OUT OF SPECIFICATION INVESTIGATION FORM

Format No.:

Initial results of test

Parameter	Limit (Spec. No.)	Actual	Result
			Pass/Fail
			Pass/Fail
Attachment: First COA with work-sheets

   Phase-I

     Analyst failure

        Ø Is there any Error in calculation?                                                                 Yes/No

Ø Is there any Error in dilution?                                                                       Yes/No

Ø Are appropriate and valid standards and reagents used?                      Yes/No

Ø Is methods followed?                                                                                    Yes/No

Ø Is the test parameters followed?                                                                 Yes/No

Ø Is sample stored appropriately?                                                                  Yes/No

Ø Is the balance used with appropriate accuracy and calibrated? Yes/No

Ø Is the sample Homogenous?                                                                       Yes/No

Ø Is the calibrated instruments/Glassware used?                                         Yes/No

Ø Is the analyst trained and evaluated?                                                          Yes/No

System Failure:

Ø      To check for Power failure                                                                           Yes/No

Ø      Is the system/Instruments are calibrated? (Calibrate again)                    Yes/No

Ø      Is the calibration standard Used is appropriate?                                      Yes/No

Ø      Is there any spillage/contamination in Standard/sample?                        Yes/No

Ø      Is suitable instrument used?                                                                        Yes/No

Ø      Is the instrument parameters set correctly?                                               Yes/No

Ø      Is the Appropriate Equipment Accessories used?                                   Yes/No

Sampling Procedure Failure:

Ø      Is Sample preparation done properly?                                                       Yes/No

Ø      Is sample taken is representative?                                                 Yes/No

Ø      Is sampling plan followed?                                                                           Yes/No

Ø      Are sampling equipments ok?                                                                    Yes/No

Ø      Are environmental conditioned were OK during Sampling?                    Yes/No

Ø      Is Appropriate Sample container / Sample bag Used?                           Yes/No

Other Checks for In-process sampling checks:

Ø      Check if there is change in reaction time.                                      Yes/No

Ø      Is the Sequential addition of components followed?                                 Yes/No

Ø      Is functioning of equipment proper?                                                            Yes/No

Ø      Is BMR/BPR reviewed and found OK?                                                       Yes/No

Ø      Review & comparison of Party COA of Raw Materials.                           Yes/No

Conclusion

v     System Failure / Analyst Failure / Sampling Failure / In-process Failure / Material Failure. (According to the above conclusion initiate the OOS Phase II as per flow chart.)

Remark:

QC In charge (Name/ Signature/ Date) _______________________________________

Authorized By: QA In Charge (Name/Sign/Date) _______________________________

OUT OF SPECIFICATION PHASE II FORM

Material/Product:                                                                               Date of Initiation:

Process/Stage:                                                                                 Date of Sampling:

Lot/Batch No.:                                                                                    OOS Number:

Lot/Batch size:                                                                                   Manufacturer’s Name:

Nature of OOS	System Failure /Analyst Failure / Sampling Failure In process Failure / Material Failure
Reason /Remark
Action Suggested As per Flow Chart	Retest By II System / Retest By II & III Analyst Re-sampling (In case of In process Samples)
Observations If any
Results of Above Action Suggested	The Material / Product: can be released / can not be released
Attachments: II COA + work-sheets
Any preventive / Further action suggested: -
Sign/ Date                                                                              Sign/Date QC in charge                                                                 QA In charge

FINAL REJECTION NOTE

Format No.:

Material/Product:                                                                               Date of Initiation

Process/Stage:                                                                                 Date of Sampling :

Lot/Batch No.:                                                                                    OOS Number

Lot/Batch size:                                                                                   Manufacturer’s Name:

To: Purchase Department / Plant Manager                                               DATE:

H.O. Mumbai

From: QA Site

Please note that the following item is finally rejected:

Details:

1. Item Code:
2. Used For:
3. Item Name:
4. Date of Receipt/Manufacturing
5. Control No./Batch No.:
6. Quantity Received:
7. Quantity Rejected:
8. Supplier’s Consignment No.:
9. Supplier’s Name:
10. Ref. Specification:

REASON FOR REJECTION:

Further Action Plan:

QA In charge

Enclosure:

Party COA, and Samples

Cc To: Corporate QA, Supplier through Purchase Department