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歐洲FAMI-QS認(rèn)證操作規(guī)范(十八)監(jiān)視和測量設(shè)備的維護(hù)和控制

6.4.  Maintenance and control of monitoring and measuring devices  

       監(jiān)視和測量設(shè)備的維護(hù)和控制


A documented maintenance programme for manufacturing operations shall be implemented.

有關(guān)生產(chǎn)操作過程(所用的監(jiān)視測量設(shè)備)的文件化維護(hù)計(jì)劃應(yīng)予以執(zhí)行。

Records shall be kept of work carried out.

記錄應(yīng)予以保持以證實(shí)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(jīng)營者應(yīng)建立過程,以確保按照與文件化程序相一致的方式實(shí)施監(jiān)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(chǎn)的各種天平和測量設(shè)備,應(yīng)適合于所測量的重量或數(shù)量范圍,并應(yīng)根據(jù)風(fēng)險定期檢測準(zhǔn)確性。


Where necessary to ensure valid results, measuring equipment shall:

有必要確保有效的結(jié)果時,測量設(shè)備應(yīng):

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(biāo)準(zhǔn)的測量標(biāo)準(zhǔn),按照規(guī)定的時間間隔或在使用前進(jìn)行校準(zhǔn)或檢定。

當(dāng)不存在上述標(biāo)準(zhǔn)時,應(yīng)記錄校準(zhǔn)或檢定的依據(jù);

b) be adjusted or re-adjusted as necessary;

進(jìn)行調(diào)整或必要時進(jìn)行在調(diào)整;

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

得到識別,以確定其校準(zhǔn)狀態(tài);

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

防止可能使測量結(jié)果失效的調(diào)整;并且

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

在搬運(yùn)、維護(hù)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(dāng)發(fā)現(xiàn)設(shè)備不符合要求時,經(jīng)營者應(yīng)對以往測量結(jié)果的有效性進(jìn)行評價和記錄。經(jīng)營

者應(yīng)對該設(shè)備和任何可能受影響的產(chǎn)品采取適當(dāng)?shù)拇胧?。校?zhǔn)和驗(yàn)證結(jié)果的記錄應(yīng)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(dāng)計(jì)算機(jī)軟件用于規(guī)定要求的監(jiān)視和測量時,應(yīng)驗(yàn)證其滿足預(yù)期用途的能力。驗(yàn)證應(yīng)在初次

使用前進(jìn)行,必要時再確認(rèn)。



Ensure that:  確保:

?  A formal calibration system is in place;  正式的校準(zhǔn)系統(tǒng)是適宜的;

?  This includes items to be calibrated;  包括將被校準(zhǔn)的項(xiàng)目;

?  Appropriate calibration intervals are defined;  以規(guī)定適當(dāng)?shù)男?zhǔn)間隔;

?  Calibration results are documented;  校準(zhǔn)結(jié)果形成文件;

?  A formal preventive maintenance system exists;  存在一個正式的預(yù)防性維護(hù)系統(tǒng);

?  Appropriate maintenance intervals are defined;  已規(guī)定適當(dāng)?shù)木S護(hù)間隔;

?  Maintenance work is documented;  維護(hù)工作形成文件;

?  Maintenance work does not interfere with product safety.  維護(hù)工作未影響產(chǎn)品安全。


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