Answer / 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.

Answer / manojmalik

Investigation of OOT ,like same as per the OOS
investigation ,Obseved the OOt as per the regrassion
cofficient .based ob 1,2and 3 sigms value .

Answer / vamsidhar reddy. b

1. Tabulate the data, calculate the average and standard deviation.
• Use excel spread sheet for average & Standard deviation calculation.
• Standard deviation will be multiplied by 3 to get the 3 sigma (3 )) value.
• Calculate ± 3 Sigma
• Maximum & Minimum limits will be fixed by the formula Average ±3 Sigma
• If the obtained maximum value is above the spec. Limit, specification limit shall be taken into consideration.
• The obtained minimum value may be below the lower spec. limit.
• The maximum and minimum limits as explained above shall be taken as the trend range for upper and lower limits.
• Any obtained value is found to be out of this range will be considered as Out of Trend (OOT) value.
2. Based on preliminary investigation OOT Results should be reconfirmed with same analyst in duplicate.
3. If the result of repeated analysis is in line with the result of 1st analysis, then results of 1st analysis shall be reported and 2nd analysis is considered ‘For confirmation only’ and further investigation is carried out for the cause of OOT result.
4. If the result of repeated analysis is line with previous trend, then result of 2nd analysis shall be reported and no further investigation is carried out with respect to the product.

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