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TB Laboratory QAP
Revision 1
September 16, 2009
Section 14
Record Keeping, Data Review and Reporting Procedures
14.1
Scope
The record keeping system allows historical reconstruction of all laboratory activities that
produce the resultant sample analytical data. The laboratory maintains complete sample
tracking records. Documentation of laboratory activities includes inter-laboratory
transfers of samples and sample extracts. The laboratory issues sample data or sample
result reports accurately and in a manner that is understandable to the recipient.
14.2
Records Maintained by the Laboratory
14.2.1 The laboratory retains records related to all procedures and activities to which a
sample is subjected. These records include:
1)
Identity of personnel involved in sampling, preparation and testing.
2)
Sample preservation, including sample container and compliance with
holding times.
3)
Sample identification number, receipt, log-in, acceptance or rejection.
4)
Sample storage and tracking, including shipping receipts, transmittal forms,
and internal routing and assignment records.
5)
Sample preparation including: cleanup and separation procedures, sample
identification codes, volumes, weights, instrument printouts, and
calculations.
6)
Sample analysis.
7)
Equipment receipt, use, specification, operating conditions and preventative
maintenance.
8)
Calculations and statistical formulas used by the laboratory, including
written procedures for calculations, raw data and supporting information
used for each calculation, correct use of significant figures, and
identification of the least precise step in accord with limitations of the
measurement system.
9)
Procedure to verify that the reported data is free from transcription and
calculation errors.
10) Data handling, including reduction, review confirmation, interpretation,
assessment or validation, and reporting.
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