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As per OOT for any product what is calculation and how to
invetigate the OOT
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Answer Posted / s jagadeesh chandra
This is only a briefe answer.
OOT means out of trend.
Definition:
In case of routene analysis any result of quantitative
chemical test that do not fall with in the defined band in
comparison to a specification.
Investigation:
Investigation procedure is same as that of OOS(Out of
specification).
OOt result in qc laboratory
.
Report with in 24 hours to qa&supervisor.
.
phase I laboratory investigation is carried out.
.
If any laboratory error is identified then it is termed as
assiagnable cause(ie system problem identified,sample
preparation,dilution in correct,improper transfer of
solvent,analyst etc etc...).There are many check points are
there to investigate.The investigator will go through the
check points.
.
After assiagnable cause identification corrective and
preventive action will be taken,and order for re testing
the original sample or another on same or another equipment
(if system performance is suspected).The person other than
who obtain the initial results should re test the
sample.After re testing results are to be evaluated and
conclude the investigation.
Re testing plan:2 sample preparetions to be done and analyse
Different different OOT limits are there for different
different tests.
For more details mail me.
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