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:
- Item Code:
- Used For:
- Item Name:
- Date of Receipt/Manufacturing
- Control No./Batch No.:
- Quantity Received:
- Quantity Rejected:
- Supplier’s Consignment No.:
- Supplier’s Name:
- Ref. Specification:
REASON FOR REJECTION:
Further Action Plan:
QA In charge
Enclosure:
Party COA, and Samples
Cc To: Corporate QA, Supplier through Purchase Department
Analytical Worksheet for raw material
Mfg. By / Supplier By
|
:
| ||
Batch No. / Lot No.
|
:
|
Batch Size /
|
:
|
Mfg Date
|
:
|
Sample quantity
|
:
|
Exp. Date
|
:
|
Date of sampling
|
:
|
Specification No.
|
:
|
Date of analysis
|
:
|
GRN No.
|
:
|
Date of release
|
:
|
|
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