiarizing themselves with:

审查人员应完全熟悉以下事宜:

  • Relevant specifications (ASME Codes etc)
  • 相关规范(美国机械工程师协会(ASME)规范等)
  • Refreshing knowledge of the relevant NQAM and relevant operational procedures.
  • 相关核质量保证手册(NQAM)和相关操作程序相关知识的更新
  • Audit personnel involved with performing external audits will obtain for review as minimum, copies of the relevant vendors Quality progamme manual.
  • 执行外部审查的审查人员,至少应取得相关供应商质量计划手册的副本,以便评审。

It is noted, that on occasions vendors may be reluctant to forward copies of confidential operating procedures in which case the auditor will obtain confirmation that such procedures will be available for review during the actual audit process to enable compliance to requirements to be established.  

    注意,如果供应商不愿将保密性操作程序副本提交给审查人员,则审查员可以要求供应商,保证在实际审查过程中,提供以上操作程序以作评审,确保该程序符合规定要求。

  • Reviewing of recorded non-conformances and corrective action reports from previous audits
  • 对以往审查工作,所作的不合格记录,以及整改活动报告,进行评审。

 

  • Preparation of the audit checklist to ensure that relevant aspects are reviewed during the      actual audit process.

 

  • 编制审查核对表,确保执行实际审查时,对各相关方面都进行评审。

 

6.2  Audit checklists will are reviewed and approved by the QA manager to establish that audit scope and activity to be audited are in accordance with the relevant NQAP requirements.

审查核对表由质量保证经理(QA)负责评审和核准,以明确审查范围,以及被审查的相关活动均符合核质量保证程序(NQAP)的相关要求。

6.3  The manager, supervisor or vendors representative responsible for the area/s defined by the scope of the proposed audit are contacted in advance with the proposed audit dates.

在计划审查日之前,应通知以下人员:对于计划审查范围中所明确的待审查内容,承担责任的经理、主管或供应商代表。

6.4       Confirmation is obtained or alternative dates are proposed for agreement by all parties. 

确认审查日期,或者,提出替代审查日期,由各方协定。

7.0         Conducting and reporting the Audit 审查工作的实施和汇报

7.1         Internal audit 内部审查

7.1.1  A brief pre-audit meeting may be conducted between the audit team members and the appropriate manager/supervisor of the department being audited to confirm scope of audit is correct.

审查组成员和被审查部门的经理/主管之间,可召开审查前会议,以确定审查范围是否正确。

7.1.2 Personnel met during the internal audit process will be recorded on the audit report.      

内部审查过程中,所遇到的人员,应记录到审查报告中。

 7.1.3        While conducting the audit, auditors seek objective evidence demonstrating whether the     audited activities conform to the requirements of the NQAP.

  执行审查时, 审查员收集客观证据,以明确审查活动是否符合核质量保证程序(NQAP)的要求。

7.1.4 Records of objective evidence reviewed during the audit will be recorded on either the                                                                          checklist or be referenced directly in the final audit report.

审查期间,经评审的客观证据应记录到核对表中,或直接记录到最终审查报告中。

              7.1.5      Non conformances against the QAP will be recorded by the auditor and will be                                                                                                        discussed during the audit.

   不符合质量保证程序(QAP)的项目,由审查员记录,并在审查期间进行讨论。

7.2         External auditing. 外部审查

              7.2.1      The audit will be performed at the vendor’s premises where objective evidence will be                                                                 examined to determine compliance with the vendor’s documented QAP and any                                                                             specific supplementary requirement imposed by BPS.

      外部审查将在供应商所在地进行,对相关的客观证据进行核查,确定其是否符合供应商已文件化的质量保证程序的要求,以及是否符合英伦管架有限公司(BPS)的任何具体补充要求。

              7.2.2      Vendors supplying NDE level 2 services may be audited during the performance of NDE                                                           within BPS manufacturing facility.

供应商提供的2级无损检验服务,可在无损检验期间,在英伦管架有限公司(BPS)的生产场所进行审查。

              7.2.3      A record will be retained of all vendor personnel contacted during the audit process                                                                            including a register of personnel attending the opening and closing audit meetings.

审查期间,所有接触过的供应商人员,均作记录保存,包括出席审查会开幕会议和闭幕会议的人员。

              7.2.4      Non conformances against the vendor’s stated QA programme or deviations to BPS                                                                          requirements will be recorded by the auditor and will be discussed during the audit.

不符合供应商质量保证计划(QA)的项目,或不符合英伦管架有限公司(BPS)要求的项目,均由审查人员记录,并在审查期间讨论。

              7.2.5      All non conformances will be reviewed with the vendor’s quality representative upon                                                                          completion of the audit.

审查工作结束后,所有不合格问题,由供应商的质量代表负责评审。

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