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 Manufacturer¶s 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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