Smartline Autosampler 3900 Manual / Handbuch V 1508 03/2007

APPENDIX C: Test Procedure 71
The measuring value’s mean (peak area) is developed for each vial and
the variation coefficient (VK2/3) is determined for both vials (see
calculation point 1).
The dilution factor F10 is determined from the ratio of the original
sample’s peak areas mean and the dilution.
The variation coefficient VK2 for the 1. vial (sample) should be = 0.5%.
The variation coefficient VK3 for the 2. vial (dilution) should be = 0.5%.
The dilution factor F10 should be within the following range:
9.85 < x > 10.25.
Record the results on the test report form.
Documentation and Archive
The results are recorded for each test on the test report form.
Additionally, the instrument number (i.e. serial number or inventory
number) of the instrument inspected, date of the inspection, date of the
next inspection, and name of the inspector are entered on the test report
form. The test report form is then chronologically filed in the instrument
log book.
If the instrument passed the inspection and fulfilled the specifications,
then it is provided with a sticker or tag (a green label). The label has the
instrument number, date of inspection, date of the next inspection, and
name of the inspector on it.
If the instrument did not pass the inspection and did not fulfil the
specifications then the instrument is given a sticker or tag (a red label
with a DEFECT label). This label has the instrument number, date of the
inspection, and the name of the inspector. The instrument may not be
operated until the required maintenance or repair has been made and the
specifications are met.
All instrument inspection documents (instructions and test reports) are
quality assurance system regulations that are archived.
The manufacturer archives documents, manuals, service manuals,
service information, and part lists that are available for reference.