BENEFITS

益处

1. Provides a documented system which controls the activity/ service/ product.

提供一个控制活动/ 服务/ 产品的文件体系

2. Produces written procedures that define authority , responsibility, interfaces.

编制书面程序，规定权力，责任和相互关系

3. Ensures activity/ service/ product meets all specified requirements.

保证活动/服务/产品符合全部规定要求

4. Promotes reputation in the market place through customer satisfaction.

通过使客户满意， 建立市场信誉

5. Provides a system which ensures that all errors/ nonconformities/ complaints/ deficiencies are immediately identified, controlled and dealt with through feedback loops.

提供一个体系，保证所有错误/不符合项/投诉缺陷立即被诊断，并通过反馈环路加以控制和处理。

6. Promotes efficiency and cost effectiveness.

提高效率和成本有效率

7. Motivates staff towards a pride in carrying out jobs.

激励工作人员的工作自豪感

8. Promotes improved industrial relations through inter- departmental co- operation.

通过部门间的协作，促进工业关系的改善

9. Controls all activity/ service/ product performance data through feedback analysis.

控制所有活动/ 服务/产品的更改

10. Provides activity /service/ product performance data through feedback analysis.

通过反馈分析，提供/服务/产品的性能资料

11. Identifies and controls training needs.

确定和控制培训需要

12. Shows commitment to quality through maintaining constant quality levels.

通过保持一定的质量水平， 显示对质量的承诺

13. Improves communications.

改进交流

14. Produces historical records to confirm levels of quality/ system effectiveness and activity/ service/ product achievement.

通过记录确定质量水平/ 体系的有效性和活动/服务/产品的业绩

15. Provides information for employee induction.

为指导员工的工作提出供信息

　

AUDIT DEFINITIONS

审核的定义

A Systematic and independent examination to determine whether quality activity and related results comply with planned arrangements and whether these arrangements are implemented effectively and suitable to achieve objectives

是一项系统和独立的考核， 以确定质量活动及其结果是否与计划安排相一致， 计划安排是否得到有效落实， 并适于达到既定的目标。

　

AUDITOR

审核员

AUDITOR`S RESPONSIBILITIES:

审核员的责任

A. Be able to address searching questions to all operating staff

          能向所有操作人员提出探险索性的问题

- Display presence

- 显示风度

- Verbal ability

- 口才

      - Quick thinking

- 敏捷的思维

      B. Stand their ground

         立场坚定

         Remain calm and polite

         保持镇静和礼貌

     C. When requested to do so, as part of audit task:

当审核任务有要求时：

- Make suggestions for improvement

- 提出改进建义

EXECUTIVE'S RESPONSIBILITY

主管的责任

THE ORGANISATION'S QUALITY EXECUTIVE IS RESPONSIBLE FOR CONTROLLONG AND PLANNING THESE ACTIVITIES:-

一个组织的质量主管负责控制和计划以下活动：-

1. The frequency of Audits-

审核的周期。

2. Defining requirements for each audit including auditor' s qualifications - team composition.

规定每次审核的要求，包括审核员的资格 - 小组组长。

3. Notifying auditors/ audits of dates and requirements.

通知审核员/ 被审核方审核日期和要求。

4. Providing all applicable

提供所有适用的；

- Documents - specifications - procedure - forms - required during the audit.

审核中需要的文件- 标准 - 程序 - 表格。

5. Appointing a lead auditor (Team leader).

任命一名主任审核员（组长）。

6. Determine need for specialist input.

决定有无必要聘用专家。

7. Supplying previous audit reports and copies of outstanding nonconformities.

提供以前的审核报告及尚未解决的不符合项报告的副本。

Some of these activities may be delegated to the “lead auditor”.

以上责任可由“主任审核员”部分代理

　

AUIT TEAM LEADER

审核组长

DEFINITION:

- 定义：

- An auditor appointed to mange a Quality Audit as the team leader.

