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
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Irruent Re-calibration Done
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Yes
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No
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Solution Re-standardized
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Yes
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No
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Fresh Standard Made
|
Yes
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No
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|
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Using Correct Method
|
Yes
|
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No
|
|
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Balance Calibrated
|
Yes
|
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No
|
|
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New Mobile Phase
|
Yes
|
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No
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|
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Instrumentation Maintained
|
Yes
|
|
No
|
|
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Correct Calculations for Product
|
Yes
|
|
No
|
|
|
Correct Formula for Calculation
|
Yes
|
|
No
|
|
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Retesting to be Performed
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Yes
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No
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Part C Results of
the Retesting
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Results for Second Test on
composite in Triplicate
|
1
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2
|
3
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Result from RM Trend Card
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Results from Manufacturer¶s C/A
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Results from Previously Passed
Retention Sample
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Lab. No. of Previously Passed
Retention Sample
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Results for
Original Individual Lab. Samples
(when applicable)
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Results for Resample
of the Bulk RM (when applicable)
|
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Lab Sample 1
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Lab Sample 1
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Lab Sample 2
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Lab Sample 2
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Lab Sample 3
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Lab Sample 3
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Lab Sample 4
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Lab Sample 4
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Lab Sample 5
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Lab Sample 5
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Lab Sample 6
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Lab Sample 6
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Lab Sample 7
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Lab Sample 7
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Lab Sample 8
|
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Lab Sample 8
|
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Lab Sample 9
|
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Lab Sample 9
|
|
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Deviation Report
Required
|
Yes
|
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No
|
|
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Comment:
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