1.0、Document and Process Control文件控制程序
1.1、Is the Factory ISO certified?工厂是否有ISO认证?
1.2、Is there a formal, documented system to control documents and ensure that they are legible, identified, reviewed, authorized, up-to-date and distributed?文件系统是否得到有效控制(包括:清楚,识别,回收,确认,最新版发布)?
1.3、Is there a documented process to ensure product specific documents such as specifications (both internal and customer's), purchase orders, etc. are controlled and updated regularly to reflect changes?文件程序是否有定期更新保证符合内部及客户要求?
1.4、Is there a documented process to identify obsolete documents and protect them from use? 是否有报废文件处理程序?
1.5、Are quality records such as test reports, laboratory results, inspection results, certificates, lot control documents, etc. kept and controlled?质量文件是否受控制(包括测试报告,验货报告,证书等)?
1.6、Is there a written procedure that defines how quality records are stored, protected and disposed of as well as a defined retention period?质量文件是否有保存期限?
1.7、Do documented PRODUCTION procedures or instructions exist?是否有生产指引流程或作业指导书?
1.8、Do documented INSPECTION procedures or instructions exist?是否有验货指引流程或作业指导书?
1.9、Are they present at each inspection operation?每个检查位是否有参与验货前会议?
1.10、Does the factory have an internal documented pre-production process?是否有进行产前会议?
1.11、Do documented Pre-Production meeting records exist?是否有产前会议记录?
1.12、Does the factory hold a pre-production meeting prior to start of production?每次生产前是否有进行开会?
1.13、Are both production and factory QC represented at the pre-production meeting?是否有生产和QC代表来参加产前会议?
1.14、Are product specifications and approval samples reviewed prior to production or at the pre-production meeting and is this documented in the meeting notes?是否有用产品规格和签板来进行开产前会议?
1.15、Are product test requirements and results reviewed prior to production or at the pre-production meeting and is this documented in the meeting notes?是否有用产品化验报告来进行开产前会议?
1.16、Are critical quality or inspection checks reviewed, identified and documented prior to production or at the pre-production meeting?严重的质量问题是否在产前会议上提到?
1.17、Are Pre-production meeting notes/issues communicated to the line supervisors?会议记录是否有分发给没参加开会之生产主管?
1.18、Does the factory perform a pilot/test run before production start with documentation?工厂在产前是否有进行试产?
1.19、Does a documented process exist for the factory QC to compare first production units produced to client approval sample and specifications?第一次生产货品时工厂QC是否有对签板及产品规格说明?
1.20、Does the factory document and track their on-time ship reliability for each of their clients? (performance)工厂是否有文件证明对于客户准时出货的可靠性保证?
1.21、Is there supervisor/manager on all shifts?每班生产车间是否有主管/经理值班?
1.22、Does the factory have an approved sample/quality standard?工厂是否有确认的签板或质量标准?
1.23、Does the factory QC compare first production units produced to the clients approved sample?工厂QC是否有用签板与首件产品进行比较?
1.24、Are documentation and records maintained for main facility equipment (i.e. boilers, Back up power plant , Centralized heating, etc.)工厂工具是否有进行维修保养及做记录(如:锅炉,发电机等)?