被任命为组长管一次质量审核的审核员

Must have management experience and capability

          必须有管理经验和能力

Must be given authority to make final decisions regarding conduct of the audit

对与审核有关的问题有权作最后决定

Make clear detailed verbal and written report to the organization’s management

          向组织的管理者作清楚详细的口头和书面报告

THE LEAD AUDITOR WILL TAKE RESPONSIBILITY FOR THE AUDIT PLANNING AND FOLLOWING ACTIVITIES:-

主任审核员要负责进行审核计划和以下活动：

1. Assist with choosing audit team and specialists.

帮助挑选审核组成员及专家。

2. Controlling, planning and co- ordinate the team and the audit，3. to ensure time used effectively and all requirements are covered.

控制，计划并协调小组活动和审核，确保审核时间得到有效利用，所有要求都得到满足。

4. Compile or advise on content of checklist

编撰核查表或对其内容提出建议

5. Liaise with audits to ensure audit intent - scope and time are understood to enable them to plan ahead.

与被审核方联系， 确保他们清楚审核范围和时间，并能事先做好准备。

6. Review existing system documentation to ensure it meets specification requirements.

审查现有体系文件，确保它们符合标准要求

7. Decide on category of any Non-conformity.

决定不符合项的分类。

8. Report critical NCR to auditee immediately .

一旦发现严重不符合项，立即向被审核方通报。

9. Representing the audit team with the auditee management

代表审核组与被审核方的管理者交涉

10. Report any major obstacles to performing audit to the Quality Executive immediately.

对审核中遇到的重大障碍向主管报告，

11. Preparing, writing and submitting the audit report

准备、起草并提交审核报告

12. Liaise with the “Quality Executive” to determine audit effectiveness and future action required.

与“质量主管”联系，确定审核的有效性和下一步的行动。

　

AUDITORIS ACTIVITIES

审核员的活动

THE AUDITOR SHOULD:-

审核员应：

1. Remain within the Audit scope. Do not attempt to change scope.

保持在审核范围内，不要试图改变审核范围。

2. Exercise objective and impartiality.

努力保持客观和公正。

3. Collect and analysis all observation to permit conclusions of system effectiveness to be made.

收集并分析所有的客观证据以得出体系有效性的结论。

4. Be alert for indications of objective evidence that may affect or influence the audit.

密切注意会影响审核的客观证据。

5. Art in an ethical manner at all times.

始终保持风度。

6. Offer observations clearly and concisely to conclusion of conformance of system.

以简洁明了的方式写出观察报告，以得出体系的符合性的结论。

7. Assist the ``Lead auditor ''to decide if any nonconformities should be raised.

帮助“主任审核员”决定应提出的不符合项。

8. Assist lead auditor to compile audit report.

帮助主任审核员编写审核报告。

AUDITEE RESPONSIBILITIES

被审核方的责任

1. Inform employees of audit objectives/ scope.

向员工解释审核的目的 / 范围。

2. Appoint responsible staff to accompany each auditor.

指定陪同每个审核员的责任人。

3. Provide resources to ensure effective audit.

提供必要的资源以保证审核高效进行。

4. Provide unrestricted access to all facilities to allow for collection of objective evidence.

使审核员能够不受限制的接触设施，收集客观证据。

5. Co-operate with auditors to ensure objectives are achieved.

与审核员合作，确保达到审核目标。

6. Report clearance of corrective actions to the auditing authority.

向审核管理部门报告纠正措施的落实。

AUDITING

审核

AUDITING IS A FACT FINDING MISSION AND NOT A POLICING OPERATION

审核是一项寻找事实的工作，而不是对工作的管制

QUALITY CONTROL IS A POLICING OPERATION

质量控制是对工作的管制

　

FREQUENCY

周期

The audit frequency depend upon individual circumstances.

