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去年FDA对一家原料厂进行现场检查，发现该公司的检验仪器如HPLC,UV,EB均为市计量所校验，并且只有校验报告没有校验记录
随即作为一条483列了出来，选取一段如下：
There is no raw data to support the balances operation qualification for the Mettler Toledo xxx(ID # xxxxxxx) and Shangping xx-xxxx (ID # xxxxxxx) conducted yearly by outside contractor. The calibration and/or qualification consist of a calibration certificate that contains results with no raw data and or individual measurements to obtain results. Furthermore, the qualification lacks to include the eccentricity test and minimum weight determination as part of the yearly operation qualification. The Quality Control unit does not have a procedure and specifications in place for the annual balance operation qualification. This is evidenced in the qualification reports (i.e. Calibration Certificate # xxxxxxx for model xxxx and # xxxxxxx for xx-xxx) conducted both annually by the outside contractor dated on x/xx/2010.
在这条483里，FDA提出两个问题，一是校验没有原始记录和规程，二是没有对天平的最小称量值做确认
大家看可以看下自己的天平校验证书，是不是没有最小称量值这一项，这是因为国标里并没有，而且一般厂商都会在铭牌里标出天平的最小称量值是多少
很快这家公司回复了FDA483，对于这条进行了如下解释：
In the future all calibration testing raw data will be requested from 市计量所 and attached to the calibration report that will be subject to 某公司 review and approval. SOP xxx-xxxx has been revised to include detailed procedures for annual balance calibration (Appendix -10a). The QA/QC teams at 某公司 have been retrained on updated SOP XX-XXX as demonstrated by the attached documentation (Appendix-10e). The following Table 3 lists the detailed items for calibration. The eccentricity has been performed. The balance minimum weight determination, missed by 市计量所 as listed in Table 3, will be added into as an annual calibration item. Based on the revised calibration procedures, 某公司 has performed the annual calibration for the balances. For more details, please refer to the Appendix-10d for revised SOPxxx-xxx and the calibration report for the balances (Appendix-10f) 这家公司由于和计量所关系好，索取到了校验的原始记录（一般计量院不愿意给你，不信可以试试），并且自己制定了年度校验规程（自己进行），并对最小称量值进行了确认。并在回复中将计量院的结果和本公司的结果进行了比较，随回信附上了计量所的校验报告及记录，本公司进行的校验记录及报告以及升版后的规程的扫描件。最后承诺建立年度校验程序并升版规程，并且以后的校验都将会有原始记录。该回复得到了FDA的认可 （说句题外话最小称量值确认有2种方法 一是根据厂商提供的最小称量值，称量10次，其结果的标准偏差乘以3再除以称量值，其结果不应大于0.001 二是用天平的重复性乘以3除以0.1%（不确定度），得到的结果即为最小称量值，再按上述方法进行验证 以上是个人浅见，如有错误，欢迎指正）
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发表于 2012-8-14 13:26:36
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