To define the procedure for conducting investigation of Out of trend (OOT) results observed during laboratory testing of samples.
1. Objective
To define the procedure for conducting investigation of Out of trend (OOT) results observed during laboratory testing of samples.
2. Scope
This SOP is applicable to analysis of raw material, finished product, in process samples, stability samples conducted at xxxxxxxxxxxxxxx
3. Responsibility
Officer - Quality Control: To notify the Head QC about the OOT result.
Head Quality Control: To authorize the re-analysis
4. Accountability
Head QA
Head QC
5. Procedure
5.1. Out of trend result shall be determined on the basis of the data of previous batches or aberrant data observed during analysis. The result may be within the specification but it may still be out of trend for a particular test.
5.2. While performing the analysis, if any OOT or aberrant data is observed, then the analyst shall immediately inform the QC Manager who shall conduct the preliminary investigation of the OOT result.
5.3. He shall store the sample and standard preparations and any other preparations used during the analysis until the investigation is completed. He shall fill the incident report as per the attached format XXXXXXX and xxxxxxx
5.4. QC Manager of the respective section along with the analyst shall investigate reasons for OOT results by checking for analytical error. For example:
5.4.1. Whether the correct STP is followed or not
5.4.2. Weight taken for standard and sample is as per the procedure
5.4.3. If more than one batch has been analysed at the same time then results of the other batches shall be checked thoroughly
5.4.4. Instrument used for analysis is within the calibration period
5.4.5. Sonication has been carried out for the proper time as given in procedure (where applicable)
5.5. During the above investigation, if the cause of OOT result is identified as laboratory error and the Head – Quality Control conclude on it, the test results shall be discarded and repeat analysis shall be carried out.
5.6. In case if the cause of OOT result is not identified as laboratory error then reanalysis shall be carried out to confirm the OOT results. The same shall be informed to the Production department and Quality Assurance.
5.7. The analyst shall record the reanalysis results in the worksheet.
5.8. The same analyst shall repeat the test with fresh sample and if required fresh standard preparation with due care to omit the errors identified.
5.9. If the retest results are now within the trend and comparable to the data of previous batches, then analyst shall report the results obtained during the second analysis and OOT investigation shall be disposed after thorough investigation of the OOT result during initial analysis.
5.10. If the cause of OOT results is not identified, and if results of re-analysis are same as the previous analysis then the results obtained during the first analysis shall be reported.
5.11. If the test result is out of trend, it shall be concluded that the material/product is not meeting the trends.
5.12. Head – Quality Control shall review the OOT results and forward the same to QA and Production for investigation and to prevent the recurrence of such incidents in the further batches.
6. Records/Formats
xxxxxxxxxxx - Quality Impacting Incident Report
xxxxxxxxxxx - Quality Non-Impacting Incident Report
7. Annexure
NA
8. Reference:
Nil
9. Abbreviations:
SOP - Standard Operating Procedure
QA - Quality Assurance
NA - Not Applicable
10. Revision History:?
|
Revision No. |
Effective Date |
Reason for Revision |
|
00 |
|
New Document |
Quality Impacting Incident Report
Format No. XXXXXX
|
QUALITY IMPACTING INCIDENT REPORT |
|
Incident Number: Date: |
|
SECTION – I |
|
Brief Description of the Incident:
|
|
Observed By: (Sign / Date) |
|
SECTION – II |
|
Investigations by the Originating Dept:
Sign and Date : |
|
Investigations by the QA Department:
Sign and Date: |
|
SECTION – III |
|
Corrective Actions: (To be filled by concerned department) |
|
Preventive Actions: (To be filled by concerned department) |
|
Disposition: Implementation Status of the Preventive Actions: Satisfactory / Not Satisfactory Comments: QA Head: (Sign and Date) |
Quality Non-Impacting Incident Report
Format No. XXXXXX
|
QUALITY NON - IMPACTING INCIDENT REPORT |
|
SECTION – I |
|
Brief Description of the Incident:
|
|
Observed By : (Sign / Date)
|
|
SECTION – II |
|
Investigations by the Originating Dept:
Sign and Date : |
|
SECTION – III |
|
Corrective Actions: (To be filled by concerned department) |
|
Preventive Actions: (To be filled by concerned department) |
|
Disposition: Implementation Status of the Preventive Actions: Satisfactory / Not Satisfactory Comments: Head of concerned Department or his designee: (Sign and Date) |
Out of trend , analysis of raw material, finished product, quality control