审核的周期视具体情况而定。

As a guide the following would normally apply:

作为参考，以下是通常的做法：

1. Each system element at least annually.

每个体系要素每年至少审核一次。

2. More frequently to clear outstanding or previous nonconformities.

纠正重大的或以前的不符合项时应加大审核频次。

3. As required to satisfy contract requirements.

按合同要求执行。

4. As specified in the certification body` s plan

认证组织计划中规定。

AUDIT PROCEDURE

审核程序

There must be system procedure to control all audits. The audit procedure shall include:

应制订系统程序（8.2.2）来控制所有审核， 审核程序应包括：

1. Statement of responsibility - organizational independence and authority of auditors

责任的说明---组织独立性和审核员的权力

2. Stated authority of the ‘Executive’ responsible for managing audits and reporting route

审核“主管”人员的权力和报告程序

3. Standard of training for auditors and team leaders

审核员和小组组长的培训标准

4. Provision for access to premises and levels of management who will carry out corrective action

允许进入的区域和允许接触执行纠正措施各级人员的规定

5. Responsibility for corrective actions.

执行纠正措施的责任

6. Use of specialists

需要时聘用专家

7. Methods for setting up - conducting of and following up all audits

策划组织进行和跟踪审核的方法

8. Rules for deciding criticality of any NCR

判定不符合项严重性的规则

9. Format and distribution of NCR` S and Audit reports

不符合项报告和审核报告的格式和分发

10. Requirements for record keeping

记录保存的要求

11. Elevate problem to management

向管理者揭示所发现的问题

12. The audit procedure needs to be distributed to all those who will be involved in audits.

审核程序需要分发给所有参加审核的人员

13. It would be prudent to ensure that they fully understand their involvement.

应保证这些人员都清楚他们的工作

　

THE AUDKT CYCLE

审核过程

THREE STAGES TO AUDITING

审核的三个阶段

1. Pre-audit Management

审核前管理

a. Preparation and planning

准备和制订计划

b. Preliminary visit

初次访问

c. Detailed plan

详细计划

2. The Audit

审核

a. Opening meeting

见面会

b. The actual audit

现场审核

c. Report preparation

准备报告

d. Closing meeting

总结会

3. Subsequent Action

后续措施

a. Prepare/ submit report

编写/提交报告

b. Close out corrective actions

贯彻纠正措施

c. Plan surveillance/ review/ re-audit

制订监督/复审计划

d. Create and store records

汇总记录

PRE-AUDLTIVITY

审核前的活动

SCHEDULING

计划

Internal Audits scheduled to ensure all applicable elements of Quality System are covered.

对内部审核进行策划以确保它覆盖了质量体系的全部适用要素。

Review Audit Schedule regularly to ensure it meets current system activities and structure

定期检查审核计划以确保它符合现行体系活动和结构。

Initiate early in life of activity to determine effectiveness and compliance with Quality System requirements.

审核应从一项活动的早期开始以确定其有效性和与体系要求的符合程度。

These measures indicate to an internal/ external auditor that the system is being controlled.

这些措施向内部/外部审核员显示体系得到了控制。

　

１．确定审核组长﹑审核组成员

２．收集被审核方资料﹑进行文件

审核

３．编制审核计划

４．编制核查表

５．通知被审核方

1. Main aid used by auditors/assessors as an aide memories

          审核员/ 评审员作为备忘录的一种主要工具。

2. Questionnaire covering all relevant points of a procedure or specification or requirements against which audits are carried out.

问题清单，包括所有有关程序或规范的要点或审核所对照的要求。

3. Ensures all elements/ requirements of a procedure or specification are covered

     确保覆盖了程序或规范的所有要素/ 要求

4. Compiled from results of a study of the procedure/ specification

     根据对程序/ 规范的研究结果编写

5. Covers all relevant requirements contained in the procedure/ specification by asking a series of questions

     通过题问方式覆盖了程序/规范的所有相关要求

6. Obtaining proof of achievement

     获得体系达到要求的证据

7. References each question to the relevant specification clause

     将每个问题与有关规范的条款对照

8. An aid to writing the audit report

     帮助编写审核报告

9. Allow space for written observations against each question

     留出空白，以便针对每个问题书写观察记录。

　

　对照标 准和体系文件(手册﹑程序文件)要求

选择典型的质量问题

结合受审核部门的特点

抽样应有代表性

　

　

　

时间要留有余地

核查表要有操作性

　

