BV质量管理系统(QMS)审核

2019-06-25 20:05:46 509

Bureau Veritas Quality Management System (QMS) Audit

BV质量管理系统(QMS审核

 

The QMS audit is designed to determine the existence and effectiveness of appropriate, documented QMS procedures in a factory. This module takes one day for a typical factory.

QMS审核的目的是检查工厂是否具有适当的文件化QMS程序及其有效性。一般情况下,本审核需要一天时间完成。

 

Audit Scope 审核范围
The areas covered in the audit include: 审核的领域包括:

GME - General Management Elements *

•GME -一般管理要素

o Building Exterior and Interior 建筑物外部和内部

o Layout/Product Flow 布局/产品流

o Lighting and Ventilation 照明和通风

o Cleaning 清洁

o Pest Control 虫害控制

o Waste/Waste Disposal 废物/废物处置

o Foreign Body Contamination 异物污染

 

SENIOR MANAGEMENT COMMITMENT AND CONTINUAL IMPROVEMENT 高级管理承诺和持续改进

MANAGEMENT SYSTEM管理系统

 o Quality Manual 质量手册

o Quality Policy Statement质量方针声明

o Organizational Structure, Responsibility and Management Authority 组织结构,职责和管理权限

o Customer Focus 顾客导向

o Management Review 管理评审

o Internal Audit 内部审核

o Supplier Approval and Performance Monitoring 供应商准收绩效监控

o Product Identification and Traceability产品标识和可追溯性

o Issue and complaint handling 问题和投诉处理

o Procedures 程序

o Document Control 文件控制

o Record Keeping 记录保存

 

PRODUCT CONTROL产品控制

o Glass Control Program玻璃控制程序

o Chemical Residue Control 化学残留控制

o Segregation and Stock Rotation 隔离和存货周转

o Product Release 产品放行

o Control of Non-Conforming Product不合格产品控制

o Reference Samples 参考样品

 

PRODUCT CONFORMITY ASSESSMENT产品合格评定

o Product Analysis /Testing产品分析和试验

o In-Process Control and Process Inspection 过程中控制和过程检验

o Pre-final and Final Inspection  最终前和最终检验

o Labelling and Packing 标签和包装

 

PROCESS CONTROL 过程控制

o Incoming Raw Materials Control 收到的原材料控制

o Calibration and Control of Measuring and Monitoring Devices 测量和监控装置的校准和控制

 

PERSONNEL 人员

o Training培训

o Health and Personal Hygiene 健康和个人卫生

 

* GME assessment is conducted during each factory assessment regardless of the number of modules requested.

 * 无论要求几种评估模块,每种工厂评估都要进行GME评估

Audit Methodology 审核方法

The audit is conducted using multiple methodologies to assure reliable, detailed results. The methodologies utilized are:

审核使用多种方法来确保可靠和详细的结果。方法包括:

o Document Review – The auditor will review procedures, work instructions, and supporting records. This review is conducted at the locations in the factory where the procedures and work instructions are being utilized and the where the records are being generated and retained.

O文件审查审核员将审查程序,作业指导书,和相关记录。审查在使用程序和作业指导书,以及生成和保存记录的地点进行。

o Observations – The auditor will visit all areas of the factory and observe that appropriate equipment, manufacturing processes, defined process controls and procedures are being followed as well as observing general factory conditions.
O
观察审核员将参观工厂的所有区域,并观察是否采用了正确的设备、制造过程、确立的过程控制和程序,并观察工厂的总体条件。

o Interviews – The auditor will interview personnel, managers as well as workers, responsible for carrying out the documented procedures or following the work instructions. These will be informal interviews carried out at the work site(s) in the factory.

O访谈审核员将访谈员工,管理人员和负责执行文件规程或作业指导书的工人。这些将是非正式的访谈,在工厂的工作现场进行。

 

 

Audit Process审核过程

o Opening Meeting – The assigned auditor will meet with factory management and review the audit scope and process.

O首次会议审核员将与工厂管理人员会面,确认审查范围和过程。

o Factory Tour – The auditor will tour the factory from the incoming material area to the finished product warehouse. During the tour the auditor will review the equipment and manufacturing processes that were specified in the Factory Profile. In addition, they will make general observations and identify the areas of the factory where they will return to conduct the detailed portions of the audit. The tour helps the auditor visualize the factory layout to optimize subsequent activities.


O
现场巡视审核员将从进料区到成品仓库参观工厂。参观期间,审核员将审查设备和制造过程是否符合工厂配置文件中的规定。此外,他们将进行一般的观察,识别工厂区域划分,以便返回进行详细审核。参观有助于审核员了解工厂布局,方便后续活动。

 

o Sectional Audit – The auditor will visit the specific areas of the factory covered within the scope and utilize the methodologies described above to assess compliance.

o Draft Findings – The auditor will then need a private area to review his findings and prepare the draft for review during the closing meeting.

o Closing meeting – The auditor presents the draft findings to factory management.


O
区域审核审核员将参观审核范围内的工厂特定区域,并利用上述方法评估符合性。
O
现场发现项审核员需要一个单独区域审查他的发现项,并准备现场报告末次会议时使用。
O
末次会议审核员向工厂管理者发现项