6.4. Maintenance and control of monitoring and measuring devices
监视和测量设备的维护和控制
A documented maintenance programme for manufacturing operations shall be implemented.
有关生产操作过程(所用的监视测量设备)的文件化维护计划应予以执行。
Records shall be kept of work carried out.
记录应予以保持以证实工作已完成。
The Operator shall establish processes to ensure that monitoring and measurement can be carried
out in a manner consistent with documented procedures.
经营者应建立过程,以确保按照与文件化程序相一致的方式实施监视和测量。
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.
用于饲料生产的各种天平和测量设备,应适合于所测量的重量或数量范围,并应根据风险定期检测准确性。
Where necessary to ensure valid results, measuring equipment shall:
有必要确保有效的结果时,测量设备应:
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;
对照能溯源到国际或国家标准的测量标准,按照规定的时间间隔或在使用前进行校准或检定。
当不存在上述标准时,应记录校准或检定的依据;
b) be adjusted or re-adjusted as necessary;
进行调整或必要时进行在调整;
c) be identified to enable the calibration status to be determined;
得到识别,以确定其校准状态;
d) be safeguarded from adjustments that would invalidate the measurement result; and
防止可能使测量结果失效的调整;并且
e) be protected from damage and deterioration during handling, maintenance and storage.
在搬运、维护和贮存期间防止损坏或失效。
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,当发现设备不符合要求时,经营者应对以往测量结果的有效性进行评价和记录。经营
者应对该设备和任何可能受影响的产品采取适当的措施。校准和验证结果的记录应予以保持。
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.
当计算机软件用于规定要求的监视和测量时,应验证其满足预期用途的能力。验证应在初次
使用前进行,必要时再确认。
Ensure that: 确保:
A formal calibration system is in place; 正式的校准系统是适宜的;
This includes items to be calibrated; 包括将被校准的项目;
Appropriate calibration intervals are defined; 以规定适当的校准间隔;
Calibration results are documented; 校准结果形成文件;
A formal preventive maintenance system exists; 存在一个正式的预防性维护系统;
Appropriate maintenance intervals are defined; 已规定适当的维护间隔;
Maintenance work is documented; 维护工作形成文件;
Maintenance work does not interfere with product safety. 维护工作未影响产品安全。