6.4. Maintenance and control of monitoring and measuring devices
監(jiān)視和測(cè)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(guò)程(所用的監(jiān)視測(cè)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(yíng)者應(yīng)建立過(guò)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(cè)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(cè)量設(shè)備,應(yīng)適合于所測(cè)量的重量或數(shù)量范圍,并應(yīng)根據(jù)風(fēng)險(xiǎn)定期檢測(cè)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(shí),測(cè)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(duì)照能溯源到國(guó)際或國(guó)家標(biāo)準(zhǔn)的測(cè)量標(biāo)準(zhǔn),按照規(guī)定的時(shí)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(shí),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(shí)進(jìn)行在調(diào)整;
c) be identified to enable the calibration status to be determined;
得到識(shí)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(cè)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(shí),經(jīng)營(yíng)者應(yīng)對(duì)以往測(cè)量結(jié)果的有效性進(jìn)行評(píng)價(jià)和記錄。經(jīng)營(yíng)
者應(yīng)對(duì)該設(shè)備和任何可能受影響的產(chǎn)品采取適當(dāng)?shù)拇胧P?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(cè)量時(shí),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(shí)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(gè)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。