[quote=min1999]When we finished the experiment according to the SOP and study plan, the results is riddiculous and the QC sample is beyond the criteria due to some strange reason from the instrument, saying that the instrument is not stable in long time running, but it is validated and works well in short time tests.
We reperfomed the analysis again in another apparatus which showed good function in both short and long time running and then the result is good.
My questions are
Do I need to report or mention the result of the first test in my final report.
Is this a deviation from study protocol or any SOP.
Can you suggest what kind of documents of procedures and records should be done?
Thank you very much for any sharing of your oppinon.
This is a case of Lab Investigation, one must raise the Laboratory investigation report in case of out of specification results (OOS). LIR covers all Errors resulting from analyst’s mistakes, malfunctioning laboratory equipment, test methods, materials or reagents, mistakes in calculations, use of incorrect standards and simple mis-measurements, etc. Once it is established wether its a lab error or out of specification, you can describe the causes and corrections in summery of investigation. In your case its a malfunctioning of lab instrument and it should be tagged out of order and should not be used for the analysis. It will not be adequate to just change in SOP and rephrasing the procedure to use instrument for short time!! If there is a history showing instrument malfunctioning please send it for maintenance and calibration.