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歐洲FAMI-QS認證操作規范(十八)監視和測量設備的維護和控制

6.4.  Maintenance and control of monitoring and measuring devices  

       監視和測量設備的維護和控制


A documented maintenance programme for manufacturing operations shall be implemented.

有關生產操作過程(所用的監視測量設備)的文件化維護計劃應予以執行。

Records shall be kept of work carried out.

記錄應予以保持以證實工作已完成。

The Operator shall establish processes to ensure that monitoring and measurement can be carried

out in a manner consistent with documented procedures.

經營者應建立過程,以確保按照與文件化程序相一致的方式實施監視和測量。

All scales and metering devices used in the manufacture of feed shall be appropriate for the range

of weights or volumes to be measured and shall be tested for accuracy regularly according to the risks.

用于飼料生產的各種天平和測量設備,應適合于所測量的重量或數量范圍,并應根據風險定期檢測準確性。


Where necessary to ensure valid results, measuring equipment shall:

有必要確保有效的結果時,測量設備應:

a) be calibrated or verified at specified intervals or prior to use, against measurement

standards traceable to international or national measurement standards. Where no standards

exist, the basis for calibration or verification shall be recorded;

對照能溯源到國際或國家標準的測量標準,按照規定的時間間隔或在使用前進行校準或檢定。

當不存在上述標準時,應記錄校準或檢定的依據;

b) be adjusted or re-adjusted as necessary;

進行調整或必要時進行在調整;

c) be identified to enable the calibration status to be determined;

得到識別,以確定其校準狀態;

d) be safeguarded from adjustments that would invalidate the measurement result; and

防止可能使測量結果失效的調整;并且

e) be protected from damage and deterioration during handling, maintenance and storage.

在搬運、維護和貯存期間防止損壞或失效。


In addition, the Operator shall assess and record the validity of the previous measuring results

when the equipment is found not to conform to requirements. The Operator shall take appropriate

action on the equipment and any product that might have been affected. Records of the results of

calibration and verification shall be maintained.

此外,當發現設備不符合要求時,經營者應對以往測量結果的有效性進行評價和記錄。經營

者應對該設備和任何可能受影響的產品采取適當的措施。校準和驗證結果的記錄應予以保持。


When used in the monitoring and measurement of specified requirements, the ability of computer

software to satisfy the intended application should be verified. This verification should be

undertaken prior to initial use and reconfirmed if necessary.

當計算機軟件用于規定要求的監視和測量時,應驗證其滿足預期用途的能力。驗證應在初次

使用前進行,必要時再確認。



Ensure that:  確保:

?  A formal calibration system is in place;  正式的校準系統是適宜的;

?  This includes items to be calibrated;  包括將被校準的項目;

?  Appropriate calibration intervals are defined;  以規定適當的校準間隔;

?  Calibration results are documented;  校準結果形成文件;

?  A formal preventive maintenance system exists;  存在一個正式的預防性維護系統;

?  Appropriate maintenance intervals are defined;  已規定適當的維護間隔;

?  Maintenance work is documented;  維護工作形成文件;

?  Maintenance work does not interfere with product safety.  維護工作未影響產品安全。


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