1.0、Document and Process Control文件控制程序
1.1、Is the Factory ISO certified?工廠是否有ISO認證?
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?文件系統是否得到有效控制(包括:清楚,識別,回收,確認,最新版發布)?
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證符合內部及客戶要求?
1.4、Is there a documented process to identify obsolete documents and protect them from use? 是否有報廢文件處理程序?
1.5、Are quality records such as test
reports, laboratory results, inspection results, certificates, lot
control documents, etc. kept and controlled?質量文件是否受控制(包括測試報告,驗貨報告,證書等)?
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?質量文件是否有保存期限?
1.7、Do documented PRODUCTION procedures or instructions exist?是否有生產指引流程或作業指導書?
1.8、Do documented INSPECTION procedures or instructions exist?是否有驗貨指引流程或作業指導書?
1.9、Are they present at each inspection operation?每個檢查位是否有參與驗貨前會議?
1.10、Does the factory have an internal documented pre-production process?是否有進行產前會議?
1.11、Do documented Pre-Production meeting records exist?是否有產前會議記錄?
1.12、Does the factory hold a pre-production meeting prior to start of production?每次生產前是否有進行開會?
1.13、Are both production and factory QC represented at the pre-production meeting?是否有生產和QC代表來參加產前會議?
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?是否有用產品規格和簽板來進行開產前會議?
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?是否有用產品化驗報告來進行開產前會議?
1.16、Are critical quality or inspection
checks reviewed, identified and documented prior to production or at the
pre-production meeting?嚴重的質量問題是否在產前會議上提到?
1.17、Are Pre-production meeting notes/issues communicated to the line supervisors?會議記錄是否有分發給沒參加開會之生產主管?
1.18、Does the factory perform a pilot/test run before production start with documentation?工廠在產前是否有進行試產?
1.19、Does a documented process exist for
the factory QC to compare first production units produced to client
approval sample and specifications?第一次生產貨品時工廠QC是否有對簽板及產品規格說明?
1.20、Does the factory document and track
their on-time ship reliability for each of their clients?
(performance)工廠是否有文件證明對于客戶準時出貨的可靠性保證?
1.21、Is there supervisor/manager on all shifts?每班生產車間是否有主管/經理值班?
1.22、Does the factory have an approved sample/quality standard?工廠是否有確認的簽板或質量標準?
1.23、Does the factory QC compare first production units produced to the clients approved sample?工廠QC是否有用簽板與首件產品進行比較?
1.24、Are documentation and records
maintained for main facility equipment (i.e. boilers, Back up power
plant , Centralized heating, etc.)工廠工具是否有進行維修保養及做記錄(如:鍋爐,發電機等)?