　

CHEGKLISTS

核查表

Checklists are :-

核查表是：

1. Confirming - knowledge based

确认- 了解

Procedure is in place

程序已具备

Procedure is in use

程序正在使用

2. Checking - Proof based

检查- 证明

Take sample of activity

对活动进行抽查

Prove operation under control

证明操作处于受空状态

Procedure is working

程序在运行

　

WRITTEN ASSESSMENT REPORT

书面评审报告

THE AUDIT REPORT DATA SHALL LIST AND CONTAIN THE FOLLOWING INFORMATIOM:

审核报告应列举和包含以下信息：

A. An introduction and description of audit aim and task

介绍和描述审核的目标和任务

B. A short summary of audit findings including total of nonconformities found.

审核中发现的问题，包括全部不符合项的简短总结。

C. Detailed description of findings including NCR`s and agreements. This is listed against the specification requirements. NCR`s are usually attached.

所发现问题的详细描述，包括不符合项和商定的措施。这应根据标准化要求列举。通常附带不符合项报告。

D. Comments on previous NCR` S cleared during this audit.

以前审核中的不符合项在这次审核中解决的情况说明。

E. Statements of agreed corrective actions . These may be included in attached NCR`S.

商定的纠正措施的说明。 这可以包含在附带的不符合项报告中。

F. Agreed follow - up actions

同意的跟踪措施。

G. Conclusions reached as a reaches as a result of audit.

作为审核结果得出的结论。

H. Recommendation being made (depends on contract).

推荐意见（依照合同）

I. Attendance sheet

参加者名单

　

RESPONSE TO AUDIT REPORT

对审核报告的反应

THERE ARE 3 PHASES OF RESPONSE TO THE AUDIT REPORT:-

对审核报告的反应分3个阶段：

PHASE 1 - Immediate response by management

阶段 1 - 管理者的立即反应

1. Review and investigate report findings.

     复审并调查所发现的情况。

2. Schedule appropriate corrective actions.

     对适宜的纠正措施的落实制订计划。

3. Respond in writing to audit team leader.

     书面答复审核组组长。

PHASE 2- Subsequent response by management

阶段2 -管理者的后续反应

1. Complete corrective actions

落实纠正措施

2. Inform auditor in writing and return completed nonconformity report forms.

     书面通知审核员并归还填好的不符合项报告

3. The auditor reviews:

     主任审核员审查：

 management response to the report and the nonconformities

管理者对报告和不符合项的反应

 declared completion of corrective actions.

完成纠正措施的声明。

4. Auditor follows up effectiveness of corrective actions.

     审核员跟踪检查纠正措施的有效性。

5. Once satisfied auditor signs off NCR` S.

     认可后审核员在不符合项报告上签字。

If management fail to respond to the audit report then the auditor initiates Phase 3.

如果管理者未能就审核报告做出反应，审核员应着手展开第三阶段。

PHASE 3 -

阶段 3 -

1. Obtain written response to audit report .

应得到对审核报告的书面反映。

2. Evaluate adequacy of response.

考虑该反映是否充分和全面。

3. Confirm corrective action is accomplished and is effective.

确认纠正措施已经落实且行之有效。

4. Follow up action through :

通过以下方法进行跟踪 ：

written communication

书面通讯

re - audit

复审

 other means

其它办法

　

AUDIT RECORDS

审核记录

THESE VARY DEPENDING UPON ORGANISATILN BUT NORMALLY COMPRISE:

每个组织各不相同，但通常包括：

a. Audit plans/program

审核计划/大纲

b. Audit summary and final reports

审核总结和最终报告。

c. Checklists

核查表

d. Response to report

对报告的反应

e. Nonconformity reports

不符合项报告

f. Records of successful clearance of agreed corrective actions

圆满完成商定纠正措施的记录

g. Any relevant correspondence

任何相关的信函

h. Follow - up reports

跟踪报告

i. List of trained auditors and their qualifications

经培训的审核员名单及其考核记录

j. Methods and retention periods for records

记录保管的方法和期限