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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 / 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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