SOP for Handling of Out of Trend (OOT)

OBJECTIVE

To lay down the procedure for conducting an investigation of out-of-trend (OOT) results observed during laboratory testing of samples. 

SCOPE

This SOP is applicable to the out-of-trend results observed in the analysis of raw materials, packing materials, finished products, in-process samples, environmental monitoring results, water results, and stability samples with respect to the previous stability test points.

RESPONSIBILITY

• It is the responsibility of QC Executives to notify the QC Manager about the OOT result. 
• QC Manager shall be accountable for the implementation of this SOP. 
• QA Manager shall review and close the Investigation Report.

PROCEDURE

• Out-of-trend results shall be determined on the basis of the data of previous batches previous analytical data or aberrant data observed during analysis. The result may be within the specification but not in the trend. 

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• While performing the analysis, if any OOT is observed, then the analyst shall immediately inform the QC Manager to conduct the preliminary investigation along with the analyst of the OOT observation as per Section – I of Annexure - I (OOT Investigation Form). 
• The executive shall store the sample and standard preparations and any other preparations used during the analysis until the investigation is completed. 
• Make the necessary entries in the OOT log (Annexure-II) by assigning the OOT No. as follows: 

       OOT/XX/ YYY 

     Where, 

        OOT: Out of Trend 

        XX: Last two digits of the current year (e.g. for 2018 mention 18) 

        YYY: Sequential number (e.g. 001,002 ……) 

• During the above investigation, if the cause of the OOT result is identified as a laboratory error QC Manager concludes on it, and repeat analysis shall be carried out and reported. 
• The same analyst shall repeat the test with a fresh sample and fresh standard preparation (if required) with due care to omit the errors identified. 
• In case if the cause of the OOT result is not identified as a laboratory error then the QC manager shall recommend for reanalysis to confirm the OOT results. If the results of repeat analysis are similar to a previous analysis the OOT results are valid and shall be informed to the concerned departments.

• The analyst shall record the re-analysis results in the datasheet. 
• If the reanalysis results are within the trend and observations are not aberrant, then the initial analysis shall be investigated for the cause of OOT and report the repeat analysis results. 
• If the cause of OOT results is not identified, and if the results of re-analysis are the same as the previous analysis then the results obtained during the first analysis shall be reported. 

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• If the test result is out of trend, it shall be concluded that the material/product is not meeting the trends and the final decision for acceptance of the material/product shall be taken by QA Manager. 
• In the case of raw and packing material: the QC manager shall review the OOT results and forward the same to the QA manager for investigation and prevent the recurrence of such incidents in future supplies.
• In the case of Finished Products: the QC manager shall review the OOT results and forward the same to QA and Production for information and investigation. A final decision will be taken by the QA manager based on the investigation report. 
• In the case of Stability Studies: OOT investigations are to be carried out and if required analysis can be performed using the samples of the previous stability test point. A final decision will be taken by the QA manager based on the investigation report in coordination with Production. 

ABBREVIATIONS

QC – Quality Control 

OOT – Out of Trend 

SOP – Standard Operating Procedure 

QA – Quality Assurance 

ATTACHMENTS: 

Attachments I: OOT Investigation Form
Attachments II: Logbook OOT Test Result

REVISION HISTORY

Nil

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