Raw Material Out of Specification Investigation and Report Form

Raw Material Out of Specification Investigation and Report Form


Raw Material Description: _________________________    Code No:  
_________________________

Manufacturers Batch No:  _________________________    Lab batch no: Limits for this Test Reason for Investigation:

Results:

 Part A

     Sign/Date................................................................. Laboratory Analyst
  Part B      Evaluation for Determinant Error (Lab Error) Results of Investigation

Irruent Re-calibration Done
Yes

No


Solution Re-standardized
Yes

No


Fresh Standard Made
Yes

No


Using Correct Method
Yes

No


Balance Calibrated
Yes

No


New Mobile Phase
Yes

No


Instrumentation Maintained
Yes

No


Correct Calculations for Product
Yes

No


Correct Formula for Calculation
Yes

No


Other Sources of Error________________________________________________________________________
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Retesting to be Performed
Yes

No





Part C      Results of the Retesting

Results for Second Test on
composite in Triplicate
1
2
3
Result from RM Trend Card


Results from Manufacturers C/A

Results from Previously Passed
Retention Sample

Lab. No. of Previously Passed
Retention Sample


Results for Original Individual Lab. Samples
(when applicable)
Results for Resample of the Bulk RM (when applicable)
Lab Sample 1

Lab Sample 1

Lab Sample 2

Lab Sample 2

Lab Sample 3

Lab Sample 3

Lab Sample 4

Lab Sample 4

Lab Sample 5

Lab Sample 5

Lab Sample 6

Lab Sample 6

Lab Sample 7

Lab Sample 7

Lab Sample 8

Lab Sample 8

Lab Sample 9

Lab Sample 9



Deviation Report Required
Yes

No




Comment:
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