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.
you are definately needed to mention the details of your first test.
Ofcourse its a deviation (un planned)
Just follow ur inhouse Deviation SOP to close the issue.
Firstly u shall rise a deviation note and get approved from the Head QA.
mention the details of deviation and possible causes through failure investigation for that.wrie the criticality of that experiment.mention the type of change (whether Minor, Major, Critical) that the deviation caused.
then go for CAPA plan. Mention the correctiontaken (at ur level) , write the corrective action(at ur reporting level) to take and propose the preventive action (at management level).then u need to change the pertaining SOP "saying that the instrument is not stable in long time running"
proceed to incorporate the changes in the protocol u have followed through Document change control procedures.
[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.
Hi,
In brief you have done analysis i n one system and it is not giving the desired results and another machine is giving the desired results.
To handle this , you ahould have to have the following SOP’s.
Handlng Out of expectation ( OOE) reults.
2.Handling out of Specification ( OOS) results
The OOE results are the results which are out of expectation ( Trend), but within the specifications. and OOS is the failing of the sample in aceptance criteria. Thess SOP.s requires through investigation to be carrried out as directed by the concerned department head/ Head QA.
Through this provision, you may ask for the reanalysis of the sample for the investigation purpose and verification ofthe instrument.
Through investigation, the faulty instrument will be ditected and the reults coming out from the corrrect instrument will be considard as valida results.