Out of Specification Form

Phase I Investigation:

Material name	:
Supplier name					OOS #	:
Batch No. / Lot No.	:				GRR No.	:
Month of Mfg.	:				Month of Expiry	:
TR No.	:				Date of receipt	:
Quantity	:
Out of specification Type: Please √ mark on applicable column
— Raw materials			— Packing material	— Semi-finished product			— Finished product

Date of original analysis: ___________

Physical characteristic	Specification		Test method	Results
Remarks: The submitted sample IS of STANDARD QUALITY / NOT OF STANDARD QUALITY as per _________________________ Specification ________________ with respect to above mentioned test.
Analyzed by: Date:		Approved by: Date:

Statement of Problem: _____________________________________________________________________________________ _____________________________________________________________________________________ _____________________________________________________________________________________

                          

Investigation into possible assignable cause(s):
Analyst failure	Yes	No	NA
Was a weighing error?
Were diluents, reagents, mobile phase, filters, chromatographic conditions, etc, included in
The analytical procedure used during the analysis?
Was reference standard used in the analysis expired or its assay value incorrectly determined?
Was expired test solution or volumetric solution used in the analysis?
Were the test and volumetric solutions properly prepared?
Were air bubbles found in the spectrophotometric cell or in the HPLC system?
Did an instrument malfunction during the analysis?
Is the balance used with appropriate accuracy and calibrated?
Is the sample homogeneous?
Was an out-of-calibration instrument used during the analysis?
Is there evidence that the equipment is contaminated?
Were there instrument problem such as: Noisy baseline poor peak resolution, poor injection reproducibility, not reproducible or unidentified peaks, or contamination that affected peak integration, etc.?
Were all other techniques included in the analytical method followed by the analyst?
Was an injection error found?
Was a dilution error found?
Were any other assignable causes found?
Is there any error in calculation?
Is sample stored appropriately?
Were standards and samples properly weighed, prepared & diluted?
Were standards, samples & reagents, etc. properly labeled?
Are the standard responses the same as previous value?
Were reagents properly standardized?
Is the analyst trained and evaluated?
System failure
To check for power failure
Is the system / instruments are calibrated?
Is the calibration standard used is appropriate?
Are there any spillage / contamination in standard / reagent / sample?
Is there evidence of degradation of standards and / pr sample (before or after preparation)?

Investigation into possible assignable cause(s):
Analyst failure	Yes	No	NA
Is suitable instrument used?
Is the instrument parameters set correctly?
Is the appropriate equipment accessories used?
Sampling plan failure
Is sample preparation done properly?
Is sampling plan followed?
Are sampling equipments ok?
Are environmental conditioned were ok during sampling?
Is appropriate sample container / sample bag used?
History
Is there a similar history with the product in the past?
Have there been similar errors in the past?

Was an assignable cause(s) found? If yes, Identify the cause(s): _____________________________________________________________________________________ _____________________________________________________________________________________ _____________________________________________________________________________________ _____________________________________________________________________________________ _____________________________________________________________________________________

Did the Assignable Cause(s) affect any other batches? If yes, explain: _____________________________________________________________________________________ _____________________________________________________________________________________ _____________________________________________________________________________________ _____________________________________________________________________________________ _____________________________________________________________________________________

Corrective action(s) if an Assignable cause(s) was found? _____________________________________________________________________________________ _____________________________________________________________________________________ _____________________________________________________________________________________ _____________________________________________________________________________________ _____________________________________________________________________________________

Result(s):

Original results	Rerun / Retest results

Conclusion / Recommendations: _____________________________________________________________________________________ _____________________________________________________________________________________ _____________________________________________________________________________________ _____________________________________________________________________________________ _____________________________________________________________________________________

Analyzed by: Date:

Approved by: Date:

Phase II Investigation:

Material name	:
Supplier name					OOS #	:
Batch No. / Lot No.	:				GRR No.	:
Month of Mfg.	:				Month of Expiry	:
TR No.	:				Date of receipt	:
Quantity	:
Out of specification Type: Please √ mark on applicable column
— Raw materials			— Packing material	— Semi-finished product			— Finished product
Phase I Investigation Start Date	:				Phase I Investigation End Date	:

Statement of Problem of Original test results: _____________________________________________________________________________________ _____________________________________________________________________________________ _____________________________________________________________________________________

Conclusion of Phase I Investigation: _____________________________________________________________________________________ _____________________________________________________________________________________ _____________________________________________________________________________________

Result(s) of Phase II Investigation:

Analyst 1: _________________________________	Analyst 2: ________________________________

Attachments
— Material arrival note	— Intimation report finished product	— Analysis report	— Certificate of analysis

Conclusion / Recommendations: _____________________________________________________________________________________ _____________________________________________________________________________________ _____________________________________________________________________________________ _____________________________________________________________________________________ _____________________________________________________________________________________

Analyzed by: Date:

Approved by: Date: